Ex Parte Virsik et alDownload PDFPatent Trials and Appeals BoardApr 17, 201914717639 - (D) (P.T.A.B. Apr. 17, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/717,639 05/20/2015 20786 7590 04/19/2019 KING & SPALDING 1180 PEACHTREE STREET, NE ATLANTA, GA 30309-3521 FIRST NAMED INVENTOR Peter A. Virsik 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. P233022.US.03 (X-0182 R2) CONFIRMATION NO. 1037 EXAMINER DECK, JASON A ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 04/19/2019 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): ATLIPDOCKETING@kslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER A. VIRSIK, DAVID J. WUSTOW, THAMIL ANNAMALAI, and SURESH K. MANTHATI 1 Appeal2017-009546 Application 14/717,639 Technology Center 1600 Before DEBORAH KATZ, JOHN G. NEW, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. § 134(a) from the Examiner's rejection of claims to compounds for treating multiple sclerosis or psoriasis 1 Appellants identify the Real Party in Interest as Xenoport, Inc. Appeal Br. 3. 2 We have considered and herein refer to the Specification of May 20, 2015 ("Spec."); Final Office Action of Jan. 26, 2016 ("Final Act."); Appeal Brief of Nov. 25, 2016 ("Appeal Br."); Examiner's Answer of May 2, 2017 ("Ans."); and Reply Brief June 30, 2017 ("Reply Br."). An oral hearing was held on Apr. 9, 2019. A copy of the transcript of the hearing will be added to the file when it becomes available. During the hearing, Appellants referred to various Power Point slides which refer to various part of the prosecution history and the references of records. That slide presentation Appeal2017-009546 Application 14/717,639 that have been rejected as obvious and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE Fumaric acid esters have been used to treat psoriasis for many years. Spec. ,r 3. Oral administration of diemthyl fumarate has shown promising results in reducing symptoms of multiple sclerosis. Id. ,r 8. Oral administration of these compounds often results in unwanted side effects such as serious digestive tract irritation with attendant nausea, vomiting, abdominal pain and diarrhea. Id. ,r,r 7-8. The specification discloses "improved methods of treating multiple sclerosis and/or psoriasis in human patients using fumaric acid esters. The methods are able to achieve high therapeutic levels of [ methyl hydrogen fumarate] in the blood plasma of a patient without causing significant gastrointestinal irritation." Id. ,r 10. Claims 1-15 are on appeal. Claim 1 is the sole independent claim and reads as follows: 1. (Original) A compound of Formula (I): /oy~ 0 (I) was used solely as a demonstrative and is not part of the record considered by the panel. 2 Appeal2017-009546 Application 14/717,639 or a pharmaceutically acceptable salt thereof, wherein: R1 and R2 are each hydrogen; R3 and R4 together with the nitrogen to which they are bonded form a ring chosen from C4-10 heterocycloalkyl and substituted C4-10 heterocycloalkyl; n is O; and X is pair of hydrogen atoms, wherein each hydrogen atom is connected to the carbon to which it is bonded by a single bond; wherein each substituent group is =O. The claims stand rejected as follows: Claims 1-15 have been rejected under 35 U.S.C. § I03(a) as unpatentable over Gangakhedkar3 in view of Sagi. 4 Claims 1-15 have been rejected for non-statutory obviousness-type double patenting over claims 1-I8ofUS 8,952,006 B2. Claims 1-15 have been rejected for non-statutory obviousness-type double patenting over claims 32-36 ofUSSN 13/967,283. 5 DOUBLE PATENTING Appellants have offered no substantive argument regarding this rejection other than to ask that it be held in abeyance until allowable subject matter has been found in the present application. Appeal Br. 17. We therefore summarily affirm this rejection. 37 C.F.R. 4I.37(c)(iv). 3 Gangakhedkar, et al, WO 2010/02217 A2, published Feb. 25, 2010 ("Gangakhedkar"). 4 Sagi et al., US 2005/0101779 Al, published May 12, 2005 ("Sagi"). 5 USSN 13,967,283 was abandoned on Sept. 6, 2017 rendering this rejection moot. 3 Appeal2017-009546 Application 14/717,639 OBVIOUSNESS Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner's conclusion that the subject matter of the claims would have been obvious over Gangakhedkar combined with Sagi. The Examiner finds that Gangakhedkar teaches the use of prodrugs of methyl hydrogen fumarate to treat multiple sclerosis. Final Act. 3. The Examiner finds that Gangakhedkar exemplifies fumarate prodrugs having the following structures: Id. at 4. The Examiner finds that Gangakhedkar teaches that the use of prodrugs results in "increased gastrointestinal permeability and absorption, improved solubility, and minimal cleavage in the gut lumen." Id. The Examiner finds that Sagi teaches a method for treating multiple sclerosis using prodrugs with carbonyl masking groups. Id. The Examiner finds that one of the masking groups used in Sagi is identical to one used in Gangakhedkar and several others, shown below, have high homology to the prodrug moieties used in Gangakhedkar. 4 Appeal2017-009546 Application 14/717,639 0 I,.,... .. b.·•· .. · .. . o~ ~ Final Act. 4, citing Sagi 28-29. The Examiner concludes It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention to make and use methyl hydrogen fumarate prodrugs with the prodrug moieties of Sagi et al. One of ordinary skill would have been motivated to make and use the instantly claimed compounds because Gangakhedkar et al. teaches that prodrugs of methyl hydrogen fumarate offer improved features over methyl hydrogen fumarate, and teaches the general type of prodrug moieties, while Sagi et al. discloses additional prodrug moieties for carboxylate groups that are of the same general type. The skilled artisan would have used the prodrug moieties of Sagi et al. for the method of Gangakhedkar et al. during the routine optimization of the properties of the compounds, and would have done so with a reasonable expectation of success in making an improved treatment for multiple sclerosis. Final Act. 5. Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prim a f acie case ofunpatentability. 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. 5 Appeal2017-009546 Application 14/717,639 In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007), citing United States v. Adams, 383 U.S. 39, 50-51 (1966). 