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 .
Status of Claims
Claims 4-7 and 12-13 are rejected. Claims 1-3 and 8-11 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 102
The previous 102 rejection of claims 1 and 7 has been withdrawn in view of the amendment.
Claim Objections
Claim 4 is objected to because of the following informalities: “a first cumulative distribution function” in lines 11-12 should recite –the first cumulative distribution function—to properly refer back to “a first cumulative distribution function” in line 7. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a first unimodal distribution” in lines 12-13 should recite –the first unimodal distribution—to properly refer back to “a first unimodal distribution” in line 8. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a second cumulative distribution function” in line 13 should recite --the second cumulative distribution function-- to properly refer back to “a second cumulative distribution function” in line 8. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a second unimodal distribution” in line 14 should recite –the second unimodal distribution—to properly refer back to “a second unimodal distribution” in line 9. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a parameter” in lines 29 and 42 should recite –the parameter—to properly refer back to “a parameter” in line 19. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a myocardium” in lines 29 and 42 should recite –the myocardium—to properly refer back to “a myocardium” in line 19. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a fifth cumulative distribution function” in line 35 should recite –the fifth cumulative distribution function—to properly refer back to “a fifth cumulative distribution function” in line 24. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a fifth unimodal distribution” in line 36 should recite –the fifth unimodal distribution—to properly refer back to “a fifth unimodal distribution” in lines 24-25. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “a first cumulative distribution function” in lines 11-12 should recite –the first cumulative distribution function—to properly refer back to “a first cumulative distribution function” in line 7. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “a first unimodal distribution” in lines 12-13 should recite –the first unimodal distribution— to properly refer back to “a first unimodal distribution” in line 8. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “a second cumulative distribution function” in line 13 should recite –the second cumulative distribution function—to properly refer back to “a second cumulative distribution function” in line 8. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “a second unimodal distribution” in line 14 should recite –the second unimodal distribution—to properly refer back to “a second unimodal distribution” in line 9. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “a first cumulative distribution function” lines 11-12 should recite –the first cumulative distribution function—to properly refer back to “a first cumulative distribution function” in line 7. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “a first unimodal distribution” in lines 12-13 should recite –the first unimodal distribution—to properly refer back to “a first unimodal distribution” in line 8. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “a second cumulative distribution function” in line 13 should recite –the second cumulative distribution function—to properly refer back to “a second cumulative distribution function” in line 8. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “a second unimodal distribution” in line 14 should recite –the second unimodal distribution—to properly refer back to “a second unimodal distribution” in line 9. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-7 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4-7 and 12-13 recite a first, a second, a fifth, and a sixth “unimodal distribution.” The specification discloses:
“Formula (1) is a Gaussian distribution (normal distribution)” (¶41).
However, there is insufficient written description under 35 U.S.C. 112(a), due to only disclosing some of the many species that encompass the broad or large genus of any or all possible unimodal distributions. MPEP 2163(II)(A)(3)(a)(ii) states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").”
There is not a sufficient number of species disclosed to encompass the broad or large genus of any or all possible unimodal distributions. A Gaussian distribution differs greatly from other species that could fall within the genus such as Poisson distributions, exponential distributions, log-normal distributions, Chi-square distributions, etc. (see NPL reference “Unimodal Distribution: A Comprehensive Guide with Interactive Tools” in the IDS filed on 11/26/25).
Applicant is encouraged to change the limitations reciting “unimodal distribution” to recite either –normal unimodal distribution—or –Gaussian unimodal distribution—to overcome the rejection.
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 4 and 7 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.
In claim 4, the limitations of “a fifth cumulative distribution function” and “a sixth unimodal distribution function” in the last two paragraphs seem unclear. It remains unclear how there is “a fifth cumulative distribution function” and “a sixth unimodal distribution function” without reciting a third unimodal distribution function and a fourth unimodal distribution function in the claim. Dependent claim 7 is rejected for the same deficiency in independent claim 4.
