Ex Parte SantilliDownload PDFPatent Trial and Appeal BoardJul 26, 201711614238 (P.T.A.B. Jul. 26, 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. KSI-16377.001 9034 EXAMINER LEVINE, JOSHUA H ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 11/614,238 12/21/2006 Albert N. Santilli 07/26/201777096 7590 WAYNE D PORTER, JR LAW OFFICES OF WAYNE D. PORTER, JR. 6200 ROCKSIDE WOODS BOULEVARD NORTH SUITE 315 INDEPENDENCE, OH 44131 07/26/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALBERT N. SANTILLI Appeal 2015-005664 Application 11/614,23s1 Technology Center 3700 Before WILLIAM A. CAPP, LEE L. STEPINA, and FREDERICK C. LANEY, Administrative Patent Judges. LANEY, Administrative Patent Judge. DECISION ON APPEAL Albert N. Santilli (Appellant) appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1, 6, 7, 9, 13, and 19—29.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We REVERSE, and enter NEW GROUNDS OF REJECTION. 1 According to Appellant, an additional interested party is Kapp Surgical Instrument, Inc. Appeal Br. 1 (filed Nov. 24, 2014). 2 Claims 2—5, 8, 10-12, and 14—18 have been canceled. Appeal Br. 24—26. Appeal 2015-005664 Application 11/614,238 INVENTION Appellant’s invention “relates to prosthetic heart components made of biological tissue and, more particularly, to tissue heart components, particularly valves, that are precisely sized for an optimized fit.” Spec. 12. Claims 1 and 13 are independent. Claim 1 is illustrative of the claimed invention and reads as follows: 1. A method of manufacturing a replacement prosthetic tissue heart component for a patient, comprising the steps of: scanning the patient's heart non-invasively by CT angiography using a multislice scanner to create CT images of the heart while the heart is beating; wherein the images generated by the scanning operation are two-dimensional and three-dimensional images; providing a programmable digital computer system having a computer readable memory, where the computer system is programmed to generate and view images and thereby provide measurements of said heart components; wherein the computer system imports the CT-scans and uses the programmed algorithms to convert scan data to create the three-dimensional images; wherein the heart component to be replaced is selected from the group consisting of tricuspid valves, aortic valves, aortic valve conduits, mitral valves, annuloplasty rings, pulmonic valves, pulmonic valve conduits, and pericardial patches; determining the specific dimensions of the said heart component to be replaced from the images generated by the non-invasive scan; and manufacturing the said replacement heart component using information from the images and the specific dimensions of the heart component to be replaced. Appeal Br. 24 (Claims App.). 2 Appeal 2015-005664 Application 11/614,238 REJECTIONS The following rejections are before us for review: I. The Examiner rejected claims 1, 6, 7, 9, 13, and 19 under 35 U.S.C. § 102(b) as being anticipated by Jarvik (US 2006/0195004 Al, iss. Aug. 31, 2006). II. The Examiner rejected claims 20, 22, 23, 25, 27, and 28 under 35 U.S.C. § 103(a) as unpatentable over Jarvik. III. The Examiner rejected claims 21, 24, 26, and 29 under 35 U.S.C. § 103(a) as unpatentable over Jarvik and True Life Anatomy (2003 winner of consensus software animations, http:// www. consensus. eom. au/Soft ware Awards/ C S Aarchi ve/C S A2003/Truelife.htm). ANALYSIS Rejection I Claims 1 and 13, from which claims 6, 7, 9, and 19 depend, recite a method for producing a replacement prosthetic heart component for a patient, “wherein the heart component to be replaced is selected from the group consisting of tricuspid valves, aortic valves, aortic valve conduits, mitral valves, annuloplasty rings, pulmonic valves, pulmonic valve conduits, and pericardial patches,” that includes the step of “manufacturing the said replacement heart component using information from the images and the specific dimensions of the heart component to be replaced.” Appeal Br. 24, 26 (Claims App.). Appellant asserts the Examiner fails to identify evidence from Jarvik that shows manufacturing tricuspid valves, aortic valves, aortic valve conduits, mitral valves, annuloplasty rings, pulmonic valves, pulmonic 3 Appeal 2015-005664 Application 11/614,238 valve conduits, or pericardial patches as a replacement prosthetic heart component for a patient. Appeal Br. 12. The Examiner finds Jarvik discloses an aortic valve replacement prosthetic heart component and the recited method steps for manufacturing the component. Final Act. 7—8 (citing Jarvik H 17, 32, 35, Abstract). Having considered the evidence cited by the Examiner, and the explanation thereof, we agree with Appellant for the following reasons. Jarvik discloses a miniature blood pump with a shaped anatomic adaptor 16 that fits within the cross sectional area of one of the three leaflets of either the aortic or pulmonary valve. Jarvik 132, Figs. \—A. “The anatomic adaptor has two facet like surfaces 18, 20, that match the size and shape of the sealing surfaces of the two valve leaflets that close against them.” Id. “The optimal shape for the anatomic adaptor 16, fills the complete sinus of valsalva in which it is placed, with no crevices where blood clots can form.” Id. 135. “The adaptor shape nests into the sinus of valsalva and helps retain the miniature blood pump in place, and also helps hold the facet like valve sealing surfaces in exact opposition to the closed valve