John P. Matonick et al.Download PDFPatent Trials and Appeals BoardMar 3, 202014597532 - (D) (P.T.A.B. Mar. 3, 2020) 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. 14/597,532 01/15/2015 John P. Matonick ETH5833USNP 6709 27777 7590 03/03/2020 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 03/03/2020 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pair_jnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN P. MATONICK, ROBERT J. TANNHAUSER, and LEO B. KRIKSUNOV Appeal 2019-002536 Application 14/597,532 Technology Center 3700 Before BRETT C. MARTIN, MICHAEL J. FITZPATRICK, and ARTHUR M. PESLAK, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge MARTIN. Opinion Dissenting filed by Administrative Patent Judge FITZPATRICK. MARTIN, 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 1–4 and 8–10. Claims 5–7 and 11–20 were canceled during prosecution. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Ethicon Inc. Appeal Br. 3. Appeal 2019-002536 Application 14/597,532 2 CLAIMED SUBJECT MATTER The claims are directed “to surgical instruments and methods designed to apply a therapeutic material to enhance the properties of repaired or adjoined tissue at a surgical site.” Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A circular surgical stapler for anastomotic joining of tissue comprising: a) a stapling head connected to an opposing anvil, said stapling head containing a plurality of deployable staples in concentric arrays; b) a plurality of solid, barbed, resorbable medicant- releasing microneedles, said microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end; said microneedles releasably and detachably disposed on or within the stapling head or the anvil; wherein said microneedles are configured to break off and detach and to be left in the tissue layers after joining of the tissue layers; and wherein said medicant is impregnated into or distributed within a polymeric material comprising said microneedle, is coated onto said microneedle, or is a discrete elongated insert within said microneedle. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Bessler US 5,411,508 May 2, 1995 Park US 2002/0082543 A1 June 27, 2002 Heinrich US 2005/0184121 A1 Aug. 25, 2005 Karp US 2013/0331792 A1 Dec. 12, 2013 Zand US 2014/0288386 A1 Sept. 25, 2014 Appeal 2019-002536 Application 14/597,532 3 REJECTIONS Claims 1, 3, 4, and 8–10 stand rejected under 35 U.S.C. § 103 as being unpatentable over Bessler, Zand, Karp, and Park. Final Act. 2. Claim 2 stands rejected under 35 U.S.C. § 103 as being unpatentable over Bessler, Zand, Karp, Park, and Heinrich. Final Act. 6. OPINION The Examiner’s rejection relies at least in part on the interpretation of Karp as disclosing the claimed microneedles. Final Act. 3. As claimed, the microneedles comprise “a plurality of solid, barbed, resorbable medicant- releasing microneedles, said microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end.” The claim further requires “said microneedles releasably and detachably disposed.” Appellant argues that Karp teaches only detachable protrusions, not detachable needles as claimed. See Appeal Br. 8–9. In response, the Examiner concedes that “in some embodiments Karp does indeed disclose detachable protrusions provided on individual needle tips,” but asserts that “in other embodiments . . . Karp provides for ‘tips’ comprising microneedles provided for in an array.” Ans. 11. Even in disclosing tips, however, Karp inherently is disclosing that only a portion of the microneedle is detachable. A tip as disclosed in Karp is merely a barb at a distal end pointed in the direction of insertion, rather than a barb pointed off to an angle. See, e.g., Karp ¶ 62. Karp’s tip at best meets the distal end, but is not an “elongated rod” with a distal end and a proximal end. The claims here require the entirety of the needle to be detachable and resorbable, not merely a portion, as taught in Karp. Appeal 2019-002536 Application 14/597,532 4 The dissent suggests that we do not credit Karp for what it fairly teaches in combination, but appears to misstate the scope of Karp. Karp does not disclose detachable microneedles, but merely detachable barbs or tips of the disclosed microneedles. Given that Karp is the only reference that discloses the detachable feature, but does not meet the limitation of the full needle, we disagree that we have not read Karp for what it fairly teaches. The combination with Zand is insufficient because Zand is silent regarding any detachment of any portion of the needle. Accordingly, the combination would still amount only to detachable barbs, not detachable needles as claimed. Appellant is also correct that the combination is improper because Zand delivers medicament through a hollow needle, whereas Karp delivers medicament via a solid, detachable barb that releases medicament from its surface. Even if the teachings of Zand were combined with Karp, which we agree is an improper combination lacking a reasonable basis with rational underpinnings due to the fact that Zand could no longer deliver medicament as intended, the result would still be barbs that detach rather than the entire needle. See App. Br. 9. Because all of the rejections rely on this misinterpretation of Karp, we do not sustain the Examiner’s rejections. CONCLUSION DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 4, 8–10 103 Bessler, Zand, Karp, Park 1, 3, 4, 8–10 2 103 Bessler, Zand, Karp, Park, Heinrich 2 Appeal 2019-002536 Application 14/597,532 5 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed Overall Outcome: 1–4, 8–10 REVERSED FITZPATRICK, Administrative Patent Judge, dissenting. I dissent from the majority’s decision. Appellant argues that “Karp discloses detachable protrusions, not microneedles, whereby protrusions appear to be attached to individual needle tips, like barbs, and protrusions then can detach.” Appeal Br. 8–9 (citing Karp ¶¶ 5, 41, 43, 44, 46, 53 and 62). The majority finds this argument dispositive of reversal of the rejection. I do not. The Examiner’s rejection relies on Zand, not Karp, for teaching microneedles. See Final Act. 3 (“Zand discloses that the surgical instrument may include a plurality of solid microneedles.”); see also Ans. 3 (“Zand only provides the general concept of combining microneedles with a circular stapler to provide for delivery of therapeutic agents.”). Although the Examiner found that Karp likewise discloses microneedles (which finding Appellant disputes), the Examiner’s rejection relies on Karp for its teaching of certain features of the disputed Karp microneedles. See Final Act. 4 (“Karp discloses . . . the microneedles releasing a variety of payloads after penetration into a substrate (Par. 83). Karp discloses that these microneedles may be provided as barbed structures (Par. 15), resorbable (Clm. 12), releasable, and detachable (Clm. 11; Par. 62) to be left in the tissue after penetration.”). The Examiner then proposed modifying Zand’s microneedles to incorporate the features taught by Karp. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the microneedles of the modified invention of Zand [i.e., Bessler/Zand] to comprise resorbable, detachable, barbed microneedles, as disclosed by Karp, in order to allow the microneedles to achieve the required penetration force without an increased pull-out force (Par. 62, Karp). Appeal 2019-002536 Application 14/597,532 2 Id. at 4; see also Ans. 4 (“[I]t would have been obvious . . . to form the microneedles of the modified invention of Bessler (the microneedles in general being provided in view of Zand) as barbed microstructures, releasable/detachable, and resorbable as disclosed by Karp.”). Karp’s disclosure “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole,” including Zand, which teaches microneedles. In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Because I find the majority’s opinion does not read Karp for what it fairly teaches in combination with Zand, I dissent. Copy with citationCopy as parenthetical citation