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 1-22 of U.S. Patent No. 11,730,967. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent requires providing HBP; detecting a response to the pacing; and using first and second COI to classify the response as a particular type of capture, wherein the COIs can include QRS COIs, activation times, etc. (see claims 2 and 3 of the patent).
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to a system (Claims 1-10) and a method (claims 11-20)
Step 2A, Prong 1
The claims recite the steps of analyzing a first segment of a response to identify an evoked response characteristic of interest; analyze a second segment to identify a QRS COI; determine an activation time based on an applied pacing pulse and the QRS COI; distinguishing between first and second capture classes using the ER COI or activation time; an utilizing another ER COI or activation time to distinguish between first and second capture types within a first or second capture class. These steps, given their broadest reasonable interpretation can involve a clinician looking at a set of data (such as an ECG readout); measuring a time interval between a pacing pulse and QRS interval; and mentally determining capture types from the information on the ECG. These steps are mental process abstract ideas.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application.
Claims 1 and 11 include the additional elements of a pulse generator; a processor for receiving sensed data and controlling the initial application of stimulation; and a memory. The pulse generator and the initial application of a stimulus amounts to insignificant, extra-solution activity as it simply sets up the environment in which the data is analyzed and the decisions/determinations are made, see MPEP §2106.04(d)(2)(c). The processor and memory amount to generic computer implementation of the abstract idea and the sensed data that is received amounts to the insignificant, extra-solution activity of data gathering. Insignificant, extra-solution activity and generic computer implementation do not amount to integration of the abstract idea into a practical application.
Step 2B
The claims do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself.
Claims 1 and 11 include the additional elements of a pulse generator; a processor for receiving sensed data and controlling the initial application of stimulation; and a memory. The pulse generator and the initial application of a stimulus amounts to insignificant, extra-solution activity as it simply sets up the environment in which the data is analyzed and the decisions/determinations are made, see MPEP §2106.04(d)(2)(c). The processor and memory amount to generic computer implementation of the abstract idea and the sensed data that is received amounts to the insignificant, extra-solution activity of data gathering. Insignificant, extra-solution activity and generic computer implementation do not amount, alone or in combination, to significantly more than the abstract idea itself.
Claims 2-10 and 12-20 only further define the abstract idea.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10 and 20 state “…with QRS correction” and “…without QRS correction”. However, the claims never require a step of correcting a QRS complex and it is unclear what Applicant means by these phrases. Does the system provide some correction to obtained QRS values? Does some other system “correct” values and then transmit to the device? Of what nature is this correction and what is being corrected? The metes and bounds of the claim are unclear.
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 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 1-7, 9, 11-17 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brisben et al. (2019/0275329).
Regarding Claims 1, 3, 7, 11, 13 and 17, Brisben discloses a system 100 comprising a HIS electrode ( either of 112a, b, see Fig. 1) configured to be located proximate to a HIS bundle (par. [0049]); a pulse generator coupled to the HIS electrode and configure to deliver HIS bundle pacing (part of HIS bundle pacing system 118, described functionally in par. [0051] as an electrostimulation circuit); a right atrial electrode configured to be located in a right atrium (not shown but described functionally as an option in par. [0053, 0117]); sensing circuitry coupled to the RA electrode and configured to define an RA sensing channel (par. [0053, 0117]; and a processor with memory (implicitly disclosed via the programmable function of the device and the execution of said programmed instructions, see par. [0051] and the mention of a control circuit) configured to collect far field cardiac signals from the RA sensing channel. Brisben discloses obtaining multiple Far Field component characteristics of interest, such as FF-QRS, FF-R wave, HV intervals (intervals between an applied pacing pulse and a QRS wave, see par. [0086]) , etc. (par. [0086-0087]) and identifying capture types from an analysis of these components. For instance a FF-QRS width (a first FF COI) can be used to distinguish between selective capture and capture of the para-Hisian myocardium (par. [0087]). These capture types fall within a class of capture types that can be identified from FF-QRS. A second FF COI could be FF-R wave width which can be used to distinguish between S-capture and para-Hisian myocardium capture (par. [0087]). These would belong to a capture class identifiable from an FF-R wave. Other types of capture can also be determined, such as NS-capture and LOC (par. [0089]).
In regard to Claims 2 and 12, the Examiner notes the applied pacing pulse used for determining the HV interval (which can be the first segment COI) occurs earlier in time than a QRS waveform, which is the second segment COI (see par. [0086-0087]).
With regards to Claims 4, 5, 14 and 15, Brisben discloses utilizing FF-R waves as a first FFC COI to distinguish between types of capture such as selective, nonselective, myocardial only and LOC (par. [0087, 0100-0101]).
Regarding claims 6 and 16, Brisben discloses utilizing a timing interval from HBP to a detected FF-QRS to determine S-Capture, NS-Capture, para-Hisian myocardial capture, see par. [0086-0087] as well as LOC and intrinsic capture (par. [0089, 0091, 0109]).
In regards to Claims 9 and 19, Brisbane discloses the area under the curve of the QRS or R wave can be sued to classify a capture type. The area under the curve is a measure of total energy (par. [0087]).
Claim Rejections - 35 USC § 103
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 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.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brisben et al. (2019/0275329) in view of Ghosh et al. (2014/0371833). Brisben discloses using an activation time between a pacing pulse and a QRS wave but fails to disclose identifying a maximum slope of the QRS wave. However utilizing a maximum slope of a QRS wave for activation time determination was known in the art before the effective filing date of the claimed invention, see Ghosh, par. [0073]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Brisbane reference to include utilizing a maximum slope of the QRS waveform for activation time determination, as taught and suggested by Ghosh, for the purpose of accurately determining activation times according to known techniques for doing so.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prillinger et al. (2019/0022378), HBP and capture classification
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
