DETAILED ACTION
Applicant's response, filed 25 September 2025, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 32-62 are currently pending and under exam herein.
Claims 1-20, 23-24, 27, and 30-31 have been cancelled.
Claims 34-62 are newly added and find support in the Specification and claims as originally filed.
Terminal Disclaimer
The terminal disclaimer filed on 25 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,504,073 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The Information Disclosure Statement filed 25 September 2025 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
Newly presented Claims 40, 49, and 52 are objected to because of the following informalities:
Claim 40 recites, “the one or more computing systems of claim 28 wherein the configuration parameter is a source location the arrhythmia, wherein the claim is missing the preposition “of”. It is suggested that the claim be amended to recite, “the one or more computing systems of claim 28 wherein the configuration parameter is a source location of the arrhythmia”.
Claim 49 recites, “the method of claim 21 wherein the configuration parameter is a source location an arrhythmia”, wherein the claim is missing the preposition “of”. It is suggested that the claim be amended to recite, “the method of claim 21 wherein the configuration parameter is a source location of an arrhythmia”.
Claim 52 recites, “performing an ablation on the heart of the patient to treat the an arrhythmia…” wherein the claim includes both “the” and “an” preceding “arrythmia”. It is suggested to delete “an” so that the claim reads, “performing an ablation on the heart of the patient to treat the
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 32-62 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. The instant rejection is necessitated by claim amendment herein.
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.
Claims 21, 28, and 52 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; 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. 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 or the like. Clarification is requested. Claims 28 and 52 and their dependent claims are also rejected herein, as claims 28 and 52 recite similar language provoking the issues above.
Claim 52 recites, “and performing an ablation on the heart of the patient to treat the an arrhythmia based on the identified source location of the arrhythmia; and”, wherein the claim is unclear with respect to the final operation as the claim concludes with an open-ended “arrhythmia; and” which makes unclear if there are following steps of not. It appears to be a typographical error (see objection above), and will be interpreted as such, however, said recitation indefiniteness in the claim. Correction is requested.
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.
Claims 21-22, 25-26, 28-29, and 32-62 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. Claims 21 and 28 are amended to recite, “performing an ablation on the heart of the patient factoring the value for the configuration parameter” and “wherein an ablation is performed on the patient to treat an arrhythmia factoring in the value of the configuration parameter for the heart of the patient”, respectively. New claim 52 recites, “performing an ablation on the heart of the patient to treat the an arrhythmia based on the identified source location of the arrhythmia”. The instant Specification fails to provide disclosure pertaining to actual “ablation” by factoring the value of a configuration parameter and “ablation” to treat based on source location, as now claimed.
The Specification provides only that “the MLMO system may generate additional features to represent the geometry of the heart, the orientation of the heart, scar location, ablation location, ablation shape, and so on. The MLMO system may input these additional features into the fully connected layer along with the output generated by the layer before the fully connected layer of a convolutional neural network (“CNN”), which is described below. The output of the layer before the fully connected layer (e.g., pooling layer) may be “flattened” into a one-dimensional array, and the MLMO system may add the additional features as further elements of the one-dimensional array. The output of the fully connected layer may provide a probability for each label used in the training data” [0018].
Further the Specification provides that, “MLMO system may classify source stability (i.e. the beat-to-beat consistency of a dominant arrhythmia source localized to a particular region in the heart) by generating training data that is based on sequences of consecutive cycles that have similar EM features. A technique for determining the stability of arrhythmia sources is described in Krummen, D., et. al., Rotor Stability Separates Sustained Ventricular Fibrillation From Self-Terminating Episodes in Humans, Journal of American College of Cardiology, Vol. 63, No. 23, 2014, which is hereby incorporated by reference. This reference demonstrates the efficacy of targeted ablation at stable source sites for preventing recurring arrhythmic episode” [0021].
However, none of said recitations include that the particular applied weights that generate values for a patient for a configuration parameter are actually applied to perform an ablation of the heart as claimed herein.
This is a New Matter rejection necessitated by claim amendment herein.
Declaration under 37 CFR 1.130(b)
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
It is noted herein that the Declaration was filed under 37 CFR 1.130(b), however, the filing is being treated a under 37 CFR 1.130(a), which is used to disqualify a disclosure relied upon under 35 USC 102(a)(1) by establishing that the disclosure was made by the inventor or a joint inventor (attribution declaration).
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.
Conclusion
No claims are allowed.
The outstanding rejection under 35 USC 101 is hereby withdrawn in view of the amendment that includes 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 said steps are rejected under New Matter herein and any amendment may necessitate re-application of the rejection.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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