Patent Docs

An Analysis of the New Rules: USPTO Releases ESD Guidelines

    By Kevin E. Noonan --

Review of the new "examination support document" rule promulgated in 37 C.F.R. § 1.265 on August 21, 2007 strongly suggested that the purpose of the rule was not to facilitate submission of relevant prior art as an improvement over current Information Disclosure Statement provisions, but rather to provide strong encouragement (coming close to coercion) for applicants to file no more than 5 independent and 25 total claims (see previous post on Rule 265).  The bases for this were the stringent requirements not only for information but for applicants to characterize the information with regard to patentability, coupled with a complete lack of any effort by the Patent Office to modify the duty of disclosure to permit an applicant or counsel to submit an ESD without the certainty of being accused of inequitable conduct.  This impression was reinforced by the guidelines issued from the Patent and Trademark Office on September 6, 2007.

The guidelines are directed to the requirements of the rule and explicate (generally) what will (and what will not) satisfy the rule.  Some highlights:

1.  The Office suggests that the preexamination search be performed giving the limitations in each of the independent and dependent claims their "broadest reasonable interpretation."  Moreover, the limitations in dependent claims should be searched independently of their combination with the limitations or elements of the independent claims.  For means-(or step-)plus-function claims, the search must encompass the embodiments explicitly-disclosed in the specification and, of course, "equivalents thereof"; it can be contemplated that any such search will be available during litigation to assert an estoppel of the embodiments satisfying the means-plus-function claim.

2.  The Office also suggests that applicants (and their representatives) include "disclosed but unclaimed features" that the applicant may wish to incorporate in their claims, in order to avoid the need to perform a supplemental search.  Thus, the extent of this search effectively extends past the scope of the claims to encompass whatever is disclosed in the specification.  Unmentioned is whether the search must also encompass all that is know to one of ordinary skill in the art (also unmentioned is the crystal-ball, tea-leaf-reading character of this requirement).

3.  Foreign patent office searches "may" not "automatically" satisfy the requirement, but it is clear from what is required for such a search to affirmatively satisfy the requirement that such a search will never suffice.  Of course, the rule does not abrogate an applicant's duty of candor in disclosing whatever a foreign patent office issues in a search report.  And an earlier search on a non-provisional application will not necessarily suffice, either; the guidelines do not state whether Examiner-conducted searches in earlier-filed applications are deemed to be insufficient by this rule.

4.  The rule requires a large amount of detail with respect to identifying the field of search and the search terms used; reliance on the M.P.E.P. standards may be (but are not necessarily) sufficient.  The guidelines refer applicants to M.P.E.P. §§ 904-904.03, and to a web-based search template (which can be found here).

5.  The Office can also deem a search insufficient if it determines that there is closer prior art than what was provided by the applicant.  It is unclear from the guidelines how an applicant could cure the deficiency, other than performing the patentability analysis using this newly-cited art, but it certainly increases the inequitable conduct exposure.  This is particularly true if the art is applicant's own art; the existence of a genuine dispute between the applicant and the office over the scope of any said art will disappear during a post-hoc inequitable conduct accusation.

6.  While providing a number of web-based resources for applicants trying to comply with the search rules (for example, the Manual of Classification, the guidance provided for ESD's with regard to accelerated examination, and a more extensive review of the classification system), the guidelines also suggest that the search be extended to "all probable classes and subclasses relevant to the subject matter of each claim," with no guidance on determining the metes and bounds of what is "probable."

7.  Classification and text searches are recommended, however, classification searches cannot be limited by any text query.  This requirement appears to require an entire class and subclass be reviewed and references eliminated one by one from the search after review.  Text searches for PCT documents should encompass the standards set forth here.

8.  "Other sources" of art outside the scope of the searches set forth in the guidelines include:

• Applicant's own work including references by at least one of the inventors.
• References cited in any prior-filed application in which a benefit or priority is claimed.
• References cited in an international search report of a national stage application.

9.  Turning to the requirement that the ESD identify references "most closely related" to the claims, the Office asserts that these references will be those that disclose the most number of limitations in an independent claim; or a limitation in an independent claim not found in any other reference; or a limitation in a dependent claim not shown in any other reference.  However, if such a reference has a priority or publication date less than one year before the applicant's filing or priority date, additional references should be identified that have a publication or priority date more than one year before the applicant's filing or priority date, even if that disclosure is "less closely related" to the claims.  However, the duty of disclosure requires that other art, "less closely related" to the claims, be submitted in an IDS, including inter alia art cited in foreign or International search reports.

10.  The Office suggests the applicant "map" (presumably using a claim chart) the portions of any reference cited in an ESD that discloses any limitation in an independent or dependent claim.  Only one portion of a reference need be recited, unless any second or other reference would not be "apparent" to the Examiner.  A requirement that the Examiner read the reference is not contained in the guidelines.

11.  With regard to the detailed explanation of patentability, the guidelines suggest that:

The ESD must set out with particularity, by reference to one or more specific claim limitations, why the claimed subject matter is not described in the references, taken as a whole.  The applicant must explain why a person of ordinary skill in the art would not have combined the features disclosed in one reference with the features disclosed in another reference to arrive at the claimed subject matter.  The applicant must also explain why the claim limitations of the independent claims render the claimed subject matter novel and non-obvious over the cited prior art.

It is unclear what evidence is required to establish what one of ordinary skill in the art would not have considered in the motivation to combine vel non, or what would be considered novel or non-obvious.

12.  The guidelines also make plain that, where an application claims priority to an earlier application, the requirement for showing explicit support for limitations in all independent and dependent claims extends to all such priority applications.

13.  The duty to file an ESD, and all its requirements, is ongoing and arises when new art is uncovered and when amendments are made to the claims.  A supplemental ESD can be required under these circumstances.

These guidelines are clearly intended to more fully explain how an applicant can comply with the ESD rules.  Whether intentional or not, what they most clearly explain is that an applicant should avoid filing an ESD under any circumstances.  This may be the intended consequence after all.

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 207
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

USPTO News: Swedish Patent Office to Help USPTO Reduce Application Backlog

    By Donald Zuhn --

The U.S. Patent and Trademark Office announced today that it has begun a pilot project with the Swedish Patent and Registration Office (PRV) in an attempt to reduce the USPTO's growing backlog of U.S. national applications waiting to be examined.  The pilot program will test the feasibility of having the PRV process international applications filed with the USPTO under the Patent Cooperation Treaty.  In particular, the PRV will search and examine 50 PCT Chapter I applications covering a range of technologies, and the USPTO will then review the PRV's work to ensure that it meets USPTO standards.

The USPTO noted in its release that each year it receives more than 50,000 PCT international applications and more than 400,000 national applications.  The Patent Office hopes that by outsourcing the search and examination of international applications, the Office can redirect resources to its backlog of approximately 750,000 U.S. national applications.

USPTO News: BPAI Decisions Now Text Searchable

    By Donald Zuhn --

On August 30, 2007, the U.S. Patent and Trademark Office announced that publicly available final decisions of the Board of Patent Appeals and Interferences (BPAI) posted on the BPAI's Final Decision FOIA web page will now be text searchable.

