Ex Parte Horvath et alDownload PDFPatent Trial and Appeal BoardAug 9, 201813138305 (P.T.A.B. Aug. 9, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/138,305 10/11/2011 Joshua Horvath 47058 7590 08/13/2018 Dickinson Wright - BD 1825 Eye St., NW Suite 900 WASHINGTON, DC 20006 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P-8421 (58433) 7450 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 08/13/2018 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): DWPatents@dickinsonwright.com ip.docket@bd.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSHUA HORVATH, EDWARD ROSEN, and PAUL UPHAM 1 Appeal2017-009710 Application 13/138,305 Technology Center 3700 Before MICHAEL L. HOELTER, PAUL J. KORNICZKY, and ANTHONY KNIGHT, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. § 134(a), from the Examiner's Final Rejection of claims 1-22. App. Br. 1, 5. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below, we AFFIRM the Examiner's rejections. 1 According to Appellants, the real party in interest is Becton, Dickinson and Company. App. Br. 3. Appeal2017-009710 Application 13/138,305 THE CLAIMED SUBJECT MATTER The disclosed subject matter "relates generally to a lubricated needle for a drug delivery device." Spec. ,r 2. Apparatus claim 1 and method claims 15 and 22 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A pen needle, comprising: a hub having an interior including an open proximal end; a needle fixedly connected to said hub, said needle having a patient end, formed for insertion into a patient, and a proximal end extending into said interior of said hub; a reusable outer cover for repeatedly receiving said hub and said needle between multiple injections of the pen needle; and a lubricant reservoir disposed in said outer cover such that at least a portion of said needle is disposed in said lubricant reservoir whenever said hub and said needle are received by said outer cover. REFERENCES RELIED ON BY THE EXAMINER Kuhlemann et al. Fischell Kayerod et al. Wang et al. Swenson et al. Bruun et al. Walton us 4,435,177 us 5,545,143 US 2001/0001443 Al US 6,458,867 B 1 US 6,726,649 B2 US 2006/0196783 Al WO 93/11814 Mar. 6, 1984 Aug. 13, 1996 May 24, 2001 Oct. 1, 2002 Apr. 27, 2004 Sept. 7, 2006 June 24, 1993 William G. Kohn et al., "Guidelines for Infection Control in Dental Health-Care Settings - 2003 ," MMWR Recommendations and Reports, December 19, 2003, 52(RR17), 1---61 (hereinafter "CDC"). J.M. Oli, et al., "Multiple use of ordinary disposable syringes for insulin injections," British Medical Journal, volume 284, January 23, 1982 (hereinafter "BMJ"). 2 Appeal2017-009710 Application 13/138,305 THE REJECTIONS ON APPEAL 2 Claims 1--4, 7, and 21 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton and Fischell. Claims 5 and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, and Wang. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, and Bruun. Claims 8 and 9 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, and Kayerod. Claims 10, 12, and 13 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, and Kuhlemann. Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, Kuhlemann, and Bruun. Claims 15, 16, 17, 20, and 22 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, Swenson, CDC, and BMJ. 3 Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as unpatentable over Walton, Fischell, Swenson, CDC, BMJ, and Kuhlemann. 2 The Examiner withdrew the initial rejections of claims 15-19 and 22 in favor of New Grounds of Rejections, which supplements the original combination of references relied upon for each such rejection with the additional references of CDC and BMJ. Ans. 3-10. Appellants responded to the Examiner's further reliance on CDC and BMJ. See Reply Br. 3--4. 3 The Examiner does not initially list claim 20 in the rejection's' summary statement, but claim 20 is discussed in the body of this rejection. See Ans. 9. We, thus, consider this omission to be inadvertent error. 3 Appeal2017-009710 Application 13/138,305 ANALYSIS The Examiner's rejection of claims 1-4, 7, and 21 as unpatentable over Walton and Fischel! Appellants argue claims 1, 3, 4, 7, and 21 together. App. Br. 10-12. Appellants also present a separate argument regarding dependent claim 2. App. Br. 19. We select claims 1 and 2 for review, with the remaining claims standing or falling with their respective parent claim. See 3 7 C.F .R. § 4I.37(c)(l)(iv). Claim 1 The Examiner primarily relies on the teachings of Walton, including the disclosure of a reservoir into which a needle is placed, for disclosure of claim 1 's limitations, but acknowledges that "Walton does not teach that said reservoir is a lubricant reservoir." Final Act. 2-3. The Examiner relies on the teachings of Fischell for disclosing a "lubricant reservoir." Final Act. 3. The Examiner concludes that it would have been obvious "to modify the reservoir, of the needle of Walton, to be a lubricant