Ex Parte Puschett et alDownload PDFPatent Trials and Appeals BoardJun 20, 201914169365 - (D) (P.T.A.B. Jun. 20, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/169,365 01/31/2014 32425 7590 06/24/2019 NORTON ROSE FULBRIGHT US LLP 98 SAN JACINTO BOULEVARD SUITE 1100 AUSTIN, TX 78701-4255 FIRST NAMED INVENTOR Jules B. Puschett 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. JBPU.P0002US.Cl 4268 EXAMINER PAGONAKIS, ANNA ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 06/24/2019 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): aoipdocket@nortonrosefulbright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JULES B. PUSCHETT and LEE SHAPIR0 1 Appeal 2018-003945 Application 14/169,365 Technology Center 1600 Before ULRIKE W. JENKS, ELIZABETH A. LA VIER, 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) involving claims to a method for treating brain injuries which have been rejected for failing to satisfy the written description requirement, for lack of enablement and for non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as Dr. Jules Puschett. Br. 3. 2 We have considered and herein refer to the Specification of Jan. 31, 2014 ("Spec."); Final Office Action of Dec. 7, 2016 ("Final Act."); Appeal Brief of Aug. 7, 2017 ("Br."); and Examiner's Answer of Dec. 13, 2017 ("Ans."). Appeal 2018-003945 Application 14/169,365 STATEMENT OF THE CASE Appellants' Specification discloses that: It has long been known that traumatic brain injuries can result in temporary problems, permanent problems, and in some instances, death. It has, more recently, been recognized that such brain injuries may not, initially, produce symptoms which cause the patient, others, or even medically-skilled individuals to be concerned even though, within a day or two, very serious consequences may result. Spec. ,-J 2. Present diagnostic techniques are not totally effective in identifying traumatic brain injuries. Id. ,-i 4. The Specification describes methods for diagnosing and treating traumatic brain injuries. Id. ,-i 8. Claims 1, 2, 11, 12, and 16 are on appeal. Claim 1 is representative and reads as follows: 1. A method of treating a patient comprising administering a therapeutically effective dose of a MBG antagonist to the patient that has experienced an indirect or direct shock to the head, and has MBG levels 30% higher than a subject that has not experienced an indirect or direct shock to the head. The claims stand rejected as follows: Claims 1, 2, 11, 12, and 16 have been rejected under 35 U.S.C. § 112, first paragraph for failing to comply with the written description requirement. Claims 1, 2, 11, 12, and 16 have been rejected under 35 U.S.C. § 112, first paragraph for lack of enablement. Claims 1, 2, 11, 12, and 16 have been rejected for non-statutory obviousness-type double patenting over claims 1-8 of US 8,642,568 B2. 2 Appeal 2018-003945 Application 14/169,365 WRITTEN DESCRIPTION Issue The issue with respect to this rejection is whether the Examiner has properly determined that the present Specification does not satisfy the written description requirement. The Examiner finds that the Specification does not provide an adequate written description of the limitations "a therapeutically effective dose of a MBG [ marinobufagenin] antagonist" and "a marinobufagenin level at least 30 percent higher than a subject [who] has not experienced an indirect or direct shock to the head." Final Act. 3. The Examiner finds that only the preferred embodiment in the Specification teaches that a traumatic brain injury exists if the elevation of MBG is at least 30 percent over that of a normal patient. Id. The Examiner also finds that the Specification is silent as to the genus of MBG antagonists as the Specification only identifies one MBG antagonist, resibufogenin ("RBG"). Id. The Examiner concludes that the claims lack sufficient written support. Appellants contend that the Specification describes the claimed invention in sufficient detail such that one skilled in the art could reasonably conclude that the inventor had the claimed invention in their possession. Br. 4. With respect to the limitation "a therapeutically effective dose of a MBG antagonist," Appellants contend that the limitation is used consistently throughout the Specification and gives an example of what is meant by the term. Appellants point to paragraph 27 of the Specification where it teaches that 120 µg of resibufogenin was administered to 10 rats to prevent brain 3 Appeal 2018-003945 Application 14/169,365 mJury. Br. 6. Appellants also point to paragraph 3 8 of the Specification where it teaches that an effective amount of RBG is an amount sufficient to prevent the formation of a glial scar. 3 Br. 5. Appellants argue that the limitation "a marinobufagenin level at least 30 percent higher than a subject that has not experienced an indirect or direct shock to the head" is supported by the Specification. Br. 6. Appellants cite to paragraph 35 of the Specification where it states "[i]n a preferred embodiment of the present invention, it is determined that a traumatic brain injury exists if the elevation ofmarinobufagenin is at least about 30 percent over that of a normal patient." Id. ( emphasis added in brief ( quoting Spec. ,i 3 5) ). Appellants contend that just because the level of MBG is disclosed in a preferred embodiment does not detract from the disclosure supporting the limitation in the claims. Id. at 7. Appellants argue that the genus of MBG antagonists is also supported. Id. at 8. Appellants contend that the Specification discloses a well-known MBG antagonist and its use in treating a head injury. Id. Appellants contend that one skilled in the art could readily substitute any other MBG antagonist and achieve the same result without undue experimentation. Id. Appellants contend that one skilled in the art would understand that Appellants clearly possessed the claimed invention. Id. 3 The Specification teaches that the formation of a glial scar is an indicator of brain injury. See Spec. ,i 38. 