Patent Docs

Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

One of the many changes introduced into U.S. patent law by the Leahy-Smith America Invents Act were provisions for post-grant review (PGR) and inter partes review (IPR).  There have been thousands of these proceedings instituted since their enactment into law, and the contours of how the Patent Trial and Appeal Board (PTAB) have executed these statutory provisions have been the subject of several Supreme Court decisions (see "Thryv, Inc. v. Click-to-Call Technologies, LP (2020)"; "Return Mail, Inc. v. United States Postal Service (2019)"; "Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (2018)"; "SAS Institute Inc. v. Iancu (2018)"; "Cuozzo Speed Technologies LLC v. Lee (2016)").  Remarkably, however, there has never been a Federal Circuit decision addressing the status of either proceeding should the PTAB fail to satisfy the one-year limitation on the Board for issuing a Final Written Decision (FWD) (subject for good cause to a six-month extension), but that changed with the Court's decision in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc.

The case arose in a post-grant review proceeding over Purdue's U.S. Patent No. 9,693,961, which is directed to opioid formulations modified to "prevent or deter" abuse (a tactic pursued by Purdue in part to expiate any responsibility that could be attributed to the company for the escalating opioid addiction crisis over the past decade or so; see, e.g., Keefe, Empire of Pain: The Secret History of the Sackler Dynasty).  The Patent Trial and Appeal Board in its Final Written Decision found all claims (1-17) invalid for lack of an adequate written description and anticipation.  Claim 1 is representative:

A method of preparing an abuse deterrent controlled release dosage form comprising:
    combining oxycodone or a pharmaceutically acceptable salt thereof as active agent, polyglycolyzed glycerides, a C₁₂ to C₄₀ fatty acid or a mixture thereof, carnauba wax and beeswax, to form a homogenous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form;
    preparing particles from the homogenous mixture; and containing the particles in a capsule;
    the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, and
    the abuse deterrent dosage form being abuse deterrent when subjected to tampering comprising heating at a temperature greater than about 45° C.

The PGR was filed after Purdue filed suit against Collegium in District Court for infringement.

Purdue argued before the PTAB that the '961 patent was not subject to PGR proceedings because it claimed priority to an earlier application having a filing date of August 6, 2001, but the Board rejected this challenge to its statutory authority when it held that the earlier-filed application did not support the priority claim for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) and that the earliest effective filing date was after March 16, 2013 (making the patent subject to PGR scrutiny).  Both the PGR and district court litigation were stayed when Purdue filed for bankruptcy on September 24, 2019.  These stays were lifted by the bankruptcy court on September 1, 2020.  Even though the Chief Patent Judge had found good cause to extend by six months the statutory one-year deadline for the Board to render a Final Written Decision (until April 4, 2020), the Board did not render its FWD until November 19, 2021.

Based on this timeline, Purdue moved the Board to terminate the PGR on the grounds that the Board's statutory authority had lapsed under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c).  The Board rejected this motion and issued the FWD, finding all '961 claims invalid.  This appeal followed.

The Federal Circuit affirmed the Board's FWD, in an opinion by Judge Dyk joined by Judges Hughes and Stoll.  The opinion notes that this is the first instance in which the Board has not issued a FWD by the statutory or extended deadlines, making this a case of first impression for the Court.  The opinion cites voluminous Supreme Court opinions, including United States v. James Daniel Good Real Prop., 510 U.S. 43, 63 (1993); Nielsen v. Preap, 139 S. Ct. 954, 967 (2019); Dolan v. United States, 560 U.S. 605, 611 (2010); Barnhart v. Peabody Coal Co., 537 U.S. 149, 159 (2003); Regions Hosp. v. Shalala, 522 U.S. 448, 459 n.3 (1998); and United States v. Montalvo-Murillo, 495 U.S. 711, 717 (1990), for the principle that "if a statute does not specify a consequence for non-compliance with statutory timing provisions, the federal courts will not in the ordinary course impose their own coercive sanction."  In particular, the Court cited the Federal Circuit's own precedent that "when a statute does not specify the consequences of non-compliance, courts should not assume that Congress intended that the agency lose its power to act," citing Hitachi Home Elecs. (Am.), Inc. v. United States, 661 F.3d 1343, 1347 (Fed. Cir. 2011) (quoting Liesegang v. Sec'y of Veterans Affs., 312 F.3d 1368, 1376– 77 (Fed. Cir. 2002)) and Transpacific Steel LLC v. United States, 4 F.4th 1306, 1320–21 (Fed. Cir. 2021).  Here the Court used this precedent and the absence of statutory direction supporting Purdue to affirm the PTAB's decision that its lack of timeliness was not sufficient basis to remove its power to issue even a tardy FWD.

The opinion specifically addresses Purdue's arguments to the contrary, for example the express use of the term "shall" in the relevant timing statutes.  This argument is contrary to the Supreme Court's decision in Brock v. Pierce Cnty., 476 U.S. 253, 266 (1986), however which was sufficient to uphold the Board's invalidity arguments.  Similarly, the panel rejected Purdue's reliance on the use of "negative words" such as "not later than" and "by not more than" under other Supreme Court precedent (specifically, French v. Edwards, 80 U.S. 506 (1871)) because that case did not involve a statutory deadline and later Supreme Court cases did not support the principle.  Another unsuccessful argument advanced by Purdue was based on the purported express tying of the statutory time limitation with the Board's statutory authority under Section 6, the interpretation of which the Federal Circuit held could be upheld under Supreme Court precedent only when Congress had clearly stated that "procedural rules, including time bars, cabin a court's power," citing United States v. Wong, 575 U.S. 402, 409 (2015) (quoting Sebelius v. Auburn Reg'l Med. Ctr., 568 U.S. 145, 153 (2013)).  The panel also rejected Purdue's argument that limitations in the statute relating to "good cause" and "joinder" circumstances evinced the required Congressional intent, particularly in view of the Court's Barnhart decision, wherein "enunciation of two exceptions does not imply an exclusion of a third."  Finally, portions of the Leahy-Smith America Invents Act which do bar the Office from acting after a time period expires use "quite different language" including Section 315(b) (that an IPR "may not be instituted" after the 1-year time bar); and Section 321(c) (wherein a PGR petition "may only be filed" not later than 9 months after patent grant).  According to the panel, these instances established that "[h]ad Congress meant to deprive the agency of power in section 326(a)(11), it knew how to do it" and had not.

Likewise the Federal Circuit did not find any support in the legislative history of the AIA to support Purdue's assertion that the Board lost its authority to issue a FWD after the statutory time period had expired.  The panel understood the purposes for the amendments to the statute to substitute PGRs and IPRs for inter partes reexamination was to make the post-grant review process more efficient, and stripping the PTAB of the capacity to render a FWD after undertaking the proceedings merely due to missing the statutory time proscriptions was not consistent with increasing efficiency of post-grant reviews.  And the Court further rejected Purdue's arguments that its decision would leave post-grant review proceedings just as open-ended as the inter partes reexaminations Congress intended that they replace; this is inaccurate according to the opinion because the Board "cannot ignore statutory deadlines," and the proper remedy under the circumstances faced by Purdue was mandamus, citing Norton v. Southern Utah Wilderness All., 542 U.S. 55, 65 (2004); Telecommunications Rsch. & Action Ctr. v. F.C.C., 750 F.2d 70, 76 (D.C. Cir. 1984); and Mylan Lab'ys Ltd. v. Janssen Pharmaceutica, N.V., 989 F.3d 1375, 1380–81 (Fed. Cir. 2021) (quoting Int'l Union, United Mine Workers of Am. v. U.S. Dep’t of Lab., 358 F.3d 40, 43 (D.C. Cir. 2004)).  Accordingly, the Court asserted that:

Here, Purdue had an available mandamus remedy and simply chose not to seek to compel an earlier decision from the Board. Failure to seek relief by mandamus does not, however, mean a loss of the Board's authority to act.

(Albeit merely in a footnote, the opinion asserts that the panel did not "reach the question of whether the bankruptcy automatic stay applies to PGRs" because "[t]his would require interpretation of the Bankruptcy Code" and the relevant provisions thereof seem not applicable to IPR or PGR proceedings.)

Turning to the merits of the PTAB's FWD, the court upheld the Board's determination that the claims lacked adequate written description support.  Specifically the panel held that "the specification makes clear that the claims require 'inclusion of at least one aversive agent' and the parties agree that the claims require the use of an aversive agent," and provides "long lists" of such agents ("a bittering agent, an irritant, a gelling agent, or combinations thereof").  Applying the syllogism that "some surfactants can be gelling agents and that gelling agents can satisfy the aversive agent requirement, [but that] not all surfactants [such as the claimed polyglycolyzed glycerides] are gelling agents," the specification's written description failure was that it did not disclose which of the claimed polyglycolyzed glycerides are gelling agents.  Indeed, the opinion states that polyglycolyzed glycerides are described in the specification as surfactants, not gelling agents and that "surfactants can be used completely separate from and in addition to the gelling agent."  Thus, according to the opinion "[t]he disclosure of the application [both the '961 patent and the earlier-filed provisional application] does not reasonably convey to those skilled in the art that the inventor had possession of the claimed drug formula containing PGGs as a gelling agent (aversive agent)" as properly determined by the PTAB in invalidating all claims of the '961 patent.

Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Dyk, Hughes, and Stoll
Opinion by Circuit Judge Dyk

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc.

The case arose in an IPR over U.S. Patent No. 10,149,820, directed to compositions and methods for treating pterygium, "an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea."  Surgery was the recognized treatment, and also recognized was the likelihood of tumor recurrence.  The '820 patent claims use of multikinase inhibitors including nintedanib, pazopanib, and sunitinib.

Nintedanib

Claims 4 and 5 were the only claims remaining after the IPR; claim 4 was set forth as representative:

1.  [disclaimed] A method for reducing hyperemia or symptoms thereof in pterygium in an affected eye of a subject in need of such treatment, without surgically excising a pterygium, comprising administering to the affected eye of the subject a therapeutically effective amount of a multikinase inhibitor.

3.  [disclaimed] The method of claim 1, wherein the multikinase inhibitor is administered to the affected eye in the form of topical ocular formulation or ocular implant.

4. The method of claim 3, wherein the multikinase inhibitor is nintedanib and the nintedanib is administered to the affected eye in the form of a topical ocular formulation and is administered topically to the affected eye.

Relevant to the issues on appeal, the Board held that Allgenesis had not shown the remaining (not disclaimed) claims of the '820 patent were invalid for anticipation or obviousness over its own PCT application because the earliest priority date for the '820 patent (June 5, 2015) was earlier than the priority date of the PCT application (June 22, 2015) and Cloudbreak's provisional application provided sufficient written description support for claims 4 and 5 of the '820 patent.  The Board also determined that the '820 claims were not obvious in view of the combination of two other references because of the '820 patent's disclosure of unexpected results of improved efficacy and safety.  Allgenesis appealed both grounds of the Board's determination of non-obviousness.

The Federal Circuit dismissed the appeal based on Allgenesis' failure to satisfy Article III requirements, in a decision by Chief Judge Moore joined by Judges Stoll and Cunningham.  The opinion sets forth the basis for Allgenesis' deficiency as being rooted in the requirement for standing of injury in fact under Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016).  This requirement, while not arising for standing to file an IPR petition, Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 279 (2016), is required to appeal the Board's decision under Consumer Watchdog v. Wis. Alumni Rsch. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014).  Allgenesis asserted standing based on "(1) its potential infringement liability and (2) the Board's priority determination."  Neither assertion was sufficient, according to the opinion, because Allgenesis' allegations of injury were speculative and insufficiently concrete to establish injury in fact.  With regard to potential liability for infringement, the opinion states that the evidence, a declaration from Allgenesis' Vice President of Finance, relied on a Phase II clinical trial in 2020 and vague assertions of future plans to produce a nintedanib commercial product.  The opinion found these assertions to be unconvincing, saying that they "fail[] to identify any specific, concrete plans for Allgenesis to develop a nintedanib product that might implicate claims 4 and 5 of the '820 patent."  Nor did Allgenesis provide testimony regarding plans for further development such as a Phase III trial.  Instead, according to the panel, Allgenesis provided "generic" statements that it had not abandoned plans for a commercial product.  However, according to the opinion, "[s]uch conclusory testimony is insufficient to establish that Allgenesis has any concrete plans to develop and bring to market a nintedanib treatment for pterygium."  Nor did Allgenesis assert any threat from Cloudbreak to file suit for infringement.  The panel concludes that "Allgenesis has failed to establish it has nonspeculative, concrete plans for future activity that creates a substantial risk of future infringement."

