Ex Parte Libbus et alDownload PDFPatent Trial and Appeal BoardJan 13, 201713867778 (P.T.A.B. Jan. 13, 2017) 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. 13/867,778 04/22/2013 Imad Libbus 279.I49US3 9192 45458 7590 01/18/2017 smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER PO BOX 2938 PATEL, NATASHA MINNEAPOLIS, MN 55402 ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 01/18/2017 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): uspto@slwip.com SLW @blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IMAD LIBBUS, QUAN NI, and KENT LEE Appeal 2015-002740 Application 13/867,778 Technology Center 3700 Before EDWARD A. BROWN, BRANDON J. WARNER, and ARTHUR M. PESLAK, Administrative Patent Judges. PESLAK, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Imad Libbus et al. (“Appellants”) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 2—21.1 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART and enter a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). 1 Appellants submit the real party in interest is Cardiac Pacemakers, Inc. Appeal Br. 2. Appeal 2015-002740 Application 13/867,778 THE CLAIMED SUBJECT MATTER Claims 2, 12, and 21 are the independent claims on appeal. Claim 2, reproduced below, is illustrative of the claimed subject matter. 2. A method for using an implantable system implanted within a congestive heart failure patient, comprising: monitoring pulmonary congestion, wherein monitoring pulmonary congestion includes sensing a physiologic parameter using a sensor implanted within the patient; and delivering a congestive heart failure therapy using a stimulator implanted within the patient, wherein delivering the congestive heart failure therapy includes delivering electrical stimulation to the patient using the sensed parameter to control the congestive heart failure therapy, the congestive heart failure therapy including a neural stimulation therapy. REJECTIONS 1) Claims 2, 4—7, 9—12, 14—16, and 19—21 are rejected under 35 U.S.C. § 103(a) as unpatentable over Pitts Crick (US 6,104,949, issued Aug. 15, 2000) and Terry (US 2003/0040774 Al, published Feb. 27, 2003). 2) Claims 3, 8, 13, and 17—18 are rejected under 35 U.S.C. § 103(a) as unpatentable over Pitts Crick, Terry, and Park (US 2003/0153953 Al, published Aug. 14, 2003). DISCUSSION Rejection 1 Independent claim 2 The Examiner finds that Pitts Crick discloses all the limitations of claim 2, except it “discloses myocardial stimulation . . . but no 2 Appeal 2015-002740 Application 13/867,778 neurostimulation.” Final Act. 3. The Examiner finds that Terry “discloses a similar CHF [“Congestive Heart Failure”] treatment that delivers a neurostimulation therapy towards increasing baroreflex sensitivity.” Id. (citing Terry, claim 36). The Examiner concludes it would have been obvious “to apply baroreceptor therapy [in Pitts Crick] since Terry teaches that doing so helps provides the heart with adequate parasympathetic support.” Id. (citing Terry 111). Appellants contend that Pitts Crick discloses sensing the “degree of CHF,” which is “a longer term disease state, and does not quickly change like a heart rate change in response to vagal nerve stimulation [as in Terry]”. Appeal Br. 12. Appellants next contend the Examiner fails to show “the control of a congestive heart failure therapy, including a neural stimulation therapy (the ‘baroreceptor therapy’), using the sensed parameter from the implanted sensor that is used in the monitoring of pulmonary congestion.” Id. at 14. Appellants next contend that Terry teaches away from the claimed subject matter. Id. In support of this contention, Appellants assert that Terry “rel[ies] on heart rate, as a quick response to vagal stimulation above the cardiac branch, to control the neural stimulation, in contrast to a slow and indirect response when the vagus nerve is stimulated below the superior cardiac branch.” Id. Appellants next contend that “simple substitution” does not support the Examiner’s conclusion of obviousness. Id. In support of this contention, Appellants assert that “[o]ne cannot simply substitute the sensed degree of CHF [Pitts Crick] in place of heart rate [Terry], For example, vagal stimulation controlled using heart rate is not the same as a CHF therapy controlled using the sensed degree of CHF,” such a substitution “would improperly change the intended purpose of Terry,” and 3 Appeal 2015-002740 Application 13/867,778 would “improperly change the principle of operation of Terry.” Id. at 15. Finally, Appellants contend that the combination of Pitts Crick and Terry is improperly based on hindsight because the rejection is not based on facts gleaned from the prior art. Id. at 16. In support of this contention, Appellants assert that the Examiner’s reasoning “is silent as to how vagal nerve stimulation is part of congestive heart failure therapy, and how the combination controls the congestive heart failure therapy, including the vagal nerve stimulation therapy, using the sensed parameter from the implanted sensor that is used in the monitoring of pulmonary congestion.” Id. The Examiner responds that Pitts Crick and Terry each disclose treatment of CHF. Ans. 5 (citing Pitts Crick, col. 1,11. 