Ex Parte Yla-HerttualaDownload PDFPatent Trial and Appeal BoardAug 18, 201713969763 (P.T.A.B. Aug. 18, 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. 13/969,763 08/19/2013 Seppo YLA-HERTTUALA FKD - 61/692,828 6511 22925 7590 08/22/2017 PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 MADISON AVENUE 4THFLOOR MORRISTOWN, NJ 07960-7397 EXAMINER PAK, MICHAEL D ART UNIT PAPER NUMBER 1646 NOTIFICATION DATE DELIVERY MODE 08/22/2017 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): docket @ LicensingLaw. net administration @LicensingLaw.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SEPPO YLA-HERTTUALA Appeal 2016-007395 Application 13/969,763 Technology Center 1600 Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and JOHN E. SCHNEIDER, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. REQUEST FOR REHEARING Appellant requested reconsideration of the Decision on Appeal entered March 27, 2017 (“DOA”) in which all the Examiner’s rejections were affirmed. Under 37 CFR § 41.52(a)(1), “Appellant may file a single request for rehearing within two months of the date of the original decision of the Board.” The request was filed May 29, 2017 (the 27th fell on a Saturday). Consequently, we treat it as a proper Request for Rehearing under 37 CFR § 41.52(a)(1) (“Req. Reh’g”). Appellant had appealed from the Examiner’s final rejection of claims 1—11 under three separate grounds of rejection. DO A 2. Appellant contends that the Board erred in affirming the rejections. We address the arguments below. Appeal 2016-007395 Application 13/969,763 REJECTION BASED ON BALDWIN Claims 1—6 and 8—10 stand rejected under 35 U.S.C. § 102(e) as anticipated by Baldwin. DOA 2. Baldwin is U.S. Pat. App. Publ. 2013/0344065 Al, publ. Dec. 26, 2013. Id. Baldwin claims benefit to PCT (filing date of Apr. 5, 2011) and provisional (filing date of Apr. 15, 2010) applications. Appellant provided declarations under 37 CFR § 1.131 by the inventor in an attempt to antedate the Baldwin publication by establishing a reduction to practice of the claimed invention prior to Baldwin’s PCT filing date and prior to Baldwin’s provisional application filing date, respectively. DOA 5-6. In the final rejection, the Examiner stated that he had considered a declaration filed by the inventor on Mar. 13, 2015 but found it ineffective to antedate Baldwin because it did not allege a reduction to practice prior to Baldwin’s provisional application filing date. Final Act. 2—3. In response to the Examiner, Appellant provided a second declaration entered into the record on Jul. 15, 2015 in which a reduction to practice at least as early as Apr. 14, 2010 was alleged, the filing date of the provisional application by Baldwin. The Examiner responded that this declaration, too, was ineffective because the “laboratory notebook page is in foreign language and it is not clear that the treatment of tumor was successful as claimed.” Advisory Action (entered Sept. 28, 2015). This second declaration was filed after a final rejection had been mailed. In a third attempt to antedate Baldwin, Appellant provided a third declaration by the inventor (received Oct. 8, 2015) which included an English translation of the laboratory notebook page. The third declaration was filed along with the Notice of Appeal and Appeal Brief (dated Oct. 8, 2 Appeal 2016-007395 Application 13/969,763 2015). The Examiner did not enter the third declaration into the record “because the appellant failed to provide a showing of good and sufficient reason why it was necessary and not earlier presented. Furthermore, appellant arguments does not discuss the information within the Declaration (Oct. 2015).” Ans. 8. In each of the declarations, the inventor provided the same laboratory notebook page, stating that “I respectfully believe this laboratory animal printed form corroborates conception and reduction to practice of my invention.” While the inventor contends that the laboratory animal printed form “corroborates” conception and reduction to practice of the claimed invention, the form is in a foreign language and an English translation was not provided to permit the Examiner to verify the corroboration. 37 CFR § 1.131 specifically states: (b) The showing of facts for an oath or declaration under paragraph (a) of this section shall be such, in character and weight, as to establish reduction to practice prior to the effective date of the reference, or conception of the invention prior to the effective date of the reference coupled with due diligence from prior to said date to a subsequent reduction to practice or to the filing of the application. Original exhibits of drawings or records, or photocopies thereof, must accompany and form part of the affidavit or declaration or their absence must be satisfactorily explained. Thus, the Examiner properly found the Declaration ineffective because it failed to provide an English translation of the only record proffered as evidence to antedate Baldwin. Lacking such translation, the Examiner could not determine whether the laboratory animal printed form was adequate “in character and weight... to establish reduction to practice prior to the effective date of the reference.” Despite being on notice of the requirements 3 Appeal 2016-007395 Application 13/969,763 of 37 CFR § 1.131, and after having filed two successive declarations, Appellant did not provide such translation until after the Final Action when the Notice of Appeal and Appeal Brief were filed. 