C. R. Bard, Inc.

Patent Trials and Appeals Board

Jan 11, 2022

2021002626 (P.T.A.B. Jan. 11, 2022)

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. 15/085,463 03/30/2016 Giridhar Thiagarajan 101672.0222P 3532 158673 7590 01/11/2022 BD/Rutan & Tucker, LLP 18575 Jamboree Road 9th Floor Irvine, CA 92612 EXAMINER FREDRICKSON, COURTNEY B ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 01/11/2022 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 GIRIDHAR THIAGARAJAN, MURTAZA YUSUF AMIN, and JERRID MATSON Appeal 2021-002626 Application 15/085,463 Technology Center 3700 Before MICHAEL J. FITZPATRICK, JEREMY M. PLENZLER, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, 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, 2, 4-18, and 31. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as C. R. Bard, Inc. Appeal Br. 4. Appeal 2021-002626 Application 15/085,463 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to “invasive medical devices that include a substantially non-eluting antimicrobial agent.” Spec. ¶ 2. Claims 1 and 7, reproduced below as the independent claims on appeal, are illustrative of the claimed subject matter: 1. A medical device, comprising: a body defining at least a portion of a fluid path having a surface, the medical device configured to provide access to a venous system of a patient; a substantially non-eluting copper coating disposed on at least a portion of the surface; and a water-shed layer disposed on the copper coating. 7. A catheter assembly, comprising: an elongate catheter tube defining at least one lumen; at least one extension leg including a luer connector, the luer connector including a body defining a first portion of a fluid passageway; a bifurcation hub including a second portion of the fluid passageway that provides fluid communication between the extension leg and the lumen; a substantially non-eluting copper coating disposed on at least a portion of a surface of at least one of the lumen, the extension leg, the luer connector, the first portion of the fluid passageway, or the second portion of [the] fluid passageway, the copper coating having a thickness from about 0.8 to about 2.6 micrometers; and a water-shed coating disposed on the copper coating, the thickness of the copper coating and the presence of the water-shed coating over the copper coating resulting in release of copper particles in a copper concentration of less than about 1.5 parts per million in an infused medicament or aspirated blood when in contact with the copper coating. Appeal Br. (Claims App.) 25-26. Appeal 2021-002626 Application 15/085,463 3 REJECTIONS2 The prior art relied upon by the Examiner is: Name Reference Date Bennett US 2005/0034723 A1 Feb. 17, 2005 Sioshansi US 5,474,797 Dec. 12, 1995 Bricault, Jr. (“Bricault”) US 5,520,664 May 28, 1996 Lynn US 7,033,339 B1 Apr. 25, 2006 Rosenblatt US 2007/0129690 A1 June 7, 2007 DiFiore US 7,347,853 B2 Mar. 25, 2008 Malik US 2013/0048336 A1 Feb. 28, 2013 Stout US 8,574,203 B2 Nov. 5, 2013 Sansoucy US 9,898,143 B2 Jan. 30, 2018 The following rejections are before us on appeal: I. Claims 1, 4, 6, 13, 15, 16, and 18 stand rejected under 35 U.S.C. § 103 as being unpatentable over Stout, Bricault, and Bennett. See Ans. 13 (entering a New Ground of Rejection of claim 6). II. Claims 2 and 31 stand rejected under 35 U.S.C. § 103 as being unpatentable over Stout, Bricault, Bennett, and Sioshansi. III. Claim 14 stands rejected under 35 U.S.C. § 103 as being unpatentable over Stout, Bricault, Bennett, and Sansoucy. IV. Claims 5 and 17 stand rejected under 35 U.S.C. § 103 as being unpatentable over Stout, Bricault, Bennett, and Malik. V. Claims 7 and 10 stand rejected under 35 U.S.C. § 103 as being unpatentable over Rosenblatt, Bricault, Bennett, and Sisoshansi. 2 The Examiner has withdrawn the rejections of claims 13-18 under 35 U.S.C. § 112(a) (see Adv. Act. 1), claims 4 and 13-18 under 35 U.S.C. § 112(b) (see id.), and claims 1, 4, 6, and 13 under 35 U.S.C. § 103 as unpatentable over Rosenblatt, et al. (see Ans. 13). Appeal 2021-002626 Application 15/085,463 4 VI. Claims 8 and 9 stand rejected under 35 U.S.C. § 103 as being unpatentable over Rosenblatt, Bricault, Bennett, and Sisoshansi, DiFiore, and Sansoucy. VII. Claims 11 and 12 stand rejected under 35 U.S.C. § 103 as being unpatentable over Rosenblatt, Bricault, Bennett, and Sisoshansi, Sansoucy, and Lynn. OPINION Rejection I Regarding independent claim 1, the Examiner finds that Stout discloses a medical device (i.e., catheter assembly 101) comprising a body (i.e., auxiliary y-port 700) defining a portion of a fluid path having a surface (i.e., ventilation channel 740 and the surface thereof), the medical device