49—57, Terry 146). The Examiner also notes that it is well known in the art to combine a pacemaker with a nerve stimulator to treat heart conditions. Id. The Examiner reiterates that Terry is relied on for disclosing the use of neural stimulation to treat CHF, and that CHF is the specific heart condition disclosed in Pitts Crick. Id. Pitts Crick discloses a device and method for “the diagnosis and treatment of congestive heart failure.” Pitts Crick, col. 1.11. 49—50. Pitts Crick uses the physiology of pulmonary edema “to indicate congestive heart failure.” Id. col. 2,11. 36—37. Pitts Crick discloses sensing trans-thoracic impedance “which is dependent on the blood or fluid content of the lungs, to assist in the detection and quantification of pulmonary edema and thus congestive heart failure.” Id. col. 2,11. 38-41. Pitts Crick also senses the patient’s posture which can affect trans-thoracic impedance. Id. col. 2,1. 44, col. 3,11. 9—11. Pitts Crick’s device may be implemented in various known 4 Appeal 2015-002740 Application 13/867,778 “implantable devices.” Id. col. 3,11. 17—20. Pitts Crick discloses treatment of a CHF patient by “electrical stimulation of the heart.” Id. col. 6,11. 28— 30. Terry discloses a “device for treating patients suffering from congestive heart failure [that] includes an implantable neurostimulator.” Terry, Abstract. Terry also discloses a method for treating CHF patients that includes vagus nerve stimulation. Id. 112. Terry also discloses that, as a result of its therapy, a patient “is expected to improve gradually over a period of several weeks or longer as a result of increase in the capillaries and the coronary blood flow.” Id. 1 37. Appellants’ first contention that Pitts Crick’s CHF therapy is different than Terry’s CHF therapy because it measures “degree of CHF” is not persuasive for the following reasons. Appellants do not direct us to any portion of Pitts Crick, or to any other evidence, to support the assertion that “degree of CHF” is a longer term disease state. In addition, Terry also discloses that its therapy results in gradual improvement to the patient over a period of several weeks indicating that its disclosed therapy is not merely short term. Terry, 137. Appellants’ next contention, i.e., the rejection fails to show the recited control of a congestive heart failure therapy, appears to be based on an argument that neither Pitts Crick nor Terry, individually, discloses this limitation. Pitts Crick discloses sensing trans-thoracic impedance in a CHF patient which is a measure of pulmonary edema or congestion with an implanted device. Terry discloses stimulating the vagus nerve to treat CHF. The rejection is based on the combined teachings of Pitts Crick and Terry. We are not persuaded by this contention because one cannot show non- 5 Appeal 2015-002740 Application 13/867,778 obviousness by attacking the references individually when the rejection is based on the combined teachings of the references. In re Keller, 642 F.2d 413, 426 (CCPA 1981). Appellants’ contentions do not persuade us that the combination of Pitts Crick and Terry fails to disclose the recited control of a congestive heart failure therapy. We are also not persuaded by Appellants’ contention that Terry teaches away from the claimed invention for the following reasons. A prior art reference does not teach away from the claimed subject matter unless the prior art reference criticizes, discredits, or otherwise discourages the solution claimed. See Crocs, Inc. v. U.S. Int’l Trade Comm ’n, 598 F.3d 1294, 1308 (Fed. Cir. 2010) (Prior art taught away by specifically discouraging use of foam straps.); In re Fulton, 391 F. 3d 1195, 1201 (Fed. Cir. 2004). In this case, Appellants contend that Terry teaches away from the claimed subject matter because it discloses vagal stimulation above the cardiac branch as opposed to below the cardiac branch. Appeal Br. 14. We note, however, that claim 2 recites “neural stimulation” without any limitation to a particular location of vagal nerve stimulation relative to the cardiac branch. Appellants, thus, do not provide persuasive argument or evidence why Terry’s vagal nerve stimulation above the cardiac branch criticizes, discredits or otherwise discourages the recited “neural stimulation” therapy. Appellants’ next contention, that substituting the sensed degree of CHF from