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 4-7 and 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 4-7 and 12-13 are directed to statutory subject matter as the claims recite a signal analysis device for indicating activity of a myocardium of the heart.
Step 2A, Prong One
Regarding claims 4-6, the recited steps are directed to mathematical concepts (see MPEP 2106.04(a)(2) subsection (I)).
Regarding claim 4, the following limitations are mathematical calculations:
upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formulas 1-18),
or upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by adding a level value to a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formula 19),
acquires at least one of at least some parameters of parameters identifying the first unimodal distribution, at least some parameters of parameters identifying the first cumulative distribution function, at least some parameters of parameters identifying the second unimodal distribution, or at least some parameters of parameters identifying the second cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Formula 19),
upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution or by an approximate residual time waveform that is a time waveform obtained by multiplying the fifth cumulative distribution function by weight, acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution or at least some parameters of parameters identifying the fifth cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Formulas 23-24), and
or upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by an approximate residual time waveform that is a time waveform obtained by a difference or a weighted difference between a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution and a sixth cumulative distribution function that is a cumulative distribution function of a sixth unimodal distribution, acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution, at least some parameters of parameters identifying the fifth cumulative distribution function, at least some parameters of parameters identifying the sixth unimodal distribution, or at least some parameters of parameters identifying the sixth cumulative distribution function as a parameter indicating activity of a myocardium of the heart” (Formulas 25-26).
Regarding claim 5, the following limitations are mathematical calculations:
upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formulas 1-18),
or upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by adding a level value to a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formula 19),
acquires at least one of at least some parameters of parameters identifying the first unimodal distribution, at least some parameters of parameters identifying the first cumulative distribution function, at least some parameters of parameters identifying the second unimodal distribution, or at least some parameters of parameters identifying the second cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Formula 19), and
where the target time waveform is an R wave, a potential at a starting end of the target time waveform as the level value (Formula 20).
Regarding claim 6, the following limitations are mathematical calculations:
upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formulas 1-18),
or upon approximating the target time waveform by an approximate time waveform that is a time waveform obtained by adding a level value to a difference or a weighted difference between a first cumulative distribution function that is a cumulative distribution function of a first unimodal distribution and a second cumulative distribution function that is a cumulative distribution function of a second unimodal distribution (Formula 19),
acquires at least one of at least some parameters of parameters identifying the first unimodal distribution, at least some parameters of parameters identifying the first cumulative distribution function, at least some parameters of parameters identifying the second unimodal distribution, or at least some parameters of parameters identifying the second cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Formula 19), and
where the target time waveform is a T wave, a potential at an end of the target time waveform as the level value (Formula 22).
Step 2A, Prong Two
For claims 4-6, the judicial exception is not integrated into a practical application. In particular, claims 4-6 recite “a biological information acquisitor and an analyzer.” The biological information acquisitor amounts to nothing more than pre-solution activity of data gathering (see specification “the electrocardiogram acquisition unit 110 is an example of a biological information acquisition unit (biological information acquisitor)” (¶203)). The analyzer is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of a biological information acquisitor amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the biological information acquisitor is recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20040030257 (¶3-ECG systems are well known, and provide information about the physiological status of a patient's heart to a physician. More specifically, so called conventional 12 lead ECG systems exist which provide twelve waveforms, called leads (lead signals), to a physician), US 20020072682 (¶26-a conventional ECG monitor), US 20160127354 (¶4-it is known practice to use portable ECG recorders which can be connected to electrodes fitted to the patient via discharge cables), and US 20040039292 (¶50-a conventional set of ten electrodes for a 12-lead electrocardiograph to monitor cardiac function). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 7 and 12-13, the limitations of claims 4-6 further define the limitations already indicated as being directed to the abstract idea.
Claims 7 and 12-13 further define the abstract idea indicated for claims 4-6.
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 4 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/265663 in view of Billah (NPL "A novel method to model ECG beats using Gaussian functions" as cited in the IDS).
This is a provisional nonstatutory double patenting rejection. 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 invention of the copending application to include the subject matter in Billah as shown below.