Allgenesis was no more successful in its second assertion of injury in fact, that the Board's decision on priority of invention in favor of Cloudbreak would impair its ability to obtain its own patent on using nintedanib to treat pterygium.  Once again, the Federal Circuit found Allgenesis' evidence and argument to be insufficient to support its injury in fact claim.  The opinion analogizes the circumstances with the Court's  earlier decision in Best Medical International, Inc. v. Elekta Inc., 46 F.4th 1346 (Fed. Cir. 2022) (despite significant distinctions between the factual circumstances, recognized by the Court).  What the cases had in common, in the Federal Circuit's view, was reliance on collateral estoppel as the basis for the injury and, as the Court notes, "[c]ollateral estoppel will not attach to the Board's non-appealable priority determination," citing SkyHawke Techs., LLC v. Deca Int'l Corp., 828 F.3d 1373, 1376 (Fed. Cir. 2016).  And again the Court states that "Allgenesis has, based on these quite vague allegations, failed to establish a concrete injury."  Even when eschewing estoppel arguments Allgenesis "failed to articulate with any specificity how the Board's priority determination will impact its issued patents or pending continuation applications which claim priority to its PCT application," those articulations being found in "a single paragraph containing only vague allegations in its opening brief and reply brief, respectively."

Having decided that Allgenesis failed to establish injury in fact as required for standing the Federal Circuit dismissed the appeal without reaching the merits.

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)
Panel: Chief Judge Moore and Circuit Judges Stoll and Cunningham
Opinion by Chief Judge Moore

Arbutus Biopharma Corp. v. ModernaTx, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

"This application claims priority to [properly identified earlier-filed application, the disclosure of which is expressly incorporated herein in its entirety" is a phrase commonly found in patents and patent applications as an attempt to bolster disclosure without burdening the specification unnecessarily.  Like many (most) stratagems, use of this phrase can give rise to unexpected (and unwanted) implications, as was noted in a Federal Circuit opinion affirming a decision by the Patent Trial and Appeal Board in inter partes review proceedings instituted at the behest of challenger ModernaTX that invalidated all claims of the challenged patent owned by Arbutus in Arbutus Biopharma Corp. v. ModernaTx, Inc.

The subject matter of the challenged patent, No. 9,404,127, was stable nucleic acid lipid particles ("SNALP") that occur in two morphologies:
wherein the structure illustrated on the left is "lamellar" and the structure illustrated on the right is "non-lamellar"; the '127 patent claims are directed to the non-lamellar form.  This "morphology limitation" is dependent upon how the SNALP is made, which is in turn dependent upon the lipids used in making the SNALP and the process used.  With regard to the process SNALPS can be made by a Stepwise Dilution Method (SDM) or a Direct Dilution Method (DDM) and the formulations can have five different ratios for the composite lipids, with 1:62 and 1:57 being those relevant to the claims at issue and referring to a conjugated lipid and a cationic lipid, respectively.  Independent claim 1 was reproduced in the opinion as being representative:

1.  A composition comprising:
    a plurality of nucleic acid-lipid particles, wherein each particle in the plurality of particles comprises:
        (a) a nucleic acid;
        (b) a cationic lipid;
        (c) a non-cationic lipid; and
        (d) a conjugated lipid that inhibits aggregation of particles, wherein at least about 95% of the     particles in the plurality of particles have a non-lamellar morphology (with this limitation being     the morphology limitation).

The '127 patent issued from an application filed on March 9, 2015 that claimed priority to a provisional application filed on June 30, 2010 (making June 30, 2009 the critical date for novelty-destroying prior art).  The '127 patent incorporated by reference published U.S. Patent Application Publication Nos. 2007/0042031 ("the '031 application, for disclosure of DDM) and 2004/0142025 (for SDM and apparatuses therefor), these publications being indisputably in the prior art at the '127 patent's earliest claimed priority date.

The PTAB held all claims of the challenged '127 patent to be invalid as being anticipated by U.S. Patent No. 8,058,069 ("the '069 patent"), which was filed on April 15, 2009 and claimed priority to a provisional application filed one year earlier (the Federal Circuit noting that the '127 patent did not claim priority to the '069 patent, even though these patents are commonly owned by Arbutus).  The basis for this decision was that the Board found that both patents:

[A]re directed to the same purpose (providing SNALP, methods of making and delivering SNALP); disclose at least the 1:57 and 1:62 formulations; explain that SNALP can be formed by any method in the art including direct dilution, and direct the reader to rely on the '031 publication for details on using DDM.

The '069 patent incorporated by reference several other patents that the Board held disclosed "several of the same disclosures and experiments" set forth in the '127 patent.

The Board's decision focused on the claim 1(d) element (the morphology limitation) and whether it was inherently disclosed in the '069 patent.  The basis for Moderna's assertion of inherent anticipation was that the non-lamellar structure arose as a consequence of the composition of the SNALP and the method (DDM) used to produce it which the Board found convincing (despite expert testimony based on experimental evidence to the contrary), and Arbutus's concession that the specification of a continuation of the '069 patent disclosed the morphology limitation.  Accordingly, the Board held all claims of the '127 patent to be invalid for anticipation.  This appeal followed.

The Federal Circuit affirmed in an opinion by Judge Reyna, joined by Judges Schall and Chen.  With regard to the question of incorporation by reference, the panel cited its precedent that "[w]hen a reference or material from various documents is incorporated, they are 'effectively part of the host document as if [they] were explicitly contained therein,'" Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). The panel, like the Board, rejected Arbutus's arguments that the DDM process comprised "many parameters that could be varied" based on Arbutus's expert's concession that the '435 patent (a continuation of the '069 patent) also disclosed the morphology limitation.  In the circumstances before the Court, "the disclosure of the '069 patent and its incorporated references sufficiently demonstrate to a person skilled in the art how to make and use the claimed compositions, processed by DDM, that results in the Morphology Limitation."  The evidence before the Board satisfied the legal requirement for inherent anticipation that production of the claimed SNALPs was a "natural result flowing from" the disclosure in the prior art under SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005).  Here, the panel asserts that "the '127 and '069 patents disclose the same formulations with 'almost identical wording,'" ("[t]he specificity of the disclosure in the '069 patent is the same as in the '127 patent") including the 1:57 and 1:62 formulation ratios (and that the other ratios disclosed and claimed in the '127 specification could be substituted without impacting the morphology limitation according to Arbutus's expert.  Both the '127 and '069 patents reference the '031 application for disclosure of the DDM method for producing SNALPs having the claimed morphology limitation with the challenged '127 patent incorporating by reference the '031 disclosure, which supported the Board's conclusion that the '127 patent discloses this method the same way it was disclosed in the prior art '031 application.  The opinion concludes that because the panel found no error in the factual question of whether the prior art taught "the same formulations and the same DDM" disclosed and claimed in the '127 patent the challenged claims were anticipated by the art and invalid.

With regard to dependent claims directed to forms of the claimed SNALPs comprising mRNA (claim 3) or "fully encapsulated" nucleic acids (claim 8) were disclosed as formulations in the prior art.  The Court found SNALPs having specific three-dimensional structures (claim 9) to recite inherent properties of the SNALPs produced according to the cited art.  And regarding claims to percent ranges for the lipid components of the claimed SNALPs (claims 10-12), the Court relied on its precedent that "[w]hen a patent claims a chemical composition in terms of ranges and a single prior art reference discloses a composition that falls within each of the ranges, the range is anticipated, citing Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985).  This disclosure arose in the cited prior art by incorporation by reference of U.S. Patent Application Publication No. 2006/0083780 (the "'780 publication"), U.S. Patent Application Publication No. 2004/0142025 (the "'025 publication"), and U.S. Patent No. 5,885,613 (the "'613 patent").

While not dispositive, this decision is relevant to the on-going disputes between owners of lipid nanoparticle IP and vaccine makers over COVID 19 and other mRNA-based vaccines against other diseases (see "Pfizer and BioNTech Sued for Patent Infringement over mRNA Vaccine").

Arbutus Biopharma Corp. v. ModernaTx, Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Reyna, Schall, and Chen
Opinion by Circuit Judge Reyna

Minerva Surgical, Inc. v. Hologic, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

Minerva and Hologic, competitors selling devices used for ablating uterine endometrial tissue, are notable for their dispute last year that gave the Supreme Court an opportunity to reassess an established patent law doctrine, assignor estoppel (reminiscent of the Court's review of the Federal Circuit's standard for obviousness in KSR Int'l v. Teleflex).  As with KSR and obviousness, the Court's decision on assignor estoppel did not do significant violence to the doctrine, but made it less certain and more difficult for courts to apply it consistently.

But Hologic and Minerva are, after all, competitors, and while they had a role to play in influencing patent law, their interests are properly their private businesses and fortunes, and in addition to the earlier case they were also embroiled in patent litigation over a different patent, U.S. Patent No. 9,186,208.  Minerva had no more luck with that case, however, the District Court deciding on summary judgment that the patent was invalid for having been used in public more than a year before its earliest priority date (under the "public use" bar in pre-AIA 35 U.S.C. § 102(b)).  Yesterday, the Federal Circuit affirmed the District Court judgment in a decision captioned Minerva Surgical, Inc. v. Hologic, Inc. & Cytyc Surgical Products, LLC.

The claimed device was illustrated in the opinion by Figure 9 in the patent:

and the claims represented by Claim 13:

A system for endometrial ablation comprising:
    an elongated shaft with a working end having an axis and comprising a compliant energy-delivery surface actuatable by an interior expandable-contractable frame;
    the surface expandable to a selected planar triangular shape configured for deployment to engage the walls of a patient's uterine cavity;
    wherein the frame has flexible outer elements in lateral contact with the compliant surface and flexible inner elements not in said lateral contact, wherein the inner and outer elements have substantially dissimilar material properties.

(where the underlined terms were the subject of the Court's analysis of invalidity).

The District Court's decision on summary judgment was based on Minerva's behavior satisfying the prongs of the test enunciated by the Supreme Court in Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67–68 (1998), that the invention was in public use by being disclosed to the public without any restrictions or confidentiality provisions more than one year from its earliest priority date, and that the invention was "ready for patenting" (i.e., what was disclosed was the claimed invention) when it was disclosed.  With regard to the latter prong, the device had ""the inner and outer elements have substantially dissimilar material properties" (abbreviated in the opinion as the "SDMP" term) which the District Court construed as meaning that the "inner and outer frame elements have different thickness and different composition."  The facts establishing the public disclosure prong recited Minerva's participation in a trade show -- the 38th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists and held November 16-19, 2009 (abbreviated in the opinion as "AAGL 2009") and testimony by one of the inventors that after some failures by the time of AAGL 2009 the device disclosed at the trade show were nearly "perfect."  Minerva had a booth at the show and several (15) "fully functional" devices that were extensively demonstrated on ex vivo uteri to an audience of doctors and industry participants, a presentation by the Chairman of Minerva's Medical Advisory Board, and an "Investigator's Brochure" that "provided a detailed description of the Aurora device and identified that its frame elements were made of 'Stainless steel (420 and 17-4)'" (consistent with CAD drawings prepared during development by Minerva and that the District Court found disclosed the SDMP feature recited in the claims).

Based on these facts, the District Court found no disputed material facts and granted Hologic's motion for summary judgment of invalidity.

In the Federal Circuit's opinion by Judge Reyna, joined by Judges Prost and Stoll, the Court agreed with the District Court that Hologic had established evidence satisfying the requirements for invalidating public use more than a year before Minerva's earliest priority date.  Relying on Delano Farms Co. v. California Table Grape Comm'n, 778 F.3d 1243, 1247 (Fed. Cir. 2015), and Dey, L.P. v. Sunovion Pharms., Inc., 715 F.3d 1351, 1355 (Fed. Cir. 2013), the panel asserted that the standard was the invention was "accessible to the public or was commercially exploited" by the inventor, "shown to or used by an individual other than the inventor under no limitation, restriction, or obligation of confidentiality" under Am. Seating Co. v. USSC Grp., Inc., 514 F.3d 1262 (Fed. Cir. 2008).  As to the "ready for patenting" prong, the Court cited Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 F.3d 1370, 1379 (Fed. Cir. 2013), for the persuasiveness of there being drawings and working prototypes of the claimed invention at the time of the disclosure.

The Court rejected Minerva's three assertions of error:  that the disclosure at AAGL 2009 was not a public disclosure; that the disclosure of the device did not have the claimed SMDP feature; and that the invention was not ready for patenting because Minerva was still improving the invention at the time of AAGL 2009.  As for the nature of the disclosure, the panel found dispositive that the "nature of and public access to activities involving" the disclosure were consistent with a public use because the audience consisted of "attendees who were critical to Minerva's budding business—such as potential investors and physicians—and Minerva had every incentive to showcase the Aurora devices to these attendees as best as it could."  The extensiveness of the disclosure also supported a determination of public use, disclosing the operation of fifteen functional devices at Minerva's booth over several days of the trade show, as well as "meetings with interested parties" and a technical presentation.  This was more than "mere display," according to the Federal Circuit in contrast to Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376 (Fed. Cir. 2007) cited by Minerva.  The panel rejected Minerva's contention that the disclosure was insufficient because observers were not permitted to "closely observe[] or physically handle[]" them, stating that "public use may also occur where, as here, the inventor used the device such that at least one member of the public without any secrecy obligations understood the invention," citing Netscape Commc'ns Corp. v. Konrad, 295 F.3d 1315, 1319–21 (Fed. Cir. 2002).  Summarizing, the opinion states that "[t]he inescapable conclusion of the detailed feedback Minerva received on the Aurora device is that Minerva allowed knowledgeable individuals to scrutinize the invention enough to recognize and understand the SDMP technology Minerva later sought to patent."

