Ex Parte SailliolDownload PDFPatent Trial and Appeal BoardNov 20, 201713817290 (P.T.A.B. Nov. 20, 2017) Copy Citation United States Patent 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. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/817,290 02/15/2013 Anne Sailliol 02970-27587US01 2577 23446 7590 11/22/2017 MCANDREWS HELD & MALLOY, LTD 500 WEST MADISON STREET SUITE 3400 CHICAGO, IL 60661 EXAMINER NGUYEN, NGHI V ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 11/22/2017 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): mhmpto @ mcandrews-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANNE SAILLIOL1 Appeal 2017-003803 Application 13/817,290 Technology Center 1600 Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and TIMOTHY G. MAJORS, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to lyophilized plasma which have been rejected as being obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE ‘“Blood plasma’ or ‘plasma’ is the liquid component of blood, in which the blood cells are in suspension.” Spec. 1. “Blood plasma is used therapy for treating serious coagulopathies with collapse of all the coagulation factors and also for treating acute hemorrhages, with overall 1 Appellant identifies the Real Party in Interest as Etat Francais (Ministere de la Defense), Service de Sante des Armees. Br. 2. Appeal 2017-003803 Application 13/817,290 coagulation factor deficiency.” Id. Currently, therapeutic plasma is fresh frozen plasma which has a limited shelf life. Id. In addition, when plasma is used, one must follow the rule of delivery based on the individual’s blood type. Id. The Specification describes a lyophilized plasma and method for making the plasma which can be stored at room temperature and can be administered to any recipient regardless of blood type. Spec. 1—2. Claims 10 and 12 are on appeal2 and read as follows: 10. A lyophilized plasma which is compatible with all blood groups characterized in that it comprises a mixture of plasmas collected from donor individuals, at least one of whom belongs to blood group A and at least one of who belongs to blood group B and in that the volume of plasma obtained from the donor individual(s) belonging to blood group A is identical to the volume of plasma obtained from the donor individual(s) belonging to blood group B, wherein said mixture of plasmas includes unit plasmas from at most ten different donor individuals and the unit plasmas constituting the mixture of plasmas are attenuated prior to the mixing of the unit plasmas via the action of a photochemical agent, and wherein said unit plasma is fresh plasma collected from a single donor individual. 12. A lyophilized plasma, leukodepleted, attenuated, free of hemolyzing antibody and which is compatible with all blood groups, characterized in that it comprises a mixture of plasmas collected from donor individuals, at least one of whom belongs to blood group A and at least one of who belongs to blood group B and in that the volume of plasma obtained from the donor individual(s) belonging to blood group A is identical to 2 Claims 1—9 and 11 are pending in the application but have been withdrawn from consideration. Final Act. 2. 2 Appeal 2017-003803 Application 13/817,290 the volume of plasma obtained from the donor individual(s) belonging to blood group B, wherein said mixture of plasmas includes unit plasmas from at most ten different donor individuals and the unit plasmas constituting the mixture of plasmas are attenuated prior to the mixing of the unit plasmas via the action of a photochemical agent, wherein said unit plasma is fresh plasma collected from a single donor individual, wherein said unit plasma originates from donors having normal coagulation test results and a factor VIII level greater than 0.9 IU/ml, and wherein the concentration of fibrinogen after reconstitution of said lyophilized plasma is comprised between 2 and 4 g/L. The claims stand rejected as follows: Claims 10 and 12 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Heger3 in view of Mueller4 and Heuft.5 Claims 10 and 12 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Du6 in view of Mueller and Heuft. 3 Heger et al., US 2007/0071829 Al, published Mar. 29, 2007 (“Heger”). 4 Markus M. Mueller et al., Effects of Pathogen Inactivation Using Amotosalen-UVA on Coagulation Parameters in Aphersis and Whole Blood Derived Frozen Plasma in a Large Blood Bank Setting, 108 Blood 942 (2006) (“Mueller”). 5 Hans-Gert Heuft et al., A General Change of the Platelet Transfusion Policy from Apheresis Platelet Concentrates to Polled Platelet Concentrates is Associated with a Sharp Increase in Donor Exposure and Infection Rates, 35 Transfus. Med. Hemother. 106—13 (2008) (“Heuft”). 6 Du et al., CN 1321468 Al, published Nov. 14, 2001 (“Du”). Citations are to the English machine translation of record. 