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 .
Information Disclosure Statement
The IDS filed 7/05/2022 has been considered by the Examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 62/013,112 filed 6/17/2014 is acknowledged.
Status of Claims
Amendments to the claims filed 9/04/2025 are acknowledged.
Claims 11-31 are under examination.
Claims 1-10 are cancelled.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11-14, 18-21 and 25-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of US 11,406,313 (‘313). Although the patented claims are not identical, they are not patentably distinct from each other because the pending claims are either species of the instant claims of have only minor differences encompassed by the instant generic claims. Instant independent claims 11, 18, 25 and dependent claims 14, 21 and 28 are broader and therefore met by claim 1 of patented ‘313. Although claim 1 of patented ‘313 recites a plurality of multivariable algorithms for analyzing rhythm classification, while instant claim 1 recites only one multivariable algorithm, it would be obvious to combine a plurality of multivariable algorithms as one “algorithm” or to employ a plurality of algorithms as needed by one of skill the in the art. Claims 12, 19 and 26 are met by patented claim 2 and claims 13, 20 and 27 are met by patented claim 3.
Response to Arguments
Applicant's arguments filed 9/04/2025 have been fully considered. Applicants have not provided arguments against the obviousness double patenting rejection and keep the rejection in abeyance. The rejection is therefore maintained.
Claim Rejections - 35 USC § 101
The rejection of claims 11-31 under 35 U.S.C. 101 is withdrawn in view of Applicant’s amendments and arguments filed 8/17/2023.
Claim Rejections - 35 USC § 112-1st paragraph
The rejection of claims 11-31 under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendments and arguments filed 9/25/2024.
Claim Rejections - 35 USC § 112-2nd paragraph
The rejection of claims 11-31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph are withdrawn in view of Applicant’s amendments and arguments filed 9/25/2024.
Claim Rejections - 35 USC § 103
The following rejection is maintained and modified in view of amendments filed 9/04/2025.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 11-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over
Moorman et al. (US 2010/0056940; IDS filed 7/05/2022).
Moorman et al. teach obtaining RR time series interval data to determine atrial fibrillation (par. 0008, 0048 and 0057); Moorman teaches classifying Cardiac Rhythms using Moments and Entropy Rates for RR intervals (i.e. first program instructions to obtain data consisting of an RR time interval series of the times between heartbeats), as in claims 11, 18 and 25.
Moorman et al. teach determination of segments of data that are arbitrarily similar with regard to moments and entropy (par. 0063, 0064 and 0066) and that the method that automatically optimally divides heart rate data into homogeneous segments (par. 0120)( i.e. second program instructions to segment the time series into a plurality of segments), as in claims 11, 18 and 25.
Moorman et al. teach determining an entropy measure called coefficient of sample entropy COSEn as a diagnostic test for atrial fibrillation (par. 0044-0046), i.e. third program to calculate a parameter corresponding to a segment of the plurality of segments, wherein the parameter is a coefficient of sample entropy, as in claims 11, 18 and 25.
Regarding the third program of claim 25, the coefficient of sample entropy COSEn (par. 0046) reads on an entropy measure that detects atrial fibrillation in interval series data by counting how many template patterns repeat themselves, as in claim 25.
Moorman et al. teach a need to distinguish atrial fibrillation from sinus rhythm with ectopy (par. 0005). Moorman et al. teach distinguishing atrial fibrillation from normal sinus rhythm with a model based on RR interval (par. 0024). Moorman et al. teach multivariable analysis to predict (i.e. classify) atrial fibrillation (par. 0055) and multivariate algorithms (par. 0050) that employ entropy measures. Moorman et al. teach that the multivariable analysis may be a logistic regression model, neural networks, nearest-neighbor analysis or others (par. 0055)(i.e. the trained multivariable algorithm includes plural models). Moorman et al. teach the model is trained to predict the probability that a segment of RR intervals in a patient is atrial fibrillation (i.e. the model corresponds to cardiac rhythm including atrial fibrillation and is trained on RR time series training data of cardiac rhythm as input).
