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 .
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in U.S. Patent Application No. 16/982,526.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on January 6, 2025 comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements being considered by the examiner. Citations which have not been considered, have not been considered because they do not comply with 37 CFR 1.98(b) which states “The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue”.
Related applications
Applicant should amend the cross-reference to related applications portion of the specification to update the current status of the cited applications.
35 USC § 101 Statutory Analysis
The claims do not recite any of the judicial exceptions enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance. Further, the claims do not recite any method of organizing human activity, such as a fundamental economic concept or managing interactions between people. Finally, the claims do not recite a mathematical relationship, formula, or calculation. Thus, the claims are eligible because they do not recite a judicial exception.
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 claims at issue 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 reference 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/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:
http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of issued U.S. Patent No. 12,186,021. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed towards the common subject matter.
The claims in the present application define the invention differently from the claims in 1-15 of issued U.S. Patent No. 12,186,021, however they are not patentably distinguishable from the claims in the issued Patent. In re White et al., 160 USPQ 417, In re Thorington et al., 163 USPQ 644.
For example, comparing representative claim 1 of the present application with representative claim 1 of issued U.S. Patent No. 12,186,021. Claim 1 of the present application recites: A computer implemented method for selecting, from a series of cardiac implants having different sizes, a cardiac implant having an optimum size, and predicting an optimum deployment position, for implantation of the cardiac implant in a patient, the method comprising (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: A computer implemented method for selecting, from a series of cardiac implants having different sizes, a cardiac implant having an optimum size, and predicting an optimum deployment position, for implantation of the cardiac implant in a patient, the method comprising); obtaining a patient-specific three-dimensional anatomical model corresponding to data representative of a patient-specific three- dimensional image of a cardiac region, the patient-specific three-dimensional anatomical model comprising a finite element mesh (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: obtaining a patient-specific three-dimensional anatomical model corresponding to data representative of a patient-specific three-dimensional image of a cardiac region, the patient-specific three-dimensional anatomical model comprising a finite element mesh); obtaining an implant model representing a finite element representation of the cardiac implant (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: obtaining an implant model representing a finite element representation of the cardiac implant); virtually deploying the implant model into the patient-specific three-dimensional anatomical model (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: virtually deploying the implant model into the patient-specific three-dimensional anatomical model); calculating a deployed shape of the implant model at a plurality of deployment locations of the patient-specific three-dimensional anatomical model (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: calculating a deployed shape of the implant model at a plurality of deployment locations of the implant model); and predicting the optimum size, and optimum position, of the cardiac implant when deployed in the cardiac region based on the patient-specific three-dimensional anatomical model and the implant model, wherein the predicting comprises entering the data representative of the patient-specific three-dimensional image of the cardiac region into an artificial intelligence device configured to output the prediction of the optimum size and associated position of the cardiac implant of the series (Claim 1 of 1-15 of issued U.S. Patent No. 12,186,021 recites: and predicting the optimum size, and optimum position, of the cardiac implant when deployed in the cardiac region based on the patient-specific three-dimensional anatomical model and the implant model, wherein the predicting comprises querying a database including a plurality of records, each record including data representative of a patient-specific three-dimensional image of a cardiac region and an associated size and associated position of the cardiac implant of the series).
As the comparison shows the claims recite common subject matter, and the differences relate to variations of the claimed limitations, and the processing is carried out on the data and/or elements in no way affects how the data would be received from an input, processed and output within the context of the claims. Therefore, the substitution of the different variations would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. While claim 1 of issued U.S. Patent No. 12,186,021 includes additional limitations that are not set forth in the instant claim 1, the use of transitional term "comprising" in the instant claim 1 fails to preclude the possibility of additional elements, so that instant claim 1 fails to define an invention that is patentably distinct from claim 1 of issued U.S. Patent No. 12,186,021. Furthermore, the elements of instant claim 1 are fully anticipated by the patented claim, and anticipation is “the ultimate or epitome of obviousness (In re Kalm, 154 USPQ 10 (CCPA 1967), also In re Dailey, 178 USPQ 293 (CCPA 1973) and In re Pearson, 181 USPQ 641 (CCPA 1974)).
Claims 2-22 of the present application recite limitations which are in most cases word for word the same limitations as found in claims 2-15 respectively of issued U.S. Patent 12,186,021.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weber discloses a system similar to applicant’s claimed invention.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jose L. Couso whose telephone number is (571) 272-7388. The examiner can normally be reached on Monday through Friday from 5:30am to 1:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella, can be reached on 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/JOSE L COUSO/Primary Examiner, Art Unit 2667
August 19, 2026
