Office Action 2: Notice of Allowance (2025-02-04)

CLAIMS:
AMENDMENTS TO THE CLAIMS

Set forth below in ascending order, with status identifiers, is a complete listing of all

claims currently under examination. Changes to any amended claims are indicated by \[\[double

brackets\]\], and/or underlining. This listing also reflects any cancellation and/or addition of claims.

1\. - 31. (Canceled)230

32\. (Previously Presented) A method of treating colon cancer in a subject comprising:determining the expression level of at least 14 biomarkers from a test sample from a subject by contacting the test sample with a plurality of agents specific to detect the expression of the at least 14 biomarkers, wherein the 14 biomarkers comprise ADRM1,
CDK4, COMT, DHCR7, HMOX2, MCM2, PDXK, POP7, SOOP, SNRPA, SORD,
STOML2, UMPS, and a housekeeping gene, wherein the housekeeping gene is MORF4L1;normalizing the expression level of each of ADRM1, CDK4, COMT, DHCR7,
HMOX2, MCM2, PDXK, POP7, SOOP, SNRPA, SORD, STOML2, and UMPS to the expression level of the housekeeping gene, thereby obtaining a normalized expression level of each of ADRM1, CDK4, COMT, DHCR7, HMOX2, MCM2, PDXK, POP7,
SlOOP, SNRPA, SORD, STOML2, and UMPS;inputting each normalized expression level into an algorithm to generate a score,
wherein the algorithm is a product of a model of colon cancer disease derived using the XGB algorithm;comparing the score with a predetermined cutoff value;
determining that the score is equal to or greater than the predetermined cutoff value, thereby identifying the subject as having colon cancer; and
administering to the subject identified as having colon cancer a therapy, wherein the therapy comprises anti-cancer therapy, chemotherapy, targeted drug therapy, radiation therapy, immunotherapy or any combination thereof.

33\. (Previously Presented) The method of claim 32, wherein the predetermined cutoff value is at least 50% on a scale of 0-100%.

34\. (Previously Presented) The method of claim 32, wherein the predetermined cutoff value is at least 60% on a scale of 0-100%.

35\. (Previously Presented) The method of claim 32, wherein the predetermined cutoff value has a sensitivity of identifying the subject as having colon cancer that is greater than 85%.

36\. (Previously Presented) The method of claim 32, wherein the predetermined cutoff value has a specificity of identifying the subject as having colon cancer that is greater than 75%.

37\. (Previously Presented) The method of claim 32, wherein at least one of the at least 14 biomarkers is RNA, cDNA or protein.

38\. (Previously Presented) The method of claim 37, wherein when the biomarker is RNA, the RNA is reverse transcribed to produce cDNA, and the produced cDNA expression level is detected.

39\. (Previously Presented) The method of claim 32, wherein the predetermined cutoff value is derived from a plurality of reference samples obtained from subjects not having or not diagnosed with a colon cancer.

40\. (Previously Presented) The method of claim 32, wherein therapy comprises chemotherapy, wherein the chemotherapy comprises FOLFOX, FOLFIRI, a combination of 5- FU and leucovorin, capecitabine, irinotecan, CapeOx or any combination thereof.

41\. (Previously Presented) The method of claim 32, wherein when the therapy comprises targeted drug therapy, wherein the targeted drug therapy comprises bevacizumab, cetuximab, panitumumab, regorafenib, a combination of trifluridine and tipiracil, an EGFR TKI inhibitor or any combination thereof.

42\. (Previously Presented) The method of claim 32, wherein when the therapy comprises anti-cancer therapy, wherein the anticancer therapy comprises anti-colon cancer therapy.

43\. (Previously Presented) The method of claim 32, wherein when the therapy comprises immunotherapy, wherein the immunotherapy comprises pembrolizumab, nivolumab or a combination of pembrolizumab and nivolumab.

OFFICE ACTION:
ALLOWANCE
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 .
An updated filing receipt was issued 1/15/2025.  The instant application is a Divisional application of 16/253,697.
The rejection under Obviousness type Double Patenting, made in the previous office action dated 6/6/2024, is withdrawn.
Claims 32-43 are allowed.

APPLICANT REBUTTAL: REMARKS
Upon entry of these amendments, 32-43 are pending. Claims 1 and 2 are canceled herein without prejudice or disclaimer. Applicant reserves the right to pursue the subject matter of the canceled claims in one or more continuation or divisional applications. Amendment and cancellation of certain claims is not to be construed as a dedication to the public of any of the subject matter of the claims as previously presented. No new matter is added.
The Specification has been amended to update the Related Applications paragraph. More specifically, the related Applications paragraph has been updated to include the patent number of USSN 16/253,697 ("the '697 Application") and to update the relationship between the instant application and '697 Application to that of divisional. Applicant submits that such an amendment is proper as the subject matter of the currently pending claims was previously withdrawn by the Office in an Office Action mailed in the '697 Application on September 15, 2021. Applicant further submits an updated Application Data Sheet indicating the change of relationship from continuation to divisional and respectfully requests the issuance of an updated filing receipt reflecting the change of relationship. For the avoidance of doubt, as put forth in MPEP §211.03, a petition under 37 CFR 1.78 is
not
required when changing the relationship between applications when a benefit claim was previously submitted in a timely manner.
Claim Rejections - 35 U.S.C. §101
Claims 1 and 2 are rejected under 35 U.S.C. §101 for allegedly being directed to a natural correlation/law of nature and an abstract idea without significantly more.
Without acquiescing to the validity of the rejection, and solely in an effort to expedite prosecution, claims 1 and 2 are canceled herein without prejudice or disclaimer. Thus, this rejection is moot.
Double Patenting
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-9 of U.S. Patent No. 11,414,707 ("the '707 Patent"). Applicant respectfully disagrees.
Without acquiescing to the validity of the rejection, and solely in an effort to expedite prosecution, claims 1 and 2 are canceled herein without prejudice or disclaimer. Thus, this rejection is moot.
Claims 32-43 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-9 of the '707 Patent in view of U.S. Publication No. 2017/0233495. Applicant respectfully disagrees.
As described supra, the instant application is a proper divisional of the '697 Application (corresponding to the '707 Patent), as the instant claims are directed to subject matter that was withdrawn by the Office during the prosecution of the '697 Application. Accordingly, pursuant to 35 U.S.C. §121, and as described in MPEP §804.01, this nonstatutory double patenting rejection is improper and should be withdrawn.
CONCLUSION