In addition, the opinion cites in support of the activities at AAGL 2009 constituting a public disclosure that on the record at the District Court "there were no 'confidentiality obligations imposed upon' those who observed the . . . device," nor did Minerva assert that the trade show had in place the "type of informal confidentiality obligations we have recognized in prior cases" to constitute sufficient confidentiality to rebut the existence of public disclosure, citing Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371, 1380–81 (Fed. Cir. 2004).

Finally on the disclosure prong, the Court found no genuine issue regarding disclosure of devices having the claimed SMDP feature, which was conceived prior to AAGL 2009 and regarding which there was evidence that the devices that were displayed had this feature (based inter alia on evidence that Minerva brought "fully functional" devices to the trade show).

With regard to the "ready for patenting" prong, the Court considered the record to show that the devices disclosed were "working prototypes" supported by inventor testimony explaining their function and incorporation of the SMDP feature and how they were used (i.e. with extirpated uteri).  To Minerva's argument that what it did not demonstrate was ablations on "live humans" the opinion counters (somewhat weakly) that "nothing in the intrinsic record indicating that the '208 patent is limited to devices only usable on live human tissue" (what else would be the device's "intended purpose"?) despite additional "fine tuning" and "later refinements" which did not rebut reduction to practice under Hamilton Beach and Atlanta Attachment Co. v. Leggett & Platt, Inc., 516 F.3d 1361, 1367 (Fed. Cir. 2008).  Similarly unavailing was Minerva's contention that the device was not ready for patenting because it was not FDA approved.  And the opinion states that, regardless of these considerations the disclosed devices were ready for patenting because the evidence of "drawings and detailed descriptions" in the inventors' notebooks were "more than enough to enable a person of skill in the art to practice the claimed invention" under the Court's Hamilton Beech precedent.

Minerva Surgical, Inc. v. Hologic, Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Prost, Reyna, and Stoll
Opinion by Circuit Judge Reyna

Pharmacyclics LLC v. Alvogen, Inc. (Fed. Cir. 2022)

By Kevin E. Noonan --

On November 15th, the Federal Circuit handed down its opinion affirming all aspects of the District Court's decision in Pharmacyclics LLC v. Alvogen, Inc.  The case illustrates once more the importance of the clear error standard in support of factual aspects of a district court's decision, even regarding ultimate questions of law, such as enablement and obviousness that are based on factual considerations.

The case arose as ANDA litigation between Pharmacyclics LLC and Janssen Biotech, Inc., whose patents for the compound ibrutinib (an inhibitor of Burton's tyrosine kinase (BTK) and the basis for their Imbruvica Product) was challenged by Alvogen and Natco Pharma Ltd.  The drug is used for treatment of immune system cancer, specifically relapsed/refractory mantle cell lymphoma (RR/MCL).  At trial, Pharmacyclics asserted five claims:

Claim 10, U.S. Patent No. 8,008,309 ("the '309 patent"):

10.  The compound of claim 1 [which claims a genus of BTK inhibitor compounds] having the formula 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one.

Claim 2, U.S. Patent No. 8,754,090 ("the '090 patent"):

1.  A method for treating mantle cell lymphoma in an individual who has already received at least one prior therapy for mantle cell lymphoma comprising administering to the individual once per day be- tween about 420 mg to about 840 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase (Btk) having the structure:

2.  The method of claim 1, wherein the once per day oral dose is about 560 mg.

Claim 5, U.S. Patent No. 9,725,455 ("the '455 patent") :

1.  A crystalline form A of [ibrutinib] that has an X-ray powder diffraction (XRPD) pattern comprising 2-Theta peaks at 5.7±0.1^o, 18.9±0.1^o, and 21.3±0.1^o.

5.  The crystalline form of claim 1, wherein the X- ray powder diffraction (XRPD) pattern further comprises 2-Theta peaks at 13.6±0.1^o, 16.1±0.1^o, and 21.6±0.1^o.

Claim 30, U.S. Patent No. 9,655,857 ("the '857 patent"):

30.  The high-load solid tablet formulation of claim 1 [which recites a genus tablet formulation for ibrutinib], consisting essentially of:
    a)  about 70% w/w of ibrutinib,
    b)  about 14% w/w of lactose monohydrate,
    c)  about 5% w/w of microcrystalline cellulose,
    d)  about 2% w/w of polyvinylpyrrolidone,
    e)  about 7% w/w of croscarmellose sodium,
    f)  about 1% w/w of sodium lauryl sulfate,
    g)  about 0.5% w/w of colloidal silicon dioxide, and
    h)  about 0.5% w/w of magnesium stearate.

Claim 37, the '857 patent:

37.  The solid tablet formation of claim 27 [which recites a genus tablet formulation for ibrutinib in an amount of about 70 mg to about 840 mg] consisting essentially of
    a)  about 69% w/w to about 71% w/w of ibrutinib,
    b)  about 13% w/w to about 15% w/w of lactose monohydrate,
    c)  about 2% w/w to about 5% w/w of microcrystalline cellulose,
    d)  about 1% w/w to about 3% w/w of polyvinylpyrrolidone,
    e)  about 6% w/w to about 8% w/w of croscarmellose sodium,
    f)  about 1% w/w to about 4% w/w of sodium lauryl sulfate,
    g)  about 0.4% w/w to about 0.6% w/w of colloidal silicon dioxide, and
    h)  about 0.4% w/w to about 0.6% w/w of magnesium stearate.

The parties stipulated to infringement of the asserted '309, '090, and '455 patent claims and the District Court found Alvogen's proposed generic ibrutinib would infringe the asserted claims of the '857 patent.  The District Court found against Alvogen on all arguments of invalidity (only some of which were the subject of this appeal, and none of these other arguments raised any additional significant issues).  Alvogen and Natco appealed.

The Federal Circuit affirmed, in an opinion by Judge Bryson joined by Judges Hughes and Chen.  The opinion addressed each ground of appeal raised against each asserted claim seriatim, noting initially that in an appeal from a bench trial the Court reviews factual determinations for clear error, citing UCB, Inc. v. Watson Lab'ys Inc., 927 F.3d 1272, 1286 (Fed. Cir. 2019), for the principle and Biogen Int'l GmbH v. Mylan Pharms. Inc., 18 F.4th 1333, 1341 (Fed. Cir. 2021), for the standard (i.e., that the Court finds clear error only when it has a "definite and firm conviction that a mistake has been made").

Regarding claim 2 of the '090 patent, the opinion addresses the District Court's finding that this claim was supported by an adequate written description, with an enabling specification, and was not obvious.  The basis for the Court's affirmance of an adequate written description was that the '090 specification disclosed two related clinical trial protocols for using a BTK inhibitor to treat R/R MCL.  The first of these taught using a variety of such inhibitors at dosages based on patient weight, and the other used a broader range of such inhibitors as a specific dosage ("about 560 mg/day).  In addition, the Summary of the Invention section of the patent expressly disclosed ibrutinib for treating R/R MCL.  Applying its "blazemarks" analysis (see Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1346 (Fed. Cir. 2013) (quoting In re Ruschig, 379 F.2d 990, 994–95 (C.C.P.A. 1967)), the Court held it was not clearly erroneous for the District Court to find an adequate written description where ibrutinib was "'the only BTK inhibitor identified by name in the Summary of the Invention and is the only BTK [inhibitor] identified for the treatment of R/R MCL' in the '090 patent."  The Court expressly distinguished the circumstances here from its decision in Biogen (a failure to satisfy the written description requirement) because there the only disclosure of the claimed dosage was as one end of a broader disclosed range (in the context of "a long series of ranges") whereas here the claimed dosage was "expressly recited by itself" both in the claim and the specification as filed.  (Undiscussed were the decidedly different circumstances arising during prosecution of the patent-in-suit in Biogen supporting the Court's opinion.)  Regarding Alvogen's similar arguments on enablement, that the specification disclosed exactly 560 mg/d and claimed "about" 560 mg/d, the Federal Circuit found no clear error in the District Court's determination that there was sufficient disclosure in the specification for the skilled artisan to follow the disclosed protocol and practice the claimed method.

As for obviousness, the Federal Circuit rejected Alvogen's argument that the District Court incorrectly determined that the skilled worker would not have been motivated to treat R/R MCL with ibrutinib from prior art references teaching treatment of MCL with the drug, in light of the District Court's finding of fact that disclosure of treating MCL would not be interpreted by the skilled worker as evidence of effective treatment of RR/ MCL.  The panel also refused to find error in the District Court's finding that disclosure of two R/R MCL patients having experienced a "partial response" to ibrutinib in a press release, in view of the small sample size and the propensity for oncology drugs to have a low frequency of receiving FDA approval ("less than five percent of oncology drugs that enter a Phase I trial ultimately receive FDA approval").  Another asserted and rejected obviousness argument was that the skilled worker was capable of finding the recited dose (560 mg/d) as a therapeutically effective amount by routine experimentation, based on evidence that "typical" dose escalation studies would have involved dosages greater than 560 mg/d and would require "a study using pharmacodynamic endpoints" that was not disclosed in Alvogen's combination of references.  With regard to the motivation to combine, the panel recognized that Alvogen's expert testified to safety concerns in 2006 rather than 2010 (when the application was filed) and Pharmacyclics asserted contrary expert testimony that the District Court found persuasive.  The panel also affirmed the District Court's decision regard a "presumption of obviousness" from the cited prior art teachings, on two grounds.  The first was that such a presumption is proper "when the only difference from the prior art is a difference in the range or value of a particular variable," citing In re Kumar, 418 F.3d 1361, 1366 (Fed. Cir. 2005), which was not the case here, and second that Pharmacyclics "would have rebutted any [such] presumption."  Finally, the Court did not reach the question of secondary considerations because the District Court's non-obviousness determination made this argument unnecessary.

Turning to claim 5 of the '455 patent, the Federal Circuit affirmed the District Court's determination that the claim was neither inherently anticipated nor obvious over the cited art.  Alvogen's inherent anticipation argument was grounded in an assertion that the Form A polymorph of ibrutinib (recited in claim 5) was the only polymorph used in clinical trials disclosed in the art, wherein Alvogen relied upon Abbott Laboratories v. Geneva Pharmaceuticals, Inc., 182 F.3d 1315 (Fed. Cir. 1999) (an on-sale bar case).  The Federal Circuit distinguished the circumstances here from those in the Abbott case, and cited Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003), as the more apt precedent.  According to the opinion, the circumstances before the District Court in this case were more analogous to those in Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1382 (Fed. Cir. 2018), upon which the District Court relied, there being no evidence in this case that the only therapeutically effective polymorph of ibrutinib was Form A, and that the District Court's factual determinations in this regard were not clearly erroneous.  As for Alvogen's obviousness arguments, the Federal Circuit affirmed the District Court based on, inter alia, there being no clear error in that court's reliance on Pharmacyclics' expert over one of Alvogen's experts (another one agreeing with Pharmacyclics), based on the District Court's appreciation that production of polymorphs and their physical properties was unpredictable.  The panel held as not clearly erroneous the District Court's finding that "given the lack of teaching in the art regarding crystalline forms of ibrutinib and the expert testimony that polymorph screening can produce unpredictable results, a skilled artisan would not have reasonably expected success in producing Form A of ibrutinib," citing Grunenthal GmbH v. Alkem Lab'ys Ltd., 919 F.3d 1333, 1344 (Fed. Cir. 2019).

Next, the Federal Circuit held as not clearly erroneous the District Court's finding that claims 30 and 37 of the '875 patent were adequately supported by the written description.  Alvogen's argument was that the specification of the '875 patent disclosed one species in a range of species recited in these claims.  Alvogen's "problem," according to the Federal Circuit, was that "the precise ranges recited in the claims are found in formulations disclosed in the specification," and on this basis the Federal Circuit affirmed the District Court's determination that these claims were adequately described.

Finally, the Federal Circuit affirmed the District Court's decision that claim 10 of the '309 patent was not anticipated by the cited art, Alvogen arguing that a skilled worker could not have synthesized a needed intermediate without undue experimentation and accordingly the '309 patent was not entitled to its earliest priority date.  Alvogen's assertion of error in this regard was that the District Court should not have relied upon Pharmacyclics' testimony that his undergraduate students could have produced the intermediate without undue experimentation based on the disclosure in the priority documents.  The District Court also relied upon the intermediate having been known in a prior art reference upon which the skilled artisan could have relied, and Alvogen argued that the District Court did not apply the proper legal standard for incorporating this document by reference.  The panel found this argument not dispositive because "a skilled artisan could have synthesized Intermediate 2 and thus ibrutinib" without reference to the reference.  Moreover, the opinion states that "formal incorporation by reference is not necessary if the material being incorporated is background art," citing Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1365 (Fed. Cir. 2006).  On these grounds, the Federal Circuit held that the District Court committed no clear error in rejecting Alvogen's argument.

To the extent there is any question about the importance of the standard of review in the Federal Circuit's opinion, mere casual perusal thereof finds 15 instances of some version of "clear error" and "clearly erroneous" recited by the Court.  A cautionary tale indeed.