Alligator Bioscience and SARomics to Collaborate

    By Jason Derry --

Alligator Bioscience has announced that it has entered a collaborative agreement with SARomics.  SARomics is a research company that provides its partners with in silico drug discovery platforms in the fields of structural biology, computational chemistry, and biostatistics.  In particular, SARomics offers many services that help its partners in the drug discovery process, including protein homology modeling, structure-based drug design, virtual screening, ligand-based drug design, QSAR analysis, experimental design, and high throughput data processing and data mining.  Alligator Bioscience focuses on developing and optimizing therapeutic and diagnostic proteins using its proprietary in vitro protein evolution technology.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Purdue Pharma LP et al. v. Apotex Inc. et al.
1:07-cv-00549; filed September 12, 2007 in the District Court of Delaware

Infringement of U.S. Patent No. 5,508,042 ("Controlled Release Oxycodone Compositions," issued April 16, 1996) following a paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Hoffmann-La Roche Inc. v. Gate Pharmaceuticals et al.
2:07-cv-04285; filed September 7, 2007 in the District Court of New Jersey

Hoffmann-La Roche Inc. v. Teva Pharmaceurticals USA, Inc. et al.
2:07-cv-04284; filed September 7, 2007 in the District Court of New Jersey

Hoffman-La Roche Inc. v. Mutual Pharmaceutical Company, Inc. et al.
2:07-cv-04350; filed September 11, 2007 in the District Court of New Jersey

The complaints in these cases are substantially similar.  Infringement of U.S. Patent Nos. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the Gate Pharmaceuticals complaint here.

Conference & CLE Calendar

September 18, 2007 - Trying a Patent Validity Case in a Post-KSR World (Practising Law Institute)

September 18-19, 2007 - Pharma/Biotech Patent Boot Camp (American Conference Institute) - San Francisco, IL***

September 19, 2007 - Final USPTO Rules on Claims and Continuations (Practising Law Institute)

September 20, 2007 - KSR International Co. v. Teleflex, Inc.: Where Do We Stand Five Months Out? (West LEGALworks)

September 24-25, 2007 - Biosimilars 2007 (Scherago International, Inc.) - George Washington University, Washington, D.C.

September 26-27, 2007 - Advanced Forum on Biotech Patents (American Conference Institute) - Boston, MA***

September 27-28, 2007 - Biotechnology: Business and Legal Developments (Law Seminars International) - Seattle, WA

October 10-12, 2007 - Stem Cells European Business Summit - Edinburgh, Scotland

October 12, 2007 - Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) - Chicago, IL

October 25-26, 2007 - Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) - Washington, D.C.***

October 25-27, 2007 - Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) - Palm Springs, CA

November 13-15, 2007 - Pharma and Biotech Collaborative Agreements (American Conference Institute) - New York, NY***

***Patent Docs is a media sponsor of this conference or CLE.

USPTO News: USPTO and UK IPO to Collaborate on Patent Prosecution Highway

    By Donald Zuhn --

On September 4, 2007, the U.S. Patent and Trademark Office announced that it has initiated a Patent Prosecution Highway (PPH) pilot program with the United Kingdom Intellectual Property Office (UK IPO).  The two offices are now accepting applications for participation in the pilot PPH, which permits an applicant having an application whose claims have been allowed by one office to fast track the examination of an application in the other office, such that the latter application would be examined out of turn.  In particular, an applicant receiving a ruling from either the UK IPO or the USPTO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application.

According to the USPTO announcement, the pilot PPH will "leverage fast-track patent examination in both offices to allow applicants in both countries to obtain corresponding patents faster and more efficiently," and "permit each office to benefit from work previously done by the other office, in turn reducing examination workload and improving patent quality."  UK Intellectual Property Office Ian Fletcher labeled the program "a further step towards a global patent prosecution highway network."

The USPTO-UK IPO initiative parallels a similar pilot PPH involving the Japan Patent Office and the USPTO, which was begun in July 2006.

The pilot program is scheduled to run until September 4, 2008.  Additional information regarding the USPTO-UK IPO pilot PPH program, including the conditions for eligibility, can be found at the USPTO website and at the UK IPO website.

For additional information regarding this topic, please see:

• "USPTO News: Patent Prosecution Highway Pilot Program to Be Extended," June 28, 2007

Teva and Dr. Reddy's Reach Agreement in Zoloft Suit

    By Sherri Oslick --

On Tuesday, Teva Pharmaceuticals and Dr. Reddy's Laboratories filed a joint stipulation of dismissal in their pending lawsuit over generic sertraline hydrochloride (the API in Pfizer's Zoloft®, used to treat depression).  The suit, originally filed on February 1, 2007 in the District Court of New Jersey, was dismissed without prejudice, with the stipulation of dismissal noting that Dr. Reddy's is not selling, and has no current intention to sell, generic Zoloft® to anyone other than Teva, and that Dr. Reddy's will provide Teva with 30 days advance notice of any importation, sale, offer to sell, or use of sertraline hydrochloride finished product or API.

The settlement of Teva's suit against Dr. Reddy's ends just one of many pending actions filed by Teva earlier this year surrounding the manufacture of generic Zoloft®.  Information on these actions can be found in our previous reports of February 25, March 4, April 15, and June 3, 2007.  At issue in each of these cases, including the action against Dr. Reddy's, are four U.S. patents:  6,600,073 ("Methods for Preparation of Sertraline Hydrochloride Polymorphs," issued July 29, 2003), 6,500,987 ("Sertraline Hydrochloride Polymorphs," issued December 31, 2002), 6,495,721 ("Sertraline Hydrochloride Form II and Methods for the Preparation Thereof," issued December 17, 2002), and 6,897,340 ("Processes for Preparation of Polymorphic Form II of Sertraline Hydrochloride," issued May 24, 2005), all directed to methods of manufacturing crystalline forms of sertraline hydrochloride.

An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document

    By Kevin E. Noonan --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. § 1.265:

One of the more controversial (and problematic) of the new rules promulgated by the U.S. Patent and Trademark Office on August 21, 2007 is the requirement that an applicant submit an examination support document (ESD) for any application having more than 5 independent claims or 25 total claims (see 5/25 Limit on Claims).  This rule is part of a broader effort to shift the examination burden from the Patent Office to applicants, which is a key motivation for the new rules (the other motivation, of course, being to reduce the number of applications pending in the Office, regardless of the effect on protecting innovation).  Although Office representatives indicated during "town hall" meetings that new rules regarding the Rule 56 duty of candor would be developed to address the enormous increase in the risk of inequitable conduct accusations occasioned by filing an ESD, no revisions to Rule 56 are forthcoming.  This severely limits the usefulness of the ESD practice, which may be in line with the Office's purpose for creating the requirement in the first place.

The ESD portion of the new rules (37 C.F.R. § 1.265) has a number of specific provisions in addition to providing the Office with prior art known to the applicant (which has been the burden imposed by Rule 56 before now).  These include the following:

1.  An applicant is required to perform (or have performed on her behalf) a preexamination search and to submit an affirmative statement that a search has been performed.  Included in the statement must be the field of search as defined by the PTO's class and subclass definitions, as well as the date of the search.  For chemical and biotechnology applications, an applicant must also submit the chemical structure or sequence searched, as well as identifying the database searched (such as Chemical Abstracts or GenBank).  Copies of all references (except U.S. patents and applications) must be submitted.

