MEDTENTIA INTERNATIONAL LTD OYDownload PDFPatent Trials and Appeals BoardDec 24, 20212021004240 (P.T.A.B. Dec. 24, 2021) 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. 14/762,382 07/21/2015 Olli Keränen P1534US01 1157 15579 7590 12/24/2021 Patent Grove LLC 1900 Campus Commons Drive Suite 100-40 Reston, VA 20191 EXAMINER COLELLO, ERIN L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 12/24/2021 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): USPTO@dockettrak.com helene@patentgrove.com tomas@patentgrove.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte OLLI KERÄNEN, JANI VIRTANEN, MARK PUGH, GER O’CARROLL, and ADRIAN MORAN Appeal 2021-004240 Application 14/762,382 Technology Center 3700 Before BENJAMIN D. M. WOOD, JEREMY M. PLENZLER, and BRANDON J. WARNER, Administrative Patent Judges. WOOD, 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, 3–8, 10, 11, and 13–16. Claims 2, 9, 12 and 17–25 have been canceled. Appeal Br. 3, 15. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Medtentia International Ltd. Oy. Appeal Br. 3. Appeal 2021-004240 Application 14/762,382 2 CLAIMED SUBJECT MATTER The claims are directed to a medical device for selecting the size and/or shape of a cardiac-valve annuloplasty implant. Spec. 1:15–19. Sole independent claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A medical device for facilitating selection of a shape and/or size of an annuloplasty implant for a patient, comprising: a catheter with a proximal end and a distal end, an extension member at least partly arranged inside the catheter with an operator end and a measurement end, wherein the measurement end of the extension member is extendable relative from the distal end of the catheter for apposition with a first commissure of a cardiac valve, such as a mitral valve of the patient, wherein a measurement related to the selection of the annuloplasty implant’s shape and/or size is based on at least an extended length of the measurement end of the extension member from the distal end of the catheter, when positioned at the cardiac valve, to the first commissure, and wherein the measurement end of the extension member comprises a guide adapted to catch and guide the annuloplasty implant, the guide having a ring-shaped or c-shaped opening sized to allow passage of the annuloplasty implant therethrough, whereby the annuloplasty implant is implantable through the ring-shaped or c-shaped opening of the guide at the first commissure when the guide is in apposition with the first commissure. REFERENCES Name Reference Date Liddicoat US 2001/0049558 A1 Dec. 6, 2001 Liddicoat ’486 US 2006/0074486 A1 Apr. 6, 2006 Ryan US 2009/0192603 A1 July 30, 2009 Appeal 2021-004240 Application 14/762,382 3 REJECTIONS Claims Rejected 35 U.S.C. § References 1, 3–6, 8, 10, 11, 132 102 Liddicoat 1, 4–8, 10, 11, 13–16 103 Ryan, Liddicoat 3 103 Ryan, Liddicoat, Liddicoat ’486 OPINION Claims 1, 3–6, 8, 10, 11, and 13—§ 102—Liddicoat Appellant argues claims 1, 3–6, 8, 10, and 11 as a group. Appeal Br. 4–9. We select claim 1 as representative of the group, and decide the appeal of these claims on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). Claim 13 will be addressed separately. Claim 1 The Examiner finds that Liddicoat teaches all of the limitations of claim 1, specifically finding that adjustable mounting ring 140 corresponds to the claimed extension member, and ring segments 210 with grooves 260 correspond to the claimed guide having a c-shaped opening. Final Act. 3–4 (citing Liddicoat ¶¶ 3–4, 13–14, 44–45, 47–48, 51, 56, Figs. 3–7, 8–12, 21, 22).3 Appellant argues that Liddicoat does not disclose: [W]herein [(i)] the measurement end of the extension member comprises a guide adapted to catch and guide the annuloplasty implant, 2 The Examiner lists claim 25 as subject to this rejection, as well as the rejection under § 103. Final Act. 3, 7. However, claim 25 was canceled by an October 7, 2020 Amendment after final action, which the Examiner entered on October 29, 2020. See Advisory Act. (Oct. 29, 2020). 3 Figure 5 of Liddicoat depicts mounting ring 140 as comprising three mounting ring segments 210. Liddicoat, Fig. 5. Appeal 2021-004240 Application 14/762,382 4 [(ii)] the guide having a ring-shaped or c-shaped opening sized to allow passage of the annuloplasty implant therethrough, [and (iii)] whereby the annuloplasty implant is implantable through the ring-shaped or c-shaped opening of the guide at the first commissure when the guide is in apposition with the first commissure. Appeal Br. 13 (Claims App.); see id. at 4–9. Appellant also argues that Liddicoat does not disclose the claimed catheter. Id. at 9. (i) the measurement end comprises a guide adapted to catch and guide the annuloplasty implant Appellant first argues that Liddicoat’s mounting ring 140/ring