PATENT OWNER
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`PATENT OWNER
`EXHIBIT 2027
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`EXHIBIT 2027
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`PATENT OWNER
`EXHIBIT 2027
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`EXHIBIT 2027
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`UNITED STA (cid:9)I ES PA (cid:9)PENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO. (cid:9)
`
`10/315,445
`
`FILING DATE
`
`12/10/2002
`
`FIRST NAMED INVENTOR (cid:9)
`
`I ATTORNEY DOCKET NO. I CONFIRMATION NO.
`
`Tony Marcel
`
`239682US0 CONT
`
`4601
`
`22850 (cid:9)
`7590 (cid:9)
`05/26/2010
`OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
`1940 DUKE STREET
`ALEXANDRIA, VA 22314
`
`EXAMINER
`
`BUNNER, BRIDGET E
`
`ART UNIT
`
`PAPER NUMBER
`
`1647
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/26/2010
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`patentdocket@oblon.com
`oblonpat @ oblon. com
`j gardner @ oblon. corn
`
`PTOL-90A (Rev. 04/07)
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`Ex parte TONY MARCEL,
`FRANCOIS ROUGEON, and CATHERINE ROUGEOT
`
`Appeal 2009-0106321
`Application 10/315,445
`Technology Center 1600
`
`Decided:2 May 24, 2010
`
`Before LORA M. GREEN, FRANCISCO C. PRATS, and
`JEFFREY N. FREDMAN, Administrative Patent Judges.
`
`PRATS, Administrative Patent Judge.
`
`DECISION ON APPEAL
`
`This appeal under 35 U.S.C. § 134 involves claims to peptide-
`
`containing pharmaceutical compositions. The Examiner rejected the claims
`
`for lack of enablement and lack of written description.
`
`'Institute Pasteur is the real party in interest (App. Br. 1).
`2 Oral argument was presented in this case on May 13, 2010.
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
`
`STATEMENT OF THE CASE
`
`Claims 45-55 are pending (App. Br. 1). Claims 52-55 have been
`
`withdrawn from consideration by the Examiner (id.). Claims 45-51 stand
`
`rejected and are on appeal (id.).
`
`Claim 45, the sole independent claim on appeal, reads as follows:
`
`45. A composition, comprising:
`
`a peptide comprising at least one amino acid sequence
`selected from the group consisting of SEQ ID NO: 1, SEQ ID
`NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and
`
`a pharmaceutical agent capable of treating impaired
`sexual behavior in a mammal having impaired sexual behavior,
`
`wherein the amount of the pharmaceutical agent in the
`composition alone is not sufficient to treat impaired sexual
`behavior in a mammal having impaired sexual behavior and
`wherein the amount of the peptide and the pharmaceutical agent
`together is sufficient to treat impaired sexual behavior in a
`mammal having impaired sexual behavior.
`
`The Examiner cites the following documents as evidence of
`
`unpatentability:
`
`Vishnu M. Dhople and Ramakrishnan Nagaraj, Conformation and
`activity of o-Lysin and its analogs, 26 PEPTIDES 217-225 (2005).
`
`Thomas Frei et al., Different Extracellular Domains of the Neural Cell
`Adhesion Molecule (N-CAM) Are Involved in Different Functions, 118 J.
`CELL BIOL. 177-194 (1992).
`
`GOODMAN AND GILMAN'S, THE PHARMACOLOGICAL BASIS OF
`THERAPEUTICS, 8th ed., pages 33-48 (1993).
`
`2
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`Johanne Louise Neiiendam et al., An NCAM-derived FGF-receptor
`agonist, the FGL-peptide, induces neurite outgrowth and neuronal survival
`in primary rat neurons, 91 J. NEUROCHEM. 920-935 (2004).
`
`The following rejections are before us for review:
`
`(1) Claims 45-51, rejected under 35 U.S.C. § 112, first paragraph, as
`
`lacking enablement for the full scope of the claimed subject matter (Ans.
