Ex Parte DIVINO et alDownload PDFPatent Trials and Appeals BoardJun 5, 201914079590 - (D) (P.T.A.B. Jun. 5, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/079,590 137574 7590 Medtronic 826 Coal Creek Circle Louisville, CO 80027 11/13/2013 06/07/2019 FIRST NAMED INVENTOR Vincent DIVINO 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. H-KN-02819US1 7318 EXAMINER DORNBUSCH, DIANNE ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 06/07/2019 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): rs. patents. two@medtronic.com docketing@fortemip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VINCENT DIVINIO, EARL FREDERICK BARDSLEY, RICHARD RHEE, MADHUR ARUNRAO KADAM, and JULIE KULAK1 Appeal2018-000959 Application 14/079,590 Technology Center 3700 Before JAMES P. CALVE, MICHELLE R. OSINSKI, and WILLIAM A. CAPP, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1, 3, 4, 7-10, 23, and 25-30.2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 Covidien LP ("Appellant") is the Applicant as provided in 37 C.F.R. § 1.46. "Covidien LP and its corporate owner, Medtronic plc" are identified as real parties in interest. Appeal Br. 3. 2 Claims 2, 11-14, 24, and 31-34 are withdrawn, and claims 5, 6, 15-22, and 35-45 are cancelled. Appeal Br. 26-29 (Claims App.). Appeal2018-000959 Application 14/079,590 THE CLAIMED SUBJECT MATTER Claims 1 and 23 are independent. Claim 1 is reproduced below. 1. A device for treatment of an aneurysm, comprising: a foam component having first, second, and third sections, the first section having a first average porosity of between about 1 µm and about 150 µm, the third section having a third average porosity of between about 150 µm and about 300 µm, and the second section having a second average porosity different from the first average porosity and the third average porosity, the component being expandable from a compressed configuration to an expanded configuration when released into the aneurysm from a catheter. Miles Mavani EVIDENCE US 2009/0112249 Al US 2010/0228184 Al THE REJECTION3 Apr. 30, 2009 Sept. 9, 2010 Claims 1, 3, 4, 7-10, 23, and 25-30 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Miles and Mavani. Final Act. 3-5. OPINION With respect to independent claim 1, the Examiner relies on Miles for teaching, among other things, a foam component that has first and second sections having different average porosities. Final Act. 4. The Examiner also relies on Miles for teaching that the foam component further comprises a third section having an average porosity different from the porosity of the second section. Id. The Examiner acknowledges that although Miles 3 A rejection of claim 45 under 35 U.S.C. § 102(b) as anticipated by Miles (Final Act. 3) has been withdrawn because claim 45 has been cancelled (Ans. 2). 2 Appeal2018-000959 Application 14/079,590 teaches that "each section can have different sizes of pores, ... Miles does not specify the size of the pores." Id. at 5. Consequently, Miles does not disclose that the first section specifically has an average porosity of between about 1 µm and about 150 µm and that the third section specifically has an average porosity of between about 150 µm and about 300 µm, as set forth in claim 1. With respect to independent claim 23, the Examiner relies on Miles for teaching, among other things, a foam component that has a region of variable average porosity. Id. at 4. Because Miles does not specify the size of the pores (id. at 5), Miles does not disclose that at least a portion of the region of variable average porosity is between about 1 µm to about 150 µm or about 150 µm to about 300 µm, as set forth in claim 23. The Examiner finds that Mavani teaches a porous foam plug in which "the pore sizes vary from 5-1000 microns." Id. ( citing Mavani ,-J 91 ). The Examiner concludes that it would have been obvious to have the pore sizes in Miles be within the range of pore sizes specified in Mavani because (i) Mavani teaches the general conditions of pore sizes for foam components; and (ii) it would promote tissue ingrowth and greater angiogenesis, which, in tum, may promote better wound healing. Id. As to the specific ranges of pore sizes for the first section (i.e., between about 1 µm and about 150 µm) and third section (i.e., between about 150 µm and about 300 µm) of claim 1 and the specific ranges of pore sizes for at least a portion of the region of variable porosity (i.e., between about 1 µm to about 150 µm or about 150 µm to about 300 µm) of claim 23, the Examiner concludes that it would have been obvious to discover the optimum or workable ranges of pore sizes ( e.g., 3 Appeal2018-000959 Application 14/079,590 for tissue ingrowth