4 Appeal 2018-003945 Application 14/169,365 Principles of Law "In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue." Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. See id. "Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims." Id. at 1323. The Federal Circuit explained that: Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004). In Ariad, the court explained: sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en bane). 5 Appeal 2018-003945 Application 14/169,365 Analysis We have considered the arguments presented by Appellants and the Examiner and find that, with respect to claims 1, 2, and 11, the Examiner's finding of a lack of written description is correct. With respect to claims 12 and 16, we find the rejection is erroneous. The Examiner found that the limitation referring to MBG levels 30% higher than a subject that has not experienced an indirect or direct shock to the head was not supported by the Specification. We do not agree. The Specification teaches "[i]n a preferred embodiment of the present invention, it is determined that a traumatic brain injury exists if the elevation of marinobufagenin is at least about 30 percent over that of a normal patient." Spec. ,-J 35. We agree with Appellants that this passage, in the context of the Specification as a whole, provides support for the recited limitation. The limitation in claim 1 calling for a therapeutically effective amount of MBG antagonist, however, is not supported by the Specification. As the Examiner points out, the Specification lists only one MBG antagonist, RBG. The disclosure of only one member of the genus, absent any disclosure of structural features common to the genus does not allow one skilled in the art to visualize or recognize the members of the genus. See Ari ad, 598 F .3d at 1350. Appellants contend that following the teachings of the Specification, one skilled in the art can readily identify other MBG antagonists without undue experimentation. Br. 8. While this is true, whether undue experimentation is needed is a question of enablement, not written description. The written description requirement is separate from the 6 Appeal 2018-003945 Application 14/169,365 enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991 ). When claiming a genus, the Specification must disclose "either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad, 598 F.3d at 1350. That one skilled in the art might be able to later identify additional members of the genus is insufficient. "One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus." AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). Claims 12 and 16 specifically claim the use of RBG, which is disclosed in the Specification. Br. 13 (Claims App'x); Spec. ,-J 37. We find that claims 12 and 16 are sufficiently supported by the Specification. Conclusion of Law We conclude that the written description requirement has not been met for claims 1, 2, and 11 but that it has been met for claims 12 and 16. Accordingly, we affirm the writing description rejection as to claims 1, 2, and 11, but reverse it as to claims 12 and 16. 7 Appeal 2018-003945 Application 14/169,365 ENABLEMENT Issue The issue with respect to this rejection is whether the Examiner has properly determined that the claims are not enabled by the present Specification. The Examiner finds that while the Specification is enabling for inhibiting glial scar formation associated with traumatic brain injury, the Specification is not enabling for treating a patient with traumatic brain injury. Final Act. 4-5. The Examiner finds "[t]he instant specification as originally filed lacks adequate guidance, direction or discussion to apprise the skilled artisan how the claimed may be used to achieve a method of reducing the risk to brain tissue." Id. at 6. The Examiner finds that the Specification does not set forth any examples of treating traumatic brain injury. Id. The Examiner contends that while the absence of working examples cannot be the sole factor in determining enablement, the absence of a working example provides additional weight to the Examiner's conclusion that the claims are not enabled. Id. at 7. The Examiner finds the Specification is devoid of any correlation between the claimed method and its efficacy in treating the disclosed conditions. Id. The Examiner finds that the Specification fails to provide any guidance or direction in support of the reasonable expectation of success in actually effecting the treatment of the disclosed disorders using the instantly claimed compound in the absence of any evidence supporting the allegation that the elected compound is, in fact, effective to achieve such a therapeutic objective, either by reduction to practice or at least by elucidating