Ex Parte AndreoniDownload PDFPatent Trial and Appeal BoardDec 14, 201712861258 (P.T.A.B. Dec. 14, 2017) 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. 12/861,258 08/23/2010 TODD RYAN ANDREONI P-8790 (066810-01317) 1681 47058 7590 12/18/2017 David W. Highet, VP & Chief IP Counsel Becton, Dickinson and Company (Dickinson Wright PLLC) 1 Becton Drive, MC 110 Franklin Lakes, NJ 07417-1880 EXAMINER PATEL, SHEFALI DILIP ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 12/18/2017 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): lorraine_kow alchuk @ bd .com ip_docket @bd.com DWPatents @ dickinson wright. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TODD RYAN ANDREONI Appeal 2016-008206 Application 12/861,258 Technology Center 3700 Before JENNIFER D. BAHR, LEE L. STEPINA, and ANTHONY KNIGHT, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Todd Ryan Andreoni (Appellant)1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision, set forth in the Final Action (Aug. 18, 2015) [hereinafter “Final Act.”] and restated in the Answer (July 1, 2016) [hereinafter “Ans.”] rejecting claims and 6-19. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 The Appeal Brief (Feb. 18, 2016) [hereinafter “Appeal Br.”] identifies Becton, Dickinson and Company as the real party in interest. Appeal Br. 3. Appeal 2016-008206 Application 12/861,258 THE CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A skin engagement member for use with a needle assembly or a medical injector to minimize irritation of a patient’s skin surrounding an injection site, the needle assembly or the medical injector including a body member, a needle extending from the body member and a shield for selectively covering a distal end of the needle, wherein the shield is movable relative to a distal end of the body member, said skin engagement member comprising; a body; a surface defined on said body for engaging the patient’s skin during injection by the needle; an aperture formed through said body configured to permit passage therethrough of the needle; and, rotatable mounting features for rotatably mounting said body to said shield to permit relative rotation therebetween about said aperture wherein the body is axially fixed relative to the shield. REJECTIONS2 I. Claims 1^1 and 6-19 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. II. Claims 1—4, 6-8, and 11 stand rejected under 35 U.S.C. § 102(b) as anticipated by Moos (US 2006/0276747 Al, published Dec. 7, 2006). 2 The Examiner withdrew rejections under 35 U.S.C. § 112, second and fourth paragraphs, set forth in the Final Action. Advisory Action 2 (Nov. 27, 2015); Ans. 8. 2 Appeal 2016-008206 Application 12/861,258 III. Claims 9, 10, and 12-19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Moos and DiBiasi (US 2008/0177235 Al, published July 24, 2008). DISCUSSION Rejection I—Written Description The Examiner finds that “the Specification does not state or describe that ‘the body is axially fixed relative to the shield,’” as recited in independent claims 1 and 11. Ans. 3. Appellant submits that paragraphs 16 and 17 of the Specification, with reference to Figure 4, provide support for this limitation. Appeal Br. 9 The fundamental factual inquiry for ascertaining compliance with the written description requirement is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. See Ariad Pharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). “This inquiry ... is a question of fact,” and “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. “The specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. Referencing Figure 4, paragraph 16 of Appellant’s Specification discloses rotatably mounting body 16 to needle assembly 12 or medical injector 14 by means of snap fingers 40 protruding from body 16 to engage mounting hole 38 in needle assembly 12 or medical injector 14 “so as to be 3 Appeal 2016-008206 Application 12/861,258 axially fixed relative thereto with relative rotation being permitted.” Paragraph 17 of the Specification describes providing needle assembly 12 or medical injector 14 with shield 42. Paragraph 17 of the Specification further discloses that “body 16 may be rotatably mounted to the shield 42 in the same manner as described above.” Appellant’s Figure 4 depicts mounting hole 38 formed in shield 42 and snap fingers 40 depending from body 16 engaged in mounting hole 38. Considering the disclosures of paragraphs 16 and 17 and Figure 4 together, a person having ordinary skill in the art would understand that, in the embodiment depicted in Figure 4, in which needle assembly 12 or medical injector 14 is provided with shield 42, the mounting of body 16 to needle assembly 12 or medical injector 14 is effected by rotatably mounting body 16 to shield 42 as described in paragraph 16—namely, with snap fingers 40 protruding from body 16 engaging mounting hole 38 in shield 42, so that body 16 is axially fixed relative to shield 42 with relative rotation being permitted. Thus, the present application conveys with reasonable clarity that, as of the filing date of the present application, Appellant was in possession of the invention recited in claims 1 and 11—in particular, a skin engagement member comprising a body and rotatable mounting features for rotatably mounting the body to the shield of a needle assembly or medical injector to permit relative rotation therebetween wherein the body is axially fixed relative to the shield. Accordingly, we do not sustain the rejection of independent claims 1 and 11 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We also do not sustain the like rejection of dependent claims 2—4, 6-10, and 12-19, which is based solely on their dependence from claim 1 or claim 11. Ans. 3. 4 Appeal 2016-008206 Application 12/861,258 Rejection II Anticipation Independent claim 1 recites “rotatable mounting features for rotatably mounting said body to said shield to permit relative rotation therebetween about said aperture wherein the body is axially fixed relative to the shield.” Appeal Br. 14 (Claims App.). Independent claim 11 contains the same limitations. Id. at 15. In rejecting claims 1 and 11 as anticipated by Moos, the Examiner reads the claimed body on Moos’s depth stop 52, the claimed shield on Moos’s threaded member 60, and the claimed rotatable mounting features on Moos’s threads 76. Ans. 4, 5. The Examiner acknowledges that Moos’s body (depth stop 52) moves axially along (i.e., relative to) the shield (threaded member 60) upon rotation of the body, but finds that “the body is also axially fixed relative to the shield in the state of Figure 2 when the body is not rotated.” Id. at 10; see Moos ^ 28 (explaining that rotation of depth stop 52 about the longitudinal axis of threaded member 60 causes depth stop 52 to move axially toward a distal end of threaded member 60). In the Reply Brief (Sept. 1, 2016) [hereinafter “Reply Br.”], Appellant submits that “the term ‘fixed’ with respect to the subject application as would be understood by one skilled in the art is ‘fastened in one position so that it does not move.’” Reply Br. 5. This proffered definition is consistent with the description in Appellant’s Specification of rotatable mounting features comprising snap fingers 40 engaging mounting hole 3 8 so as to permit relative rotation but cause the engaging components to be axially fixed relative to one another. Spec. ^ 16; see id. ^ 17 (describing rotatable mounting of body 16 to shield 42 in this manner). Moreover, the Examiner 5 Appeal 2016-008206 Application 12/861,258 does not proffer a different definition for the term “fixed.” Accordingly, we apply the definition of “fixed” asserted by Appellant. The threaded engagement of Moos’s body (depth stop 52) with the shield (threaded member 60) by means of threads 76, 64 does not fasten the body in one position so that it does not move relative to the shield. Rather, as explained in Moos (^ 28), rotation of the body (depth stop 52) about the longitudinal axis of the shield (threaded member 60) causes the body to move axially relative to the shield. As Appellant submits, “the lack of relative motion, at a particular time, between the depth stop 52 and threaded member 60 does not imply that the two are not movable, and therefore ‘fixed,’ relative to one another.” Reply Br. 5. Thus, Appellant demonstrates error in the Examiner’s finding that Moos anticipates the subject matter of independent claims 1 and 11. Accordingly, we do not sustain the rejection of independent claims 1 and 11 or claims 2—4 and 6-8, which depend from claim 1, under 35 U.S.C. § 102(b) as anticipated by Moos. Rejection III—Obviousness The Examiner’s application of DiBiasi in rejecting claims 9, 10, and 12-19, which depend from either claim 1 or claim 11, does not cure the deficiency in the Examiner’s finding that Moos anticipates the subject matter of claims 1 and 11. See Ans. 6-8. In particular, the Examiner does not articulate any findings or reasoning that would explain how adding a drive element (i.e., spring) to allow for biasing Moos’s shield (threaded member 60) away from the body member (distal handle member 24) and toward the injection end of the needle, as proposed in the rejection, would cause the 6 Appeal 2016-008206 Application 12/861,258 body (depth stop 52) to be axially fixed relative to the shield (threaded member 60). See Ans. 4, 5, 6-8. Accordingly, we do not sustain the rejection of claims 9, 10, and 12-19 under 35 U.S.C. § 103(a) as unpatentable over Moos and DiBiasi DECISION The Examiner’s decision rejecting claims and 6-19 under 35 U.S.C. § 112, first paragraph, is REVERSED. The Examiner’s decision rejecting claims 1—4, 6-8, and 11 under 35 U.S.C. § 102(b) is REVERSED. The Examiner’s decision rejecting claims 9, 10, and 12-19 under 35 U.S.C. § 103(a) is REVERSED. REVERSED 7 Copy with citationCopy as parenthetical citation