Patent Docs: Definiteness

Definiteness

January 04, 2016

September 09, 2015

Media Rights Technologies, Inc. v. Capital One Financial Corp. (Fed. Cir. 2015)

Broad Claim Terms and Inadequate Support in Specification Render Patent Invalid

In Media Rights Technologies, Inc. v. Capital One Financial Corp. (September 4, 2015), the Federal Circuit first transformed a broadly described element in a claim into a means-plus-function claim term, and then found the disclosure to be inadequate for the term rendering the claims indefinite under § 112.

When claim drafting, a patentee must be mindful that 35 U.S.C. § 112, ¶ 6 can be invoked in many ways. Even when unintended, if inadequate structure is recited in the claim, or broad/vague claim terms are used, 35 U.S.C. § 112, ¶ 6 can rear its head.

In this case, Media Rights sued Capital One alleging infringement of U.S. Patent No. 7,316,033 (the "'033 Patent"). The '033 Patent is generally directed to preventing illegal copying or sharing of copyrighted media.

Claim 1 is illustrative of the invention, and it recites:

A method of preventing unauthorized recording of electronic media comprising:
    activating a compliance mechanismin response to receiving media content by a client system, said compliance mechanismcoupled to said client system, said client system having a media content presentation application operable thereon and coupled to said compliance mechanism;
    controlling a data output pathway of said client system with said compliance mechanismby diverting a commonly used data pathway of said media player application to a controlled data pathway monitored by said compliance mechanism; and
    directing said media content to a custom media devicecoupled to said compliance mechanismvia said data output path, for selectively restricting output of said media content.

The District Court concluded that (1) the term "compliance mechanism" is indefinite and, (2) because every claim of the '033 Patent contained the term, all of the claims of the '033 Patent are invalid.

Claim Term – "compliance mechanism"

With respect to the "compliance mechanism" claim term, the District Court found that the claim language itself stated that the "compliance mechanism" was activated in response to the client system receiving media content, that it controlled a data output path, and that it monitored a controlled data pathway. Because this language only describes how the components of the invention are combined and the functions performed by the "compliance mechanism," without suggesting anything about the structure of the mechanism itself, the District Court determined that the claim language did not recite sufficient structure for the "compliance mechanism" term itself, and so the term must be a means-plus-function term. Next, following basic means-plus-function claim construction, the District Court considered what functions it performs, and then determined what structure identified in the specification performs these functions. Four functions were identified in the claims as being performed by the "compliance mechanism":

(1) "controlling a data output of [the] client system . . . by diverting a commonly used data pathway of [the] media player application to a controlled data pathway" (Claim 1);
(2) monitoring the controlled data pathway (Claims 1, 10 and 19);
(3) "managing an output path of [the] client system . . . by diverting a commonly used data pathway of [the] media player application to a controlled data pathway" (Claim 10); and
(4) "stop[ping] or disrupt[ing] the playing of [the] media content at [the] controlled data pathway when said playing of said media file content is outside of [the] usage restriction applicable to said media file" (Claims 10 and 19).

Because the structure for computer-implemented functional claims must be supported by a specific algorithm, and the specification here failed to describe "an algorithm whose terms are defined and understandable," the District Court determined that the "compliance mechanism" term is indefinite for lack of written description support.

Is "compliance mechanism" a means-plus-function claim term?

On its face, the claim term "compliance mechanism" does not seem like it would invoke § 112, ¶ 6, since the claim lacks the traditional "means for . . ." claim language.

For claim terms that use "means for . . ." language, it is presumed that § 112, ¶ 6 applies, and the opposite is true as well -- for claim terms lacking the word "means for . . .", it is presumed that § 112, ¶ 6 does not apply. However, the presumption that § 112, ¶ 6 does not apply can be overcome if a party can "demonstrate[] that the claim term fails to 'recite sufficiently definite structure' or else recites 'function without reciting sufficient structure for performing that function.'"

MPEP § 2181 describes a general three prong analysis to determine if § 112, ¶ 6 is invoked:

1. Does the claim use magic phrase "means for" or "steps for"?
2. Is the "means for" modified by functional language? and
3. Does the phrase "means for" lack any modification by structure, material or acts for achieving the specified function?

Here, even though the magic "means for . . ." terms were not used, the Federal Circuit found that the claims do not use the term "compliance mechanism" as a substitute for an electrical circuit, or anything else that might connote a definite structure. Rather, the claims simply state that the "compliance mechanism" can perform various functions. Therefore, the phrase "compliance mechanism" lacks any modification by structure, and was instead, used for pure functional claiming.

Consequently, the claim term was interpreted as a means-plus-function claim term, and then held indefinite by the Federal Circuit because nowhere does the specification define "compliance mechanism" in specific structural terms. The Federal Circuit found that description alone of how the "compliance mechanism" is connected to and interacts with the other components of the system, what processes the "compliance mechanism" performs, and what structural subcomponents might comprise the "compliance mechanism" is insufficient to avoid the application of § 112, ¶ 6. Input and output "mechanisms" will not provide the necessary written description support for the component itself.

Here, because the specification does not disclose a specific algorithm for all of the four recited functions associated with the "compliance mechanism" means-plus-function claim limitation, it is treated as if the specification has no supporting algorithm disclosed at all. For the specific claim language, the specification fails to disclose an operative algorithm for both the "controlling data output" and "managing output path" functions. These two functions both require diverting a data pathway. The cited algorithm by Media Rights does not explain how to perform the diverting function, making the disclosure inadequate.

The Federal Circuit concluded that the claim term "compliance mechanism" is indefinite, and thus, the Federal Circuit did not need to address the additional arguments that the "custom media device" term is not indefinite, or Capital One's alternative argument that the District Court's invalidity decision also can be affirmed on 35 U.S.C. § 101 grounds.

In this case, the Federal Circuit followed well-established case law that provides a strict requirement for how to describe and claim a "means for [performing] . . ." a specific computer-implemented function. Disclosure of only a general purpose computer as structure for a function in a means-for claim term amounts to pure functional claiming, and will result in the claim being found to be indefinite. Thus, a specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer for adequate support for the means-for claim term. The algorithm must describe, in detail, how to perform each of the recited claim functions.

Notably, in the decision, the Federal Circuit stated that "[w]e have never found that the term 'mechanism' -- without more -- connotes an identifiable structure." Certain claim terms, such as "mechanism" or "module" often are found by courts to invoke § 112, ¶ 6. As a practice tip, if it is the intention of the claim drafter to avoid § 112, ¶ 6, it seems a good idea to avoid use of the magic "means for . . ." language, as well as the problematic vague terms "mechanism" and "module". Sometimes using these terms, while written with good intention hoping to provide broad claim scope, can cause undesirable claim interpretation. However, if such terms are used, dependent claims can further define the specific structure of what comprises the "module" or "mechanism" for backup support.

While the Federal Circuit found the claims invalid due to indefiniteness, it would have been interesting to see if such claims could have survived the § 101 challenge.

Media Rights Technologies, Inc. v. Capital One Financial Corp. (Fed. Cir. 2015)
Panel: Circuit Judges O'Malley, Plager, and Taranto
Opinion by Circuit Judge O'Malley

Posted at 11:59 PM in Definiteness, Federal Circuit, Written Description | Permalink | Comments (1)

July 07, 2015

Eon Corp. IP Holdings LLC v. AT&T Mobility LLC (Fed. Cir. 2015)

By David Grosby and Michael Borella --

On September 23, 2010, Eon filed suit against seventeen defendants in the District Court of the District of Delaware, alleging infringement of U.S. Patent No. 5,663,757. During the case, the '757 patent went through two reexaminations. The claims were amended in the first reexamination, and then confirmed valid as amended in the second reexamination. After the reexaminations, the District Court granted summary judgment for the defendants, holding that all claims of the '757 patent were indefinite under 35 U.S.C. § 112 ¶ 6.

Eon appealed. On May 6, 2015, Chief Judge Prost of the Federal Circuit authored a decision clarifying the structure that patentees must disclose when using means-plus-function language in software patents. Judges Newman and Bryson joined the opinion.

The '757 patent is directed to software embodied in a "local subscriber data processing station that operates in tandem with a television to interconnect various interactive features of the television." The software supports actions including "impulse purchase transactions with immediate payment, audience participation voting, and sorting television programs by theme." Eon's infringement position centered on the defendants' alleged manufacture and use of a smartphone as a modern iteration of the '757 patent's local subscriber data processing station.

Example claim terms that were held to be indefinite include "means under control of said replaceable software means for indicating acknowledging shipment of an order from a remote station" (claim 7); and "means controlled by replaceable software means operable with said operation control system for . . . reconfiguring the operation modes by adding or changing features and introducing new menus" (claims 1-6, 8-10).

35 U.S.C. § 112 ¶ 6 states that if the patentee uses means-plus-function claim limitations, the claims will be construed to cover only the corresponding structure in the specification and the equivalents thereof. It is well-settled that the "structure" for functions performed by software is the particular algorithm that performs these functions, rather than just the computer hardware that the software runs on. In Aristocrat Techs. Austl. Pty Ltd. v. Int'l Game Tech., the Federal Circuit stated that "in cases involving a computer-implemented invention in which the inventor has invoked means-plus-function claiming, this court has consistently required that the structure disclosed in the specification be more than simply a general purpose computer or microprocessor." There is one narrow exception to this rule, as explained in In re Katz Interactive Call Processing Patent Litigation, that a standard microprocessor can serve as a sufficient structure if the functions claimed "can be achieved by any general purpose computer without special programming."