The rules require a search of U.S. and foreign patents and applications, as well as any other prior art source such as the scientific literature.  Failure to cite any references in these categories must be accompanied by a statement justifying with "reasonable certainty" that no more pertinent reference would be found in the eliminated prior art source than have been found elsewhere.  Unresolved by the rule is whether an Examiner will be required to duplicate the search (which would reduce the benefits to the Office resulting from the rule) or rely upon it; such reliance would only bolster any inequitable conduct allegations made against any claims granted as the result, and raises questions on the legitimacy of the search fees charged by the Office as part of the filing fee for a new application.

2.  The results of the search must be provided as a list of references.  Unlike current Information Disclosure Statement (IDS) practice, however, an applicant must identify the references deemed (by the applicant) as being "most closely related" to the subject matter of each of the claims.  This list must contain substantially the same bibliographic information on each reference (title, author/inventor, publication date, priority date, etc.) as is now required for an IDS.

Unlike an IDS, the new rule requires an applicant to go on the record with particularity by characterizing the significance of each reference to each claim.  No doubt there will be instances where this is clear and unambiguous; however, the frequency with which charges of inequitable conduct are raised under the less specific disclosure rules in place prior to these new rules suggests that any information provided according to this portion of the rule will expose patent practitioners to a much greater risk of these allegations.  Filing an ESD will also give patent infringement defendants a much greater opportunity to elicit information at deposition from the prosecuting attorney.

3.  Not satisfied with requiring specific identification of the "most closely related" references, the new rules also require an applicant to identify all of the limitations in each of the claims that are contained in or disclosed by the reference.

The purpose of this requirement is clearly to improve Examiner efficiency, but at the risk of serious second-guessing during litigation, particularly in instance where additional limitations are added during prosecution.

(This portion of the new rules do not apply to small entities as defined by the rule.  These include businesses not having more than 500 employees, not-for-profit enterprises not "dominant in its field," and government entities from populations of 50,000 or less.)

4.  Not satisfied with the above requirements, the rules also require an applicant to provide a "detailed explanation" of why each of the independent claims is patentable over the cited art.

This provision completes the burden-shifting from the Office to the applicant, and raises the question of whether the rule is in compliance with the provisions of 35 U.S.C. § 102 which state that an applicant is entitled to a patent unless there is novelty-destroying prior art in one of the seven subcategories of the statute.

5.  Finally, an applicant is required to provide a showing of support in the specification under 35 U.S.C. § 112, first paragraph, for "each limitation in each of the claims."  Where there is a priority claim made, this showing must be provided for each of the priority applications.

With this provision of the rule, the Office has abandoned any pretense that Examiners are required to read the applications under examination, something known to be a pretense for anyone who has experienced a rejection under 35 U.S.C. § 112 based on the absence of a term definition or explicit support where the specification clearly contains the required disclosure.

6.  The filing of an Information Disclosure Statement does not satisfy the rule.  In addition, should the Office determine that an ESD is insufficient, an applicant will be notified and given a non-extendable, two-month period to file a corrected or supplemental ESD.  Alternatively, the claims can be amended to fall within the 5/25 rule, thereby removing the ESD requirement.

It is unlikely that the alternative is truly a viable one; having submitted an ESD in the first place, an applicant is exposed to the increased likelihood of an inequitable conduct charge since the ESD is part of the prosecution history.  Moreover, any defect in the ESD resulting in a determination that it is "insufficient" will not be cured by amending the claims to remove the ESD requirement.

In view of the liability that will predictably attach by filing an ESD, it would be folly for any applicant to comply with this rule except in cases where there is objectively no prior art to be cited.  Although such instances may exist (for example, where an International Search Report provides only "A" references), they can be expected to be both unlikely and rare.  The potential for a later determination that a patent is unenforceable for inequitable conduct in any other circumstance should severely limit the instances where ESDs are filed, further influencing applicant behavior to conform to the 5/25 rule.  The Office's failure to address the Rule 56 changes needed to enable applicants to comply with the rule suggests that the purpose of the rule is merely to provide a sufficient incentive for applicants to restrict their claims to 5 independent claims and 25 total claims.  The Office's use of the ESD rules to force compliance with the 5/25 limitation is yet another reason for practitioners to question the Office's honesty and good faith in promulgating these rules.

For additional articles in this series, please see:

• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Changes to Rules 265:

(a) An examination support document as used in this part means a document that includes the following:

(1) A statement that a preexamination search in compliance with paragraph (b) of this section was conducted, including an identification of the field of search by United States class and subclass and the date of the search, where applicable, and, for database searches, the search logic or chemical structure or sequence used as a query, the name of the file or files searched and the database service, and the date of the search;
(2) A listing of the reference or references deemed most closely related to the subject matter of each of the claims (whether in independent or dependent form) in compliance with paragraph (c) of this section;
(3) For each reference cited, an identification of all of the limitations of each of the claims (whether in independent or dependent form) that are disclosed by the reference;
(4) A detailed explanation particularly pointing out how each of the independent claims is patentable over the cited references; and
(5) A showing of where each limitation of each of the claims (whether in independent or dependent form) finds support under the first paragraph of 35 U.S.C. 112 in the written description of the specification. If the application claims the benefit of one or more applications under title 35, United States Code, the showing must also include where each limitation of each of the claims finds support under the first paragraph of 35 U.S.C. 112 in each such priority or benefit application in which such support exists.

(b) The preexamination search referred to in paragraph (a)(1) of this section must involve U.S. patents and patent application publications, foreign patent documents, and non-patent literature, unless the applicant justifies with reasonable certainty that no references more pertinent than those already identified are likely to be found in the eliminated source and includes such a justification with the statement required by paragraph (a)(1) of this section. The preexamination search referred to in paragraph (a)(1) of this section must be directed to the claimed invention and encompass all of the limitations of each of the claims (whether in independent or dependent form), giving the claims the broadest reasonable interpretation.
(c) The listing of references required under paragraph (a)(2) of this section as part of an examination support document must include a list identifying each of the cited references in compliance with paragraphs (c)(1) and (c)(2) of this section, a copy of each reference if required by paragraph (c)(3) of this section, and each English language translation if required by paragraph (c)(4) of this section.

(1) The list of cited references must itemize U.S. patents and U.S. patent application publications (including international applications designating the U.S.) in a section separate from the list of other references. Each page of the list of the cited references must include:
(i) The application number, if known, of the application in which the examination support document is being filed;
(ii) A column that provides a space next to each cited reference for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is part of an examination support document listing of references.
(2) The list of cited references must identify each cited reference as follows:

(i) Each U.S. patent must be identified by first named patentee, patent number, and issue date.
(ii) Each U.S. patent application publication must be identified by applicant, patent application publication number, and publication date.
(iii) Each U.S. application must be identified by the applicant, application number, and filing date.
(iv) Each foreign patent or published foreign patent application must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(v) Each publication must be identified by publisher (e.g., name of journal), author (if any), title, relevant pages of the publication, date, and place of publication.

