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 .
This action is in response to papers filed 2/20/2026.
Applicant’s election of the species of B7H3 in the reply filed on 2/18/2022 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13, 15-16, 21, 26-40 are pending. Claims 1-12, 14, 17-20, 22-25 have been cancelled.
The following rejections are modified as necessitated by amendment. Response to arguments follows.
This action is FINAL.
Withdrawn Rejections
The 35 USC 112(b) rejection made in the previous office action is withdrawn based upon amendments to the claims.
Modified 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 13, 15-16, 21, 26-40 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.
The claims have been amended to determining the level of B7H3 CAFs in a cancer sample and selecting a patient with levels of B7H3 CAFs lower than a reference as a responder to PD1 and administering PD1. Therefore the claims as amended are drawn to a correlation of any level types of B7H3 CAFs and response to PD-1.
The specification teaches that the terms quantity, amount and level are used interchangeable and may refer to an absolute quantification of a molecule in a sample or a relative quantification of a molecule (p. 10). Furthermore the specification describes B7H3 positive when it is a CAF that expresses B7H3 (p. 22). The specification describes patients with low percentages of B7H3 CAF and association with treatment (p 32). The specificiaotn teaches mRNA levels of B7H3 (p. 6).
Therefore the specification appears to teach that “level” can mean any qualification or quantification of a molecule. Although the specification describes patients with low percentages of B7H3 CAF compared to percentages of B7H3 CAF in nonresponders and association with treatment (p 32). Further, the specification teaches low levels mRNA of B7H3 CAF compared to levels of mRNA of B7H3 CAF in nonresponders and association with treatment. However these do not provide guidance to determination of any level type which would include any absolute quantification of a molecule in a sample or a relative quantification of a molecule and the functionality of treatment of PD1.
The specification states that figure 5 probes that CAF-S1 markers are involved in immunosuppression including B7-H3 (p. 7). The specification states that CAF-S1 signature (includes B7-H3) is provided on the left with response to antiPd1 therapy (p. 8). However, figure 5 provides a p value for just B7-H3 of the non-responder to responder of 0.31 and as such figure 5 with the elected CAF-S1 marker does not provide support for functionally providing response to PDL1 treatment as it does not provide support for detecting a lower level of expression for a responder or non-responder. Figure 6 appears to be based upon a combination of genes and measurement of levels, which is not claimed. As such the specification does not describe the any B7H3 levels detection and predicting the functionality of response to Pd1 therapy based upon being less or equal to a level compared to a cohort.
Response to arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following.
The reply asserts that Example 3 provides an increase in B&H3 CAF in breast cancer patients (p. 8). The reply asserts that the declaration filed 8/15/2022 shows a different in CAF B7H3 levels who respond and does not respond to anti PD1 treatment (p. 8). The reply asserts that the data of Figure A comprise responders vs non-responders using Welch two sample t test (p. 8). The reply asserts that on page 30 that the skilled person in the rt would be able to determine appropriate thresholds (p. 9). The reply asserts that it would be easy to differentiate between the quantification of the mRNA or protein to determine whether or not a CAF expressions the B7H3 markers and quantifications of CAFs expressing B7H3 (p. 9).
These arguments have been reviewed but have not been found persuasive.
The arguments asserts are directed to mRNA, however, the breath of the term level is not the same scope. Therefore the specification appears to teach that “level” can mean any qualification or quantification of a molecule. The reply points to example 2, however, example 3 is not directed to the claimed selection of patients based upon immune checkpoint inhibitor treatment. The declaration does provide that B7H3 CAFs mRNA expression is associated with PDI inhibitor treatment, however, the declaration does not provide guidance for any level and the functionality. Furthermore the reply has not provided evidence that even for mRNA and protein expression that these have the same relationship to the recited functionality. As such the specification does provide guidance for mRNA expression and functionality of PD1 inhibitor in at least lung and breast cancer, but does not describe the breadth of the claims.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached on 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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