DETAILED ACTION
I. ACKNOWLEDGEMENTS
The current application, 17/992994 ("the instant application"), was filed November 23, 2022. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
The instant application is a reissue application of US Patent 10,846,367 (the ‘367 patent). The ‘367 Patent was filed as application 16/131570 (“the ‘570 application”), on September 14, 2018, entitled “PREDICTING RECURRENCE IN EARLY STAGE NON-SMALL CELL LUNG CANCER (NSCLC) WITH INTEGRATED RADIOMETRIC AND PATHOMIC FEATURES.
The Examiner further notes that a litigation search revealed that no litigation was pending involving the ‘367 patent. Also based upon the Examiner's independent review of the ‘367 patent itself and the prosecution history, the Examiner cannot locate any previous or additional reexaminations, supplemental examinations, certificates of correction, or other ongoing proceedings involving the ‘367 patent before the Office.
This action is being issued following Applicant’s response of 6/23/2026, which included 1) claim amendments and 2) arguments.
II. CLAIM STATUS
The ‘367 Patent issued with claim 1-22 (“Patented Claim”). The preliminary amendment of 11/23/2022 amends claims 19, 21 and 22 and adds claims 23-32. The amendment of 12/2/2024 amends claims 1, 13, 14, 17, 20, 23, and 30. The amendment of 7/14/2025 amends claims 1, 4, 19, 23, 25, and 30 cancelled claims 2, 3, 26, 27, 31, and 32, and added claims 33-34. The amendment of 6/23/2026 amends claims 1, 17, and 23, and adds claim 35. As of the date of this Office Action, the status of the claims is:
a. Claims 1, 4-25, 28-30, and 33-35 are pending (“Pending Claims”).
b. As a result of this office action, claims 1, 4-25, 28-30, and 33-35 are examined on the merits below.
III. AMENDMENT OF 6/23/2026
The amendment to claims filed 6/23/2026 has been entered and considered.
IV. PRIORITY AND CONTINUING DATA
Based upon a review of the instant application and ‘367 Patent, the Examiner finds that
the ‘367 patent claims priority to US Provisional Application 62/558979, filed September 15, 2017. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 102, 103, and 112 are to the current provisions.
In accordance with MPEP §609.02 A. 2 and MPEP §2001.06(b) (last paragraph), the Examiner has reviewed and considered the prior art cited in the ‘570 application. Also, in accordance with MPEP §2001.06(b) (last paragraph), all documents cited or considered ‘of record’ in the prior applications are now considered cited or ‘of record’ in this application. Additionally, Applicant(s) are reminded that a listing of the information cited or ‘of record’ in the prior applications need not be resubmitted in this application unless Applicant(s) desire the information to be printed on a patent issuing from this application. See MPEP §609.02 A. 2. Finally, Applicant(s) are reminded that the prosecution histories of the prior applications are relevant in this application.
V. REISSUE DECLARATION
The reissue oath/declaration filed 12/2/2024 is approved.
VI. CLAIM OBJECTIONS
Claims 4 and 5 are objected to as depending from claim 3, which has been canceled.
VII. REJECTIONS UNDER 35 USC 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 23-25, 28-30, and 33-35 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Using claim 23 as a representative example, the claim recites the limitations:
extracting a set of pathomic features from the pathology image …
extracting a set of radiometric features …
providing the set of pathomic and radiometric features to a machine learning model that is trained to generate a prediction of a characteristic of the lung cancer …
outputting the prediction of the characteristic …
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is a method, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. The claim recites a judicial exception in that the steps of extracting and providing under their broadest reasonable interpretation, amount to a mental processes that can be carried out in the mind or by a pen and paper. The Examiner recognizes that the disclosure in column 14, lines 5+ states that the extracting step extracts features at a higher order or higher level than a human can resolve in the human mind or with a pen and pencil. However, the Examiner notes that there is no limiting definition of the term extract in the disclosure. As such, the claims are not limited to the types of extracting recited in the disclosure. Rather, the term must be given its broadest reasonable interpretation (BRI) and in the current case, the BRI includes features that can be extracted either mentally or determined using a pen and paper. According to MPEP 2106.04(a), mental processes are abstract ideas. See also MPEP 2106.04(a)(2). As such, claim 23 recites an abstract idea or abstract ideas.
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The outputting step is merely insignificant extra-solution activity recited at a high level of generality. As such, these steps do not integrate the abstract idea into a practical application, as the additional steps do not impose any meaningful limits on the practice of the abstract idea. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Nothing in the claim integrates the exception into a practical application.
Claims 24, 25, 28-30 and 33-35 do not add anything that changes the analysis.
VIII. ALLOWABLE SUBJECT MATTER
Claims 1, 6-22 are allowable.
Claims 4 and 5 would be allowable if the objection were overcome.
Claims 23-25, 28-30 and 33-35 would be allowable if the rejection under 35 USC 101 were overcome.
Claims 1, 4-22, 24, and 25 define over the art of record in that none of the art uses pathomic features extracted from a pathology image and radiometric features extracted from a radiology image to compute the probability that a region of tissue will experience NSCLC recurrence.
Claims 23-25, 28-30 and 33-35 define over the art of record in that none of the art uses pathomic features extracted from a pathology image and radiometric features extracted from a radiology image to predict a characteristic of lung cancer.
IX. ANSWER TO ARGUMENTS
Applicant’s arguments regarding claims 1 and 4-22 have been found convincing as the claims recite a disclosed improvement in the technology by combining both pathomic and radiometric features to classify a region as recurrent or not (see column 8, lines 51+).
The Examiner also notes that Desjardins is not relevant to the current claims. Desjardins improved how a computer performed machine learning. The current claims apply generic machine learning to the data. However, the argument as to the improvement of a technological field has been found to be convincing.
However, claim 23 does not recite the improvement, as the improvement is disclosed as predicting the recurrence of NSCLC and claim 23 only recites determining the characteristic of the cancer. As such, the claim is not commensurate with the scope of the improvement and therefore, the 101 rejection is being maintained.
XII. 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 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 ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached on (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/ Primary Examiner, Art Unit 3992
CONFEREES:/JOSHUA D CAMPBELL/Primary Examiner, Art Unit 3992
/ALEXANDER J KOSOWSKI/Supervisory Patent Examiner, Art Unit 3992
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