(3) The listing of references required under paragraph (a)(2) of this section must also be accompanied by a legible copy of each cited reference, except for references that are U.S. patents or U.S. patent application publications.
(4) If a non-English language document is being cited in the listing of references required under paragraph (a)(2) of this section as part of an examination support document, any existing English language translation of the non-English language document must also be submitted if the translation is within the possession, custody, or control of, or is readily available to any individual identified in § 1.56(c).

(d) If an information disclosure statement is filed in an application in which an examination support document is required and has been filed, the applicant must also file a supplemental examination support document addressing the reference or references in the manner required under paragraphs (a)(3) and (a)(4) of this section unless the information disclosure statement cites only references that are less closely related to the subject matter of one or more claims (whether in independent or dependent form) than the references cited in the examination support document listing of references under paragraph (a)(2) of this section.
(e) If an examination support document is required, but the examination support document or preexamination search is deemed to be insufficient, or the claims have been amended such that the examination support document no longer covers each of the claims, applicant will be notified and given a two-month time period that is not extendable under § 1.136(a) within which, to avoid abandonment of the application, the applicant must:

(1) File a corrected or supplemental examination support document in compliance with this section that covers each of the claims (whether in independent or dependent form); or
(2) Amend the application such that it contains no more than five independent claims and no more than twenty-five total claims.

(f) An examination support document, or a corrected or supplemental examination support document, is not required to comply with the requirements set forth in paragraph (a)(3) of this section if the examination support document is accompanied by a certification that any rights in the application have not been assigned, granted, conveyed, or licensed, and there is no obligation under contract or law to assign, grant, convey, or license any rights in the application, other than a security interest that has not been defaulted upon, to any entity other than:

(1) A business or other concern:

(i) Whose number of employees, including affiliates, does not exceed 500 persons; and
(ii) Which has not assigned, granted, conveyed, or licensed (and is under no obligation to do so) any rights in the invention to any person who made it and could not be classified as an independent inventor, or to any concern which would not qualify as a non-profit organization or a small business concern under paragraph (f)(1)(i) of this section.

(2) A not-for-profit enterprise which is independently owned and operated and is not dominant in its field; or
(3) A government of a city, county, town, township, village, school district, or special district, with a population of less than fifty thousand.

Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007)

    By Kevin E. Noonan --

The contours of the Federal Circuit's obviousness jurisprudence post-KSR continued to be revealed today with the CAFC's decision in Aventis Pharma Deutschland GmbH v. Lupin, Ltd.  The Federal Circuit reversed a finding in the District Court that the Aventis claims were non-obvious, based on what it termed a "too rigid" application of the CAFC's teaching-suggestion-motivation (TSM) test, which was repudiated by the Supreme Court in KSR Int'l Co. v. Teleflex, Inc.

The case involves Lupin's filing of an Abbreviated New Drug Application (ANDA) for a generic version of the blood pressure medication ramipril (marketed by Aventis' co-plaintiff King Pharmaceuticals, Inc. as Altace®).  Ramipril is an angiotensin-converting enzyme (ACE) inhibitor for treating high blood pressure by "inhibit[ing] a biochemical pathway that constricts blood vessels."  The District Court found Lupin to be an infringer on summary judgment under the doctrine of equivalents, and also found after a bench trial that the asserted claims of the patent-in-suit, U.S. Patent No. 5,061,722 were not invalid for obviousness.  The pharmaceutical compound Ramipril is one of a plurality of stereoisomers of the chemical compound represented below, where the stereoisomeric conformation of all the chiral carbon atoms designated by an asterisk are in the (S) configuration:

Thus, the pharmaceutical ramipril is one of 32 different stereoisomers; it is known as the "5(S)" or "SSSSS" enantiomer.

Claim 1 of the '722 reads as follows:

1.  A compound of the formula

or a physiologically acceptable salt thereof, wherein R2 is hydrogen, methyl, ethyl, or benzyl, and wherein hydrogen atoms on the ring carbon atoms in the 1- and 5-positions are in the cis-configuration relative to one another, the carboxyl group on the ring carbon atom in the 3-position is in the endo position relative to the bicyclic ring system, and the chirality centers in the chain and on the ring carbon atom in the 3-position all have the S-configuration, said compound or salt being substantially free of other isomers.

This claim is limited to the 5(S) enantiomer.

Prior art ACE inhibitors, including a naturally-occurring molecule isolated from snake venom and several synthetic analogues, were structurally similar to ramipril, and importantly had multiple chiral carbon atoms all in the S configuration.  The "all S" enantiomer of the most closely-related molecule, enalapril (produced by Merck) had been described as having 700 times the biological activity of the "SSR" stereoisomer; the prior art described how the SSS isomer of enalapril could be separated from the other seven stereoisomeric species of that compound.  There was also evidence that a Schering scientist had conceived of the ramipril chemical structure and filed and obtained U.S. patents on her invention.  However, these patents do not disclose the active stereochemical conformation of the molecule, and the experimental examples in these patents would be expected to produce less than the complete complement of 32 stereoisomers (perhaps as few as four of them).  There was also evidence that the Schering scientist thereafter produced a mixture of the SSSSS and SSSSR enantiomers.  All this work occurred prior to Aventis producing ramipril for the first time, but since the 5(S) enantiomer was not known in the prior art, Aventis' claims were novel over this art.

There was one more interesting feature of the factual predicate of the lawsuit.  Aventis licensed the Schering patents, and when the Patent and Trademark Office declared an interference between the Schering patents and Aventis' applications, the interference settled.  Thus, the invalidity question did not arise during the interference.  However, Aventis did concede priority as to the generic ramipril structure, i.e., without specifying the stereochemical configuration of the active ramapril enantiomer.

The District Court found that, on this record, Lupin had failed to present clear and convincing evidence that the patent was invalid for obviousness, but indicated that it was a close case, decided mainly because of the requirement that invalidity be proven by clear and convincing evidence.

The Federal Circuit reversed in a decision by Judge Linn (joined by Judge Mayer and Judge Robertson of the D.C. District Court, sitting by designation).  Judge Linn asserted that the prior art contained "a litany of potential prior art references" besides the ones asserted at trial.  However, the Federal Circuit focused its analysis on the prior art relating to the Merck compound elanapril, and the Schering invention of the mixture of ramapril stereoisomers, including the mixture of the SSSSS and SSSSR enantiomers.  The CAFC noted that the District Court's reasoning in deciding that the claims were not obvious was based primarily on a lack of clear and convincing evidence of any motivation in the art to separate the SSSSS isomer, as required by Aventis' patent claims in suit.

This was error, according to the Federal Circuit.  The CAFC cited KSR for the principle that applying the TSM test in a "rigid and mandatory" fashion was erroneous, and for the proposition that it is "necessary to show 'some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness,' but such reasoning 'need not seek out precise teachings directed to the specific subject matter of the challenged claim.'"  The Federal Circuit said that requiring an explicit teaching to separate the SSSSS enantiomer as the active species was "precisely the sort of rigid application of the TSM test that was criticized in KSR."

The CAFC focused on the "structural similarity" between the claimed compounds and the prior art.  Explicit teaching of a particular utility is not required, the Federal Circuit said, but there must be sufficient structural similarity to show a "sufficiently close relationship" that the skilled worker would expect the new compound to have "similar properties" to the prior art compound(s).  And the Federal Circuit's precedents held that structural similarity was enough to establish a prima facie case of obviousness.  This analysis extends to mixtures of enantiomers, because the existence of the mixture is not sufficient in every case to render the separated enantiomer non-obvious.  For example, the Federal Circuit said a separated enantiomer would be non-obviousness in situations where the existence of a particular enantiomer or its identity as an active ingredient were unknown, or that the art does not teach how to separate the mixture.

However, here the Federal Circuit found ample evidence of invalidity due to obviousness.  For example, the CAFC found that the skilled worker would have known how to separate the SSSSS enantiomer of ramipril and would have expected the greater activity results found for the Schering mixture in the prior art.  In particular, the Federal Circuit found that the two enantiomers in the Schering mixture, SSSSS and SSSSR, differed at only one position, and that the earlier prior art compounds were all consistent with the "all (S)" enantiomer having the greatest potency.  The art, in particular certain of Schering's prior patents, described the SSS configuration as being 700-fold more potent and described how to isolate the 5(S) enantiomer from the other stereoisomers.  Moreover, the differences in potency shown for the two enantiomers of elanapril (SSS and SSR) would have lead the skilled worker to expect the activity of ramapril to reside preferentially in the SSSSS enantiomer, due to the close structural similarity between these two molecules.  This evidence was enough to convince the Federal Circuit that Aventis' claims were obvious in view of the prior art.

The CAFC also rejected Aventis' argument for unexpected results, and stated that the proper comparator for analyzing whether Aventis' results were unexpected was not all 32 of ramipril's enantiomers but the Schering mixture of the 5(S) and SSSSR enantiomers.

This case is consistent with the results from Pfizer, Inc. v. Apotex, Inc. and Forest Labs., Inc. v. Ivax Pharm., Inc. and indicates that the Federal Circuit's reaction to the Supreme Court's criticism of its jurisprudence in KSR is to emphasize the primacy of structural obviousness in its determinations.  The Federal Circuit also appears to be ready to base its decisions on the factual grounds for a non-obviousness determination, where the standard for reversing (clear error) is higher and any judgments are less likely to be invalidated by the Supreme Court.

Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007) 
Panel: Circuit Judges Mayer and Linn and District Judge Robertson
Opinion by Circuit Judge Linn

Additional information regarding this case can be found at the Orange Book Blog and Patently-O.

An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice

    By Christopher P. Singer --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

Final Action Practice:

Because the revised rules relating to continuation practice limit the number of continuation applications and requests for continued examination (RCE) to two and one, respectively, per application family (see our earlier reports on 37 C.F.R. § 1.78(d)(1)(i) and 1.114), applicants and practitioners receiving Final Office actions will view them with a new gut-churning sense of dread.  Thus, the Final Office action represents an important crossroads for the applicant, and warrants a carefully thought out plan of action.  In this situation, the case can be taken to appeal, one of the precious continuations or single RCE can be filed, or the application can be abandoned.

Assuming that one elects to continue with prosecution by filing either a continuation application or the RCE, it will very important to guard against receiving a first Office action final rejection (or a second Office action final rejection).  The Patent Office reminds applicants that Final actions are improper in a first action after filing a continuation or RCE if the application contains material that was presented after final rejection, or close of prosecution, but was denied entry because it either raised new issues that require new consideration or search or new matter concerns.  Accordingly, applicants can hedge against a first Office action final rejection by requesting entry of the amendment, argument, or new evidence under 37 C.F.R. § 1.116.  Also, it will be important to confirm that the finality of the Office action is appropriate.

Interestingly, in the "Background" section of final rule notice the Patent Office mentions that it considered eliminating first Office action final practice as unnecessary in view of the limited availability to file continuing applications.  Nevertheless, the Patent Office decided to retain this practice because the continuation and claims rules provide that an applicant may file the RCE in any application in the family without any justification (the reasoning of which escapes me, as one may have just used the RCE to continue prosecution).

The Patent Office is also revising aspects of its second action final practice.  Such actions can be made final except when the action contains a new ground of rejection that is not: (1) necessitated by an amendment of the claims, including an amendment to eliminate unpatentable alternatives; (2) based on an IDS filed after a first Office action on the merits; (3) based on a double patenting rejection; or (4) necessitated by applicant's identification of claims in a CIP that find 35 U.S.C. § 112 support in a prior-filed application.  These changes reflect aspects of the shifting of certain burdens to applicants, such as required by 37 C.F.R. § 1.78(f) (identifying applications and patents naming a common inventor) and § 1.78(d)(3) (identifying earliest support for claims in a CIP application).  Certainly, the changes to continuing application practice has underscored the importance of avoiding or delaying Final Office actions and will force practitioners to be creative in crafting strategies for effective responses to Final Office actions.

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Rules Challenger Amends Complaint and Withdraws PI Motion

Tafas v. Dudas, No. 07-CV-846 (E.D. Va.) (filed Aug. 22, 2007)

    By Robert Dailey --

Triantafyllos Tafas has amended his complaint challenging the new USPTO rules set to take effect November 1, 2007.  In addition, Tafas has withdrawn his motion for a preliminary injunction (PI) enjoining the PTO from implementing the new rules.  His notice withdrawing the PI motion states that he is withdrawing the motion because it relied on his previous complaint.  But he has yet to file a new PI motion based on the newly filed amended complaint.

The amended complaint largely repeats the claims of the original complaint.  In the previous complaint, though, Tafas had been rather vague about the manner in which the new rules violate the Patent Act and the Administrative Procedure Act (APA).  The amended complaint fleshes out these statutory claims with greater specificity.  As discussed in a previous post, Tafas is most likely to prevail, if at all, on these statutory arguments.

Tafas has added one additional statutory argument based on the Regulatory Flexibility Act (RFA).  Under the RFA, when a federal agency issues new rules that could affect small entities, "the agency shall prepare and make available for public comment an initial regulatory flexibility analysis" in relation to the proposed rule.  See 5 U.S.C. § 603(a).  The agency must then prepare a final flexibility analysis when the final rules issue.  Id. at § 604.  The RFA permits the agency to avoid these requirements only "if the head of the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities."  Id. § 605(b).  In this instance, the PTO simply claimed the exception for itself without listening to the chorus of small entities decrying the innovation-squelching effects of the new rules.

Tafas appears to have a strong argument under the RFA.  This complements his solid arguments under the APA.  Of course, what Congress gives (via the APA or the RFA), it can take away through patent reform.

We will keep watching the progress of this case and provide periodic updates as they become available.

• Tafas' amended complaint can be viewed here.

• Tafas' withdrawal of motion for a preliminary injunction can be viewed here.

