West Affum Holdings Corp.Download PDFPatent Trials and Appeals BoardMay 19, 20202019005878 (P.T.A.B. May. 19, 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. 14/485,594 09/12/2014 Joseph L. Sullivan WAHC169400 1056 153490 7590 05/19/2020 COJK - Kestra Medical 1201 Third Avenue Suite 3600 Seattle, WA 98101 EXAMINER STICE, PAULA J ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 05/19/2020 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): efiling@cojk.com eofficeactions@appcoll.com larry.lycke@kestramedical.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOSEPH L. SULLIVAN, ROBERT P. MARX, and ZHONG QUN LU ____________ Appeal 2019-005878 Application 14/485,594 Technology Center 3700 ____________ Before JOHN C. KERINS, STEFAN STAICOVICI, and LISA M. GUIJT, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE. Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision in the Final Office Action (dated July 19, 2018, hereinafter “Final Act.”) rejecting claims 106 and 107.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. West Affum Holdings Corp. is identified as the real party in interest in Appellant’s Appeal Brief (filed Feb. 28, 2019, hereinafter “Appeal Br.”). Appeal Br. 3. 2 Claims 1–100 and 108–118 are canceled, and claims 101–105 are withdrawn. Appeal Br. 46–48, 50, Appendix E. Appeal 2019-005878 Application 14/485,594 2 SUMMARY OF DECISION We REVERSE and enter a NEW GROUND of REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). INVENTION Appellant’s invention relates to a wearable cardiac defibrillator. Spec. para. 4.3 Claims 106 and 107 are independent. Claim 106 is representative of the claimed invention and reads as follows: 106. A non-transitory computer-readable storage medium storing one or more programs which, when executed by at least one processor of a wearable cardiac defibrillator (WCD) system that includes a support structure configured to be worn by a patient, an energy storage module configured to store an electrical charge, a discharge circuit coupled to the energy storage module, and a measurement circuit configured to render a physiological input from a patient Electrocardiogram (ECG) signal, the WCD system cooperating with a motion detector, result in: receiving the physiological input; performing an ECG rhythm analysis based on the physiological input; generating a shock advice parameter from the ECG rhythm analysis; determining whether or not the motion detector detected a motion event by a motion detection input from the motion detector or an absence of such a motion detection input; and responsive to it being determined that no motion event has been detected, determining whether or not the shock advice parameter has a numerical value greater than a first threshold 3 Like Appellant and the Examiner, we refer to the Specification filed Sept. 12, 2014. Appeal 2019-005878 Application 14/485,594 3 and, responsive to so determining cause the discharge circuit to discharge the stored electrical charge through the patient, else responsive to it being determined that a motion event has been detected, determining whether or not the shock advice parameter has a numerical value greater than a second threshold different from the first threshold and, responsive to so determining cause the discharge circuit to discharge the stored electrical charge through the patient. REJECTIONS4 I. The Examiner rejects claims 106 and 107 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. II. The Examiner rejects claims 106 and 107 under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. III. The Examiner rejects claims 106 and 107 under 35 U.S.C. § 102(a)(1) as being anticipated by Volpe.5,6 ANALYSIS Rejection I The Examiner finds that Appellant’s original disclosure does not support the limitations “performing an ECG rhythm analysis” and “generating a shock advice parameter from the ECG rhythm analysis,” as 4 The Examiner has withdrawn the rejection under 35 U.S.C. 112(b) of claims 106 and 107. Examiner’s Answer 3 (dated June 5, 2019, hereinafter “Ans.”). 5 Volpe et al., US 2008/0312709 A1, published Dec. 18, 2008. 6 We consider the inclusion of claim 100 in the heading of this rejection to be a typographical error because claim 100 is canceled. See footnote 2. Appeal 2019-005878 Application 14/485,594 4 recited by each of independent claims 106 and 107. See Final Act. 7–9 (citing Spec. paras. 48, 101).7 With respect to the first limitation in dispute, the Examiner notes that “[t]here are numerous manners in which ECG signals can be analyzed” and “there are also numerous rhythms which are to be determined from ECG analysis,” such as “Atrial Fibrillation, Ventricular Fibrillation, Atrial Flutter, bradycardia, tachycardia, normal sinus rhythm etc.” Ans. 4–5. Thus, according to the Examiner, “the [S]pecification does not describe in any meaningful way how the ECG analysis is performed” because “[n]owhere is there an algorithm, or equations, or steps which specifically provide verification of what type of analysis is performed or what specific signals are used to perform the rhythm analysis.” Id. at 4 (emphasis added). In regards to the second limitation, the Examiner takes the position that “it is unclear what an ‘advice parameter’ would be, could be or is in relation to [the] ECG rhythm analysis.” Final Act. 7. According to the Examiner, “there is no disclosure as to how this parameter is generated, [i.e., calculated,] what variable, equations, steps etc. are used to determine [such] a parameter.” Id. (citing Spec. paras. 