Claims of the Present Application (18/039553)
Claims of Copending Application (18/265663)
Secondary Reference Billah (NPL "A novel method to model ECG beats using Gaussian functions" as cited in the IDS)
4
1, 4, 6
Billah teaches wherein the analyzer, upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution or by an approximate residual time waveform that is a time waveform obtained by multiplying the fifth cumulative distribution function by weight (page 615, right col., section (vi)-subtracting ym(t) from yo(t) the residual error signal e(t) is obtained which is also depicted in Fig. 5 and the root mean square (RMS) value of this error, eRMS, is calculated; page 616, right col., Data Analysis section-the proposed algorithm was then applied to model these ECG beats and the overall RMS value of the error signals for each type of beat was calculated; page 616, right col., Results section-the approximation error depends on the number of Gaussian functions NG, used to model ECG beat. Fig 7 shows the reduction of modeling error computed over 1000 NSR beats with the increase of NG. Since the diminishing rate of error becomes small after NG=16, we propose sixteen (NG=16) Gaussian functions to model an ECG beat), acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution or at least some parameters of parameters identifying the fifth cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Abstract-the RMS error of this method has been determined to be 0.02569, 0.02846, 0.05916, 0.02002 and 0.03169 mV for NSR, APC, PVC, LBBB and RBBB beats respectively; Table I), or upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by an approximate residual time waveform that is a time waveform obtained by a difference or a weighted difference between a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution and a sixth cumulative distribution function that is a cumulative distribution function of a sixth unimodal distribution (page 615, right col., section (vi)-subtracting ym(t) from yo(t) the residual error signal e(t) is obtained which is also depicted in Fig. 5 and the root mean square (RMS) value of this error, eRMS, is calculated; page 616, right col., Data Analysis section-the proposed algorithm was then applied to model these ECG beats and the overall RMS value of the error signals for each type of beat was calculated; page 616, right col., Results section-the approximation error depends on the number of Gaussian functions NG, used to model ECG beat. Fig 7 shows the reduction of modeling error computed over 1000 NSR beats with the increase of NG. Since the diminishing rate of error becomes small after NG=16, we propose sixteen (NG=16) Gaussian functions to model an ECG beat), acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution, at least some parameters of parameters identifying the fifth cumulative distribution function, at least some parameters of parameters identifying the sixth unimodal distribution, or at least some parameters of parameters identifying the sixth cumulative distribution function as a parameter indicating activity of a myocardium of the heart (Abstract-the RMS error of this method has been determined to be 0.02569, 0.02846, 0.05916, 0.02002 and 0.03169 mV for NSR, APC, PVC, LBBB and RBBB beats respectively; Table I). 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 invention of the copending application to include wherein the analyzer, upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution or by an approximate residual time waveform that is a time waveform obtained by multiplying the fifth cumulative distribution function by weight, acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution or at least some parameters of parameters identifying the fifth cumulative distribution function as a parameter indicating activity of a myocardium of the heart, or upon approximating a residual time waveform that is a time waveform obtained by a difference between the target time waveform and the approximate time waveform by an approximate residual time waveform that is a time waveform obtained by a difference or a weighted difference between a fifth cumulative distribution function that is a cumulative distribution function of a fifth unimodal distribution and a sixth cumulative distribution function that is a cumulative distribution function of a sixth unimodal distribution, acquires at least one of at least some parameters of parameters identifying the fifth unimodal distribution, at least some parameters of parameters identifying the fifth cumulative distribution function, at least some parameters of parameters identifying the sixth unimodal distribution, or at least some parameters of parameters identifying the sixth cumulative distribution function as a parameter indicating activity of a myocardium of the heart of Billah in order to model an ECG beat very accurately (Billah, page 612, right col., ¶2).