segments 210/grooves 260 are not “adapted to catch and guide the annuloplasty implant.” Appeal Br. 5–7. Appellant asserts that this limitation “is understood to mean that the annuloplasty implant is ‘caught’ by the guide in order to direct the movement of the annuloplasty implant.” Appellant bases its understanding of this limitation on the following excerpt of the Specification: For example, when using rings as anchors 7 the annuloplasty implant is inserted through and slides in the rings securing the annuloplasty implant at the commissures 5. In an example the anchors 7 are arranged in the atrium and catch and guides an upper part of the helix ring. . . . after the annuloplasty implant is implanted in the patient, through the opening of the c-shape. Id. at 5 (quoting Spec. 9:1–4, 20–21) (emphasis added by Appellant) (internal quotation marks omitted). Appellant submits that Liddicoat teaches that a tissue annuloplasty band is “mounted onto” and “placed into groove 260 on the adjustable mounting ring 140,” and is “guided into place, with the tissue annuloplasty band 100 seated in place.” Id. at 7 (citing Liddicoat ¶ 47, Fig. 12) (emphasis omitted). According to Appellant, “Liddicoat’s Appeal 2021-004240 Application 14/762,382 5 disclosure that the tissue annuloplasty band ‘is mounted onto’ the ring segments 210 is incompatible with the function of catching and guiding an annuloplasty implant because the function of the groove 260 and the entire mounting ring 140 is to prevent the annuloplasty implant from moving until it is sutured to the annulus.” Id. (citing Liddicoat ¶ 13). Appellant acknowledges that Liddicoat teaches that “[t]he implant can be guided to a position in the body while mounted to mounting ring 140 but this is functionality [sic] distinct from what is recited in claim 1, which is to catch and guide the annuloplasty implant.” Id. The Examiner responds that mounting the tissue annuloplasty band onto the mounting ring and placing it into groove 260 means that the grooved mounting ring segments catch the annuloplasty band, and that guiding the mounting ring and tissue in place means that the tissue is guided; the Examiner therefore submits that Liddicoat teaches a guide capable of catching and guiding the implant. Ans. 4. The Examiner further contends that the Specification does not provide a special definition for “guide the annuloplasty implant,” and also does not provide “additional details in the limitation ‘adapted to catch and guide the annuloplasty implant’ that [would] require the implant to move relative to the guide or that would preclude the implant from being mounted to the guide for a portion of the procedure.” Id. at 4–5. In the Reply Brief, Appellant counters that one of ordinary skill in the art would understand the difference between “to catch” and “to mount” based on “the difference between the commonly understood meanings” of these terms. Reply Br. 3 (emphasis omitted). Appellant also contends that “[t]he paragraph bridging pages 8 and 9 of the specification provides Appeal 2021-004240 Application 14/762,382 6 sufficient description for one of ordinary skill to understand what is meant by being configured ‘to catch and guide an annuloplasty implant.’” Id. We are not persuaded of Examiner error. As an initial matter, Appellant does not appear to dispute that Liddicoat’s mounting ring segments are adapted “to guide” an annuloplasty implant. See Appeal Br. 7 (“[t]he implant can be guided to a position in the body while mounted to mounting ring 140”). Nor does there appear to be any dispute that grooves 260 are “c-shaped.” The dispute, then, is whether the grooved mounting ring segments are adapted “to catch” an annuloplasty implant. During prosecution, the PTO gives claims their broadest reasonable interpretation consistent with the specification. In re Bigio, 381 F.3d 1320, 1324 (Fed. Cir. 2004). Although Appellant alludes to a “commonly understood meaning” of “to catch” (Reply Br. 3), Appellant does not set forth this meaning or support such a meaning with evidence. Nor does the excerpt of the Specification that Appellant relies on (Spec. 9:1–4, 20–21) provide any specific definition for “to catch.” Although this excerpt discusses an embodiment that “catch[es] and guides an upper part of [a] helix ring,” that embodiment does so using “anchors 7” attached to the commissures of the annulus, each in the form of a “guiding unit or ring,” rather than a ring-shaped or c-shaped opening at the measurement end of an extension member, as recited in claim 1. Spec. 8:23–9:8, Fig. 5. Thus, while the Specification discloses using implanted anchors to catch and guide an annuloplasty implant, we are unable to find any discussion in the Specification of a guide having “a c-shaped opening” that catches and guides an annuloplasty implant, in whole or