Pharmacyclics LLC v. Alvogen, Inc. (Fed. Cir. 2022)
Panel: Circuit Judges Chen, Bryson, and Hughes
Opinion by Circuit Judge Bryson

Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp. (Fed. Cir. 2022)

By Kevin E. Noonan --

The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) Final Written Decision (FWD) in an inter partes review (IPR) that Mylan Pharmaceuticals failed to show the claims of U.S. Patent No. 7,326,708 were either anticipated or rendered obvious by the asserted prior art, in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.

The claimed subject matter at issue was sitagliptin dihydrogenphosphate ("sitagliptin DHP"), a dihydrogenphosphate salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine:

This compound is useful for treating non-insulin dependent (Type 2) diabetes based on its activity as a dipeptidyl peptidase-IV inhibitor.  Claims 1-4, 17, 19, and 21-23 of U.S. Patent No. 7,326,708 were challenged in the IPR.

Mylan argued that International Patent Publication No. WO 2003/004498 (equivalent to another Merck patent, U.S. Patent No. 6,699,871) anticipated the claims at issue in the IPR.  Specifically, the '498 application disclosed dipeptidyl peptidase-IV inhibitors for treatment of diseases such as Type 2 diabetes.  The application disclosed 33 species of these inhibitors, including sitagliptin.  Also disclosed were the preparation of pharmaceutically acceptable salts (as a class) and hydrates thereof, including but not specifically directed to phosphoric acid.  The Board rejected Mylan's anticipation argument because the '498 application did not disclose all of the limitations in the challenged claims (specifically a 1:1 sitagliptin DHP salt), based inter alia on "evidence, both experimental and from the technical literature, undeniably showed that 1:1 sitagliptin DHP does not form every time sitagliptin and DHP were reacted" (which was the basis for the Board rejecting Mylan's inherent anticipation argument).

The Board also rejected Mylan's obviousness assertions, based on the combination of the '498 application with two scientific publications:  Brittain, which disclosed the "pharmaceutical importance and prevalence of crystalline hydrates of pharmaceutical compounds"; and Bastin, which disclosed "salt selection and optimization procedures during the development of pharmaceutical compounds."  For claims 1, 2, 17, 19, and 21-23 the Board held that Merck was able to antedate the '498 application under pre-AIA 35 U.S.C. § 102(a), and while the related '871 patent was available as prior art under pre-AIA § 102(e), application of the reference was prohibited under pre-AIA § 103(c) because the '871 and '708 patents were commonly owned or subject to an obligation for assignment.

With regard to claim 3 (directed to the (S)-configuration of sitagliptin) and claim 4 (directed to the (R)-configuration), the Board found that none of the cited references disclosed (S)-sitagliptin and thus claim 3 was not obvious.  Regarding (R)-sitagliptin recited in claim 4 the Board found that "Mylan provided no rationale to explain why a person of ordinary skill would have been motivated to make the claimed crystalline monohydrate form of 1:1 sitagliptin DHP of claim 4 and failed to show that a skilled artisan would have had a reasonable expectation of success in making the crystalline monohydrate form of the 1:1 sitagliptin DHP salt."

The Federal Circuit affirmed in an opinion by Judge Lourie, joined by Judges Reyna and Stoll.  Regarding Mylan's anticipation argument, the Court held the Board's decision was supported by substantial evidence, based in part on the testimony of Mylan's own expert witness that the '498 application did not expressly disclose sitagliptin DHP nor the production of dihydrogenphosphate salts.  The panel also found substantial evidence supported the Board's determination that the '498 application did not inherently anticipate the sitagliptin dihydrogenphosphate claimed in the '708 patent.  This decision distinguished the circumstances here from those in In re Petering (relied upon by Mylan), on the basis that Petering was based on their being only a limited number of members of the class of compounds. 301 F.2d 676, 681 (C.C.P.A. 1962).  In this case, the evidence of record showed that the 33 disclosed dipeptidyl peptidase inhibitors could result in 957 combinations with various pharmaceutically acceptable salts, under circumstances where another Mylan expert admitted that "salt formation is an unpredictable art that requires a 'trial and error process.'"  While not ruling on what would or could constitute a limited class that would satisfy the Petering standard the Court held that the proper standard was not met under these circumstances.

In considering the Board's decision on obviousness grounds, the Court first considered and rejected Mylan's argument concerning whether Merck's experimental evidence and the status of the '871 and '708 patents under pre-AIA §§ 102(a) and 102(e) precluded assertions of the '498 application as prior art.  Once again, the Court held that the Board's decision was supported by substantial evidence, including that the '498 application did not disclose 1:1 sitagliptin DHP and thus could not and did not disclose a monohydrate of the salt.

Finally, with regard to claims 3 ((S)-sitagliptin) and 4 ((R)-sitagliptin), the panel also found the Board's decision supported by substantial evidence.  The FWD held that Mylan failed to establish a motivation to combine the '498 application and the Bastin reference and that the skilled artisan would not have had any reasonable expectation of success had the reference been combined.  Considering claim 3 (again relying on Mylan's expert's testimony that the (S)-sitagliptin enantiomer was not disclosed in the '498 application, the panel held the Board was correct in concluding that Mylan had "advanced no expected or theoretical benefit to making the (S)-enantiomer of 1:1 sitagliptin DHP, and that the general disclosure on diastereomers in [the '498 application] encompasses millions of potential compounds and salts with no motivation to make the (S)-enantiomer with a reasonable expectation of success, particularly in an unpredictable activity like salt formation."  Similarly, the Court held the PTAB's decision regarding claim 4 was also supported by substantial evidence that there would have been no motivation to combine the cited references nor any reasonable expectation of success in doing so (yet again relying on Mylan's expert's testimony in this regard and also Merck's expert regarding the art teaching away from hydrates due to their unpredictability).  (In an aside, the opinion also affirms the Board's consideration of secondary indicia of non-obviousness).

While there is nothing particularly earth-shattering or precedent-setting in the Court's precedential opinion, it does illustrate once again the difficulty parties have in overcoming the presumption of substantial evidence in IPRs (and the advantages to be accrued by attempting to avoid IPR institution in the first place).

Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp. (Fed. Cir. 2022)
Panel: Circuit Judges Lourie, Reyna, and Stoll
Opinion by Circuit Judge Lourie

Silly § 102 Tricks

By Michael Borella --

With further apologies to David Letterman.

Almost two years ago we published Stupid § 101 Tricks, an article discussing some of the annoying, improper, and yet disappointingly common patterns seen in rejection and invalidation of claims for allegedly lacking patentable subject matter.  Moving on from there, Section § 102 of the patent statute sets forth the requirement of novelty.  In sum, it is a rather simple requirement, far easier to determine, less nuanced, and less subjective than the inquiry of § 101 or even the obvious analysis set forth in § 103 and related case law.

Nonetheless, it is not uncommon to observe deviations from the straight lines of the § 102 analysis.  As § 102 does not lend itself to the same level of shenanigans as § 101, we characterize these tricks as being "silly" rather than "stupid."  Still, they are problematic in practice as they not only are misaligned with the statue and case law, but also unnecessarily increase the cost of patent acquisition.

Let's start by defining the legal concept of anticipation.  In Verdegaal Bros. v. Union Oil Co. of California, the Federal Circuit stated that "[a] claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."  The Court has further clarified that "anticipation is not proven by multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention."  Microsoft Corp. v. Biscotti, Inc.  And, "unless a reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it . . . cannot anticipate under 35 U.S.C. § 102."  Net MoneyIN, Inc. v. VeriSign, Inc.

This is cut and dry -- one reference must disclose all claim elements as arranged in the claim under analysis.  As noted in M.P.E.P. § 2131.01, secondary references can be relied on to establish anticipation when these references "(A) Prove the primary reference contains an 'enabled disclosure;' (B) Explain the meaning of a term used in the primary reference; or (C) Show that a characteristic not disclosed in the reference is inherent."  Nonetheless, the use of secondary references in § 102 considerations remains rare.

With all this in mind, on to the tricks.  All of these tricks have been observed during patent prosecution at the USPTO, and therefore we focus on how they are used by examiners.  We expect that they are less prevalent at the PTAB and in courts but have not yet made that determination.

For any of the tricks described below, a recommended course of action is to interview the examiner in a non-confrontational fashion.  It is likely that they simply made an oversight, or that they have interpreted the claim in some fashion that is not explicit in the Office action (more on that later).  In some cases, reminding the examiner of the requirements for anticipation set forth in the M.P.E.P. § 2131 might also help.

Trick 1: The Ghost Claim Element

As noted, to anticipate a claim, a prior art reference must recite all of the claim elements.  However, some § 102 rejections silently ignore an entire claim element.  In some cases, the rejection ignores part of a claim element, such as the content of a wherein clause.  While the default is to consider all words of a claim during examination, there are a few oddball instances where the examiner is permitted to ignore part of a claim.  Intended use clauses and certain types of conditional claim language are two examples.  But even in those cases, the examiner is expected to provide a rationale for why a claim element is ignored.  For ghost claim elements, however, there is no rationale at all and the claim element is simply not addressed.

Trick 2: The Throwaway Claim Element

Here, the examiner finds a prior art reference that arguably teaches all claim elements except for one.  But for some reason, the examiner really wants to give a § 102 rejection rather than searching for a secondary reference to fill the gap.  Or, maybe the examiner cannot find such a secondary reference.  Regardless, the rejection cites to a passage in the primary reference that has nothing to do with the claim element to which it is being applied.  In many situations, this mapping is so far off base that you end up shaking your head a few times, cleaning your glasses, and questioning your own sanity.  But further analysis and consideration results in the same conclusion.  It is surprising to see this when the examiner otherwise did an admirable job in applying the prior art to the claim.

Trick 3: The Low-Effort Rejection of Dependent Claims

A related trick is to find a decent prior art reference for the independent claims -- let's say for sake of argument that the reference properly anticipates the independent claims.  But then the rejection uses the same reference as allegedly anticipating all of the dependent claims as well.  While this might be case for a few dependent claims, at least some get the same "throwaway" tactic described above -- the reference clearly has nothing to do with what is recited.  This low-effort approach allows the examiner to quickly turn around a rejection without searching for secondary references.  For at least some examiners, this is a pattern of behavior that you will see over and over.

Trick 4: The Stealth § 103 Rejection

In this type of rejection, the examiner finds an analogous prior art reference, but one that does not exhibit all claim elements as arranged.  Nonetheless, the examiner formulates a § 102 rejection, using vigorous hand-waving over the missing elements, and arguing that at some high level of abstraction the claim elements and the reference's teachings are the same or at least close.  To paraphrase a cliché, closeness only matters in horseshoes, hand grenades, and obviousness.  The problem is that some examiners will shut their ears to any argument that their rejection is improper -- ignoring the M.P.E.P. and case law in the process.  In practice, the applicant often ends up making claim amendments because the reference -- while insufficient to establish anticipation -- could be used in a single-reference § 103 rejection.  Still, this possibility does not justify an improper § 102 rejection.

Trick 5: The <Ctrl>-F Rejection

Earlier this year we published an article on examination annoyances and how to handle them.  One of these annoyances, the <ctrl>-f rejection, applies here as well.  This type of rejection is based on the examiner selecting certain keywords from the claims, finding a prior art reference that contains the same keywords, and stitching the disparate passages in the reference together into an anticipation rejection.  Of course, the context in which the keywords are used in the claim is lost.  The prior art may contain the same language as the claims but is often not otherwise related.  The key to addressing a § 102 <ctrl>-f rejection is to focus on the arrangement of claim elements, as that is likely what the examiner ignored.

Trick 6: Broadest Unreasonable Interpretation

It is no secret that an examiner's take on the broadest reasonable interpretation (BRI) of a claim can be quite different from that of an attorney or agent who drafted or is prosecuting the claim.  In most cases, it is helpful to be informed of the examiner's interpretation, and it would be nice for examiners to set forth their BRI explicitly in Office action.  But as noted in the examination annoyances article, BRI can be misused.  BRI is tempered by how claimed elements fit into the overall structure of the claims and how they relate to other claim elements, as well as how the constituent words and phrases are defined in the specification and drawings.  M.P.E.P. § 2111 helps in this regard, stating that BRI is not the broadest possible interpretation, and that examiners must apply the ordinary and customary meaning of claim terms unless these terms have been given special definitions in the specification.  Further, BRI must be consistent with the use of the claim term in the specification and drawings.  Nonetheless, examiners may argue in interviews that their unspecified claim interpretation is proper under BRI, thus allowing them to wedge a § 102 rejection out of a reference that might be better used as just one of a § 103 rejection, if at all.

Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)

By Kevin E. Noonan --

The Leahy-Smith America Invents Act prescribed two very different post-grant review proceedings in U.S. patent law.  The first, post-grant review (PGR), had some analogies with European opposition practice, in that petitions for PGR could be filed no later than nine months after the patent had granted and any ground of patentability was available as the basis for challenge (see 35 U.S.C. § 321 et seq.).  The other proceeding, inter partes review (IPR), was available throughout an unexpired patent term but the subject matter of challenge was limited to anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103 (see 35 U.S.C. § 311 et seq.).  However, Section 112 issues can be considered in an IPR as a part of construing the claims when questions of priority are raised, and this was the basis for the Patent Trial and Appeal Board (PTAB) to find invalid all but one of the challenged claims in Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A.

