Christina D'Arrigo et al.Download PDFPatent Trials and Appeals BoardJun 23, 20212020002656 (P.T.A.B. Jun. 23, 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. 12/376,151 10/12/2009 Christina Joy D'Arrigo P-6889/1 4392 67309 7590 06/23/2021 Servilla Whitney LLC/BDX 33 Wood Ave South, Suite 830 Iselin, NJ 08830 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 06/23/2021 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): docket@dsiplaw.com ip.docket@bd.com lmurphy@dsiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CHRISTINA JOY D’ARRIGO and ERIC R. SCHILLER Appeal 2020-002656 Application 12/376,151 Technology Center 3700 ____________ Before MURRIEL E. CRAWFORD, MICHAEL C. ASTORINO, and TARA L. HUTCHINGS, Administrative Patent Judges. ASTORINO, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision to reject claims 1 and 4–24. 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. The Appellant identifies “[t]he real party in interest [a]s Becton, Dickinson and Company, the assignee of record.” Appeal Br. 4. Appeal 2020-002656 Application 12/376,151 2 STATEMENT OF THE CASE Subject Matter on Appeal The Appellant’s “invention relates to a syringe and needle assembly having structure for consistently minimizing dead space in a syringe barrel while containing an effective seal between the syringe barrel and the needle assembly.” Spec. ¶ 1. Dead space refers to the “space inside the barrel tip and between the end of the barrel tip and the end of the cavity in the hub . . . [that] contain[s] liquid that cannot be delivered by the syringe.” Id. ¶ 2. Claims 1, 22, and 24 are the independent claims on appeal.2 Claim 1, reproduced below with some paragraphing added, is illustrative of the claimed subject matter. 1. A syringe and detachable needle assembly having reduced dead space features comprising: an elongate syringe barrel having a longitudinal axis, an inside surface defining a chamber for retaining fluid, an open proximal end, an open distal end including a collar and a flat distally facing annular surface projecting inwardly from said collar, a portion of said collar having a cylindrically shaped, axially aligned circular side wall; a needle assembly including a hub having a body portion including a proximal end, a distal end, a conduit therethrough, a flat proximally facing annular surface at the proximal end of said body portion positioned at an angle in the range of 88° to 92° with respect to the longitudinal axis of the syringe barrel; wherein said flat proximally facing annular surface on said body portion contacting said annular surface of said barrel forming a primary seal between said hub and said barrel, said hub of the needle assembly further including an outwardly 2 We determine that the Claims Appendix in the Appeal Brief mislabeled claim 24 as claim 25. See also Appeal Br. 9–10. Appeal 2020-002656 Application 12/376,151 3 projecting annular sealing ring contained in an annular groove around the body portion of the hub, the annular groove and sealing ring positioned proximal of an entirety of a collar- engaging structure on the hub of the needle assembly for engaging complementary hub-engaging structure on an inside surface of the circular side wall of the collar of the syringe barrel, the annular sealing ring sealingly engaging said inside surface of the circular side wall of said collar of the syringe barrel to form a secondary seal between said hub and said inside surf ace of said circular side wall of said collar wherein the secondary seal is a backup seal in the event that a user fails to provide enough rotational torque while connecting the hub to the barrel to adequately engage the primary seal, said needle assembly further including a cannula having a distal end, a proximal end and a lumen therethrough, said proximal end of said cannula being connected to said distal end of said hub so that said lumen is in fluid communication with said chamber; and the collar-engaging structure is positioned distal to an entirety of the annular groove for releasably engaging said hub to said collar, wherein a first position where said circular side wall of said collar and said annular sealing ring of said hub are engaged with each other is positioned between a second position and a third position, said second position being a position where said annular surface of said barrel and said annular surface of said hub are contacted each other, said third position being a position where said collar-engaging structure and said hub-engaging structure are engaged with each other. References The prior art relied upon by the Examiner is: Name Reference Date Bell et al. (“Bell”) US 5,273,543 Dec. 28, 1993 Botich et al. (“Botich”) US 5,788,677 Aug. 4, 1998 Nguyen et al. (“Nguyen”) US 5,827,218 Oct. 27, 1998 Wiklund US 6,629,957 B1 Oct. 7, 2003 Sharp US 6,699,223 B2 Mar. 2, 2004 Caizza et al. (“Caizza”) US 6,840,291 B2 Jan. 11, 2005 Appeal 2020-002656 Application 12/376,151 4 Donnan et al. (“Donnan”) US 2004/0006312 A1 Jan. 8, 2004 Fangrow US 2006/0161115 A1 July 20, 2006 Watts et al. (“Watts”) US 2006/0200085 A1 Sept. 7, 2006 Rejections Claims 1, 4, 5, 7, 10, 12–18, 20, 22, and 23 are rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, and Nguyen. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Bell. Claims 8, 9, 11, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Wiklund.3 Claims 9, 11, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Botich.4 Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Fangrow. Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Donnan. 3 Although the Examiner sets forth separate statements for the rejection of claims 8, 9, and 11 (Final Act. 13) and claim 24 (id. at 17), we consolidate the statements into a single ground of rejection because they are each based upon same the combination of references. 4 Although the Examiner sets forth separate statements for the rejection of claims 9 and 11 (Final Act. 14) and claim 24 (id. at 25), we consolidate the statements into a single ground of rejection because they are each based upon same the combination of references. Appeal 2020-002656 Application 12/376,151 5 ANALYSIS The Appellant argues claims 1, 4, 5, 7, 10, 12–18, 20, 22, and 23 as a group. See Appeal Br. 11–25. We select claim 1 as representative. Claims 4, 5, 7, 10, 12–18, 20, 22, and 23 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). The Appellant argues that the Examiner’s rejection of claim 1 is improper because “(a) prima facie obviousness has not been established, and (b) the cited primary reference teaches away from the [c]laimed [i]nvention.” Appeal Br. 11. For the foregoing reasons we determine that the Appellant’s arguments are not persuasive of Examiner error. (A) Prima Facie Obviousness Has Been Established The Appellant points out that the Examiner’s rejection includes a finding that “Caizza does not disclose sealing engagement provided by an annular sealing ring.” Id. at 18. The Appellant argues: None of Watts, Sharp or Nguyen teach or suggest a device in which the annular groove and the sealing ring it contains are positioned on the hub of the needle assembly proximal to the entirety of a collar-engaging structure which is also on the needle hub to form a secondary seal between the needle hub and the inside surface of the circular side wall of the collar of the syringe barrel. Id. at 19–20. The Appellant’s argument is not persuasive of Examiner error. The Examiner’s rejection includes a modification of Caizza’s syringe and detachable needle assembly with teachings from Watts, Sharp, and Nguyen to result in, said hub of the needle assembly further including an outwardly projecting annular sealing ring contained in an annular groove around the body portion of the hub, the annular groove and Appeal 2020-002656 Application 12/376,151 6 sealing ring positioned proximal of an entirety of a collar- engaging structure on the hub of the needle assembly for engaging complementary hub-engaging structure on an inside surface of the circular side wall of the collar of the syringe barrel, as recited claim 1. See Final Act. 5–11; Ans. 20–27. More specifically, the Examiner finds that Caizza’s syringe and detachable needle assembly includes a sealing engagement between “a collar-engaging structure (i.e. threads 358) for engaging a complementary hub-engaging structure (331) on the circular side wall of the collar.” Final Act. 5 (citing Caizza Fig. 20); see Caizza Figs. 21–24. The Examiner also finds that Caizza fails to teach “the hub of the needle assembly further include[s] an outwardly projecting annular sealing ring.” Final Act. 5. Similar to Caizza, the Examiner finds that Watts teaches a sealing engagement between the cooperative geometry of a hub and syringe alone. Id. (citing Watts Fig. 2). Different from Caizza, the Examiner finds that Watts teaches an alternative sealing engagement that further includes a projecting annular sealing ring at various locations on the hub to form a cooperative seal with the syringe. See id. (citing Watts ¶¶ 44–46, Figs. 2); see also Watts Figs. 3A, 3B, 3C. The Examiner determines that it would have been obvious for one having ordinary skill in the art to modify Caizza’s sealing engagement with Watts’ teaching of an alternative