Edwards Lifesciences CorporationDownload PDFPatent Trials and Appeals BoardFeb 10, 20222021003378 (P.T.A.B. Feb. 10, 2022) 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. 16/230,368 12/21/2018 Ottavio Alfieri HVTRG-5695US06 4596 30452 7590 02/10/2022 EDWARDS LIFESCIENCES CORPORATION LEGAL DEPARTMENT ONE EDWARDS WAY IRVINE, CA 92614 EXAMINER SCHILLINGER, ANN M ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 02/10/2022 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): USDOCKET@edwards.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte OTTAVIO ALFIERI, ALAIN F. CARPENTIER, FRANCESCO MAISANO, ALBERTO REDAELLI, and PATRICK M. MCCARTHY Appeal 2021-003378 Application 16/230,368 Technology Center 3700 Before JENNIFER D. BAHR, DANIEL S. SONG, and JEREMY M. PLENZLER, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-6, 10-14, and 19-24.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Edwards Lifesciences Corporation. Appeal Br. 1. 2 Claims 7-9, 15-18, and 25-27 stand withdrawn from consideration. Final Act. 1, 3-4. Appeal 2021-003378 Application 16/230,368 2 CLAIMED SUBJECT MATTER Appellant’s invention is directed to annuloplasty rings for repairing mitral valves. Spec. ¶ 2. Of the pending claims, claims 1, 10, and 19 are independent; claim 10, reproduced below, is representative of the claimed subject matter. 10. A set of prosthetic annuloplasty rings configured to attach to and remodel a mitral valve annulus, each ring comprising: a generally oval shaped inner body including a posterior section contiguous with an anterior section together forming a continuous periphery oriented about a flow axis, wherein the flow axis defines an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle, and wherein in atrial plan view as seen along the flow axis the ring has a major axis perpendicular to a minor axis, wherein a maximum dimension lies along the major axis and a minimum dimension lies along the minor axis, and wherein the set of rings is includes [sic] annuloplasty rings of increasing labeled ring sizes from a smallest labeled ring size to a largest labeled ring size, and wherein a ratio of the minimum dimension to the maximum dimension increases between at least two pairs of rings of adjacent labeled ring sizes. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Angell US 4,042,979 Aug. 23, 1977 Carpentier US 4,055,861 Nov. 1, 1977 Rhee US 6,019,739 Feb.1, 2000 Appeal 2021-003378 Application 16/230,368 3 REJECTIONS Claims 1-6, 10-14, and 19-24 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Angell and Rhee. Claims 10-14 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Carpentier and Rhee. OPINION Arguments Traversing Withdrawal of Claims Appellant presents arguments, in the “ARGUMENT” section of the Appeal Brief, traversing the withdrawal of certain claims from consideration and requesting that the Board reverse the Examiner’s decision withdrawing claims 7, 15, 16, 25, and 26. Appeal Br. 4-8. As Appellant recognizes (Appeal Br. 8), this issue relates to a petitionable matter and not to an appealable matter. See MPEP § 1201 (the Board will not ordinarily hear a question that is reviewable by petition). Thus, the relief sought by the Appellant should have been presented by a petition to the Director under 37 C.F.R. §§ 1.181 and 1.144 instead of by appeal to this Board. Ex parte Frye, 94 USPQ2d 1072, 1077-78 (BPAI 2010) (precedential). Appellant’s attempt to present such a petition as part of the Appeal Brief is improper and unavailing, as matters to be considered by different branches or sections of the United States Patent and Trademark Office (PTO) must each be contained in a separate paper. 37 C.F.R. § 1.4(c). Obviousness Rejection-Angell and Rhee Appellant groups independent claims 1, 10, and 19 together in contesting this rejection, and does not present any separate arguments for dependent claims 2-6, 11-14, and 20-24. Appeal Br. 8-12. We decide the appeal of this rejection on the basis of claim 10, with claims 1-6, 11-14, and Appeal 2021-003378 Application 16/230,368 4 19-24 standing or falling with claim 10. See 37 C.F.R. § 41.37(c)(1)(iv) (permitting the Board to select a single claim to decide the appeal as to a single ground of rejection of a group of claims argued together). The Examiner finds that Angell discloses, in pertinent part, “a set of prosthetic annuloplasty rings configured to attach to and remodel a mitral valve annulus,” wherein each ring comprises a generally oval shaped inner body (drawstring 14) and a major axis having a maximum dimension and a minor axis having a minimum dimension.3 Final Act. 8-9 (citing Angell Figs. 1-4). The Examiner further finds that Angell teaches that the ring “may be provided with larger sized dimensions to suit a patient’s particular anatomy,” but does not explicitly teach a set of rings with increasing sizes. Id. at 7 (citing Angell 3:47-4:5). The Examiner finds that “Rhee teaches [providing] a plurality of annuloplasty rings having various sizes and accompanying ring sizers that provide information regarding the rings’ sizes” from which the surgeon may select an appropriately sized ring “to ensure that the ring will properly fit the patient to repair a defective [heart valve].” Final Act. 7 (citing Rhee 3:43-60; 6:62-7:20). According to the Examiner, Rhee teaches that “[t]he ratio of the dimensions of the rings and their corresponding sizers changes between at least two pairs of rings of adjacent labeled ring sizes,” and “[t]he labeled ring sizes [range] from 24 mm to 36 mm in 2 mm increments, and the ratio changes or increases between at least two pairs of rings of adjacent labeled ring sizes.” Id. (citing Rhee 6:62-7:20). 