While Eon did not dispute that the '757 patent failed to disclose an algorithm, it did attempt to invoke the Katz exception. But, the Federal Circuit had only analyzed this exception once, finding that it did not apply. In Ergo Licensing, LLC v. CareFusion 303, Inc., the Court held that "[i]t is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed." Eon attempted to distinguish this case by claiming the '757 patent does not involve any "special programming" because it is relatively simple to implement.

The Federal Circuit rejected this contention, stating a microprocessor can only serve as the structure if the claimed function is "coextensive" with a microprocessor itself. The Court's three examples of coextensive functions are receiving data, storing data, and processing data. The Court followed this reasoning to hold "[a] microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor . . . [a]ll other computer-implemented functions require disclose of an algorithm."

The Court further stated that the purpose of § 112 ¶ 6 is to "limit . . . the scope of the claim to the particular structure disclosed, together with equivalents." Eon contradicted this purpose, because claiming a general purpose computer or microprocessor does little or nothing to limit the ways in which the claimed functions can be implemented. Thus, "when a patentee invokes means-plus-function claiming to recite a software function, it accedes to the reciprocal obligation of disclosing a sufficient algorithm as corresponding structure."

Eon did not argue that the functions at issue are coextensive with those of a microprocessor, and its expert stated that a person skilled in the art would need to consult algorithms outside the specification to implement the claimed functions. As a result, the Federal Circuit found that the mere disclosure of a microprocessor was insufficient for the '757 patent, and therefore the claims containing those terms are indefinite.

This case reiterates that an algorithm must almost always be disclosed in the specification if the patentee is using means-plus-function claiming. The narrow interpretation of the Katz exception will likely deter future parties from arguing that a general purpose computer or microprocessor serves as a sufficient structure for means-plus-function claim limitations. However, the Court still left the boundaries of the Katz exception undefined. Microprocessors are also capable of carrying out tasks such as adding, subtracting, multiplying, and dividing numbers, as well as moving data. Most microprocessors are also capable of floating point and even graphics operations. Since the Court seems to have limited the Katz exception to only "basic functions" of a microprocessor, it remains unclear where the Court would draw the line between such a basic function and one that is more advanced. Thus, the Court has left room -- albeit not much -- for parties using more advanced functions to argue that these functions are supported by standard microprocessors.

Eon Corp. IP Holdings LLC v. AT&T Mobility LLC (Fed. Cir. 2015)
Panel: Choef Judge Prost and Circuit Judges Newman and Bryson
Opinion by Chief Judge Prost

Posted at 11:59 PM in Definiteness, Federal Circuit | Permalink | Comments (0)

April 27, 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)

By Kevin E. Noonan --

The Federal Circuit considered the question of indefiniteness on remand from the Supreme Court's reversal in Nautilus v. Biosig and, perhaps not surprisingly, found again that the Biosig's claims were not indefinite.

To recap, this case involves claims to heart rate monitors on exercise equipment that determine heart rate by detecting electrocardiograph ("ECG") and subtracting the confounding electromyogram ("EMG") signals. Claim 1 of U.S. Patent No. 5,337,753 is illustrative:

1. A heart rate monitor for use by a user in association with exercise apparatus and/or exercise procedures, comprising:
    an elongate member;
    electronic circuitry including a difference amplifier having a first input terminal of a first polarity and a second input terminal of a second polarity opposite to said first polarity;
    said elongate member comprising a first half and a second half;
    a first live electrode and a first common electrode mounted on said first half in spaced relationship with each other;
    a second live electrode and a second common electrode mounted on said second half in spaced relationship with each other;
    said first and second common electrodes being connected to each other and to a point of common potential . . .
    whereby, a first electromyogram signal will be detected between said first live electrode and said first common electrode, and a second electromyogram signal, of substantially equal magnitude and phase to said first electromyogram signal will be detected between said second live electrode and said second common electrode; so that, when said first electromyogram signal is applied to said first terminal and said second electromyogram signal is applied to said second terminal, the first and second electromyogram signals will be subtracted from each other to produce a substantially zero electromyogram signal at the output of said difference amplifier.

(where the italicized term "in spaced relationship" was at issue in the indefiniteness determination).

In the earlier proceedings in this litigation, the District Court had found the term "in spaced relationship" indefinite as a matter of law. The Federal Circuit reversed, using its "insolubly ambiguous" test enunciated in Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed. Cir. 2005), to hold that the claim was amenable to construction and thus not indefinite. Relevant to its decision on remand, the Court held that "[c]onsidering the 'intrinsic evidence,' we found that it provided 'certain inherent parameters of the claimed apparatus, which to a skilled artisan may be sufficient to understand the metes and bounds of 'spaced relationship.'" But the Supreme Court rejected this standard, holding that "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty those skilled in the art about the scope of the invention," according to the Court, and reversed and remanded for reconsideration by the Federal Circuit under this standard.

On remand the Federal Circuit again reversed the District Court's indefiniteness determination, in an opinion by Judge Wallach joined by Judges Newman and Schall. The opinion noted that its review is plenary on questions of law, such as indefiniteness, but that its review is based on how the claims are construed. For claim construction, the Federal Circuit's review falls within the framework set forth by the Supreme Court in Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 842 (2015), where conclusions of law are reviewed de novo but findings of fact ("based on extrinsic evidence") are reviewed using a "clear error" standard. However, the opinion also stated that, provided that the District Court's construction as based solely on the intrinsic evidence there are no "facts" to be found and, thus, the Federal Circuit can apply de novo review.

Regarding the question of indefiniteness, the opinion cited precedent that "words of degree" used in a claim are not per se indefinite but depends on "whether the patent provides 'some standard for measuring that degree.'" Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984). Nor did the panel believe that the Supreme Court's Nautilus decision was to the contrary, as the Court stated in Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014) ("Claim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention.") Moreover, the opinion asserted that whether a claim limitation recited in functional language was indefinite was "highly dependent on context," i.e., the disclosure in the specification and the knowledge of those skilled in the art, citing Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008).

The panel acknowledged that the Supreme Court had changed the standard in Nautilus, but also referenced the Court's recognition of "competing interests" (i.e., the inherent ambiguities in language and the need for sufficient certainty for the claims to satisfy their notice function), as well as the policy consideration that the definiteness requirement counters "powerful incentives to inject ambiguity into [patent] claims." These considerations resulted, according to the panel, in the "reasonable certainty" standard that the Supreme Court mandated the Federal Circuit to apply in this case.

Turning to the claims on appeal, the opinion sets forth the parties' reasoning, wherein Nautilus contended that the Supreme Court set out a "new, stricter standard" which requires the Federal Circuit to affirm the District Court's indefiniteness conclusion. According to Nautilus, the intrinsic evidence "point[s] in two opposite directions" and thus the claims are indefinite. Biosig, on the other hand, argued that "reasonable certainty" is not a new standard but rather requires a "degree of clarity" consistent with a century of precedent and that the Federal Circuit's enunciation of its insolubly ambiguous standard "could send the wrong message to district courts and the patent bar."

With regard to the "reasonable certainty" standard, the panel cite (in footnotes) copious precedent for "reasonableness" in its own, Supreme Court, and other courts' cases far afield of patent law (including Palsgraf v. Long Island R.R. Co., 162 N.E. 99 (N.Y. 1928)), and then turned to how it had interpreted the "reasonable certainty" standard in DDR Holdings, LLC v. Hotels.com, 773 F.3d 1245, 1260–61 (Fed. Cir. 2014), and Interval Licensing in particular:

We do not understand the Supreme Court to have implied in Nautilus [II], and we do not hold today, that terms of degree are inherently indefinite. . . . Although absolute or mathematical precision is not required, it is not enough as some of the language in our prior cases may have suggested to identify "some standard for measuring the scope of the phrase." . . . The patents' "unobtrusive manner" phrase is highly subjective, and, on its face, provides little guidance to one of skill in the art. . . . The patents contemplate a variety of stimuli that could impact different users in different ways. As we have explained, a term of degree fails to provide sufficient notice of its scope if it depends on the unpredictable vagaries of any one person's opinion.

With these precedents in mind, the panel concluded that Biosig's claims were not indefinite. The opinion reminds that the Court did not express an opinion regarding whether Biosig's claims were indefinite (and thus, impliedly, that it was not constrained by that decision to come to a different conclusion under the Court's standard). The opinion also asserts that the District Court had relied entirely on the intrinsic evidence in construing the claims related to rendering its indefiniteness determination, and thus that its review was entirely de novo.

Returning to the grounds for its earlier decision reversing the District Court, the panel states that "[w]e noted an ordinarily skilled artisan would be able to determine this language requires the spaced relationship to be neither infinitesimally small nor greater than the width of a user's hands." Further:

[T]he district court is correct that the specification of the '753 patent does not specifically define "spaced relationship" with actual parameters, e.g., that the space between the live and common electrodes is one inch. Nevertheless, the '753 patent's claim language, specification, and the figures illustrating the "spaced relationship" between the live and common electrodes are telling and provide sufficient clarity to skilled artisans as to the bounds of this disputed term. For example, on the one hand, the distance between the live electrode and the common electrode cannot be greater than the width of a user's hands because claim 1 requires the live and common electrodes to independently detect electrical signals at two distinct points of a hand. On the other hand, it is not feasible that the distance between the live and common electrodes be infinitesimally small, effectively merging the live and common electrodes into a single electrode with one detection point. See '753 patent col. 3 ll. 26–31 (describing how each hand is placed over the live and common electrodes so that they are "in physical and electrical contact with both electrodes").

The prosecution history was not to the contrary according to the opinion, particularly with regard to the whereby clause in claim 1 that was used during reexamination to over come rejection. This clause "describes the function of substantially removing EMG signals that necessarily follows from the previously-recited structure consisting of the elongate member, the live electrode, and the common electrode" and:

The EMG signal is detected between the live and common electrodes, which are in a "spaced relationship" with each other. Even more significantly, the PTO examiner found this function to be "crucial" as a reason for overcoming the cited prior art and confirming the patentability of the asserted claims upon reexamination. . . . Thus, the recitation of this function in claim 1 is highly relevant to ascertaining the proper bounds of the "spaced relationship" between the live and common electrodes.