`
`3-8); and
`
`(2) Claims 45-51, rejected under 35 U.S.C. § 112, first paragraph, as
`
`lacking written description (id. at 8-10).
`
`During prosecution, the Examiner made a species election
`
`requirement between the sequences recited in claim 45, and in response to
`
`Appellants' election, examination of the claims was limited to SEQ ID NO:
`
`2 (see Final Rejection 3 (entered January 24, 2008)).
`
`We limit our consideration of the merits of the appealed rejections to
`
`the elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI
`
`1987).
`
`ISSUE
`
`ENABLEMENT
`
`The Examiner concedes that the Specification enables (a) a
`
`composition "comprising a peptide consisting of the amino acid sequence of
`
`SEQ ID NO: 2," and (b) a composition comprising a peptide "consisting of
`
`the amino acid sequence of SEQ ID NO: 2 in an amount sufficient to
`
`increase the number and duration of sexually-related behaviors in male rats
`
`(increased non-sexual contact, increased latency of the first mount; increased
`
`number of ejaculations per sexual episode, and increased number of mounts
`
`with intromissions)" (Ans. 3-4).
`
`3
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`The Examiner contends, however, that the Specification does not
`
`reasonably provide enablement for a composition comprising a peptide
`
`comprising SEQ ID NO: 2, and a pharmaceutical agent capable of treating
`
`impaired sexual behavior in a mammal, "wherein the amount of the
`
`pharmaceutical agent in the composition alone is not sufficient to treat
`
`impaired sexual behavior and wherein the amount of the peptide and the
`
`pharmaceutical agent together is sufficient to treat impaired sexual behavior
`
`in a mammal having impaired sexual behavior" (id. at 4).
`
`The Examiner reasons that Appellants' Specification shows only that
`
`the pentapeptide consisting of SEQ ID NO: 2 changes the sexual behavior in
`
`normal male rats, whereas the claims encompass treating impaired sexual
`
`behavior in any mammal (id. at 5). Given the complexities of modeling
`
`human behavioral disorders in rats, the Examiner contends, a skilled artisan
`
`would expect that undue experimentation would be required to apply the
`
`claimed peptide to all disorders encompassed by the claims (id.).
`
`The Examiner also urges that claim 45 encompasses polypeptides that
`
`include a peptide having SEQ ID NO: 2, but having flanking peptides of up
`
`to 500 amino acids (id.). Given this breadth, and the fact that even nominal
`
`changes in amino acid composition can affect a particular peptide's
`
`biological activity, the Examiner reasons that a skilled artisan would have
`
`had to perform an undue amount of experimentation to determine which
`
`polypeptides encompassed by the claims would or would not have the
`
`required biological activity (id. at 6 (citing Frei, Dhople, and Neiiendam)).
`
`Moreover, the Examiner urges, the Specification fails to teach
`
`co-administration of any pharmaceutical encompassed by the claims, much
`
`less any synergistic activity that the claims require (id. at 6-7). Given the
`
`4
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`unlikely prospect of generating true synergistic activity, and the absence of
`
`any demonstrated effect in female rats, the Examiner reasons that undue
`
`experimentation would be required to practice the full scope of the claimed
`
`invention (id. at 7 (citing Goodman and Gilman's)).
`
`Appellants contend that the Examiner has not established that
`
`practicing the claimed invention would have required undue experimentation
`
`(App. Br. 3-4).
`
`In view of the positions advanced by Appellants and the Examiner,
`
`the issue with respect to this rejection is whether the Examiner's conclusion
`
`of non-enablement is supported by the evidence of record.
`
`FINDINGS OF FACT ("FF')
`
`1.
`
`The Specification discloses that tests were conducted to determine the
`
`effect of the pentapeptide encoded by SEQ ID NO: 2 on the sexual behavior
`
`of male Wistar rats who, after treatment with the peptide, were exposed to
`
`sexually receptive female rats (Spec. 17-18 (Example 3)).
