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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/30/2026 has been entered.
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 04/30/2026.
In the paper of 04/30/2026, Applicant submits a new information disclosure statement and amends claim 5, 20, 40-41, 44-47 and cancels claim 13 and 43 and adds new claims 48-50. Accordingly, claims 5-6, 9-12, 15, 17, 20, 40-42, 44-50 are under review and claims 1-4, 7-8, 13-14, 16, 18-19 and 21-39 and 43 are canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2026 was filed after the mailing date of the Final Office action on 10/31/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Moot and/or Withdrawn Rejection(s)
The objections to claims 18-19 for minor informalities stated in para 7, page 3 of the Final Office of 10/31/2025 are now withdrawn in view of claim amendments.
The rejection of claims 5-6, 9-13, 15, 17, 20, 40-47 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reasons stated in para 9, page 3 of the Final Office of 10/31/2025 is withdrawn in view of claim amendments.
The rejections of claims 13 and 43 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for reasons stated in para 12, pages 4-8 of the Final Office of 10/31/2025 are moot based on the cancellation of these claims.
The rejection of claims 5-6, 9-13, 15, 17, 20, 40-42 and 44-47 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for reasons stated in para 11, page 4 of the Final Office of 10/31/2025 is withdraw based no claim amendments. A new rejection 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph was necessitated by claim amendments.
The rejections of claims 13 and 43 under 35 U.S.C. 103 as being unpatentable over Faruki et al. (WO2019/160914A1, filed 02/13/2019) for reasons stated in para 16, pages 8-11 of the Final Office of 10/31/2025 are moot based on the cancellation of these claims.
The rejection of claims 5-6, 9-12, 15, 17, 19-20 and 40-42 under 35 U.S.C. 103 as being unpatentable over Faruki et al. (WO2019/160914A1, filed 02/13/2019) is withdrawn as Faruki et al. do not teach a logistic regression that is classifier trained (FGFR3+ and FGFR3-).
The rejections of claims 13 and 43 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No.11,208,697 (published Dec 28, 2021, filed Jan 19, 2018) in view of Faruki et al. (WO2019/160914A1, filed 02/13/2019) are now moot based on the cancellation of these claims.
The rejection of claims 5-6, 9-12, 15, 17-20 and 40-42, 44-45 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No.11,208,697 (published Dec 28, 2021, filed Jan 19, 2018) in view of Faruki et al. (WO2019/160914A1, filed 02/13/2019) is withdrawn in view of claim amendments.
Claim Rejections - 35 USC § 112
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 5-6, 9-12, 15, 17, 20, 40-42 and 44-47 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 5 and (dependent claims, 9-12, 15, 17, 20, 40-42 and 44-50) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
Claim 5 recites the limitation: “assigning or having assigned the bladder cancer an FGFR3 genomic classifier status of FGFR3+ or FGFR3- based at least on the levels of expression of the plurality of genes of i), wherein the FGFR3 genomic classifier status is calculated using a classifier trained using a logistic regression having a probability threshold selected to provide at least 70% accuracy”.
This limitation renders claim 5 indefinite.
The omitted elements include a probability threshold value calculated from the gene expression levels interrogated in (i) so as to conclude a FGFR3+ classifier status is detected with an accuracy of at least 70%, and once the probability threshold value establishes the presence of the FGFR3+ classifier status, a bladder cancer treatment suitable for FGFR3+ classifier status can be initiated.
Claim 5 also omits a limitation to recite the probability threshold value that should be measured/calculated from the gene expression levels interrogated in (i) so as to conclude a FGFR3- classifier status is detected, having an accuracy of at least 70% and once the probability threshold value establishes the presence of the FGFR3- classifier status, a bladder cancer treatment suitable for FGFR3- classifier status can be initiated.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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