2021002311 (P.T.A.B. Oct. 4, 2021)

C. R. Bard, Inc.

Patent Trials and Appeals BoardOct 4, 2021

2021002311 (P.T.A.B. Oct. 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. 15/947,610 04/06/2018 Daniel B. Blanchard 101672.0061P3 5774 158673 7590 10/04/2021 BD/Rutan & Tucker, LLP 18575 Jamboree Road 9th Floor Irvine, CA 92612 EXAMINER BOUCHELLE, LAURA A ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 10/04/2021 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): ip.docket@bd.com patents@rutan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DANIEL B. BLANCHARD, KELLY B. POWERS, and WILLIAM R. BARRON ____________ Appeal 2021-002311 Application 15/947,610 Technology Center 3700 ____________ Before JEREMY M. PLENZLER, BRANDON J. WARNER, and MICHAEL L. WOODS, Administrative Patent Judges. WARNER, 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 1–15, which are all the pending claims. Appeal Br. 4. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as C.R. Bard, Inc. Appeal Br. 4. Appeal 2021-002311 Application 15/947,610 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention relates to “a medical device comprising a diaphragm having at least one slit valve disposed therein and at least one valve control member.” Spec. ¶ 6. Claim 1, reproduced below with emphasis added, is the sole independent claim and is representative of the subject matter on appeal. 1. A catheter assembly, comprising: a catheter including a lumen; and a valve assembly coupled to a proximal end of the catheter, the valve assembly including a diaphragm, the diaphragm comprising: a first unidirectional slit valve located in a central portion of the diaphragm, wherein the first unidirectional slit valve is structurally designed to: open distally in response to an infusion- induced pressure; and remain closed when subjected to an aspiration-induced pressure; and a second unidirectional slit valve located in a lateral portion of the diaphragm, the lateral portion connecting the central portion to a peripheral portion of the diaphragm, wherein the second unidirectional slit valve is structurally designed to: open proximally in response to the aspiration-induced pressure; and remain closed when subjected to the infusion-induced pressure. Appeal 2021-002311 Application 15/947,610 3 EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Nordgren US 2006/0253084 A1 Nov. 9, 2006 REJECTIONS The following rejections are before us for review:2 I. Claim 10 stands rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. Ans. 9–10. II. Claims 1–15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Nordgren. Final Act. 5–10. ANALYSIS Rejection I – Claim 10 as indefinite The Examiner makes a new ground of rejection in the Answer to point out that claim 10 is technically indefinite due to a lack of antecedent basis for the recitation “the dome shape.” Ans. 9–10. The Examiner also points out that this indefiniteness issue, based on the lack of antecedent basis, is due to a typographical error—as claim 10 currently depends from claim 7, when claim 10 is intended to depend from claim 9 (which provides antecedent basis for “a dome shape”). Id. at 10; see also Appeal Br. 16, 2 We note that a rejection of claims 1–4, 6, and 8–14 on the ground of nonstatutory obviousness-type double patenting has been withdrawn by the Examiner, in light of a terminal disclaimer, and thus is not before us for review as part of the instant appeal. Ans. 9; see Final Act. 4–5. Appeal 2021-002311 Application 15/947,610 4 note 2 (initially explaining the same typographical error); Reply Br. 6 (reiterating same). As both Appellant and the Examiner acknowledge the cause of the problem to be a typographical error, and Appellant has expressed a clear intent to correct the dependency error “at the next opportunity” (Reply Br. 6), there is no real dispute for us to resolve. Accordingly, while the rejection is noted, we do not otherwise reach it. Rejection II – Claims 1–15 as unpatentable over Nordgren Claims 1, 2, 5, 7–9, 12, and 13 Appellant presents arguments against the rejection of independent claim 1 (see Appeal Br. 9–13), and relies on the same arguments for dependent claims 2, 5, 7–9, 12, and 13 (see id. at 13–15, 17). We select independent claim 1 as representative of the issues that Appellant presents in the appeal of this rejection, with claims 2, 5, 7–9, 12, and 13 standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv). Independent claim 1 recites, in relevant part, a valve assembly