reservoir, as taught by Fischell" because "the lubricant of the lubricant reservoir will lubricate and coat the exterior surface of the needle as it is inserted through tissue ( column 6, lines 8-10) in order to aid in its insertion through the skin ( column 8, lines 40-42)." Final Act. 3; see also Ans. 13-14 (referencing Fischell 3:33--41). Appellants contend, "Fischell fails to overcome the deficiencies of Walton because ... Fischell does not disclose multiple medication applications ... [and Fischell's injection assembly] is not removed and reapplied with antibiotic ointment between applications." App. Br. 11. Appellants state, "based on what is explicitly disclosed in Walton and Fischell, there is no evidence and there is no motivation for one skilled in the 4 Appeal2017-009710 Application 13/138,305 art to provide a reusable outer cover for repeatedly receiving a hub and a needle between multiple injections of a pen needle, as claimed." App. Br. 11. First, the Examiner relies on Fischell for teaching that Walton's reservoir can be a "lubricant" reservoir as recited. Final Act. 3. Fischell is not relied upon for disclosing multiple medication applications, although, in the Examiner's Answer, the "Examiner submits that there is nothing physically preventing the needle of Fischell from performing a plurality of penetrations." Ans. 13. Regarding Appellants' contention as to what is "explicitly disclosed in Walton and Fischell," we have been instructed that a "person of ordinary skill is also a person of ordinary creativity, not an automaton." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007). We have further been instructed, "[t]he use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1333 (Fed. Cir. 1983). These instructions become important when one skilled in the art considers Walton's teaching of the danger of contracting a virus "if a needle, once used, is reused in an unsterilized form." Walton 1.4 From this, one skilled in the art would comprehend that Walton discloses needle re-use and that the danger of needle re-use recedes if the needle is sterilized between uses. More particularly, the Examiner, when addressing Appellants' contention regarding "repeatedly receiving a hub and a needle between 4 Walton does not provide line or paragraph numbering. Hence, reference to Walton will be by page number only. 5 Appeal2017-009710 Application 13/138,305 multiple injections of a pen needle, as claimed" (App. Br. 11 ), finds such multiple injection language to be "functional language directed toward the intended use of the claimed pen needle." Ans. 11. The Examiner explains that "the invention need only be capable of performing the specified function" and "submits that there is no structural reason why the invention of Walton could not be used to provide multiple medication applications, particularly in a serialized fashion to a single patient over a plurality of injection sites." Ans. 11; see also Ans. 12. Appellants' argument that Walton pertains to a "single use" assembly (App. Br. 11; see also Reply Br. 3 addressing both Walton and Fischell) does not address or identify any structural distinction that would preclude the device of Walton ( or Fischell, see above) from being employed multiple times. We are instructed, "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). We are further instructed that merely asserting that Walton is capable of performing the recited function is not sufficient; the Examiner need also provide a motivation to do so. See KSR, 550 U.S. at 418; see also In re Giannelli, 739 F.3d 1375, 1380 (Fed. Cir. 2014). Here, Appellants do not address or dispute the Examiner's above-stated rationale regarding re-use, i.e., "to provide multiple medication applications, particularly in a serialized fashion to a single patient over a plurality of injection sites." Ans. 11. Finally, it is also noted that Appellants themselves acknowledge, "[m]any existing pen needles are used for multiple injections." Spec. ,r 11. Appellants also assert the Examiner relied on "hindsight." App. Br. 15-18. However, in rejecting claim 1, the Examiner specifically relied on 6 Appeal2017-009710 Application 13/138,305 the teachings expressed in Fischell as a basis for combining Walton and Fischell together. See Final Act. 3 (referencing Fischell 6:8-10; 8:40-42); Ans. 13-14 (referencing Fischell 3:33--41). Appellants further contend that "Walton teaches away from the obviousness analysis" (App. Br. 18-19) but does not disclose where Walton criticizes, discredits or otherwise discourages investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); see also Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069-70 (Fed. Cir. 2018) (holding that even in the absence of a teaching away, general preferences as stated in the prior art are still relevant to determining whether a skilled artisan would be motivated to combine the prior art in the manner claimed). Here, Walton can be said to specifically suggest re-sterilization of the needle after each use so as to avoid the risk of contracting viruses. See Walton 1. Appellants additionally contend that Walton and Fischell are "unrelated" and, thus, it would not have been obvious to combine them. App. Br. 11, 17. However, we agree with the Examiner's assessment that "Walton and Fischell are both directed toward medical, drug delivery devices which utilize a needle." Ans. 13. Accordingly, and based on the record presented, we are not persuaded by Appellants of Examiner error. We sustain the Examiner's rejection of claims 1, 4, 7, and 21 as unpatentable over Walton and Fischell. Claim 2 Claim 2 depends from claim 1 and further recites "wherein a seal is removably connected to said outer cover." The Examiner references Walton's cap 12 that is "removably connected to said outer cover (Figure 2A)" as disclosing this limitation. Final Act. 3. Appellants contend, Walton's cap 12 "is not removably connected to the housing 11." App. Br. 7 Appeal2017-009710 Application 13/138,305 19. However, Walton specifically teaches that "cap 12 may be folded closed and snap engaged about the finger guide 16." Walton 3. Walton also teaches, "[a]ltematively the cap may be formed as a separate component." Walton 2. Consequently, Appellants' contention is not persuasive that the Examiner erred in relying on Walton's cap 12 as disclosing this limitation. Final Act. 3; see also Ans. 12. Accordingly, and based on the record presented, we are not persuaded by Appellants of Examiner error. We sustain the Examiner's rejection of claim 2 (and its dependent claim 3) as unpatentable over Walton and Fischell. The rejection of claims 15, 16, 17, 20, and 22 as unpatentable over Walton, Fischel!, Swenson, CDC, and BMJ Appellants argue claims 15 and 22 together (Reply Br. 3--4) and do not present separate arguments regarding claims 16, 17, and 20. See Reply Br. 5; App. Br. 19--20. We select claim 15 for review, with the remaining claims standing or falling therewith. Consistent with arguments previously presented with respect to claim 1, Appellants also contend that the Examiner "is ignoring the basic operation of the devices of' the cited references. Reply Br. 3. For example, Appellants contend, "Walton explicitly teaches away from the proposed modification" regarding re-use of the needle and that "the Examiner's Answer is inconsistent with the explicit configuration and operation of the device disclosed in Walton." Reply Br. 3--4. However, as above, a review of Walton would at least suggest a need to re-sterilize a needle before it is re-used to avoid contracting viruses. See Walton 1. Hence, Appellants do not explain how Walton "teaches away" from using a needle multiple times 8 Appeal2017-009710 Application 13/138,305 (provided proper safeguards are taken). Appellants also contend, "none of the applied references discloses repeated lubrication of the needle between injections." Reply Br. 4. However, the Examiner states, "the general concept of the reapplication of a fluid material via introduction of the implement into a reservoir containing said material is notoriously well known." Ans. 8. As support, the Examiner provides such examples as "re- inking the nib of a fountain pen or rewetting the bristles of a paint brush." Ans. 8. Thus, according to the Examiner, "an ordinary artisan would reasonably recognize and appreciate that the act of reinserting the needle of Walton back into the modified outer cover would result in the reapplication of the lubricating antibiotic ointment." Ans. 8. Appellants do not dispute this assertion by the Examiner, or indicate how it might be in error. Appellants again acknowledge that "multiple injection needles are commonly known" (see, e.g., Spec. ,r 11) but that this does not mean that one skilled in the art would "modify a single-use pen needle device to arrive at the Appellants' claimed device." Reply Br. 4. However, the matter of "single-use," and how Walton is capable of multiple uses, has previously been discussed, with Appellants' contentions found wanting. In view of the above, Appellants do not indicate how the Examiner erred in concluding that claims 15, 16, 17, 20, and 22 are unpatentable over Walton, Fischell, Swenson, CDC, and BMJ. The Examiner's rejections of claims 5, 6, 8-14, 18, and 19 Appellants do not separately argue the further rejections of these claims based on the Examiner's additional reliance on the teachings of Wang, Bruun, Kayerod, and Kuhlemann. See App. Br. 19-20, Reply Br. 5. We sustain their rejection. 9 Appeal2017-009710 Application 13/138,305 DECISION The Examiner's rejections of claims 1-22 are affirmed. No time period for taking any subsequent action in connection with this appeal (see 37 C.F.R. § 1.136(a)(l)) may be extended (see 37 C.F.R. § 1.136(a)(l )(iv)). AFFIRMED 10 Copy with citationCopy as parenthetical citation