Covidien LP

Patent Trials and Appeals BoardDec 2, 2021

2021003285 (P.T.A.B. Dec. 2, 2021)

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. 14/689,639 04/17/2015 JEFFREY SCHMITT 356050 (203-10640) 8706 50855 7590 12/02/2021 Covidien LP 60 Middletown Avenue Mailstop 54, Legal Dept. North Haven, CT 06473 EXAMINER FERRERO, EDUARDO R ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 12/02/2021 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@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 JEFFREY SCHMITT ____________ Appeal 2021-003285 Application 14/689,639 Technology Center 3700 ____________ Before MICHAEL L. HOELTER, MICHAEL J. FITZPATRICK, 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 non-final rejection of claims 1, 4–11, 13–19, and 21–23. 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(a). Appellant identifies Covidien LP as the Applicant and real party in interest. Appeal Br. 1. Appeal 2021-003285 Application 14/689,639 2 THE INVENTION Appellant’s invention relates to electromechanical surgical instruments. Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A surgical stapling apparatus comprising: a handle assembly; an elongated body extending distally from the handle assembly; an end effector coupled to a distal end of the elongated body; a control handle operatively coupled to the handle assembly, the control handle including a rotation knob disposed proximal of the handle assembly; and an ablation catheter that extends through the handle assembly, the elongated body, and the end effector, wherein rotation of the rotation knob causes corresponding rotation of the ablation catheter relative to the end effector. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Kordis US 5,476,495 Dec. 19, 1995 Mollenauer US 2003/0144660 A1 July 31, 2003 Heard US 2014/0005663 A1 Jan. 2, 2014 Ladtkow US 2014/0046175 A1 Feb. 13, 2014 The following rejections are before us for review: 1. Claim 21 is 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 regards as the invention. Appeal 2021-003285 Application 14/689,639 3 2. Claims 1, 4, 7–11, 13, 16–18, and 21–23 are rejected under 35 U.S.C. § 103 as unpatentable over Heard, Mollenauer, and, alternatively, also over Kordis. 3. Claim 19 is rejected under 35 U.S.C. § 103 as unpatentable over Heard, Mollenauer, and Kordis. 4. Claims 5, 6, 14, and 15 are rejected under 35 U.S.C. § 103 as unpatentable over Heard, Mollenauer, Ladtkow, and, alternatively, also over Kordis. OPINION Indefiniteness of Claim 21 Claim 21 depends from claim 1 and adds the limitation: “wherein a proximal end of the catheter assembly is connect to a distal end of the control handle.” Claims App. The Examiner states that there is insufficient antecedent basis for the “catheter assembly” limitation in claim 21. Non- Final Act. 3. Appellant explicitly elects not to traverse the Examiner’s indefiniteness rejection. Appeal Br. 3. Under the circumstances, we summarily sustain the Examiner’s indefiniteness rejection of claim 21. Unpatentability of Claims 1, 4, 7–11, 13, 16–18, and 21–23 over Heard and Mollenauer or, alternatively, over Heard, Mollenauer and Kordis Claims 1, 4, 7–11, 13, 16–18, and 21–23 Appellant argues claims 1, 4, 7–11, 13, 16–18, and 21–23 as a group. Appeal Br. 3–9. Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Heard discloses the invention substantially as claimed except for disclosing a stapler for which the Examiner relies on Appeal 2021-003285 Application 14/689,639 4 Mollenauer. Non-Final Act. 3–4. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to incorporate the teachings of Mollenauer regarding a surgical stapler into the device of Heard. Id. at 4. According to the Examiner, a person of ordinary skill in the art would have done this to staple tissue together in conjunction with the functions of Heard. Id. The Examiner further finds that Heard discloses a rotation knob that defines a longitudinal axis and causes corresponding rotation of an end effector ablation catheter. Id. at 4–5. However, the Examiner admits that Heard’s rotation knob is not disposed proximal to and longitudinally spaced from its handle assembly. Id. at 5. To overcome this deficiency in modified Heard, the Examiner relies on two alternative findings and rationales. First, the Examiner relies on In re Japikse, 181 F.2d 1019 (CCPA 1950) for the proposition that rearranging parts of an invention involves only routine skill in the art and, further in that regard, finds that Appellant fails to disclose that placement of the knob provides an advantage, serves a particular purpose, or solves a stated problem. Non-Final Act. 5. Secondly and in the alternative, the Examiner, instead of relying on Japikse, finds that Kordis discloses an ablation system with a handle (90) that satisfies the claim limitation directed to a proximal, longitudinally spaced apart knob. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Heard by disposing its rotation knob in the location taught by Kordis. Id. According to the Examiner, a person of ordinary skill in the art would have done this as it is merely a well-known alternative that would properly allow for rotation of the ablation catheter. Id. Appeal 2021-003285 Application 14/689,639 5 We first address the Examiner’s alternative ground that relies on Kordis. Appellant argues that the Examiner’s proposed combination fails to disclose a rotation knob disposed in the manner claimed. Appeal Br. 3. This argument is not persuasive in view of the facts of record. Heard is directed to a surgical forceps device. Heard, Abstract. Heard’s device features first and second jaw members configured to grasp tissue. Id. Heard’s device also includes a housing 20, handle assembly 30, slide assembly 60, rotating assembly 70, trigger 80, and end effector 100 which includes the jaw members. Id. ¶ 51, Figs. 2–3. Heard discloses a rotation knob (70) that causes rotation of the ablation catheter. Handle assembly 30 includes fixed handle 50 and a movable handle 40. Fixed handle 50 is integrally associated with housing 20 and movable handle 40 is moveable relative to fixed handle 50. Rotating assembly 70 is rotatable in either direction about longitudinal axis “X-X” to rotate end effector 100 about longitudinal axis “X-X.” Heard, ¶ 52, Fig. 2. Thus, any suggestion by Appellant that Heard fails to disclose a knob for rotating an ablation catheter is not supported by the record before us. The deficiency in Heard, if any, relates to the fact that rotation assembly 70 is disposed in housing 20 which is integral with handle 50 and thus arguably is not disposed proximal to and spaced apart from the handle assembly as claimed by Appellant. Claims App. (claim 1 – “proximal of the handle assembly;” claim 10 – “longitudinally spaced from the handle assembly”). The Examiner relies on Kordis to satisfy this deficiency. Kordis is directed to an ablation catheter that is used in cardiac diagnosis and treatment. Kordis, Abstract, col. 11, l. 40 – col. 12, l. 17. Kordis discloses a knob (handle 98) that, when rotated by the operator, Appeal 2021-003285 Application 14/689,639 6 causes rotation of ablating element 88. Id., col. 12, ll. 11–17. Kordis’ handle 98 is depicted as being disposed proximal to and longitudinally spaced apart from handle 20. Id. col. 12, ll. 1–17, Figs. 24, 27. Thus, any suggestion by Appellant that Kordis fails to disclose a rotation knob proximal to and longitudinally spaced apart from a handle assembly is not supported by the record before us. The Examiner’s findings of fact that the combined teachings of Heard and Kordis disclose a rotation knob disposed as claimed is supported by a preponderance of the evidence. This brings us to the question of whether a person of ordinary skill in the art would have been motivated to combine the references in the manner proposed by the Examiner. On that score, Appellant argues that Heard is designed for one-handed operation. Appeal Br. 7–8. Appellant argues that modifying Heard to dispose the rotation knob proximal to and longitudinally spaced apart from the handle would require two-handed operation and that such would change the principle of operation of Heard. Id. at 7. Appellant also argues that requiring Heard to be operated by two hands would render it inoperable for its intended purpose. Id. Next Appellant argues against the proposed combination of Heard and Kordis by first arguing that three hands, not one, are necessary to operate Kordis. Id. at 8. According to Appellant, one hand grasps handle 98, a second hand operates steering mechanism 74, and a third hand operates mapping probe 18. Id. In response, the Examiner observes that Appellant’s argument limiting Heard to one-handed operation is not supported by the actual teachings of the reference. Ans. 11–12. The Examiner further notes the absence of any teaching disclosure in Appellant’s Specification regarding how many hands are required to operate Appellant’s invention. Appeal 2021-003285 Application 14/689,639 7 Id. We also note the absence of any limitation in Appellant’s claim 1 directed