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 .
Claims 1-87 and 97 are cancelled.
Claims 88-96 and 98-107 are pending.
Applicant’s election without traverse of Group I, claims 88-104, in the reply filed on 07/12/2024 is re-acknowledged.
Claims 88-96 and 98-104 are allowable. Claims 105-107, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions (Groups I-III), as set forth in the Office action mailed on 06/30/2025, is hereby withdrawn and claims 105-107 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 88-96 and 98-107 are under examination on the merits.
Priority
This application is a CON of US Patent Application No. 17/266,250 (US Patent No. 12084497), filed 02/05/2021, which is a 371 of PCT/US2019/045654, filed 08/08/2019, which claims benefit of US Provisional Application No. 62/715,903, filed 08/08/2018.
Withdrawn Objections/Rejections
The objections to the drawings for failure to comply with sequence rules are withdrawn in light of the corrective replacement drawings dated 02/25/2026. The rejections for lack of written description of the modified signaling agent are withdrawn in response to the claim amendments dated 02/25/2026 which narrow the genus of modified signaling agents encompassed by the claims to what is described. The rejections for double patenting are withdrawn in light of the acceptance of Applicant’s filed terminal disclaimer dated 02/25/2026.
Maintained-Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color (see figures 2A, 2B, and 3). Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
New-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.
Claim 105 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating melanoma, does not reasonably provide enablement for treating other cancers or for preventing any cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP 2164.01(a) states that in order to determine compliance with the enablement requirement, the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.”
These factors include but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims
Claim 105 is broadly directed to a method for treating or preventing cancer.
The nature of the invention
Claim 105 is broadly directed to a method for treating or preventing cancer. The claims are directed to biological subject matter which is understood to be complex and often unpredictable.
The state of the prior art
The state of the prior art supports that the heterogeneity of cancers and lack of a universal cure (see Allison et al (Heterogeneity and Cancer, retrieved from: https://www.cancernetwork.com/view/heterogeneity-and-cancer (2014) at exemplary paragraph 1 of the Introduction) and American Cancer Society (Can Cancer be Cured?, American Cancer Society, retrieved from: https://www.cancer.org/cancer/understanding-cancer/can-cancer-be cured.html)(2021)). Likewise, the prior art supports that there is no sure way to prevent every cancer (see for example, American Cancer Society (How to Interpret News About Ways to Prevent Cancer (2023); obtained from: https://www.cancer.org/healthy/cancer-facts/how-to-interpret-news-about-ways-to-prevent-cancer.html).
The level of one of ordinary skill
As the claims are directed to prevention or treatment of cancer, the artisan is presumed to be highly skilled, tending to have an advanced degree (such as a Ph.D. or an M.D.).
The level of predictability in the art
The art supports that cancer represents a genus of highly heterogenous diseases affecting different tissues and driven by different factors such that no universal cure or preventative is known in the art. This supports a high level of unpredictability in the art for treating and/or preventing cancer.
(F) The amount of direction provided by the inventor
Applicant does not provided a closed definition of what cancer is to be treated and does not provide convincing evidence that all cancers would be treated. The only cancer that Applicant provides evidence for treating is melanoma through examples using a B16 murine model (see for example, Example 2 at pages 202-203 and Example 5 at pages 205-206 of the instant specification).
The existence of working examples
Applicant provides 2 examples showing an anti-tumor effect of the claimed anti-SIRP1α constructs in murine B16 models (melanoma; see for example, Example 2 at pages 202-203 and Example 5 at pages 205-206 of the instant specification).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
The case is directed to biological subject matter, which is by nature complex. There are no working example provided for treating cancers other than melanoma and the state of the art fails to step in to provide enablement where the instant disclosure is lacking. There are no examples provided for preventing any type of cancer and the state of the art fails to step in to provide enablement where the instant disclosure is lacking. The artisan would be forced into burdensome experimentation so as to effectively invent what applicant only suggests may be possible.
Thus, in light of total disclosure in view of the state of the art, the claims are only deemed enabled for treating melanoma.
Conclusion
Claims 88-96, 98-104, and 106-107 are allowed for reasons noted in the Notice subsection below.
Claim 105 is rejected and is not allowed.
Notice:
The CDR1-3 combinations recited in instant claim 88, and the recombinant nucleic acids encoding said CDR1-3 combinations (recited by claims 106-107), remain free from the art and allowable, subject to resolution of the above noted deficiencies, for reasons made of record in the non-final office action dated 08/01/2023 issued as part of the prosecution of copending US application 17/266,250 (now US Patent 12084497) and in the in the notice of allowance dated 01/04/2024 issued as part of the prosecution of copending US application 17/266,250 (now US Patent 12084497) (as indicated in the previous office action dated 11/26/2025).
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.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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