HANCOCK JAFFE LABORATORIES, INC.

Patent Trials and Appeals BoardJun 2, 2021

2021002265 (P.T.A.B. Jun. 2, 2021)

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. 15/711,314 09/21/2017 NORMAN JAFFE 072510/01020 8539 31013 7590 06/02/2021 KRAMER LEVIN NAFTALIS & FRANKEL LLP INTELLECTUAL PROPERTY DEPARTMENT 1177 AVENUE OF THE AMERICAS NEW YORK, NY 10036 EXAMINER MATHEW, SEEMA ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 06/02/2021 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): dtorniali@kramerlevin.com klpatent@kramerlevin.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ Ex parte NORMAN JAFFE _______________ Appeal 2021-002265 Application 15/711,314 Technology Center 3700 ________________ Before BENJAMIN D. M. WOOD, WILLIAM A. CAPP, and JILL D. HILL, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 13, 14, and 17–23 as unpatentable under 35 U.S.C. § 103 over Duran and Rinaldi. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM, but designate our affirmance of claim 18 as a NEW GROUND OF REJECTION pursuant to our discretionary authority under 37 C.F.R. § 41.50(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Hancock Jaffe Laboratories, Inc., as the applicant and real party in interest. Appeal Br. 3. Appeal 2021-002265 Application 15/711,314 2 THE INVENTION Appellant’s invention is a biological valve. Spec. ¶ 2. Claim 13, reproduced below, is illustrative of the subject matter on appeal. 13. A method of manufacturing a replacement venous valve for a host vein in a subject, the method comprising: obtaining a xenogeneic heart valve; and excising a portion of the heart valve so as to include a leaflet selected to provide adequate obstruction of the host vein when a free edge of the selected leaflet is in an open position once the portion of the heart valve is attached to the host vein. THE REJECTION The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Duran2 non patent literature Mar. 1980 Rinaldi3 non patent literature June 1986 The following rejection is before us for review:4 Claims 13, 14, and 17–23 are rejected under 35 U.S.C. § 103 as being unpatentable over Duran and Rinaldi. 2 Carlos M.G. Duran, M.D., Ph.D., et al., A new composite xenograft monocusp patch for reconstruction of the right ventricular outflow tract: A preliminary report, Vol. 7, BULLETIN OF THE TEXAS HEART INSTITUTE, CARDIOVASCULAR DISEASES, No. 1, March 1980. 3 Raul Garcia-Rinaldi, M.D., Ph.D., et al., Femoral vein valve incompetence: Treatment with a xenograft monocusp patch, Vol 3, JOURNAL OF VASCULAR SURGERY, No. 6, June 1986. 4 A ground of rejection under 35 U.S.C. § 102 has been withdrawn by the Examiner. Ans. 5–6. Appeal 2021-002265 Application 15/711,314 3 OPINION Claims 13, 14, 17, and 19–23 Appellant argues claims 13, 14, 17, and 19–23 as a group. Appeal Br. 7–16. Claim 13 is representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Duran discloses the invention substantially as claimed except for disposing the prosthetic valve in a vein, for which the Examiner relies on Rinaldi. Final Act. 5–6. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time of the invention to combine the teachings of Duran and Rinaldi to achieve the claimed invention. Id. at 6. According to the Examiner, a person of ordinary skill in the art would have done this to treat venous insufficiency in a patient’s leg. Id. Appellant argues that Duran is directed to the right ventricular outflow tract of the heart, not legs. Appeal Br. 8. “Duran necessarily fails to describe or suggest the claimed heart-to-vein reconstruction.” Id. Appellant further argues that Rinaldi fails to disclose the use of a natural leaflet of a xenogeneic heart. Id. “Rinaldi describes use of an artificial (e.g., man- made) monocusp patch made of bovine pericardium . . . .” Id. According to Appellant, a person of ordinary skill in the art would not consider it obvious to combine the teachings of Duran and Rinaldi to achieve a venous valve replacement as claimed. Id. at 9. Appellant accuses the Examiner of engaging in improper hindsight analysis to combine the references in the manner proposed in the rejection. Id.; Reply Br. 5. Appellant further argues that the Examiner’s proposed modification would change Duran’s principle of operation. Appeal Br. 10. Appeal 2021-002265 Application 15/711,314 4 We can quickly dispose of Appellant’s “change the principle of operation” argument. The Examiner is merely relocating Duran from the heart to the leg, not changing the way that it operates. With respect to Appellant’s hindsight argument, the Examiner explains that the rejection is based on established medical practices of using a xenogeneic monocusp valve as demonstrated by Duran and Rinaldi. Ans. 7. The Examiner finds that Duran discloses a monocusp valve excised from a porcine heart valve for treating valvular deficiency in a pulmonary outflow tract. Id. (citing Duran, Fig. 2, p. 58, ll. 1–6, p. 59, ll. 2–29). The Examiner further finds that Rinaldi discloses a xenogeneic monocusp valve for treating lower extremity blood flow insufficiency. Id. (citing Rinaldi Figs. 2A–C, abstract, and p. 932, col. 2, ll. 11–26, and p. 933, ll. 18–26). According to the Examiner, both references treat blood flow incompetency using monocusp xenogeneic valves. Id. In the final rejection, the Examiner concludes that it would have been obvious to combine the teachings of Duran and Rinaldi “to mitigat[e] deep venous incompetency of the lower extremities.” Final Act. 6. The Examiner’s reasoning and analysis is sufficient to support the rejection. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring an obviousness conclusion to be based on explicit articulated reasoning with rational underpinning), cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Examiner’s reasoning, furthermore, is sufficient to overcome Appellant’s hindsight argument. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (explaining that a hindsight argument is of no moment where the Examiner provides a sufficient, non-hindsight reason to combine the references). Appeal 2021-002265 Application 15/711,314 5 Appellant next argues that Duran “teaches away” from the present claims. Appeal Br. 11; Reply Br. 3. There is no support for this argument in the record. It is well settled that the “mere disclosure of alternative designs does not teach away.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). Teaching away requires “clear discouragement” from implementing a technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017). Thus, a reference does not teach away if it merely discloses an alternative invention but does not “criticize, discredit, or otherwise discourage” investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Appellant presents no language from Duran that criticizes, discredits, or discourages the use of porcine heart valve leaflets to remedy venous insufficiency. See generally Appeal Br.; Reply Br. At most, Appellant argues that the purposes for which Duran and the instant application are used, i.e., heart versus leg vein valves, are “completely different.” Appeal Br. 11; Reply Br. 4. In the context of the facts and circumstances of the instant case, such does not equate to “teaching away.” Next, Appellant argues that Rinaldi fails to cure the deficiencies of Duran, because Rinaldi is directed to an artificial patch made of pericardium tissues instead of a leaflet from a xenogeneic heart valve. Appeal Br. 12. Appellant argues that “natural xenogeneic heart leaflets and bovine pericardium tissue have very different tissue characteristics.” Id. at 13. According to Appellant, [A]n artificial heterologous patch made of pericardium has more flexibility due to less tensile strength compared to a natural heart leaflet. Therefore, one skilled in the art would understand that Rinaldi’s artificial patch has more flexibility and thus could be expected to effectively open and close the Appeal 2021-002265 Application 15/711,314 6 venous valve in responding to differing pressures (e.g., lower pressure) in the deep venous system. Id. Appellant further argues that it is “unexpected” that the free edge of a natural porcine heart leaflet can respond to the low pressure environment in a vein to provide an acceptable obstruction. Appeal Br. 15. In response, the Examiner reminds Appellant that the rejection under review is an obviousness rejection over a combination of references and that Appellant cannot show non-obviousness by attacking references individually. Ans. 9 (citing In re Keller, 642 F.2d 413 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)). This is a correct statement and application of prevailing law. The Examiner explains: Rinaldi was not used to teach how to create an artificial monocusp patch, instead Rinaldi was used to teach a xenogeneic monocusp valve for use in a different application than the teaching of Duran. Rinaldi teaches the use of a monocusp valve in the lower extremities, in venous veins, specifically to mitigate blood flow insufficiency to the right ventricular outflow tract. Ans. 9. Duran is directed to a xenograft monocusp patch for reconstruction of the right ventricular outflow tract. Duran, Abstract. In Duran, porcine aortic valve cusps are removed and trimmed to allow a cuff of aortic wall and subaortic tissue. Id. at 59. Duran’s patch is constructed of: (1) a porcine aortic valve cusp; (2) a Dacron-covered vitalium ring; and (3) a rectangular patch of porcine pericardium tissue. Id. The aortic cusp is sutured to the mesothelial aspect of the pericardium. Id. At surgery, the appropriate monocusp size is selected according to the required enlargement of the pulmonary annulus. Id. The pericardial patch is trimmed to allow an adequate length and shape for the outflow tract, pulmonary trunk, and Appeal 2021-002265 Application 15/711,314 7 branches. Id. Duran reports that the