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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/14/2025 has been entered.
This action is being issued following Applicant’s response of 7/14/2025, 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. As of the date of this Office Action, the status of the claims is:
a. Claims 1, 4-25, 28-30, and 33-34 are pending (“Pending Claims”).
b. As a result of this office action, claims 1, 4-25, 28-30, and 33-34 are examined on the merits below.
III. AMENDMENT OF 7/14/2025
The amendment to claims filed 7/14/2025 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.
IX. 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 1, 4-25, 28-30, and 33-34 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 1 as a representative example, the claim recites the limitations: accessing a pathology image of a region of tissue … extracting a set of pathomic features from the pathology image … accessing a radiological image of the region … extracting a set of radiometric features … generating a combined feature set… computing a probability that the region will experience NSCLC recurrence … and classifying the region … based on the probability.
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 non-transitory computer-readable storage medium, 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 for two reasons. First, computing step is a mathematical process that recites a computation. Second, the steps of extracting, extracting, generating, computing, and classifying …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. In addition, the computing step is also a mathematical concept that recites a computation. According to MPEP 2106.04(a), both mental processes and mathematical concepts are abstract ideas. See also MPEP 2106.04(a)(2). As such, claim 1 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. When viewing the exception as a mathematical process, the preliminary steps, accessing, extracting, extracting accessing, extracting and generating are additional steps. However, the additional steps merely amount to a process of gathering data to be processed, which is insignificant pre-solution activity. Alternatively, when viewing the exception as mental processes, the two accessing steps are 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. Here, the accessing steps simply recite well-understood, routine, and conventional steps of gathering image data. Hence, the accessing steps do not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claim 4, in view of Recentive Analytics v. Fox Corp. 134 F.4th 1205 (Fed. Cir. 2025), the use of a convolutional neural network is still the application of a generic network to a new field.
As to claim 5, the BRI of global graph features, nuclear cluster graph features, nuclear shape features, and nuclear orientation features all includes features that can be determined mentally or using a pen and paper. As such, the specific features do not change the fact that the feature extraction is still a mental process and hence the claim is still directed to an abstract idea.
As to claim 6-8, the claims do not recite determining an image only accessing an image. As such, the type of image does not amount to more than insignificant extra-solution activity, and the claims are still directed to an abstract idea.
As to claims 9, 10, and 12, it is the Examiner’s position that the BRI of claim 9 still includes features that are obtainable through mental processes.
As to claim 11, at least some of the recited features, for example the Haralick feature, appear to be calculable by hand, and hence the claim is still drawn to an abstract idea.
As to claim 13, the claim recites a mathematical computation and the machine learning classifier is recited at a high level of generality, which does not amount to significantly more than the abstract idea.
As to claim 14, the use of a linear discriminant neural network is still just an application of a generic known machine to a new field, and therefore the claim is non-statutory (see Recentive Analytics v. Fox Corp, 134 F.4th 1205 (Fed. Cir. 2025)).
As to claim 15, displaying is recited at a high level of generality and is therefore insignificant post solution activity.
As to claim 16, the claim still encompasses a mental process and therefore the claim is not patent eligible.
As to claims 17-19, while the claim recites some structural features, the structure is recited at a high level of generality and does not therefore amount to significantly more than the abstract idea. The analysis given above with respect to claims 1-16 applies here and the claims are not patent eligible.
With regards to claims 20-25, 28-30, and 33, the claims are non-statutory for basically the same reasons given above, as the steps fall under the realm of mental processes, with a mathematical step of classifying.
X. ALLOWABLE SUBJECT MATTER
Claims 1, 4-25, 28-30, and 33-34 would be allowable if the rejections under 35 USC 101 were overcome.
Claims 1, 4-25, 28-30, and 33-34 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 lung cancer disease characteristic (claims 23-25, 29, 33, and 34) or compute the probability of NSCLC recurrence (claims 1-4-22).
XI. ANSWER TO ARGUMENTS
As to the 101 rejection, the Examiner notes that whether or not the claim is drawn to a mental process, the claim embodies a mathematical process, as previously pointed out. Therefore the 101 rejection would stand regardless of whether the claim is drawn to a mental process.
Applicant has argued with respect to the mental process that the Examiner is not applying the BRI with respect to the specification to determine whether the steps can be processed mentally. The Examiner disagrees. Specifically, the disclosure states:
Embodiments described herein, including at least methods 100 or 1400, the sets of operations 800, 900, and 1500, apparatus 1100 and 1200 resolve features extracted from digitized H&E stained images and CT imagery at a higher order or higher level than a human can resolve in the human mind or with pencil and paper. For example, the local cluster graphs are not biological properties of cancerous tissue that a human eye can perceive. A tumor does not include a set of pixels with intensities, a set of cluster graphs or entropy features, and these features cannot be stored in a human mind. Column 14, lines 5+.
The claim merely states extracting by segmenting …and extracting features from the segmented image. The claim scope is therefore not the same scope as the disclosure, as the disclosure states that it resolves features extracted from digitized H & E images and CT imagery. For example, the disclosure states the local cluster graphs are not biological properties that the human eye can perceive. The current claims do not say anything about local cluster graphs. Therefore, the claims are drawn to broader scope than the disclosure. Currently, the claim has two steps for extracting pathomic features, which in the Examiner’s opinion, can be performed mentally on an enlarged image. As the Examiner noted above, the claimed steps are simply generic recitations of the step and the BRI of extracting a set of radiometric features, for example, covers a process that can be performed mentally. As such, the rejection stands.
XII. CONCLUSION
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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