IVANTIS, INC

Patent Trials and Appeals BoardMay 4, 2021

2020002714 (P.T.A.B. May. 4, 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. 14/363,409 06/06/2014 John Wardle 10502-712.US0 7066 66854 7590 05/04/2021 SHAY GLENN LLP 2929 CAMPUS DRIVE SUITE 225 SAN MATEO, CA 94403 EXAMINER ZIMBOUSKI, ARIANA ART UNIT PAPER NUMBER 3781 NOTIFICATION DATE DELIVERY MODE 05/04/2021 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): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JOHN WARDLE and ANDREW T. SCHIEBER __________ Appeal 2020-002714 Application 14/363,409 Technology Center 3700 __________ Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and TARA L. HUTCHINGS, Administrative Patent Judges. REIMERS, 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 86–88 and 90–94. Claims 1–85 have been canceled. Appeal Br. 9 (Claims App.). Claim 89 is allowed. Final Act. 1, 6.2 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. Appellant identifies the real party in interest as Ivantis, Inc. Appeal Brief (“Appeal Br.”) 2, filed July 29, 2019. 2 Final Office Action (“Final Act.”), dated Apr. 19, 2019. Appeal 2020-002714 Application 14/363,409 2 CLAIMED SUBJECT MATTER The claimed subject matter relates to “methods for delivering ocular implants into the eye for treating glaucoma.” Spec. ¶ 2. Claims 86 and 92 are independent. Claim 86 is illustrative of the claimed subject matter and recites: 86. A method of delivering an ocular implant into Schlemm’s canal of an eye, the method comprising: an inserting step comprising inserting a distal end of a cannula into Schlemm’s canal so that Schlemm’s canal wall tissue extends over a distal portion of a trough of the cannula; an advancing step comprising advancing the ocular implant distally through a cannula lumen into the trough below the Schlemm’s canal wall tissue and further distally into Schlemm’s canal, the ocular implant having a height less than a depth of the distal portion of the trough over which the Schlemm’s wall tissue extends; and viewing the ocular implant as it advances through the trough prior to entering Schlemm’s canal. THE REJECTIONS Claims 86, 87, and 90–93 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schieber (US 2010/0121342 A1, published May 13, 2010) and Becker (US 2013/0023837 A1, published Jan. 24, 2013). Claims 88 and 94 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schieber, Becker, and Kaplan (US 2007/0265582 A1, published Nov. 15, 2007). Appeal 2020-002714 Application 14/363,409 3 ANALYSIS Obviousness over Schieber and Becker Claims 86, 87, and 90–93 Appellant does not offer arguments in favor of independent claim 92 or dependent claims 87, 90, 91, and 93 separate from those presented for independent claim 86. See Appeal Br. 3–7. We select claim 86 as the representative claim, and claims 87 and 90–93 stand or fall with claim 86. 37 C.F.R. § 41.37(c)(1)(iv) (2018). Claim 86 is directed to “[a] method of delivering an ocular implant into Schlemm’s canal of an eye,” the method including the step of “viewing the ocular implant as it advances through the trough [of the cannula] prior to entering Schlemm’s canal.” Appeal Br. 9 (Claims App.). The Examiner finds that Schieber describes each method step recited in claim 86, with the exception of “viewing the ocular implant as it advances through the trough prior to entering Schlemm’s canal.” Final Act. 4. In order to address this deficiency, the Examiner finds that Becker would have suggested extending the trough at the distal end of Schieber’s cannula by means of a slot sufficiently long to enable the physician to view a portion of the implant outside Schlemm’s canal and the trabecular meshwork. Id. at 4–5; see also Ans. 6–8.3 Appellant contends that Becker would not have had suggested extending the trough at the distal end of Schieber’s cannula as proposed by the Examiner. Appeal Br. 7. More specifically, Appellant contends that: [T]he [proposed modification] would not have been obvious since the problem solved by the invention recited in the instant 3 Examiner’s Answer (“Ans.”), dated Dec. 27, 2019. Appeal 2020-002714 Application 14/363,409 4 claims is different than the problem solved by the notch 63 on Becker’s insertion tool, that Schieber did not identify that problem, and that a skilled artisan would not have been motivated to add Becker’s notch to Schieber’s cannula. Reply Br. 3;4 see also id. at 4 (“Becker . . . does not identify the problem solved by this invention or any other problem the Schieber cannula might have, and Becker would not have motivated a skilled artisan to add a notch to Schieber’s cannula.”); Appeal Br. 5–7. Appellant also contends that the Examiner “fail[s] to establish the prima facie obviousness” of claim 86 because the Examiner “misconstrues the language of claim[] 86.” Reply Br. 2. In particular, Appellant states that claim 86 “recite[s] ‘viewing the implant as it advances through the trough prior to entering Schlemm’s canal,’ not ‘viewing the implant inside of the insertion tool’ or ‘viewing the implant during placement.’” Id. We begin by pointing out that the prior art need not teach the particular problem that Appellant alleges the instant claims solve in order to render those claims obvious. Instead, “any need or problem known in the field of endeavor at the time of invention and addressed by the [claims] can provide a reason for combining the elements in the manner claimed.” KSR Int’l, Inc. v. Teleflex Co., 550 U.S. 398, 420 (2007); see also In re Kahn, 441 F.3d 977, 987–88 (Fed. Cir. 2006) (establishing that the reason to modify the reference may often prompt a person of ordinary skill in the art to do what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by an applicant). 