part, helix-ring shaped or otherwise. From what we can glean from the Specification’s discussion of the anchors Appeal 2021-004240 Application 14/762,382 7 “catch[ing]” and guiding a part of an annuloplasty ring, “to catch” means to hold in place. With this understanding, we are not persuaded that the Examiner erred in finding that Liddicoat’s grooved mounting ring segments catch the annuloplasty band because the band is mounted to the segments. (ii) the guide having a ring-shaped or c-shaped opening sized to allow passage of the annuloplasty implant to pass through it Appellant next argues that Liddicoat does not teach “[a] guide having a ring-shaped or c-shaped opening sized to allow passage of the annuloplasty implant therethrough.” Appeal Br. 5–8. Appellant asserts that “[p]assing through an opening inherently requires relative motion between the object that is moving and the opening through which the object passes.” Id. at 5. Appellant contends that “it would be impossible for an annuloplasty implant to pass through groove 260 because passing through the [groove] would require an annuloplasty implant to enter into, traverse, and exit the groove 260.” Id. at 7–8. Appellant further submits that Liddicoat’s mounting ring “is specifically designed to prevent the implant from moving.” Id. at 8. According to Appellant, “[p]assing an implant through an opening is in no way equivalent to mounting an implant in a groove and later dismounting the implant.” Id. The Examiner responds that “the claims are drawn to the structure of the device and not to specific method steps . . . i.e. no mention that the implant needs to slide from one end to an opposite end or that require the implant to enter into, traverse the groove and exit the groove.” Ans. 5. The Examiner finds that “the opening of [Liddicoat’s] guide allows an implant to pass into/out of the opening and is therefore sized to allow the implant to pass through it.” Id.; see id. at 6 (Examiner’s annotated Figure 5 of Appeal 2021-004240 Application 14/762,382 8 Liddicoat). In its Reply Brief, Appellant counters that “[t]he Examiner provides no explanation for how an implant could pass through the groove 260 as opposed to entering into the groove and coming back out the same way it entered,” and “[i]t appears that the Examiner does not acknowledge the objective fact that there is a difference in meaning between ‘to pass through’ and mounting followed by dismounting.” Reply Br. 3 (emphasis omitted). The Examiner is correct that claim 1, as an apparatus claim, is “drawn to the structure of the device and not to specific method steps.” Ans. 5. Claim 1 is drawn to the “size[]” of the opening: the opening should be of sufficient size to allow passage of the annuloplasty implant through the opening. Contrary to the implicit premise of Appellant’s argument, claim 1 does not actually require that an annuloplasty implant be passed through the guide opening.4 Thus, the fact that Liddicoat teaches mounting the implant to the mounting ring segments rather than passing the implant through them is insufficient to show error in the Examiner’s finding that Liddicoat teaches an opening having the claimed size. (iii) the annuloplasty implant is implantable through the ring- shaped or c-shaped opening of the guide at the first commissure when the guide is in apposition with the first commissure According to Appellant, this limitation means that “the annuloplasty implant can pass through the opening even when the guide is close to or touching the commissure.” Appeal Br. 6. Appellant asserts that “[i]t is not possible for an implant [to] pass through the groove 260 as the implant is 4 Further, the size requirement of claim 1 is quite broad, because claim 1 does not specify the size of the annuloplasty implant that should be able to pass through the opening. Appeal 2021-004240 Application 14/762,382 9 inserted into or affixed to the heart valve because the implant is fixedly mounted to the mounting ring 140 until after the implant has been implanted.” Id. at 8 (citing Liddicoat ¶ 47, Fig. 12). Appellant contends that “the very concept of ‘passing through’ does not apply to an annuloplasty implant in relation to the groove 260.” Id. Appellant further submits that “because Liddicoat’s annuloplasty band must exit the groove 260 in the same direct [sic] from which it is mounted, Liddicoat literally discloses that the groove 260 is sized and shaped to prevent the tissue band (implant) from passing through the groove.” Id. The Examiner responds that “the claims are drawn to the structure of the device and do not include any specific steps about how the implant is implanted through the opening nor does the claim include any limitations specifying a specific order to steps of implanting an implant.” Ans. 7. That is, according to the Examiner, “the