The panel thus concluded:

In this case, a skilled artisan would understand the inherent parameters of the invention as provided in the intrinsic evidence. The term "spaced relationship" does not run afoul of "the innovation-discouraging 'zone of uncertainty' against which [the Supreme Court] has warned," and to the contrary, informs a skilled artisan with reasonable certainty of the scope of the claim [citing Interval Licensing, 766 F.3d at 1374 (quoting Nautilus II, 134 S. Ct. at 2130)].

Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)
Panel: Circuit Judges Newman, Schall, and Wallach
Opinion by Circuit Judge Wallach

Posted at 11:59 PM in Definiteness, Federal Circuit | Permalink | Comments (0)

January 06, 2015

June 03, 2014

Nautilus, Inc. v. Biosig Instruments, Inc. (2014)

By Kevin E. Noonan --

In the universe of the toxic interplay between the Federal Circuit and the Supreme Court, an affirmance or even a begrudging acknowledgement of the Federal Circuit's "special expertise" in patent law has become as rare as the apocryphal newspaper headline "Man bites dog." Once again, in an opinion rendered yesterday in Nautilus, Inc. v. Biosig Intruments, Inc., the mythical patent law dog is safe: the Court predictably reversed and in doing so overruled the lower court's "insolubly ambiguous" standard for patent claim indefiniteness.

The facts are unremarkable. The claims at issue were directed towards components of exercise equipment that enabled the user to detect her heart rate during exercise using sensors placed in such a way that the signals from skeletal muscles in motion (the electromyogram signals) don't interfere with or mask the signals from the heart (the electrocardiogram or ECG). The patent-in-suit, U.S. Patent No. 5,337,753, disclosed methods and apparatus that take advantage of the difference in polarity between the right hand and the left hand exhibited by the ECG that is absent in the signals detected as the EMG. Accordingly, the ECG can be detected by eliminating the EMG signals based on this polarity difference. The claim term at issue related to the relative placement of electrodes, specifically that they are "mounted . . . in spaced relationship with each other." Exactly how these electrodes are so spaced was asserted by the patentee to be the result of a "trial and error" process to adapt the invention to different exercise machines having different configurations, inter alia, of the positions of the handgrips on the machine.

The dispute between the parties related to the proper construction of the claim term "in spaced relationship with each other." Biosig's interpretation was that the phrase meant the difference in spacing between the electrodes in each electrode pair, while Nautilus contended that the term meant a spacing "greater than the width of each electrode," based on the prosecution history of an ex parte re-examination provoked by Nautilus. The District Court construed the claims in the absence of any reliance on electrode width, deciding that the term meant that there was a "defined relationship" between the electrodes on the sensor for one hand that was the same as the defined relationship between the electrodes on the other hand. Based on this construction, the District Court granted Nautilus's motion for summary judgment that the claims were indefinite, finding that the term "did not tell [the court] or anyone what precisely the space should be," or "even supply 'any parameters' for determining the appropriate spacing." The Federal Circuit reversed, in a ruling that applied the "insoluably ambiguous" test first enunciated by that Court in Datamize, LLC v. Plumtree Software, Inc., 417 F. 3d 1342, 1347 (Fed. Cir. 2005). As characterized in the Supreme Court's opinion, the Federal Circuit held that the intrinsic evidence surrounding the claim term contained "certain inherent parameters of the claimed apparatus, which to a skilled artisan may be sufficient to understand the metes and bounds of 'spaced relationship.'" (These properties related to the disclosure that the electrodes must detect signals from two distinct points on each hand, so that the "spaced relationship" could not be greater than the width of user's hand, nor could the distance be "infinitesimally small, effectively merging the [two] electrodes into a single electrode with one detection point.")

The Supreme Court vacated this judgment and remanded to the Federal Circuit, in a unanimous (what else?) opinion written by Justice Ginsberg. The Justice noted that the parties held several principles regarding indefiniteness in common:

• "First, definiteness is to be evaluated from the perspective of someone skilled in the relevant art," citing General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938) and the words of Section 112, second paragraph of the Patent Act.

• "Second, in assessing definiteness, claims are to be read in light of the patent's specification and prosecution history," citing United States v. Adams, 383 U.S. 39, 48-49 (1966) (specification) and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U. S. 722, 741 (2002) (prosecution history).

• "Third, "[d]efiniteness is measured from the viewpoint of a person skilled in [the] art at the time the patent was filed," citing the Respondent's Brief and E. Manzo [(ed.)], Patent Claim Construction in the Federal Circuit §0.2, p. 9 (2014).

The difference in the parties' views, according to the opinion, is in "just how much imprecision §112, ¶2 tolerates," with Nautilus espousing the view that a claim is indefinite when "readers could reasonably interpret the claim's scope differently," while Biosig (and the Solicitor General) contended that "the patent provide reasonable notice of the scope of the claimed invention" in order to satisfy the statutory standard.

The Court discerned that the statutory section "entails a 'delicate balance,'" citing Festo, wherein "[o]n the one hand, the definiteness requirement must take into account the inherent limitations of language," while on the other hand "a patent must be precise enough to afford clear notice of what is claimed, thereby " 'appris[ing] the public of what is still open to them,'" citing Markman v. Westview Instruments, 517 U.S., at 373 quoting McClain v. Ortmayer, 141 U.S. 419, 424 (1891). The considerations involved in the "inherent limitations of language" include that there is a "modicum of uncertainty" that is necessary to encourage innovation in view of the target audience of the patent claim, which are "'not addressed to lawyers, or even to the public generally,' but rather to those skilled in the relevant art," citing Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 437 (1902). Nevertheless, this inherent ambiguity cannot become so great that it creates a "zone of uncertainty" around the patent claims, which would discourage innovation without any benefit to the public says the Court, citing United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). And the Court also apparently was persuaded (at least to some degree) that "patent applicants face powerful incentives to inject ambiguity into their claims" unless countervailing disincentives (in the form of being put at risk of being invalidated) are in place, citing (predictably) to Petitioner Nautilus's brief but also to a Federal Trade Commission report, The Evolving IP Marketplace: Aligning Patent Notice and Remedies With Competition 85 (2011), regarding "testimony that patent system fosters 'an incentive to be as vague and ambiguous as you can with your claims' and 'defer clarity at all costs,'" statements that even the FTC does nothing more than quote.

Being "[c]ognizant of the competing concerns," the Court announced its test for indefiniteness (citing Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 270 (1916)(other citations omitted)):

[W]e read §112, ¶2 to require that a patent's claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty. The definiteness requirement, so understood, mandates clarity, while recognizing that absolute precision is unattainable. The standard we adopt accords with opinions of this Court stating that "the certainty which the law requires in patents is not greater than is reasonable, having regard to their subject-matter."

The Court's justification for adopting this test, over the Federal Circuit's "insolubly ambiguous" test, is that the Federal Circuit's test would "breed lower court confusion," an ironic statement from a Court whose recent patent law decisions have bred so much confusion that even the Court having "special expertise" in patent law has been seriously befuddled in attempting to apply their decisions (see the Federal Circuit's en banc opinion in CLS Bank v. Alice). Further, the Court's opinion asserts that claim terms must be unambiguous at the time the patent is granted to a person skilled in the art and "not [to] a court viewing matters post hoc." The Court asserts that the consequence of upholding the "insolubly ambiguous" test would be to 'diminish the definiteness requirement's public-notice function and foster the innovation-discouraging "zone of uncertainty," citing again the Court's Union Carbide decision.

However, while the Court evinces no (express) interest in "micromanaging" the Federal Circuit, it "must ensure that the Federal Circuit's test is at least 'probative of the essential inquiry,'" citing Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 40 (1997). Finding that the lower court's current test for indefiniteness does not meet this standard, the opinion stated that the Court "agree[s] with Nautilus and its amici that such terminology can leave courts and the patent bar at sea without a reliable compass" and reversed. The Court was in no mood to actually apply the "reasonable certainty" test it created, however; instead, the Court remanded the matter to the Federal Circuit to "reconsider, under the proper standard, whether the relevant claims in the '753 patent are sufficiently definite, " citing Johnson v. California, 543 U.S. 499, 515 (2005).

This is a decision that raises the question of why the Court even bothered to make the effort, except for its apparent knee-jerk impulse to want to school the Federal Circuit once again regarding its interpretation of patent law. The patent community can take some measure of comfort that the Court recognizes the difficulties in translating the tangible fruits of innovation into patent claims, in language reminiscent of the Court's consideration of these difficulties in Graver Tank v. Linde Air Products, 339 U.S. 605 (1950):

In determining whether an accused device or composition infringes a valid patent, resort must be had in the first instance to the words of the claim. If accused matter falls clearly within the claim, infringement is made out and that is the end of it.

But courts have also recognized that to permit imitation of a patented invention which does not copy every literal detail would be to convert the protection of the patent grant into a hollow and useless thing. Such a limitation would leave room for -- indeed encourage -- the unscrupulous copyist to make unimportant and insubstantial changes and substitutions in the patent which, though adding nothing, would be enough to take the copied matter outside the claim, and hence outside the reach of law. One who seeks to pirate an invention, like one who seeks to pirate a copyrighted book or play, may be expected to introduce minor variations to conceal and shelter the piracy. Outright and forthright duplication is a dull and very rare type of infringement.