described graft was successfully used to treat a 12-year old girl suffering from tetralogy of Fallot. Id. at 59–64. Rinaldi is directed to treatment for femoral vein valve incompetence. Rinaldi, 932. Rinaldi reports the successful outcome of insertion of a monocusp patch into the vein of a 36-year-old woman with primary vein incompetence of the lower extremities. Id. The prosthesis used by Rinaldi consists of an anatomically exact sinus of Valsalva made of bovine pericardium mounted on a bovine pericardial patch. Id. at 934. The xenograft monocusp patch was originally designed for treatment of right ventricular outflow tract obstruction, such as that in tetralogy of Fallot. Id. at 932, 934. In other words, Rinaldi’s leg vein prosthetic valve has previously been successfully used in the exact same prosthetic heart valve situation described in Duran. Compare id., with Duran, 59–64. Having considered the competing positions of Appellant and the Examiner, it is our opinion that the Examiner has the better position. Appellant’s principal focus appears to be on the alleged differences in environment in which the prosthetic valve functions. For example, much of Appellant’s argument and analysis is devoted to the notion that a heart valve operates in a relatively high-pressure environment whereas leg veins present a relatively low-pressure environment. Appeal Br. 13–14. Appellant, however, fails to address the fact that Rinaldi adapts a known, prosthetic monocusp heart valve for use in a leg vein. Rinaldi, 932, 934. Appellant’s arguments against the combinability of Duran and Rinaldi primarily go the issue of whether a person of ordinary skill in the art would have had a reasonable expectation of successfully treating leg vein insufficiency with a porcine monocusp valve prosthesis. Appeal Br. 15–16. Appeal 2021-002265 Application 15/711,314 8 The obviousness inquiry requires a determination that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the artisan would have had a reasonable expectation of success in doing so. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012). “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). In other words, “one must have a motivation to combine accompanied by a reasonable expectation of achieving what is claimed in the patent-at-issue.” Id. “For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O'Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988). Thus, the expectation of success need not be absolute, only “reasonable.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). The Federal Circuit rejects any requirement of conclusive proof of efficacy for obviousness. Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310, 1333 (Fed. Cir. 2018). Here, the fact that Rinaldi demonstrates that a prosthetic heart valve can be adapted for use in a leg vein is sufficient for us to conclude that a person of ordinary skill in the art would have had a reasonable expectation of success in adapting Duran’s porcine monocusp patch for use in leg veins. Appellant’s argument that it is “unexpected” that a porcine heart leaflet can respond to a low-pressure environment in a vein amounts to little more than unsubstantiated attorney argument. Appeal Br. 15. “It is well settled that unexpected results must be established by factual evidence. Appeal 2021-002265 Application 15/711,314 9 Mere argument or conclusory statements in the specification does not suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). An unexpected results analysis requires consideration of what a skilled artisan would have expected. Pfizer 480 F.3d at 1371. Here, Appellant provides no persuasive analysis, supported by facts from the record, as to what a skilled artisan would or would not have expected in using a porcine heart valve leaflet in a vein. Appellant merely argues that its prosthetic valve can tolerate some degree of leakage or backflow. Appeal Br. 15. We are at a loss to understand how Appellant’s lack of success in completely controlling venous backflow promotes the non-obviousness of the claimed subject matter. Indeed, the fact that backflow need not be completely eliminated, if anything, contributes to the reasonable expectation of success in adapting Duran to a leg vein application. Appellant’s unsubstantiated attorney argument is effectively refuted by the fact that Rinaldi’s prosthetic valve proved effective in both the environment of a heart valve and the environment of a leg vein. Again, this is sufficient to provide a skilled artisan with a reasonable expectation that Duran’s prosthetic valve could be successfully used in a leg vein. We have considered Appellant’s remaining arguments and find them to be unpersuasive. The Examiner’s findings of fact are supported by a preponderance of the evidence and the Examiner’s legal conclusion of unpatentability is well founded. In view thereof, we sustain the Examiner’s unpatentability rejection of claims 13, 14, 