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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 20-35 have an effective filing date of 06 FEB 2020.
Status of Claims
Claims 20-35 are currently pending.
Claims 20, 32, and 35 are amended.
Claims 1-19 are canceled.
Claims 22, 25, and 31 are withdrawn.
Rejections Withdrawn
The rejection filed under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s amendments to claims.
The rejections filed under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s amendments to claims.
The rejections filed under 35 U.S.C. 103 are maintained.
Response to Arguments
In Applicant Arguments, dated 12/17/2025, Applicant asserts that Wang et al teaches away from the claimed invention - “Wang teaches that ‘over-expression of CSF1’ has ‘a positive impact on the survival of colorectal cancer patients’ and exhibits ‘inhibitory effects on macrophage infiltration and tumor growth’.” Furthermore “Wang teaches that administration of Ad-hCSF1 inhibits tumor growth.” Applicant further points out that while Wang et al teach a CSF1-neutralizing antibody, said antibody is not specifically used in the treatment of cancer.
MPEP 2145 states that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (‘a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.’)” In the Abstract, Wang et al. teach that “we found that CSF1 was over-expressed exclusively in colon cancer cells.” Furthermore as indicated by Applicant, Wang et al teach a CSF1-neutralizing antibody. Based upon these teachings, one of ordinary skill in the art would have been motivated to administer said CSF1-neutralizing antibody to colon cancer patients with colon cancer cells that over-express CSF1, because there would have been a reasonable expectation that such a method would provide a therapeutic benefit to said patients. Specifically there would have been a reasonable expectation that said antibody would bind to colon cancer cells that over-express CSF1 and recruit immune effector cells, such as NK cells, which would be expected to provide effector functions that result in the death of colon cancer cells that over-express CSF1.
With respect to Applicant’s evidence of unexpected results, following a review of said results, it is submitted that the data provided demonstrates an unexpected efficacy attributable to the simultaneous inhibition of CXCL12, PD-1, and CSF1; however said results are not commensurate in scope with the instant claims. For example the claims are drawn to co-administering any CXCL12 inhibitor, any CSF1 inhibitor, and any cancer immunotherapy agent to the subject; however Applicant’s evidence of unexpected results was obtained with a CXCL12 inhibitory antibody, a CSF1 inhibitory antibody, and a PD-1 inhibitory antibody. Applicant is informed that the rejection of the claims under 35 U.S.C. 103 may be overcome by amending the claims to recite treatment with a CXCL12 inhibitory antibody, a CSF1 inhibitory antibody, and a PD-1 inhibitory antibody.
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 DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642