Pitts Crick for the sensed heart rate of Terry is improper because it would change the intended purpose and/or principle of operation of Terry, is not persuasive for the following reasons. The rejection is based on substituting Terry’s neural stimulation therapy for the direct stimulation of the heart in Pitts Crick. Ans. 5; Final Act. 3. The Examiner, thus, has not 6 Appeal 2015-002740 Application 13/867,778 proposed modifying Terry’s method or device in any way, let alone in a manner that would change its intended purpose or principle of operation of Terry. Appellants’ contention that the rejection is improperly based on hindsight is also not persuasive. Pitts Crick discloses using an implanted sensor to sense trans-thoracic impedance to determine pulmonary congestion and to use the sensed condition to treat a patient suffering from congestive heart failure. Terry discloses that vagal nerve stimulation is used in CHF therapy. Thus, all elements of claim 2 are disclosed in the proposed combination of Pitts Crick and Terry. Appellants do not dispute the Examiner’s rationale for the combination as quoted above. Appeal Br. 17. Appellants thus fail to apprise us of error in the Examiner’s rationale for the combination, which we determine to be reasonable and supported by the disclosure in the cited references. See KSR Int’l Co. v. Teleflex Inc., 550 US 398, 416 (2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”); see also In re Cree, 818 F.3d 694, 702, n.3 (Fed. Cir. 2016) (Impermissible hindsight argument not persuasive when “the proffered combination is merely a predictable use of prior art elements according to their established functions.”). We sustain the rejection of claim 2. Appellants do not argue separately for the patentability of claims 4—6, and 9—10, which depend from claim 2. Appeal Br. 11—23. We also sustain the rejection of claims 4—6 and 9—10 for the same reasons as stated for claim 2. Independent claim 12 Claim 12 recites “a controller configured to monitor pulmonary congestion using the sensed physiologic parameter and use the sensed 7 Appeal 2015-002740 Application 13/867,778 physiologic parameter to control the congestive heart failure therapy.” Appeal Br. 34 (Claims App.). Appellants contend that the rejection fails to show the recited controller. Id. at 19. Appellants also raise the same contentions as discussed above for claim 2. Id. We note that the Examiner did not make a specific finding concerning the controller recited in claim 12. Final Act. 3. Terry discloses a logic/control section 35 “for producing the output pulse waveform according to the prescribed therapy” in order “to bring the patient’s detected ventricular rate to a target level.” Terry 129. Pitts Crick discloses impedance measurement circuit 42 for measuring trans-thoracic impedance and pace pulse generator 36 for delivering “pace pulses under influence of control circuitry or control 37, for delivery through lead 32 to the patient’s heart.” Pitts Crick, col. 1,11. 49—51; col. 3,11. 55—64. Control 37, thus, controls impedance measurement circuit 42 and pace pulse generator 36 for delivering therapy to the patient. Id. Fig. 2, col. 3,11. 57— 64. Control 37 also controls CHF drug therapy delivery to the patient as an alternative to electrical stimulation therapy. Id. Fig. 6, col. 6,11. 28—30, col. 6,1. 66-col. 7,1. 3. In light these teachings in Pitts Crick and Terry, we determine that it would have been obvious to one of ordinary skill in the art at the time of the present invention to modify Pitts Crick’s control circuitry to control electrical stimulation of a nerve as disclosed in Terry, rather than the patient’s heart, in order to provide neural stimulation to treat CHF in the manner disclosed in Terry. As discussed above, Appellants’ contentions in connection with claim 2 are not persuasive. Thus, we sustain the rejection of claim 12 for similar reasons. However, because the Examiner did not make a specific finding 8 Appeal 2015-002740 Application 13/867,778 concerning the recited controller, we designate our affirmance for claim 12 as a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) to provide Appellants with a fair opportunity to respond. Appellants do not argue separately for the patentability of claims 14—16 and 19 which depend from claim 12. We also sustain the rejection of claims 14—16 and 19 for the same reasons as for claim 12, and likewise designate our affirmance for these claims as a new ground of rejection. Independent claim 21 Claim 21 recites, inter alia, that “the sensor is configured to sense ventricular filling pressure.” Appeal Br. 35 (Claims App.). The Examiner finds that Pitts Crick discloses this limitation. Final Act. 4 (citing Pitts Crick, col. 1,11. 10-13, col. 2,11. 