to operation by any particular number of hands. Claims App. The Examiner finds that there has been no evidence presented by Appellant that Heard would not operate properly if it is operated by using two hands instead of only one. Ans. 11–12. The Examiner also notes the absence of any evidence presented by Appellant that operation of Kordis actually requires three hands. Id. at 12. Next, regarding whether a person of ordinary skill in the art would have had a reason to modify Heard with the teachings of Kordis, the Examiner refers to Appellant’s own Appeal Brief as providing ample reason for disposing the rotation knob spaced apart from the handle. Id. We understand the Examiner to be referring to the following passage in Appellant’s Appeal Brief. Appellant further submits that a person of ordinary skill in the art of surgical forceps would appreciate that having rotational control of a catheter spaced from the handle would minimize inadvertent contact with the rotation knob during operation of the handle. Appellant further contends that a person of ordinary skill in the art of surgical forceps would appreciate that the positioning of the rotation knob proximal of, or longitudinally spaced from, the handle permits for two- handed operation of the surgical stapling instrument which may allow for increased control of the rotation of the ablation catheter. Appeal Br. 6. In reply, Appellant refers to its Appeal Brief and then states, in conclusory fashion, that relocating the operating controls of Heard would “modify the operation” of the device. Reply Br. 2. Appellant otherwise offers no rebuttal to the Examiner’s Answer pointing out that Appellant’s Appeal Brief essentially admits that a person of ordinary skill in the art Appeal 2021-003285 Application 14/689,639 8 would have had ample motivation to modify the prior art to longitudinally space apart the rotation knob from the handle. See generally Reply Br. We agree with the Examiner that Appellant’s Appeal Brief argument undermines, rather than supports, Appellant’s position on motivation to combine Heard and Kordis. As aptly expressed by the Supreme Court: Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). The prospect that using a longitudinally spaced apart rotation knob in Heard, as taught by Kordis, would minimize inadvertent contact with the knob and allow for increased control of the catheter is reason enough for a person of ordinary skill in the art to combine the teachings of Heard and Kordis. We find Appellant’s arguments regarding changing the principle of operation of Heard and rendering it inoperable for its intended purpose particularly unpersuasive. The Examiner’s proposed combination may change, to some degree, the manner of how Heard is operated by a user, but that should not be confused with changing the principle of operation of the device itself. Heard provides an end effector assembly with means to grasp and deliver electrical energy to tissue to provide medical therapy. See, e.g., Heard, ¶¶ 51–55. Operation of Heard includes means to rotate the end effector in delivery of such medical therapy. Id. This principle of operation remains unchanged by the Examiner’s proposal to reconfigure Heard’s rotation knob. Appellant’s ‘inoperable for its intended use’ argument is without merit. Although Appellant fails to actually articulate what it means by Appeal 2021-003285 Application 14/689,639 9 referring to Heard’s “intended use,” we deduce from Appellant’s argument that it believes Heard’s “intended use” is one-handed operation. Appellant’s argument confuses how a device is operated by a user with what the “intended use” is of the device itself. Heard’s intended use is to operate an end effector. Merely relocating one or more of its controls, as proposed by the Examiner, will not interfere with, much less render inoperable, that use. In any event, we are not persuaded, in the first instance, that Heard is supposed to be limited to one hand use. Heard’s handle/housing includes a number of controls that appear to be sufficiently spaced apart that two-hand operation, if not required, might at least be desirable. Looking at Figure 1 of Heard, we note a fixed handle 50, a trigger 80, a rotating assembly (knob) 70, an activation switch 90, and a slide knob 64. Heard, Fig. 1. Having reviewed Heard and considered Appellant’s arguments, we find no evidence to support Appellant’s unsubstantiated attorney argument that Heard is limited to one hand operation. Attorney arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). It