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 .
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.
Claim 21, is rejected on the ground of nonstatutory double patenting as being unpatentable over allowed claim 21 respectively of application 18046604 wherein these claims have been allowed. Although the claims at issue are not identical, they are not patentably distinct from each other because the scopes of allowed claims anticipate the scopes of current application claims as outlined in the chart below. "Anticipation is the epitome of obviousness", Realtime Data, LLC v. lancu; MPEP 1207.03(a)(ll)(2).
Current Application 18513860
Allowed claims (11/22/2024) application 18046604
21. (Currently Amended) A computer-implemented method of predicting a likelihood that a patient having breast cancer will experience a recurrence following treatment for breast cancer in the patient, said method comprising:
receiving a digital image of a histologic section of a breast cancer sample derived from the patient, the digital image including
appended spatial information; receiving one or more patient attributes associated with the patient; determining a digital image score, of the digital image, using a first machine learning model, the first machine learning model having been trained by processing a plurality of training images to predict the likelihood of recurrence; determining a clinical score using a second machine learning model and the one or more patient attributes, the second machine learning model having been trained using one or more training patient attributes from different patients; determining a continuous score for the patient based on the digital image score, and the clinical score, wherein the continuous score corresponds to the likelihood that the patient will experience the recurrence following treatment and is
determined by analyzing the appended spatial information of the digital image to: incorporate a predicted genomic expression, a predicted number of cells having a particular cell type, a predicted number of cells having a particular cell sub-type, a predicted protein expression, a predicted measurement of physical size, or a combination thereof; and incorporate a location of one or more cells, a spatial distribution of predicted genomic expression, a spatial distribution of predicted protein expression, or a combination thereof; and based on the continuous score, identifying that the patient is at a high risk of recurrence for breast cancer
21.(Currently Amended) A computer-implemented method of determining a continuous values value prediction for one or more digital medical images, the method comprising:
receiving one or more digital medical images of a sample associated with a patient, the one or more digital medical images comprising pixels and/or voxels;
appending spatial information to the pixels and/or voxels of the one or more digital medical images, wherein the spatial information is appended by concatenating coordinates of each pixel and/or voxel to each pixel and/or voxel; determining, by providing the appended digital medical images to a trained machine learning system, a continuous value prediction of a level of one or more biomarkers, the trained machine learning system having been trained directly using a plurality of medical images and a continuous score prediction loss function; and providing the continuous value prediction for output to a display and/or storage, wherein determining a continuous value prediction based on analyzing the pixels and/or voxels with appended spatial information
comprises: incorporating a predicted genomic expression, a predicted number of cells having a particular cell type, a predicted number of cells having a particular cell sub-type, a predicted protein expression, a predicted measurement of physical size, or a combination thereof; and incorporating a location of one or more cells, a spatial distribution of predicted genomic expression, a spatial distribution of predicted protein expression, or a combination thereof.
Response to Amendment
Claims 21, 30, and 36 has been amended.
Claims 21-40 are still pending for consideration.
Response to Arguments
Applicant’s arguments, see “Remarks” filed on 06/16/2026, have been fully considered and are persuasive. The rejection has been withdrawn.
Allowable Subject Matter
Claims 21-40 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art taken either singly or in combination fails to anticipate or fairly suggest the
limitation of the independent claim, in such a manner that a rejection under 35 USC or 103 would be improper.
Regarding claim 21 the closet prior arts are Yip et al. (US 20210166785A1) and Chukka et al. (US20220051804 A1). The combination of Yip et al. and Chukka et al. disclose most of the claim limitations as explained in previous office action. However, the combination of Yip et al. and Chukka et al. fails to disclose or reasonably suggest that “determined by analyzing the appended spatial information of the digital image to: incorporate a predicted genomic expression, a predicted number of cells having a particular cell type, a predicted number of cells having a particular cell sub-type, a predicted protein expression, a predicted measurement of physical size, or a combination thereof; and incorporate a location of one or more cells, a spatial distribution of predicted genomic expression, a spatial distribution of predicted protein expression, or a combination thereof”.
Regarding claims 22-29 these claims depend directly or indirectly on an allowable base claim 21 and are therefore allowable for the reasons stated supra.
Re Claim 30, is allowable for the same reason as independent claim 21 discussed above.
Regarding claims 31-35 these claims depend directly or indirectly on an allowable base claim 30 and are therefore allowable for the reasons stated supra.
Re Claim 36, is allowable for the same reason as independent claim 21 discussed above.
Regarding claims 37-40 these claims depend directly or indirectly on an allowable base claim 30 and are therefore allowable for the reasons stated supra.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINTA GEBRESLASSIE whose telephone number is (571)272-3475. The examiner can normally be reached Monday-Friday9:00-5:00.
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/WINTA GEBRESLASSIE/Examiner, Art Unit 2677
/Jonathan S Lee/Primary Examiner, Art Unit 2677
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