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 .
Applicant Response
Applicant's response, filed 12/18/2025, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 3, 10, and 22-23 are canceled.
Claim 24 is newly added.
Claims 1-2, 4-9, 11-21 and 24 are pending and under examination herein.
Claims 1, 20 and 24 are objected to.
Claims 1-2, 4-9, 11-21 and 24 are rejected.
Priority
The instant application is the National Stage entry of PCT/US2019/027518 , International Filing Date: 04/15/2019, which claims priority to US Provisional Application 62/657273 , filed 04/13/2018, Provisional Application 62/686856 , filed 06/19/2018 and Provisional Application 62/721279 , filed 08/22/2018. However, the priority documents do not disclose the newly recited instant claim 1 claim limitations of “recommending an immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor-infiltrating lymphocyte (TIL) therapy, or a combination thereof, for the cancer patient that is predicted to respond to immune-based or targeted therapy; and administering the immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor- TIL therapy, or a combination thereof to the cancer patient based on the predicted response.” As such, the effective filing date assigned to each of claims 1-2, 4-9, 11-21 and 24 is 10/13/2020.
Drawings
The drawings submitted on 10/13/2020 were accepted by the examiner in the office action mailed 03/01/2024.
Claim Objections
Claim 1 and 20 are objected to because of the following informalities:
in the last step of claim 1, “or a combination thereof” should be “or [[a]] the combination thereof”.
in claim 20, “wherein statistically analyzing the violin plots comprises” should be “wherein statistically analyzing the violin plots further comprises”.
In claim 24, “wherein the graphical display is configured” should be “further comprising
Appropriate correction is required. This objection is newly recited.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-2, 4-9, 11-21 and 24 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claim 1 limitations of “recommending an immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor-infiltrating lymphocyte (TIL) therapy, or a combination thereof, for the cancer patient that is predicted to respond to immune-based or targeted therapy; and administering the immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor- TIL therapy, or a combination thereof to the cancer patient based on the predicted response” are not described in the instant disclosure. This rejection is newly recited and necessitated by the claim amendments.
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 1-2, 4-9, 11-21 and 24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This rejection is newly recited and necessitated by the claim amendments.
In claim 1, it is unclear if the” plurality of immune based or targeted therapies” for which a response is predicted comprises “immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor-infiltrating lymphocyte (TIL) therapy, or a combination thereof”. For the purposes of examination, this limitation is interpreted to include the specific therapies recited.
Furthermore, the limitation of “recommending an immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor-infiltrating lymphocyte (TIL) therapy, or a combination thereof, for the cancer patient that is predicted to respond to immune-based or targeted therapy” is unclear, because it reads as recommending a treatment to a cancer patient that is predicted to response to a therapy, but the previous step of the claim predicts a response to at least one of a plurality of immune- based or targeted therapies in the cancer patient. For the purposes of interpretation, this limitation is interpreted as “recommending an immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor-infiltrating lymphocyte (TIL) therapy, or a combination thereof, for the cancer patient that is predicted to respond to the immune-based or targeted therapy”.
The final step of the claim 1, the administration step, is also indefinite, because it is unclear if the administered therapy and the recommended therapy of the previous step are the same. For the purposes of examination, this limitation is interpreted as administering the recommended therapy to the cancer patient.
Claims 2, 4-9, 11-21 and 24 are also indefinite for failing to remedy the indefiniteness of claim 1 on which they depend.
Claim Rejections - 35 USC § 101
The rejection of claim 10 under 35 U.S.C. 101 is withdrawn in view of cancelation of the claim in the claim amendments filed 12/18/2025.
The rejection of claims 1-2, 4-9, and 11-21 under 35 U.S.C. 101 is withdrawn in view of claim amendments filed 12/18/2025, which integrate any recited judicial exceptions into practical application, by applying or using the recited judicial exception to effect a particular treatment for a disease or medical condition. Specially, the step of administering the immune checkpoint blockade therapy, antibody therapy, chemotherapy, tumor- TIL therapy, or a combination thereof to the cancer patient based on the predicted response provides a particular treatment. Claim 24 is also free from a rejection under 35 U.S.C. 101 for the same reasons discussed above.
Claim Rejections - 35 USC § 103
The rejection of claims 10 under 35 U.S.C. 103 as being unpatentable over Azizi et al. (bioRxiv 2018, 221994; previously cited) in view of Krieg et al. (Nat Med 2018, 24, 144–153; previously cited) is withdrawn in view of cancelation of the claim in the claim amendments filed 12/18/2025.
The rejection of claims 1-2, 4-9, 11 and 13-21 under 35 U.S.C. 103 as being unpatentable over Azizi et al. (bioRxiv 2018, 221994; previously cited; hereafter referred to as Azizi) in view of Krieg et al. (Nat Med 2018, 24, 144–153; previously cited; hereafter referred to as Krieg) is withdrawn in view of claim amendments filed 12/18/2025, as neither Azizi nor Krieg suggest or teach determining positive and negative cutoff values for each of a plurality of cell parameters corresponding with the plurality of nodes, superimposing the clustered data on a previously determined tree describing known patient phenotype data for at least some of the plurality of nodes, using the determined cutoff values to generate the violin plots, or predicting a response to the therapy by analyzing the violin plots based on both a detected variation in immune cell phenotypes with one at least one node and from analysis of the superimposed clustered data.
The rejection of claims 12 under 35 U.S.C. 103 as being unpatentable over Azizi et al. (bioRxiv 2018, 221994; hereafter referred to as Azizi) in view of Krieg et al. (Nat Med 2018, 24, 144–153; previously cited; hereafter referred to as Krieg), and further in view of Marigo et al. (Cancer cell 2016, 30(3), 377-390; previously cited hereafter referred to as Marigo) is withdrawn in view of claim amendments filed 12/18/2025, as none of Azizi, Krieg, or Marigo suggest or teach determining positive and negative cutoff values for each of a plurality of cell parameters corresponding with the plurality of nodes, superimposing the clustered data on a previously determined tree describing known patient phenotype data for at least some of the plurality of nodes, using the determined cutoff values to generate the violin plots, or predicting a response to the therapy by analyzing the violin plots based on both a detected variation in immune cell phenotypes with one at least one node and from analysis of the superimposed clustered data.
Claim 24 is also free from a rejection under 35 U.S.C. 103 for the same reasons discussed above.
Conclusion
No claims allowed.
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.
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687