`
`2.
`
`The tests showed that the male rats exhibited "a significantly
`
`increased latency of first mounts" (Spec. 18 (Example 4)), that the "number
`
`of episodes of intercourse . . . are significantly increased" (id. (Example 5)),
`
`and that the peptide-induced improvement in the rats' sexual behavior was
`
`dose-responsive (id. at 20 (Example 7)).
`
`PRINCIPLES OF LAW
`
`The Examiner bears the burden of establishing that practicing the full
`
`scope of the claimed subject matter would have required undue
`
`experimentation. In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993)
`
`("[T]he PTO bears an initial burden of setting forth a reasonable explanation
`
`as to why it believes that the scope of protection provided by that claim is
`
`5
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`not adequately enabled by the description of the invention provided in the
`
`specification of the application.").
`
`"The enablement requirement is met if the description enables any
`
`mode of making and using the invention." Johns Hopkins Univ. v. Cellpro,
`
`Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel Indus., Inc. v.
`
`Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
`
`ANALYSIS
`
`We agree with Appellants that the Examiner has not made a prima
`
`facie case of non-enablement.
`
`As the Examiner concedes, the Specification enables "a composition
`
`comprising a peptide consisting of the amino acid sequence of SEQ ID NO:
`
`2" (Ans. 3-4). Thus, the composition conceded by the Examiner as being
`
`enabled may contain not only the pentapeptide of SEQ ID NO: 2, but also
`
`any other pharmaceutical agent, in any amount, including the agent recited
`
`in claim 45, in the amount recited in the claim.
`
`The Examiner's enablement conclusion regarding the conceded
`
`enabled subject matter is supported by the Specification's undisputed
`
`disclosure that the pentapeptide of SEQ ID NO: 2 can be used to increase the
`
`libido of male rats (FF 1-2). Thus, as the method of making the claimed
`
`composition is not in dispute, and as the Examiner concedes (Ans. 4) the
`
`Specification enables the use of a composition containing the pentapeptide
`
`having the claimed sequence in methods of increasing the libido of male
`
`rats, we conclude that Appellants' Specification provides an adequate
`
`disclosure of how to both make and use the claimed composition.
`
`We note, as the Examiner argues, that the claims encompass any
`
`number of flanking peptides that might affect the demonstrated biological
`
`6
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`activity of the pentapeptide of SEQ ID NO: 2. We also note that the claims
`
`encompass virtually any additional pharmaceutical agent capable of treating
`
`impaired sexual behavior.
`
`However, as Appellants point out (App. Br. 4), an ordinary artisan
`
`need only test a peptide encompassed by claim 45 in accordance with the
`
`procedures outlined in the Specification to determine whether it functions
`
`adequately in the enabled method of use. Given Appellants' disclosure of
`
`specific procedures for testing the peptides, and combinations of the peptides
`
`with other agents, to determine whether they retain the function of the
`
`pentapeptide of SEQ ID NO: 2 (see FF 1-2), we are not persuaded that
`
`practicing the full scope of the claimed invention would have required undue
`
`experimentation.
`
`We further note, as the Examiner argues, that the claims do not limit
`
`the composition to any particular method of use. However, as noted above,
`
`"[t]he enablement requirement is met if the description enables any mode of
`
`making and using the invention." Johns Hopkins Univ. v. Cel1pro, Inc., 152
`
`F.3d at 1361 (emphasis added).
`
`In the instant case, claim 45 recites a composition, not a process, and
`
`the Examiner does not dispute that the Specification enables the use of a
`
`composition containing a pentapeptide having the claimed sequence in
`
`methods of increasing the libido of male rats (see Ans. 3-4). As the
`
`evidence of record supports Appellants' position that an ordinary artisan
`
`would have required only routine experimentation guided by the
`
`Specification to determine whether a particular flanking sequence, or
`
`impaired sexual behavior treating agent, encompassed by the claims would
`
`be applicable to the use enabled by the Specification, we agree with
`
`7
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`Appellants that the Examiner's conclusion of non-enablement is not
`
`supported by the evidence of record.