But in other ways the Court's opinion (which does so little to define what is "reasonable certainty" in patent claim drafting under its newly enunciated test) raises tensions with other areas of patent law. For example, although the opinion emphasizes that the meaning of claim terms is directed not to judges but to the worker of ordinary skill, the Court has also mandated that courts, including the Federal Circuit, construe the meaning of claim terms as a matter of law (Markman). In practice, lawyers write freedom-to-operate and patentability opinions, and district court judges write their opinions, with an eye towards review by trial courts and the Federal Circuit, respectively, and thus how claim terms appear to lawyers and judges is an important consideration. Pretending does not make it so, and the Court here has raised legitimate questions regarding whether claim indefiniteness is to be determined as a matter of law by the court in construing claims, or by determining (purportedly using expert testimony) whether the skilled worker would understand the term and the claim thus "inform[s] the skilled worker with reasonable certainty" what the claim terms mean. Thus, there is now another opportunity for the Federal Circuit to "get it right" on this patent requirement, until the next time the Court decides that its test, rather than the Federal Circuit's next test, is the test that all courts must apply.

Hat tip to Greg Ahorenian regarding the tension between these two areas of the Supreme Court's jurisprudence.

Nautilus, Inc. v. Biosig Instruments, Inc. (2014)
Opinion of the Court by Justice Ginsburg

Posted at 11:59 PM in Definiteness, Supreme Court | Permalink | Comments (7)

May 18, 2014

In re Packard (Fed. Cir. 2014)

By Kevin E. Noonan --

Oft times it appears that, serendipitously or by design, the Federal Circuit issues an opinion on an aspect of patent law that the Supreme Court is also considering. And sometimes the shadow of the Court's impending decision, like an unobserved new planet or dark star bends the appellate court's decisions in ways consistent with the likely view of the law expected to issue from the Court (because the Supreme Court rarely grants certiorari in an appeal from a Federal Circuit decision just to affirm). In its decision in the Packard case, the Federal Circuit takes a different tack, relying on the differences in how a claim's compliance with the patent statute's indefiniteness standard is assessed during prosecution compared with the "insolubly ambiguous" standard now under Supreme Court review in Nautilus v. Biosig. Incredibly, the panel asserts that the Court has never addressed this question of the proper pre-issuance indefiniteness standard that the Patent Office should apply.

The case arose as an appeal from the Patent Trial and Appeal Board's affirmance of the Examiner's final rejection for indefiniteness of the claims of Mr. Packard's patent application directed towards a coin change holder illustrated by Figures 1 and 2 from the application:

Claims 28, 29 and 34 were declared to be representative in the opinion:

28. I claim a small, thin, flat plane, rectangular change holding card and wallet/billfold or purse construction with the front top side of the card comprising three raised, straight, parallel, double flanged separators and two raised, straight, parallel, double flanged side edges and a raised side edge end thereby forming four parallel, side by side, flanged coin holding channels or rows of the same length and of different widths, one for quarters, one for dimes, one for nickels, and one for pennies, that are similarly blocked at one side edge by the raised side end edge with the other side of the channel/rows open except for small, fixed, flexible, partially moveable, rubber or plastic retainers that are attached to the topside and ends of the double flanged separators such that coins can be retained on the card and yet slide freely above the surface of the card and obliquely overlap as necessary within the channel/rows between the separators while the bottom, back side of the card is constructed with a wallet, billfold or purse extending from it.

29. The change holding card wallet, billfold, purse of claim 28, wherein the change holding card is constructed as part of the wallet, billfold, or purse and affixed to a surface and contained within the wallet, billfold or purse.

34. I claim a small thin uniformly flat plane rectangular coin holding card [c]omprising side edge retainers, a closed side retainer, small inclined/sloped end protrusions, multiple raised parallel, straight and double flanged channel/row separators, small flexible protruding retainers on the top side ends of the channel/row separators, all of which are arranged on the upper surface of the card such that a various denomination of coins can be held and retained on the card within a respective channel/row and can slide freely within the double flanges and slightly above the flat surface of the card and can also be stored obliquely partially overlapping.

The Examiner's rejections were based on the following terms, and the corresponding contrary rationales between the Applicant and the Office:

During prosecution the applicant refused to further disclose the meaning of these terms or their bases, and as a result the Examiner maintained her rejection that these terms were indefinite for being (merely) "unclear," pursuant to the Manual of Patent Examining Procedure (MPEP) § 2173.05(e). Before the Federal Circuit, as he had before the Board, the applicant maintained that the proper basis for rejecting claims under 35 U.S.C. § 112(b) was to apply the Federal Circuit's "insolubly ambiguous" standard, and further argued that under this standard if any meaning can be ascribed to the term(s) then the Office could not maintain an indefiniteness rejection.

The Federal Circuit disagreed, affirming the Patent Office's grounds of rejection in a per curiam opinion by a panel including Judges Plager, O'Malley, and Taranto. The panel cited the statutory provisions relating to what it termed "the USPTO's examination function (35 U.S.C. § 131) in applying the substantive law under § 112(b). As stated in Keystone Bridge Co. v. Phoenix Iron Co., 95 U.S. 274, 278 (1877), an applicant's "claim is, or is supposed to be, examined, scrutinized, limited, and made to conform to what he is entitled to" by the Office. Under prevailing Patent Office procedure, the process is iterative between the Office and an applicant, wherein the Office identifies deficiencies and failures to satisfy the statutory requirements of patentability in claims it examines and the applicant has the opportunity to amend, argue, or both in response. The panel noted that the Court has expressly approved this "procedural mechanism" in In re Piasecki, 745 F.2d 1468 (Fed. Cir. 1984), placing the initial burden of rejection (establishing a prima facie case) on the Office (through its examiners). That procedural approach is appropriate here, according to the Court.

In reviewing the question of indefiniteness, the panel noted that the basis for indefiniteness rejections during prosecution differ from the grounds that can be asserted after a patent has granted, citing Exxon Research & Eng'g v. United States, 265 F.3d 1370, 1380 (Fed. Cir. 2001). As a policy matter this makes sense, in the panel's view, due to the differences between the two circumstances (inter alia, the presumption of validity and the clear and convincing evidence standard for invalidating a granted claim, and without any consideration for the litigation standard -- the Court referencing that standard being under review in Nautilus, Inc. v. Biosig Instruments, Inc., 715 F.3d 891 (Fed. Cir. 2013), cert. granted, 82U.S.L.W. 3195 (U.S. Jan. 10, 2014) (No. 13-369)). This policy also protects the public interest, requiring a patentee to "notify the public of what is within the protections of the patent, and what is not," citing Merrill v. Yeomans, 94 U.S. 568, 573-74 (1876); and United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). But the panel noted the requirement does not compel claim language that operates with "mathematical precision" but rather is tailored to the claimed subject matter, citing Georgia-Pacific Corp. v. U.S. Plywood Corp., 258 F.2d 124, 136 (2d Cir. 1958) for this principle.

The panel also places the responsibility for claims lacking the statutorily required clarity on the applicant, stating that "[g]iven the role of the applicant in the process, it is a reasonable implementation of the examination responsibility, as applied to § 112(b), for the USPTO, upon providing the applicant a well-grounded identification of clarity problems, to demand persuasive responses on pain of rejection." "That approach decides this case," according to the panel, "because Mr. Packard did not offer a satisfactory response to well-grounded indefiniteness rejections in this case." And:

In some cases it is difficult enough for courts to construe claims when the draftsperson has made every effort to be clear and concise, let alone when the claims have readily observable ambiguities or incoherencies within them. Because Mr. Packard had an opportunity to bring clarity to his claim language, we affirm the Board's findings as to indefiniteness under the MPEP standard properly applied by the USPTO, the standard which we have here approved.

Judge Plager wrote separately because his view is that "a petitioner to this court seeking reversal of a decision is entitled to an explanation of why the arguments on which he relied for his appeal did not prevail" (and he believed that the per curiam opinion did not directly address the "significant" issues Mr. Packard raised). These involve the proper standards for indefiniteness, which Judge Plager writes the Supreme Court has considered "[a]s far back as 1853 in Brooks v. Fiske, 56 U.S. 212 (1853)" and concluded that "the overriding policy considerations [are] that claims must unambiguously define any invention over the prior art, and provide notice to the public." These considerations have been consistently applied by the Court, Judge Plager citing White v. Dunbar, 119 U.S. 47, 52 (1886), Merrill v. Yeomans, 94 U.S. 568, 570-74 (1887), Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 372 (1938), and United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942), in support of this proposition (as well as explicating all prior versions of the Patent Act back to 1836 as having the same requirements) ("throughout this history of patents, the statutory language regarding claim clarity remained largely unchanged, and indeed so did the understanding of what the statute requires").

Judge Plager also gets to the heart of Mr. Packard's argument, that the "insolubly ambiguous" standard for indefiniteness enunciated by the Federal Circuit in Exxon Research and Engineering Company v. United States, 265 F.3d 1371 (Fed. Cir. 2001), is the standard that must be applied by the Office during prosecution. That phrase, according to Judge Plager, was new, and the rest of the Federal Circuit's opinion hewed to the "traditional test for claim construction: whether the claims were so ambiguous that one of skill in the art could not reasonably understand their scope." Even this standard has not survived intact, according to Judge Plager, who cites the language from Datamize, LLC v. Plumtree Software, Inc., 417 F.3d. 1342,1347 (Fed. Cir. 2005), that "[s]ome objective standard must be provided in order to allow the public to determine the scope of the claimed invention." And to the extent that the "insolubly ambiguous" standard as "taken on a life of its own" it has also "generated considerable controversy (citing law review articles and blog posts).

But Judge Plager did not perceive it to be necessary to decide "whether the traditional test employed by courts for determining indefiniteness has or has not been modified or superseded by Exxon's 'insolubly ambiguous' phrase." Rather, he set forth the two types of difficulties in claim interpretation relevant to the definiteness question: whether a claim term is "incoherent" or whether it is ambiguous. The former results in a term that cannot be construed, because "there is no reasonably understandable meaning of the term in the context in which it appears." For such terms the skilled worker "cannot ascertain any reasonable meaning of the term as used" (emphasis in opinion). An ambiguous term, on the other hand, is just one that is subject to multiple reasonable meanings. This leads to the situation where there can be one of three choices in construing the term:

1) Give controlling weight to the policy of upholding the USPTO's decision to issue a presumptively valid patent, with substantially less concern for the notice function of patents.

2) Give weight to the notice function of patents, while still recognizing the role of the presumption of validity.

3) Give full weight to the importance of the notice function of patents, recognizing that it is the claim drafter/patentee who is ultimately responsible for problems created by ambiguous terms.

Judge Plager identifies the first of these options as being most consistent with the "insolubly ambiguous" standard. These considerations are used by courts post-issuance, according to Judge Plager; in contrast, the PTO's standard, as Judge Plager states it, is that ambiguity in claiming, whether intended or inadvertent, is not acceptable (a standard that comports most closely to the third option above). This standard "goes well beyond what this court is known to apply to claim interpretation when the issue is post-issuance compliance with § 112(b)" according to Judge Plager. But "it is within the authority of the USPTO to so interpret the applicable standard," in Judge Plager's view, and moreover "as a policy matter, [the Federal Circuit] should support the USPTO in so doing." Nothing in the statute precludes this application of the law by the Office, nor does any precedent from the Federal Circuit or the Court preclude the assertion of this standard. And cases such as In re Zletz, 863 F.2d 319 (Fed. Cir. 1989), and Halliburton Energy Servs., Inc. v. M-ILLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008), "highlighted the important role that the USPTO, through its examination process, plays in ensuring the quality of patents and compliance with the statutory requirements." In summary:

In short, there are no legal obstacles to the USPTO's proposed interpretation, and there are compelling reasons why, as a policy matter, this court should not preclude or otherwise interfere with the USPTO carrying out its full responsibilities under the Patent Act. Further, there is no reason why those trained and employed in the art of patent and patent claim drafting cannot comply with the USPTO requirements, recognizing that the nature of the invention and the particular art involved will affect the degree to which precision in language is possible.

Any efforts to improve the quality and clarity of patent claims should be encouraged, according to Judge Plager, who takes the time (in a portion of the opinion that illustrates how significantly the zeitgeist against patents has turned) to set forth a litany of "good reasons why unnecessary incoherence and ambiguity in claim constructions should be disapproved (citing many from the academy and other commentators critical of the patent system):

• they generate many of the claim construction disputes that plague the courts;

• they increase the cost to the society of new products and ideas. As one study put it, "[l]ow quality patents are those that protect inventions of limited novelty or that provide overly broad protection . . . ,which can be costly to society," citing Patents and Innovation: Trends and Policy Challenges, OECD, 28 (2004);

• they inhibit the opportunity for design-arounds and legitimate competition. A Federal Trade Commission Study observed that an overly broad patent "can block competition . . . and harm innovation," Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, A Report by the Federal Trade Commission, at 3 (October 2003);

• and they waste scarce judicial resources on claim construction cases that should never have been necessary to litigate, supporting and encouraging the kinds of litigation that have made "patent trolls" dirty words. (Patent trolls are also known by a variety of other names: "patent assertion entities" (PAEs), "non-practicing entities" (NPEs).

In re Packard (Fed. Cir. 2014)
Panel: Circuit Judges O'Malley, Plager, and Taranto
Per curiam opinion

Posted at 11:20 PM in Definiteness, Federal Circuit | Permalink | Comments (1)

July 29, 2013

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)

By Andrew Williams --

A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This is because it is not possible to determine whether potential infringing activity will fall within the scope of the claims. This principle of patent law was reaffirmed by the Federal Circuit last week in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The Court held that because the claim term "molecular weight" can be calculated at least three different ways, resulting in three different values, the asserted claims that included this value were invalid as indefinite. However, the Court also held that at least some of the claims that included this term, but which explained in the claim how to calculate "molecular weight," were correctly found to be definite. In addition, the Court determined that there was insufficient evidence to overturn the lower court's determinations that the asserted claims were enabled, not obvious, and infringed. The impact, therefore, was that Teva's injunction of the various ANDA filers was maintained, but the issue of the length of the injunction was remanded to the lower court.

As with most ANDA cases, it is important to have a grasp of the technology to understand the issues involved in this case. The drug at issue in this case was Copaxone®, which is marketed by Teva for treating multiple sclerosis. The active ingredient is copolymer-1, or glatiramer acetate, which is a polypeptide product that consists of four different amino acids (alanine, glutamic acid, lysine, and tyrosine). Copolymer-1, however, is a mixture of individual polymer molecules with different constituent ratios, and different molecular weights. Therefore, it is often expressed as "average molecular weight." However, statistically speaking, there are at least three ways to calculate average molecular weight: peak average molecular weight (M_p), number average molecular weight (M_n), and weight average molecular weight (M_w). One way to measure "molecular weight" of these molecules is to use Size Exclusion Chromatography (SEC). A simplistic way to think about SEC is as a technique that utilizes a column "sieve" that allows different size (or weight) molecules to leave (elute) the column at different times. If the column is calibrated, you can determine the size or weight of the molecules in question depending on when they elute from the column. The peak average molecular weight (M_p) is the molecular weight of the most abundant molecule in the sample, which occurs as the highest peak in the elution profile. The number average molecular weight (M_n) is the combined total mass of all of the molecules in the sample divided by the total number of molecules. Judge Moore, writing for the three-judge panel, chose to not define weight average molecular weight (M_w), instead referring to it as "still another average molecular weight measure that is calculated differently from M_p and M_n." For readers that are curious, weight average molecular weight (M_w) is similar to number average molecular weight, except instead of dividing the sample by total number of molecules, you take into account the weight fraction of each molecule. Therefore, the larger the molecule, the more "weight" it will have in the value.

There is a second way to express molecular weight, which was used in the patents-in-suit in the so-called "Group II" claims. Claim 1 of U.S. Patent No. 6,054,430 is representative of these Group II claims:

    1. Copolymer-1 having over 75% of its molar fraction within the molecular weight range from about 2 kDa to about 20 kDa, prepared by a process comprising the steps of:
    reacting protected copolymer-1 with hydrobromic acid to form trifluoroacetyl copolymer-1 having over 75% of its molar fraction within the molecular weight range from about 2 kDa to about 20 kDa, wherein said reaction takes place for a time and at a temperature predetermined by test reaction, and
    treating said trifluoroacetyl copolymer-1 having over 75% of its molar fraction within the molecular weight range from about 2 kDa to about 20 kDa with aqueous piperidine solution to form copolymer-1 having over 75% of its molar fraction within the molecular weight range from about 2kDa to about 20kDa.

In this case, the molecular weight is not expressed as a statistical measure, but rather the percentage of copolymer-1 molecules that fall within a defined range. As a result, the measurement is not dependent on the type of calculation performed because it requires a determination of the actual values.

The procedural posture of this case is typical for an ANDA case (notwithstanding the fact that there appear to be generic companies on both sides of the "V"). Teva holds the NDA for Copaxone®, for which eight patents are listed in the Orange Book. Several companies separately submitted Abbreviated New Drug Applications (ANDAs) to market generic versions of this drug. Teva sued these companies for patent infringement, and at least seven of the eight Orange Book listed patents were asserted. All seven of these patents shared the same specification, because they descended from the same parent, U.S. Patent No. 5,800,808 ("the '808 patent"), which was also asserted in this case. This is significant because the '808 patent was filed on May 22, 1995, and therefore has a later expiration date than all of the other patents (seventeen years from date of issuance, or Sept. 1, 2015, instead of May 24, 2014, the expiration date of the remaining patents). Thus, when the Court determined the claims of the '808 patent to be indefinite, it remanded the case to the lower court to determine the impact this would have on the length of the injunction. As for the lower court's findings, it defined the term "molecular weight" in the Group I claims as peak average molecular weight (M_p), and rejected the argument that the term was insolubly ambiguous. It also held that all of the asserted claims were infringed, and that they were not invalid for obviousness or lack of enablement. The ANDA filers appealed.

Indefiniteness

The Appellants challenged the lower court's determination that "molecular weight" could be defined, because one of skill in the art would not understand which measurement (M_p_,M_w_,M_n, or something else) should be used. The specification of the patents-in-suit was silent as to which measurement was appropriate, other than to describe the use of SEC (which can be used to obtain all three values). Statements made in the prosecution history compounded the problem. In response to an indefiniteness rejection in one of the patents, the patentees said that "[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that 'average molecular weight' refers to the molecular weight at the peak of the molecular weight distribution curve," or M_p. However, in response to an identical rejection in an earlier related application, the patentees said that ""[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," or M_w.

Teva argued that one skilled in the art would have understood that average molecular weight could only be M_p. Teva asserted that use of SEC without more suggests M_p because determining M_n and M_w required additional calculations. The Court appeared skeptical of this argument, because SEC can be used to calculate all three values. Teva also downplayed the prosecution history by explaining that a skilled artisan would recognize that the statement in the earlier application was false -- because "kilodalton units" does not imply weight average. Teva appears to have alleged that the second statement rectified the earlier misstatement. However, there is no indication that the patentees in the later application retracted the earlier statement. Therefore, the Court was left with two contradictory statements that could not be rectified. As such, the claims in Group I were held to be indefinite.

However, the claims in Group II survived the invalidity challenge. The Appellants argued that the claim term "molecular weight" was the same in all of the asserted claims, and therefore they should all rise and fall together. However, the Federal Circuit pointed out that the use of the term "molecular weight" in these claims was not in reference to an average, but rather to a range, as shown in the representative claim above. Therefore, because the claim had exact values instead of statistical measures, the scope was readily ascertainable.

