Ex Parte Daw et alDownload PDFPatent Trial and Appeal BoardMay 19, 201612229794 (P.T.A.B. May. 19, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/229,794 08/27/2008 96000 7590 05/23/2016 C R Bard, IndBBS Intellectual Property Department 1415 W. 3rd St. Tempe, AZ 85281 FIRST NAMED INVENTOR Derek Daw 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. 297-PDD-10-116 US [06003] CONFIRMATION NO. 1398 EXAMINER GOOD, SAMANTHA M ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 05/23/2016 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): raust@austiplaw.com BBSIP.Docket@crbard.com Charles.Runyan@crbard.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DEREK DAW and JAMES HUNTINGTON DABNEY Appeal2014-003326 1 Application 12/229,794 2 Technology Center 3700 Before ANTON W. PETTING, PHILIP J. HOFFMANN, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's decision finally rejecting claims 46, 48, and 63-70. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Throughout this opinion, we refer to the Appeal Brief ("Appeal Br.," filed May 14, 2013), the Reply Brief ("Reply Br.," filed Jan. 24, 2014), the Examiner's Answer ("Ans.," mailed Nov. 26, 2013), the Final Office Action ("Final Act.," mailed Oct. 18, 2012), and the Specification ("Spec.," filed Aug. 27, 2008). 2 According to the Appellants, the real party in interest is SenoRx, Inc. Appeal Br. 3. Appeal2014-003326 Application 12/229,794 STATEMENT OF THE CASE The Appellants' invention is directed to "medical device system including an electrosurgical generator and method for operating and controlling the electrosurgical generator to perform operations on a patient." Spec. i-f 8. Claim 46 is the only independent claim on appeal, is exemplary of the subject matter on appeal, and is reproduced below: 46. A medical device comprising: a. an electrosurgical tissue cutting electrode; b. an RF electrosurgical generator electrically coupled to the electrosurgical tissue cutting electrode, the RF electrosurgical generator being configured to provide a start mode with a first RF power output and a first RF duty cycle and a run mode with a second RF power output and a second RF duty cycle; c. a determining device configured to determine when said electrosurgical tissue cutting electrode has started cutting tissue; and d. a control device configured to switch the RF electrosurgical generator from the start mode to the run mode in response to the determining device when the electrosurgical tissue cutting electrode has started to cut tissue. Appeal Br. 36, Claims App. REJECTIONS Claims 64, 65, 67, and 68 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement. 3 3 The 35 U.S.C. § 112, first paragraph, rejection of claims 63 and 66 and the 35 U.S.C. § 112 second paragraph rejection of claim 66 have been withdrawn. Ans. 2. 2 Appeal2014-003326 Application 12/229,794 Claims 46 and 63-68 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Hagen (US 5,133,711, iss. July 28, 1992) and Rexroth (US 4,473,075, iss. Sept. 25, 1984). Claim 48 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Hagen, Rexroth, and Lindenmeier (US 5,749,869, iss. May 12, 1998). Claims 69 and 70 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Hagen, Rexroth, and Albrecht (US 2003/0229341 Al, pub. Dec. 11, 2003). FINDINGS OF FACT We have determined that the findings of fact in the Analysis section below are supported at least by a preponderance of the evidence. 4 ANALYSIS 35 USC§ 112,first paragraph The Examiner rejects claims 64, 65, 67, and 68 for failing to comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, because the Specification does not contain a description of "DC voltage ... to enable one of ordinary skill in the art to make and/or use the invention" but describes producing only an AC signal. Final Act. 3. The Examiner finds that the Specification does not describe "how, when or where the DC input voltage is produced," how "a DC voltage appears across the RF 4 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Patent Office). 3 Appeal2014-003326 Application 12/229,794 outputs," and how the cut quality signals "affect[] the desired RF power output and the desired RF duty cycle." Id. at 3-4. The Examiner further finds that the portions of the Specification cited by the Appellants "do not teach a clear connection between the DC voltage and this predetermined level in such a way that one of ordinary skill in the art would be able to make and/or use the invention is not described in an enabling way." Ans. 2- 3 (citing Spec. i-f 48); see also Advisory Action, mailed Feb. 6, 2013. The Appellants contend the rejection is in error because paragraphs 48, 67, and 78 discuss a DC voltage being produced at the cutting electrode and being monitored, and that once the system has entered a cut mode (synonymous with run mode), the system maintains the cut quality above a minimum level. Appeal Br. 13-14. The Appellants further argue "it appears that the Examiner is requiring an identification of a specific voltage level of the DC voltage threshold [but] does not consider [the] determination criteria that is [sic] expressly stated in claim 64 ... which may be routinely determined by experimentation by one of ordinary skill in the art." Reply Br. 6. "[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, ( 4) the nature of the invention, ( 5) the state of the prior art, ( 6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. 