DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 47 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/2025.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered .The amendment to claim 1 is sufficient to overcome the previous 101 rejection. However, newly submitted claim 64 is not sufficient to overcome a 101 rejection.
The Applicant argues regarding claim 64 the method is implemented by a cardiac device and not a human. In addition, the Applicant argues the claim requires automatically processing the cardiac response data based on information from a sensor, which implies data analysis using a specific medical device context. The Applicant also argues the claim involves a medical concept and taken together is directed to a device-implements data analysis and decision method and therefore passes Step2A, prong one. The Applicant also argues the claim integrates the underlying natural correlation into a practical application using a specific machine (cardiac device controller). Applicant argues the controller, cardiac response data, and processing into a decision are not generic computer steps since they are specific to a medical device domain. The examiner respectfully disagrees, determining by a controller, that said patient can benefit from cardiac contractility modulation therapy in spite of said potential difficulty is an abstract idea. Regarding the controller, the published paragraph [0144]-[0146] discloses for example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. In other words, the controller is a generically recited computer element which does not improve the functioning of a computer, or any other technology or technical field. The other additional elements of a cardiac device and a sensor are not sufficient to integrate the abstract idea into a practical application as the delivery of CRT data and sensing are a pre-solution activity. The controller, cardiac device and sensor are not amount to sufficient more than the abstract idea because the controller is a generically claimed computer component which enables the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. Furthermore the cardiac device and sensor are well-known, routine and conventional as explained in the 101 rejection below. Applicant argues Doerr does not disclose detecting a potential difficulty in effective delivery of CRT. Applicant argues Doerr is connected to a rhythm evaluation unit which can either detect a sinus rhythm that is present or classify an atrial arrythmia and therefore does not detect a potential difficulty in effective delivery of CRT. The Applicant states CRT is the preferred in the case of sinus rhythm and CCM therapy is delivered in the case of atrial arrythmia. The examiner respectfully disagrees as the claim as currently written does not preclude the use of detecting atrial arrythmia (Afib) as a potential difficulty in effective delivery of CRT. Doerr in paragraph [0039] states that it may not be possible to synchronize CCM therapy correctly in the presence of atrial arrythmias (a potential difficulty). Therefore, detecting afib is equivalent to detecting a potential difficulty in effective delivery of CRT to said patient due to the presence of at least one comorbidity. Doerr as a result determines that the patient can benefit from CCM therapy in spite of said potential difficulty and treats the patient with CCM as shown in Figure 3 and Paragraph [0064].
The examiner argues claim 32 for the same reasons explained above with regards to claim 1. Regarding claim 5, Applicant argues that Doerr teaches away from the proposed modification because it states an “assumption that CRT stimulation is clearly superior to CCM therapy for cases of sinus rhythm” and therefore a person having ordinary skill in the art would not modify Doerr with a reference teaching that it is advisable to use CCM treatment in patients with detecting CRT delivery of said patient does not result in a beneficial effect on at least one of ejection fraction, intracardiac pressure, intra cardiac pressure gradient over a selected time period, NYSA class score, peak VO2 and 6 minute walk score as set forth in Kuschyk page 174, paragraphs 3 and 4 and 2.1 patient population paragraph 2. Kuschyk discloses in the abstract that the patients are CRT non-responders and then received CCM therapy based on 6-minute walk score and peak VO2. The conclusion of Kuschyk determines that those who fail to benefit from CRT and receive CCM treatment may result in a significant improvement in function, quality of life, NYHA class and peak VO2. Therefore, Applicant is using “teaching away” in a much broader sense that it is legally accepted. For a reference to be considered to teach away from a proposed modification such reference must criticize, discredit, or otherwise discourage the proposed combination. In re Fulton, 73 USPQ2d 1141 (Fed. Cir. 2004). The applicant is further advised that disclosed examples and/or preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, even if such nonpreferred embodiments are described as somewhat inferior. See In re Susi, 169 USPQ 423 (CCPA 1971), and In re Gurley, 31 USPQ2d 1130 (Fed. Cir. 1994). In this case, Doerr