Moorman et al. does not specifically teach that the plural models also correspond to sinus rhythm with ectopy.
However, Moorman et al. teach that sinus rhythm with ectopy shares many time series features with AF (par. 0005); Moorman et al. then teaches distinguishing between sinus rhythm, sinus rhythm with ectopy and atrial fibrillation (par. 0149-0150 and Figure 10); Moorman teaches distinguishing sinus rhythm with ectopy from AF from EKG signals (which suggest the use of RR time series data which results from EKG/ECG measurement)(par. 0168)(i.e. a model corresponding to at least normal sinus rhythm, atrial fibrillation and sinus rhythm with ectopy)(i.e. fourth program instructions to analyze the obtained data and the calculated parameters using a plurality of multivariable algorithms for rhythm classification), as in claims 11, 18 and 25.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Moorman et al. for trained multivariate models that distinguish atrial fibrillation from sinus rhythm with the teaching of Moorman et al. for distinguishing normal sinus rhythm, normal sinus rhythm with ectopy and atrial fibrillation (par. 0149-0150 and Figure 10); Moorman et al. suggest that the distinguishing discussed in par. 0149-0150 is performed by recognition of RR interval data. Moorman et al. therefore teach an algorithm which recognizes and distinguishes between sinus rhythm, sinus rhythm with ectopy and atrial fibrillation. One of ordinary skill could combine the logistic regression model of Moorman et al. (par. 0055) to recognize and classify ectopic sinus rhythm, as also taught in Moorman et al. (par. 0149-0150). Combining the prior art elements of Moorman et al. is merely a combination of known elements that would arrive at the predictable result of a multivariable algorithms that distinguish between sinus rhythm, sinus rhythm with ectopy and atrial fibrillation.
Moorman et al. teach a diagnostic recording device (par. 0005) that monitor heard activity including atrial fibrillation (par. 0043 and 0109)(i.e. detect arrhythmia and transmit the detection of a heart rhythm recording device or a device that detects arrhythmia based on the rhythm classification), as in claims 11, 18 and 25.
Regarding claim, 25 it is obvious that once atrial fibrillation (AF) is determined, the AF would be a predictor for rhythm classification. That is, the rhythm classification would be AF (atrial fibrillation).
Moorman et al. teach predicting a probability that a segment of an RR interval is from atrial fibrillation (par. 0055), i.e. fifth program to obtain a rhythm classification based on the probability estimate, as in claims 11, 18 and 25.
Moorman et al. teach time series data of 30 minutes (par. 0018-0019, 0034 and 0076) but does not specifically teach time series of 10 minutes (claims 12, 19 and 26). However it would be obvious to one of skill in the art to segment time series data to obtain relevant spans of data or to calculate parameters over segments of data. Segmenting time series data is well known, i.e. Examiner takes Official Notes (as in MPEP 2144.03), as in claims 12, 19 and 26.
Moorman et al. teach segments of 30 second intervals (par. 0156), as in claims 13, 20 and 27.
Moorman et al. teach multivariable analysis including logistic regression, nearest neighbor analysis, and neural networks (par. 0055), as in claims 14, 21 and 28.
Moorman et al. teach parameters of the RR interval distribution including a set of parameters (par. 0120); wherein the parameters are calculated over individual segments of an interval (par. 0054-0055, 0063, 0064, 006 and 66); and a parameter is calculated for each “m” (par. 0112) which is a template length (par. 100). Further, Moorman teaches density parameters such as mean, standard deviation and coefficient of variation (CV) measured using histogram summary statistics (par. 0054) which would be obvious to calculate per segment or over a plurality of segments given time series data, as in claims 15-16, 22-24 and 29-31.
Moorman et al. teach recording by an electrocardiographic device and other recording devices (par. 0005), as in claim 25.
Moorman et al. teach a computer system, processor and computer program product (par. 0044), as in claims 11, 18 and 25.
Moorman et al. does not specifically teach a first, second, third, fourth and fifth program instructions for performing each of the claimed process steps. However, separate program instructions that perform separate calculations are well known. It would be obvious for one of ordinary skill in the art to write separate program instructions. Therefore Examiner is taking Official Notice (MPEPE 2144.03) that the first, second, third, fourth and fifth program would be obvious and well known.
Response to Arguments
Applicant's arguments filed 9/04/2025 have been fully considered but they are not persuasive.
Applicants argue (Remarks, page 10) that the features of the claims recite a coefficient of sample entropy, a detrended fluctuation analysis and/or a local dynamics score. Applicants argue that these features obviate the need to perform waveform analysis, which Moorman is reliant upon.
In response, the claims do not exclude performing waveform analysis. Furthermore, the standard meaning of “waveform analysis” is the examination of the shape and characteristics of a signal over time. Moorman teaches determining a entropy measure called coefficient of sample entropy COSEn, exactly as recited in the claims. Herein, Moorman teaches that the COSEn is a measure of regularity (par. 0046) and therefore Moorman does not rely on waveform analysis but rather uses the COSEn as a diagnostic test for atrial fibrillation (par. 0044-0046). Additionally, the claims do not exclude waveform analysis; Moorman does not rely on waveform analysis to use COSEn for detection of AF versus a normal sinus rhythm.
Applicants argue (Remarks, page 10-11) that Moorman does not teach separating the classes of rhythm wherein the trained multivariable algorithm includes plural models, each model corresponding to a class rhythm. Moorman does not address a situation when the entropy measurement is ambiguous.
In response, the claims are not particular with respect to how the models correspond to each of the class rhythms, what variables make up the models or how the probability of a candidate rhythm class is calculated. The claim is broad and only requires obtaining “a probability estimate of a candidate rhythm of normal sinus rhythm, atrial fibrillation and sinus rhythm with ectopy.” Moorman teaches distinguishing AF from normal sinus rhythm wherein the AF estimate could also be sinus rhythm with ectopy. Moorman recognizes that determining of AF could be a false positive and that the AF could instead by sinus rhythm with ectopy. This reads on obtaining a “probability estimate of” either AF or sinus rhythm with ectopy. When the entropy measure is used to determine AF, a probability that it is sinus rhythm with ectopy also exists. Therefore the teaching of Moorman reads on the claim. The instant claims do not recite specifically how the probability is determined.
Furthermore, the claims recite plural models, at least one of each model corresponding to a cardiac rhythm including at least a normal sinus rhythm, AF and sinus rhythm with ectopy. The claims do not require a particular model for only AF, a particular model for only sinus rhythm with ectopy and a particular model to for only normal sinus rhythm. The claims do not even require any specific model parameters, structures, or distinguishing AF from sinus rhythm with ectopy with particular models or parameters, e.g. a distinct entropy measure or model for AF versus sinus rhythm with ectopy. Moreover, Moorman teaches distinguishing AF from simus rhythm with ectopy (par. 0150 and 0168) and therefore suggests a model for AF and sinus rhythm with ectopy
Additionally, Moorman teaches that sinus rhythm with ectopy shares many time series features with AF (par. 0005). Therefore, Moorman teaches a multivariable algorithm (i.e. at least a mental process) that recognizes AF and ectopy versus normal sinus rhythm and suggests a RR feature based model for AF and ectopy versus normal sinus rhythm. Moorman then teaches distinguishing AF and ectopy (par. 0150 and 0168) in EKG data (i.e. RR signals) which reads on a model for AF and sinus rhythm with ectopy.
The instant claims merely recite analyzing obtained data and the entropy based parameter “using a trained multivariable algorithm” but are not specific as to how the RR data and parameter are used within the trained multivariable algorithm or if the parameter is somehow applied to models for AF, ectopy and normal sinus rhythm.
Due to the breath and high level of generality of the claim, the teachings of Moorman read on the process of claim 11 and the 35 USC 103 rejection is maintained.
Additional Noted Prior Art
Staniczenko et al. teach (page 1, col. 2, par. 2) “spectral entropy values that distinguish normal sinus rhythm from two arrhythmias: atrial fibrillation and atrial.”
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635