leaflets.” Id. “[WJhere the patient’s natural valve leaflets are preserved, [the anatomic adaptor] shape is based on custom geometric measurements from CT or MRI imaging of the individual patient’s natural valve . . . [and] custom fabricate^]... to exactly fit the patient.” Id. Jarvik teaches an object of the disclosed device is “to provide a transvalvular pump custom matched to the individual patient’s anatomy for optimal performance.” Id. 117. Put more simply, Jarvik discloses a medical pump with an adaptor, which is customizable using measurements from CT or 4 Appeal 2015-005664 Application 11/614,238 MRI medical imagery to match the size and shape of the natural surfaces that it will contact within the aortic or pulmonary valve. Other than simply identifying paragraphs 17, 32, and 35 from Jarvik’s Specification, the Examiner provides little guidance for how the disclosed pump with a customizable adapter discloses, “manufacturing the said replacement heart component using information from the images and the specific dimensions of the heart component to be replaced,” as claims 1 and 13 recite. In particular, it is unclear how Jarvik’s pump qualifies as a “replacement heart component” with “specific dimensions of the heart component to be replaced.” First, the Examiner does not provide any evidence that a skilled artisan would have viewed the pump Jarvik discloses as a “replacement heart component.” Although Jarvik discloses locating a pump within the area created by a removed leaflet, the Examiner has not offered any reasonable interpretation of “replacement heart component” that extends its scope to any device that supplants a component in the heart. In the context of the claims and the Specification, the broadest reasonable construction requires a heart component that is intended to replicate (i.e., mimic) the component being replaced. And, we cannot find any evidence suggesting the pump Jarvik discloses is designed to replicate the leaflet it will replace. Second, while Jarvik discloses that the pump may be customizable to fit exactly within the void that a removed leaflet creates, we are unable to find any supportive evidence that the pump, or its adaptor, replicates the specific dimensions of the leaflet itself that is being replaced. Jarvik instead describes customizing the size and shape of the leaflets remaining in the aortic valve that will close against them. Jarvik 132. Moreover, the 5 Appeal 2015-005664 Application 11/614,238 Examiner does not offer any reasonable interpretation of the claim language that would cover any article of manufacture that is designed to fit within the specific cross sectional area created by the removed heart component, regardless of whether the dimensions of the article do not resemble the heart component being replaced in any other way. Nor are we able to find any support for such an interpretation. There is no proof the pump and adaptor that Jarvik discloses is designed to have the “specific dimensions” of the leaflet being replaced, other than the dimension defining the space created by its removal. Finally, in response to Appellant’s argument that Jarvik does not disclose manufacturing the recited heart components, the Examiner states, claims 1 and 13 include a Markush group with its species defining the genus of heart component. Therefore, if any one of the species is considered anticipated then the genus is considered anticipated. The genus of a heart component is considered anticipated as Jarvik disclosed at least an aortic valve (itransvalvular pump implanted into the non-coronary cusp of the aortic valve . . .). Final Act. 4 (citing Jarvik 122); Ans. 6. The Examiner’s response does not address the pertinent issue. Regardless of the fact that claims 1 and 13 identify a “Markush group,” the Examiner does not identify why the transvalvular pump implanted into the non-coronary cusp of the aortic valve is proof Jarvik discloses manufacturing an aortic valve itself. Still further, there is no evidence the pump is replacing an aortic valve or has the “specific dimensions” of the aortic valve to be replaced. Because a claim is anticipated only “if a single prior art reference discloses each and every limitation of the claimed invention,” the Examiner’s determination that Jarvik anticipates claims 1 and 13 is 6 Appeal 2015-005664 Application 11/614,238 improper. In re Rambus, Inc., 753 F.3d 1253, 1256 (Fed. Cir. 2014). Although a preponderance of the evidence supports the Examiner’s finding that Jarvik discloses many of the manufacturing steps recited in claims 1 and 13, Jarvik is insufficient as proof that the manufacturing method was known to manufacture a “replacement heart components” (and, in particular, an aortic valve) with the “specific dimensions of the heart component to be replaced,” which is also a limitation of claims 1 and 13. Therefore, we do not sustain the Examiner’s rejections of claims 1, 6, 7, 9, 13, and 19. New Grounds Of Rejection Unpatentability Over Jarvik And Admitted Prior Art Claims 1 and 13 Notwithstanding the foregoing reversal of the anticipation grounds of rejection, we are convinced the broad scope of claims 1 and 13, and the Examiner’s supportable factual findings, demonstrate these claims are unpatentable in view of Jarvik and Appellant’s description of prior knowledge in paragraph 3—5 of the Specification (referred to hereinafter as, “AAPA”). The AAPA makes clear that the desirability of providing a precise fit for a replacement heart valve was known. See Spec. 14 (“Surgeons must settle for choosing the closest size from among tissue valves of varying predetermined sizes; the surgeon then must do his or her best to form or adapt the valve to fit the area in the patient where the prosthetic valve will be placed.”). When considering the obviousness of claimed subject matter, it is appropriate to consider whether “a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the 7 Appeal 2015-005664 Application 11/614,238 claims.