`
`Accordingly, we reverse the Examiner's enablement rejection of
`
`claim 45 and its dependents.
`
`WRITTEN DESCRIPTION
`
`ISSUE
`
`In rejecting claims 45-51 for lack of written descriptive support, the
`
`Examiner again notes that, in view of the Specification, the claims broadly
`
`encompass peptides as large as 500 amino acids (Ans. 9).
`
`However, the Examiner reasons, "the description of four short peptide
`
`sequences (SEQ ID NOs: 1-4) is not adequate written description of an
`
`entire genus of functionally equivalent polypeptides which incorporate any
`
`larger amino acid sequence that contains the amino acid sequence of SEQ ID
`
`NO: 2 and all possible peptide variants thereof' (id.).
`
`Moreover, the Examiner finds, "[t]here is also not adequate written
`
`description of an entire genus of pharmaceutical agents capable of treating
`
`impaired sexual behavior in a mammal" (id.).
`
`Appellants contend that the complete sequence set forth in SEQ ID
`
`NO: 2 is a structural feature common to all members of the claimed genus,
`
`and is therefore adequately representative of the genus' members (App. Br.
`
`5, citing Example 4 and Example 9, claim 1, of the Written Description
`
`Training Materials, rev. 1, March 25, 2008 (included in Evidence
`
`Appendix)).
`
`Appellants further contend that the genus of pharmaceutical agents
`
`that treat impaired sexual behavior "were well-known at the time the present
`
`application was filed. A patent need not teach, and preferably omits, what is
`
`8
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`well-known in the art" (App. Br. 5 (citing In re Buchner, 929 F.2d 660, 661
`
`(Fed. Cir. 1991))).
`
`In view of the positions advanced by Appellants and the Examiner,
`
`the issue with respect to this rejection is whether the evidence of record
`
`supports that Examiner's finding that the claims lack adequate descriptive
`
`support in the Specification.
`
`FINDINGS OF FACT
`
`3.
`
`The Specification discloses that "the invention relates to the treatment
`
`of DSM-III disorders [Diagnostic and Statistical Manual of Mental
`
`Disorders], such as impaired interpersonal and behavioral disorders" (Spec.
`
`1).
`
`4.
`
`The Specification discloses that "included in these disorders are
`
`sexual defects, including arousal disorders, impaired sexual behavior in the
`
`form of a lack of affective attention, and impaired social activity linked to
`
`sexuality. These latter disorders can manifest in part as a condition known
`
`as male erectile dysfunction (M.E.D.)" (id.).
`
`5.
`
`The Specification discloses that "PDES inhibitors, such as sildenafil,
`
`alpha blocking agents, such as moxysylate or phentolamine, and
`
`prostaglandins have been used" to treat M.E.D. (Id. at 2.)
`
`6.
`
`The Diagnostic and Statistical Manual of Mental Disorders (Third
`
`Edition) (hereinafter "DSM-III"), provides an extensive list of
`
`"[p]sychosexual disorders," which include M.E.D. at page 279 (see App.
`
`Br., Evidence Appendix).
`
`PRINCIPLES OF LAW
`
`To meet the initial burden of establishing a prima facie case of
`
`unpatentability based on a lack of written description, the Examiner must "
`
`9
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`"`present[] evidence or reasons why persons skilled in the art would not
`
`recognize in the disclosure a description of the invention defined by the
`
`claims." In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
`
`Recently addressing the description requirement, the Federal Circuit
`
`noted that, If] or generic claims, we have set forth a number of factors for
`
`evaluating the adequacy of the disclosure, including 'the existing knowledge
`
`in the particular field, the extent and content of the prior art, the maturity of
`
`the science or technology, [and] the predictability of the aspect at issue.'
`
`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed.
`
`Cir. 2010) (en banc) (quoting Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed.
`
`Cir. 2005).