Dr. Reddy's petitioned for inter partes review (IPR) of U.S. Patent No. 9,687,454 on the grounds that all claims were anticipated by U.S. Patent Publication 2011/0033541 to Myers.  The claims are directed to therapeutic agent-containing films that can be orally dissolved as an administration route for various medicines.  The '454 patent is the latest in a series of related applications, the earliest (U.S. Patent Application 12/537,571) dating to 2009.  At issue in this IPR was whether the challenged claims were entitled to this earliest filing date, which antedated the publication of the '541 application asserted by Dr. Reddy's for anticipation.

The opinion sets forth claims 1, 7, 8, and 12 as representative of the issues before the Board.

Claim 1:

1.  An oral, self-supporting, mucoadhesive film comprising:
    (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
    (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
    (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
    (d) an acidic buffer;
    wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;
    wherein the weight ratio of (b):(c) is about 4:1;
    wherein the weight ratio of (d):(b) is from 2:1 to 1:5;
and
    wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine Cmax from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.

7.  The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

8.  The film of claim 7, wherein the film comprises about 48.2 wt % of the water-soluble polymeric matrix.

12.  The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

(emphasis in each instance in the opinion).  As is evident from the emphasized limitations, the distinction between claim 8 and the other claims is that this claim has a particularly specified composition of the water-soluble polymeric matrix making up the film while the other claims have a broader range of values for this parameter.

The Board considered whether the written description in the '571 priority specification had support for these features.  The Board found express disclosure for the "about 48.2 wt %" limitation in the '571 specification (albeit as the result of calculation by the skilled artisan); the Tables containing these data were reciprocated in the Federal Circuit opinion.  (While express disclosure of a claimed range can readily satisfy the written description requirement, inherent disclosure of such ranges by example is also in some cases adequate for written description purposes; see Union Oil of Cal. v. Atl. Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000)).  The ranges of water-soluble polymer in the films recited by the other claims did not find support in the '571 specification, according to the Board.  Moreover, the Board did not find Indivior's expert witness testimony to be credible on this issue.  Finally, the Board held that a person of ordinary skill in the art "would have been led away" from these ranges based on the '571 disclosure that "[t]he film may contain any desired level of self-supporting film forming polymer."  Accordingly, the Board held that the challenged claims of the '454 patent were not entitled to the priority date of the '571 application and thus claims 1-5, 7, and 9-14 were invalid for being anticipated by the teachings of the prior art '541 application while claim 8 was not anticipated.  Both parties appealed the Board's judgment.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Dyk and joined in part by Judge Linn, who dissented in part.  Regarding Indivior's appeal of the Board's invalidation of claims 1-5, 7, and 9-14, the panel majority agreed with the Board that the portions of the '571 specification Indivior attempted to rely upon did not disclose, expressly or inherently, the ranges recited in claims 1-5, 7, or 9-14.  Instead, there are instances in the disclosure that are "only specific, particular examples" but they are not ranges according to the opinion.  The panel majority expressly rejected Indivior's argument that written description is adequate when the skilled worker would need to "pluck[] out the polymer components and create[] a range from the percentage totals" which the opinion states "amounts to cobbling together numbers after the fact."  And "[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention" because "a patent is not a hunting license," citing (with some irony) Brenner v. Manson, 383 U.S. 519, 536 (1966).  The Federal Circuit illustrated the doctrinal difficulties of applying the written description requirement consistently by rejecting Indivior's resort to its case law by stating "written description cases are intensively fact-oriented, and the cases vary, just as ranges vary."

Because Indivior did not dispute that the '541 application would anticipate claims 1-5, 7, and 9-14 if the '454 patent was not entitled to the priority date of the '721 application, the Court affirmed the Board's decision that these claims were invalid for being anticipated.

Turning to Dr. Reddy's cross-appeal, the panel understood the argument to be that the skilled worker "would not have immediately discerned that the '571 application discloses a polymer component comprising 48.2 wt % of a film because the tables do not state the total polymer weight of various formulations."  The panel agreed with Dr. Reddy's that the 48.2 wt% is not expressly disclosed but deferred to the Board's fact-finding as being supported by substantial evidence.  To the possibility that this decision be perceived as being contrary if not contradictory to the Court's decision affirming invalidity of the other claims in the '454 patent, the opinion states that "given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board's decision concerning claim 8" and accordingly affirmed.

Judge Linn's dissent illustrated the difficulties of analyzing compliance with the written description requirement.  Citing some of the same caselaw Indivior unsuccessfully relied upon, including Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019), and In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976), Judge Linn contended the majority was incorrect in failing to find written description support in the '571 specification for the '454 patent's claims 1-5, 7, and 9-14, saying the panel majority had "applie[d] an overly demanding standard for written description for ranges" contrary to this precedent.  His dissent then performs the Judge's assessment of the '571 disclosure and comes to a conclusion opposite from the panel majority.  In Judge Linn's assessment, the reason for this difference with the panel majority is that Judges Lourie and Dyk took statements in the specification out of context and considered the specification to contain "inconsistent language" that Judge Linn is at a loss to perceive.  Indeed, Judge Linn chides the panel majority for doing just what the majority opinion states should not be done, applying "strict rules" to show possession of the claimed range(s).  Judge Linn also states that in his analysis the Tables set forth in the '571 application (and reproduced in the opinion) disclose the 48.2 wt% and 58.6 wt% in the recited ranges and required no "cobbling together numbers after the fact" as the majority had asserted in support of their decision.  Finally, Judge Linn found the Wertheim and Nalpropion opinions to be "directly on point" and support his opinion that the '571 specification provided an adequate written opinion of the challenged claims of the '454 patent.

Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie; opinion concurring in part and dissenting in part by Circuit Judge Linn

Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020)

By Kevin E. Noonan --

Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided.  The Federal Circuit recently reinforced the primacy of these rubrics in Biogen MA, Inc. v. EMD Serono, Inc.

The issues arose in litigation over Biogen's Rebif* product for the treatment of multiple sclerosis comprising a recombinant interferon-β ("IFN-β").  Biogen asserted U.S. Patent No. 7,588,755 ("'755 patent") in this litigation; the Federal Circuit identified Claim 1 as being representative:

1.  A method for immunomodulation or treating a viral condition[ ], a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
    a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
        (a) DNA sequences which are capable of hybridizing to any of the DNA inserts of G-pBR322(Pst)/HFIF1, G-pBR322(Pst)/HFIF3 (DSM 1791), G-pBR322(Pst)/HFIF6 (DSM 1792), and GpBR322(Pst)/HFIF7 (DSM 1793) under hybridizing conditions of 0.75 M NaCl at 68° C. and washing conditions of 0.3 M NaCl at 68° C., and which code for a polypeptide displaying antiviral activity, and
        (b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a);
    said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.

The jury found the patent to be invalid under 35 U.S.C. § 102(b) as being anticipated by two prior art references that taught MS treatment using naturally occurring IFN-β.  The jury also found that Defendants had not established by clear and convincing evidence that the asserted claims were invalid for obviousness, lack of enablement, or for failing to provide an adequate written description and that patients and prescribers directly infringed and Serono contributorily infringed but did not induce infringement.

The District Court granted Biogen's motion for judgment as a matter of law that the cited art did not anticipate the '755 patent claims, and granted a new trial contingent on the outcome of this appeal.  Under the District Court's reasoning, the cited references did not disclose recombinant IFN-β and thus no reasonable jury could find these references anticipated the '755 patent claims.  The District Court also found no anticipation because the claims recited administration of a "therapeutically effective amount" of recombinant IFN-β that "displays antiviral activity" not taught in the cited art.  The District Court also held in this regard that "the jury lacked substantial evidence that the native IFN-β protein as disclosed in [the cited art] was structurally or functionally identical to the claimed three-dimensional recombinant IFN-β protein," based in part on differences in glycosylation patterns in the recombinant IFN-β protein compared with the naturally occurring human IFN-β protein; the District Court relied on expert testimony in coming to its conclusion.  Particularly, the District Court did not construe the claims as product-by-process claims.

The District Court sustained the jury's determination in all other respects (as well as granting Biogen's motion that the claims recited patent-eligible subject matter).  This appeal followed.

The Federal Circuit reversed the District Court grant of JMOL on anticipation and grant of a new trial, in an opinion by Judge Linn joined by Judges Newman and Hughes.  The panel found two sources of error in the District Court's grant of JMOL in favor of Biogen.  First, in the Federal Circuit's judgment that the claims were indeed product-by-process claims and should have been construed that way.  Second, the District Court's construction "required identity of three-dimensional structures not specifically recited in the claims rather than relying on the claimed and lexicographically defined 'polypeptide.'"

With regard to the differences between naturally occurring and recombinant IFN-β proteins, the Federal Circuit opined that the District Court unnecessarily "categorized the 'produced; and 'transformed' limitations in the '755 claims as meaningful 'source limitations.'"  The District Court also identified the recombinant source of the recited IFN-β as "overcoming the shortcomings of the prior art" with regard to be able to access sufficient quantities of IFN-β to achieve practicable treatment of MS.

The Federal Circuit agreed with Serono that "a source limitation alone cannot confer novelty unless the product itself is novel" and that the District Court erred by ignoring the "longstanding rule" that an "old" product (i.e., one in the prior art) is not patentable by being made by a new process (in contrast with the process, which if new and otherwise in satisfaction of the statute is patentable), citing (among more recent precedent) Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884).  Amongst that more recent (and in many ways more apt) precedent was Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), regarding comparison between recombinant erythropoietin and prior art human urinary EPO.  The key question there, and here, is whether production of a protein recombinantly resulted in a new product (which, if the primary amino acid sequence is identical devolves into a comparison of glycosylation patterns).  Merely reciting the recombinant origins of the protein at issue does not produce additional structural limitations distinguishing the proteins according to the opinion, the Court citing Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1353 (Fed. Cir. 2016), for this proposition.

Here, the panel properly recognized that the only point of novelty Biogen can rely upon is that a therapeutically effective amount of recombinant IFN-β is administered (which was not in the prior art). The composition itself is claimed by its method of making ("recombinant") and to recognize novelty here based solely on administration would in the Court's opinion "defy all reason," because in that case "a recombinant composition could be non-novel, the method of administration could be non-novel, but the method of administration of the composition defined by the process of its manufacture would be novel as a matter of law."

And with regard to using a product-by-process analysis within a method of treatment claim, the panel cited to Purdue Pharma for the proposition that it is the novelty of the composition itself, rather than how it was made, that is the proper basis for deciding whether the claim recites novel subject matter.

The Court provided two rubrics for the principles it set forth.  First, put succinctly, "the recombinant origin of the recited composition cannot alone confer novelty on that composition if the product itself is identical to the prior art non-recombinant product."  And further, "an old method of administration of an old product made by a new process is not novel and cannot be patented."

The District Court's final point of error according to the panel was in considering the novelty of the process of making IFN-β -- recombinantly -- as giving "force and effect" to the "heart of the claimed invention."  The error is in the consequence:  by doing so the claim removed old products from the public domain, the cardinal sin that the novelty requirement seeks to avoid.

The Federal Circuit also found error in the District Court's emphasis on the three-dimensional structure (and differences between) naturally occurring and recombinant IFN-β.  This preoccupation was contrary to the definition of the term "polypeptide" in the specification as "[a] linear array of amino acids connected one to the other by peptide bonds between the α-amino and carboxy groups of adjacent amino acids."  This art-recognized definition is without regard to the three-dimensional structure of the polypeptide (indeed, it is a fundamental rubric of protein chemistry that the linear array -- termed the polypeptide's "primary structure" -- determines, with some limitations, its three-dimensional structure).  Biogen acknowledged the identity of the "sequential order" of amino acids between naturally occurring and recombinant IFN-β as claimed, which should have been the end of it.  But the District Court considered the further claim limitation that the recombinant IFN-β must be "therapeutically effective" and have "antiviral activity" as imparting significance to identity of three-dimensional structure.

The District Court's errors, according to the Federal Circuit, were three-fold.  First, consideration of the three-dimensional structure was contrary to the definition in the specification, and thus a contradiction of the inventor's lexicographic choices.  Second, there was no disclosure in the specification or limitation recited in the claims relating the three-dimensional structure of recombinant IFN-β to antiviral activity.  And finally the jury was not given and Biogen did not request an instruction that required comparison of the three-dimensional structures of prior art naturally occurring IFN-β and recombinant IFN-β.  But the jury was given proper instruction on the definition of novelty and that the linear amino acid sequence of naturally occurring IFN-β was identical to that of recombinant IFN-β and in the panel's opinion came to the right conclusion.

For these reasons the Federal Circuit remanded with instructions that the jury verdict of invalidity for lack of novelty be reinstated by the District Court.

* Although the Federal Circuit opinion identified Biogen's drug in this way, a review of the District Court litigation reveals that Biogen's drug is Avonex®; Rebif® is the trademark for Merck's IFN-beta product.  We thank Henry Einav for the correction.

Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020)
Panel: Circuit Judges Newman, Linn, and Hughes
Opinion by Circuit Judge Linn

BASF Corp. v. SNF Holding Co. (Fed. Cir. 2020)

By Kevin E. Noonan --

In what may be simple happenstance, the Federal Circuit issued opinions on the same day reversing a District Court grant of summary judgment in opinions written by Judge Lourie, here in BASF Corp. v. SNF Holding Co.