sealing engagement having a projecting annular sealing ring (i.e., a secondary seal) for the purposes of redundancy to ensure there is no contamination or leakage of the retained contents of the syringe. See Final Act. 5–6; Ans. 21. As for the particular location of the seal, the Examiner relies on Sharp’s teachings as well as Nguyen’s teachings. See Final Act. 6–8; see also id. at 8–11. Specifically, the Examiner finds that Sharp teaches: Appeal 2020-002656 Application 12/376,151 7 a syringe having a collar (16) engageable with a hub (20) via a collar-engaging structures (54)[,] which corresponds to complimentary hub engaging structures (56)[,] wherein the hub further includes an outwardly projecting annular sealing ring (60) contained in an annular groove (65) around the body portion of the hub ([s]ee Fig. 2), the annular groove and sealing ring being positioned proximal of an entirety of the collar- engaging structure (see Fig. 2 on the hub of the needle assembly) the annular sealing ring sealingly engaging an inside surface of the circular side wall of said collar (see Fig[.] 2) to form a seal between the hub and the collar[,] and the collar engaging structure is positioned distal to an entirety of the annular groove for releasably engaging the hub to the collar (Fig. 2). As such, Sharp establishes a known suitable location for a sealing ring in a threaded needle hub which is received within and engages corresponding threads of a circumferential syringe collar (a mounting structure shared with the Caizza syringe construction). See id. at 6–7. The Examiner makes additional findings based on Nguyen (id. at 7), but clarifies in the Answer that “Nguyen is only purported to demonstrate the effectiveness of a secondary seal (53) retained within an annular groove between two threaded cooperating geometries of a medical device structure” (Ans. 26 (italics added)). The Examiner determines: It would have been obvious for one having ordinary skill in the art . . . to configure the device of Caizza to include an annular sealing ring provided within an annular groove in the hub to form a secondary seal between the hub and the collar, as disclosed by Sharp and Nguyen[,] thereby only providing a well-known means of affixing a[n] o-ring seal to a hub as is known in the medical environment. Furthermore, it would have been obvious for one having ordinary skill in the art . . . to provide the annular groove proximal to collar engaging threads, as disclosed by Sharp, thereby only achieving the expected results of utilizing a well-known location for such a[n] annular o-ring seal to provide for known, suitable and predictable results of provide a sealing function between a cannula hub and Appeal 2020-002656 Application 12/376,151 8 syringe collar. . . . Only the expected and predictable results of selecting a known location, to provide a known sealing device, to provide a secondary seal between a syringe and cannula hub as is known in the art would be achieved. Final Act. 7–8. We determine that the foregoing findings and determinations from the Examiner’s rejection are adequately supported and result in said hub of the needle assembly further including an outwardly projecting annular sealing ring contained in an annular groove around the body portion of the hub, the annular groove and sealing ring positioned proximal of an entirety of a collar- engaging structure on the hub of the needle assembly for engaging complementary hub-engaging structure on an inside surface of the circular side wall of the collar of the syringe barrel, as recited claim 1. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds . . . [require] some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). The Appellant argues that each of the embodiments in Watts’ Figures 3A–3C individually do not include the claimed configuration in which the annular sealing ring sealingly engages the inside surface/interior threaded surface of the circular side wall of the collar of the syringe barrel to form a secondary seal. Appeal Br. 19–21. The Appellant’s argument, however, is not consistent with the Examiner’s rejection. As we explain above, the Examiner does not rely on Watts for the location of the sealing ring. Rather, the Examiner relies on Watts to teach a secondary seal for the purposes of redundancy and Sharp to teach the location of the secondary seal. Appeal 2020-002656 Application 12/376,151 9 The Appellant argues that Sharp’s “seal is formed between the adapter and the reduced diameter section of the syringe barrel, not between the needle hub and the inside surface of the circular side wall of the syringe