THE SPECTRANETICS CORPORATIONDownload PDFPatent Trials and Appeals BoardMay 19, 20212020006552 (P.T.A.B. May. 19, 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. 14/700,550 04/30/2015 Blaine Schneider 2014P02047US01 1074 24737 7590 05/19/2021 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus Avenue Suite 340 Valhalla, NY 10595 EXAMINER TOWA, RENE T ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 05/19/2021 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): katelyn.mulroy@philips.com marianne.fox@philips.com patti.demichele@Philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BLAINE SCHNEIDER ____________ Appeal 2020-006552 Application 14/700,550 Technology Center 3700 ____________ Before STEFAN STAICOVICI, JOSIAH C. COCKS, and CARL M. DeFRANCO, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE. Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision in the Final Office Action (dated May 22, 2019, hereinafter “Final Act.”) rejecting claims 1–7, 9–15, 17–21, 24, 27, and 30.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. THE SPECTRANETICS CORPORATION, which is a subsidiary of KONINKLUKE PHILIPS N.V., is identified as the real party in interest in Appellant’s Appeal Brief (filed Oct. 21, 2019, hereinafter “Appeal Br.”). Appeal Br. 2. 2 Claims 8, 16, 22, 23, 25, 26, 28, and 29 are canceled. See Appeal Br. 15– 17 (Claims App.). Appeal 2020-006552 Application 14/700,550 2 SUMMARY OF DECISION We AFFIRM. INVENTION Appellant’s invention is directed “to expandable irrigation and aspiration catheters used in the containment and removal of material resulting from therapeutic treatment of occlusions within blood vessels.” Spec., para. 2. Claims 1, 6, and 15 are independent. Claim 1 is illustrative of the claimed invention and reads as follows: 1. A catheter system for cutting bodily material of a subject, the catheter system comprising: a catheter having a wall, the wall comprising a distal end carrying a cutting instrument adapted to cut bodily material of the subject, the distal end being reconfigurable from a collapsed configuration to an expanded configuration, the wall further comprising at least two flexible components, wherein the at least two flexible components have a first flexibility that is different than a flexibility for another portion of the wall, wherein the wall comprises two folds in the collapsed configuration, wherein the at least two flexible components are within the two folds, respectively, wherein the two folds create two folded portions, wherein a first of the two folded portions comprises a first U shape having a concave surface, wherein the second of the two folded portions comprises a second U shape having a convex surface, the second U shape coupled to the first U shape at the two folds, the wall further comprising a U shaped orifice disposed at the distal end between the first U shape and the second U shape, the orifice being in fluid communication with a lumen extending proximally from the distal end, the lumen being adapted to receive cut bodily material; and Appeal 2020-006552 Application 14/700,550 3 a release mechanism coupled to the catheter, the release mechanism being actuatable to reconfigure the distal end from the collapsed configuration to the expanded configuration. Appeal Br. 13 (Claims App.). REJECTIONS I. The Examiner rejects claims 1–3 under 35 U.S.C. § 103 as being unpatentable over Tu, Ziarno, and Hamilton. II. The Examiner rejects claims 1–7, 9, 10, 13–15, 17, 18, 20, 21, 24, 27, and 30 under 35 U.S.C. § 103 as being unpatentable over Raybin, Ziarno, and Hamilton. III. The Examiner rejects claims 11, 12, and 19 under 35 U.S.C. § 103 as being unpatentable over Raybin, Ziarno, Hamilton, and Tu. ANALYSIS Rejection I Appellant does not present arguments for the patentability of claims 2 and 3 apart from claim 1. See Appeal Br. 6, 11. Therefore, in accordance with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 1 as the representative claim to decide the appeal of the rejection of these claims, with claims 2 and 3 standing or falling with claim 1. The Examiner finds Tu discloses a catheter assembly for cutting bodily material including, inter alia, catheter 77 having a distal wall configurable from a collapsed configuration to an expanded configuration and a lumen for receiving bodily material, release mechanism 17, and cutting instrument 22, 24. See Final Act. 3–4 (citing Tu, paras. 3, 36, 37, Appeal 2020-006552 Application 14/700,550 4 40–44, 49, Figs. 4A, 4B, 4C). The Examiner further finds that Tu fails to disclose that catheter 77 includes U-shaped folds in its collapsed configuration and flexible components, as called for by independent claim 1. Id. at 4. Nonetheless, the Examiner finds that Ziarno discloses an instrument having U-shaped folds in its collapsed configuration and Hamilton discloses the use of at least two flexible components 44 mounted within wall 34 to obtain wall portions with different flexibilities. Id. at 4–6 (citing Ziarno, para. 103, Fig. 14; Hamilton, paras. 