The case arose over BASF's allegations of infringement by SNF of U.S. Patent No. 5,633,329.  The technology relates to an improved method for preparing high-molecular-weight polymers produced by polymerization of "water-soluble, monoethylenically unsaturated monomers."  The art recognized a problem in making such polymers in that they are "sticky" and attach to the walls of the reaction vessel.  Prior art solutions, acknowledged to be unsatisfactory, included mechanical "scraping," inter alia, with a piston (which damaged the reactor walls), injecting a separating liquid (which contaminate the reactor), or injecting an inert gas (which is ineffective because it tended to blow through gaps between the polymer and the reactor wall).  The '329 patent provided a solution by including a conical taper in the reaction vessel with specific dimensions as illustrated in this patent drawing:

The Court considered Claim 1 to be representative:

1.  A process for preparing high molecular weight polymers, which comprises polymerizing water-soluble, monoethylenically unsaturated monomers and, if desired, crosslinkers which contain at least two nonconjugated, ethylenically unsaturated double bonds in the molecule, and, if desired, water-insoluble monoethylenically unsaturated monomers in aqueous solution in the presence of polymerization initiators
    in a tubular reactor which has a conical taper at the end, the ratio of the diameter of the reactor (D1) to the diameter at the end of the conical taper of the reactor (D2) being from 2:1 to 25:1 and the angle between D1 at the start of the conical taper and the inner cone wall being >45° and <90°, and
    removing the gelatinous reaction mixture by injection of an inert gas.

In response to BASF filing a complaint against SNF, Defendant petitioned for inter partes review, which petition was granted but resulted in a Final Written Decision that the challenged claims were not unpatentable.  Trial ensued and the District Court granted summary judgment that asserted claims 1 and 3-7 were invalid as being anticipated and claim 2 invalid for obviousness.  The prior art applied by the District Court to these claims was a polymer synthesis process termed the Sanwet® Process that was earlier developed buy Sanyo Chemical Industries in Japan.  Sanyo entered into an agreement with Celanese to produce polymers using the Sanwet® Process prior to the critical date under the terms of a confidentiality agreement (i.e., the process could not be publicly disclosed until a time after the critical date).

The District Court applied the following interpretation to subsections of 35 U.S.C. § 102 (as it was codified prior to enactment of the Leahy-Smith America Invents Act):

• "one person's use or knowledge" of the claimed invention would satisfy the provisions of §102(a) that the invention was "known or used by others in this country" (and whether the invention was kept secret or confidential was irrelevant); and

• commercial use of a claimed process raised the public use and/or on sale bar set forth in 102(b).

The District Court granted summary judgment of anticipation on both the public use and on-sale bars.  Evidence supporting this judgment was that Celanese gave tours of the plant where the process was being practiced, and was using the process commercially before the critical date.  The license agreement, together with disclosure of the technical details of the Sanwet® Process constituted a sale, not only a license, because "the transmission of the process description to a user with the ability to perform the process constitutes putting the process 'on-sale,'" citing Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373, 1378 (Fed. Cir. 2003)).  This appeal followed.

The Federal Circuit reversed and remanded for further proceedings, in an opinion by Judge Lourie, joined by Judges Moore and Chen.  With regard to prior art knowledge or use under pre-AIA § 102(a), the Federal Circuit held that the District Court had misapplied the meaning of the terms "known or used by others" under the statute.  The Federal Circuit agreed with BASF that knowledge or use not accessible to the public did not qualify as invalidating prior art, citing Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 139 (Fed. Cir. 1986); Woodland Tr. v. Flowertree Nursery, Inc., 148 F.3d 1368, 1370 (Fed. Cir. 1998); and Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1306 (Fed. Cir. 2002) for this principle.  The opinion sets forth the history of this principle, including In re Borst, 345 F.2d 851, 854 (CCPA 1965), Supreme Court precedent from Pennock v. Dialogue, 27 U.S. (2 Pet.) 1 (1829); Gayler v. Wilder, 51 U.S. (10 How.) 477, 498 (1850); Coffin v. Ogden, 85 U.S. (18 Wall.) 120, 124–25 (1873); and UCB, Inc. v. Watson Labs. Inc., 927 F.3d 1272, 1289–91 (Fed. Cir. 2019); as well as two Second Circuit cases from the legendary Judge Learned Hand, Metallizing Eng'g Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2d Cir. 1946), and Gillman v. Stern, 114 F.2d 28 (2d Cir. 1940).  The opinion finds this principle is consistent with the constitutional requirement that a patent grant "promote progress," stating that "[p]rior knowledge or use that is not accessible to the public "upon reasonable inquiry," confers no benefit on the public, and thus does not suffice as a defense under § 102(a)."

With regard to the District Court's grant of summary judgment, the opinion finds that there are genuine issues of material fact with regard to the "extent to which Sanyo's technical information and the performance of the Sanwet® Process at the Portsmouth plant were actually subject to confidentiality restrictions."  The existence of such questions is almost always fatal to summary judgment and thus the court reversed summary judgment granted by the District Court on these grounds.

Turning to the public use and on-sale bar grounds for summary judgment relied upon by the District Court, the panel agreed with BASF that the hidden commercial use by Celanese did not satisfy the statutory requirements.  Citing the Supreme Court's "rule of Shimadzu," the opinion states that such public use requires the invention to be "'not purposely hidden' and . . . that the use of a process in the ordinary course of business—where the process was 'well known to the employees' and no 'efforts were made to conceal' it from anyone else."  Electric Storage Battery Co. v. Shimadzu, 307 U.S. 5, 20 (1939); the opinion cites numerous precedent for this standard, including Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376, 1384–85 (Fed. Cir. 2007); Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1382 (Fed. Cir. 2005); New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1297 (Fed. Cir. 2002); W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548–50 (Fed. Cir. 1983); and Egbert v. Lippmann, 104 U.S. (14 Otto) 333, 336 (1881).  Once again, the Court found disagreement between the parties on factual matters (including the purportedly public tours, and the content of newspaper articles) sufficient to raise genuine issues of material fact.  Accordingly, the Federal Circuit reversed summary judgment on these grounds and remanded to the District Court.

In this regard, the panel also rejected as "simply wrong" SNF's contention that "a third party's commercial exploitation of a secret process creates a per se public-use bar to another inventor," under the Gore and Metallizing precedent.  These cases stand for loss of right for secret commercial use by an inventor; the Court rejected SNF's attempt to extend the bar based on secret, third-party use.  "The primary reasons for the statutory bars are to prevent the public from being deprived of that which it has come to rely on as publicly available, to encourage prompt disclosure of inventions, and to prevent effective extension of patent term by gamesmanship," according to the opinion, citing TP Labs., Inc. v. Prof. Positioners, Inc., 724 F.2d 965, 968 (Fed. Cir. 1984).  None of these policy goals would be furthered by precluding patenting based on the secret use of a claimed invention by a third party.

Finally, with regard to SNF's on-sale grounds for invalidating the asserted '329 patent claim, the Federal Circuit agreed with BASF that the commercial agreements between Sanyo and Celanese nor the later acquisition of Celanese (by Hoechst) were commercial "sales" under the statute.  Here, the Court relied on definitions for "sales" on the Uniform Commercial Code, as the court did in Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1048 (Fed. Cir. 2001).  And the opinion held that this case was governed by the Court's decision in In re Kollar, 286 F.3d 1326 (Fed. Cir. 2002), where a license to practice a claimed method was not a sale, unless "the essential features of the claimed process here were . . . embodied in a product sold or offered for sale before the critical date," citing Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003).  For substantially the same reason, the panel rejected SNF's argument that later acquisition of Celanese by Hoechst constituted a sale that raised the on-sale bar.

BASF Corp. v. SNF Holding Co. (Fed. Cir. 2020)
Panel: Circuit Judges Lourie, Moore, and Chen
Opinion by Circuit Judge Lourie

Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)

By Kevin E. Noonan --

Last week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc. v. Hospira, Inc.  In doing so, the panel majority (over a dissent by Judge Newman) illustrated anew the importance of the deference the U.S. Patent and Trademark Office (and particularly the Patent Trial and Appeal Board) is due under the Administrative Procedures Act, and how that deference can be outcome determinative under the right circumstances.

The case arose before the PTAB in an inter partes review (IPR) of U.S. Patent No. 7,807,799, which claimed methods for purifying antibodies comprising a C_H2/C_H3 region using Protein A affinity chromatography.  The claimed methods are directed to an improvement wherein the amount of Protein A contaminant in the antibody eluate is minimized (substantially to zero).  The opinion characterized the claimed method as a "standard purification technique," relying on high affinity, reversible binding to C_H2/C_H3 regions, which methods were capable of "reducing leaching of protein A . . . by reducing [the] temperature" of the "composition that is subjected to protein A affinity chromatography."  The inventors found that leaching can be minimized by performing chromatography at temperatures between 10-18°C (the specification also disclosing a broader range of 3-20°C).  Claim 1 of the '799 patent is representative:

A method of purifying a protein which comprises CH2/CH3 region, comprising subjecting a composition comprising said protein to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C.

The primary references asserted by Hospira in its IPR was International Publication No. WO 95/22389 and a scientific reference contributed by van Sommeren and colleagues to a treatise entitled Effects of Temperature, Flow Rate and Composition of Binding Buffer on Adsorption of Mouse Monoclonal IgG1 Antibodies to Protein A Sepharose 4 Fast Flow, 22 PREPARATIVE BIOCHEMISTRY 135 (1992), as well as other secondary references that were applied in combination with the '389 PCT publication for the Board's obviousness determinations.  The '389 PCT publication disclosed Protein A purification of antibodies performed at room temperature, defined as 18-25°C, which overlapped with the '799's temperature range of from about 10°C to about 18°C.  The Board held all claims in IPR (1-3 and 5-11) to be anticipated by the '389 PCT publication or obvious in light of the '389 PCT publication or the van Sommeren reference as primary reference, in combination with other secondary references.  Genentech appealed and also challenged the constitutionality of applying IPRs retroactively in view of the '799 patents priority date; the Federal government intervened to address this issue on appeal.

The Federal Circuit affirmed, in an opinion by Judge Chen joined by Chief Judge Prost; Judge Newman dissented.  Regarding the Board's anticipation decision, the Federal Circuit relied on the overlap of the temperature ranges, on the basis that the method disclosed in the '389 PCT publication was directed to purifying antibodies comprising the CH2/CH3 region and included a Protein A purification step performed at room temperature, defined in the specification as the range of 18-25°C.  The Federal Circuit's opinion  states that "[a] prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range," citing Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870–71 (Fed. Cir. 2015).  The question that a court must answer, according to the opinion, is "whether the patentee has established that the claimed range is critical to the operability of the claimed invention," citing Ineos and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018).  The Board found that Genentech had not carried this burden and (curiously, perhaps) Genentech did not challenge this finding on appeal.

The Board also found that the '389 PCT publication taught that Protein A column chromatography was performed throughout at room temperature (18-25°C, i.e., the overlapping temperature range).  Genentech attempted to challenge this interpretation on the ground that "room temperature" as disclosed in the '389 PCT publication was precisely that, the temperature of the room in which the chromatography was performed and not the temperature of the components, buffers, etc. used in the purification.  Genentech based this argument in part on the temperature of the source material to be subjected to chromatography (i.e., antibody preparations from cells cultured at 37°C) in the absence of instructions in the '389 PCT publication to cool this material to "room temperature" and relied on testimony from its expert.  Hospira's expert, on the contrary, argued that those of skill in the art would perform chromatography at "ambient" (room) temperature.  The Federal Circuit majority held that "substantial evidence supports the Board's finding that the HCCF subject to protein A affinity chromatography in WO '389 is within the claimed temperature range of claim 1."  The majority identified portions of Genentech's expert's testimony that it disagreed with (correctly, in the majority's view) and held that "to the extent the experts disagreed with one another, the Board reasonably chose to credit the testimony of [Hospira's expert] over the testimony of [Genentech's expert], another instance where the deference the Court is mandated to give fact questions to the Board under Dickinson v. Zurko was dispositive.  The Federal Circuit majority also rejected Genentech's argument that the Board's decision was contrary to the Court's precedent (thus converting the issue to a question on law) and affirmed the Board's determination that Genentech's claims were invalid for anticipation by the disclosure in the '389 PCT publication.

Turning to the Board's decision that the claims were also obvious over the combination of the disclosure of the '389 PCT publication in combination with a variety of other prior art references, the panel majority relied on their precedent that "[i]f the relevant comparison between a disputed claim limitation and the prior art pertains to a range of overlap-ping values, 'we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness,'" citing In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).  This has the effect of raising a presumption of obviousness, according to the opinion, thus shifting the burden on the patentee to rebut the presumption (which the Board held Genentech did not do and the panel majority affirmed).  Genentech neither showed that the temperature range was critical to the invention nor that the prior art did not recognize temperature as being "result-effective" (two ways to achieve the required rebuttal).  This latter stratagem was ineffective in the Board's view because the prior art understood Protein A leaching to be the result of proteolysis, and that proteolysis was affected by temperature.  Moreover, according to the Court, "[t]he Board reasonably found that a skilled artisan would have been motivated to optimize the temperature given the teachings of the prior art, and that given the ease with which temperature can be varied, finding an optimal temperature range would have been nothing more than routine experimentation."  The panel majority rejected Genentech's argument that the purported desire to reduce Protein A leaching was relevant only in large-scale, industrial applications of the technique, not at least because Genentech's claim was not limited to these circumstances.