17, and 19–23. Claim 18 Claim 18 depends directly from claim 17 and indirectly from claim 13 and adds the limitation: “wherein the selected leaflet is a noncoronary Appeal 2021-002265 Application 15/711,314 10 leaflet.” Claims App. The Examiner finds that Duran discloses a valve where the selected leaflet is a noncoronary leaflet. Final Act. 6. Appellant argues that neither Duran nor Rinaldi explicitly mentions the use of a natural noncoronary leaflet as a replacement venous valve. Appeal Br. 16–18. “Absent the teachings of Appellant's invention, it was not foreseeable that a noncoronary leaflet of an aortic heart valve would be suitable for the claimed method.” Id. at 17. In its Reply Brief, Appellant accuses the Examiner of ignoring its Appeal Brief arguments concerning claim 18 in the Answer. Reply Br. 8. In the final rejection, the Examiner cites page 58, lines 2–16 of Duran as providing evidentiary support for the noncoronary leaflet limitation. Final Act. 6. The Examiner repeats this finding verbatim in the Answer. Ans. 4. In the “Response to Argument” section of the Answer, the Examiner does not explicitly discuss claim 18 or otherwise acknowledge that claim 18 is separately argued by Appellant. See generally Ans. Otherwise, the Examiner does generally mention that Duran uses a porcine leaflet. Ans. 6. The Examiner finds that the appropriate monocusp heart valve size is selected according to its intended use which depends on factors such as patient size and the amount of diseased or affected area. Id. (citing Duran, p. 59, ll. 2–9). We have reviewed the passages of Duran cited by the Examiner and find insufficient evidence to support a finding that Duran explicitly discloses selecting a noncoronary valve leaflet. Thus, the Examiner’s findings, on their face, are insufficient to support the rejection. Nevertheless, as previously discussed, Rinaldi demonstrates that a prosthetic valve originally designed for use as a heart valve could be successfully used in a leg vein. Duran’s prosthetic heart valve uses a single Appeal 2021-002265 Application 15/711,314 11 porcine aortic valve cusp. Duran, 59. The cusp is “removed and trimmed” to provide a cuff of aortic wall and subaortic tissue. Id. Duran is otherwise silent as to whether the particular cusp selected is the noncoronary cusp. It is known that the human aortic valve includes a left coronary cusp, a right coronary cusp, and a noncoronary cusp.5 It is also known that human and porcine aortic valves are similar, but not identical. 6 In selecting which aortic valve cusp to use in a monocusp valve, the skilled artisan is faced with a finite number of choices, namely, three. It is well settled that when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, skilled artisans have good reason to pursue known options within their technical grasp. KSR, 550 U.S. at 421. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. Id. Here, Duran teaches the use of a porcine aortic cusp and Rinaldi teaches that a known prosthetic valve for treatment of right ventricular outflow obstruction can be successfully used as a valve in a leg vein. Duran is silent on which cusp should be used. Duran certainly does not explicitly encourage the selection of the right or left coronary cusps to the exclusion of the noncoronary cusp. Under the circumstances, it is our opinion that evaluation and selection of the noncoronary cusp instead of 5 Atlas of Human Cardiac Anatomy, http://www.vhlab.umn.edu/atlas/ anatomy-tutorial/cardiac-valve-nomenclature.shtml (last accessed May 18, 2021). 6 EK Sim, et al., Comparison of human and porcine aortic valves. Clin Anat. 2003 May;16(3):193–6. doi: 10.1002/ca.10149. PMID: 12673813. Abstract located at https://pubmed.ncbi.nlm.nih.gov/12673813/ (last accessed May 18, 2021). Appeal 2021-002265 Application 15/711,314 12 either the left or right coronary cusps entails no more than ordinary skill. In other words, determining whether which of the three known valve cusps is appropriate for a particular product application involves no more than routine experimentation, which falls within the ambit of ordinary skill. In view of the foregoing, we sustain the Examiner’s unpatentability rejection of claim 18. However, inasmuch as our findings and determination arguably change the thrust of the Examiner’s original rejection, we designate our affirmance as a NEW GROUND OF REJECTION. See In re Biedermann, 733 F.3d 329, 337 (Fed. Cir. 2013) (explaining that applicant is entitled to fair opportunity to react to the thrust of a rejection). CONCLUSION Claims Rejected 35 U.S.C. § References Affirmed Reversed New Ground 13, 14, 17-23 103 Duran, Rinaldi 13, 14, 17-23 18 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b), which provides that “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: Appeal 2021-002265 Application 15/711,314 13 (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. AFFIRMED; 37 C.F.R. § 41.50(b)