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
Applicant’s election without traverse of Species I, i.e. claims 51-61 in the reply filed on April 25, 2025 is acknowledged.
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) 50-52 & 54-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abraham et al. (‘A Randomized Controlled Trail to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation’, 2018) in view of Hartley et al. (US 2005/0142070).
Abraham et al. discloses:
50.
A method of increasing peak VO2 comprising:
E.G. via the disclosed study optimal medical therapy providing cardiac contractility modulation (CCM) therapy, in which the statistic analysis plan measures the efficacy of said therapy based on the change in pVo2 (pp. 3, para 5).
selecting a patient having impaired peak VO2 and estimated, based on pulmonary assessment, to have a potential for improving peak VO2;
E.G. via the disclosed step of ‘randomized’ method of selecting a patient which establishes baseline testing including peak oxygen consumption assessed on CPX (pp. 2, para 5) wherein the mean treatment difference is estimated of the PVo2 of each treatment group versus a control group (pp. 4, para 2).
and applying cardiac contractility modulation stimulation to the patient’s heart.
E.G. via the disclosed assessments of the CCM treatment effects in patients (pp. 4, para. 3).
Abraham et al. discloses the claimed invention having a method of increasing peak VO2 comprising selecting a patient having impaired peak VO2 and estimated to have potential for improving peak VO2 except wherein said selecting comprises a patient estimated to have a pulmonary reserve suitable to achieve an increase in peak VO2 in response to cardiac contractility modulation stimulation. Hartley et al. teaches that it is known to use a therapy device that incorporates sensors to sense a physiological condition and/or parameters associated with pulmonary disease, wherein the sensed condition detects and/or assesses a presence of pulmonary issue/function and said assessment is used to control said therapy (abstract). Pulmonary function testing is also disclosed, which measures values indicative of the ability of the lungs to exchange oxygen based on the total lung capacity, inspiratory/expiratory reserve volume, etc. parameters in order to efficiently and effectively evaluate pulmonary performance {[0045] & [0047]-[0048])}.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Abraham et al. with the pulmonary function/parameter testing as taught by Hartley et al. since such a modification would provide the predictable results pertaining to effectively and efficiently evaluating the pulmonary function of a patient, such as parameters associated with reserve volume in order to control the delivery of therapy {Hartley, [0045] & [0047]-[0048])}.
51.
method of claim 50, wherein the selecting comprises selecting a patient who already has an implant suitable for providing Cardiac Contractility Modulation treatment.
E.G. via the disclosed study group having a higher EF being ‘required’ to have an implantable cardiac-defibrillator (ICD) (Abraham, pp. 2, para. 5).
52.
The method of claim 50, wherein the selecting comprise selecting a patient not known to have another medical condition which may prevent increasing peak VO2.
E.G. via the disclosed randomization use of a ‘study ’group with subjects with moderate-to-severe heart failure defined by a specific EF range (Abraham, pp. 2, para. 4-5).
54.
The method of claim 50, wherein the selecting the patient comprises selecting a patient with a NYHA class selected from a group consisting of: NYHA class II; NYHA class III; and NYHA class IV.
E.G. via the disclosed ‘study design’ that utilizes patients within the NYHA functional class III or IV (Abraham, pp. 2, para 4).
55.
The method of claim 50, wherein the selecting the patient comprises selecting a patient with at least one pulmonary status selected from a group consisting of: a Breathing Reserve (BR) above 30%; an Oxygen Uptake Efficiency Slope (OUES) below 90%; a peak RER above 1.05; VE/VCO2 ratio above 30; and O2 saturation falling less than 10% over a period of 20 minutes of exercise.
E.G. via the disclosed use of measuring the ‘effort’ of each patient comprising respiratory exchange (Abraham, pp. 3, para. 1).
56.
The method of claim 50, wherein the selecting the patient comprises selecting a patient with an ejection fraction above 35% and below 45%.
E.G. via the disclosed subjects of the study having an EF ranging from 25% to 45% (Abraham, pp. 2, para. 3-4).
57.
The method of claim 50, wherein the selecting the patient comprises selecting a patient with heart failure.
E.G. (Abraham, pp. 2, para. 4).
58.
The method of claim 50, wherein the selecting the patient comprises selecting a patient with at least one condition selected from a group consisting of: atrial fibrillation (AF); Systolic heart failure (HF); Diastolic HF; Atrial Tachycardia; Angina; Myocarditis; Small vessel disease; Pulmonary hypertension; Chronic Obstructive Pulmonary Disease (COPD); and Sleep Apnea.
E.G. see (Abraham, Table 1).
59.
The method of claim 50, wherein the selecting the patient comprises selecting a patient having impaired peak VO2 and not known to have another medical condition which may limit increasing peak VO2 comprises selecting a patient which is not known to have a condition selected from a group consisting of: a limitation in pulmonary intake of oxygen; lung disease; a limitation in blood flow; and peripheral blood vessel disease.
E.G. see (Abraham, Table 1).
Response to Arguments
The examiner notes that the pending claims are 50-52 and 54-59 based on the previous election of claims, the cancellation of claims and the amendments to claims. All pending claims have been addressed with prior art. Further note that if the claim is currently withdrawn and/or cancelled the examiner will not address any arguments and/or amendments made to said claims.
Applicant's arguments filed September 22, 2025 have been fully considered but they are not persuasive. The applicant argues the following statements in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the primary reference, Abraham et al., fails to disclose the claimed limitation “…selecting a patient having impaired peak VO2 and estimated, based on pulmonary assessment, to a have a potential for improving peak VO2,” since Abraham “apparently” does not disclose a pulmonary assessment for the purpose of estimating whether the patient has potential for said improvement.
Based on the broadest interpretation of the claims the examiner disagrees and further points out that “…to have potential for improving peak VO2,” is an intended use recitation.
In response to applicant's argument that Abraham is silent in regards to pulmonary assessment for the purpose of estimating whether the patient has “potential for improvement,” the examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The examiner argues that the function of the cited and disclosed ‘criteria’ for the inclusion and exclusion of patient conditions, such as the indication that a patient is showing implications of impaired peak VO2 is capable of performing the claimed task of showing potential for improving peak VO2 based on the other disclosed ‘criterion’ such as lack of pulmonary edema, levels of pulmonary hypertension, etc. Therefore, based on the broadest interpretation of the claims the examiner argues that the disclosed method of the primary reference, Abraham et al., is capable of providing the claimed pulmonary assessment.
Applicant’s arguments with respect to claim(s) 53 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner notes that claim 53 is currently “cancelled” and was incorporated into independent claim 50.
The examiner notes that the claim language of claim 53 was incorporated into the language of claim 50. The examiner also notes that additional claim language, such as “…suitable to achieve an increase in peak VO2 in response to cardiac contractility modulated stimulation…” is an amended claim limitation added which was not previously disclosed in the pending claims, and therefore constitutes a final office action based on amendments.
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796