and healing) for each section or region through routine experimentation. Id. Appellant argues that Miles does not disclose three foam sections with different porosities, but merely provides "specific examples in which the foam body has two different levels of porosity." Appeal Br. 11 (citing Miles ,-J 70). Miles discloses that "for a spherical configuration, the central region of the foam body may include a different number of [pores] than the outer regions of the foam body so as to manipulate the compactive and expansive characteristics of the foam body." Miles ,-J 70. Miles then further discloses that "[a]dditionally, or alternatively, one-half of the sphere may exhibit one level of porosity while the other half exhibits a different level of porosity." Id. ( emphasis added). Miles explicitly states that the exemplary modifications to the portions of a spherical configuration are additive or cumulative. Thus, Miles discloses a spherical foam body having a central region of one porosity, a first half of an outer region having a second porosity, and a second half of the outer region having a third porosity. Consequently, we are not persuaded that the Examiner erred in finding that Miles teaches first and second sections having different average porosities, as well as a third section having an average porosity different from that of the second section. See Final Act. 4. Appellant also argues that "the Examiner's rationale for modifying Miles' device to include the pore sizes disclosed in Mavani (i.e., to promote angiogenesis and wound healing) is specifically tied to foam bodies without a broad distribution of pore sizes." Appeal Br. 14 (emphasis omitted). Appellant continues that "the claimed ranges would not deliver the advantage taught by Mavani and relied upon by the Examiner to support 4 Appeal2018-000959 Application 14/079,590 [the] conclusion of obviousness." Id. at 14-15. We do not find this argument persuasive because the Examiner's rejection relies on Mavani only for the general condition of pore sizes for foam components. The Examiner's rationale adequately explains why it would have been obvious to have the pore sizes in Miles be within the broad range of pore sizes specified in Mavani. Appellant also argues that "[i]n direct contrast to the Examiner's rationale, treatment of aneurysms avoid angiogenesis and associated tissue ingrowth." Appeal Br. 15. However, the Examiner's articulated rationale relates to why one of ordinary skill in the art would modify Miles with the teachings of Mavani. Miles is directed to an expanding body for occluding a left atrial appendage ("LAA") to prevent existing embolic material from leaving the LAA and to prevent further entry of blood into the LAA to prevent the further production of embolic material within the LAA. Miles ,-J 49. Miles contemplates the body including a tissue in-growth member for promoting tissue growth. Id. ,-i,-i 11-13, 48. Consequently, it appears that the Examiner's articulated rationale is relevant to Miles-which is the reference being modified by the teachings of Mavani. To the extent Appellant is suggesting with its arguments (see Appeal Br. 17) that the combination of Miles and Mavani would not result in "[a] device for treatment of an aneurysm" with a "component being expandable from a compressed configuration to an expanded configuration when released into the aneurysm" as claimed, we are not persuaded of error in the positions taken by the Examiner in the Final Action and further explained in the Advisory Action. See Final Act. 4; Adv. Act. (Apr. 26, 2017), 2. More particularly, we agree with the Examiner's position that the preamble 5 Appeal2018-000959 Application 14/079,590 reciting "for treatment of an aneurysm" is not given patentable weight where it merely recites the intended use of a structure. Adv. Act. 2. In addition, we agree with the Examiner's position that the device of Miles as modified by Mavani would be capable of expanding from a compressed configuration to an expanded configuration when released into an aneurysm from a catheter. Id. We have not been persuaded of a structural difference between the Miles/Mavani device and the claimed device. Although features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78 (Fed. Cir. 1997). Therefore, the device of the prior art meets the recited functionally defined limitation (i.e., "being expandable from a compressed configuration to an expanded configuration when released into the aneurysm from a catheter") if it is capable of the recited function. The prior art reference need not envision the device actually being used to perform the claimed function. See Schreiber, 128 F.3d at 1477. Appellant does not provide evidence or persuasive technical reasoning as to why the component of Miles/Mavani is incapable of the claimed function of expanding from a compressed configuration to an expanded configuration when released into an aneurysm from a catheter. Appellant also presents arguments regarding the Examiner's determination of optimum or workable ranges of pore sizes for each section by routine experimentation. Appeal Br. 17-18. More particularly, Appellant argues that "the Examiner[' s] conclusory statement appears to suggest that the 'result-effective variable' is pore size and the 'effective result' is tissue ingrowth and angiogenesis for wound healing." Id. at 17. 