the mechanism by which the 8 Appeal 2018-003945 Application 14/169,365 claimed compound works and correlating such activity to therapeutic improvement of the disclosed disorders or diseases. Id. at 7-8. The Examiner concludes As the cited art and discussion of the above factors establish, practicing the claimed method in the manner disclosed by Applicant would not imbue the skilled artisan with a reasonable expectation or ability to make and use the full scope of the invention as instantly claimed, given the disclosure and supporting examples provided in the present specification and the state of the art at the time of the invention. In order to actually achieve the claimed invention, it is clear from the discussion above that the skilled artisan could not rely upon Applicant's disclosure as required by 35 U.S.C. 112, first paragraph, and would have no alternative recourse but the impermissible burden of undue experimentation in order to practice the full scope of the embodiments presently claimed. Id. at 8-9. Appellants contend that the Specification describes the effects of brain injury and shows that glial scar formation is an indicator of brain injury. Br. 9-10. Appellants contend that one skilled in the art would accept amelioration of glial scar formation as an indicator that the claimed method is an effective treatment for brain injury. Id. Appellants also contend that It is clear the current application provides one of skill sufficient description to enable one of skill to make and use the claimed invention without undue experimentation. Based on the guidance provided by the current specification in combination with what is known in the art one of skill would recognize (1) elevated levels of MBG are pathogenic, (2) traumatic brain injuries are associated with an elevation in 9 Appeal 2018-003945 Application 14/169,365 MBG, and (3) the pathogenic consequences of elevated MBG can be treated by administering a MBG antagonist, such as resibufogenin (RBG). Id. at 11. Principles of Law The Federal Circuit explained that: 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, 11 F.3d 1046, 1050 (Fed. Cir. 1993) ("[T]he specification must teach 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). "[ A ]n invention may be enabled even though it has not been described." University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 921 (Fed. Cir. 2004). The court in Amgen explained that: [t]he enablement requirement is often more indulgent than the written description requirement. The specification need not explicitly teach those in the art to make and use the invention; the requirement is satisfied if, given what they already know, the specification teaches those in the art enough that they can make and use the invention without "undue experimentation." Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003) ( citation omitted). 10 Appeal 2018-003945 Application 14/169,365 Analysis We have considered the positions advanced by the Examiner and Appellants and find that Appellants have the better position. The Specification teaches that traumatic brain injury can result in the formation of glial scars, a loss of GP AP-labeled astrocytes and the appearance of hypertrophied astrocytes. Spec. ,-J 27. The Specification also teaches that the administration of RPG prevents the formation of glial scars and ameliorates the other effect of brain injury. Id. The Specification teaches how to determine whether a patient has suffered a brain injury. Specifically, the Specification teaches how to measure MBG levels and that MBG levels that are 30 percent higher than normal indicate the brain injury has occurred. Id. ,-i,-i 33-35. Finally, the Specification provides a working example where rats were subject to traumatic brain injury by impact and a group of the rats were treated with 120 µg of RBG 90 minutes after imposition of brain trauma. Id. ,-J 27. The group of rats treated with RBG exhibited no glial scars, and, when compared to the untreated rats, exhibited a reduction in the decrease in GP AP immunoreactivity and a greater portion of the astrocytes had a normal appearance. Id. ,-i 38. Therefore, we agree with Appellants (see Br. 10) that extension of this study to human subject experiencing head trauma would be routine and would not involve undue experimentation. Conclusion of Law We conclude that the Examiner has not demonstrated that the claims are not enabled. Accordingly, we reverse the enablement rejection. 11 Appeal 2018-003945 Application 14/169,365 OBVIOUSNESS-TYPE DOUBLE PATENTING Appellants have offered no substantive argument with respect to this rejection, other than to off er to file a terminal disclaimer upon allowance of the present claims. Br. 11. Therefore, we summarily affirm this rejection. See 37 C.F.R. § 421.37(c)(iv). SUMMARY We affirm the rejection of claims 1, 2, and 11 under 35 U.S.C. § 112, first paragraph for lack of written description. We reverse the rejection of claims 12 and 16 under 35 U.S.C. § 112, first paragraph for lack of written description. We reverse the rejection of claims 1, 2, 11, 12, and 16 under 35 U.S.C. § 112, first paragraph for lack of enablement. We affirm the rejection of claims 1, 2, 11, 12, and 16 for non-statutory obviousness-type double patenting. 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. § l .136(a). AFFIRMED 12 Copy with citationCopy as parenthetical citation