in Paragraph [0037] discloses applying the particular treatment that is the superior therapy concept. In light of Kuschyk, it would have been obvious to modify Doerr when the patient fails to benefit from CRT treatment as described in Kuschyk to improve quality and quantity of life. Regarding claims 6-8, Applicant argues Abraham states CRT has been available for patients with EF ≤35% , normal sinus rhythm, QRS duration ≥130 ms. Therefore a person having ordinary skill in the art would not combine Doerr, which prefers treating with CRT, with the reference of Abraham, which only selects patients having QRS<130ms. The skilled person would not have had any motivation to substitute the CRT treatment of Doerr with the CCM treatment of Abraham since Doerr teaches that CCM is only used in case of atrial arrythmia such as atrial fibrillation. The examiner respectfully disagrees as identified above Doerr in Paragraph [0037] discloses applying the particular treatment that is the superior therapy concept and does not criticize, discredit, or otherwise discourage the proposed combination. Abraham discloses using CRT with an EF ≤35%, and normal sinus rhythm, and QRS duration QRS duration ≥130 ms, and persistent NYHA functional class III or ambulatory class IV symptoms. Abraham also teaches in the conclusion that CCM is safe and improves exercise tolerance and quality of life with EF ranging from 25% to 45%, and with EFs between 35% and 45% CCM clinical effectiveness was even greater.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 64 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of determining that said patient can benefit from cardiac contractility modulation therapy in spite of said potential difficulties. This judicial exception is not integrated into a practical application because a cardiac device controller that generates CRT and a sensor for detecting a potential difficulty are pre-solution activities of gathering data and the controller is a generic computing device used to implement the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a cardiac device controller that generates CRT, and a sensor for detecting a potential difficulty are well-known routine and convention as evidenced by Stahmann (US Publication 2010/0069985) discloses in the background that CRT devices include delivering electrostimulations and Figure 1 illustrates sensing circuit 108 and 112 and Paragraph [0215] discloses delivering CRT. Hansen et al (US Publication 2007/0066998) discloses a cardiac device comprising sensors (Figure 3) and delivering CRT (Paragraph [0037]). The use of a controller does not amount to significantly more since it is a generic computing structure and the courts have ruled a generic processor is not sufficiently more than the abstract idea itself.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 9, 12, 16, 18, 19, 22-23, 26, 32, and 64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doerr (US Publication 2013/0006319).
Referring to Claim 1, Doerr teaches a method of selecting a patient for cardiac contractility modulation (CCM) therapy, comprising: selecting a patient meeting a criteria for cardiac resynchronization therapy (CRT) (e.g. Paragraphs [0035] and [0040]); detecting a potential difficulty in effective delivery of said CRT to said patient due to a presence of at least one comorbidity (e.g. Figure 3 and Paragraphs [0039] discloses detection of Afib and [0046] discloses renal function sensor); determining that said patient can benefit from the CCM therapy in spite of said potential difficulty (e.g. Paragraphs [0046] and [0064] discloses controlling CCM therapy by the identified sensor); and treating the patient with the CCM therapy in response to said determining (e.g. Figure 3 and Paragraph [0064]).
Referring to Claim 3, Doerr teaches a method according to claim 1, wherein at least one comorbidities is selected from a list comprising renal insufficiency, diabetes mellitus, chronic obstructive pulmonary disease, sleeping disorders, and anemia (e.g. Paragraph [0046]).
Referring to Claim 4, Doerr teaches a method according to claim 1, wherein said detecting comprises receiving an indication that said patient suffers from cardiac arrhythmia (e.g. Paragraph [0046] worsening heart failure sensor or cardiac function sensor).
Referring to Claim 9, Doerr teaches a method according to claim 1, wherein said determining comprises setting a pulse generator of a cardiac device with parameters of a testing electric field for cardiac contractility modulation to be delivered through at least one electrode lead to the heart, and determining that an effect of said testing electric field on said patient indicates that said patient can benefit from cardiac contractility modulation therapy through said at least one electrode lead (e.g. Figure 1, lead 112 and Paragraph [0057] and Figure 2, CCM electrodes 250 and stimulation unit 260).
Referring to Claim 12, Doerr teaches a method according to claim 1, comprising: selecting a cardiac tissue location suitable for delivery of cardiac contractility modulation and CRT therapy through said at least one electrode lead (e.g. Figure 1, leads 110, 112, 114 and 116).