Finally, the Board held that the objective indicia of nonobviousness did not change their conclusion that Genentech's claims were obvious, and the panel majority affirmed this determination.

The majority's opinion closes with the Court's rejection of Genentech's challenge that inter partes review are an unconstitutional violation of the Fifth Amendment (for reasons substantially identical to the Court's earlier opinion in Celgene Corp. v. Peter, 931 F.3d 1342, 1356–63 (Fed. Cir. 2019)), nor the Seventh Amendment nor Article III.

Judge Newman dissented, on the basis inter alia that the invention had actually solved a real world problem and that the majority's affirmance ignored the value the invention brought to the art.  "The court presents a hindsight determination that this apparently simple solution to a difficult problem is anticipated and obvious, although it was not known or obvious to the scientists who were attempting to solve the problem of leaching contamination, and the experts for both sides agreed that the solution presented in the '799 patent was new to them," Judge Newman writes.  She sees the complexities involved in arriving at this solution, and the failure in the art to disclose the solution rebuts, for the Judge the Board's invalidation on anticipation and obviousness grounds.  On the merits, Judge Newman discounts the overlap at 18°C as supporting anticipation, because her understanding of the law would require the temperature range disclosed in the  '389 PCT publication (18-25°C) to be the same as the claimed temperature range (10-18°C).  And Judge Newman rejects the "optimization" basis for the Board's obviousness determination (and the majority's affirmance), stating that:

[T]he question is not whether it would have been easy to cool the material to the 10°C - 18°C range; the question is whether it would have been obvious to do so.  Contrary to the Board's and the court's view, this is not a matter of optimizing a known procedure to obtain a known result; for it was not known that cooling the material for chromatography would avoid contamination of the purified protein with leached protein A.

Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)
Panel: Chief Judge Prost and Circuit Judges Newman and Chen
Opinion by Circuit Judge Chen; dissenting opinion by Circuit Judge Newman

Top Five Stories of 2019

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 13th annual list of top patent stories.  For 2019, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  In previous posts, we counted down stories #15 to #11 and stories #10 to #6, and today we count down the top five stories of 2019.  As with our other lists (2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2019" on January 22, 2020 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

5.  USPTO Updates Subject Matter Eligibility Guidance (Not Once, But Twice)

In January, the U.S. Patent and Trademark Office published updated examination guidance regarding the subject matter eligibility of inventions involving abstract ideas.  At first blush, the updated guidance does not appear to be a radical departure from substantive USPTO examination practice despite raising a few additional procedural hurdles that examiners are to overcome before rejecting claims under 35 U.S.C. § 101.  In October, the USPTO released an update to its January 2019 Subject Matter Eligibility Guidance, in which the Office sought to clarify issues brought up in public comments on the January Guidance.  The patent community will have to wait and see how the new guidance plays out in practice.  If anything, the additional procedural requirements introduced and the limiting of abstract ideas to only three categories is likely to favor applicants for at least some types of inventions.  It is unlikely, however, that any claims that could be found patent-eligible under previous examination procedures are suddenly going to be viewed as ineligible under the new guidance.

For information regarding this and other related topics, please see:

• "USPTO Subject Matter Eligibility October Update: Example 46," November 17, 2019
• "USPTO Publishes Update to Its Subject Matter Eligibility Guidance," October 17, 2019
• "The PTAB Goes to Europe: Four Recent Section 101 Decisions Designated as Informative," July 28, 2019
• "USPTO Presentation on Evaluating Computer-Implemented Functional Claiming under 35 U.S.C. § 112," June 18, 2019
• "USPTO on Patent Eligibility -- Examples 41 and 42," January 24, 2019
• "USPTO on Patent Eligibility -- Example 40," January 20, 2019
• "USPTO on Patent Eligibility -- Examples 38 & 39," January 15, 2019
• "USPTO on Patent Eligibility -- Example 37," January 14, 2019
• "USPTO Issues Updated Subject Matter Eligibility Guidance," January 7, 2019

4.  Post-grant Review of Pre-AIA Patents Constitutional -- USPTO Appointment of APJs at PTAB Unconstitutional

In July, the Federal Circuit in Celgene Corp. v. Peter affirmed a determination by the Patent Trial and Appeal Board (PTAB) that two patents owned by Celgene Corp. were invalid.  In rendering that decision, however, the Federal Circuit also addressed on the merits Celgene's argument that retroactive invalidation of its patents under the inter partes review (IPR) procedures introduced into U.S. patent law by the Leahy-Smith America Invents Act (AIA) is unconstitutional because its patents were granted before enactment of these IPR procedures and thus amounted to a taking under the Fifth Amendment.  The Federal Circuit based its decision that IPRs are not unconstitutional on the history, beginning in 1980, of Patent Office review of previously granted patents, which at least put patentees on notice that the Office could reconsider the validity of the patent grant.  This history made that grant contingent on there not being a successful post-grant challenge, and thus an IPR is nothing more than the latest iteration of such proceedings.

And then in October, the Federal Circuit in Arthrex, Inc. v. Smith & Nephew, Inc. determined that the way in which the U.S. Patent and Trademark Office has appointed administrative patent judges at the PTAB violates the Appointments Clause of the Constitution (Art. II, sec. 2, cl. 2).  According to the opinion, because administrative patent judges are principal officers they must be nominated by the President and confirmed by the Senate.

For information regarding this and other related topics, please see:

• "Federal Circuit Holds APJs Are Principal Officers," October 31, 2019
• "OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019)," October 8, 2019
• "Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2019)," August 21, 2019
• "Celgene Corp. v. Peter (Fed. Cir. 2019)," August 5, 2019

3.  Courts Continue to Address Question of Sovereign Immunity in Patent Cases

In April, the U.S. Supreme Court denied a petition for writ of certiorari by the St. Regis Mohawk Indian Tribe on the question (answered in the negative by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office and the Federal Circuit) of whether tribal sovereign immunity could protect the tribe from being named as a party in an inter partes review (IPR) proceeding after Allergan assigned to the tribe its patents in IPR.  Then in June, in Regents of the University of Minnesota v. LSI Corp., the Federal Circuit determined that State sovereign immunity does not preclude institution of IPR proceedings before the PTAB.  In September, the State of Minnesota filed a petition for certiorari, contending that the Federal Circuit erred in deciding that the University of Minnesota, as an "arm of the state," could not assert sovereign immunity against LSI Corp., which sought to have the PTAB institute an IPR against University-owned patents.  And last fall, the Federal Circuit in Board of Regents of the University of Texas System v. Boston Scientific Corp. refused to recognize the immunity as advanced by the State, in this case asserted over the question of proper venue.  Given the number of cases in which the issue of sovereign immunity in patent cases has been raised, this issue is likely to be selected again for our top stories list in 2020.

For information regarding this and other related topics, please see:

• "Board of Regents of the University of Texas System v. Boston Scientific Corp. (Fed. Cir. 2019)," September 19, 2019
• "State of Minnesota Petitions for Certiorari in Regents of University of Minnesota v. LSI Corp.," September 15, 2019
• "Regents of the University of Minnesota v. LSI Corp. (Fed. Cir. 2019)," June 16, 2019
• "Supreme Court to Revisit Abrogation of State Sovereign Immunity From IP Infringement," June 4, 2019
• "Supreme Court Denied Certiorari Writ by St. Regis Mohawk Indian Tribe in Restatis® IPR," April 15, 2019

2.  Federal Circuit Strikes Down Diagnostic Patent in Athena v. Mayo, But Cannot Find Consensus on Subject Matter Eligibility Solution

In February, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit affirmed a District Court decision holding claims 6-9 of U.S. Patent No. 7,267,820 invalid under 35 U.S.C. § 101.  The '820 patent is directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK).  In July, the Federal Circuit issued a per curiam Order, denying a petition for rehearing en banc filed by Athena.  The per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition.  The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another.  The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents.  Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.  The Federal Circuit had difficulty reaching a consensus on the solution to the problem of subject matter eligibility.  Some judges felt the Federal Circuit was bound by the Supreme Court's decision in Mayo, some hinted that the problem could only be solved by the Supreme Court or that the Federal Circuit would at least benefit from the Supreme Court's guidance, some thought the Federal Circuit could solve the problem by better distinguishing Mayo, and some thought Congress should step in to solve the problem.  Last fall, Athena filed a petition for a writ of certiorari in the case, requesting that the Supreme Court "provide much-needed guidance on the important question of the patent eligibility of medical diagnostic tests."  (In his brief in Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., the Solicitor General suggested that the Supreme Court "should provide additional guidance in a case where the current confusion has a material effect on the outcome of the Section 101 analysis," offering as one example a case involving the patent eligibility of medical-diagnostic methods, and pointing in particular to Athena v. Mayo.)  The Supreme Court is scheduled to discuss Athena's petition at Conference on January 10, 2020.

For information regarding this and other related topics, please see:

• "Athena Diagnostics Seeks Supreme Court Review of Athena Diagnostics v. Mayo Collaborative Services," December 16, 2019
• "iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019)," September 3, 2019
• "Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)," August 22, 2019
• "Australia Reigns Supreme over U.S. in Patenting Diagnostic Methods," August 6, 2019
• "The Proper Role of the Federal Circuit," July 25, 2019
• "Athena Diagnostics v. Mayo Collaborative Services -- The Dissents," July 17, 2019
• "Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences," July 14, 2019
• "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)," July 9, 2019
• "Invitation to Join Amicus Brief in Athena Diagnostics v. Mayo," April 11, 2019
• "Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2019)," April 7, 2019
• "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)," February 12, 2019

1.  Supreme Court: Secret Sales Trigger On-sale Bar under AIA

In January, the Supreme Court addressed the question of whether Congress intended to change the status of "secret" sales so as not to trigger the on-sale bar of revised 35 U.S.C. § 102 of the Leahy-Smith America Invents Act (AIA) by adding the phrase "or otherwise known to the public."  The Federal Circuit had held that Congress had not done so, and the Supreme Court agreed.  The Court's decision, authored by Justice Thomas, was short (9 pages), unanimous (9-0), and issued quickly (handed down less than seven weeks after oral argument).  The Court recognized that it had "never addressed the precise question presented in this case," but voiced its opinion that "our precedents suggest that a sale or offer of sale need not make an invention available to the public."  The Court based its decision on the well-established principle that, under prior versions of § 102, "secret sales" could trigger the on-sale bar.  These cases were as recent as Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998), and as ancient as a trio of 19th Century cases (Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92 (1877); Smith & Griggs Mfg. Co. v. Sprague, 123 U.S. 249 (1887); Elizabeth v. Pavement Co., 97 U.S. 126 (1878)).  The opinion credits the Federal Circuit with making "explicit what was implicit in our precedent" with regard to the on-sale bar, citing Special Devices, Inc. v. OEA, Inc., 270 F. 3d 1353 (2001), and Woodland Trust v. Flowertree Nursery, Inc., 148 F. 3d 1368 (1998), in support of its conclusion.  Based on this various precedent, the Court was able to reach the conclusion that Congress did not change what activities raised the on-sale bar, which includes secret sales, because there was insufficient evident of that intent.  The Court relied expressly on the Solicitor General's argument that "if 'on sale' had a settled meaning before the AIA was adopted, then adding the phrase 'or otherwise available to the public' to the statute 'would be a fairly oblique way of attempting to overturn' that 'settled body of law.'"  The Court pointed out that the catch-all phrase "otherwise available to the public" is better interpreted to capture "material that does not fit neatly into the statute's enumerated categories but is nevertheless meant to be covered."

For information regarding this and other related topics, please see:

• "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc. (2019)," January 22, 2019

Wilson v. Martin (Fed. Cir. 2019)

By Kevin E. Noonan --

Ever since the Supreme Court's decision in Dickerson v. Zurko, decisions from the U.S. Patent and Trademark Office (whether in ex parte examination or any of the many varieties of actions before the Patent Trial and Appeal Board) involving questions of fact are treated on appeal with almost overwhelming deference.  This lesson was learned again by the losing party in an interference, styled Wilson v. Martin, where the PTAB held the claims corresponding to the count in the interference were anticipated by the prior art.

The interference was declared between Wilson's U.S. Patent No. 8,809,044 and Martin's U.S. Application No. 14/814,267.  The claims of the '044 patent were directed to methods for using a cell culture apparatus comprising semipermeable membranes (that permit passage of gas but not liquids like culture media).  The culture apparatus comprises multiple vertical shelves with two or more compartments for culturing cells wherein cells and the liquid culture media are placed:

Martin's '276 application is also directed to a liquid cell culture apparatus having two or more compartments having a gas permeable membrane.

