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 .
The current application has the effective filing date of 06/02/2020 according to the priority chain on the record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 12,161,474 (Pat’474) in view of claims 1 and 8 of U.S. Patent No. 12,150,770 B2 (Pat’770).
Claim 1 is rejected by claim 10 of Pat’474 and claim 1 of Pat’770. Claim 10 of Pat’474 teaches a device that wholly encompasses the implantable device for classifying a potential arrhythmia episode as a false positive as recited in claim 1 of the instant application. Claim 10 does not teach allow therapy circuit to deliver therapy when the potential arrhythmic episode is not classified as being a false positive and prevent the therapy circuit from delivering therapy when the potential arrhythmic episode is classified as being a false positive. Claim 1 of Pat’770 teaches an implantable device for classifying whether a potential arrhythmia episode as a false positive, and in response thereto, prevent the therapy circuit from delivering therapy to the patient's heart. It would have been obvious to a person of ordinary skill in the art at the time of invention to combine Pat’474 and Pat’770 so as to teaches distinguishing true-positive and false-positive arrhythmia event as conditional requirement for delivering therapy to a patient, the motivation would have been to avoid incorrectly delivering therapy to affect a patient that is not truly exhibiting arrythmia symptoms (i.e. false-positive event).
Claim 22 is rejected by claim 1 of Pat’474 and claim 8 of Pat’770. Claim 1 of Pat’474 teaches a method that wholly encompasses the method for use by an implantable device for classifying a potential arrhythmia episode as a false positive as recited in claim 22 of the instant application. Claim 1 does not teach withholding the therapy circuit from delivering therapy when the potential arrhythmic episode is classified as being a false positive. Claim 8 of Pat’770 teaches method for use by an implantable device for classifying the detection of the potential arrhythmia episode as a false positive, and in response thereto, preventing delivery of therapy to a patient's heart. It would have been obvious to a person of ordinary skill in the art at the time of invention to combine Pat’474 and Pat’770 so as to teaches distinguishing true-positive and false-positive arrhythmia event as conditional requirement for delivering therapy to a patient, the motivation would have been to avoid incorrectly delivering therapy to affect a patient that is not truly exhibiting arrythmia symptoms (i.e. false-positive event).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites a limitation (i.e. “determine whether the potential arrhythmic episode is classified as being false positive based on whether at least a threshold amount of the R-R intervals, within the window leading up to the detection of the potential arrhythmic episode, are classified as being false R-R intervals”) that is substantially the same as the recitation in claim 1 lines 20-23 (i.e. “determine whether to classify the potential arrhythmic episode as being a false positive based on an amount of the R-R intervals, within the window leading up to the detection of the potential arrhythmic episode, that are classified as being false R-R intervals”). The only noted difference is the underlined features above, but these terms are not patentably distinct from one another.
Claim 21 recites a limitation (i.e. “wherein: the classifying the potential arrhythmic episode as being a false positive is based on whether at least a threshold amount of the R-R intervals, within the window leading up to the detection of the potential arrhythmic episode, are classified as being false R-R intervals”) that is substantially the same as the recitation in claim 11 lines 16-18 (i.e. “classifying the potential arrhythmic episode as being a false positive based on an amount of the R-R intervals, within the window leading up to the detection of the potential arrhythmic episode, that are classified as being false R-R intervals”).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 22 is allowed.
Claims 2-5, 7-10, 12-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Note to Applicant: there are no art rejections in this application, the applicant is invited to schedule an interview with the Examiner to expedite prosecution.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Badie et al. US 11,559,242 B2 discloses a method and system for monitoring heart rate and for arrhythmic episodes based on sensed intervals including, methods of distinguishing true R-R intervals from false R-R intervals, by comparing -R intervals to a first specified threshold.
Badie et al. US 11,647,940 B2 discloses a method, device and system for improving arrhythmia episodic detection specificity including obtaining an ordered list of R-R intervals within a window leading up to a detection of a potential arrhythmia episode.
Neither one of these references disclose determining for each R-R interval of a plurality of the R-R intervals included in a window of the electric cardiac signal leading up to the detection of the potential arrhythmic episode, whether to classify the R-R interval as being a false R-R interval based on the criteria recited in the current application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached on M-F 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on 5712724156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 11, 2024
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