3 Appeal 2017-003803 Application 13/817,290 HEGER COMBINED WITH MUELLER AND HEUFT Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that claims 10 and 12 would have been obvious over Heger combined with Mueller and Heuft. The Examiner finds that Heger teaches the preparation of blood plasma prepared by mixing plasma from donors of groups A and B wherein the group A plasma comprises 4—8 parts of the mixture and the group B plasma comprises 3—7 parts of the mixture. Final Act. 3. The Examiner finds that Heger teaches that the resulting plasma has reduced ABO compatibility issues. Id. The Examiner goes on to find that Heger discloses various methods for inactivating blood viruses and that the plasma can be lyophilized. Id. The Examiner finds that Mueller teaches the use of a photochemical agent, amotosalen, to inactivate pathogens in plasma. Final Act. 4. The Examiner finds that Heuft teaches that the higher the number of donors pooled together, the greater the risk of infection. Id. The Examiner concludes: It would have been obvious to one of ordinary skill in the art at the time of the invention was made to limit the number of plasmas obtained from different donor individuals such as taught by Heuft in the disclosure of Heger. The ordinary artisan would have been motivated to limit the number of donor individuals in the teachings of modified Heger because Heuft suggests higher donors would be unfavorable due to increase pathogen risk. The ordinary artisan would have had a reasonable expectation of success because both modified Heger and Heuft are concerned with the risk of transfusion related 4 Appeal 2017-003803 Application 13/817,290 infections in blood products and each reference teaches how to extract blood from a donor in various volumes. With regard to the limitations of "wherein said mixture of plasmas is obtained from at most ten different donor individuals" and "the unit plasmas are attenuated prior to the mixing of the unit plasmas via the action of a photochemical agent" and "wherein the unit plasmas is collected from a single donor individual", these limitations are interpreted as a product- by-process. The MPEP § 2113 reads, "Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps." Final Act. 4—5 (emphasis omitted). Appellant contends that Heger does not teach or suggest using equal amounts of type A and type B plasma. Br. 12. Appellant argues that Heger does not teach limiting the number of donors and that Heger is limited to plasma derived from non-Caucasian donors. Br. 12—13. Appellant argues that the teachings of Heuft are limited to pooled platelet concentrate and is not applicable to pooled plasma. Br. 14—15. With respect to Mueller, Appellant argues that Mueller is limited to treating frozen, not fresh plasma and plasma where the donors are from the same blood type. Br. 15—16. Appellant argues that the Declaration of Dr. Sailliol7 demonstrates that one skilled in the art would not have combined the teachings of Heuft and Mueller with Heger. Appellant contends that one skilled in the art would not have used amotosalen to inactivate pathogens because it was highly unpredictable and could lead to inactivation of coagulation factors. Br. 21. Appellant contends that this would have led one skilled in the art 7 Declaration of Anne Sailliol submitted under 37 C.F.R. § 1.132, filed March 11, 2015 (“Sailliol Deck”). 5 Appeal 2017-003803 Application 13/817,290 away from combining the teachings of Mueller with those of Heger and Heuft. Br. 21. Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). When determining obviousness, “the prior art as a whole must be considered. The teachings are to be viewed as they would have been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986). “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Combining references can be based on common sense as long as the reasoning is explained sufficiently. See Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29 (Fed. Cir. 2009). “The patentability of a product does not depend on its method of production. ... If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even 6 Appeal 2017-003803 Application 13/817,290 though the prior product was made by a different process.” In re Thorpe, 111 F.2d 695, 697 (Fed. Cir. 1985). Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Office Action and Answer regarding this rejection. We find the Examiner has established that the subject matter claims would have been obvious over Heger combined with Mueller and Heuft to one of ordinary skill in the art. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Brief have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim 10 as representative; therefore, all claims fall with claim 10. We address Appellant’s arguments below. Appellant begins by arguing that Heger does not teach or suggest using equal volume of plasmas from type A and type B donors. Br. 12. We are unpersauded. As the Examiner points out, the ranges for the amounts of type A and type B plasma taught by Heger embraces equal parts of both. Ans. 10. For Example, a mixture of 5 parts type A plasma with 5 parts type B plasma is within the range of 4—8 parts type A plasma and 3—7 parts type B plasma taught by Heger. Id. Appellant next argues that Heger does not teach limiting the number of donors to 10 or less. Br. 13. While this may be true, Heuft provides