49, 101) (emphasis added); see also Ans. 4. In particular, the Examiner notes, “there is no way of knowing, from the disclosure as written, how to generate a shock advice parameter from an 7 The Examiner also finds that Appellant’s original disclosure does not support “that an ECG rhythm analysis based on physiological input is used in a first manner and in a second manner to determine shock or no shock criterion.” Final Act. 9. However, as neither claim 106 nor claim 107 recites such limitations, we consider this rejection to be moot. We note that these limitations are recited in claim 100, which is canceled. See Appellant’s Amendment 2, filed Oct. 17, 2017. Appeal 2019-005878 Application 14/485,594 5 ECG rhythm analysis.” Final Act. 8 (emphasis added). Thus, according to the Examiner, “the [S]pecification fails to provide adequate disclosure as to 1) what appellant intends a shock advice parameter to be, 2) what signals are used to determine a shock advice parameter, 3) how the signal is analyzed or 4) how an ECG analysis is performed.” Ans. 6. We appreciate the Examiner’s position that the Specification does not explicitly describe, “how the ECG analysis is performed” (Ans. 4) or “how to generate a shock advice parameter from an ECG rhythm analysis,” (Final Act. 8) as it is not clear what signals are used, how they are analyzed, and how an ECG analysis is performed. However, the lack of such descriptions may constitute a failure to comply with the enablement requirement, whereas the instant rejection is based on a failure to comply with the written description requirement. The written description requirement found in 35 U.S.C. § 112 is separate and distinct from the enablement requirement of that provision. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)). In particular, “[t]he test for the sufficiency of the written description ‘is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’” Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015) (quoting Ariad, 598 F.3d at 1351). Here, we agree with Appellant that paragraph 85 of the Specification provides written descriptive support for the limitation of “performing an ECG rhythm analysis,” as recited by each of independent claims 106 and 107. See Reply Br. 4–6. In particular, in paragraph 85, Appeal 2019-005878 Application 14/485,594 6 Appellant’s Specification describes an ECG rhythm analysis where a physiological input is derived from an ECG signal that can be “high-pass filtered at a first cut-off frequency” or “high-pass filtered at a second cut-off frequency different from the first cut-off frequency.” Moreover, as the Examiner specifically states that “ECG rhythm analysis is known in the art” (see Ans. 4), Appellant is correct that “one skilled in the art would not need every detail of the ECG rhythm analysis explained in order to understand that the Applicant(s) had possession of the invention and be informed of the invention sought to be patented.” Reply Br. 6. As such, Appellant’s original disclosure supports the limitation “performing an ECG rhythm analysis,” as recited by each of independent claims 106 and 107. As to the second disputed limitation noted above, we agree with Appellant that paragraph 101 of the Specification supports the limitation of “generating a shock advice parameter from the ECG rhythm analysis,” as recited by each of independent claims 106 and 107. See Appeal Br. 22. In particular, paragraph 101 describes performing a rhythm analysis from a physiological input and then generating a shock advice parameter from the rhythm analysis, wherein the shock advice parameter has a numerical value from zero to 10. As such, Appellant’s original disclosure supports the limitation “generating a shock advice parameter from the ECG rhythm analysis,” as recited by each of independent claims 106 and 107. In conclusion, for the foregoing reasons, we do not sustain the rejection under 35 U.S.C. § 112(a) of claims 106 and 107 as failing to comply with the written description requirement. Appeal 2019-005878 Application 14/485,594 7 Rejection II The Examiner finds that “the [S]pecification, while being enabling for ventricular fibrillation, does not reasonably provide enablement for all types of ECG rhythm analysis,” such as “atrial fibrillation, atrial flutter, ventricular flutter, heart failure, long-QT syndrome etc.” Final Act. 10 (emphasis added). Insofar as the enablement requirement is concerned, the dispositive issue is whether Appellant’s disclosure, considering the level of ordinary skill in the art as of the date of Appellant’s application, would have enabled a person of such skill to make and use applicant’s invention without undue experimentation. See In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982). In calling into question the enablement of Appellant’s disclosure, the Examiner has the initial burden of advancing acceptable reasoning inconsistent with enablement so as to shift the burden to Appellant to show that one of ordinary skill in the art could have practiced the claimed invention without undue experimentation. See id. Determining whether any necessary experimentation is undue involves consideration of many relevant factors including, but not limited to: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). In this case, the Examiner has not discussed any of these factors in establishing that Appellant’s disclosure is non-enabling with respect to other types Appeal 2019-005878 Application 14/485,594 8 of ECG rhythm analysis besides ventricular fibrillation and ventricular tachycardia. See Spec. para. 48. In other words, the Examiner does not set forth the requisite findings and analysis to show that a person of ordinary skill in the art could not make or use the invention without undue experimentation. Nonetheless, we note that “a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws.” In re Fischer, 427 F.2d 833, 839 (CCPA 1970). Here, because “ECG rhythm analysis is known in the art” (see Ans. 4), the enabled embodiments of using ECG signals to detect ventricular fibrillation or ventricular tachycardia provide broad enablement in the sense that a person of ordinary skill in the art would know how to make and use other types of ECG rhythm analysis for other cardiovascular conditions without undue experimentation. See Reply Br. 11. Accordingly, for the foregoing reasons, we do not sustain the rejection under 35 U.S.C. § 112(a) of claims 106 and 107 as failing to comply with the enablement requirement. Rejection III Each of claims 106 and 107 requires, inter alia, “generating a shock advice parameter from the ECG analysis” and comparing it to first and second thresholds. Appeal Br. 39–40, Appendix A. The Examiner finds that Volpe discloses a processor 54 “configured to . . . perform rhythm analysis based on the physiological input in a first manner if no motion is detected, perform rhythm analysis in a second manner different from the first if motion is detected . . . determine whether a Appeal 2019-005878 Application 14/485,594 9 shock is necessary and discharge a shock to the patient.” Final Act. 12–13 (citing Volpe, 69–73, Fig. 5). Appellant argues that Volpe fails to disclose comparing the numerical value of the claimed “shock advice parameter” to different thresholds. Appeal Br. 36. In response, the Examiner takes the position that because Volpe’s “algorithm analyzes the data and determines if a shock is necessary” Volpe discloses “a shock advice parameter from the ECG data.” Ans. 9. According to the Examiner, “[i]f the shock is delivered then there would inherently be some type of threshold to determine if the shock is, in fact, necessary” and “if there is not enough evidence that a shock is necessary this would be below the threshold and no shock would be given.” Id. Volpe discloses an arrhythmia detection algorithm in which patient motion detected in conjunction with detection of a treatable arrhythmia determines whether a shock is delivered. Volpe, para. 72, Fig. 5. In particular, Volpe discloses that if the patient becomes motionless when the treatable arrhythmia is detected, it is more probable that the arrhythmia diagnosis is correct, and, thus, a shock is delivered. Id. However, if patient motion is detected after the treatable arrhythmia is detected, the probability that that the arrhythmia diagnosis is correct is lower, and, thus, delivery of the shock is delayed. Id. As such, Appellant is correct that only a single threshold comparison is made in Volpe, namely, when the treatable arrhythmia is detected, i.e., step V51 in Appellant’s amended Figure 5 of Volpe. See Reply Br. 15. After the treatable arrhythmia is detected in Volpe, the shock is either administered immediately, or is merely delayed. See Volpe, Fig. 5. Appeal 2019-005878 Application 14/485,594 10 Thus, we agree with Appellant that because in Volpe “[t]he decision to shock the patient is made singularly at V51,” “there are not multiple thresholds to which a number is compared.” Reply Br. 16. Hence, “Volpe . . . does not disclose ‘generating a shock advice parameter from the ECG rhythm analysis’, and compare its numerical value to different thresholds, as recited in both claims 106 and 107.” Id. at 17 (emphasis omitted). Accordingly, we do not sustain the rejection under 35 U.S.C. § 102(a)(1) of claims 106 and 107 as anticipated by Volpe. NEW GROUND OF REJECTION Claims 106 and 107 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. The original disclosure does not provide enabling support for the limitation “generating a shock advice parameter from the ECG rhythm analysis,” as recited by each of independent claims 106 and 107. Although the Specification describes a shock advice parameter as a numerical value from zero to 10 (see Spec. para. 101), the Specification does not describe how the shock advice parameter is determined from a rhythm analysis, that is, what variables, equations, and/or algorithms are used to determine it. The Specification additionally provides no information or guidance as to how one skilled in the art would arrive at a value of from zero to 10 for the shock advice parameter. Hence, the disclosure, as filed, is not sufficiently complete to enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation. Most notably, as per In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), because the original disclosure does not set forth prior art that discloses a shock advice Appeal 2019-005878 Application 14/485,594 11 parameter, fails to provide any direction as to how a skilled artisan would determine the shock advice parameter from a rhythm analysis, and does not disclose any working examples, the necessary experimentation to determine the shock advice parameter is undue. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 106, 107 112(a) Written description 106, 107 106, 107 112(a) Enablement 106, 107 106, 107 102(a)(1) Volpe 106, 107 106, 107 112(a) Enablement 106, 107 Overall Outcome 106, 107 106, 107 This Decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides (emphasis added): When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: Appeal 2019-005878 Application 14/485,594 12 (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the [E]xaminer, in which event the prosecution will be remanded to the [E]xaminer. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the [E]xaminer, overcomes the new ground of rejection designated in the decision. Should the [E]xaminer reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01 (9th ed. 2018). 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). REVERSED 37 C.F.R. § 41.50(b) Copy with citationCopy as parenthetical citation