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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/17/2026 has been entered.
Status of Claims
In the amendment filed 07/17/2026 the following occurred: Claims 1, 11, 17-18, and 20 were amended; and Claims 21-23 were added as new. Claims 1-4, 7, 11, 13-18, and 20-23 are presented for examination.
Claim Rejections - 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, 7, 11, 13-18, and 20-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-4, 7, 11, 13-18, and 20-23 are drawn to systems, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites limitations to modify information received from the second plurality of parameters using information received from the first plurality of parameters or modify information received from the first plurality of parameters using information received from the second plurality of parameters, and generate an algorithm that uses one or more parameters from the first plurality of parameters and one or more parameters from the second plurality of parameters, wherein the algorithm generates an overlay map by weighting imaging information from the quantitative or semi-quantitative molecular imaging with the second plurality of parameters from the laboratory test, the overlay map providing a course of therapy to the patient.
Independent claim 20 recites limitations to modify information received from the second plurality of parameters using information received from the first plurality of parameters or modify information received from the first plurality of parameters using information received from the first plurality of parameters, and generate an algorithm that uses one or more parameters from the first plurality of parameters and one or more parameters from the second plurality of parameters, wherein the algorithm generates an overlay map by weighting imaging information from the quantitative or semi-quantitative molecular imaging with the second plurality of parameters from the laboratory test, the overlay map providing a course of therapy to the patient.
The respective dependent claims 2-4, 7, 11, 13-18, and 21-23, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations above, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention is to “a combinatorial approach that links functional and quantitative modalities (or semi-quantitative modalities) such as imaging and molecular diagnostics into one combined multi-modality biomarker approach. This combined multi-modal biomarker approach informs decision making and facilitates the development of a platform from which correlations between the results obtained from imaging and those obtained from molecular diagnostics can be identified. This platform can also facilitate the identification of mutual synergistic benefits between functional and quantitative modalities for developing personalized treatments for patients. This method is very useful in the early detection of cancers” (see: specification paragraph 6). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address problems regarding where “personalized and precision medicine are expected to increase the per patient costs in the initial treatment phase, a key driver of implementation (of these types of treatments) is to improve the accuracy of the designed course of personalized treatment, thereby reducing costs to the healthcare provider by making unnecessary, treatments that might prove to be ineffective. In addition, the clinical accuracy (sensitivity and specificity) to avoid both false negative and false positive results needs to be improved to make healthcare more efficient and reduce overall costs” (see: specification paragraph 3). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “a microprocessor; where the microprocessor is operative to…” (claim 1) and “a microprocessor operative to…” (claim 20), which are additional elements that are recited at a high level of generality (e.g., the “microprocessor” is configured through no more than a statement than that it is “operative” to perform claimed functions) such that they amount to no more than mere instruction to apply the exception using generic computer elements. See: MPEP 2106.05(f).
The claims recite the additional elements of “collect and store a first plurality of parameters obtained from quantitative or semiquantitative molecular imaging conducted on a patient, wherein the quantitative or semi-quantitative molecular imaging includes quantitative functional multi-parametric molecular imaging, and wherein the quantitative functional multi-parametric molecular imaging includes x-ray computed tomography, magnetic resonance imaging, ultrasound and single-photon emission computed tomography, positron emission tomography, or a combination thereof, wherein the first plurality of parameters include standardized uptake value, metabolic tumor volume, total lesion glycolysis, Ki, VB [Patlak, Logan], K1, k2, k3, k4, or a combination thereof, collect and store a second plurality of parameters obtained from a laboratory test conducted on the patient, wherein the second plurality of parameters includes molecular information from a combination of any of circulating tumor cells, circulating-free DNA, circulating-free RNA, circulating-free nucleic acids, circulating tumor DNA (ctDNA), circulating tumor RNA (ctRNA), circulating tumor nucleic acids (ctNA), mutational load/burden, fraction of genome altered, microsatellite instability, mismatch repair deficiency, methylated tumor DNA fraction, nucleosomal organization/fragmentation of circulating free or tumor DNA” (claim 1), “collect and store a first plurality of parameters obtained from a quantitative or semi-quantitative molecular imaging conducted on a patient by an imaging system, wherein the quantitative or semi-quantitative molecular imaging includes quantitative functional multi-parametric molecular imaging, and wherein the quantitative functional multi-parametric molecular imaging includes x-ray computed tomography, magnetic resonance imaging, functional magnetic resonance imaging, ultrasound and single-photon emission computed tomography, positron emission tomography, or a combination thereof, wherein the first plurality of parameters include standardized uptake value, metabolic tumor volume, total lesion glycolysis, Ki, VB [Patlak, Logan], K1, k2, k3, k4, or a combination thereof, collect and store a second plurality of parameters obtained from a laboratory test conducted on the patient, wherein the second plurality of parameters includes molecular information from a combination of any of circulating tumor cells, circulating-free DNA, circulating-free RNA, circulating-free nucleic acids, circulating tumor DNA (ctDNA), circulating tumor RNA (ctRNA), circulating tumor nucleic acids (ctNA), mutational load/burden, fraction of genome altered, microsatellite instability, mismatch repair deficiency, methylated tumor DNA fraction, nucleosomal organization/fragmentation of circulating free or tumor DNA” (claim 20), and “the imaging system configured to perform the quantitative or semi-quantitative molecular imaging on the patient” (claim 23), which are nominal or tangential addition to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. Similarly, the claims recite the additional elements of “wherein the patient performs the course of treatment” (claim 1) and “wherein the patient performs the course of therapy” (claim 20), which are considered an insignificant post-solution activity concerning an insignificant application, and the addition of insignificant extra-solution activity does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instruction to apply the exception(s) using generic computer elements and limitations directed toward extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic elements. Mere instructions to apply an exception using generic elements cannot provide an inventive concept. See MPEP 2106.05(f).
The claimed additional elements directed toward extra-solution activity, identified above, are not sufficient to amount to significantly more than the judicial exception because they are understood by the courts to perform well-understood, routine, and conventional activities previously known to the industry. The claimed limitations of systems to collect and store a first plurality of parameters obtained from quantitative or semiquantitative molecular imaging conducted on a patient by an imaging system configured to perform the quantitative or semi-quantitative molecular imaging on the patient, and to collect and store a second plurality of parameters obtained from a laboratory test conducted on the patient, are representative of concepts to electronic recordkeeping, receiving or transmitting data over a network, such as using the Internet to gather data or sending messages over a network, and storing and retrieving information in memory. Said representative concepts have been identified by the courts as well-understood, routine, and conventional activities; therefore, the corresponding claimed limitations are shown to be well-understood, routine, and conventional activities. It is noted that the lab tests themselves are not positively claimed as part of the invention and lie outside the scope of invention. For example, that a laboratory test is a liquid biopsy according to claims 21-22 is non-functional descriptive material as the invention itself is to systems with microprocessors that merely collect and store laboratory test data. Even if positively claimed, said laboratory tests represent techniques that are well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner or as insignificant extra-solution activity. Such is similarly noted regarding molecular imaging, and while claim 23 positively teaches the system further including the imaging system itself, said imaging system is claimed at a high level of generality such that is merely “configured to” perform quantitate or semi-quantitative molecular imaging on the patient. See: MPEP 2106.05(d)(II). Further, the claimed wherein limitations that the patient performs the course of therapy, are representative of concepts to an insignificant application, which the courts have found to be insignificant extra-solution activity; therefore, the corresponding claimed limitations are shown to be insignificant extra-solution activity. The claims recite the additional elements directed to pre-solution and post-solution activity, as recited and indicated above, each of which amount to extra-solution activity. Said additional elements have been shown to be recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea(s), and/or does not provide anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are presently). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2-4, 7, 11, 13-18, and 21-23, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above and are therefore rejected for at least the same rationale as applied to their parent claims above and incorporated herein.
Claim Rejections - 35 USC § 112
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 of carrying out his invention.
Claims 1-4, 7, 11, 13-18, and 20-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per claim 1, the claim recites collecting and storing a second plurality of parameters obtained from “a laboratory test”, but the claims and specification do not provide a corresponding description of said laboratory test. For example, paragraph 49 of the originally filed specification teaches “and combining it with the best laboratory test, e.g. liquid biopsy”, and paragraph 64 teaches the “remote access of images and laboratory (including molecular) data and testing of patients in remote regions of the world”, but the claimed laboratory test is not described in the specification sufficiently to show possession. The MPEP, at 2163 (II)(A)(3)(a)(ii), states that the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice…,reduction to drawings…, or by disclosure of relevant, identifying characteristics...sufficient to show the inventor was in possession of the claimed genus.” As cited above, the specification describes a liquid biopsy species embodiment but does not disclose a representative number of species sufficient to show possession of the claimed laboratory test genius. Claim 20 is rejected for the same reasons.
Claims 2-4, 7, 11, 13-18, and 21-23 depend on and incorporate the specifically rejected claims above; therefore, they are rejected here for similar reasons.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7, 11, 13-18, and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As per claim 1, the claim recites collecting and storing a second plurality of parameters obtained from “a laboratory test”, but the metes and bounds of this term are unclear beyond a liquid biopsy; therefore, beyond a liquid biopsy, it is unclear as to what constitutes a laboratory test within the context of the claimed invention.
Claims 2-4, 7, 11, 13-18, and 21-23 depend from and incorporate the specifically rejected claims above while failing to remedy the limitations shown as indefinite; therefore, they are rejected here for similar reasons.
Response to Arguments
Applicant’s arguments from the response filed on 07/17/2026 have been fully considered and will be addressed below in the order in which they appeared.
In the remarks, Applicant argues in substance that (1) “Claims 1-4, 7, 11, 13-18 and 20 were previously allowed in the Notice of Allowance mailed April 29, 2026. Applicants believe the application, including amended claims 1-4, 7, 11, 13-18 and 20 remain in condition for allowance. Additionally, claims 21-23 are allowable at least by virtue of their dependency.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
In consultation with the Examiner’s supervisor, it was determined that the previous allowance was in error regarding statutory status of the claims under 35 U.S.C. 101, and that the claim amendments received on 07/17/2026 necessitated further rejection under 35 U.S.C. 112.
Conclusion
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, Fonya Long can be reached on (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A SOREY/ Primary Examiner, Art Unit 3682
Prosecution Insights