is settled law that when a patent “simply arranges old elements with each performing the same function it had been known to perform” and yields no more than one would expect from such an arrangement, the combination is obvious. KSR, 550 US at 417, quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976). Similarly, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR at 417. In the instant case, Appellant simply rearranges the location of the controls Appeal 2021-003285 Application 14/689,639 10 for an ablation catheter. The controls perform the same function that they had been known to perform in the prior art. The implements on the end effector that are controlled by such controls perform the same function that they had been known to perform in the prior art. Kordis shows that it was known to use the claimed configuration of the relative dispositions of a control knob and a handle. Appellant admits that locating the controls to permit two handed operation, as in Kordis, is advantageous and desirable. Appeal Br. 6. In short, there is ample evidence to support the Examiner’s finding that a person of ordinary skill in the art would have been motivated to modify Heard in the manner proposed in the rejection as a well-known alternative position for the rotating knob. We do not, however, sustain the Examiner’s alternative ground of rejection over Heard and Mollenauer in light of In re Japikse, 181 F.2d 1019 (CCPA 1950). Japikse is generally limited to situations where the relocation of a specifically identified part is determined to not modify the operation of a device. Id. at 1023. The invention before us relates to a surgical instrument that is operated manually by a surgeon. Surgery is generally recognized to require considerable manual skill by the surgeon and, in many cases, successful surgery can be facilitated by using surgical instruments that are well-designed from an ergonomic standpoint. In the absence of specific findings that are substantiated by something more than mere speculation regarding whether relocation of the controls would affect operation of Heard, we decline to extend the limited holding in Japikse to situations such as in the instant case. Indeed, the Examiner’s adoption of Appellant’s argument from page 6 of the Appeal Brief in page 12 of the Examiner’s Appeal 2021-003285 Application 14/689,639 11 Answer undermines any basis for finding that Heard’s operation would not be affected by relocation of the controls. Nevertheless, for the reasons otherwise detailed hereinabove we determine that the Examiner’s findings of fact are supported by a preponderance of the evidence and the Examiner’s legal conclusion of unpatentability is well-founded. In view thereof, we sustain the Examiner’s unpatentability rejection of claims 1, 4, 7–11, 13, 16–18, and 21–23. Unpatentability of Claim 19 over Heard, Mollenauer and Kordis Claim 19 is an independent claim that is substantially similar in scope to claims 1 and 10. Claims App. In traversing the rejection, Appellant relies on the same arguments that we previously considered and found unpersuasive with respect to claim 1 and find equally unpersuasive here. Appeal Br. 10–12. We sustain the rejection of Examiner’s rejection of claim 19 over the combination of Heard, Mollenauer, and Kordis. Unpatentability of Claims 5, 6, 14, and 15 over Heard, Mollenauer, Kordis, and Ladtkow These claims depend, directly or indirectly, from either claim 1 or claim 10. Claims App. Appellant does not argue for their separate patentability apart from arguments presented with respect to claims 1 and 10 which we have previously considered. Appeal Br. 9–10. Appellant’s argument that Ladtkow does not cure the deficiencies in Heard, Mollenauer, and Kordis does not apprise us of Examiner error because, as previously noted, we do not agree with Appellant that those references are deficient with respect to claims 1 and 10. Consequently, we sustain the Examiner’s rejection of claims 5, 6, 14, and 15. See 37 C.F.R. § 41.37(c)(1)(iv) (failure Appeal 2021-003285 Application 14/689,639 12 to separately argue claims constitutes a waiver of arguments for separate patentability). CONCLUSION Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 21 112 Indefiniteness 21 1, 4, 7-11, 13, 16-18, 21-23 103 Heard, Mollenauer, Kordis 1, 4, 7-11, 13, 16-18, 21-23 19 103 Heard, Mollenauer, Kordis 19 5, 6, 14, 15 103 Heard, Mollenauer, Kordis, Ladtkow 5, 6, 14, 15 Overall Outcome 1, 4-11, 13- 19, 21-23 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