6 Appeal2018-000959 Application 14/079,590 Similar to the argument above, Appellant asserts that "one of ordinary skill in the art would not have been motivated to find an optimum or workable pore size (i.e., the 'variable') to promote angiogenesis, tissue ingrowth, and wou[ n ]d healing (i.e., the 'effective result') because the sought after result would not be suitable for an aneurysm treatment device." Id. at 18. As described in more detail above, we note that the Examiner's proposed rejection relates to the modification of Miles with the teachings of Mavani, both of which are concerned with tissue ingrowth, thereby supporting that one of ordinary skill in the art would have been led to optimize the average porosity of the various sections/regions of the foam component so as to achieve a desired level of tissue growth. We have also considered Appellant's argument that "Mavani is directed to technology located in a completely different part of the body than Miles and the claimed device, and is used to treat a different problem (i.e., fistula closure) than Miles and the claimed device," such that "Mavani fails to disclose the 'general conditions' of both Miles' LAA occlusion device and the pending claims (i.e., treating aneurysms)" and "it would not have been routine skill in the art to determine the claimed porosities recited in claim l." Id. at 19. Both Miles and Mavani are concerned with tissue ingrowth to close off an area within the body. See Miles ,-J 48 ("The frame 120 [of the cover member 110] can be configured to support a tissue in- growth member 122, such as a polymer substrate, or any suitable tissue promoting or enhancing member. Such tissue in-growth member 122 can be a porous member, such as reticulated foam, fabric or Dacron®, configured to hold blood cells and to promote and induce tissue growth."); id. ,-i 49 ("[T]he medical device 100 covers or occludes the opening 114 of the LAA 7 Appeal2018-000959 Application 14/079,590 to seal off the LAA from the left atria."); Mavani ,-J89 ("Expansion of bodies 15 within the tract 10 provides a porous scaffold to the fistula tract and may partially or entirely stop the flow of bodily fluids through the tract. The scaffold provides a matrix that may promote tissue in-growth allowing the fistula to close."). Thus, we are not persuaded (i) that Mavani fails to disclose the general conditions of a foam component used to close off an area of the body, such as Miles' LAA occlusion device nor (ii) that it would have been beyond routine experimentation to arrive at the specific claimed porosities. 4 For the foregoing reasons, Appellant does not apprise us of error in the Examiner's conclusion that the combination of Miles and Mavani renders obvious the subject matter of independent claims 1 and 23. Accordingly, we sustain the rejection of claims 1 and 23 under 35 U.S.C. § 103(a) as unpatentable over Miles and Mavani. We also sustain the rejection of claims 3, 4, 7-10, and 25-30 under 35 U.S.C. § 103(a) as unpatentable over Miles and Mavani, for which Appellant relies on the same arguments and reasoning as the independent claims. Appeal Br. 19, 24-25. 4 Although not relied on by the Examiner, we note that Miles discloses that "manipulating the number of [pores] per square inch in the material forming the body 302, so that the body exhibits a graded porosity" can enable "various portions of the body [to] compact smaller than other portions of the body." Miles ,-J 70. Thus, Miles itself provides evidence that the number of pores per square inch is recognized in the art as a result-effective variable, with the recognized result being the amount of compacting of the body that is possible. 8 Appeal2018-000959 Application 14/079,590 DECISION The Examiner's decision to reject claims 1, 3, 4, 7-10, 23, and 25-30 under 35 U.S.C. § 103(a) as unpatentable over Miles and Mavani is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R. § l.136(a)(l )(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation