Ex Parte Saarma et al

Patent Trial and Appeal BoardApr 28, 2016

12086397 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/086,397 09/18/2008 127226 7590 05/02/2016 Birch, Stewart, Kolasch & Birch, LLP P.O. Box 747 Falls Church, VA 22040-0747 FIRST NAMED INVENTOR Mart Saarma 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 0933-0342PUS 1 7577 EXAMINER ULM,JOHND ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 05/02/2016 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): mailroom@bskb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MART SAARMA, JURA LAUREN, P AIVI LINDHOLM, TONIS TIMMUSK, RAIMO TUOMINEN AND MERJA VOUTILAINEN 1 Appeal2014-004823 Application 12/086,397 Technology Center 1600 Before JEFFREY N. FREDMAN, JACQUELINE T. HARLOW, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to the use of certain neurotrophic factor proteins to treat drug addiction, which have been rejected for failure to comply with the written description requirement and as non-enabled. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm. STATEMENT OF THE CASE The present invention relates to the treatment of drug addiction by the administration of a novel neurotrophic factor protein MANF2 or a functional fragment of the protein. Br. 5. 1 Appellants identify the Real Party in Interest as Hermo Pharma, Ltd. Br. 1. Appeal2014-004823 Application 12/086,397 Claims 41 and 44 are on appeal. Claim 41 is illustrative and reads as follows: 41. A method for the treatment of drug addiction, comprising: administering a pharmaceutically effective amount of a protein consisting of the amino acid sequence of SEQ ID N0:2 or SEQ ID NO: 14 to a patient in need of such treatment. Br. 20 (Claims Appendix). The claims stand rejected as follows: Claims 41 and 44 have been rejected under 35 U.S.C. Â§ 112 first paragraph for failure to satisfy the written description requirement. Claims 41 and 44 have been rejected under 35 U.S.C. Â§ 112 first paragraph for lack of enablement. I Issue The Examiner has rejected claims 41 and 44 under 35 U.S.C. Â§ 112, first paragraph for failing to satisfy the written description requirement. The Examiner finds that the Specification fails to convey to one skilled in the art that the inventors had in their possession the claimed invention. Ans. 2. The Examiner finds that the lack of any protocol or working example specifically addressing the treatment of drug addiction with the proteins of SEQ ID NOs:2 or 14 shows that the Appellants did not have the claimed method in their possession when the application was filed. Id. The Examiner also finds that the Specification "does not demonstrate an established nexus between the administration of any particular amount of that protein to an 2 Appeal2014-004823 Application 12/086,397 individual suffering from a 'drug addiction', or an art accepted model thereof, and a beneficial result." Ans. 3. Appellants contend that the Specification contains sufficient disclosure to convey to one skilled in the art that they had the claimed method in their possession when they filed the application. Br. 8. Appellants point to page 57 of the specification where it states that the MANF and MANF2 proteins "may have protective effects and can be used for the treatment of drug addiction (to drugs of abuse cocaine, morphine, amphetamine, alcohol)" as sufficient disclosure to convey to one skilled in the art that the inventors had the claimed method in their possession when the application was filed. Br. 9--12. The issue with respect to this rejection is whether the preponderance of evidence supports the Examiner's conclusion that the claims fail to comply with the written description requirement as defined by 35 U.S.C. Â§ 112, first paragraph. Findings of Fact FF 1. The Specification discloses that the described proteins and fragments "can be used for the treatment of drug addiction (to drugs of abuse cocaine, morphine, amphetamine, alcohol)." Spec. 57. Principles of Law A description adequate to satisfy 35 U.S.C. Â§ 112, first paragraph, "must 'clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.' In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys 3 Appeal2014-004823 Application 12/086,397 to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane) (citation omitted, alteration in original). "Examples are not necessary to support the adequacy of a written description. The written description standard may be met ... even when actual reduction to practice of an invention is absent." Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). Analysis We agree with Appellants that the Specification meets the written description requirement. The disclosure clearly states that the proteins described in the specification "can be used to treat drug addiction" and specifically references cocaine addiction. FF 1. This is conveys to one skilled in the art that the inventors had the claimed method in their possession when the instant application was filed. The Examiner's arguments that the Specification fails to meet the written description requirement because there are not working examples regarding treatment of drug addiction and there is no guidance as to how to use the disclosed proteins to treat addiction are without merit. Working examples and specific guidance is not required to meet the written description requirement. Falkner, 488 F.3d at 1357. All the Specification needs to do is to convey to one skilled in the art that the inventors had in their possession the claimed invention when the application was filed. Ariad, 568 F.3d at 1351. The recited paragraph on page 57 of the disclosure meets that requirement. 