coupled to a catheter and having a diaphragm, where the diaphragm includes both (1) “a first unidirectional slit valve located in a central portion of the diaphragm” to open distally only upon infusion pressure, and (2) “a second unidirectional slit valve located in a lateral portion of the diaphragm” to open proximally only upon aspiration pressure. Appeal Br. 20, Claims App. The Examiner determined that a combination of teachings from Nordgren renders obvious the subject matter recited in claim 1. See Final Act. 5–6. Appellant argues that the Examiner’s conclusion is in error, premised on a repeated assertion that Nordgren does not expressly “show or describe” all Appeal 2021-002311 Application 15/947,610 5 of the features of slit valves (1) and (2) being located as claimed. Appeal Br. 9–11; see Reply Br. 7–8. After careful consideration of the record before us, Appellant’s arguments do not apprise us of error in the Examiner’s conclusion of obviousness. Appellant argues that the specific arrangement of slit valves (1) and (2), as recited in the claim, would not have been obvious from the depicted arrangements of slit valves in Nordgren. See Appeal Br. 9–11; Reply Br. 6–8. But these arguments, which focus on the particular arrangements shown in Nordgren, do not apprise us of error in the Examiner’s determination that slightly modifying the locations of the slit valves in Nordgren to correspond with those claimed would have been within the level of ordinary skill in the art, particularly in light of the arrangement variability depicted and described in the embodiments of Nordgren. See Final Act. 6; Ans. 11–12. Stated another way, Appellant’s arguments do not identify error in the Examiner’s ultimate conclusion that the claimed subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. See 35 U.S.C. § 103(a). We discern no shortcoming in the Examiner’s position that arranging Nordgren’s slit valves to correspond with the arrangement recited “would have been within the skill of a person of ordinary skill in the art without undue experimentation.” Final Act. 6; Ans. 12. And Appellant does not explain how such a slight modification to the arrangement of Nordgren’s slit valves would have yielded any unpredictable results or somehow been beyond the level of ordinary skill in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In this regard, Appellant’s Appeal 2021-002311 Application 15/947,610 6 arguments neglect to adequately consider that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. The analysis under 35 U.S.C. § 103(a) presumes not only common sense, but also skill in the art. See In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985). Appellant also asserts that Nordgren does not show a slit valve located in a “lateral portion” of the diaphragm, where the lateral portion connects a central portion of the diaphragm to a peripheral portion of the diaphragm. See Appeal Br. 11–12; Reply Br. 8–10. This assertion is unpersuasive, as we agree with the Examiner’s reasonable explanation of the identified portions relied on from Nordgren. See Ans. 12–13 (including an annotated reproduction of Nordgren, Fig. 20). We note that the plain meaning of the recited “portions,” as interpreted by the Examiner, is more expansive than is implied by Appellant’s argument (e.g., a peripheral portion is much more than just an outermost periphery). See id. at 12. After careful consideration of the record before us, Appellant’s arguments do not apprise us of error in the Examiner’s factual findings, which are supported by a preponderance of the evidence, or the Examiner’s reasonable conclusion of obviousness, which is rationally articulated based on prior art teachings. See KSR, 550 U.S. at 417. Accordingly, we sustain the rejection of independent claim 1, and claims 2, 5, 7–9, 12, and 13 falling therewith, under 35 U.S.C. § 103(a) as being unpatentable over Nordgren. Claim 3 In arguing against the rejection of dependent claim 3, which adds a third unidirectional slit valve located in a lateral portion of the diaphragm to Appeal 2021-002311 Application 15/947,610 7 only open proximally upon aspiration pressure, Appellant relies on “the same reasons set forth above in connection with independent claim 1.” Appeal Br. 13. For the same reasons explained above, we also sustain the rejection of claim 3. Claims 4 and 6 With respect to dependent claims 4 and 6, which each add a limitation that the slit valves are substantially parallel to one another, Appellant