DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 April 2026 has been entered.
Applicant's response has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Status
Claims 21-22, 25-26, 28-29, and 32-39, 41-48, and 50-65 are currently pending and under exam herein.
Claims 1-20, 23-24, 27, 30-31, 40, and 49 have been cancelled.
Claims 63-65 are newly added and find support in the Specification and claims as originally filed.
Information Disclosure Statement
The Information Disclosure Statement filed 13 April 2026 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20210321960.
Claim Objections
The outstanding rejections of claims 40, 49, and 52 are withdrawn in view of claim cancellation and amendments filed herein.
Newly recited claim objections:
Claim 50 is objected to because of the following informalities:
Claim 50 depends from cancelled claim 49. It is suggested that the claim be amended to properly depend from a preceding claim. For examination purposes it is assumed that claim 50 depends from claim 21. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 21-22, 25-26, 28-29, and 32-39, 41-48, and 50-65 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A. Claim 21, 52 and their dependent claims recite, “performing machine learning training based on the training cardiograms to learn weights for generating a value for the configuration parameter given a target cardiogram”, wherein there are no steps recited whereby weight learning occurs and therefore it is not clear as to process of “learning” in the context of the claim. Rather, the claim directed to performing machine learning with intended language of “to learn” and “for generating”. It is suggested that the claim be amended to further elucidate this aspect of the claims. The Specification discusses “weights” only at [0027] with respect to learning weights for a CNN and classifying a VCG based on weights. Clarification is requested through clearer claim language. Claim 52 recites similar language is also rejected herein. Claims dependent from claims 21 and 52 are also rejected as they fail to remedy the above issues.
It is noted that claim 28 is clear with respect to this rejection as claim 28 includes that the weights are accessed only and that they include weights learned (previously) by performing ML training based on the cardiograms and that they are derived from specific parameters.
B. Claims 21 and 28 and dependent claims recite, “applying the weights to a patient cardiogram collected from a patient to generate a patient value for the configuration parameter for the heart of the patient, wherein the configuration parameter is associated with a source location of an arrhythmia ; and performing an ablation on the heart of the patient factoring the value for the configuration parameter”, wherein the recitation of performing ablation on the heart of the patient factoring the value for the configuration parameter is not clear with respect to the value of the configuration parameters that would be “factored” such that ablation would be performed. The weights appear to be associated with some configuration value, however it is not clear what about that parameters provides for application of weights as claimed. The “association” with a source location is not clear. It is suggested that, for example, the ablation is performed upon application of the weights to classify a parameter such that ablation would be performed on a particular configuration (a source location) or the like.
Claims 28 and dependent claims are also rejected herein, as claims 28 recites similar elements provoking the issues above. Said recitations are, “applying the weights to the patient cardiogram to identify a source location of the arrhythmia of the patient; and performing an ablation on the heart of the patient to treat the arrhythmia based on the identified source”. Clarification is requested.
C. Claims 28-29, 32-39, 41-42, and 64 recite, “one or more computing systems for generating a value for a configuration parameter of a heart of a patient, the one or more computing systems comprising: one or more computer-readable storage mediums that store computer-executable instructions for controlling the one or more computing systems to: access a patient cardiogram of the patient; access weights that are learned by performing machine learning training…applying the weights…wherein an ablation is performed on the patient to treat the arrhythmia factoring in the value of the configuration parameter of the heart of the patient; and one or more processors for controlling the one or more computing systems to execute the one or more computer-executable instructions”. The claim is unclear with respect to a “computing system” as claimed that is capable of performing an ablation in the context of the claim. It is suggested that the claim recite clearer claim language such as, “and further wherein an ablation is performed on the patient to treat the arrhythmia modeled by said computing system” or similar.
Claim Rejections - 35 USC § 112(a)
The outstanding rejections over 35 USC 112(a) for failing to comply with the written description requirement therein are withdrawn in view of Applicant’s arguments with respect to the instant Specification at [0002] describing that “arrhythmias can be treated with ablation using different technologies […] by targeting the source of the heart disorder[,]” and “targeted therapies require the source of the arrhythmia to be identified”. Further the Specification at [0016] includes that configuration parameters “may be cardiac geometry, rotor location, focal source locations”.
Newly recited claim rejections under 35 USC 112(a)-Lack of Written Description
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.
Claims 28-29, 32-39, 41-42 and 64 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims 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 at the time the application was filed, had possession of the claimed invention.
Instant claim 28 recites, ““one or more computing systems for generating a value for a configuration parameter of a heart of a patient, the one or more computing systems comprising: one or more computer-readable storage mediums that store computer-executable instructions for controlling the one or more computing systems to: access a patient cardiogram of the patient; access weights that are learned by performing machine learning training…applying the weights…wherein an ablation is performed on the patient to treat the arrhythmia factoring in the value of the configuration parameter of the heart of the patient; and one or more processors for controlling the one or more computing systems to execute the one or more computer-executable instructions”. However, the instant Specification fails to find support for a computing system, as claimed that can also perform an ablation by implementing learned values, as claimed. Rather, the Specification is directed to learning weights by ML training of training cardiograms and application of weights to generate some value of a configuration parameter of the heart via simulations and/or classifications (MLMO system) [0014]; [0017]; [0044].
As such the claims lack written description of a system that performs an ablation.
Conclusion
No claims are allowed.
With respect to 35 USC 101, the claims recite the practical application of “performing an ablation on the heart of the patient factoring the value for the configuration parameter” (claim 21); “an ablation is performed on the patient to treat an arrhythmia factoring in the value of the configuration parameter of the heart of the patient” (claim 28); and “performing an ablation on the heart of the patient to treat an arrhythmia based on the identified source location of the arrythmia” (claim 52). It is noted that with respect to claim 28 and dependent claims, the steps are rejected under New Matter herein and any amendment may necessitate re-application of the rejection.
With respect to the prior art, the Declaration submitted under 37 CFR 1.130(a) [see note above] filed on 3 September 2019 is sufficient to overcome the rejection of claims 1-15 and 21-35 based on US 2017/0178403 to Krummen et al. The inventor of the instant application, Villongco, has established by way of attribution, that he is the sole inventor of US Application 16/162,695 (the parent application) entitled “Machine Learning Using Simulated Cardiograms” filed on 17 October 2018 and claiming the benefit to US Provisional Application 62/663,049, filed 26 April 2018 and that he is the joint inventor on US Application 2017/0178403, entitled Computational Localization of Fibrillation Sources”, published 22 June 2017 (the above Krummen reference), with other inventors Andrew McCulloch and Gordon Ho. Inventor Villongco has established that he is the inventor of the subject matter relating to the machine learning aspect as claimed herein.
As such the prior art rejections under 35 USC 102 and 35 USC 103 are hereby withdrawn.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
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