configured to provide access to a venous system of a patient (i.e., “tubing 40 . . . is functionally capable of accessing a vein”), as required by claim 1. Final Act. 6 (citing Stout, Fig. 21); see also, e.g., Stout 18:16-37. The Examiner also finds that Stout discloses “an antimicrobial coating disposed on a portion of the surface [of the body].” Final Act. 6; see, e.g., Stout 19:55-58 (disclosing that “any septum”-i.e., septum 722 within y-port 700-“may also include a coating of antimicrobial substance on any of its surfaces, especially those surfaces which have contact with fluid”). The Examiner finds that Stout fails to disclose, inter alia, a substantially non-eluting copper coating, as required by claim 1, and the Examiner relies on Bricault’s disclosure of “an improved catheter treated with a substantially nonleaching antimicrobial metal to enhance the bactericidal/fungicidal properties of a tissue interfacing surface,” wherein Appeal 2021-002626 Application 15/085,463 5 the metal may be “copper.” Final Act. 7 (citing Bricault 4:64-5:8). In the Examiner’s Answer, the Examiner relies, more specifically, on Bricault’s method of “coating the antimicrobial metal ions on the surface of the catheter” (citing Bricault 3:31-58), wherein “the antimicrobial metal ions can be embedded within or upon the surface” (citing Bricault 3:44-47) to support the Examiner’s finding that Bricault indeed discloses an antimicrobial coating. Ans. 14. The Examiner finds that “Bricault offers no disclosure over the benefit of implanting the metal ions into the surface of the device versus applying the ions to the surface [(i.e., coating)] and discloses that antimicrobial metals which are incorporated into or onto the surface are suitable for providing a long-lasting medical device.” Id. at 15- 16 (citing Bricault 3:31-34). The Examiner reasons that it would have been obvious to modify Stout’s antimicrobial coating to be a substantially non- leaching copper coating, as taught in Bricault, to “prolong[] the antimicrobial effects of the device, as taught by Bricault.” Id. (citing Bricault 5:48-52). Appellant argues that the Examiner’s reasoning lacks factual underpinning because it is the implantation of the antimicrobial metal ions that “lengthen[s] the time period over which the component implanted with the antimicrobial metal [ions] exhibits antimicrobial properties,” or, as the Examiner asserts, “prolong[s] the antimicrobial effects of the device”-not simply the use of an antimicrobial metal as the Examiner appears to suggest. Appeal Br. 14. Appellant submits that while Stout might “teach[] an antimicrobial coating on the interior of the surface” of the catheter assembly 101 and Appeal 2021-002626 Application 15/085,463 6 Bricault might teach “a substantially non-leaching copper coating disposed on the surface” of the catheters, the substantially non-eluting copper coating disposed on the fluid- path surface of the claimed medical device is not possible by Bricault’s atom-and-ion embedding process. Again, Bricault only discloses forming a metallic surface on the tissue- interfacing or outer surfaces of the catheters. This is because Bricault’s atom-and-ion embedding processes rely on ion beams, which, like laser beams, consist of linearly propagated particles that are not amenable to non-linear operations of the kind that would be required to effectuate Bricault’s surface treatment on the interior of Stout’s catheter assembly and, thus, arrive at the claimed medical device. Reply Br. 10-11.3 Bricault discloses “an ion beam assisted deposition process (IBAD),” wherein “an ion source accelerates ions into a growing film formed by physical vapor deposition,” whereby “[t]he resulting collisions mix the film atoms with the catheter surface and cause the film atoms to become embedded within and/or upon the tissue interfacing surface.” Bricault 3:40- 47. Bricault further discloses, as relied on by the Examiner supra, that “[a]n object of the invention is to lengthen the time period over which the component implanted with the antimicrobial metal exhibits antimicrobial properties,” such that “according to one preferred embodiment, the metallic surface treatment is substantially nonleaching.” Id. at 5:48-52. Bricault 3 Appellant presents the same argument relative to dependent claim 6, in response to the Examiner’s New Ground of Rejection of claim 6, which is presented for the first time in the Examiner’s Answer. Reply Br. 11-12. Thus, although we do not have the benefit of the Examiner’s response to this argument, the argument is timely presented, at the least as applied to claim 6, which is as relevant to the Examiner’s rejection of claim 1, and therefore, before