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 .
DETAILED ACTION
The amendment filed January 22, 2026 in response to the Office Action of October 23, 2025 is acknowledged and has been entered.
Claims 1, 11 and 13 have been amended.
Claims 2-4, 8-10 and 12 been cancelled.
Claims 1, 5-7, 11, and 13-31 are pending.
Claims 16-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claims 1, 5-7, 11, and 13-15 are currently under consideration as drawn to the elected invention.
In view of cancellation of claims 8 and 9, the claim objections set forth in the Office Action of 10/23/2025 are hereby withdrawn.
In view of claim 1 amendment, the 112(b) rejections set forth in the Office Action of 10/23/2025 are hereby withdrawn.
In view of claim 1 amendment, the 112(a) rejections set forth in the Office Action of 10/23/2025 are hereby withdrawn.
The amended claim 1 added step e, which overcome the 101 rejections set forth in the Office Action of 10/23/2025. Thus, the rejections are hereby withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed on 01/22/2026 has been considered and entered by examiner.
New Claim Objections
Claim 1 is objected to because of the following informalities: “where n= is the number of genes” should be “where n is the number of genes”. Appropriate correction is required.
NEW REJECTION
Claim Rejections - 35 USC § 112(b)
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, 5-7, 11, and 13-15 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.
Claim 1 recites the limitations "the anti-VEGF-A inhibitor antibody" in claim 1(d) and claim 1(e). There is insufficient antecedent basis for this limitation in the claim.
Claims 5-7, 11, and 13-15 are also rejected because these claims depend on claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6, which depends on claim 1, recites “the expression levels of said genes are normalized”. However, claim 1 (c) recites “the VIRP-score is calculated as the weighted sum of the normalized gene expression level…”. Thus, claim 6 fails to further limit the subject matter of claim 1.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13, which depends on claim 1, recites “the malignant tumor is a primary breast cancer …”. However, claim 1 recites “wherein the malignant tumor is a primary malignant tumor or a metastatic malignant tumor selected from the group consisting of HER-2 negative breast cancer, colorectal cancer, and ovarian cancer”. Thus, claim 13 fails to include all the limitations of claim 1.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15, which depends on claim 1, recites “wherein said subject has been diagnosed with breast cancer”. However, claim 1 recites “wherein the malignant tumor is a primary malignant tumor or a metastatic malignant tumor selected from the group consisting of HER-2 negative breast cancer, colorectal cancer, and ovarian cancer”. Thus, claim 15 fails to include all the limitations of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
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