The count in the interference is identical to claim 1 of the '044 patent:

1.  A method of culturing animal cells in a gas permeable multi-shelf cell culture apparatus, the method comprising:
    adding animal cells and media into a gas permeable multi-shelf apparatus comprising two or more culture compartments, each compartment including a shelf comprised of gas permeable, liquid impermeable material for cells to reside upon, each shelf connected to an opposing surface, a fluid pathway shared by said culture compartments, and each said shelf is in contact with a gas space,
    whereby said apparatus is incubated in the presence of ambient gas suitable for animal cell culture, oriented in a position such that said culture compartments are located one above the other, each said shelf is in a horizontal position with said gas space located below it, animal cells reside upon at least a portion of each said shelf, said culture compartments include media in contact with said shelf and said opposing surface, and ambient gas resides within each said gas space and is in contact with each shelf.

For comparison, the opinion set forth claim 2 of the '267 application:

2.  A method of culturing cells in a gas permeable multi-shelf cell culture apparatus, the method comprising:
    adding cells and media into a gas permeable multi-shelf apparatus comprising two or more culture compartments, each compartment including a shelf comprised of gas permeable, liquid impermeable material for cells to reside upon, each shelf connected to an opposing surface, a fluid pathway shared by said culture compartments, and each said shelf is in contact with a gas space,
    whereby said apparatus is incubated in the presence of ambient gas suitable for cell culture, oriented in a position such that said culture compartments are located one above the other, each said shelf is in a horizontal position with said gas space located below it, cells reside upon at least a portion of each said shelf, said culture compartments include media in contact with said shelf and said opposing surface, and ambient gas resides within each said gas space and is in contact with each shelf.

The "ambient gas" term italicized in each claim was the basis for the PTAB's invalidation of Wilson's claims and the Federal Circuit's review.

Martin filed a motion in the interference that a prior art reference to Toner (U.S. Patent No. 6,759,245) anticipated most of Wilson's claims-in-interference corresponding to the Count, supported by two expert witness declarations.  The Toner reference discloses "systems and methods for culturing animal cells using modular cell culturing devices with gas-permeable membranes" having structures with common (left, 222) or individual (right, 20) oxygenated fluid compartments:

The parties proposed different constructions for the term "ambient gas" that were not used by the Board, which did not construe the term because the Toner reference, in its opinion, disclosed the "ambient gas' limitation using either of the proposed constructions.

The Board held that the reference disclosed a multiplicity of ports that communicate between the interior and exterior of the device that would permit outside air to enter the device.  The Board held that the gas could be air or other oxygenated "fluid" and that "ambient gas" describes "[a]ir passing from the exterior of the device into the interior of the device" supported by Martin's expert who averred that "the common gas space inside the device is open to the ambient environment for venting air or the mixture of air with other gases supplied into the gas space via the inlet."

Wilson contended before the Board that the Toner reference did not anticipate its claims-in-interference because it required the gas to be "pumped or forced into the device."  The Board rejected this interpretation because the reference disclosed "static, as well as directional, flow of the oxygenated fluid."  The Board also rejected Wilson's characterization of the nature of the gas disclosed in the Toner reference as having "carefully controlled characteristics different from 'those found in standard ambient cell culture conditions,'" stating that the gas in Toner needs merely to be "ambient" (albeit conceding that Toner does not expressly use the word "ambient" but that it is "inherent or otherwise implicit" in the reference, citing Standard Havens Prods., Inc. v. Gencor Indus., Inc., 953 F.2d 1360, 1369 (Fed. Cir. 1991)).

Finally, the Board refused to preclude Martin from asserting the Toner reference for disclosing the "ambient gas" reference based on judicial estoppel because assignee Corning (the real party in interest) had made inconsistent statements during prosecution of the parent application to the '267 application-in-interference, inter alia because the Board could rely on the expert testimony before it from both parties.

Consequently, the Board held that all Wilson's claims in the '044 patent at issue in the interference were invalid as being anticipated or obvious over the Toner reference.  Wilson appealed.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Chief Judge Prost and Judge Stoll.  With regard to the Board's anticipation determination, the panel found that this conclusion was supported by the written description of the Toner patent and the figures set forth therein.  Important in this outcome was Wilson's argument that Toner only disclosed embodiments wherein the gas was provided by a gas tank (and thus not "ambient"), where the Federal Circuit pointed to Figure 8A not showing a gas tank and disclosure that embodiments having a gas tank as the source of gas were "preferable" but not required.  Further, the panel credited (and gave deference to) the Board's consideration of Martin's expert.  Despite the absence of the conventional bases for giving deference to expert witness testimony at trial (that the factfinder can observe the witness' demeanor, for example, which the Board cannot, relying on only the written record and portions of deposition transcripts), the Federal Circuit states that "the Board was entitled to weigh and credit that testimony," citing Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018); Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982); and Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010).  Under the substantial evidence standard, the panel held that the Board's determination was "such that a reasonable mind might accept as adequate to support the Board's conclusion," citing Fleming v. Escort Inc., 774 F.3d 1371, 1375 (Fed. Cir. 2014).

The panel also rejected Wilson's other arguments, that the expert witness testimony was extrinsic evidence, stating that "[e]xtrinsic evidence may be used to interpret the allegedly anticipating reference and to shed light on what it would have meant to a person of ordinary skill in the art," citing Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1345 (Fed. Cir. 2018) (citing In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).  The panel held that the expert's testimony was consistent with the disclosure in the Toner reference and did not "provide missing disclosure of the claimed invention."  In like manner, the panel rejected Wilson's arguments regarding differences between "air" as disclosed in the Toner reference and "ambient gas" recited in its claims, based on its previous rejection of Wilson's argument (reiterated here) that Toner required a gas tank, and again in reliance on Martin's expert declarations.

Turning to the question of judicial estoppel (that "where a party successfully urges a particular position in a legal proceeding, it is estopped from taking a contrary position in a subsequent proceeding where its interests have changed," citing Data Gen. Corp. v. Johnson, 78 F.3d 1556, 1565 (Fed. Cir. 1996) (citing Davis v. Wakelee, 156 U.S. 680, 689 (1895)), the panel states that the Board has the authority to apply the doctrine.  The opinion then sets forth the factors to be considered in deciding to apply judicial estoppel:

(1) whether a party's later position is "clearly inconsistent" with its earlier position; (2) whether a court has accepted the party's prior position, such that accepting its "inconsistent position in a later proceeding would create the perception that either the first or the second court was misled"; and (3) whether the party changing its position "would derive an unfair advantage or impose an unfair detriment on the opposing party if not estopped,"

citing New Hampshire v. Maine, 532 U.S. 742, 751 (2001).  The standard of review for this Board determination is abuse of discretion (an even more deferential standard) and the Federal Circuit held that the Board's decision here satisfied those criteria.  The opinion notes two distinctions in support of its decision.  The first is that the purported arguments made in the related prosecution were made regarding an embodiment of the Toner invention different from the ones at issue here (specifically, Figure 8b, rather than Figure 8a which the Board relied upon here).  The purportedly inconsistent argument is based, according to the opinion, on the different configuration of the two embodiments and are thus not inconsistent and do not raise the estoppel.  The second basis for finding no abuse of discretion is that "Martin's current position is not clearly inconsistent with Corning's prior statements because those statements were made in a different context and were part of a different evidentiary record," specifically that the claims in the earlier, related patent were directed to the structural components of the apparatus rather than methods for culturing cells with it.  Indeed, according to the panel opinion the claims of this earlier patent did not recite the "ambient gas" limitation.  Finally, the Court held that the differences in context between ex parte examination and the interference here (specifically the expert testimony) was sufficient to support the conclusion that the Board did not abuse its discretion.

Of course, anyone familiar with interference practice will recognize that a finding of anticipation of one party's claims in interference will usually result in the moving party's claims also being held to be anticipated, and that is the final conclusion in the opinion, i.e., all claims in interference were held anticipated by the Toner reference.  The Federal Circuit, at least, awarded Martin its costs.

Wilson v. Martin (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Reyna and Stoll
Opinion by Circuit Judge Reyna

Quest USA Corp. v. PopSockets LLC (PTAB 2019)

Functional Language in Device Claim Ignored for Patentability Purposes

By Joseph Herndon --

The U.S. Patent and Trademark Office Patent Trial and Appeal Board recently issued a decision indicating that certain claims of a patent directed to the popular PopSockets are invalid.  In Quest USA Corp. (Petitioner) v. PopSockets LLC (Patent Owner) (Case IPR2018-00497), the PTAB determined that Quest showed, by a preponderance of the evidence, that claims 9–11, 16, and 17 ("challenged claims") of U.S. Patent No. 8,560,031 are unpatentable.

Quest filed a Petition for inter partes review of claims 9–11, 16, and 17 of the '031 patent based on the five different grounds.  Only one is discussed below—namely, claims 9–11, 16, and 17 as being anticipated by UK Patent Application GB 2 316 263 (Grinfas).

The '031 Patent

The '031 patent, entitled "Extending Socket for Portable Media Player," was filed on February 23, 2012.  The '031 patent specification describes extending sockets for attaching to the back of a portable media player or media player case.

Figure 3A illustrates a preferred embodiment of the socket in an accordion shape in its expanded configuration.

Of the challenged claims, claims 9 and 16 are independent, and claim 9 is representative and reproduced below.

9.  A socket for attaching to a portable media player or to a portable media player case, comprising:
    a securing element for attaching the socket to the back of the portable media player or portable media player case; and
    an accordion forming a tapered shape connected to the securing element, the accordion capable of extending outward generally along its [axis] from the portable media player and retracting back toward the portable media player by collapsing generally along its axis; and
    a foot disposed at the distal end of the accordion.

Overview of Grinfas

Grinfas relates to a collapsible sound conduit for attaching to a cellular telephone earpiece.  Grinfas states that a concern had arisen regarding the safety of users of portable hand-held cellular telephones, namely with regard to radiation emitted by such telephones.  To address such concern, Grinfas discloses a collapsible sound conduit placed between the telephone's earpiece and the user's ear, for enabling a user to maintain the telephone at a spaced distance away from the user's head to reduce radiation exposure while nevertheless maintaining an acceptable level of hearing.

Grinfas discloses that the collapsible sound conduit can be "attached to either the telephone or the carrying case," by bonding or fastening.

Figure 2 of Grinfas (shown below), shows an example of the collapsible sound conduit in use.  Figure 3 of Grinfas (shown below) shows a cellular telephone 40 and collapsible sound conduit 42, wherein conduit 42 includes adhesive pad 46 for bonding the conduit to earpiece 44 of telephone 40.

Petitioner identified the collapsible sound conduit as the asserted socket for attaching to a portable media player or portable media player case.

Patent Owner disputed Petitioner's assertions that Grinfas discloses "a securing element" and "an accordion," as those terms are used in the claim.

The Board found that with regard to the recitation in claim 9 that the socket comprises "a securing element for attaching the socket to the back of the portable media player or portable media player case" ("securing element limitation"), there is no genuine dispute that Grinfas discloses the recited structure, namely "a securing element."  However, the parties disputed whether the remaining language, "for attaching the socket to the back of the portable media player or portable media player case," recites 1) functional language that must be given patentable weight, or 2) an intended use that is not limiting.

As the Patent Owner pointed out, Grinfas describes attaching the collapsible sound conduit to the front of the telephone, whereas claim 9 recites a securing element for attaching the socket to the back of a portable media player.

The Board pointed to a number of Federal Circuit decisions, in which the Court stated that in an apparatus claim, "choosing to define an element functionally, i.e., by what it does, carries with it a risk."  This is because it is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable.  This finds support from the notion that an apparatus claim covers what a device is, not what a device does.  Thus, "[w]here all structural elements of a claim exist in a prior art product, and that prior art product is capable of satisfying all functional or intended use limitations, the claimed invention is nothing more than an unpatentable new use for an old product."  Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 654 (Fed. Cir. 2011).

Thus, the Board found that because Grinfas discloses securing structures that are inherently capable of performing the function of attaching the asserted socket to the back of the portable media player, it has supporting disclosure for the limitation "a securing element for attaching the socket to the back of the portable media player or portable media player case."

The Patent Owner argued that the issue is not whether Grinfas' securing structures would adhere the conduit to the back of a phone, but rather was whether Grinfas discloses attaching the conduit to the back of a phone.  Therefore, Patent Owner's argument was not about whether Grinfas' securing structures are capable of attaching a conduit to the back of a phone, but rather was about whether Grinfas discloses the function of attaching to the back of a phone.  The Patent Owner argued that an expert declaration failed to provide evidence that the claimed function is necessarily present in Grinfas, and that expert testimony, without (additional) evidence is insufficient to establish inherency.

The Board disagreed that the Petitioner failed to establish inherency.  In particular, the Board disagreed that the Petitioner is required to show that the claimed function is actually performed or must be performed when the full structure is described.

Thus, despite the cited art failing to describe the full use of the structure, as recited in the claim, and also being directed to a clearly different use altogether, it was found to anticipate the claim because the structure in Grinfas was capable of performing the recited use.

As a result, because Grinfas discloses a securing element inherently capable of being attached to the back of a portable media player, the Board found that Grinfas discloses the securing element limitation.  Thus, the Board determined that Petitioner demonstrated, by a preponderance of the evidence, that claim 9 is anticipated by Grinfas.

Panel: Administrative Patent Judges Zado, Kaiser, and Margolies
Final Written Decision by Administrative Patent Judge Zado