Enablement

Appellants also alleged that the claims were not enabled because the specification did not specify how the SEC column should be calibrated, and therefore either self-standards or universal calibration could be used. They argued that copolymer-1 is complex and exhibits an unpredictable behavior. In fact, they pointed to Teva's difficulties in identifying an appropriate calibration method.

The Federal Circuit found no clear error with the fact finding of the lower court. The lower court weighed the testimony of the experts, and found Teva's expert to be more convincing. Moreover, there was no evidence that Teva's own alleged difficulties were based on faulty measurements as opposed to regulatory or scale-up issues. As a result, the lower court's determination was affirmed.

Obviousness

Appellants also challenged the lower court's holding that the patents at issue would not have been obvious in view of the prior art. The closest prior art reference disclosed compounds with a molecular weight higher than 10 kDa. Appellants alleged that there was no evidence that copolymer-1 with a molecular weight less than 10 kDa exhibits an improved toxicity profile over the prior art. However, the Federal Circuit found no error with the District Court's determination that there was a preference in the prior art for higher molecule weight compounds, and therefore it taught away from the claimed invention. Also, the Court noted that Copaxone® was coextensive with the asserted claims. Therefore, a nexus was presumed for purposes of the undisputed commercial success of the drug product, and Appellants had not rebutted this presumption. As a result, because the Appellants failed to establish the obviousness of the claimed invention, the Federal Circuit affirmed.

Infringement

Finally, Appellants challenged the finding of infringement. First, they challenged the Court's construction of the term "approximately" in relation to the molar ratio of the amino acid subunits. However, "approximately" was not a claim term, but instead it was found in a claim term definition. The term at issue was "copolymer-1" and the District Court construed it to mean "a mixture of polypeptides composed of alanine, glutamic acid, lysine, and tyrosine in a molar ratio of approximately 6:2:5:1." As such, the application of the term "approximately" was part of the infringement analysis, not of claim construction, and therefore the standard of review was clearly error.

In making the infringement analysis, the lower court determined that a ratio of 6:2:5:1 was equivalent to a percentage ratio of 42.9%, 14.3%, 35.7%, and 7.1%. In comparison, Mylan's ratio was 42.7%, 14.4%, 33.6%, 9.2% (the ratio for Sandoz was comparable, so only Mylan's product will be discussed here). The court calculated that this aggregate difference was only 4.5%. As compared with the prior art, which tolerated aggregate differences of 12%, it found the accused products to fall within the scope of the claims. Appellants asserted that the relative proportions were important, not the aggregate. Therefore, because Mylan's ratios were 4.6:1.6:3.7:1.0, the ratio of lysine to tyrosine was 3.7:1.0, and therefore deviated more than 16% from the ratio of 5.0:1.0. The Federal Circuit agreed with Teva, however, that Appellants were performing a "mathematical sleight of hand." In essence, they were normalizing the ratio to the least abundant amino acid, tyrosine, which will skew the results. Ultimately, the Federal Circuit found that the lower court did not clearly err by looking at the aggregate percentage difference and finding it less than 5% from the ideal.

Finally, Appellants asserted that the Teva had disclaimed copolymer-1 compositions having M_w greater than 10kDa. The basis for this assertion was that the patentees had compared the pending claims to a reference describing copolymer-1 with a minimum molecular weight of 10 kDa, stating that the then-pending claims cover copolymer-1 having a molecular weight of about 5 to 9 kDa. Somewhat ironically, the Federal Circuit found that there was no a clear disavowal of the claim scope, because it was unclear that the patentees were referring to M_w. Therefore, for almost the same reason that some of the claims were found to be indefinite, the Court found that there was no disavowal, and therefore infringement determination was affirmed.

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)
Panel: Chief Judge Rader, Circuit Judge Moore, and District Judge Benson
Opinion by Circuit Judge Moore

Posted at 11:26 PM in Claim Construction, Definiteness, Enablement, Federal Circuit, Infringement - Literal or DOE, Obviousness | Permalink | Comments (3) | TrackBack (0)

September 15, 2011

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011)

By Kevin E. Noonan --

The Federal Circuit reaffirmed the primacy of the factual disclosures used to establish obviousness, and how deficiencies thereof can defeat an obviousness claim, in reversing an invalidity determination in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. It also showed how persistently defendants pursue the tarnish of inequitable conduct even under circumstances where the Federal Circuit has held that no inequitable conduct occurred.

The patents-in-suit, U.S. Patent Nos. 6,202,649 and 6,425,401 (filed as a continuation of the '649 patent), were directed to methods for curing tobacco in a way that reduced the amount of a carcinogen, tobacco-specific nitrosamines (TSNAs), in the cured product used in cigarettes and other tobacco-containing products. The patents were specifically directed to "indirect" flue curing with gas or propane heaters. Former methods used "direct" flue curing that mixed the exhaust gasses with the tobacco, but this resulted in an oxygen-free environment that fostered the growth of bacteria on the leaves, leading to production by the bacteria of the carcinogenic TSNAs. The patented methods can be used with either direct or indirect curing methods by using "controlled conditions" involving humidity, temperature, rate of temperature exchange, carbon monoxide levels, carbon dioxide levels, oxygen levels, and how the tobacco plants are arranged in the curing shed. The claims specify "controlling conditions" by "determining and selecting" the "appropriate" values for these variables that results in the reduction of TSNA production "at least one"). However, the patents admit that the choice of these conditions are "more art than science," so need to choose the appropriate combination of these variables; however, the important consideration is maintaining an aerobic environment that prevents bacterial growth.

Claims 4 and 12 of the '649 patents are set forth for the Court as being representative (emphasis in the opinion):

4. A process of substantially preventing the formation of at least one nitrosamine in a harvested tobacco plant, the process comprising:
    drying at least a portion of the plant, while said portion is uncured, yellow, and in a state susceptible to having the formation of nitrosamines arrested, in a controlled environment and for a time sufficient to substantially prevent the formation of said at least one nitrosamine;
    wherein said controlled environment comprises air free of combustion exhaust gases and an airflow sufficient to substantially prevent an anaerobic condition around the vicinity of said plant portion; and
    wherein said controlled environment is provided by controlling at least one of humidity, temperature, and airflow.

12. The process according to claim 4, wherein the treatment time is from about 48 hours up to about 2 weeks.

The lawsuit arose after R.J. Reynolds (RJR) acquired previous licensee Brown and Williamson and terminated the license. In addition, RJR has its own patents (referenced in the opinion as the Peele reference), issued as U.S. Patent No. 6,805,134 that specified a "not direct" heat source and curing in the absence of nitrocv oxide gas, which was performed by retrofitting direct cure barns into indirect-cure barns.

As an initial matter, the District Court granted summary judgment that the '649 and '401 patents were not entitled to priority to a provisional application, based on disclosure in the provisional that the claimed methods utilized an air flow of "at least 28,000 cubic feet per meter (CFM)" whereas the common specification of the '649 and '401 patents specified an air flow of "approximately 25,000 CFM." As a consequence, the District Court was able to consider intervening art to be prior art, and to decide that the patentee did not disclose the best mode (based on development of the commercial embodiment (and acknowledged best mode) in the period between the provisional and non-provisional filing dates.

In an earlier decision, the Federal Circuit reversed a finding that the claims were indefinite for reciting the term "anaerobic condition" and reversed a finding of inequitable conduct for failure to disclose a purported prior art reference (termed the "Burton letter"). Despite this decision, the District Court permitted defendants to display a slide (below) during closing argument showing a shadowy person disclosing information to the PTO examiner but holding the disputed Burton letter reference behind his back, during part of closing argument relating to invalidity rather than inequitable conduct.

The jury delivered a verdict of non-infringement and invalidity based on obviousness, anticipation, indefiniteness, and failure to disclose the best mode. The obviousness determination was based on a prior art scientific journal review relating to methods for air curing and a published Japanese patent. In view of the District Court's decision on the priority question, the jury applied the method disclosed in the Peele '134 patent as well as the practice of methods at two farms (Spindletop and the Brown farm) as a public use (the Brown tobacco farm being under contract to RJR). The indefiniteness determination was directed at the term "controlled environment," which the Court found as a matter of law was incapable of being construed because the disclosed "controlled environment" conditions overlapped with "conventional" curing conditions so that the skilled worker could not understand the difference. The best mode determination was based squarely on the District Court's priority determination, since it was uncontested that the best mode commercial embodiment was not disclosed and had been developed prior to the non-provisional filing dates. Finally, the jury found that there was no infringement, based on oxygen levels in RJR's barns alleged to be infringing. The District Court denied Star's motions for JMOL of these adverse decisions.

The Federal Circuit, in an opinion by Chief Judge Rader, joined by Judge Linn and by Judge Dyk in part, who dissented as to the Court's decision to reverse invalidation for indefiniteness, reversed the District Court's grounds for invalidating the '649 and '401 patents, and affirmed the District Court's denial of JMOL on the jury's non-infringement decision. The Federal Circuit also reversed the finding that the '649 and '401 patents were not entitled to the provisional filing date, on the basis that the specification satisfied the priority standard: that the specification disclosed an adequate written description and enabled the patents' claims.

This part of the opinion was supported by an intervening decision by the USPTO in a reexamination of the '649 and '401 patents that these patents were entitled to the priority date (although the PTO found certain of the claims were invalid for obviousness). The Court based its decision on language in the provisional specification that the recited air flow speed (in CFM) could "vary according to conditions and may be determined on a routine basis," and thus held that the District Court had improperly narrowed the claim scope based on later examples in the non-provisional application.

