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 .
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,357,834. Although the claims at issue are not identical, they are not patentably distinct from each other because both claimed inventions require sensing circuitry; memory; processing circuitry; and pulse generation circuitry, wherein the processing circuitry is configured to, for each of a plurality of pacing pulses, determine a match score to a morphology template; identifying first and second groups of scores based on the comparison to the template (to determine a type of capture). Based on the type of capture, the pulse generator is configured to generate pacing pulses. Claim 1 of the Patent also includes the limitations form claims 5, 6, 15 and 16 of the present application regarding determining frequency distributions of the matching scores.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-14 and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Min et al. (2020/0353266).
Regarding Claims 1, 8, 9, 11 and 18-20, Min discloses a system and method for detecting and classifying His bundle capture comprising memory for storing a morphology template and a control circuit 60 configured to receive a cardiac electrical signal form a sensor after application of a pacing pulse by a pulse generator (par. [0113]). This process is repeatable for a plurality of pacing pulses. Min further discloses that for each pulse, the response is compared to the template; and the type of capture is determined based on the matching score. Specifically, the electrical signal can be compared to a template using cross-correlation. If the correlation coefficient exceeds 80% then the morphology is considered a match for a specific capture type. If it is below 80%, then a new template can be compared to identify a different capture type (par. [0100]). Therefore, Min discloses detecting first groups of matching scores (those that match to a template) and a second group of matching scores (those that do not match a template) and selecting a particular pacing pulse output to be applied based on the template the response matches to. For instance, if selective or non-selective capture is detected pulse can be selected to apply next (par. [0136-0137]). If the template is for loss of capture, the device can adjust the stimulation so that it can achieve the proper capture threshold (see par. [0119, 0138-0142]).
In regards to Claims 2 and 12, Min discloses identifying pulses that are 80% or greater match for a template (par. [0100]) and therefore any matching scores that pass the threshold tests are within 20% of one another.
With regard to Claims 3, 4, 13 and 14, Min discloses that’s cores less than an 80% match are in a second group of non-matching scores. These values are within a range of values less than the first matching scores (par. [0100]).
In regard to Claims 7 and 17, Min discloses a first template can be one indicative of selective or non-selective capture of the His-Purkinje system (par. [0099-0101]).
Regarding Claim 10, Min discloses testing for specific types of capture and selecting the lowest pulse output that obtains the capture goal, such as non-seletcive capture, see example of par. [0168]).
Allowable Subject Matter
The Examiner notes claims 5, 6, 15 and 16 do not have any prior art rejections applied but are not in condition for allowance due to the outstanding double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Casavant et al. (2020/0129772) discloses using morphology templates to determine match scores for types of capture (see par. [0097])
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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