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 .
Claim Status
Claims 1-2 are pending.
Claims 1-2 have been examined.
Priority
This application is a CON of 17/799,552 08/12/2022 ABN
17/799,552 is a 371 of PCT/CN2020/075599 02/17/2020
foreign priority of CHINA 202010089778.X 02/13/2020
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/7/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-2 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” neuroblastoma, does not reasonably provide enablement for “preventing” neuroblastoma. 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. Wands factors are analyzed as shown follows.
(A) The breadth of the claims is much broader than the support of enabled examples and any disclosure in the specification.
(B) The nature of the invention is a method of administering the peptide of SEQ ID NO: 1 to treat neuroblastoma.
(C) The state of the prior art, American Childhood Cancer Organization, shows that there is no way to prevent these DNA changes or the development of neuroblastoma. In fact, at this time, there are no known ways to prevent most forms of childhood cancer (p2, para 3, Can Neuroblastoma Be Prevented?)
(D) The level of one of ordinary skill is low because there is no known way for one of ordinary skill in the art to prevent neuroblastoma.
(E) The level of predictability in the art is low because there is no evidence that neuroblastoma can be prevented.
(F) The amount of direction provided by the inventor is insufficient to support “preventing” neuroblastoma.
(G) The existence of working examples are insufficient to support “preventing” neuroblastoma.
(H) The quantity of experimentation needed to make or use the invention based on the content of
the disclosure is unknown because there is no way to prevent these DNA changes or the
development of neuroblastoma. In fact, at this time, there are no known ways to prevent most
forms of childhood cancer according to American Childhood Cancer Organization (p2, para 3, Can Neuroblastoma Be Prevented?).
Claim 1 fails to satisfy the criteria of Wands factors; thus, claim 1 is rejected under 112(a) and claim 2 is rejected as depending on claim 1.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Durden et al. (WO 01/37871 A1) in view of Canadian Cancer Society (https://cancer.ca/en/cancer-information/cancer-types/neuroblastoma/staging, January 2020) and Yang et al. (CN 104530199 A, English translation attached).
Claim 1 is drawn to a method of treating metastatic neuroblastoma comprising administering a therapeutically effective amount of SEQ ID NO: 1 (RGDMHSRGDHRDFQPV-LHLVALNSPLSGGM) to a subject.
Durden et al. teach a method of treating neuroblastoma (Abstract), including stage IV neuroblastoma (p4, line 13-15). Durden et al. teach the therapeutic peptide containing an active motif of RGD triplet (claim 11). Durden et al. further suggest the administered therapeutic peptide is preferable to inhibit angiogenesis and/or induce apoptosis in neuroblastoma (p12, line 11-12). Canadian Cancer Society is cited to show common knowledge of stage 4 of neuroblastoma known to have spread to other parts of the body, such as to distant lymph nodes, bone, bone marrow, liver, skin or other organs. This is called metastatic neuroblastoma (p2, 2nd last para).
Durden et al.in view of Canadian Cancer Society do not specify administration of the peptide of SEQ ID NO: 1 to inhibit angiogenesis to treat metastatic neuroblastoma.
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Yang et al. teach an anti-tumor polypeptide of SEQ ID NO: 1 with 100% homology to the instant SEQ ID No: 1 (p11, SEQ ID No: 1; claim 1) as shown follows. Yang et al. show the peptide of SEQ ID No: 1 comprising an underlined integrin inhibitor of RGD triplet. Yang et al. further teach the polypeptide SEQ ID No: 1 inhibits angiogenesis activity and inhibits tumor cell proliferation activity used as an antitumor drug (p15, para 2). Because Yang’s SEQ ID No: 1 is not only comprising a RGD triplet as an integrin inhibitor but also capable of inhibiting angiogenesis used as an antitumor drug consistent with Durden’s teaching of administered anti-tumor peptide to treat neuroblastoma(e.g., stage 4 metastatic neuroblastoma), one of ordinary skill in the art before the effective filing date of this invention would have found it obvious to administer Yang’s antitumor peptide of SEQ ID No: 1 to treat Durden’s metastatic neuroblastoma.
With respect to claim 2, Durden et al. teach a therapeutically effective amount of an RGD based anti-tumor peptide per body weight may be optimized from about 0.1 mg/kg to about 3 mg/kg in one or more dose administrations daily (p12, line 17-18), reading on claim 2. See MPEP 2144.05 (I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Durden et al. in view of Canadian Cancer Society with (ii) Yang et al. because (a) Durden et al. teach administration of an RDG-containing peptide able to inhibit angiogenesis to treat stage IV neuroblastoma (p4, line 13-15; p12, line 11-12; claim 11) and (b) Yang et al. show the peptide of SEQ ID No: 1 comprising an integrin inhibitor of RGD triplet and teach the polypeptide SEQ ID No: 1 inhibits angiogenesis activity and inhibits tumor cell proliferation activity used as an antitumor drug (p15, para 2). The combination would have reasonable expectation of success because both Durden et al. and Yang et al. teach administration of a therapeutic peptide to inhibits angiogenesis activity to treat cancers. Canadian Cancer Society is cited to show common knowledge of stage 4 of neuroblastoma known to be metastatic neuroblastoma (p2, 2nd last para).
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
22-August-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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