37 CFR § 41.37(c)(2) specifically states that “A brief shall not include any new or non-admitted amendment, or any new or non-admitted affidavit or other Evidence.” Consequently, the Examiner acted in compliance with the rules in not entering the declaration. In the Decision on Appeal, we considered the translation to give the inventor the benefit of it, despite it being tardily produced and hence not entered by the Examiner. Appellant now complains that we raised new grounds of rejection in considering it. Req. Reh’g 4. Upon reconsideration, to avoid any impropriety of raising a new ground of rejection, we shall strike from the Decision on Appeal any discussion of the third declaration, and the English translation included in it, and we shall not rely on such discussion in affirming the Examiner’s decision that the first and second declarations are ineffective in antedating Baldwin. Accordingly, we do not rely on the discussion of whether a “control” was performed, the issue Appellant contends constitutes a new ground of rejection. DOA 6; Req. Reh’g 5. Instead, we affirm the Examiner’s decision in finding the first and second declarations ineffective because the “laboratory notebook page is in foreign language and it is not clear that the treatment of tumor was successful as claimed” and because of the lack of explanation. Advisory Action (entered Sept. 28, 2015). For example, the declaration states that “Assessment includes measurement of tumor size by MRI” but does not 4 Appeal 2016-007395 Application 13/969,763 disclose or explain the results of the MRI and how it established success of the treatment. DO A 6. In Decision on Appeal, it was stated “Dr. Yla Herttuala did not make a statement in his declaration that the cancer was treated.” Id. Appellant contends that the inventor did not have to make such a statement in the declaration because the statement was made in the Specification. Req. Reh’g 5—6. We disagree. In a § 1.131 Declaration, the “showing of facts for an oath or declaration under paragraph (a) of this section shall be such, in character and weight, as to establish reduction to practice prior to the effective date of the reference . . . .” 37 CFR § 1.131(b). Accordingly, it is clear from the rule that the Declaration must contain such a showing. The application, itself, was filed later than the experiment described in the Declaration; consequently, it must be established that the inventor recognized at the time of the purported reduction to practice that the cancer was treated, not at the later time when the subsequent application was filed. Appellant also contends that it is new ground of rejection in the Decision on Appeal to have found that the inventor failed to make a statement that the cancer was treated. Req. Reh’g. 6. The Examiner found in the Advisory Action that it was not clear that the tumor treatment was successful and formed a basis for finding the declaration ineffective to antedate Baldwin. The further discussion in the Decision on Appeal that the inventor, himself, did not make such a statement in the declaration is wholly consistent with the Examiner’s reasoning and did not change the basis of the rejection, but rather simply expounded on it in a more thorough explanation. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 5 Appeal 2016-007395 Application 13/969,763 2011). Neither new facts nor rationale was cited to advance the rejection. Rather, the Board merely agreed with the Examiner’s rationale in the Advisory Action, further noting that the inventor failed to state in the Declaration that the cancer treatment was successful. Consequently, the further explanation provided in the Decision on Appeal does not constitute a new ground of rejection. See In re Stepan, 660 F.3d. 1341, 1344^45 (Fed. Cir. 2011). Indeed, despite the Examiner’s indication that it was not clear that tumor treatment was successful, Appellant stated erroneously in the Brief that “Examiner found no defect in that Declaration.” Appeal Br. 5. Furthermore, Appellant, on notice that the Examiner considered the declaration ineffective because there was no showing that the tumor treatment was successful, did not avail himself of the opportunity to address this substantive concern by the Examiner. In sum, Appellant did not identify an error in the rejection. HU Claims 1—5 stand rejected under 35 U.S.C. § 102(b) as anticipated by Hu. DO A 2. Appellant contends that he did not have an opportunity to provide evidence responding to the Holash publication. Req. Reh’g 7—8. Holash was cited in the Final Action in response to Appellant’s contention that Hu did not utilize a VEGF trap with an Fc portion “adequate to ensure efficient dimerization of said decoy receptor” as required by the claim. Final Act. 6—7. The Holash publication was identified from a publication provided by Appellant. Id. at 6. The Examiner explained in the Final Action: 6 Appeal 2016-007395 Application 13/969,763 Applicants argue that VEGF Trap does not form a dimer because the evidence of record fails to say exactly what fragments are included nor whether these fragments have been modified to include the dimer binding sites nor whether these fragments have been modified to exclude the tyrosine kinase domains. Applicants refer to passage in Hu et al. describing VEGF-Trap with reference to Byrne et al. However, Hu et al. cite Byrne et al. (2003) for the VEGF-trap and Byrne et al. (2003) cite Holash et al. (PNAS, 2002) regarding the VEGF- Trap construction. Holash et al. provide evidence that the VEGF-TRAP of Hu et al. comprises the same construction as claimed — the extracellular portion of the VEGF receptor without the transmembrane and tyrosine kinase domains is fused to the constant region (Fc) of the human IwgGl. Id. at 6—7. The citation to Holash, in response to Appellant’s argument, did not change the basis of the rejection in any way, i.e., that Hu’s construct was capable of dimerization, meeting the corresponding limitation of the claim. Holash was cited by the Examiner as additional evidence of this fact. Appellant, at no time, before or since, provided adequate evidence that Hu’s construct did not dimerize as found by the Examiner. As stated in the Decision on Appeal, despite the fact the Holash was of record prior to the filing of the Appeal Brief, no attempt by Appellant could be found to rebut the Examiner’s findings regarding this publication despite the opportunity to do so after the Final Action, and in the subsequently filed Appeal and Reply Briefs. DOA 9—10. Consequently, Appellant’s argument that somehow there was error in not giving Appellant opportunity to respond to Holash, merely confirmatory evidence of a finding made by the Examiner when the initial rejection over Hu was set forth, is unavailing. 7 Appeal 2016-007395 Application 13/969,763 SUMMARY We decline to modify the Decision on Appeal affirming the Examiner’s decision that claims 1—11 are unpatentable. See DO A 2 for a list of the affirmed rejections. However, we modify the Decision on Appeal to the extent that we do not rely on the third declaration containing an English translation of the laboratory printed form. REHEARING DENIED 8 Copy with citationCopy as parenthetical citation