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 1-150 have been cancelled. Claims 151-170 have been newly added.
Specification
The disclosure is objected to because of the following informalities:
The original sequence listing submitted 4/25/2024 had 518 sequences. The replacement sequence listing submitted 12/19/2024 had only 510 sequences. The second replacement sequence listing submitted 1/23/2025 had only 510 sequences. The specification references SEQ ID NOS: 511-518; however, they are no longer present in the sequence listing. See at least paragraphs [0300, 0302, 0304] and Tables 13-16
Clarification and appropriate correction is required.
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 151-153 and 158-170 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.
Claims 151-153 and 158-170 are not original claims. They were added by amendment on 12/19/2024. No specific basis was pointed to and none is apparent. At least for example, the abstract and original claim 1 disclose a multispecific antibody comprising an EpCAM binding domain and a CD47 binding domain. By comparison, claim 151 is directed to a multispecific antibody having an EpCAM binding domain and where no other antigen binding is recited. Claim 151 and its dependent claims are broader than the supporting disclosure.
The claims constitute new matter.
Claims 151-154 and 156-170 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 a multispecific antibody comprising an Fab having the CDRs recited in claim 151 that binds EpCAM and an scFv that binds CD47 or a multispecific antibody comprising an scFv having the CDRs recited in claim 151 that binds EpCAM and a Fab that binds CD47, does not reasonably provide enablement for all multispecific antibodies encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 151 requires only an EpCAM binding domain with six specific CDRs. However, the claim does not require that these CDRs be present within a known antibody framework such as an scFv or Fab. At least for example, the specification does not define a binding domain as including particular frameworks as evidenced by specification paragraphs [0010-0012]. That is, the multispecific antibody of claim 151 includes the six recited CDRs fused to each other in any order. This would not have been expected to have any EpCAM binding activity. In addition, claim 151 requires no particular antibody structure for other intended binding activities required to make it multispecific. Claim 154 does not require any particular structure for the CD47 binding domain.
The claims as written encompass highly variable structures that would not have been expected to result in a multispecific antibody having antigen binding activities in addition to EpCAM.
With respect to the method of treatment in claim 165-170, even for an enabled antibody, the breadth of the method claims would not have been enabled. Paragraph [0114] defines “treatment” as clinical intervention in an attempt to alter the natural course of the individual being treated, and can be performed either for prophylaxis or during the course of clinical pathology. Desirable effects of treatment include, but are not limited to, preventing occurrence or recurrence of disease, alleviation of symptoms, diminishment of any direct or indirect pathological consequences of the disease, preventing metastasis, decreasing the rate of disease progression, amelioration or palliation of the disease state, and remission or improved prognosis. In some embodiments, the molecules of the invention are used to delay development of a disease or to slow the progression of a disease.
Claims 165-170 do not require any particular therapeutic effect and must enable all therapeutic effects encompassed “treatment” as defined above. These claims encompass prevention and cure of any cancer as well as ameliorating any direct or indirect pathological consequences. There is no evidence of record or reason to believe that administration of any of the antibodies of claim 151 would prevent or cure any cancer. At least for example, a pathological consequence of lung cancer is loss of pulmonary function due to lung tissue destruction. There is no evidence of record or reason to believe that administration of any of the antibodies of claim 151 would reverse this tissue damage or restore lost pulmonary function. At least for example, a pathological consequence of prostate cancer, testis cancer, and ovarian cancer is infertility. There is no evidence of record or reason to believe that administration of any of the antibodies of claim 151 would restore fertility.
The scope of the claims is not enabled.
Independent claim 151 requires an EpCAM binding domain having HCDRs of SEQ ID NOS: 243, 244, and 245 and having LCDRs of SEQ ID NO: 297, 298, and 299. Dependent claim 152 recites a VH having at least 90% identity to SEQ ID NO: 407 or a VL having at least 90% identity to SEQ ID NO: 425. Note that the variability permitted would have to be outside the CDRs of claim 151; otherwise, the claim would not be properly dependent.
The prior art of record does not disclose any EpCAM antibodies with a VH having the HCDRs of SEQ ID NOS: 243, 244, and 245 and a VL having the LCDRs of SEQ ID NO: 297, 298, and 299.
The prior art of record does not disclose any EpCAM antibodies having a VH of SEQ ID NO: 407 and a VL of SEQ ID NO: 425.
The prior art of record and not relied upon is considered pertinent to applicant's disclosure.
Shi et al. (WO 2021/213511, of record, published 28 October 2021, filed 23 April 2021) discloses bispecific CD47/EpCAM antibodies. CD47 antibodies within the scope of the instant claims are disclosed. SEQ ID NO: 13 corresponds to instant SEQ ID NO: 123. SEQ ID NO: 14 corresponds to instant SEQ ID NO: 144. See at least instant claim 157. The inventors are Shi, Wang, Chen, Post, and Wong. All of these inventors are inventors of the instant application. The instant application has an additional inventor Fei. WO 2021/213511 is not valid prior art under 102(a)(2) as it is not by other. U.S. Application 17/996,837 is the 371 application of the PCT that published as WO 2021/213511. The 4/6/2026 claims in the co-pending ‘837 application are directed to multispecific EpCAM/CD47 antibodies that differ from those in the instant claims. The EpCAM sequences do not correspond. The corresponding PGPUB is 20230159663 (of record).
Mei et al. (WO 2021/078219, of record, published 29 April 2021, filed 23 October 2020) discloses anti-CD47 antibodies. SEQ ID NO: 7 contains instant SEQ ID NOS 1, 2, and 3. SEQ ID NO: 7 is not identical to instant SEQ ID NO: 123 but is at least 90% identical. SEQ ID NO: 8 contains instant SEQ ID NOS: 4, 5, and 6. SEQ ID NO: 8 is not identical to instant SEQ ID NO: 144 but is at least 90% identical. U.S. Application 17/770,039 (now U.S. Patent No. 12,410,250) is the 371 application of the PCT that published as WO 2021/078219. See also corresponding PGPUB 20220403023.
Conclusion
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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