relies on the arguments for the respective base claims and additionally asserts that “there is no embodiment shown” in Nordgren that includes parallel slits. Appeal Br. 13–15; see Reply Br. 10–12. Appellant’s assertion is also unconvincing, however, as we agree with the Examiner’s explanation that, “given [Nordgren’s] explicit disclosure that valves can be arranged parallel to each other,” the recited arrangement would have been obvious to a person of ordinary skill in the art. Ans. 14; see id. at 14–15 (including an annotated reproduction of Nordgren, Fig. 20); see also Final Act. 7 (citing Nordgren ¶ 34, which specifically discloses the option of parallel slits). Therefore, we sustain the rejection of claims 4 and 6. Claim 10 In arguing against the rejection of dependent claim 10, which adds limitations of the central portion having a dome shape and being designed to maintain the dome shape upon aspiration pressure, Appellant urges that Nordgren’s Figure 8C shows the valve “collapsing inward” upon aspiration pressure. Appeal Br. 16; see Reply Br. 12–13. We are unpersuaded by Appeal 2021-002311 Application 15/947,610 8 Appellant’s argument because we agree with the Examiner’s explanation that, given the modified valve assembly of Nordgren as applied in base claim 1, the central slit valve that opens only upon infusion pressure will remain closed upon aspiration pressure, thereby necessitating that the dome shape is not meaningfully deformed (which would open the valve). Ans. 16. Accordingly, we sustain the rejection of claim 10. Claim 11 With respect to dependent claim 11, which adds a limitation that the central portion comprises a reinforced area, Appellant takes issue with the Examiner’s reliance on an area of the valve with a thicker wall in Nordgren to meet this limitation, urging instead that exemplary embodiments from the Specification include a separate arm or protrusion. Appeal Br. 16–17; see Reply Br. 13. But Appellant’s proffered meaning of reinforce, to include strengthening with some added material, is met by the Examiner’s reliance on an area of the valve having a thicker wall (additional material compared to an area with a thinner wall), as the Examiner reasonably explains. Ans. 17 (citing Nordgren ¶ 37). Therefore, we sustain the rejection of claim 11. Claims 14 and 15 As for dependent claims 14 and 15, we note that claim 14 adds a limitation that the diaphragm “includes a reinforcing member coupled to the lateral portion” thereof, and that claim 15 depends from claim 14. Appeal Br. 21, Claims App. (emphasis added). Appellant makes a similar argument to that presented for claim 11, discussed above, again taking issue with the Appeal 2021-002311 Application 15/947,610 9 Examiner’s reliance on an area of the valve with a thicker wall in Nordgren as meeting this limitation. Appeal Br. 17; see Reply Br. 13–14. The Examiner’s response for claim 14 also mirrors that provided for claim 11. Ans. 17. The relevant claim limitation, however, is meaningfully different between claims 11 and 14, in that claim 14 requires an additional element in the form of “a reinforcing member” that is “coupled to” the lateral portion of the diaphragm (compared with claim 11 requiring only “a reinforced area” as part of the central portion). Appeal Br. 21, Claims App. In light of this difference, we agree with Appellant that the Examiner’s reliance on an area with a thicker wall is an insufficient finding to account for the limitation recited in claim 14. Accordingly, we do not sustain the rejection of claims 14 and 15. DECISION We DO NOT REACH the Examiner’s decision rejecting claim 10 under 35 U.S.C. § 112, second paragraph, as set forth above. We AFFIRM the Examiner’s decision rejecting claims 1–13 under 35 U.S.C. § 103(a) as being unpatentable over Nordgren, as set forth above. We REVERSE the Examiner’s decision rejecting claims 14 and 15 under 35 U.S.C. § 103(a) as being unpatentable over Nordgren, as set forth above. 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 2021-002311 Application 15/947,610 10 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 10 112 Indefiniteness3 1–15 103(a) Nordgren 1–13 14, 15 Overall Outcome 1–13 14, 15 AFFIRMED IN PART 3 As explained in detail above, we do not reach this rejection, as there is no meaningful dispute for the Board to resolve because both Appellant and the Examiner agree that the indefiniteness rejection is the result of a typographical error that Appellant has agreed to correct.