4 Reply Brief (“Reply Br.”), filed Feb. 24, 2020. Appeal 2020-002714 Application 14/363,409 5 We further point out that claim 86 recites nothing as to the trough being “long enough so that some of it remains outside of Schlemm’s canal during advancement of the implant” and being “deep enough so that the implant does not catch on tissue as it advances through the portion of the trough outside of Schlemm’s canal into the portion of the trough within Schlemm’s canal.” Reply Br. 4; see also Appeal Br. 9 (Claims App.); id. at 3–4; Spec. ¶ 170. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993); In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (limitations not appearing in the claims cannot be relied upon for patentability). Schieber teaches positioning the implant partially in Schlemm’s canal and partially in the anterior chamber of the eye to promote the flow of aqueous humor from the anterior chamber. Schieber ¶ 83, Fig. 11; see also Appeal Br. 3. Although we acknowledge Appellant’s position that “[b]lood reflux from Schlemm’s canal caused by the insertion of the cannula’s trough into the canal obscures the physician’s view through the trabecular meshwork of an implant moving through the cannula trough while both implant and trough are already in Schlemm’s canal” (Reply Br. 4; see also Spec. ¶ 170), experience would have taught one of ordinary skill in the art that the physician could not see the implant as the implant is advanced through the trough because a portion of the trough is embedded beneath the Schlemm’s canal wall tissue and the remainder of the trough is positioned beneath the trabecular meshwork (see Schieber ¶ 119, Fig. 28; see also Appeal Br. 4; Final Act. 2, 4). These teachings would have suggested to one of ordinary skill in the art that it would have been desirable to “[view] the Appeal 2020-002714 Application 14/363,409 6 ocular implant as it advances through the trough prior to entering Schlemm’s canal,” as recited in claim 86. Becker teaches that “because of the relatively large forces typically required to insert the typically tight-fitting plug, it can be difficult for the physician to judge whether the plug is located at the proper optimum depth with respect to the punctum.” Becker ¶ 6. In order to address this problem, Becker teaches adding a notch to the cup to provide the physician a view of a proximal portion of the plug as the plug is inserted into the punctum. Id. ¶ 66, Fig. 5. The notch not only allows the physician to better see the insertion site prior to insertion, as suggested by Appellant (Appeal Br. 6), but also allows the physician to judge the depth to which the plug is being inserted into the punctum (Ans. 7). Becker’s teachings would have suggested to one of ordinary skill in the art that the problem of allowing the physician to judge whether Schieber’s implant was inserted into Schlemm’s canal to the proper optimum depth could be addressed by adding a notch to extend the trough of Schieber’s cannula to provide the physician a view of the ocular implant. Final Act. 4–5; see also Ans. 3–4, 6–8. Therefore, one of ordinary skill in the art would have been motivated to modify Schieber’s cannula to enable the physician to “[view] the ocular implant as it advances through the trough prior to entering Schlemm’s canal,” as recited in claim 86. See Ans. 6–8. In other words, in view of the combined teachings of Schieber and Becker, a physician inserting an ocular implant would have the ability to see the implant as it advances through the trough of the cannula to verify that the implant is inserted into Schlemm’s canal to the proper optimum depth. See id. Appeal 2020-002714 Application 14/363,409 7 Additionally, we are not persuaded that the Examiner engages in impermissible hindsight in combining the teachings of the references. See Appeal Br. 7; see also Reply Br. 3. The Examiner cites to specific teachings in Schieber and Becker themselves, not Appellant’s disclosure, in support of the Examiner’s articulated reasoning for combining Schieber and Becker as proposed in the rejection. See Final Act. 2, 4–5; see also Ans. 3–4, 6–8. We further are not persuaded of error, because Appellant has not made a showing that the Examiner’s rationales were outside of the level of ordinary skill in the art at the time the claimed invention was made or were gleaned only from Appellant’s disclosure. See Appeal Br. 3–7; see also Reply Br. 2– 4; KSR, 550 U.S. at 421 (explaining that a “person of ordinary skill is also a person of ordinary creativity, not an automaton.”). Appellant contends that “the Examiner has . . . not explained where on Schieber’s cannula the skilled artisan would add that notch or why the addition of Becker’s notch would necessarily result in the user viewing the ocular implant as it advances in the cannula trough prior to entering Schlemm’s canal.” Reply Br. 4; see also id. at 3 (“What is missing from the Examiner’s analysis is . . . an explanation of how such a modification would necessarily result in the performance of the viewing step recited by claim[] 86.”). We note that Appellant presents this argument for the first time in the Reply Brief despite the Examiner’s reliance on the teachings of Becker for the “viewing” step in the Non-Final Office Action dated October 2, 2018 and in the Final Office Action dated April 19, 2019. We need not consider untimely new arguments presented in a Reply Brief that are not accompanied by a showing of good cause why they could not have been presented in the Appeal Brief. 