claims do not include any limitations that discuss the direction an implant can enter/pass through or be implanted nor do they include any limitations that would preclude an implant from entering/exiting the same direction.” Id. We agree with the Examiner. Appellant’s argument is premised on claim 1 requiring implantation of an annuloplasty implant. Instead, claim 1 is drawn to the structure of a medical device intended to catch and guide an implant for implantation; it does not require implantation of an implant (or, for that matter, the implant itself). Therefore, the specific way Liddicoat teaches that its device is used is not particularly relevant to whether Liddicoat’s device satisfies the structural and functional requirements of claim 1. Further, even if we were to apply Appellant’s interpretation of this limitation as meaning that “the annuloplasty implant can pass through the Appeal 2021-004240 Application 14/762,382 10 opening even when the guide is close to or touching the commissure,” Appellant has not adequately explained why Liddicoat’s device does not satisfy this limitation. Accordingly, we are not persuaded of Examiner error. (iv) Liddicoat disclosing a catheter The Examiner finds that cylinder 150 of handle 130 (or, alternatively, handle 130B) corresponds to the claimed catheter. Final Act. 3 (citing Liddicoat, Figs. 3–7, 8–11, 21, 22). Appellant responds that “a catheter must be flexible to function as a catheter” (implying cylinder 150/handle 130B is not flexible). Appeal Br. 9. Appellant notes that the Examiner had, in an earlier Advisory Action, previously interpreted “catheter” as “a tubular medical device for insertion into canals, vessels, passageways, or body cavities,” but Appellant submits “[t]he interpretation that a catheter need not be flexible is in contradiction to the medical usage of the term, which requires flexibility.” Id. In the Answer the Examiner responds that because “Liddicoat includes a tubular member that is inserted into a body cavity/passageway to deliver the guide towards the valve, the handle of Liddicoat can be interpreted as a catheter.” Ans. 8. Appellant does not appear to dispute the Examiner’s finding that “Liddicoat includes a tubular member that is inserted into a body cavity/passageway to deliver the guide towards the valve.” Instead, Appellant’s argument is that this tubular member is not a catheter because it is not flexible. However, Appellant has not provided any evidence that one of ordinary skill in the art would have understood that all catheters are flexible, or what degree of flexibility would necessarily be required for a catheter. Appellant’s assertion that “[a]ll definitions for ‘catheter’ of which Appellant is aware include variations of ‘flexible’ or ‘soft’” is therefore Appeal 2021-004240 Application 14/762,382 11 unsupported attorney argument, to which we accord little weight. Appeal Br. 10; see Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017) (explaining that unsworn attorney argument is not evidence). In sum, as we are not persuaded that the Examiner erred in rejecting claim 1, we sustain the Examiner’s rejection of claims 1, 3–6, 8, 10, and 11 as anticipated by Liddicoat. Claim 13 Claim 13 reads: “The medical device according to claim 1, further comprising a leaflet limiter arranged at the extension member.” Appeal Br. 15 (Claims App.). The Examiner finds that the lateral stays 240 on mounting ring 140 correspond to the claimed leaflet limiter. Final Act. 6; see Liddicoat, Fig. 5. Appellant responds that “[t]he rejection does not explain how the stays 240 disclosed by Liddicoat anticipate the leaflet limiter recited in claim 13 and therefore fails to establish prima facie anticipation.” Appeal Br. 10 (emphasis omitted). The procedural burden of establishing a prima facie case of unpatentability is met by a rejection that complies with 35 U.S.C. § 132; that is, the rejection must state reasons for the rejection together with information and references as may be useful to the applicant in judging the propriety of continuing prosecution. See In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (“all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132”); Chester v. Miller, 906 F.2d Appeal 2021-004240 Application 14/762,382 12 1574, 1578 (Fed. Cir. 1990) (“Section 132 merely ensures that an applicant ‘at least be informed of the broad statutory basis for [the rejection of] his claims, so that he may determine what the issues are on which he can or should produce evidence.’”). The Examiner has identified the statutory basis for the rejection–§ 102(b)–and the specific reference and portion thereof that corresponds to the structure recited in claim 13—e.g., lateral stays 240 on mounting ring 140 of Liddicoat corresponding to claim 13’s leaflet limiter. Therefore, the Examiner has established a prima facie case of anticipation with respect to claim 13. See Jung, 637 F.3d at 1363 (holding that “the examiner’s discussion of the theory of invalidity (anticipation), the prior art basis for the rejection (Kalnitsky), and the identification of where each limitation of the rejected claims is shown in the prior art reference by specific column and line number was more than sufficient to meet this burden”). Because the Examiner established a prima facie case of anticipation, the burden shifted to Appellant to rebut it. Jung, 637 F.3d at 1365. Appellant has failed to do so. At best, Appellant’s response can be considered an assertion that Liddicoat does not disclose a leaf limiter. But Appellant does not, for example, explain why lateral stays 240 cannot be considered as corresponding to the claimed leaflet limiter, as the Examiner finds. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[W]e hold that the Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”). Therefore, we are not persuaded that the Examiner erred in rejecting claim 13 as anticipated by Liddicoat. Appeal 2021-004240 Application 14/762,382 13 Claims 1, 4–8, 10, 11, and 13–16—§ 103—Ryan and Liddicoat Appellant argues claims 1, 4–8, 10, 11, and 13–16 as a group. Appeal Br. 10–11. We select claim 1 as representative of the group, and decide the appeal of this rejection on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Ryan teaches the medical device of claim 1 except that Ryan “fails to disclose means for guiding the annuloplasty implant.” Final Act. 8. The Examiner relies on Liddicoat, particularly ring mount segments 210 with grooves 260, “where the implant can occupy the groove and therefore the groove is being interpreted as a c-shaped opening that is sized to allow passage of the implant therethrough.” Id. at 9. In response, Appellant contends that: Given that no portion of the Liddicoat system is sized or configured for catheter delivery and that Ryan discloses a device that is delivered via a minimally invasive route, one of ordinary skill in the medical arts would not reasonably have modified Ryan’s device according to the teachings of Liddicoat. Doing so would have rendered Ryan’s device inoperable for its intended minimally invasive purpose, making any expectation of success unreasonable. Appeal Br. 11. The Examiner responds that the rejection does not propose modifying Liddicoat’s device, but rather “the combination was used to modify the sizer of Ryan to include a guide/groove around the edge of the sizer device of Ryan; where the guide/groove is adapted to catch/guide an annuloplasty implant as suggested by Liddicoat such that a single system could be used to measure the site and deliver the correct sized/shaped implant.” Ans. 9. According to the Examiner, “[s]ince the combination does not incorporate Appeal 2021-004240 Application 14/762,382 14 the actual device of Liddicoat and modifying the sizer of Ryan to include the guide/groove would still allow the device to operate as intended for a minimally invasive procedure the arguments are not persuasive.” Id. We are not persuaded of Examiner error. Appellant’s argument appears to be based on the bodily incorporation of Liddicoat’s device with Ryan’s device, where the resulting device is contended to be unsuitable for minimally invasive surgery. But the rejection is based on a much more limited combination of the teachings of the two references. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . [r]ather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.”). That is, the Examiner is proposing only modifying Ryan’s device by adding a guide/groove around the edge of the device. Ans. 9. Appellant does not explain why this modification would have rendered Ryan’s device unfit for minimally invasive surgery. Because we are not persuaded that the Examiner erred in rejecting claim 1, we sustain the Examiner’s rejection of claims 1, 4–8, 10, 11, and 13–16 as unpatentable over Ryan and Liddicoat. Claim 3—§ 103—Ryan, Liddicoat, and Liddicoat ’486 Appellant advances no separate arguments in support of the patentability of claim 3, but instead relies on claim 3’s dependency from claim 1 for patentability. Appeal Br. 12. As we are not persuaded that the Examiner erred in rejecting claim 1 as unpatentable over Ryan and Liddicoat, we also sustain the Examiner’s rejection of claim 3 as unpatentable over Ryan, Liddicoat, and Liddicoat ’486. Appeal 2021-004240 Application 14/762,382 15 CONCLUSION The Examiner’s rejections are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–6, 8, 10, 11, 13 102 Liddicoat 1, 3–6, 8, 10, 11, 13 1, 4–8, 10, 11, 13–16 103 Ryan, Liddicoat 1, 4–8, 10, 11, 13–16 3 103 Ryan, Liddicoat, Liddicoat ’486 3 Overall Outcome 1, 3–8, 10, 11, 13–16 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