4 Appeal2014-003326 Application 12/229,794 In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Examiner asserts that the Specification does not provide how DC voltage, rather than an AC signal, is produced (Final Act. 3), and does not provide what predetermined level the DC voltage must be less than to operate in a start mode or meet or exceed to operate in the run mode (Ans. 2). Neither the Final Action nor the Answer, however, provides any discussion of the Wands factors. As a result, the Examiner has failed to articulate a prima facie case of lack of enablement. For this reason, we will not sustain the rejection of claims 64, 65, 67, and 68 under 35 U.S.C. § 112, first paragraph, for not meeting the enablement requirement. 35 USC§ 103 The Appellants contend, in relevant part, that the Examiner's rejection of independent claim 46 is in error because Hagen does not disclose limitation ( d) of a control device configured to switch the generator from a start mode to a run mode in response to the determination that the electrode has started to cut tissue. See Appeal Br. 24-26; see also Reply Br. 9-11. Specifically, the Appellants argue "in Hagen the setpoint is used for both the cutting start condition and for continued cutting until such time as the tuning has occurred, and does not correlate to a switching between a start mode and a run mode at the start of cutting." Reply Br. 10. After careful consideration and review of the Examiner's findings and reasoning (see Ans. 3-4; Final Act. 5-6), we agree that the Examiner does not show by a preponderance of the evidence that Hagen discloses switching from a start mode to a run mode when the electrode has started cutting the tissue. The Examiner relies solely on Hagen for disclosing the limitation 5 Appeal2014-003326 Application 12/229,794 (Ans. 4), finding that Hagen discloses the generator being configured to provide a start mode with a first RF output and a run mode with a second RF output, and the control device configured to switch the generator from the start mode to the run mode in response to determining the electrode has started to cut the tissue. Final Act. 5-6; Ans. 3--4. The Examiner does not explain with particularity what, in Hagen, the Examiner finds as the start mode and the run mode. The Examiner cites to Hagen for a start mode and run mode (Ans. 3 (citing Hagen, col. 2, 11. 25--49, col. 5, 11. 5-36)), and in reference to claim 64, finds "Hagen teaches wherein the RF electrosurgical generator (10/12) is configured to operate in the start mode when the DC voltage is less than a level that designates tissue cutting and operates in the run mode when the DC voltage is at or exceeds the level that designates tissue cutting." Id. (citing Hagen col. 3, 11. 39-45, col. 4, 1. 36-col. 5, 1. 8, col. 5, 11. 29-66). To the extent the Examiner finds that Hagen discloses a start mode of the "applied setpoint value" entered by the first adjustment means and the microprocessor switching to a run mode of the "reduced setpoint value" as the microprocessor detects the control circuit being tuned for the first time (see Ans. 4; Hagen, col. 2, 11. 25--49), it appears the Examiner's finding is based on the detecting of the control circuit being tuned for the first time being equivalent to the determination that the electrode has started to cut the tissue. This basis is not adequately supported; it is not clear that Hagen's tuning of the circuit for the first time indicates a commencement of the cut such that the microprocessor switches from the applied setpoint value (start mode) to the reduced or second setpoint value (run mode). Thus, we are persuaded of error on the part of the Examiner, and we 6 Appeal2014-003326 Application 12/229,794 do not sustain the Examiner's rejection of independent claim 46. We also do not sustain the rejections of claims 48 and 63-70, each of which ultimately depends from independent claim 46. Cf In re Fritch, 972 F.2d. 1260, 1266 (Fed. Cir. 1992) ("dependent claims are nonobvious if the independent claims from which they depend are nonobvious"). DECISION The Examiner's rejection of claims 64, 65, 67, and 65 under 35 U.S.C. § 112, first paragraph, is REVERSED. The Examiner's rejections of claims 46, 48, and 63-70 under 35 U.S.C. § 103(a) are REVERSED. REVERSED 7 Copy with citationCopy as parenthetical citation