As a consequence of the Court granting the priority date of the provisional application to the '649 and '401 patents the best mode violation evaporated, since it was equally undisputed that the commercial method was not known at the time the provisional application was filed. Another consequence, germane to anticipation and obviousness is that the Peele '134 patent was not prior art that could be asserted against the patents in suit.

In reversing the District Court's indefiniteness determination, the majority opinion cites Datamize LLC v. Plumtree Software Inc. for the standard that a claim must be "insolubly ambiguous" or "not amenable to construction" to be found indefinite. However, the majority cautioned that "[a]bsolute clarity [is] not required" and that the term at issue -- "controlled environment" -- does not require disclosure of exact values for the various parameters because the skilled worker would understand the variable and empirical nature of determining these conditions. In this the opinion cites language from the Peele '134 patent -- owned by RJR -- consistent with its interpretation of the understanding of the worker skilled in the art.

Regaring obviousness, the Court disagreed with jury verdict that the references render the claims obvious. The opinion characterized the Japanese patent as being directed at improving fast curing to avoid "nasty odor" (an advantage not related to TSNA production) and found the Wiernik reference to be inconclusive on whether bacteria were involved in TSNA production. In addition, the opinion notes that neither reference discusses exhaust gases or anaerobic conditions. Thus, the Court found that there would be no motivation (or in the mantra approved by the KSR Court, "reasoned basis") for the skilled worker to combine these references to arrive at a solution to the problem of TNSA production during tobacco curing. The Court also found significant evidence of secondary considerations, including: a recognized, unmet need in the art for reducing TSNA in cured tobacco; unsuccessful attempts (i.e., failure) by others to solve this recognized problem; purported unexpected results (never expressly set forth in the opinion); and commercial success (ironically for RJR, using the lucrative B&W licenses as evidence thereof).

The Court reversed the jury's anticipation finding as to the Peele method because it was no longer prior art in view of the earlier priority date. The two "public uses" were not prior art, because the Court found that the "Spindletop" use involved tobacco cured before treatment in the drying shed (so that it was not "uncured" tobacco, as required by the claims). The "Brown farm" use did not anticipate, according to the Court's opinion, because the reported test results were below the detection threshold for TNSAs and thus provided no evidence that this method satisfied the specifically recited range of TSNA reduction required by the claims.

Finally, the Court upheld the non-infringement decision based on the jury's prerogative to believe one (RJR's) expert over another (Star's), and that the evidence did not establish that no reasonable jury could come to such a decision (i.e., the District Court properly denied Star's JMOL motion).

The Court also refused to deny Star's appeal on evidentiary rulings permitting (inter alia) display of the "shadowy figure" slide (although the Court found its use "troubling"), because Star did not show harm resulting from the objectionable evidence.

Judge Dyk dissents in part, arguing that the patents are invalid for indefiniteness -- in his view, the specification did not sufficiently distinguish the "controlled" conditions from "conventional" conditions and thus did not "particularly point out and distinctly claim" the invention so that the skilled worker could not ascertain the metes and bounds of infringing behavior.

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Federal Circuit 2011)
Panel: Chief Judge Rader and Circuit Judges Linn and Dyk
Opinion by Chief Judge Rader; opinion concurring-in-part and dissenting-in-part by Circuit Judge Dyk

Posted at 11:59 PM in Definiteness, Federal Circuit, Inequitable Conduct, Novelty, Obviousness | Permalink | Comments (4) | TrackBack (0)

April 13, 2010

Enzo Biochem, Inc. v. Applera Corp. (Fed. Cir. 2010)

By Donald Zuhn --

On March 26, the Federal Circuit reversed the judgment of the District Court for the District of Connecticut that U.S. Patent Nos. 5,328,824 and 5,449,767 are invalid, affirmed the judgment of the District Court that U.S. Patent No. 5,476,928 is anticipated, and affirmed the judgment of the District Court that 5,082,830 is not infringed.

The '824, '767, '928, and '830 patents, which are owned by Plaintiffs-Appellants Enzo Biochem, Inc., Enzo Life Sciences, Inc., and Yale University ("Enzo"), are directed to various techniques for labeling and detecting nucleic acids. More particularly, the '824, '767, and '928 patents are directed to a compound, or a method of using that compound as a detection probe. In this compound (shown below), a nitrogenous base B is covalently attached, either directly or through a "linkage group" (dotted line), to a chemical moiety A.

In the asserted claims, the linkage group is recited functionally (rather than structurally) as "not interfering substantially" with both hybridization and detection (in the '824 and '767 patents) or detection alone (in the '928 patent). Chemical moiety A is a label that facilitates detection, "compris[ing] at least three carbon atoms and represent[ing] at least one component of a signalling moiety capable of producing a detectable signal" (claim 1 of the '824 and '767 patents) or "represent[ing] at least three carbon atoms and an indicator molecule selected from the group consisting of fluorescent dyes, electron-dense reagents, enzymes which can be reacted with a substrate to produce a visually detectable reaction product, and radioisotopes" (claim 1 of the '928 patent). The '830 patent is directed to a compound and a method of detection using a compound, wherein the claimed compound is a nucleotide labeled with "at least one non-radioactive moiety directly or indirectly attached to each of the 5′ and 3′ end nucleotides thereof," and the detection method is accomplished using a "preformed detectable molecular complex."

In June 2004, Enzo brought suit against Defendants-Appellees Applera Corp. and Tropix, Inc. ("Applera") for infringement of the '824, '767, '928, and '830 patents (as well as U.S. Patent Nos. 4,711,955 and 4,994,373, which were not at issue in the appeal). In October 2006, the District Court issued a claim construction ruling, determining that the "not interfering substantially" functional language for the linkage group means that "the linkage group neither substantially interferes with the ability of the compound to hybridize with the nucleic acid nor substantially interferes with the ability of [moiety] A to be detected." As for moiety A, the District Court determined that for the '824 and '767 patents, "[moiety] A may be a part of or the entire signalling moiety"; for the '928 patent, the plain language of the patent "precludes a construction where A is the entire [indicator] molecule"; and for the '830 patent, the term "non-radioactive moiety" means "a moiety that is utilized in indirect detection, i.e., a moiety that can be detected with a preformed detectable molecular complex."

Enzo conceded that under the District Court's construction, it could not prove infringement of the '830 patent, and the District Court granted summary judgment of noninfringement to Applera. Applera then moved for summary judgment of lack of written description, lack of enablement, indefiniteness, and anticipation with respect to the three remaining patents. The District Court granted summary judgment of indefiniteness and anticipation, finding the "not interfering substantially" language in the asserted claims to be indefinite because "[t]he specifications neither set forth how one would gauge substantial interference, nor delimit the threshold at which interference with the procedure prevents [the claimed] method from being implemented," and determining that the asserted claims were anticipated by three references (Kasai et al., 1979; Pingoud et al., 1977; and Bauman, 1980).

Indefiniteness

On appeal, Enzo argued that the District Court incorrectly determined that the "not interfering substantially" language in the '824, '767, and '928 patents is indefinite. In particular, Enzo argued that the specifications provide specific examples of linkage groups that do not substantially interfere with hybridization and detection and a test for measuring the degree of interference (i.e., comparing the melting temperature of a modified polynucleotide with that of an unmodified polynucleotide). Applera countered that nothing in the patents explains how to measure "interference" or how to determine whether such interference is "substantial."

In determining that the claims of the '824 and '767 patents are not indefinite, the Federal Circuit noted that "[t]he claims in this case provide at least some guidance as to how much interference will be tolerated." Pointing to a dependent claim that recites the structure –CH=CH–CH₂–NH–, the panel observed that "[a] person of ordinary skill would presume that a structure recited in a dependent claim will perform a function required of that structure in an independent claim," and "[t]hus, it may be presumed that the term 'not interfering substantially' in the independent claims allows for at least as much interference as that exhibited when the linkage group has the structure specified in the dependent claims."

The panel also looked to examples of suitable linkage groups, as well as criteria for selecting such linkage groups, disclosed in the specification. For example, the specification discloses that more preferred chemical linkage groups be derived from a primary amine and have the structure –CH2–NH–, and further, that thermal denaturation profiles and hybridization properties of a polynucleotide can be used to measure the degree to which a linkage group interferes with hybridization. In view of the teachings in the specification, the panel concluded that the specification indicates that "when a linkage group is incorporated into a DNA strand having a length and sequence similar to those used in the specification, a decrease in Tm of up to 5 ^oC implies that the linkage group does not 'substantially interfere' with hybridization, and a decrease of up to 15 ^oC is acceptable if the degree of cooperativity and the extent of hyperchromicity are the same for the modified and unmodified strands."

Finally, the panel noted that during the prosecution of the patents, Enzo overcame an indefiniteness rejection by submitting a declaration under 37 C.F.R. § 1.132 listing eight specific linkage groups, including the –CH=CH–CH2–NH– group listed in the patents' dependent claims. Thus, the panel concluded that:

Because the intrinsic evidence here provides "a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine [the scope of the claims]," the claims are not indefinite even though the construction of the term "not interfering substantially" defines the term without reference to a precise numerical measurement. When deciding whether a particular linkage group is or is not "substantially" interfering with hybridization within the meaning of the district court's construction, a person of ordinary skill would likely look to the thermal denaturation profiles and hybridization properties (including Tm) of the modified nucleotide, to see whether they fall within the range of exemplary values disclosed in the intrinsic evidence.

(citations omitted).

The Federal Circuit similarly found the claim language not indefinite with respect to detection (Wherein the '824 and '767 patents concern the effect of the linkage group on hybridization and detection, the '928 patent only concerns the effect of the linkage group on detection.) In support of this additional finding, the panel noted that the eight linkage groups listed in the declaration "were said not to 'interfere[] with the ability of biotin in an oligo- or polynucleotide probe of this invention to form a detectable complex with one of avidin, streptavidin or antibodies to biotin or iminobiotin.'" Thus, the panel concluded that:

So long as moiety A can be detected within the level of detection achieved by the applicants using the exemplary linkage groups disclosed in the intrinsic evidence, a person of ordinary skill would understand that a different linkage group (one that is not disclosed in the intrinsic evidence) likewise does not "substantially interfere" with the detection of moiety A.

Anticipation

The Federal Circuit next addressed the issue of anticipation, finding that Enzo had raised a genuine issue of material fact as to the Kasai et al. and Pingoud et al. references sufficient to survive summary judgment of anticipation of the '824 and '767 patents, but that Enzo had failed to raise a genuine issue of material fact with respect to the Bauman reference and '928 patent. Looking at the first two references, the panel noted that each "employ[s] a –CH2–NH– linkage group, which arguably belongs to the set of linkage groups disclosed in the patents-in-suit as 'even more preferred' embodiments," adding that "[i]f unopposed, this evidence would entitle Applera to judgment as a matter of law." At trial, Enzo responded by offering an expert declaration stating that the –CH2–NH– linkage group of Kasai et al. "would not provide sufficient rigidity to prevent significant interference with hybridization of a complementary polynucleotide," and "[i]ndeed, one would predict based on the flexibility of this functional group and the concomitant high degree of motion, there would be significant interference due to free rotation about the single bonds."

On appeal, Applera argued that Enzo's expert declaration could not be credited because it conflicted with Enzo's Rule 132 declaration, and further, because Enzo's expert offered no support for his assertion that Kasai et al. would substantially interfere. The Federal Circuit, however, determined that:

Viewing the [expert] declaration in a light most favorable to Enzo requires that [the expert's] explanation be read as limited to the specific one-carbon aminomethyl group [i.e., –CH2–NH–] disclosed in Kasai and not as a sweeping condemnation of single bonds or an unyielding requirement of double bonds. . . . [The expert's] statement that the aminomethyl group disclosed in Kasai would substantially interfere and [the Rule 132 declaration's] statement that a six-carbon diamine group would not are not inconsistent, particularly when viewed in a light most favorable to Enzo, as it must be.

The panel also noted that while Enzo's expert focused on the impact of the nature of the bonds in the linkage group (i.e., single or double) on hybridization and detection, the specification also recognizes that the length of linkage group impacts hybridization and detection.

Lastly, the panel addressed Applera's argument that the –CH2–NH– linkage group, which is described in Kasai et al., was also within Enzo's "even most preferred" embodiments. In response, the Court determined that Enzo's counterargument that "the 'even more preferred' language is properly read as describing a subset of the preferred embodiments -- i.e., those with carbon-carbon double bonds at the α-positition -- such that the most preferred embodiments have both a carbon-carbon double bond at the α-position, and are derived from a primary amine and include a –CH2–NH– group," was reasonable and should have been credited on summary judgment.

Turning to Pingoud et al., the Court noted that "[o]n its face, Pingoud notes that there was substantial interference with hybridization." In particular, the panel pointed to a statement in the reference that "[c]odon-anticodon interaction . . . is severely affected by the [fluorescent labeling] modification," stating that "'[c]odon-anticodon interaction' is indicative of hybridization, and 'severely affected' suggests substantial interference." The panel therefore concluded that there was a genuine issue of material fact as to whether the linkage group disclosed in Pingoud et al. substantially interferes with hybridization. The Court also rejected Applera's argument that the –CH2–NH– linkage group, which is similarly described in Pingoud et al., was within Enzo's "even most preferred" embodiment.

Turning to the final reference, the panel noted that in Bauman, hybridization is performed before moiety A is attached to base B via the linkage group. Enzo argued that in view of this chronology, Bauman did not anticipate the '928 patent. However, the Court determined that "[i]t is irrelevant, for purposes of anticipation, what method is used, much less what order of steps is used, to attach both moiety A and the linkage group to base B." The Court also noted that because the '928 patent is silent as to hybridization, "[a]ll that is required of this particular linkage group is that it not substantially interfere with the ability of A to be detected."

Infringement

Addressing the last issue on appeal (i.e., infringement of the '830 patent), the Federal Circuit first reviewed the District Court's construction of the term "non-radioactive moiety," which the lower court had found to mean "a moiety that is utilized in indirect detection, i.e., a moiety that can be detected with a preformed detectable molecular complex." The Federal Circuit found the District Court's construction to be reasonable, and affirmed the lower court's judgment of noninfringement with respect to the '830 patent. In response to Enzo's argument that the District Court's construction violated the doctrine of claim differentiation because dependent claim 14 adds "a preformed detectable molecular complex" to claim 1, the panel stated that:

[T]he district court's construction imposes no requirement that a preformed detectable molecular complex is actually present in claim 1; rather, it simply requires the "non-radioactive moiety" to be capable of performing a function: "can be detected with a preformed detectable molecular complex." Claim Construction, 2006 WL 2927500, at *11 (emphasis added). Claim 1, unlike claim 14, is infringed even in the absence of a preformed detectable molecular complex.
Enzo Biochem, Inc. v. Applera Corp. (Fed. Cir. 2010)
Panel: Chief Judge Michel and Circuit Judges Plager and Linn
Opinion by Circuit Judge Linn

Posted at 11:59 PM in Definiteness, Federal Circuit, Infringement - Literal or DOE, Novelty | Permalink | Comments (0) | TrackBack (0)

October 27, 2006

Ex parte Bandman (B.P.A.I. 2004)

By Donald Zuhn --

In an appeal from a final rejection of claims 3, 6, 7, 9, and 12 of U.S. Application No. 09/915,694, the Board of Patent Appeals and Interferences reversed the rejection of the claims under both the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, and entered a new ground of rejection under 35 U.S.C. § 112, second paragraph, for claim 12.

Claims 3 and 12 of the '694 application, which were representative of the subject matter on appeal, recite, inter alia, an isolated polynucleotide encoding a polypeptide comprising a naturally occurring amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO: 1 (claim 3) and an isolated polynucleotide comprising a naturally occurring polynucleotide sequence at least 95% identical to the polynucleotide sequence of SEQ ID NO: 2 (claim 12).

The Examiner had rejected claims 3, 6, 7, 9, and 12 for failing to comply with the written description requirement, asserting that the specification provides only a single representative species -- the polynucleotide of SEQ ID NO: 2, and fails to disclose any structure-function relationship in this species. The Examiner had also rejected claims 3, 6, 7, 9, and 12 for failing to comply with the enablement requirement, asserting that because the specification does not teach the specific amino acids and structural motifs in the proteins encoded by the claimed polynucleotides that are essential for protein activity (specifically, malate dehydrogenase activity), the amount of experimentation required to make the claimed polynucleotides was undue. Appellants contended that because the claims at issue recite polynucleotides having a naturally occurring polynucleotide sequence, or that encode a polypeptide having a naturally occurring amino acid sequence, "through the process of natural selection, nature will have determined the appropriate amino acid sequences [i.e., those retaining malate dehydrogenase activity]."

With regard to the written description rejection, the Board noted that "[t]he written description requirement . . . does not require a description of the complete structure of every species with a chemical genus" (Ex parte Bandman, No. 2004-2319, slip op. at 3 (B.P.A.I. January 6, 2005)). The Board also compared the circumstances of the instant case with those faced by the Federal Circuit in Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002). In Enzo Biochem, the Federal Circuit determined that an "[a]dequate written description may be present for a genus of nucleic acids based on their hybridization properties, 'if they hybridize under highly stringent conditions to known sequences because such conditions dictate that all species within the genus will be structurally similar'" (Ex parte Bandman, No. 2004-2319, slip op. at 4 (B.P.A.I. January 6, 2005) (citing Enzo Biochem, Inc., 296 F.3d at 1327)). In the instant case, the Board determined that the genus of molecules defined by the claims was similarly limited and reversed the Examiner's written description rejection.

With regard to the enablement rejection, the Board disagreed with the Examiner's assertion that in order to satisfy this requirement, the specification must provide guidance regarding the specific amino acid residues that are tolerant to change without affecting malate dehydrogenase activity. Instead, the Board deemed persuasive Appellants' argument that because the claims were limited to naturally occurring sequences, nature will have determined the amino acid residues that are tolerant to change (i.e., naturally occurring variants will presumably retain malate dehydrogenase activity). In particular, in reversing the Examiner's enablement rejection, the Board determined that the Examiner had not provided sufficient evidence that a naturally occurring polypeptide that is at least 95% identical to the amino acid sequence of SEQ ID NO: 1 or a polypeptide encoded by a naturally occurring polynucleotide sequence that is at least 95% identical to the polynucleotide sequence of SEQ ID NO: 2 would not retain malate dehydrogenase activity.

Although the Board reversed both the written description and enablement rejections, it also entered a new ground of rejection for claim 12 under 35 U.S.C. § 112, second paragraph. The Board found that the specification provided no guidance that would allow one of ordinary skill in the art to determine, with a reasonable degree of confidence, whether a polynucleotide sequence that is at least 95% identical to the polynucleotide sequence of SEQ ID NO: 2 occurs naturally. The Board concluded that the metes and bounds of claim 12 were unclear, and therefore, that the claim was indefinite.

Ex parte Bandman (B.P.A.I. 2004)
Panel: Administrative Patent Judges Smith, Grimes, and Green
Opinion by Administrative Patent Judge Green

This article was originally published on Patently-O on June 14, 2005.

Posted at 10:19 AM in Board of Patent Appeals and Interferences, Definiteness, Enablement, Written Description | Permalink | Comments (1) | TrackBack (0)

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