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). From the evidence of record in this case, we conclude a skilled artisan, based on the understandings and knowledge reflected in Jarvik and AAPA, and motivated by the general need to replace a patient’s diseased or damaged heart valve with a replica heart valve that provides a precise fit, would have been led to make the arrangement recited in the claims. We first note that we agree with the Examiner’s findings that Jarvik discloses that it was known to use a CT scanner to obtain two and three- dimensional imagery for the purpose of getting specific dimensional information about a heart component and to enable a prosthetic heart device to be manufactured to match the shape and size of a patient’s heart component. See Final Act. 4—8; Ans. 6—9. As such, although Jarvik does not disclose manufacturing the heart components specifically recited in claims 1 and 13, we agree, for the reasons articulated by the Examiner, that Jarvik discloses each of the remaining manufacturing steps claims 1 and 13 recites. Because Jarvik discloses using a CT scanner to generate medical imagery of a heart component, i.e., leaflets, for manufacturing a pump with surfaces that “match the size and shape of the sealing surfaces of the two valve leaflets that close against them” (Jarvik 132), and because a skilled artisan recognized an implanted aortic valve needs to fit the patient precisely (AAPA 14), the skilled artisan artisan would have been led to use the known technique of using CT scanner imagery to get the specific dimensional geometry of a patient’s aortic valve to manufacture an aortic valve that matches the size and shape of the one being replaced. Therefore, pursuant to 37 C.F.R. § 41.50(b), we enter a NEW GROUNDS OF 8 Appeal 2015-005664 Application 11/614,238 REJECTION, and reject claims 1 and 13 under 35 U.S.C. § 103(a) as unpatentable over Jarvik and APAA. Claims Depending From Claims 1 and 13 Regarding the dependent claims, we leave it to the Examiner, upon return of this application for further prosecution, to determine whether it is appropriate to allow or reject the dependent claims in light of the new ground of rejection that we have entered. No inference should be drawn from our lack of entering a new ground of rejection of other claims.3 Rejection II Claims 20, 22, and 23 depend from claim 1, and claims 25, 27, and 28 depend from claim 13. The Examiner’s rejection of these claims, therefore, rely upon the same unsupported findings discussed above with respect to independent claims 1 and 13. See Final Act. 8—9. The Examiner does not remedy the deficiencies of claims 1 and 13. Asa result, for similar reasons set forth above for independent claims 1 and 13, we likewise do not sustain the Examiner’s rejection of claims 20, 22, 23, 25, 27, and 28. We note the Examiner’s rejection of claims 20, 22, 23, 25, 27, and 28 on obviousness grounds simply identifies the elements missing and finds that those elements were well known without any articulated reason with some rational underpinning for why a skilled artisan would have known to 3 See 37 C.F.R. § 41.50(b); see also Manual of Patent Examining Procedure (MPEP), 8th ed., rev. 8, July 2010, § 1213.02. Under 37 C.F.R. § 41.50(b), the Board may, in its decision, make a new rejection of one or more of any of the claims pending in the case. Because the exercise of authority under 37 C.F.R. § 41.50(b) is discretionary, no inference should be drawn from the decision to exercise that discretion with respect to some but not all of the claims on appeal. 9 Appeal 2015-005664 Application 11/614,238 make the claimed combinations. See id. The Federal Circuit has held, however, that “[a] rejection on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d at 988. Rejection III Claims 21 and 24 depend from claim 1, and claims 26 and 29 depend from claim 13. The Examiner’s rejection of these claims, therefore, relies upon the same unsupported findings discussed above with respect to independent claims 1 and 13. See Final Act. 9. The Examiner does not remedy the deficiencies of the rejection of claims 1 and 13. Asa result, for similar reasons set forth above for independent claims 1 and 13, we likewise do not sustain the Examiner’s rejection of claims 21, 24, 26, and 29. DECISION We reverse the Examiner’s rejections of claims 1, 6, 7, 9, 13, and 19- 29. We enter a NEW GROUND OF REJECTION of claims 1 and 13, pursuant to 37 C.F.R. § 41.50(b), under 35 U.S.C. § 103(a) as unpatentable over Jarvik and APAA. 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 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 grounds of rejection to avoid termination of the appeal as to the rejected claims: 10 Appeal 2015-005664 Application 11/614,238 (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 proceeding 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 MPEP § 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). REVERSED; 37 C.F.R, $ 41.50(b) 11 Copy with citationCopy as parenthetical citation