barrel collar as claimed.” Id. at 22. The Appellant’s argument is not persuasive of Examiner error. We agree and adopt as our own the Examiner’s response at pages 22–25 of the Answer, which explains how one of ordinary skill in the art would understand that Sharp’s adapter is part of a hub and that Sharp’s seal is positioned between the hub and syringe barrel collar. The Appellant submits that “Nguyen is also cited as evidence of the claimed configuration of the annular sealing ring on a needle hub” and argues that Nguyen fails to teach a seal “between a needle hub and an inside surface of a syringe barrel collar.” Id. at 23. The Appellant’s argument is not persuasive of Examiner error. As we explained above, the Examiner clarifies in the Answer that “Nguyen is only purported to demonstrate the effectiveness of a secondary seal (53) retained within an annular groove between two threaded cooperating geometries of a medical device structure.” Ans. 26 (italics added). The Appellant also argues that the Examiner’s “rejection is merely an assertion that the claimed configuration could have been made, likely with aid of impermissible hindsight.” Appeal Br. 24. Similarly, the Appellant argues “that one of skill in the art would not have a reason to look to the secondary references for the inclusion of a gasket in the device.” Id. at 19. The Appellant’s arguments are not persuasive of Examiner error. As we discussed above, we determine that the Examiner’s findings and determinations are adequately supported. Appeal 2020-002656 Application 12/376,151 10 (B) Caizza Does Not Teach Away from the Claimed Invention The Appellant argues that “Caizza teaches away from the use of gaskets, including a projecting annular sealing ring.” Id. at 17; see generally id. at 13–18; Reply Br. 2–5, 10–16.5 The Appellant’s argument primarily relies on two assertions: (1) Caizza’s “invention provides a clear departure and improvement over the prior art by offering features such as leakage protection without the use of gaskets” (Appeal Br. 13 (emphasis omitted); see also Reply Br. 3–16); and (2) Caizza’s non-retractable needle embodiment, which is relied upon by the Examiner, lacks “a clear location of a gasket, nor is there a clear need in Caizza to include an annular sealing ring” (id. at 14). The Appellant’s argument is not persuasive of Examiner error. The Appellant bases the first assertion on the following description regarding Caizza’s retracting needle embodiment: One of the issues not well addressed by the prior art is leakage. During use, the contents of the syringe are subject to high pressures, both positive and negative, when trying to draw in and deliver medications, especially with viscous medications. To help prevent leakage, preferably without having to use a gasket, the preferred embodiment includes tapered cylindrical surface 69 on inner hub 61 and tapered cylindrical surface 35 on the inside of cylindrical collar 31 of the barrel. When the retracting needle assembly engages the collar of the barrel, the tapered cylindrical surface 35 on the collar engages tapered cylindrical surface 69 on the inner hub to seal the interface 5 The Reply Brief lacks page numbers. We designate page 1 as the page that includes the heading “REPLY BRIEF” and number the remaining pages in the Reply Brief consecutively therefrom. Appeal 2020-002656 Application 12/376,151 11 between the hub and the collar to prevent leakage during normal use. The present invention provides a clear departure and improvement over the prior art by offering features such as leakage protection without the use of gaskets, and low dead- space in combination with a removable retracting needle assembly. Caizza col. 8, ll. 45–62 (italics added); see id. at Figs. 6–10. According to the Appellant: The [Examiner’s] assertion that Caizza acknowledges the usefulness of gaskets in preventing leakage is not explicitly supported by the specification of Caizza. Even if Caizza’s disclosure of “[to] help prevent leakage, preferably without the use of a gasket” may imply the usefulness of gaskets in preventing leakage, Caizza read as a whole “provides a clear departure and improvement over the prior art by offering features such as . . . leakage protection without the use of gaskets, and low dead-space in combination with a removable retracting needle assembly.” Reply Br. 4 (footnotes omitted). The Examiner responds that Caizza’s use of the word “‘preferably’ is not a blanket prohibition against the usage of gaskets.” Ans. 8 (“The term ‘preferably’ is ordinarily defined as ‘ideally; if possible.’” (citing Oxford University Press Online