Referring to Claim 16, Doerr teaches a method according to claim 1, comprising: identifying that an effect of CRT is not a planned effect (e.g. Paragraph [0040] discloses determining the presences of arrythmia from CRT therapy).
Referring to Claim 18, Doerr teaches a method according to claim 16, wherein said identifying comprises identifying that said CRT effect comprises at least one undesired side effect (e.g. Paragraph [0040]).
Referring to Claim 19, Doerr teaches a method according to claim 18, wherein said at least one undesired side effect comprises pain sensation and/or arrhythmia (e.g. Paragraph [0040]).
Referring to Claim 22, Doerr teaches a method according to claim 1, comprising selecting a treatment plan in which a dual purpose device is configured to generate electric fields for both CRT and cardiac contractility modulation therapy (e.g. abstract, Paragraph [0054]).
Referring to Claim 23, Doerr teaches a method according to claim 22, wherein said dual purpose device is configured to time said CCM electric field during a refractory period of the heart as a train of biphasic bipolar pulses (e.g. Paragraph [0025]).
Referring to Claim 26, Doerr teaches a method according to claim 1, wherein said CCM therapy is combined with said CRT (e.g. abstract and Paragraph [0054]).
Referring to Claim 32, Doerr teaches a method of selecting a patient for cardiac contractility modulation therapy comprising: identifying that an effect of CRT delivered is not a beneficial effect on said patient (e.g. Paragraph [0040] discloses determining the presences of arrythmia from CRT therapy); modifying a setting of a cardiac device controller to generate a cardiac contractility modulation electric field based on the results of said identifying (e.g. Paragraph [0040]).
Referring to Claim 64, Doerr teaches a method implemented by a cardiac device controller of selecting a patient for cardiac contractility modulation (CCM) therapy, comprising: receiving cardiac response data generated during the delivery of cardiac resynchronization therapy (CRT) (e.g. Paragraphs [0035] and [0040]); detecting a potential difficulty in effective delivery of said CRT to said patient by automatically processing the cardiac response data based on information from at least one sensor connected to an implantable pulse generator (IPG) unit; (e.g. Figure 3 and Paragraphs [0039] discloses detection of Afib and [0046] discloses renal function sensor); determining that said patient can benefit from the CCM therapy in spite of said potential difficulty (e.g. Paragraphs [0046] and [0064] discloses controlling CCM therapy by the identified sensor).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doerr (US Publication 2013/0006319) in view of Kuschyk et al (Kuschyk et al. "Cardiac Contractility Modulation Treatment in Patients With Symptomatic Heart Failure Despite Optimal Medical Therapy and Cardiac Resynchronization Therapy (CRT)", International Journal of Cardiology, 277: 173- 177, Available Online 29 October 2018, cited in IDS dated 2/5/2023).
Referring to Claim 5, Doerr teaches a method according to claim 4, except wherein said cardiac arrhythmia comprises a non-left bundle branch block (non-LBBB).
Kuschyk et al teaches that it is known to use detecting comprises receiving an indication that said patient suffers from non-left bundle branch block as set forth in page 173 CRT recommendations and page 175 discussion paragraph 2 to provide identification of factors that would result in CRT being less effective. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with detecting comprises receiving an indication that said patient suffers from non-left bundle branch block as taught by Kuschyk et al, since such a modification would provide the predictable results of identification of factors that would result in CRT being less effective.
Referring to Claim 36, Doerr teaches a method according to claim 1, except wherein said detecting comprises identifying that said CRT delivery to said patient does not result in a beneficial effect on at least one of ejection fraction, intracardiac pressure, intra cardiac pressure gradient over a selected time period, NYHA class score, Peak VO2 and 6 minute walk score.