10, 11, 15, 19, 22–24, 28, 35, 35, Figs. 1–3). Thus, the Examiner concludes that it would have been obvious for a skilled artisan to modify Tu’s catheter system in its collapsed state to have Ziarno’s U-shaped folds in order to “selectively collaps[e] the funnel in the manner taught by Ziarno.” Id. at 5. The Examiner also determines that it would have been obvious to a person of ordinary skill in the art to further modify the catheter assembly of Tu, as modified by Ziarno, to include Hamilton’s flexible components in order to “forc[e] the funnel and/or fold(s) into the expanded configuration once it’s no longer constrained within the working channel.” Id. at 6–7 (citing Hamilton, para. 24). According to the Examiner, the modifications of Tu’s catheter system, according to Ziarno and Hamilton, constitute applying a known technique to a known device ready for improvement to achieve a predictable result. Id. at 5, 6 (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, (2007); MANUAL OF PATENT EXAMINING PROCEDURE §§ 2143, 2144–2144.09). Furthermore, the Examiner determines that locating Hamilton’s flexible elements within the folds of Tu’s catheter, as modified by Ziarno, “would be an obvious expedient of merely rearranging known parts . . . to Appeal 2020-006552 Application 14/700,550 5 achieve the same function of forcing the flexible cup of Ziarno into the expanded configuration.” Id. at 31. Thus, the Examiner takes the position that such a modification “is a mere design choice that would have produced the same improvement of forcing the funnel and/or fold(s) into an expanded configuration once it’s no longer constrained within the working channel.” Advisory Action (mailed Aug. 1, 2019, hereinafter “Adv. Act.”) 2. Appellant argues that “the Examiner has not explained why one of skill in the art would rearrange the parts to ultimately provide the device with the same function.” Appeal Br. 8 (emphasis added). According to Appellant, “the Examiner has essentially ignored the language [of the claims], stating that the positioning of the flexible members is a mere design choice.” Reply Brief (filed Sept. 21, 2020, hereinafter “Reply Br.”) 2. We are not persuaded because in appropriate circumstances, a modification of prior art teachings may be a matter of design choice. E.g., ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1367 (Fed. Cir. 2016) (where the prior art consistently located two sensors in shredder’s feed, skilled artisan faced two design choices of placing the thickness sensor above or below the presence sensor and each design choice was an obvious combination of prior art elements). Design choice may apply when alternative elements or configurations in the prior art perform the same function as the claimed structures with no unexpected results. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (explaining that the use of the claimed feature “would be an obvious matter of design choice” when it “solves no stated problem” and “presents no novel or unexpected result” over the disclosed alternatives). Appeal 2020-006552 Application 14/700,550 6 Here, in the context of a rejection based on design choice, the relevant issue is whether the alleged differences between the claimed invention and the prior art “result in a difference in function or give unexpected results.” See In re Rice, 341 F.2d 309, 314 (CCPA 1965). In this case, we agree with the Examiner that “Appellant has not disclosed that locating the flexible components within the two folds provides an advantage, is used for a particular purpose, or solves a stated problem.” Examiner’s Answer (dated July 21, 2020, hereinafter “Ans.”) 7. The Specification explicitly states that “flexible components 120 may be disposed at multiple locations about the distal end 106,” but does not specify any preference or advantage for locating the flexible elements at a specific location, namely, within the two folds of the wall, as required by claim 1. Spec., para. 45 (emphasis added). In particular, we note that Appellant’s reliance on paragraphs 9–12 of the Specification as evidence of the benefits provided by positioning “the at least two flexible components . . . within the two folds,” as called for by claim 1, is misplaced. Reply Br. 4. These paragraphs discuss the benefits provided in general by the claimed invention, but do not describe any benefits resulting from specifically locating flexible components 120 in the claimed location, i.e., “within the two folds.” Thus, Appellant does not adequately explain why a skilled artisan would not have reasonably expected Hamilton’s flexible elements 44 to perform in the same manner, whether located along the perimeter of flexible cup 34 or within the folds of Tu’s catheter wall, as modified by Ziarno. See Hamilton, para. 24, Fig. 3; Final Act. 5–6. The Examiner is correct that both “arrangements would perform the same function of forcing the funnel and/or fold(s) into the expanded configuration once it’s no longer constrained Appeal 2020-006552 Application 14/700,550 7 within the working channel.” Ans. 7. Simply selecting one of a plurality of a finite number of identified locations to position Hamilton’s flexible elements 44 within Tu’s catheter wall, as modified by Ziarno, is not the product of innovation but something that occurs in the ordinary course of using a known device. See, e.g., In re Kubin, 561 F.3d 1351, 1358–61 (Fed. Cir. 2009). Appellant further argues that, absent hindsight, a skilled artisan would not have modified the catheter assembly of Tu, as modified by Ziarno, to include Hamilton’s flexible components to “forc[e] the funnel and/or fold(s) into the expanded configuration