DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 03/27/2026 are acknowledged.
Claims 1-4, 8-10, 12-15, 17-22 and 26-32 are pending.
3. Applicant’s election without traverse of the invention of Group I (claims 1-4, 8-10, 12-15 and 26-27) in the reply filed on 03/27/2026 is acknowledged. Applicant further elected the species of anti-IL-25 antibody comprising SEQ ID NOS: 3, 6, 7, 9, 12, 20, 25 and 41.
Claims 10, 12, 14-15, 17-22 and 28-32 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions and species.
Claims 1-4, 8-9, 13 and 26-27 are presently under consideration.
4. 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.
5. Claims 8 and 9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 8 and 9 are indefinite in the recitation of “functional” fragments of the respective domains, because it is unknown which functions are within the scope of the claims.
(ii) Claims 8 and 9 are further indefinite in the recitation of “derivatives” of the respective domains, because neither the nature nor the degree of derivation is defined.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Al-Daccak et al. (US 20190151346).
Al-Daccak teaches a method of treating cancer comprising administering an IL-17E inhibitor, wherein the cancer is colorectal cancer and wherein the IL-17E inhibitor is an anti-IL-17E antibody (e.g. claims 16, 21, 26, 29). IL-17E is an art-recognized synonym of IL-25. Accordingly, Al-Daccak’s teachings anticipate claims 1 and 2.
Claims 3 and 4 are included in the rejection, because Al-Daccak does not exclude patients with APC mutations, or patients with increased ILC2s in the tumor, which are therefore inherently present in the patient population.
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claims 1, 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Daccak et al. (US 20190151346) in view of Matthews et al. (US 20110250195; cited on IDS).
As addressed in section 7 above, Al-Daccak teaches a method of treating intestinal cancer comprising administering an inhibitory anti-IL-25 antibody.
While Al-Daccak does not specifically exemplify anti-IL-25 antibody comprising the amino acid sequences recited in claims 8-9 and 13, such antibody, and its advantages, are taught by Matthews.
Specifically, Matthews teaches humanized anti-IL-25 antibody RH2.5 comprising an R71V substitution in the heavy chain, which enhances binding to human IL-25 (e.g. [0182]). The antibody comprises a VH of SEQ ID NO: 2 and a VL of SEQ ID NO: 25, which are identical to SEQ ID NO: 25 and SEQ ID NO: 41, respectively, recited in instant claim 13 (see SCORE). Instant VH of SEQ ID NO: 25 comprises CDRs of SEQ ID NOS: 12, 3 and 20, and instant VL of SEQ ID NO: 41 comprises CDRs of SEQ ID NOS: 6, 7 and 9, recited in instant claims 8 and 9.
Matthews’ teachings that anti-IL-25 antibody RH2.5 is humanized and that the R71V substitution enhances binding to human IL-25 would have provided both the motivation and expectation of success in using this antibody in Al-Daccak’s treatment method. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
10. Claims 1 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Daccak et al. (US 20190151346) in view of Maecker et al. (US 9724413).
Al-Daccak teaches a method of treating intestinal cancer comprising administering an inhibitory anti-IL-25 antibody in combination with additional immunotherapeutic antibodies (e.g. claims 16, 19, 21, 26, 29).
While Al-Daccak does not specifically exemplify PD-1:PD-L1 inhibitors as additional immunotherapeutic antibodies, is was recognized by those skilled in the art before the effective filing date of the claimed invention that combining PD-1:PD-L1 inhibitors with specific cancer therapeutics is beneficial in treating various types of cancer, including colorectal cancer.
For example, Maecker teaches and claims a method of treating colorectal cancer comprising administering an anti-PD-L1 antibody in combination with other therapeutics. This would have provided both the motivation and expectation of success in combining a PD-1:PD-L1 inhibitor such as an anti-PD-L1 antibody with Al-Daccak’s treatment method. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1-4, 8-9 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 8658169 (cited on IDS) in view of Al-Daccak et al. (US 20190151346).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of US ‘169 in view of Al-Daccak.
US ‘169 issued from application USSN 13121898, which was published as US 20110250195 (Matthews et al.) described in section 9 above.
Claims 15 and 31 of US ‘169 claims recite an anti-IL-25 antibody comprising VH and VL of SEQ ID NOS: 2 and 25, respectively, which are within the scope of instant claims 8, 9 and 13, as explained in section 9 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this antibody in for treating colorectal cancer, as taught by Al-Daccak, for the same reasons as presented in section 9 above.
Claims 3 and 4 are included in the rejection for the same reasons as presented in section 7 above.
13. The following prior art is cited of record but not presently relied upon:
US 20110318353 teaches a humanized IL-25 antibody comprising variable regions of SEQ ID NOS: 9 and 2, identical to instant SEQ ID NOS: 25 and 41, respectively (see SCORE).
US 20100111968 teaches treating colorectal carcinoma comprising administering an inhibitory anti-IL-25 antibody (e.g. claims 8-11, 30-31 and [0046]).
14. Conclusion: no claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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