30—34.). Appellants contend that Pitts Crick does not disclose the recited sensing of ventricular filling pressure or using sensed ventricular filling pressure to control the congestive heart failure therapy. Appeal Br. 22—23. Pitts Crick discloses CHF “is the inability of the heart to pump blood at an adequate rate in response to the filling pressure.” Pitts Crick, col. 1,11. 11—12. We acknowledge this citation by the Examiner; however, the Examiner does not direct us to any portion of Pitts Crick that discloses the sensing of ventricular filling pressure as recited in claim 21. The Examiner’s finding is thus not supported by sufficient evidence. Consequently, we do not sustain the rejection of claim 21. Dependent claim 7 Claim 7 recites the “therapy includes stimulating a phrenic nerve.” Appeal Br. 33 (Claims App.). Appellants contend that neither Pitts Crick nor Terry discloses therapy that includes stimulating a phrenic nerve. 9 Appeal 2015-002740 Application 13/867,778 Appeal Br. 17. The Examiner does not cite to any portion of either Pitts Crick or Terry that discloses stimulating a phrenic nerve. Final Act. 3. The Examiner’s finding is, thus, not supported by the disclosure of either Pitts Crick or Terry. Consequently, we do not sustain the rejection of claim 7. Dependent claim 11 Claim 11, similarly to claim 21, recites “sensing ventricular filling pressure.” Appeal Br. 34 (Claims App.). The Examiner relies on Pitts Crick for disclosure of this limitation. Final Act. 4. However, as with claim 21 discussed above, the Examiner has not identified sufficient evidence that Pitts Crick discloses sensing ventricular filling pressure. Consequently, we do not sustain the rejection of claim 11 for the same reasons stated above in connection with claim 21. Rejection 2 Dependent claims 3 and 13 Claim 3, which depends ultimately form claim 2, recites “delivering at least one disordered breathing therapy” that includes “stimulating a hypoglossal nerve.” Appeal Br. 33 (Claims App.) (emphasis added). Claim 13, which depends ultimately from claim 12, contains a similar limitation as claim 3. Id. at 34. The Examiner finds that “Park discloses stimulating the hypoglossal nerve or the phrenic nerve to address breathing disorders.” Final Act. 4. The Examiner reasons that stimulating the hypoglossal nerve is one of a “finite number of identified, predictable solutions” for treating disordered breathing and “it would have been obvious to stimulate whichever nerve was necessary to address the adverse effects of CHF.” Id. at 4—5. 10 Appeal 2015-002740 Application 13/867,778 Appellants contend that Park discloses treatment of sleep apnea by stimulating the hypoglossal nerve to hold open an airway. Appeal Br. 26— 27. Appellants do not dispute the Examiner’s finding that Park discloses stimulating the hypoglossal or phrenic nerves. Id. Instead, Appellants contend that treatment of CHF is not equivalent to treatment of sleep apnea and the rejection is “silent as to how the ‘hypoglossal nerve stimulation’ for ‘sleep apnea’ would be incorporated with Pitts Crick [] and Terry.” Id. at 28. Appellants also contend that the Examiner’s rationale for the combination of Pitts Crick, Terry, and Park is unsupported because the Examiner did not identify the problem to be solved, took official notice of facts, and failed to provide rational underpinnings for the combination. Id. at 28-29. Appellants’ Specification describes disordered breathing as a “disruption of the normal respiratory cycle.” Spec. 1. Further, sleep apnea is described as “a fairly common form of disordered breathing.” Id. at 2. The Specification also describes that “[disordered breathing is particularly prevalent among congestive heart failure patients.” Id. at 7. The Specification describes hypoglossal nerve stimulation “to provide therapy for disordered breathing.” Id. at 13. Appellants’ contention that disordered breathing treatments for CHF patients are different than the disordered breathing treatments for sleep apnea is not supported by the Specification, or by any other evidence identified by Appellants. Both sleep apnea and CHF patients are described in Appellants’ Specification as suffering from disordered breathing. Appellants do not direct us to any part of the Specification describing that the disordered breathing treatments applied to sleep apnea patients are 11 Appeal 2015-002740 Application 13/867,778 different than the disordered breathing treatments applied to CHF patients. Appellants, thus, do not apprise us of error in the Examiner’s determination that the breathing disorder therapy recited in claim 3 reads on Park’s disclosure of stimulating the hypoglossal nerve to treat breathing disorders. The “problem” the Examiner refers to in the rejection is the problem solved by the claimed subject