3 The Examiner labels the major and minor axes in an annotated reproduction of Figure 3, captioned as “Figure A” on page 7 of the Answer. Appeal 2021-003378 Application 16/230,368 5 The Examiner determines it would have been obvious to modify Angell to provide a plurality of annuloplasty rings of various sizes, as taught by Rhee “for the purpose of providing the surgeon with a variety of annuloplasty ring sizes in order to ensure that the ring will properly fit the patient to repair a defective [heart valve].” Final Act. 7-8. Appellant argues that Angell’s frame 12 is C-shaped, not oval, and that the remainder of the ring lacks the capacity to remodel the annulus. Appeal Br. 9. Along similar lines, Appellant disputes the Examiner’s finding “that Angell discloses ‘the inner body including a posterior section contiguous with an anterior section together forming a continuous periphery oriented about a flow axis’” as claimed. Id. The argument regarding the shape of frame 12 is not germane to the rejection because the Examiner does not rely on Angell’s frame 12 as being a generally oval shaped inner body. Rather, as discussed above, the Examiner considers drawstring 14 to be a generally oval shaped inner body. See Final Act. 9. Further, the Examiner points out that Angell’s Figure 3 “shows that after the ends of element 14 have been tied together, the device has a continuous periphery formed by a back/posterior section and a front/anterior section.” Ans. 10. Moreover, Angell discloses that drawstring 14, acting in concert with non-constrictable frame 12 and expandable-contractable sleeve 13, is capable of remodeling the defective orifices and/or valves. Angell 2:28-29; 3:26-31, 47-49, 53- 61. Appellant provides no evidence to support its assertion to the contrary.4 4 The burden of rebutting the presumption of enablement of the cited prior art by a preponderance of the evidence falls on the applicant. In re Sasse, 629 F.2d 675, 681 (CCPA 1980). Appeal 2021-003378 Application 16/230,368 6 Appellant admits that Angell discloses rings of different sizes and, further, “stipulate[s] that it is customary to provide a set of rings of different (meaning increasing) sizes.” Appeal Br. 9-10 (citing Angell 5:49-53).5, 6 According to Appellant, A range of sizes is commonplace and addresses the need for patients of differently-sized annuluses. But that’s not what is claimed. What is claimed is a set of rings of different sizes with proportionally different shapes. Providing a set of differently sized rings as in Rhee is not new, and in fact Angell already discloses that. Id. at 11. Appellant concedes that Rhee teaches that rings are provided in increasing sizes, but submits that Rhee does not teach or suggest that differently sized rings have different ratios of the minimum dimension (along the minor axis) to the maximum dimension (along the major axis). Appeal Br. 10-11. For the reasons that follow, Appellant’s argument is not persuasive. 5 Appellant’s citation to column 3 (Final Act. 9) is ostensibly an inadvertent typographical error. 6 In the Reply Brief, Appellant presents a new argument, seemingly contradicting this statement, stating that Angell discloses “not a set of rings that are differently proportionally shaped, but instead a single ring whose circumference may be altered in vivo.” Reply Br. 2. This argument is untimely, and Appellant does not present any evidence or explanation to show good cause why it should be considered by the Board at this time. See 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer . . . will not be considered by the Board for purposes of the present appeal, unless good cause is shown.”). Moreover, this argument attacks Angell individually and does not take into account the teachings of Rhee, discussed below. Appeal 2021-003378 Application 16/230,368 7 Rhee teaches that, “[t]o perform a successful annuloplasty, the size of the valve annulus where the annuloplasty ring is to be implanted must be accurately measured,” and that “[s]izing is achieved by measuring the width and the height of the anterior leaflet” using sizers. Rhee 2:56-59 (emphasis added). In accordance with Rhee’s nomenclature, the major-axis length (maximum dimension) corresponds to the width of the leaflet and the minor-axis length (minimum dimension) corresponds to the height of the leaflet. Id. at 6:46-49. Further, Rhee teaches that the ratio of the major-axis length to the minor-axis length for the sizers is preferably between about 3:2 and about 4:3, but that other ratios may be used for specific valve-sizing applications. Id. at 6:38-46. Rhee also teaches providing a plurality of different sizers of different dimensions to a surgeon during an annuloplasty surgery to measure a valve annulus accurately, “with each of the sizers corresponding to the size of an annuloplasty ring.” Id. at 6:62-67; see also id. at 7:58-63. To summarize, Rhee teaches that it is necessary to measure both the height (minimum dimension) and the width (maximum dimension) of the leaflet in order to select the proper annuloplasty ring (Rhee 2:58-62); it is not enough to simply measure the width (maximum dimension). A person having ordinary skill in the art would readily appreciate from this that, for any particular size (maximum dimension), the ratio of the minimum dimension to the maximum dimension may vary. Thus, regardless of whether Rhee expressly teaches providing a set of rings having different sizes, wherein a ratio of the minimum dimension to the maximum dimension changes, or increases, for rings of different sizes, Rhee provides ample incentive to a person having ordinary skill in the art to provide a variety of Appeal 2021-003378 Application 16/230,368 8 ratios for each size. “The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. In this case, a person having ordinary skill in the art would have appreciated, from Rhee’s teaching of the need to measure both the height and width of the leaflet to select the proper annuloplasty ring, the desirability of offering a set of annuloplasty rings with a variety of ratios of minimum dimension to maximum dimension for each of the various ring sizes. Thus, Appellant does not apprise us of error in the Examiner’s determination that the subject matter of claim 10 would have been obvious over the combined teachings of Angell and Rhee. Accordingly, we sustain the rejection of claim 10, and of claims 1-6, 11-14, and 19-24, which fall with claim 10, as being unpatentable over Angell and Rhee. Obviousness Rejection-Carpentier and Rhee In contesting this rejection, Appellant groups claims 10-14 together. Appeal Br. 12-13. We decide the appeal of this rejection on the basis of claim 10, with claims 11-14 standing or falling with claim 10. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Carpentier discloses a mitral valve annuloplasty ring substantially as recited in claim 10, but does not disclose “a set of rings of increasing labeled ring sizes from a smallest labeled ring size to a largest labeled ring size, and wherein a ratio of the minimum dimension to the maximum dimension changes for at least some of the Appeal 2021-003378 Application 16/230,368 9 annuloplasty rings of increasing labeled ring sizes.” Final Act. 10. The Examiner relies on Rhee, in a similar manner as for the rejection based on Angell and Rhee discussed above, to overcome this deficiency. Id. at 10-11. In contesting the rejection based on Carpentier and Rhee, Appellant presents essentially the same arguments attacking the Examiner’s findings with respect to the teachings of Rhee as for Appellant’s traversal of the rejection based on Angell and Rhee. See Appeal Br. 12-13. For the reasons discussed above in addressing the rejection based on Angell and Rhee, these arguments are not persuasive. In addition, Appellant “question[s] whether an annular bundle of 2-8 turns of a cylindrical polymer bristle” as disclosed by Carpentier, “is adequate” for remodeling. Appeal Br. 12. The Examiner finds that Carpentier’s statement “that its device is used to support and correct malformations of the heart valve” (Carpentier 1:4-7; 2:2-24) “indicat[es] that its device and the materials used to form it are configured to remodel the heart valve.” Ans. 10. In response, Appellant maintains that it “doubts it still,” but does not articulate any substantive reason, or present persuasive evidence, for such question or doubt.7 Reply Br. 3. For the above reasons, Appellant does not apprise us of error in the Examiner’s conclusion that the subject matter of claims 10-14 would have been obvious in view of the combined teachings of Carpentier and Rhee. Accordingly, we sustain the rejection of claim 10, and of claims 11-14, which fall with claim 10, as being unpatentable over Carpentier and Rhee. 7 Appellant’s response amounts to unsupported attorney argument, and therefore we give it little weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Appeal 2021-003378 Application 16/230,368 10 CONCLUSION The Examiner’s rejections are AFFIRMED. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-6, 10-14, 19-24 103(a) Angell, Rhee 1-6, 10-14, 19-24 10-14 103(a) Carpentier, Rhee 10-14 Overall Outcome 1-6, 10-14, 19-24 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation