Covidien LP

Patent Trials and Appeals BoardMar 15, 2022

2021003942 (P.T.A.B. Mar. 15, 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. 15/935,260 03/26/2018 Joseph Guerrera C00015376.USU1(203-11663 1113 50855 7590 03/15/2022 Covidien LP 60 Middletown Avenue Mailstop 54, Legal Dept. North Haven, CT 06473 EXAMINER LEEDS, DANIEL JEREMY ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 03/15/2022 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): docket@carterdeluca.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JOSEPH GUERRERA, CHARLIE KOLLAR, and PATRICK MOZDZIERZ ____________ Appeal 2021-003942 Application 15/935,260 Technology Center 3700 ____________ Before STEFAN STAICOVICI, CHARLES N. GREENHUT, and WILLIAM A. CAPP, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1-20. 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(a). Appellant identifies Covidien LP, Inc. as the Applicant and real party in interest. Appeal Br. 1. Appeal 2021-003942 Application 15/935,260 2 THE INVENTION Appellant’s invention is a circular stapler. Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A surgical stapling device comprising: an approximation assembly including an anvil retainer; an anvil assembly including an anvil shaft having at least one anvil spline and an anvil head having an anvil surface defining a plurality of staple deforming recesses, the anvil head being supported on a distal portion of the anvil shaft; and a shell assembly including a shell housing having an inner housing portion defining a bore, a plurality of shell splines supported on the inner housing portion within the bore, each of the plurality of shell splines having spaced side walls and a pair of tapered surf aces that intersect at an apex extending distally from the spaced side walls and, each of the spaced side walls of adjacent shell splines of the plurality of shell splines defining a primary channel and the spaced side walls of each of the plurality of shell splines defining a secondary channel, the secondary channel of each of the shell splines defining a longitudinal axis that is positioned in axial alignment with the apex of the shell spline, wherein the primary and secondary channels are dimensioned to receive one of the at least one anvil splines. THE REJECTIONS AND OBJECTION The following rejections are before us for review: 1. Claims 1-20 are rejected under 35 U.S.C. § 112(a) as failing to satisfy the written description requirement. 2. Claims 1-20 are rejected under 35 U.S.C. § 112(b) as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. 3. Claims 1-4, 6-11, 13-18, and 20 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Main (US 5,350,104 iss. Sept. 27, 1994). Appeal 2021-003942 Application 15/935,260 3 4. The Examiner objects to the Specification as failing to provide antecedent basis for the secondary channel limitation in claims 1, 9, and 15. OPINION Problem Addressed by Appellant’s Invention Appellant’s surgical stapler is used to create an anastomosis such as, for example, in a procedure to resection the colon of a patient. Spec. ¶¶ 1-2. Such devices typically feature a shell assembly that is attached to the body portion of the stapler and a detachable anvil assembly. Id. ¶ 3. During a medical procedure, the shell assembly and anvil assembly are attached and drawn toward each other to clamp body tissue segments together. Id. The shell assembly features splines that are oriented substantially parallel to each other and also to parallel splines disposed on the anvil assembly. Id. ¶ 50, Fig. 14. As the shell assembly and anvil assembly are drawn toward each other the respective, converging, pointed ends of the splines (referred to by Appellant as the “apex” of the splines) will typically be offset from each other in which case the anvil assembly will rotate in relation to the shell assembly by operation of the anvil splines sliding along cam surfaces 62 and 64 of the shell assembly splines. Id. ¶ 50, Figs. 12, 13. After the shell assembly and anvil assembly are sufficiently drawn together, the sliding of the splines and the consequent rotation of the anvil result in the anvil splines being directed into what Appellant refers to as “primary channels” that reside between the shell assembly splines. Id. Fig. 14. However, it is possible that, as the shell assembly and anvil assembly are drawn together, their respective splines are so aligned that they will meet head-on or “crash.” Id. ¶ 4. Appellant’s invention addresses this problem of the splines “crashing” head-on into each other. Basically, Appellant Appeal 2021-003942 Application 15/935,260 4 provides what it refers to as “secondary channels” that reside along the centerline of shell assembly splines. Id. ¶ 51, Figs. 16-18. If the shell assembly splines and anvil assembly splines “crash” into each other, the anvil assembly splines are accommodated by the secondary channels disposed in the center of the shell assembly splines. Id. Fig. 18. Indefiniteness We review the Examiner’s indefiniteness rejection before reaching the written description rejection. See Ex parte Moore, 439 F.2d 1232, 1235 (CCPA 1971) (explaining that definiteness should be determined before conducting an analysis under the written description requirement). In the Final Action, the Examiner considers the phrase “the secondary channel of each of the shell splines defining a longitudinal axis that is positioned in axial alignment with the apex of the shell spline” to render independent claims 1, 9, and 15 indefinite. Final Act. 5. According to the Examiner, the apex is a point and, as such, could be in axial alignment with any line. Id. The test for definiteness under 35 U.S.C. § 112, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations omitted). We have reviewed Appellant’s Specification and drawings in general and Figure 9 in particular. Appellant’s Specification teaches that A-frame splines 58 include left and right cam surfaces 62 and 64 that form apex 66. Spec. ¶ 48. Internal side walls 68 within the splines define secondary channels that are positioned beneath the apex and each have a longitudinal axis bisecting that apex. Id. Based on Appellant’s disclosure, we are of the opinion that a Appeal 2021-003942 Application 15/935,260 5 skilled artisan would understand that each secondary channel 70 defines a longitudinal axis that is “positioned in axial alignment with the apex” 66 because the longitudinal axis projects from the channels to bisect, or at the very least, intersect with, the apex. See Figs. 9, 16-18. This is the case whether apex 66 is a point or a line that is defined by the intersection of the cam surfaces 62 and 64. Thus, in light of the Specification, one skilled in the art would understand “a longitudinal axis that is positioned in axial alignment with the apex” to refer to a longitudinal axis that bisects, or at the very least, intersects with the apex. In view of the foregoing, we do not sustain the Examiner’s Section 112 indefiniteness rejection of independent claims 1, 9, and 15. The remaining pending claims are rejected solely on the basis of their dependency from an independent and they each stand with the respective independent claim from which they depend. Written Description and Objection to Specification The Examiner takes the position that the “secondary channel” limitation discussed above lacks written description support. Final Act. 4. We have summarized what we consider to be written description support in the section above in that a skilled artisan would understand that each secondary channel 70 illustrated in Figures 9 and 16-18 defines a longitudinal axis that is “positioned in axial alignment with the apex” 66 because the longitudinal axis projects from the channels to bisect, or at the very least, intersect with, the apex. The written description requirement is met when the disclosure “allow[s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Enzo Biochem, Inc. v. Gen-Probe Appeal 2021-003942 Application 15/935,260 6 Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). Drawings may be used to provide the descriptive support required by 35 U.S.C. § 112(a). Vas-Cath Inc. v. Mahurkar, 935 F. 2d 1555, 1565 (Fed. Cir. 1991). In view of the summary of Appellant’s invention that we have provided hereinabove, we are of the opinion that Appellant’s claims have written description support because Appellant’s disclosure demonstrates possession of the claimed subject matter. As the Examiner’s objection to the Specification is premised on a supposed failure to provide antecedent basis in the Specification for this very same subject matter, our resolution of the written description rejection is determinative of the objection. Thus, contrary to the Examiner’s position (Ans. 4) this objection is therefore within our jurisdiction (MPEP § 12012). We do not sustain either of the Examiner’s Section 112 written description rejection of claims 1-20 or the Examiner’s objection to Specification. Anticipation of Claims 1-4, 6-11, 13-18, and 20 by Main Claim 1 The Examiner finds that Main discloses each limitation of the invention. Final Act. 6-7. In particular, the Examiner finds that Main discloses secondary channels as claimed and provides an annotated figure from Main that purportedly shows a secondary channel. Id. at 7-8. 2 “[W]hen the objection is ‘determinative of the rejection’ the matter may be addressed by the Board”; cf also, e.g., MPEP § 2163.06 (“If both the claims and specification contain new matter either directly or indirectly, and there has been both a rejection and objection by the examiner, the issue becomes appealable and should not be decided by petition.”) Appeal 2021-003942 Application 15/935,260 7 We have reviewed the annotated drawing in the Final Action and agree with Appellant that the Examiner’s finding regarding secondary channels lacks evidentiary support. Appeal Br. 8. The structure that the Examiner identifies in the annotated drawing as a “secondary channel” is the same structure that the Examiner relies on as a “primary channel,” albeit between different shell splines 156. Final Act. 7-8; Ans. 7. According to the Examiner: The channel itself is designated as ‘Primary’ and ‘Secondary’ channels. The Examiner contends that so long as there is more than one channel, the claim limitation is met as any first channel can be labeled ‘primary’ and any second channel can be labeled ‘secondary’. Ans. 7. However, as Appellant correctly points out claim 1 clearly calls for “each of the spaced side walls . . . defining a primary channel” and “each of the plurality of shell splines defining a secondary channel.” Reply Br. 2-3. The “each” language precludes the Examiner’s interpretation because under the Examiner’s interpretation only some side walls would define primary channels and only some splines would define secondary channels. This is clearly inconsistent with the plain language of claim 1. See, e.g., In re Skvorecz, 580 F.3d 1262, 1266 (Fed.Cir.2009) (“The Board erred in holding that some wire legs of the Skvorecz device, as claimed, need not have an offset, when the claims state that each wire leg has an offset.”). For a prior art reference to anticipate a claim, it must disclose all of the limitations of the claim, “arranged or combined in the same way as in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008). Here, the Examiner’s finding that Main discloses all of the limitations of claim 1 is not supported by a preponderance of the evidence. Appeal 2021-003942 Application 15/935,260 8 Consequently, we do not sustain the Examiner’s Section 102 rejection of claim 1 as being anticipated by Main. Claims 2-4, 6-11, 13-18, and 20 The Examiner’s rejection of these claims suffers from the same infirmity that we identified above with respect to claim 1 and, for the same reason, we do not sustain the Examiner’s Section 102 anticipation rejection of claims 2-4, 6-11, 13-18, and 20. Objection to Drawings An objection to the drawings has been withdrawn by the Examiner. Final Act. 2-3, Ans. 3-4. CONCLUSION Ans. Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1-20 112 Written Description3 1-20 1-20 112 Indefiniteness 1-20 1-4, 6-11, 13-18, 20 102 Main 1-4, 6-11, 13-18, 20 Overall Outcome 1-20 REVERSED 3 Our resolution of the written description rejection is dispositive as to the objection to the Specification under MPEP § 608.01(o).