`
`The court also advised that the "doctrine never created a heightened
`
`requirement to provide a nucleotide-by-nucleotide recitation of the entire
`
`genus of claimed genetic material; it has always expressly permitted the
`
`disclosure of structural features common to the members of the genus." Id.
`
`at 1352.
`
`In accordance with these concepts, Example 4 of the Written
`
`Description Training Materials 3 (http://www.uspto.gov/web/menu/
`
`written.pdf) (pages 13-16) explains that, in the context of expressed
`
`sequence tags, open "comprising" language that includes unnamed
`
`nucleotides flanking a sequence recited a claim does not lack descriptive
`
`support because each member of the genus necessarily contains the named
`
`sequence, and because adding any desired sequence would be within the
`
`knowledge and skill in the art.
`
`3
`
` Revision 1, March 25, 2008.
`
`10
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`Example 9 of the Training Materials advances a similar result with
`
`respect to a claim reciting an isolated protein "comprising" a specific
`
`sequence, since the all members of the genus share the structural feature of
`
`the claim-recited sequence, and since additions to the named sequence
`
`would have been within the knowledge of skilled artisans (id. at 31).
`
`ANALYSIS
`
`We agree with Appellants that the Examiner's finding of lack of
`
`written description is not supported by the evidence of record.
`
`We acknowledge that claim 45 encompasses peptides that, in addition
`
`to the pentapeptide recited in SEQ ID NO: 2, also have flanking
`
`polypeptides of considerable size. However, every member of that genus
`
`includes the common structural feature of the sequence recited in SEQ ID
`
`NO: 2, and, as discussed above regarding enablement, determining which
`
`members of the genus possess the required functional properties involves
`
`only routine experimentation.
`
`In view of the disclosure of a structural feature common to all
`
`members of the genus, and methods allowing an ordinary artisan to routinely
`
`determine peptides that fall within the language of the claims, we agree with
`
`Appellants that the Specification provides adequate descriptive support for
`
`the peptide recited in claim 45.
`
`Regarding the "pharmaceutical agent capable of treating impaired
`
`sexual behavior in a mammal having impaired sexual behavior" recited in
`
`claim 45, we note, as the Examiner points out (Ans. 23), that the patents
`
`cited by Appellants to support the well known nature of such agents appear
`
`to have been first submitted at the Appeal Brief stage. We do not agree with
`
`the Examiner, however, that "even if the evidence supplied by the Appellant
`
`11
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`had been filed prior to the Brief, the references still would not have been
`
`persuasive" (id.).
`
`Specifically, the Specification discloses that disorders involving
`
`impaired sexual behavior were well known in the art, as evidenced by their
`
`inclusion and characterization in the DSM-III manual (FF 3, 6). In
`
`particular, the Specification lists male erectile dysfunction (M.E.D) as an
`
`example of such disorders (FF 4). Moreover, the Specification provides
`
`examples of prior art agents useful for treating M.E.D. (FF 5).
`
`Given the Specification's disclosure, and the Examiner's failure to
`
`present any specific evidence supporting the assertion that a skilled artisan
`
`would fail to recognize a disorder involving impaired sexual behavior, or an
`
`agent useful for treating it, we find that a preponderance of the evidence
`
`supports Appellants' position. Accordingly, we reverse the Examiner's
`
`rejection of claim 45, and its dependents, for failure to meet the written
`
`description requirement.
`
`SUMMARY
`
`We reverse the Examiner's rejection of claims 45-51 under 35 U.S.C.
`
`§ 112, first paragraph, as lacking enablement for the full scope of the
`
`claimed subject matter.
`
`We also reverse the Examiner's rejection of claims 45-51 under 35
`
`U.S.C. § 112, first paragraph, as lacking written description.
`
`REVERSED
`
`12
`
`
`
`Appeal 2009-010632
`Application 10/315,445
`
`cdc
`
`OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
`1940 DUKE STREET
`ALEXANDRIA VA 22314
`
`13
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