once it’s no longer constrained within the working channel.” Appeal Br. 10. According to Appellant, the catheter of Tu, as modified by Ziarno, “is already selectively collapsible.” Id. We are not persuaded that the Examiner’s determination of obviousness is based on impermissible hindsight reconstruction. See Appeal Br. 10. We appreciate that the distal end of Tu’s catheter 77 is disclosed as “self-expandable” when released from the constraint of catheter shaft 19. See Tu, Figs. 2, 4B, 4C, para. 43. However, Tu does not disclose the mechanism that allows the distal end of catheter 77 to expand. Therefore, as Tu does not disclose the expansion mechanism of the distal end of catheter 77, Hamilton’s disclosure of using flexible elements 44 for automatically expanding flexible cup 34 is merely providing details that are missing from Tu. In other words, as Tu does not disclose the expansion mechanism of the distal end of catheter 77, providing Hamilton’s flexible elements 44 to the catheter of Tu, as modified by Ziarno, is merely the application of a known technique (i.e., a known expansion mechanism) to a piece of prior art ready for the improvement. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 Appeal 2020-006552 Application 14/700,550 8 (2007) (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”). We, thus, agree with the Examiner that the modification is an improvement to the catheter of Tu, as modified by Ziarno, to have at least two flexible elements in the same way as taught by Hamilton to lead to a predictable result, namely, “to force the funnel to the deployed configuration once it’s no longer constrained within a working channel.” See Ans. 9. Accordingly, the Examiner’s determination of obviousness does not amount to impermissible hindsight. Lastly, Appellant argues that “there is no evidence showing there is a reasonable expectation of success of combining the teachings of these references.” Appeal Br. 10. According to Appellant, “the Examiner has not demonstrated how one of skill in the art would combine the funnel of Hamilton with the modified funnel of Tu and Ziarno.” Id. “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988); see also Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (“the expectation of success need only be reasonable, not absolute”). In the instant case, the Examiner provides an adequate reasoning to modify Tu’s catheter, as modified by Ziarno, namely, “to force the funnel to the deployed configuration once it’s no longer constrained within a working channel.” See Final Act. 6–7 (citing Hamilton, Appeal 2020-006552 Application 14/700,550 9 para. 24). Further, the Examiner provides an informed explanation and analysis as to how Hamilton’s flexible elements 44 provide for different flexibilities to expand flexible cup 34. Id. at 5–6. Furthermore, in the Examiner’s combination, Hamilton’s flexible elements 44 are being used in accordance with their typical expansion function. As such, a person of ordinary skill in the art would have had a reasonable expectation of success in using Hamilton’s flexible elements 44 to expand the distal end of Tu’s catheter 77, as modified by Ziarno. Appellant presents neither evidence nor persuasive technical reasoning that making the Examiner’s combination requires more than the ordinary skill or produces unexpected results. In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103 of independent claim 1 as unpatentable over Tu, Ziarno, and Hamilton. Claims 2 and 3 fall with claim 1. Rejection II In contrast to Rejection I, Rejection II is based on a different combination of references, namely, Raybin, Ziarno, and Hamilton. See Final Act. 8–28. Appellant relies on the same arguments discussed supra in Rejection I, which for the reasons stated above, we did not find persuasive. See Appeal Br. 11 (“Applicant respectfully disagrees with the rejection of claim 1 for similar reasons to those described above in view of the rejection based on the combination of Tu, Ziarno, and Hamilton.”). In particular, we do not agree with Appellant’s position that a skilled artisan would not combine the teachings of Raybin, Ziarno, and Hamilton because “the funnels from the corresponding references are already selectively collapsible” for the Appeal 2020-006552 Application 14/700,550 10 same reasons discussed above in Rejection I with respect to the combination of Tu, Ziarno, and Hamilton. Accordingly, for the foregoing reasons, we also sustain the rejection under 35 U.S.C. § 103 of claims 1–7, 9, 10, 13–15, 17, 18, 20, 21, 24, 27, and 30 as unpatentable over Raybin, Ziarno, and Hamilton. Rejection III Appellant relies on the same arguments discussed supra in Rejection II. See Appeal Br. 12. Therefore, for the same reasons discussed above, we also sustain the rejection of claims 11, 12, and 19 over the combined teachings of Raybin, Ziarno, Hamilton, and Tu. CONCLUSION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3 103 Tu, Ziarno, Hamilton 1–3 1–7, 9, 10, 13–15, 17, 18, 20, 21, 24, 27, 30 103 Raybin, Ziarno, Hamilton 1–7, 9, 10, 13–15, 17, 18, 20, 21, 24, 27, 30 11, 12, 19 103 Raybin, Ziarno, Hamilton, Tu 11, 12, 19 Overall outcome 1–7, 9–15, 17–21, 24, 27, 30 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). Appeal 2020-006552 Application 14/700,550 11 AFFIRMED Copy with citationCopy as parenthetical citation