For additional information on this case, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007

An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination

    By Donald Zuhn --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. §§ 1.78(d)(1) and 1.114:

As discussed in our earlier reports on 37 C.F.R. §§ 1.78(d)(1) and 1.114, the new continuation and claims rules establish a "2 + 1" rule, which allows an applicant to file two continuation or continuation-in-part (CIP) applications and only one request for continued examination (RCE) per application family without any justification.  Because an applicant cannot agree to forgo a continuation application (or CIP) to obtain a second or third RCE or forgo an RCE in exchange for a third continuation or CIP under the new rules, the Patent Office will be implementing a new streamlined continuation application procedure.  This new procedure recognizes the time to examination differences between continuation applications and RCEs (i.e., continuation applications generally take longer to be examined than RCEs).

Under the new streamlined continuation application procedure, an applicant may request to have a continuation application filed on or after November 1, 2007 placed on an examiner's amended docket (otherwise known in PTO parlance as the examiner's Regular Amended docket).  In the absence of such a request, the continuation application will be placed on the examiner's new continuing application docket (otherwise known in PTO parlance as the examiner's New Special Docket).  Continuation applications placed on an examiner's Regular Amended docket will ordinarily be picked up for action quicker than continuation applications placed on the examiner's New Special docket.

To properly request that a continuation application be placed on an examiner's Regular Amended docket, the following conditions must be satisfied:

1.  The applicant must make a request that the continuation application be placed on an examiner's Regular Amended docket.

2.  The application must disclose and claim an invention or inventions that were disclosed and claimed in the prior-filed application.

3.  The applicant must agree to abide by any invention or species election made in the prior-filed application.

4.  The prior-filed application must be under a final Office action or under appeal at the time the continuation application is filed.

5.  A letter of express abandonment must be filed for the prior-filed application at the time the continuation application is filed.

In addition, in order for a continuation application to be placed on an examiner's Regular Amended docket, the continuation application must also be complete under § 1.51(b), or completed under § 1.53(f), and in condition for publication under § 1.211.  Thus, if an applicant delays in submitting the filing fee and oath or declaration (or a copy of the oath or declaration from the prior-filed application), the Patent Office will delay the docketing of a continuation application even if the applicant has requested streamlined docketing.

In its final rule notice, the Patent Office notes that the new streamlined continuation application procedure only applies to the placement of the continuation application on an examiner's Regular Amended docket, and that the continuation application will be otherwise treated as a new application.  In particular, the Office notes that for streamlined continuation applications:

1.  An applicant must pay the basic filing fee ($300), search ($500), and examination ($200) fees, and any required excess claims fees ($200 per independent claim and $50 for dependent claims), rather then the lower RCE ($790) fee.  [Cynical applicants may not be surprised to learn that the Patent Office has managed to turn the "2 + 1" rule - which makes no more sense than a "3 of anything" rule - into a revenue generating proposition.]

2.  The application will be assigned a new application number.

3.  The continuation application is subject to the patent term provisions of 35 U.S.C. 154(b) and § 1.702 et seq. as a new continuation application.

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Changes to Rules 78(d)(1) and 114:

• Changes to Rule 78(d)(1) can be found here.
• Changes to Rule 114 can be found here.

An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims

    By Christopher P. Singer --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. § 1.117:

In light of the new and harsh rule changes relating to the consequences of a patent application containing more than 5 independent or 25 total claims (see our earlier report), the USPTO has anticipated that applicants may wish to file amendments that cancel pending claims in order to avoid filing the unsavory examination support document (ESD).  Amended rule 37 C.F.R. § 1.117 details the circumstances under which an applicant may request a refund of excess claims fees in an application that has yet to be examined on the merits.

Applicants can request a refund for any excess claims fees under 37 C.F.R. §§ 1.16(h), (i), or (j) or under §§ 1.492(d), (e), or (f), paid on or after December 8, 2004, in an application that has yet to have an examination on the merits.  Any amendments filed with a certificate of transmission or mailing under 37 C.F.R. § 1.8 will not be considered as filed on the date indicated on the certificate for the purpose of determining whether it was filed before an examination on the merits has been made.  Subsection (b) of this rule states that if the request for a refund is not made within two months (non-extendable) from the filing date of the amendment cancelling the excess claim(s), the Office may keep the excess fees.

In the section of the Patent Office's final rule notice entitled "Discussion of Specific Rules," the Office notes that an examination on the merits (35 U.S.C. § 131) for the purposes of this rule has been made once: (a) the Office issues a first Office action on the merits; (b) the Office issues a notice of allowability or allowance; or (c) an action under Ex parte Quayle is shown in the Patent Application Locating and Monitoring (PALM) system as having been counted.  The discussion in the final rule notice also notes that the Office lacks authority to grant a refund for claims withdrawn from consideration that were directed to a non-elected invention or species.

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Changes to Rule 117:

(a) If an amendment canceling a claim is filed before an examination on the merits has been made of the application, the applicant may request a refund of any fee under § 1.16(h), (i), or (j) or under § 1.492(d), (e), or (f) paid on or after December 8, 2004, for such claim. If an amendment adding one or more claims is also filed before the application has been taken up for examination on the merits, the Office may apply any refund under § 1.117 to any excess claims fees due as a result of such an amendment. The date indicated on any certificate of mailing or transmission under § 1.8 will not be taken into account in determining whether an amendment canceling a claim was filed before an examination on the merits has been made of the application.
(b) If a request for refund under this section is not filed within two months from the date on which the claim was canceled, the Office may retain the excess claims fee paid in the application. This two-month period is not extendable. If an amendment canceling a claim is not filed before an examination on the merits has been made of the application, the Office will not refund any part of the excess claims fee paid in the application except as provided in § 1.26.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Sepracor Inc. et al. v. Sun Pharmaceutical Industries Ltd.
3:07-cv-04213; filed September 4, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,211,582 ("Methods for treating urticaria using descarboethoxyloratadine," issued May 1, 2007), 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007) following a paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Sepracor's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

Patent "Reform" Bill Passes House of Representatives

    By Kevin E. Noonan --

On Friday, the U.S. House of Representatives passed H.R. 1908, a bill intended to "reform" U.S. patent law.  Pushed by special interests (mostly in the IT arena) frustrated by the proliferation of patent rights over the past twenty-five years, the bill would fundamentally change U.S. patent law.  Whether "reform" is needed or not, this bill constitutes more overhaul than reform, and is unlikely to better improve U.S. technology or inventors; sole inventors and universities are the parties most likely to be harmed.

The scope of the bill is sufficiently all-encompassing that a thorough analysis must wait until Patent Docs has had a chance to review it more completely.  However, there are a few highlights (or lowlights) that can be immediately gleaned from a cursory review.  These include:

1.  Section 102 has been replaced by a novelty section providing for a first-to-file system, where a patent filing can more easily be made in the name of the "real party in interest" (i.e., an assignee or someone that the inventor owes a duty to disclose).  First-to-file does not include acts of derivation, where the first to file derives the invention from the true inventor.  The provisions also retain the one-year grace period for disclosure, publication, public use, or sale by the inventor.  Section 103 is changed to specify the effective filing date, rather than the date of invention, for determining obviousness.  Section 104, relating to inventions made abroad, is repealed in its entirety.  These provisions will not be implemented, however, until the President provides an Executive Order finding that Europe and Japan have enacted a one-year grace period for disclosure, public use, or sale of an invention by the inventor or real party in interest.

2.  Interference proceedings are abolished, replaced by actions to show derivation of an invention from the "true" inventor.  A floor amendment to the bill by Congressman Conyers of Michigan preserved the right to an interference for any patent application filed before the effective date of the amendment.

3.  A post-grant opposition proceeding is created, requiring that a petition to cancel claims of a granted patent be filed within one year of the patent grant date.  The Director is also given the power to sua sponte institute a cancellation proceeding.  As with current re-examination practice, the Director's decision to grant or refuse a cancellation proceeding cannot be appealed.  Moreover, a third party who fails to invalidate a patent in a civil action cannot provoke a cancellation proceeding against that patent, and repetitive petitions by the same party against the same patent are also prohibited.  Sanctions are available for abuses of these provisions.  A cancellation proceeding can be initiated on the basis of art that had been cited or considered during prosecution (i.e., eliminating the current reexamination standard that a new question of patentability be supported by the assertion of new art not considered during prosecution).  A floor amendment to the bill by Congressman Conyers of Michigan preserved the right of a patentee to pursue infringement actions despite concurrent cancellation proceedings, and precludes the use of the existence of a cancellation proceeding as evidence of invalidity or unenforceability in any civil action or before the ITC.  These provisions take effect one year after the bill becomes law.

4.  Derivation proceedings, appeals, and cancellation proceedings are to be held before the Patent Trial and Appeal Board, which replaces the Board of Patent Appeals and Interferences.

5.  Available damages (where actual damages are not established) are limited to a reasonable royalty depending on the "economic value properly attributable to the patent's specific contribution over the prior art."  Damages are not to be determined from the "entire market value" of sales of the infringing article, but a court (or jury) can consider the terms of any non-exclusive licensing of the patents.  A patentee can provide evidence of additional value for combination inventions where the components of the combination are in the prior art.

6.  Willful infringement can be found only when the infringer was put on notice in writing by the patentee.  The notice must raise a reasonable apprehension of suit in the accused infringer, and set forth with specificity how the allegedly infringing article infringes each claim of the patent asserted by the patentee.  Frank copying, or persisting in the infringing activity after a court determines infringement, are also grounds for finding willful infringement. Willful infringement cannot be found where the infringer has "an informed good faith belief that the patent was invalid or unenforceable, or would not be infringed by the conduct later shown to constitute infringement of the patent."  Such a belief can be established by an opinion of counsel or behavior directed at avoiding infringement.  Willfulness cannot be plead (and presumably, not expressed to a jury) until after the court finds infringement.

7.  The opportunity for third parties to submit art and other information during ex parte examination is expanded.

8.  The prior inventor defense is expanded to no longer be limited to business method patents.

9.  Methods for avoiding taxes are expressly excluded from patentable subject matter under Section 101.

10.  Venue rules are made more limited, requiring venue to be where the defendant is incorporated or has its principle place of business, or has committed "a substantial portion of the acts of infringement" and has "an established physical facility."

11.  Interlocutory appeals regarding claim construction are created, at the discretion of the trial court but not the Federal Circuit.

12.  The provisions of the bill also authorize the Patent and Trademark Office to require information from applicants including search reports and other information relating to patentability searches.  These requirements do not apply to "microentities," which encompass traditional small entities but do not include parties named on more than 5 patents or applications, or that have more than 2.5 times the median household taxable income.

13.  Inequitable conduct is defined by statute and requires findings of materiality and intent, but the provisions of this section do not immunize applicants or their attorneys from liability attendant to filing search reports or patentability reports.

14.  The bill also authorizes retroactively the actions recently taken by the Patent Office with regard to the continuation rules by expanding the Director's rulemaking authority under Section 2. However, a floor amendment by Mr. Issa of California provided for a stay of any such regulations for 60 days to permit Congress time to disapprove such regulations.

15.  Violation of the best mode requirement is no longer grounds for invalidating a patent.

The vote in the House was 220-175, with Democrats voting 160-58 and Republicans voting 60-117.  There are significant differences with the Senate version of the bill, which may come to a vote in the next few weeks.  The Bush administration opposes certain provisions of the House version as well, and the political considerations make it unlikely that the bill as passed in the House will be the final version of any bill signed into law by the President.  Those considerations are but cold comfort to those who view many of these provisions with disapproval or despair, since they appear to significantly decrease the advantages U.S. patent law has provided for over a generation, to solve alleged problems many believe exist only for certain special interest groups.

Patent Docs will provide a more detailed analysis of the rules over the next several days.

Conference & CLE Calendar

September 10, 2007 - New USPTO Rule Packages on Claim Examination and Continuation Applications (American Intellectual Property Law Association)

September 12, 2007 - Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office)

September 18, 2007 - Trying a Patent Validity Case in a Post-KSR World (Practising Law Institute)

September 18-19, 2007 - Pharma/Biotech Patent Boot Camp (American Conference Institute) - San Francisco, IL***

September 19, 2007 - Final USPTO Rules on Claims and Continuations (Practising Law Institute)

September 20, 2007 - KSR International Co. v. Teleflex, Inc.: Where Do We Stand Five Months Out? (West LEGALworks)

September 24-25, 2007 - Biosimilars 2007 (Scherago International, Inc.) - George Washington University, Washington, D.C.

September 26-27, 2007 - Advanced Forum on Biotech Patents (American Conference Institute) - Boston, MA***

September 27-28, 2007 - Biotechnology: Business and Legal Developments (Law Seminars International) - Seattle, WA

October 10-12, 2007 - Stem Cells European Business Summit - Edinburgh, Scotland

October 12, 2007 - Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) - Chicago, IL

October 25-26, 2007 - Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) - Washington, D.C.***

October 25-27, 2007 - Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) - Palm Springs, CA

November 13-15, 2007 - Pharma and Biotech Collaborative Agreements (American Conference Institute) - New York, NY***

***Patent Docs is a media sponsor of this conference or CLE.

AIPLA CLE on New Continuation and Claims Rules

The American Intellectual Property Law Association (AIPLA) will be offering a live online seminar entitled:  "New USPTO Rule Packages on Claim Examination and Continuation Applications" on September 10, 2007 from 12:30-2:30 PM (EST).  Speakers Charles E. Van Horn of Finnegan, Henderson, Farabow,Garrett & Dunner, LLP and Susan P. Pan of Sughrue Mion PLLC will provide their insights on adapting one's practice in light of the USPTO rule changes.

The registration fee for the online seminar ranges from $145 to $625 depending on the number of attendees and AIPLA membership status.  Those interested in registering for the online seminar, can do so here.

NAPP Opposes New Continuation and Claims Rules

    By Donald Zuhn --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will significantly impact the way patent attorneys and agents prosecute applications before the Patent Office.  While patent practitioners  - especially those prosecuting applications directed to biotech and pharmaceutical inventions - have decried the new rules for the adverse effect they are likely to have on the protection of patentable inventions, industry groups have curiously remained silent.  It now appears, however, that at least one industry group to be affected by the new rules - the National Association of Patent Practitioners (NAPP) - has broken the silence.

In a statement released to its members on the NAPP Discussion List, the nonprofit trade association for patent attorneys and patent agents recently announced that "upon receipt of a vocal outcry" against the new rules from its membership, the NAPP had begun taking action to oppose the rulemaking.  In addition, the NAPP statement noted that while "[c]ertain recent postings on the NAPP Discussion List have expressed concern that our organization has not taken any action in response to the release of the new rules relating to claims and continuations," the group's Directors and Officers had met to discuss these concerns, and "unanimously agreed that implementation of the new rules will be detrimental to all of our practices," and therefore, shared its members' concerns about the "significant adverse impact of these rules."

In addressing its membership's concerns, the NAPP also recalled that when the new rules were first proposed by the USPTO in January 2006, the organization "provided a vigorous and forceful response to that proposal" (see "Response to Request for Comments; Proposed PTO Rule on Continuation Practice" and "Response to Request for Comments; Proposed PTO Rules on Claim Limits"), and observed that a number of the organization's suggestions had been adopted by the Patent Office, thereby "lessening the adverse impact of the final rule package."  The NAPP acknowledged that "despite the overwhelmingly negative comments of NAPP and over 300 other individuals and organizations (many of which are more powerful and have deeper pockets than NAPP), the PTO has nevertheless promulgated [a] restrictive rule package," noting that "[i]n the face of the PTO's determination to proceed with restrictions on the number of claims and continuing applications, and the legislature's apparent unwillingness to take any action to restrain the PTO, NAPP's options, and indeed those of the entire patent bar, are limited."

With respect to the group's future plans, the NAPP stated that it could be most effective in continuing to express its opposition to the new rules "by filing or joining an amicus brief, if a case arose which posed the appropriate question(s) in an appropriate forum."

We thank Patent Docs reader Jerry Miller for directing our attention to the NAPP announcement and for graciously providing us with a copy of the organization's statement.

An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements

    By Donald Zuhn --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. § 1.142:

In view of the "2 + 1" rule, which allows an applicant to file only two continuation or continuation-in-part applications and only one RCE per application family without any justification (see our earlier reports on 37 C.F.R. §§ 1.78(d)(1) and 1.114), the new continuation and claims rules will almost certainly leave patent practitioners seeking out that which they previously disdained: restriction requirements.  The reason for this change of heart?  Under the new rules, an applicant is allowed to file a divisional application for each restricted invention after receiving a restriction requirement, and each divisional application forms the basis of a new application family entitling an applicant to file an additional two continuations and an RCE (under the new rules, an applicant cannot file a continuation-in-part off of a divisional).

Under newly added 37 C.F.R. § 1.142(c), the Patent Office has provided a mechanism by which applicants can now actively seek a restriction requirement: the suggested restriction requirement (SRR).  In particular, this provision of the rules allows an applicant to file a suggested requirement for restriction if two or more independent and distinct inventions are claimed in a single application.  Under Rule 142(c), an SRR must be filed before the earlier of the first Office action on the merits or an Office action that contains a restriction requirement or invitation to comply with the unity of invention requirement.  In addition, the SRR must be accompanied by an election without traverse of an invention to which there are no more than five independent claims and no more than twenty-five total claims (i.e., to comply with the 5/25 rule; see our earlier report on 37 C.F.R. § 1.75(b)), and must identify the claims to the elected invention.

If the examiner accepts an applicant's SRR, then the claims to the nonelected invention, if not canceled by the applicant, will be withdrawn from further consideration by the examiner.  If the examiner refuses the applicant's SRR, the applicant will be notified in an Office action, which may contain a notice requiring the applicant to file an examination support document (ESD) or reduce the number of claims to satisfy the 5/25 rule, as well as the examiner's own restriction requirement.  If the examiner makes his or her own restriction requirement, the applicant will be notified of the restriction requirement and given a two-month period - that is not extendable under § 1.136(a) - within which to make an election consistent with the examiner's restriction requirement in order to avoid abandonment of the application.

Because of changes to Rule 142(a), applicants should not discount the possibility that the Patent Office may find that the examination of multiple inventions in a single application no longer presents the Office with undue hardship (especially when the alternatives for the applicant are filing an ESD or canceling claims).  In particular, Rule 142(a) has been amended to read:

If two or more independent and distinct inventions are claimed in a single application, the examiner in an Office action may require the applicant in the reply to that action to elect an invention to which the claims will be restricted.

(emphasis added).  The prior version of Rule 142(a) stated that the "examiner in an Office action will require" (emphasis added).  According to the Patent Office, the change to Rule 142(a) finds support in 35 U.S.C. § 121, which "authorizes, but does not compel, the Director to require that an application containing two or more independent and distinct inventions be restricted to one of the inventions," and is "consisten[t] with current Office practice under which a requirement that an application containing claims to two or more independent and distinct inventions be restricted to a single invention is discretionary" (see final rule notice).

Citing M.P.E.P. § 803, the Patent Office also notes in the final rule notice that "[a]n application containing claims to two or more independent and distinct inventions typically is not restricted to a single invention if the search and examination of all of the claims in the application can be made without serious burden."  Thus, while it may have been difficult to convince the Patent Office to examine two or more inventions in a single application under the old rules, cynical patent practitioners can be forgiven for believing that such a task may have just gotten easier under the new rules.  With respect to appealing an examiner's decision not to restrict, the final rule notice states that:

[a] decision not to restrict an application to a single invention is not an action or requirement within the meaning of § 1.181(a).  Thus, any review of an examiner's requirement for restriction that differs from a suggested restriction requirement will only concern the appropriateness of the examiner's restriction requirement and will not address the appropriateness of the applicant's suggested restriction requirement or compare the examiner's restriction requirement and the suggested restriction requirement.

The changes to 37 C.F.R. § 1.142(c) are applicable to any nonprovisional application that is filed (or enters national stage) on or after November 1, 2007, and any pending nonprovisional application in which a first Office action on the merits was not mailed before November 1, 2007.  Unfortunately, patent practitioners may have to wait until well into 2008 to see how the Patent Office actually applies the "slight" change to Rule 142(a) and the added provisions of Rule 142(c).

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Changes to Rule 142:

(a) If two or more independent and distinct inventions are claimed in a single application, the examiner in an Office action may require the applicant in the reply to that action to elect an invention to which the claims will be restricted, this official action being called a requirement for restriction (also known as a requirement for division). Such requirement will normally be made before any action on the merits; however, it may be made at any time before final action.

* * *

(c) If two or more independent and distinct inventions are claimed in a single application, the applicant may file a suggested requirement for restriction under this paragraph. Any suggested requirement for restriction must be filed prior to the earlier of the first Office action on the merits or an Office action that contains a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121 in the application. Any suggested requirement for restriction must also be accompanied by an election without traverse of an invention to which there are no more than five independent claims and no more than twenty-five total claims, and must identify the claims to the elected invention. If the suggested requirement for restriction is accepted, the applicant will be notified in an Office action that will contain a requirement for restriction under paragraph (a) of this section. Any claim to the non-elected invention or inventions, if not canceled, is by the election withdrawn from further consideration.