7
1, 4, 6
Billah teaches wherein each unimodal distribution is a Gaussian distribution (Abstract-a novel method is developed to model ECG beats using Gaussian fitting of order eight; page 612, right col., Gaussian Model of ECG Signal section-an ECG beat is approximated as a linear combination of NG number of Gaussian functions). 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 invention of the copending application to include wherein each unimodal distribution is a Gaussian distribution of Billah in order to model an ECG beat very accurately (Billah, page 612, right col., ¶2).
Claims 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/265663 in view of Zhang (US 20120302903 as cited in the IDS).
This is a provisional nonstatutory double patenting rejection. 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 invention of the copending application to include the subject matter in Zhang as shown below.
Claims of the Present Application (18/039553)
Claims of Copending Application (18/265663)
Secondary Reference Zhang (US 20120302903 as cited in the IDS)
5
1, 4, 6
Zhang teaches wherein the analyzer assumes, in a case where the target time waveform is an R wave, a potential at a starting end of the target time waveform as the level value (¶22-action potentials, even in the same ECG signal portion (e.g. the QRS complex) such as QR portion and RS portion, may represent different kinds of procedure. For ischemia and infarction monitoring and event characterization, a precise portion of electrophysiological signals is extracted and analyzed by processor 15; ¶26-processor 15 detects changes including ST segment change, RS and RT portion change. An RT ROI signal portion is defined from R wave peak to early onset time of a T wave and is used as a ventricular depolarization portion. An RT ROI signal may be an 80-100 mS window from an R wave peak time; ¶25). 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 invention of the copending application to include wherein the analyzer assumes, in a case where the target time waveform is an R wave, a potential at a starting end of the target time waveform as the level value of Zhang in order to diagnose electrophysiological activities of the heart tissue and functional status (Zhang, ¶22).
6
1, 4, 6
Zhang teaches wherein the analyzer assumes, in a case where the target time waveform is a T wave, a potential at an end of the target time waveform as the level value (¶26-processor 15 detects changes including ST segment change, RS and RT portion change. An RT ROI signal portion is defined from R wave peak to early onset time of a T wave and is used as a ventricular depolarization portion. An RT ROI signal may be an 80-100 mS window from an R wave peak time; ¶28-changes in the QRS and T waves, for example, can be utilized for myocardial ischemia (MI) and infarction characterization; ¶25; ¶36). 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 invention of the copending application to include wherein the analyzer assumes, in a case where the target time waveform is a T wave, a potential at an end of the target time waveform as the level value of Zhang in order to diagnose electrophysiological activities of the heart tissue and functional status (Zhang, ¶22).
Claims 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/265663 in view of Zhang and Billah.
This is a provisional nonstatutory double patenting rejection. 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 invention of the copending application to include the subject matter in Zhang and Billah as shown below.
Claims of the Present Application (18/039553)
Claims of Copending Application (18/265663)
Secondary Reference Zhang (US 20120302903 as cited in the IDS)
Secondary Reference Billah (NPL "A novel method to model ECG beats using Gaussian functions" as cited in the IDS)
12
1, 4, 6
Billah teaches wherein each unimodal distribution is a Gaussian distribution (Abstract-a novel method is developed to model ECG beats using Gaussian fitting of order eight; page 612, right col., Gaussian Model of ECG Signal section-an ECG beat is approximated as a linear combination of NG number of Gaussian functions). 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 invention of the copending application to include wherein each unimodal distribution is a Gaussian distribution of Billah in order to model an ECG beat very accurately (Billah, page 612, right col., ¶2).
13
1, 4, 6
Billah teaches wherein each unimodal distribution is a Gaussian distribution (Abstract-a novel method is developed to model ECG beats using Gaussian fitting of order eight; page 612, right col., Gaussian Model of ECG Signal section-an ECG beat is approximated as a linear combination of NG number of Gaussian functions). 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 invention of the copending application to include wherein each unimodal distribution is a Gaussian distribution of Billah in order to model an ECG beat very accurately (Billah, page 612, right col., ¶2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CN 109998529: relates to the technical field of biomedical signal processing, in particular to a method for detecting P wave and T wave in an electrocardiogram (ECG) signal based on Gaussian function fitting (Technical field section).
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