Kuschyk et al teaches that it is known to use detecting comprises identifying that said CRT delivery to said patient does not result in a beneficial effect on at least one of ejection fraction, intracardiac pressure, intra cardiac pressure gradient over a selected time period, NYHA class score, Peak VO2 and 6 minute walk score as set forth in page 174 paragraphs 3 and 4 and 2.1 patient population paragraph 2 to provide treatment for CRT non-responders to improve quality and quantity of life. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with detecting comprises identifying that said CRT delivery to said patient does not result in a beneficial effect on at least one of ejection fraction, intracardiac pressure, intra cardiac pressure gradient over a selected time period, NYHA class score, Peak VO2 and 6 minute walk score as taught by Kuschyk et al, since such a modification would provide the predictable results of treatment for CRT non-responders to improve quality and quantity of life.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doerr (US Publication 2013/0006319) in view of Abraham et al (Abraham et al. "A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation", Journal of the American College of Cardiology, JACC: Heart Failure, 6(10):874-883, Published Online 10 May 2018, ISSN 2213-1779, https://doi.org/10.1016/j.jchf.2018.04.010; copy provided 7/11/2025).
Referring to Claims 6-8, Doerr teaches a method according to claim 1, except wherein said determining comprises receiving an indication that said patient suffers from heart failure in NYHA classes II-IV; or wherein said determining comprises receiving an indication that said patient suffers from a left ventricular ejection fraction in a range between 25%-55%; and/or wherein said determining comprises receiving an indication that the patient exhibits a normal QRS duration, which is larger than 130 ms. Abraham et al teaches that it is known to determining CCM can be beneficial when a subject has an ejection factor of 25-45% (e.g. page 875, left column, paragraphs 3-5 and page 881 “discussion” paragraph 1),a QRS duration of <130ms (e.g. page 875 “study population section” paragraph 1 and page 881 “discussion” paragraph 1); and a NYHA of class III or IV as set forth in page 875 “study design” and page 881 “discussion” paragraph 1 to provide , improving exercise tolerance and quality of life in the specified group of HF patients. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with determining CCM can be beneficial when a subject has an ejection factor of 25-45%; a QRS duration of <130ms; and a NYHA of class III or IV as taught by Abraham et al, since such a modification would provide the predictable results of improving exercise tolerance and quality of life in the specified group of HF patients.
Claim(s) 28, 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doerr (US Publication 2013/0006319) in view of Stahmann (US Publication 2010/0069985).
Referring to Claim 28, Doerr teaches a method according to claim 26, except wherein said treating comprises delivering an electric field for CRT and cardiac contractility modulation therapy through a same electrode lead.
Stahmann teaches that it is known to use delivering an electric field for CRT and cardiac contractility modulation therapy through a same electrode lead as set forth in Figure 17 and Paragraph [0310] to provide improved versatility by allowing the electrodes to generate various vectors for CCM or CRT. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with delivering an electric field for CRT and cardiac contractility modulation therapy through a same electrode lead as taught by Stahmann, since such a modification would provide the predictable results of improved versatility by allowing the electrodes to generate various vectors for CCM or CRT.
Referring to Claim 30, Doerr teaches a method according to claim 26, except wherein said treating comprises delivering an extended pacing signal for both CRT and cardiac contractility modulation therapy effects during a non-refractory period of the right ventricle.
Stahmann teaches that it is known to use delivering an extended pacing signal for both CRT and cardiac contractility modulation therapy effects during a non-refractory period of the right ventricle as set forth in Paragraphs [0008] and [0227] to provide reducing interference when stimulation is applied to the right atrium, or left ventricle. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with delivering an extended pacing signal for both CRT and cardiac contractility modulation therapy effects during a non-refractory period of the right ventricle as taught by Stahmann, since such a modification would provide the predictable results of reducing interference when stimulation is applied to the right atrium, or left ventricle.
Referring to Claim 31, Doerr teaches a method according to claim 26, except comprising: determining if treating said patient with said cardiac contractility modulation and said CRT has a desired effect on cardiac output and/or heart contraction; and modifying said CRT therapy based on the results of said determining.
Stahmann teaches that it is known to use determining if treating said patient with said cardiac contractility modulation and said CRT has a desired effect on cardiac output and/or heart contraction; and modifying said CRT therapy based on the results of said determining as set forth in Paragraphs [0008], [0010], and [0217] to provide a potential increase in effectiveness in treating or counteracting a worsening cardiac condition. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Doerr, with determining if treating said patient with said cardiac contractility modulation and said CRT has a desired effect on cardiac output and/or heart contraction; modifying said CRT therapy based on the results of said determining as taught by Stahmann, since such a modification would provide the predictable results of a potential increase in effectiveness in treating or counteracting a worsening cardiac condition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796