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 .
Status of the Claims
Claims 1-12 and 15-22 are pending and being examined on the merits.
Objections/rejections withdrawn
All previous rejection of claims 13 and 14 are moot in view of claim cancellation.
Objection to the specification for sequence noncompliance issues are withdrawn in view of amendments to the specification.
Previous rejection of claims 17-19 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of claim amendments.
Previous rejection of claims 4, 7, 8, 11, 12, 14 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matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant) is withdrawn in view of claim amendments.
Previous rejection of claim 6-20 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of claim amendments.
Attempts were made to contact Applicant for an examiner’s amendment, but the phone number provided in the latest response (November 12, 2025) is out of service.
New Rejections Necessitated by Claim Amendments
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 17-19 are 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 cancer comprised of administering the PD-L1 single domain antibody of claim 1, does not reasonably provide enablement for preventing cancer comprised of administering the PD-L1 single domain antibody of claim 1. 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue or reasonable experimentation. (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include:
(A) The nature of the invention;
(B) The breadth of the claims;
(C) The amount of direction provided by the inventor;
(D) The existence of working examples;
(E) The state of the prior art;
(F) The level of predictability in the art;
(G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure and
(H) The level of one of ordinary skill. While all of these factors are considered, a sufficient amount for amount for a prima facie case are discussed below.
The nature of the invention
The claims are drawn to a method for treating or preventing cancer comprising administration of a PD-L1 single domain antibody comprising the amino acid sequences of SEQ ID NOs:6, 15, and 25; SEQ ID NOs:7, 16 and 26; SEQ ID NOs:8, 16, and 27; SEQ ID NOs:9, 17, and 28; SEQ ID NOs:7, 16 and 29; SEQ ID NOs:10, 18 and 30; or a fusion protein comprising the PD-L1 single domain antibody.
The breadth of the claims
The claim is broad in that it encompasses the prevention of all cancers, including lung cancer, melanoma, gastric cancer, ovarian cancer, colon cancer, liver cancer, kidney cancer, bladder cancer, breast cancer, classic Hodgkin lymphoma, hematological malignancies, head and neck cancer or nasopharyngeal cancer.
Instant specification defined preventing as:
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The term prevent includes “preventing the occurrence or recurrence of cancer.
The amount of direction provided by the inventor/the existence of working examples
The instant specification disclosed administering the PD-L1 single domain antibodies reduced colon cancer tumor growth in mice (example 9; figure 4).
The examples provided do not demonstrate the prevention of cancers. Additionally, the disclosure does not discuss, or demonstrate through working examples, a method that could be used to determine that tumors were prevented comprised of administering the claimed PD-L1 single domain antibodies.
The state of the art/the level of predictability in the art
There are no methods to establish that the occurrence of tumors can be prevented using the claimed therapeutic method in the prior art. Additionally, there are no methods that could be used to identify subjects who would have predictably developed tumors in order to determine that tumors were prevented using the claimed methods.
One of ordinary skill in the art would understand that there are risk factors associated with certain cancers, and that an individual can lower their risk of cancer(s) but there is no sure way to prevent cancer, as evidenced by the American Cancer Society (Cancer Risk and Prevention webpage, 21 Mar 2025).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Studies regarding the treatment and prevention of cancer are underway to improve early detection and provide better treatments. However, based on the instant disclosure and prior art, there is no known method through which one of ordinary skill in the art would have been able to reliably predict which subject(s) would have predictably developed tumors in order to determine that the tumors were prevented using the instant claimed methods. Therefore, in order to practice the invention as claimed, one of ordinary skill in the art would have to perform undue experimentation to develop a method which accurately predicts tumor prevention.
Conclusion
Applicant is enabled for treatment of cancer comprised of administering the PD-L1 single domain antibodies of claim 1. However, in view of the Wands factors as discussed above, one of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the instant claimed invention.
Double Patenting
Claim 1-12 and 15-20 remained, and new claims 21 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 6-9, 11-13, 15-17, 19-22 of copending Application No. 18277996 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because.
The reference Application provides "fusion" protein comprising anti-PDL1 single domain antibody fusion proteins with, in particular embodiments, composition which is identical to the instant claims. Fusion proteins of reference patent represent species of the instant claimed fusion protein and/or antibody-fusion protein-immunoconjugates as components which bind to effector cells for example TGF-beta, and an anti-VEGF binder as for example a "functional molecule" linked to the single domain antibody or fusion protein of the instant claims. As the reference claims describe the instant single domain antibody it would like-wise be obvious to provide unconjugated single domain antibody of the instant claims as a required "building block" for the reference fusion protein. Regarding instant claims 20-22, the reference claims are directed to a method of treating tumors, including head and neck cancer, comprising the PD-L1 single domain antibody (claim 17).
Conclusion
No claims allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE WU whose telephone number is (571)272-5205. The examiner can normally be reached M-F 9-5PM.
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, Bonnie Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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