matter, i.e., providing at least one disordered breathing therapy. The Examiner did not take official notice of facts as asserted by Appellants, but cited to evidence from Park for disclosure of stimulating the hypoglossal nerve to provide disordered breathing therapy. Appellants have not apprised us of error in the Examiner’s rationale for the combination of Pitts Crick, Terry, and Park which is supported by the disclosure in the cited references. We, thus, sustain the rejection of claims 3 and 13. Dependent claims 8 and 18 Claim 8, which depends from claim 2, recites “delivering at least two disordered breathing therapies” including “stimulating at least two of a baroreflex target... a phrenic nerve, or a hypoglossal nerve.” Appeal Br. 33—34 (Claims App.). Claim 18, which depends from claim 12, contains similar limitations. Id. at 35. The Examiner finds that Terry discloses delivering at least two disordered breathing therapies. Final Act. 4 (citing Terry H 30, 48-49). Appellants contend that Terry discloses only one therapy, i.e., vagal stimulation therapy. Appeal Br. 29—30. Terry discloses one mode of disordered breathing therapy, i.e., stimulating the vagus nerve. Terry 130. The Examiner has not directed us to any disclosure in Terry of stimulating either a phrenic nerve or a hypoglossal nerve. The Examiner’s finding that Terry discloses delivering 12 Appeal 2015-002740 Application 13/867,778 at least two disordered breathing therapies is not supported by the disclosure in Terry. Therefore, we do not sustain the rejections of claims 8 and 18. Dependent claim 17 Claim 17, which depends ultimately from claim 12, recites providing disordered breathing therapy that “wherein the at least one disordered breathing therapy includes electrical stimulation of the phrenic nerve.” Appeal Br. 35 (Claims App.). The Examiner finds that Park discloses stimulating “the phrenic nerve to address breathing disorders.” Final Act. 4. Appellants’ Specification also discloses phrenic nerve stimulation as a disordered breathing therapy that is not limited to sleep apnea patients. Spec. 13. Appellants do not dispute the Examiner’s finding but, similar to the arguments made in connection with stimulating the hypoglossal nerve as recited in claims 3 and 13, Appellants contend that Park stimulates the phrenic nerve to treat sleep apnea, not as part of CHF therapy. Appeal Br. 30. Appellants also interpose the contention from claims 3 and 13 that the Examiner’s rationale for the combination is not supported by rational underpinnings. Id. We determine above that none of these contentions are persuasive. We, thus, sustain the rejection of claim 17 for the same reasons stated above in connection with claims 3 and 13. New Ground of Rejection of claim 7 We exercise our discretion under 37 C.F.R. § 41.50(b) and enter a NEW GROUND OF REJECTION against claim 7 under 35 U.S.C. § 103(a) as unpatentable over Pitts Crick and Terry as applied by the Examiner to claim 2 (from which claim 7 ultimately depends) and Park as applied by the Examiner to claim 17. 13 Appeal 2015-002740 Application 13/867,778 Claim 7, similarly to claim 17, recites “wherein delivering at least one disordered breathing therapy includes stimulating a phrenic nerve.” Appeal Br. 33 (Claims App.). Park discloses “phrenic nerve stimulation” as a disordered breathing therapy. Park | 65. For the reasons stated by the Examiner in the rejection of claim 17, we determine it would have been obvious to one of ordinary skill in the art at the time of the present invention to modify the combination of Pitts Crick and Terry as applied to claim 2 by the Examiner to use the stimulation of the phrenic nerve as a disordered breathing therapy for a patient suffering from CHF. DECISION The Examiner’s decision rejecting claims 3—6, 9, 12—16, and 19 is affirmed, with the affirmance for claims 12, 14—16, and 19 being designated as a new ground of rejection. The Examiner’s decision rejecting claims 7, 8, 11, 18, and 21 is reversed. We enter a new ground of rejection against claim 7. FINALITY OF DECISION This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides: When the Board enters such a non-final decision, [Appellants], 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: 14 Appeal 2015-002740 Application 13/867,778 (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 examiner, in which event the prosecution will be remanded to the examiner. 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 examiner, overcomes the new ground of rejection designated in this decision. Should the examiner reject the claims, [Appellants] 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 new grounds of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART; 37 C.F.R, $ 41.50(b) 15 Copy with citationCopy as parenthetical citation