37 C.F.R. § 41.41(b)(2); Ex Appeal 2020-002714 Application 14/363,409 8 Parte Borden, 93 USPQ2d 1473, 1476–77 (BPAI 2010) (informative). Nonetheless, we address Appellant’s argument below as a matter of adjudicative economy. We begin by pointing out that the Examiner’s rejection is based on obviousness over the combined teachings of Schieber and Becker and that the Examiner’s rejection does not rely on the doctrine of inherency, as suggested by Appellant. See Final Act. 2, 4–5; see also Ans. 3–4, 6–8; Reply Br. 4. We further point out that to the extent Appellant is arguing the references must be capable of bodily incorporation in order to combine their teachings, the test for obviousness is not whether the claimed invention is expressly suggested in any one or all of the references, but whether the claimed subject matter would have been obvious to those of ordinary skill in the art in light of the combined teachings of those references. In re Keller, 642 F.2d 413, 425 (CCPA 1981). That Becker may teach additional structure does not prevent the Examiner from relying on the Becker reference for a particular purpose. See Final Act. 2. Contrary to Appellant’s assertion that the Examiner has not explained where on Schieber’s cannula the skilled artisan would add a notch (Reply Br. 4), the Examiner explains that “the necessary structure of Schieber allowing for the viewing, such as the slot placed on the side of the distal end of the delivery tool adjacent the opening end of the delivery tool, [as taught in Becker,] would also have to be incorporated [into Schieber]” (Ans. 4). Appellant does not apprise us of Examiner error. See Reply Br. 3–4. Further, contrary to Appellant’s assertion that the Examiner has not explained why the addition of a notch would result in the user viewing the Appeal 2020-002714 Application 14/363,409 9 ocular implant as it is inserted (Reply Br. 4), the Examiner explains that adding a notch would extend the trough of Schieber’s cannula, thus, enabling a physician inserting an ocular implant to view its end placement into Schlemm’s canal (see Final Act. 4–5; see also Ans. 3–4, 6–8). More precisely, as already discussed above, the Examiner determines that Becker’s teachings would have suggested to one of ordinary skill in the art that the problem of allowing the physician to judge whether Schieber’s implant was inserted into Schlemm’s canal to the proper optimum depth could be addressed by adding a notch to extend the trough of Schieber’s cannula to provide the physician a view of the ocular implant. Final Act. 4– 5; see also Ans. 3–4, 6–8. Therefore, the Examiner concludes that one of ordinary skill in the art would have been motivated to modify Schieber’s cannula to enable the physician to “[view] the ocular implant as it advances through the trough prior to entering Schlemm’s canal,” as recited in claim 86. See Ans. 6–8. In other words, the Examiner explains that in view of the combined teachings of Schieber and Becker, a physician inserting an ocular implant would have the ability to see the implant as it advances through the trough of the cannula to verify that the implant is inserted into Schlemm’s canal to the proper optimum depth. See id. Appellant does not provide persuasive evidence or argument to the contrary. See Reply Br. 3–4. In summary, and based on the record presented, we are not persuaded the Examiner erred in rejecting independent claim 86 as unpatentable over Schieber and Becker. Accordingly, we sustain the Examiner’s rejection of claim 86. We further sustain the rejection of claims 87 and 90–93, which fall with claim 86. Appeal 2020-002714 Application 14/363,409 10 Obviousness over Schieber, Becker, and Kaplan Claims 88 and 94 Appellant’s sole argument regarding the patentability of claims 88 and 94 is that Kaplan fails to remedy alleged deficiencies in the combined teachings of Schieber and Becker, as applied to respective parent claims 86 and 92. Appeal Br. 7. As we find no deficiencies in the Examiner’s rejection of claims 86 and 92 as unpatentable over Schieber and Becker, for the reasons discussed above, we likewise sustain the Examiner’s rejection of claims 88 and 94 as unpatentable over Schieber, Becker, and Kaplan. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 86, 87, 90–93 103(a) Schieber, Becker 86, 87, 90– 93 88, 94 103(a) Schieber, Becker, Kaplan 88, 94 Overall Outcome 86–88, 90– 94 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