the necessary teaching that limiting the number of donors reduces the risk of 7 Appeal 2017-003803 Application 13/817,290 infection. Ans. 10. It is the combination of the references that renders the present claims obvious. Attacks on the teachings of the individual references do not persuasively rebut the Examiner’s conclusion of obviousness. In re Merck & Co., 800 F.2d at 1097. Appellant contends that one skilled in the art would only look to the ranges of Heger when the plasma mixture includes substantial amounts of plasma from non-Caucasian donors. Br. 13. This argument is unpersuasive. As discussed above, Heger teaches that use of mixed plasmas including using equal amounts of plasma from type A and type B donors. We agree with the Examiner that one skilled in the art would apply this teaching broadly and would not limit the ratios to only mixtures with significant amounts of non-Caucasian derived plasma. See, Ans. 10. Moreover, the present claims do not recite a limitation regarding the use of Caucasian or non-Caucasian blood. Appellant’s argument that Heuft is limited to platelet concentrate and is not applicable to plasma is also not persuasive. Br. 14. Heger teaches that one of the objectives of the disclosed plasmas is to reduce the risk of transfusion related infections. Heger 115. Thus, in view of Heuft, a person of ordinary skill in this art would have recognized that reducing the number of donors would reasonably be expected to reduce the risk of infection in pooled blood products. Heuft 7, Ans. 10. We agree with the Examiner that the combined teachings of Heger and Heuft would motivate one skilled in the art to limit the number of donors. Ans. 11. Turning to Mueller, Appellant argues that Mueller is limited to inactivating pathogens in fresh frozen plasma and not individual units as 8 Appeal 2017-003803 Application 13/817,290 claimed. Br. 15. Appellant also argues that Mueller does not teach inactivation of mixed plasmas. Id. Appellant also argues that one skilled in the art would not have used the photo inactivation compound of Mueller because the compound adversely effects the clotting ability of the plasma. Br. 21. In support of this argument, Appellant relies on the Declaration of Dr. Sailliol wherein Dr. Sailliol states that using the photo inactivator of Mueller could produce a low quality plasma and discourage one skilled in the art from using the specific inactivator. Sailliol Decl. 1 6, Br. 21—22. We have considered Appellant’s argument as well as the Sailliol Declaration and find them unpersuasive. As the Examiner points out, the limitation at issue “the unit plasmas are attenuated prior to the mixing of the unit plasmas via the action of a photochemical agent” is interpreted as a product-by-process limitation. Ans. 11. Appellant has not shown that the process limitation infers a structural difference in the final product. Thus, this limitation does not render the claims non-obvious. Appellant’s argument regarding the limited teachings of Mueller are also unpersuasive. Br. 17. Again, Appellant is improperly focusing on the teachings of the individual reference and not the teachings of the combined references. Heger teaches that the plasma can be inactivated by any one of a number of techniques and that the plasma can be lyophilized. Heger || 22 and 23. Mueller teaches that amotosalen effectively reduces the number of pathogens in blood products. Mueller Abstract. One skilled in the art would have been motivated to use amotosalen in the plasma of Heger to reduce the number of pathogens. 9 Appeal 2017-003803 Application 13/817,290 Appellant’s contention with respect to one skilled in the art being dissuaded from using amotosalen is also unpersuasive. Br. 21. Dr. Sailliol’s statement that the use of amotosalen might produce a poor quality plasma is contradicted by the teachings of Mueller. While Muller states that the plasmas treated with amotosalen exhibited reduced factor VIII activity, Mueller did not attribute this to the amotosalen, but to an additional freeze- thaw cycle used to prepare the plasma. Mueller 943. Moreover, Mueller reports that inactivation using amotosalen did not significantly influence other coagulation parameters, and concludes that use of amotosalen to inactivate pathogens “can be performed in a large blood bank setting without significant decreases in coagulation factor activities and thus without major impairment of the functional capacity of therapeutic plasma.” Id. Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner’s conclusion that claims 10 and 12 would have been obvious over Heger combined with Mueller and Heuft. DU COMBINED WITH MUELLER AND HEUFT Appellant’s arguments with respect to this rejection are the same as presented for the prior rejection. Br. 19—20. For the reasons stated above, we find these arguments unpersuasive and affirm this rejection. SUMMARY We affirm the rejections under 35 U.S.C. § 103(a). 10 Appeal 2017-003803 Application 13/817,290 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. § 1.136(a). AFFIRMED 11 Copy with citationCopy as parenthetical citation