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 Action and Answer regarding this rejection. We find the Examiner has established that the subject matter of the claims would have been obvious to one of ordinary skill in the art at the time the invention was made over Gangakhedkar combined with Sagi. Appellants have not produced evidence showing, or persuasively argued, that the Examiner's determinations on obviousness are incorrect. Only those arguments made by Appellants in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015). We have identified claim 1 as representative; therefore, all claims fall with claim 1. We address Appellants' arguments below. Appellants contend that the references either alone or in combination do not teach or suggest the claimed compound. Appeal Br. 7. Appellants argue that the prodrugs disclosed in Gangakhedkar contain an additional carbonyl group at the carbon alpha to the nitrogen and Sagi is directed to prodrugs of phenylalanine derivatives and not methyl hydrogen fumarate. 6 Appeal2017-009546 Application 14/717,639 Id. Appellants argue that Sagi does not teach or suggest that the masking moieties disclosed therein can be sued with other drug compositions. Id. at 8. Appellants also argue that even if one skilled in the art were motivated to use the prodrug moieties of Sagi with the fumarate of Gangakhedkar, it would not result in the claimed compound but would produce a compound with the following structure: See id. at 10. We have considered Appellants arguments and are not persuaded that the Examiner's rejection is in error. Appellants' arguments about the teachings of the individual references is not persuasive as it is the combined teachings of the references that serves as the basis for this rejection. "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., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Gangakhedkar teaches the preparation of prodrugs of methyl hydrogen fumarate and the benefits of such prodrugs. Gangakhedkar, 3--4. 7 Appeal2017-009546 Application 14/717,639 Both Gangakhedkar and Sagi teach the use of carboxyl masking groups including those which are structurally the same or similar. Compare, Gangakhedkar, 63, example 3 and 65, example 9 with Sagi, 28-29, Table A. It is prima facie obvious to substitute structurally similar compounds where there is evidence that the compounds share similar properties. In re Dillon, 919 F.2d 688, 691 (Fed. Cir. 1990). Given the teaching of the use of the same or structurally similar prodrug moieties, we agree with the Examiner that "[t]he skilled artisan would have understood that the carbonyl masking utility espoused by Sagi et al. for the taught prodrug moieties could be successfully used with additional carboxylates, including those of Gangakhedkar et al." Ans. 9-10. The lack of any teaching in Sagi that the prodrug moieties disclosed therein can be used for other active compounds does not negate the combined teachings of the references. As the Examiner points out Id. the disclosure of Gangakhedkar et al. is directed to carboxylate prodrugs of monomethyl fumarate, wherein the carboxylate was the site of prodrug-moiety functionalization, and Sagi et al. similarly taught prodrug functionalization of carboxylates. The skilled artisan would have understood that the carboxylate of monomethyl fumarate was a beneficial location to append a prodrug-moiety, and would have used additional prodrug moieties, including those of Sagi et al. Appellants' argument that the combination of Gangakhedkar and Sagi would result in a structure different from what is claimed is also not persuasive. Appellants offer no evidence, other than attorney argument, to support their contention that combining monomethyl fumarate with the 8 Appeal2017-009546 Application 14/717,639 prodrug moieties of Sagi would result in a peroxy-ester or per-ester. See, Appeal Br. 11-12. "Attorney's argument in a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Appellants contend that one skilled in the art would not have has a reasonable expectation of success in creating the claimed compound following the teachings of Gangakhedkar and Sagi. Appeal Br. 15. Appellants contend that given the structural dissimilarities of the drug cores of Gangakhedkar and Sagi and the lack of any teaching in Sagi that the prodrug moieties could be used with other drug cores, one skilled in the art would not expect the prodrug moieties of Sagi to work with the monomethyl fumarate of Gangakhedkar. Id. at 15-16. We are not persuaded by Appellants' argument. "Obviousness does not require absolute predictability of success .... For obviousness under § 103, all that is required is a reasonable expectation of success." In re O'Farrell, 853 F.2d 894, 903---04 (Fed. Cir. 1988). We agree with the Examiner that Gangakhedkar and Sagi teach the use of prodrug moieties to improve the effectiveness of carboxylic-acid- based drugs. Ans. 16. As discussed above, Gangakhedkar and Sagi teach the use of the same or structurally similar prodrug moieties. Compare, Gangakhedkar, 63, example 3 and 65, example 9 with Sagi, 28-29, Table A. We agree with the Examiner's conclusion that: The skilled artisan would have been aware of both the disclosures of Gangakhedkar et al. and Sagi et al., would have been aware that carboxylate-prodrugs were useful and known, would have been aware that the prodrug-moieties could be successfully substituted in the same drug-core, would have been aware that the prodrug-moieties could be successfully used in 9 Appeal2017-009546 Application 14/717,639 differing drug-cores, and would have combined the teachings of the successful use of carboxylate-promoieties and would have done so with a reasonable expectation of success. Ans. 16. Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner's conclusion that the subject matter of claim 1 would have been obvious over Gangakhedkar combined with Sagi. Claims 2-15 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv). SUMMARY We affirm the rejection for non-statutory obviousness-type double patenting. We affirm the rejection under 35 U.S.C. § 103(a). 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 10 Copy with citationCopy as parenthetical citation