4 Appeal2014-004823 Application 12/086,397 Conclusion of Law We conclude that the Examiner has failed to establish by a preponderance of the evidence that claim 1 is unpatentable for failing to satisfy the written description requirement as defined by 35 U.S.C. Â§ 112, first paragraph. II Issue The Examiner has rejected claims 41 and 44 as unpatentable for failure to comply with the enablement requirement of 35 U.S.C. Â§ 112, first paragraph. The Examiner finds the instant Specification fails to disclose how to use the claimed proteins to treat drug addiction. Ans. 2. The Examiner also finds that the Specification only details how that invention can be used to treat Parkinson's disease. Ans. 3. The Examiner finds that the Specification does not include a discussion as to how to use MANF or MANF2 to treat drug addiction. Ans. 4. With respect to example 8, the Examiner finds that it is limited to the possible use of the MANF2 protein to treat Parkinson's disease. The Examiner further finds that nothing in the disclosure suggests that the mouse protocol used to simulate Parkinson's disease is applicable to drug addiction. Ans. 4--5. Thus, one skilled in the art would be unable to use the disclosed peptides to treat drug addiction without undue experimentation. Ans. 7. Appellants contend that the Specification gives one skilled in the art sufficient guidance to practice the invention without undue experimentation. Br. 13-14. Appellants argue that the declaration submitted by Mr. Saarma demonstrate that the Specification provides sufficient guidance to one skilled 5 Appeal2014-004823 Application 12/086,397 in the art to use the claimed proteins to treat drug abuse. Br. 14--15. Appellants further argue that the teachings of the Messer2 and Georgievska3 articles show that one skilled in the art would understand that the rat model used in example 8 of the specification would be applicable to treatment of drug abuse generally and cocaine addiction specifically. Br. 17-18. The issue with respect to this rejection is whether the Examiner has established by a preponderance of the evidence that the specification is not enabled as defined by 35 U.S.C. Â§ 112, first paragraph. Findings of Fact drug. Breadth of the Claims FF2. Claim 41 is broadly drawn to treatment of addiction to any Presence of Working Examples FF3. The Examiner finds that there are no working examples. Ans. 5. Amount of Direction or Guidance Presented FF4. Example 8 of the instant Specification discloses the use of MANF2 protein to treat Parkinson's disease. Spec. 75-78. FF5. Example 8 of the instant Specification uses rats exposed to 6- Hydroxydopamine ("6-0HDA") to simulate Parkinson's disease. Spec. 75. 2 Messer, et al., "Role for GDNF in Biochemical and Behavioral Adaptations to Drugs of Abuse," 26 NEURON 247-257 (2000)("Messer"). 3 Georgievska et al., "Neuroprotection in the rat Parkinson model by intrastriatal GDNF gene transfer using a lentiviral vector, 13 REGENERATION AND TRANSPLANTATION 75-82 (2002)("Geogievska"). 6 Appeal2014-004823 Application 12/086,397 FF6. The Specification teaches that "the novel neurotrophic factor, MANF2 may have protective effects and can be used for the treatment of drug addiction (to drugs of abuse cocaine, morphine, amphetamine, alcohol)." Spec. 57. FF7. The Examiner finds that the Specification fails to provide "disclosure of an effective route, duration and quantity of administration of that protein to a subject" and "has also failed to disclose how these parameters are to be determined [or] how a similar method was practiced in the art with a different agent." Ans. 5. State of the Prior Art and Unpredictability of the Art FF8. Greogievska discloses the use of the rats exposed to 6-0HDA to simulate Parkinson's disease. Greogievska 75. FF9. Messer teaches that the "involvement of GDNF ... in drug- induced neural and behavioral plasticity could be particularly important for the very long-lived changes in brain function associated with addiction." Messer 253. FF 10 Messer teaches that "[ t ]hese results also raise the interesting possibility that medications targeted to GDNF or to its signaling pathway could be useful as novel treatment agents for addictive disorders in humans." Messer 253-54. FFl 1 The Sarma 2012 Declaration4 states that "[a]fter withdrawal from extensive heroin self-administration training there were no differences 4 Declaration of Dr. Mart Saarma, dated Jan. 3, 2012, filed Feb. 24, 2012. 7 Appeal2014-004823 Application 12/086,397 in MANF and CDNF mRNA levels in any of the brain regions studied" (Sarma Dec. 5). FF12 The Sarma 2012 Declaration states that the "different results of mRNA level changes after cocaine versus heroin self-administration training suggest that there is different regulation of CDNF and MANF synthesis after withdrawal when comparing these two drugs" (Sarma Dec. 5). Quantity of Experimentation FF 13 The Examiner finds that "a practitioner would have to resort to a substantial amount of undue experimentation involving the variation in the amount and duration of administration of a protein consisting of the amino acid sequence of SEQ ID N0:2 (MANF2) or SEQ ID NO: 14 to a patient in need of such treatment and in determining a suitable route of administration." Ans. 5-6. Skill in the Art FF 14 The Examiner makes no finding regarding the skill level in the art. Principles of Law "Section 112 requires that the patent specification enable those skilled in the art to make and use the full scope of the claimed invention without undue experimentation .... [S]ee also In re Goodman, 11F.3d1046, 1050 (Fed. Cir. 1993) (' [T]he specification must treach those of skill in the art how to make and how to use the invention as broadly as it is claimed.')." Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070-71 (Fed. Cir. 2005) (internal quotes omitted). Some experimentation, even a considerable amount, is not "undue" if, e.g., it is merely routine, or if the specification provides a reasonable amount 8 Appeal2014-004823 Application 12/086,397 of guidance as to the direction in which the experimentation should proceed. Tabuchi v. Nubel, 559 F.2d 1183, 1186 (CCPA 1977) "Factors to be considered in determining whether a disclosure would require undue experimentation ... include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims." In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Analysis The issue before us is whether undue experimentation is needed to practice the claimed method of treating drug addiction. The Appellants and the Examiner have focused their arguments on only three of the factors listed above: the amount of direction presented, the presence of working examples and the state and unpredictability of the prior art. As we evaluate the Wands factors we conclude that the claims are not enabled as it would require undue experimentation to practice the claimed invention. Appellants argue that the teachings of example 8 would provide sufficient guidance to one skilled in the art to use the claimed proteins to treat drug addiction. Br. 13. We do not agree. Example 8 is directed to the use of MANF2 proteins to treat Parkinson's disease. FF4. In the example, rats are treated with 6-0HDA to simulate Parkinson's disease. FF5. Nothing in example 8 teaches or suggests that the guidance would be applicable to drug addiction. Appellants have not pointed to any other section of the Specification to 9 Appeal2014-004823 Application 12/086,397 support their position that the Specification provides sufficient guidance to one skilled in the art. Appellants next point to the February 2012 Declaration of one of the inventors, Dr. Saanna to show that the claimed method can be practiced without undue experimentation. Br. 14. We agree with the Examiner that the 2012 Declaration of Dr. Saarma is unpersuasive. The Declaration only relates to the reduction in MANF and MANF2 that occurs in rats who self- administer addictive drugs over time. Deel. 5. Nothing in the Declaration addresses how one skilled in the art, reading the instant specification would know how to use the claimed proteins to treat drug addiction, let alone cocaine addiction. Moreover, the Declaration supports the Examiner's unpredictability finding because it demonstrates different results for GDNF expression for heroin and cocaine. FFl 1-12. Because claim 41 broadly encompasses treatment of addiction with any drug, the evidence in the Saarma 2012 Declaration that heroin and cocaine yield different results demonstrates unpredictability in the application of GDNF as a treatment for all types of drug addiction. Finally, Appellants argue that given the state of the prior art as evidenced by Messer and Greogievska, one skilled in the art, reading example 8, would know how to practice the claimed method without undue experimentation. Br. 18. Again, we are unpersuaded. Greogeivska only addresses the use of GDNF in rats treated with 6-0HDA to simulate Parkinson's disease. FF8. Messer discloses the possible protective effect of GDNF against cocaine and suggests that drugs affecting GDNF might be 10 Appeal2014-004823 Application 12/086,397 useful in treating drug addiction. FF 9-10. Neither of the references provides any guidance as to how to use GDNF or MANF to treat drug addiction, with Messer at best providing a direction for research, but no specific guidance on therapeutic modalities. FF 10 From the foregoing analysis, we conclude that one of ordinary skill in the art could not practice the claimed method without undue experimentation. Conclusion of Law We find that the Examiner has established by a preponderance of the evidence that the claims are unpatentable as non-enabled as defined by 3 5 U.S.C. Â§ 112, first paragraph. SUMMARY We reverse the rejection of claims 41 and 44 for failure to comply with the written description requirement and affirm the rejection of claims 41 and 44 as non-enabled. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 11