us, on this record, on appeal. See 37 C.F.R. § 41.41(b)(2). Appeal 2021-002626 Application 15/085,463 7 discloses that “[t]o achieve a substantially nonleaching surface treatment, in the illustrative example of FIG. 2, the atoms 212 are embedded in the material of the catheter and the atomic penetration extends below the surface 216.” Id. at 5:64-67. Thus, although we agree with the Examiner that Bricault teaches a coating, as required by claim 1 (see, e.g., id., Fig. 2), the nonleaching property of the coating is dependent, in Bricault, upon the IBAD process. A preponderance of the evidence from Bricault does not support a finding that the IBAD process is applicable to an interior surface of a catheter, but rather, Bricault consistently discloses and describes the IBAD process as applicable to the tissue interfacing (outside) surface of the catheter (see, e.g., id. 44-46), and not the lumen. Thus, the Examiner’s reasoning to apply a copper coating, as taught in Bricault, to the surface of Stout’s fluid path, which is on the interior of ventilation channel 740, lacks factual underpinning. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring an obviousness conclusion to be based on explicit articulated reasoning with rational underpinning) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). Accordingly, we cannot sustain the Examiner’s rejection of independent claim 1 and claims 4, 6, 13, 15, 16, and 18 depending therefrom. Rejections II to IV The Examiner’s reliance on Sioshansi for disclosing a copper coating thickness, in the rejection of claims 2 and 31 (Final At. 10-11), on Sansoucy for disclosing a copper coating on an outer surface of a luer connector, in the rejection of claim 14 (id. at 11-12), and on Malik for disclosing a water-shed layer comprised of butoxyethanol or butoxyethoxyethanol, in the rejection of Appeal 2021-002626 Application 15/085,463 8 claims 5 and 17 (id. at 12-15), does not cure the deficiency in the Examiner’s reasoning as discussed supra with respect to independent claim 1. Accordingly, we cannot sustain the Examiner’s rejection of claims 2, 5, 14, 17, and 31, which depend from independent claim 1. Rejection V Independent claim 7 Regarding independent claim 7, the Examiner finds that Rosenblatt discloses, inter alia, a catheter assembly with an elongate catheter tube (i.e., main body 102 of catheter 100) defining a lumen (i.e., first and second lumens 108, 110), an extension leg including a luer connector (i.e., first and second connector tubes 118, 120 and luer lock fittings 128, 130), and a bifurcation hub (i.e., connector hub 116), as claimed. Final Act. 13 (citing Rosenblatt ¶ 29, Fig. 3). The Examiner also finds that Rosenblatt discloses “an antimicrobial coating disposed on at least a portion of a surface of at least one of the lumen, the extension leg, the luer connector, the first portion of the fluid passageway, or the second portion of the fluid passageway,” as required by claim 7. Id. (citing Rosenblatt ¶ 30); see Rosenblatt ¶ 30 (“the antimicrobial agent 132 may be coated over the entire main body 102 of the catheter 100 . . . [or] over the connector hub 116 and/or the connector tubes 118, 120 as well as the proximal region 134 of the main body 102”). The Examiner relies on Bricault for teaching “a substantially non- leaching copper antimicrobial coating” and reasons that it would have been obvious to modify Rosenblatt’s antimicrobial coating “to be a substantially non-leaching copper coating,” as taught by Bricault, to provide “the added Appeal 2021-002626 Application 15/085,463 9 advantage of prolonging the antimicrobial effects of the catheter,” as taught by Bricault. Final Act. 13. The Examiner relies on Bennett for disclosing “the use of a water- shed layer” (i.e., “oxide layer . . . over a copper substrate . . . to prevent oxidation”). Final Act. 14 (citing Bennett ¶ 7). The Examiner reasons that it would have been obvious to have modified Rosenblatt, as modified by Bircualt, “to include the water-shed layer over the copper coating since Bennett teaches that this layer is beneficial in the prevention of oxidation of the copper.” Id. Appellant argues that Bricault fails to disclose a substantially non- leaching copper microbial coating, as relied on by the Examiner, because “a coating disposed on a surface is markedly different than Bricault’s antimicrobial metal ion-implanted tissue-interfacing surface,” because “antimicrobial metal ions embedded [in a surface] does not correspond to the coating disposed on the surface,” as claimed. Appeal Br. 12; Reply Br. 16- 18. However, as discussed supra, a preponderance of the evidence supports the Examiner’s finding that Bricault’s use of the IBAD process results in a coating, as claimed. See, e.g., Bricault 3:51-55 (incorporating by reference U.S. Pat. No. 5,236,509, Titled, “Modular IBAD Apparatus for Continuous Coating” (emphasis added)), 5:29-47 (discussing “the growing film” and a surface treatment that “includes the coating 220”), Fig. 2A (depicting coating 220 incorporating coating atoms). Regarding Appellant’s argument that Bricault’s IBAD process is only disclosed as applicable to the outer surface of a catheter (see, e.g., Reply Br. 8-9, 9-11), in comparison to claim 1 supra, claim 7 does not require the substantially non-eluting copper coating to be disposed only on a portion of Appeal 2021-002626 Application 15/085,463 10 a surface of a lumen (i.e., the inner surface or bore of a tube, or portions of an inner fluid passageway), but rather, claim 7 recites that “a substantially non-eluting copper coating [is] disposed on at least a portion of a surface of at least one of the lumen, the extension leg, the luer connector, the first portion of the fluid passageway, or the second portion of [the] fluid passageway,” Emphasis added; cf. Appeal Br. 26 (Claims App.) (see claim 8, which further limits claim 7 by reciting, “wherein at least an interior surface of the luer connector and an interior surface of the second portion of the fluid passageway of the bifurcation hub includes the copper coating thereon”); id. (claim 11, which further limits claim 7 by reciting, “wherein at least one of an interior surface or an exterior surface of the luer connector includes the copper coating thereon”). Rosenblatt discloses that “antimicrobial agent 132 may be coated . . . over the connector hub 116,” which the Examiner relies on for disclosing a bifurcation hub, such that a preponderance of the evidence supports the Examiner’s finding that Rosenblatt discloses an antimicrobial coating on at least a portion of a surface of a luer connector, which may include an outer (or tissue interfacing) surface, such that the Examiner’s reasoning has factual underpinning. Notably, we do not read the limitation in claim 7 that recites, the thickness of the copper coating and the presence of the water-shed coating over the copper coating resulting in release of copper particles in a copper concentration of less than about 1.5 parts per million in an infused medicament or aspirated blood when in the contact with the copper coating, as limiting the copper coating to an inner surface of a lumen through which infused medicament or aspirated blood must pass; rather, the limitation is the Appeal 2021-002626 Application 15/085,463 11 recitation of a threshold that must be met when such coatings are subjected to such contact. Next, Appellant argues that Bennett’s “layer of oxidized metal” is not a “water-shed layer,” as claimed. Appeal Br. 12-13; see also Reply Br. 8-9. In particular, Appellant submits that Appellant’s Specification discloses that “the water-shed layer prevents tarnishing of the copper coating by oxidation” (citing Spec. ¶ 36) and that “[i]f a metal oxide layer was suitable for the water-shed layer, the copper coating disposed on the claimed medical device would simply be allowed to oxidize”; to the contrary, “a metal oxide layer is not suitable for the water-shed layer because the metal oxide layer would be an impenetrable barrier precluding the copper coating from contacting microbes and functioning as an antimicrobial.” Id. Appellant submits that the claimed water-shed layer “is penetrable by microbes by way of the antimicrobial efficacy of a copper-coated Luer connector,” as depicted in Figure 16 of the Specification. Id. at 13. (citing Spec. ¶ 56, Fig. 16); see also Reply Br. 8-9. The Examiner responds that Appellant fails to provide sufficient evidence that an oxide layer is an impenetrable barrier that causes the copper coating not to function as an antimicrobial layer, and further, that Appellant is arguing limitations that not recited in claim 1. Ans. 15. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Appeal 2021-002626 Application 15/085,463 12 Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A construction that is “unreasonably broad” and which does not “reasonably reflect the plain language and disclosure” will not pass muster. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015). “Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.” SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). During patent prosecution, when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). The Specification discloses that [a] final water-shed overcoating layer can then be applied in one embodiment to prevent tarnishing via oxidation of the coating 42. In one embodiment, the water-shed layer is applied by immersing the coated component in a solution containing butoxyethanol and butoxyethoxyethanol for a predetermined time. . . . FIG. 12 shows a representative cross-sectional view of a coated portion of a medical device . . . , showing surface 100 of the medical device with the coating 42 atop the surface and a water-shed layer 104 atop the coating 42. Spec. ¶ 36. Thus, although the Specification discloses that the purpose of this water-shed coating is to prevent tarnishing via oxidation of substantially non-eluting antimicrobial coating 42 (see Spec. ¶ 31), the Specification does not expressly provide a definition for a water-shed coating, for example, as a coating that must have a non-oxidizing property-nor has Appellant Appeal 2021-002626 Application 15/085,463 13 provided a definition for the claim term (i.e., a definition of the term as known in the art).4 We agree with the Examiner that to require the water-shed coating to be a coating that prevents tarnishing via oxidation of the substantially non- eluting copper coating is to improperly import a limitation into claim 1. We also agree with the Examiner that Appellant does not present sufficient argument or evidence addressing the Examiner’s rationale for modifying Stout, as modified by Bricault, in view of Bennett, namely, to prevent oxidation of the copper; rather, Appellant merely concludes that Bennett’s metal oxide layer would be an impenetrable barrier precluding Stout’s copper coating, as modified by Bricault, from functioning as an antimicrobial. Attorney argument cannot take the place of evidence in the record. Estee Lauder, Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed.Cir. 1997). Thus, Appellant’s argument fails to apprise us of error in the Examiner’s finding of a water-shed coating relative to Bennett, or reasoning that the water-shed coating may be applied to prevent oxidation of the copper coating. Appellant further argues that “the Examiner does not provide a valid rationale for why a [person having ordinary skill in the art] would look to Bricault for an antimicrobial metal coating as a sub-genus of Rosenblatt’s antimicrobial coating, much less an antimicrobial copper coating as a species thereof.” Appeal Br. 20. Appellant submits that “Bricault merely 4 The Examiner notes in the Advisory Action (dated June 26, 2020) that the claim term “water-shed coating” raises “indefiniteness issues since it cannot be determined what other compounds would meet this claimed term,” however, there is no indefiniteness rejection on the record before us. Adv. Act. 2. Appeal 2021-002626 Application 15/085,463 14 appears to teach a benefit of implanting antimicrobial metal ions over some unidentified alternative(s)”: “lengthen[s] the time period over which the component implanted with the antimicrobial metal [ions] exhibits antimicrobial properties.” Id. (citing Bricault 5:48-52). We disagree with Appellant, in that the Examiner proposes substituting one known antimicrobial for another, relying on Bricualt’s teaching that “the term ‘antimicrobial metal’ refers to atoms or molecules which exhibit antimicrobial properties, wherein such metals include . . . copper.” Bricault 5:2-7. Where “a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). We also find that the Examiner’s reasoning has rational underpinning as Bricault itself teaches that “[a]n object of the present invention is to lengthen the time period over which the component implanted with the antimicrobial metal exhibits antimicrobial properties.” Bricault 5:49-50. As discussed supra, a preponderance of the evidence supports the Examiner’s finding that Bricault discloses a coating, in addition to (or while at the same time) embedding metal ions to provide a nonleaching property. See, e.g., Bricault, Fig. 2A. Accordingly, we sustain the Examiner’s rejection of independent claim 7. Dependent claim 10 Claim 10 depends from independent claim 7 and recites, in relevant part, “wherein the copper coating elutes less than about 0.01% of a total Appeal 2021-002626 Application 15/085,463 15 copper content of the copper coating after about 24 hours of fluid contact with the copper coating.” Appeal Br. 26 (Claims App.). The Examiner finds that Bricault teaches that “the leachability of the antimicrobial ions should be optimized to produce as small a release as possible.” Final Act. 15 (citing Bricault 12:58-68). The Examiner relies on the disclosure in Bricault wherein “the antimicrobial metal ions can be embedded within or upon the surface,” which the Examiner finds discloses the general conditions of the claim. Ans. 19 (citing Bricualt 3:44-47). The Examiner reasons that although Bricault does not disclose the claimed range of about 0.01%, “Bricault teaches that it is advantageous to have minimal leaching of the metal ions from the coating,” and therefore, it would have been obvious to have optimized the amount of copper which elutes from the copper coating for the purposes of developing an antimicrobial coating which retains as much of its antimicrobial properties for as long as possible since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Id. (citing In re Aller, 220 F.2d 454,456 (CCPA 1955)). Appellant argues that “the tissue-interfacing surface of Bricault include the antimocrbial ions embedded therein, which simply does not correspond to the coating disposed on the surface of the medical device such as the claimed catheter,” and therefore, Bricault does not disclose the general conditions of the claim. Appeal Br. 21; see also Reply Br. 18. We are not persuaded by Appellant’s argument. Claim 7 requires a substantially non-eluting copper coating disposed on at least a portion of a surface of, for example, a luer connector, and the Examiner relies on Appeal 2021-002626 Application 15/085,463 16 Bricualt’s coating, which involves embedding ions to achieve non-eluting properties as discussed supra. In other words, although the Specification discloses that non-eluting properties may “vary according to various factors, including device surface composition, the type of fluid the copper coating is exposed to, copper coating thickness, the presence of an over-coating atop the copper coating, etc.” (Spec. ¶ 32), the claims do not exclude embedding the ions in the surface to achieve the non-eluting properties while forming a copper coating. Thus, we are not apprised of error in the Examiner’s reliance on Bricualt as disclosing the general conditions of the claim relative to the release of copper particles from a substantially non-eluting copper coating. Accordingly, we sustain the Examiner’s rejection of claim 10. Rejection VI Claim 8 depends from claim 7 and recites, in relevant part, “wherein at least an interior surface of the luer connector and an interior surface of the second portion of the fluid passageway of the bifurcation hub includes the copper coating thereon.” Appeal Br. 26 (Claims App.). The Examiner relies on DiFiore for teaching application of an antimicrobial coating to the claimed interior surfaces. Final Act. 16. Appellant argues that “DiFiore does not indicate the antibacterial agent or material is a copper coating,” noting that “the Examiner relies on the modification of Rosenblatt with Bricault for the alleged ‘[] added advantage of prolonging the antimicrobial effects to the device’ of a copper coating.” Appeal Br. 22; see also Reply Br. 19-20. Appellant further argues that the Examiner’s proposed modification of Rosenblatt, in view of Bricault, and further, in view of DiFiore, “would require undue Appeal 2021-002626 Application 15/085,463 17 experimentation” and “would not have a reasonable expectation of success.” Id. We are persuaded by Appellant’s argument for the reasons discussed supra with respect to independent claim 1, in that the Examiner’s modification of Rosenblatt to include a substantially non-eluting copper coating, as taught by Bricault, on inner surfaces, as further taught by DiFiore, lacks a factual basis, as Bricault’s non-eluting copper coating is achieved by embedding metal ions into the surface and Bricault does not disclose doing so on the inner surface of a catheter (i.e., on a lumen). Accordingly, we do not sustain the Examiner’s rejection of claim 8 and claim 9 depending therefrom. Rejection VII Appellant does not present arguments for the patentability of claims 11 and 12, which depend from independent claim 7, apart from the arguments presented for independent claim 7 supra. Therefore, for essentially the same reasons as presented supra, we also sustain the Examiner’s rejection of claims 11 and 12. Appeal Br. 23. CONCLUSION The Examiner’s rejections of claims 1, 2, 4-6, 8, 9, 13-18, and 31 are reversed, and the Examiner’s rejections of claims 7 and 10-12 are affirmed. Appeal 2021-002626 Application 15/085,463 18 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 6, 13, 15, 16, 18 103 Stout, Bricault, Bennet 1, 4, 6, 13, 15, 16, 18 2, 31 103 Stout, Bricault, Bennet, Sioshansi 2, 31 14 103 Stout, Bricault, Bennet, Sansoucy 14 5, 17 103 Stout, Bricault, Bennet, Malik 5, 17 7, 10 103 Rosenblatt, Bricault, Bennett, Sioshansi 7, 10 8, 9 103 Rosenblatt, Bricault, Bennett, Sioshansi, Sansoucy 8, 9 11, 12 103 Rosenblatt, Bricault, Bennett, Sioshansi, Sansoucy, Lynn 11, 12 Overall Outcome 7, 10-12 1, 2, 4-6, 8, 9, 13-18, 31 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 IN PART