Dictionary)). The Examiner explains: an ordinary artisan would reasonably recognize and appreciate that Caizza implicitly acknowledges (by usage of “preferably” versus a clear and unambiguous prohibition upon the usage of gaskets) that in some instances the usage of gaskets may be necessary to prevent leakage, e.g. medicaments which are required to be sealed against air infiltration, viscous medicaments which require substantial forces to expel, thin hydrophobic medicaments that tend to leak past non- elastomeric seals ... etc. Id. The Examiner has the better position. Appeal 2020-002656 Application 12/376,151 12 First, we agree with the Examiner that Caizza does not exclude the possibility of using a gasket for leakage protection. This is why Caizza also describes, “[t]o help prevent leakage, preferably without having to use a gasket, the preferred embodiment includes tapered cylindrical surface 69 on inner hub 61 and tapered cylindrical surface 35 on the inside of cylindrical collar 31 of the barrel” (Caizza col. 8, ll. 48–52 (italics added)), which implies that a gasket may be included. We determine that one of ordinary skill in the art would understand Caizza to allow the use of a gasket for further leakage protection when there would be a benefit to its inclusion; for example, redundant protection by way of a secondary seal. See Final Act. 5–6. Second, as the Appellant acknowledges in the Reply Brief (see Reply Br. 3), Caizza attributes the improved leakage protection without the use of gaskets to the tapered surfaces of the retracting needle embodiment. See Caizza col. 8, ll. 48–62. Specifically, when the retracting needle assembly engages the collar of the barrel, tapered cylindrical surface 35 on the collar engages tapered cylindrical surface 69 on the inner hub to seal the interface between the hub and the collar to prevent leakage. Id. at col. 8, ll. 53–57; see also id. at Figs. 6–10. We agree with the Appellant that one of ordinary skill in the art would understand that, in terms of leakage protection, Caizza’s retracting needle assembly with tapered cylindrical surfaces 35, 69 is a clear departure and improvement over a prior art retracting needle assembly that lacks these tapered cylindrical surfaces. However, as the Appellant also acknowledges (see Reply Br. 4), the Examiner relies on the non-retractable needle embodiment, which does not include tapered surfaces, to reject the claims. See, e.g., Final Act. 3 (citing Appeal 2020-002656 Application 12/376,151 13 Caizza Figs. 20, 22); Ans. 7 (citing Caizza Fig. 20). Nonetheless, the Appellant contends that Caizza’s “superior leak protection” without the use of gaskets, which is afforded by tapered surfaces, applies equally to the non- retractable needle embodiment. See Reply Br. 3; see also id. at 4 (asserting that “Caizza read as a whole ‘provides a clear departure and improvement over the prior art by offering features such as . . . leakage protection without the use of gaskets”). Specifically, the Appellant argues that in Caizza’s non- retractable needle embodiment, a “tight fitment between a distal surface 335 of the barrel and a ‘proximally-facing frustoconically shaped surface 359 [is] positioned to contact distal surface 335 on the barrel to prevent liquid flow . . .’ without the use of a gasket.” Id. According to the Appellant: Caizza distinguishes between retractable and non- retractable needle assemblies only with regard to low dead space. The reason why Caizza discloses a retractable needle assembly (of the “preferred embodiment” of Figures 6-10) and a non-retractable needle assembly (of Figure 20) is because the retractable needle assembly is directed to the second aim of Caizza. The second aim of Caizza is disclosed as “[another] important feature of the present invention is providing a retracting needle syringe with low dead space”. Caizza directs the feature of low dead space only with the embodiments having a retractable needle assembly. As such, a fair reading of Caizza is “[the] present invention provides a clear departure and improvement over the prior art by offering features such as leakage protection without the use of gaskets,” (of the invention as a whole) “and low dead-space in combination with a removable retracting needle assembly.” The comma which separates these two clauses is clearly in line with the previously disclosed “important feature”; namely “[another] important feature of the present invention is providing a retracting needle syringe with low dead space”. Reply Br. 12 (footnotes omitted); see id. at 8–9. Appeal 2020-002656 Application 12/376,151 14 Yet, the structure of the two embodiments differ substantially. For example, unlike tapered cylindrical surfaces 31 and 69 in the retracting needle embodiment, the corresponding proximally-facing frustoconically shaped surface 359 and distal surface 335 on the barrel/collar in the non- retracting needle embodiment are not located on cylindrical surfaces that extend away from the terminal end surfaces of the hub and collar. Compare id. at Figs. 6, 8 with Figs. 22, 24. Additionally, tapered cylindrical surfaces 31 and 69 in the retracting needle assembly are not threaded (see, e.g., id. at Figs. 6, 8–10), whereas the corresponding cylindrical surfaces in the non- retracting needle assembly are threaded (see, e.g., id. at Figs. 20, 22, 24). When comparing the “tight fitment” between the hub and the collar for each embodiment, one of ordinary skill in the art would understand that the corresponding surfaces are at different locations and have different structural characteristics. Accordingly, the Appellant does not persuade us that Caizza’s non-retractable needle embodiment, which forms the basis of the Examiner’s rejection, provides similar leakage protection to the superior leakage protection provided without gaskets by the retracting needle embodiment. As such, we understand the features of Caizza’s present invention that provide a “clear departure and improvement over the prior art,” as described in column 8, lines 58–62, to be directed solely to the retracting needle assembly embodiment. However, even if we were to agree with the Appellant that Caizza’s non-retractable needle embodiment also provides a clear departure and improvement over the prior art by offering leakage protection without the use of gaskets, we do not understand Caizza to discourage the use of a gasket for further leakage protection if there is a benefit to its inclusion, as Appeal 2020-002656 Application 12/376,151 15 we describe above. In view of the foregoing, we are not persuaded that a person of ordinary skill, upon reading Caizza, would be discouraged from using a gasket for further leakage protection or would be led in a direction divergent from using projecting annular sealing ring. See Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). Therefore, we disagree with the Appellant that Caizza teaches away from the use of gaskets, including a projecting annular sealing ring. The Appellant’s second assertion — i.e., Caizza’s non-retractable needle embodiment, which is relied upon by the Examiner, lacks “a clear location of a gasket, nor is there a clear need in Caizza to include an annular sealing ring” (Appeal Br. 14) — is also not persuasive. First, the Examiner’s rejection adequately supports the modification of Caizza’s assembly to include a secondary seal (i.e., gasket/annular sealing ring) and the location thereof by articulating reasoning with rational underpinning. Second, the Appellant’s argument confuses silence as to the inclusion of a gasket in Caizza’s non-retractable needle embodiment with a teaching that discourages and/or diverges from the inclusion of a gasket. See Galderma Labs., 737 F.3d at 738. The Appellant submits additional arguments that are similar to those addressed above. See Appeal Br. 18; Reply Br. 5–9. One such argument is that the Examiner’s proposed combination “would frustrate the principle of operation of the needle assembly of Caizza.” Appeal Br. 18. Each of these additional arguments is not persuasive of Examiner error as they are each premised on the same or similar points and assertions discussed above. We have considered the Appellant’s remaining points and assertions in the Appeal 2020-002656 Application 12/376,151 16 Appeal and the Reply Briefs as to why the Examiner erred and determine that they are not persuasive. Thus, we sustain the Examiner’s rejection of claim 1 as well as claims 4, 5, 7, 10, 12–18, 20, 22, and 23. See 37 C.F.R. § 41.37(c)(1)(iv). The Appellant includes further headings, but lacks further arguments for the rejections of claims 6, 8, 9, 11, 19, 21, and 24. Id. at 25–30. We likewise sustain the Examiner’s rejections of these claims as well. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1, 4, 5, 7, 10, 12–18, 20, 22, 23 103(a) Caizza, Watts, Sharp, Nguyen 1, 4, 5, 7, 10, 12–18, 20, 22, 23 6 103(a) Caizza, Watts, Sharp, Nguyen, Bell 6 8, 9, 11, 24 103(a) Caizza, Watts, Sharp, Nguyen, Wiklund 8, 9, 11, 24 9, 11, 24 103(a) Caizza, Watts, Sharp, Nguyen, Botich 9, 11, 24 19 103(a) Caizza, Watts, Sharp, Nguyen, Fangrow 19 21 103(a) Caizza, Watts, Sharp, Nguyen, Donnan 21 Overall Outcome 1, 4–24 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation