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 Application
Claims 1-20 are pending and are examined herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 1-20 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 method of treating cancer by administering neocuproine, wherein the cancer is a mutated form of melanoma, gastrointestinal, lung, pancreas, and breast cancer, does not reasonably provide enablement for any and all cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547, the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the breadth of the claims; (4) the amount of direction or guidance presented; (5) the predictability or unpredictability of the art; (6) the relative skill of those in the art; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The Nature of the Invention: The rejected claims are drawn to an invention which pertains to a method of treating any and all cancers by administering neocuproine, wherein the cancer is characterized by cells having the claimed mutation.
(2) State of the Prior Art: The state of the art regarding treating cancer with neocuproine is limited to lymphoma (Mohindru) and colon cancer (Gaal).
(3) Breadth of Claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The claims encompass treating any and all cancers by administering neocuproine.
(4) Guidance of the Specification: The guidance of the specification is limited to the following cancers: melanoma, gastrointestinal, lung, pancreas, and breast cancer (Figures 3, 5-7, 10, 11-13, Example 1, Table 1).
(5) The Predictability or Unpredictability of the Art: The invention is directed to treating any and all cancers by administering a single active agent (neocuproine).
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to effectively treat any and all cancers by administering a single active agent (neocuproine).
(7) Working Examples: The specification is limited to treating following cancers: melanoma, gastrointestinal, lung, pancreas, and breast cancer.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the method of treating any and all cancers by administering neocuproine. Nor does it provide information to practice the claimed invention, absent undue experimentation. Genetech, 108 F. 3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5, 15, 20 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claims 3-5, 15, 20, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 4, 13-18 are rejected under 35 U.S.C. 103(a) as being obvious over Mohindru et al. (“2,9-Dimethyl-1,10-Phenanthroline (Neocuproine): A Potent, Copper-Dependent Cytotoxin with Anti-Tumor Activity,” Biochemical Pharmacology, 1983, vol. 32, no. 23, 3627-3632, of record) in view of Coffey et al. (WO 2019/213589).
The instant claims are directed to a method of treating cancer by administering neocuproine.
Mohindru et al. teach that 2,9-Dimethyl-1,10-Phenanthroline (Neocuproine) is a copper-specific chelator, showed significant chemotherapeutic activity against the P388 murine lymphoma (abstract).
However, Mohindru et al. fail to disclose the claimed mutations and second compounds.
Coffey et al. teach that lymphoma can express KRAS mutations (page 3, lines 17-20). Treatment can also be combined with inhibitors of Raf, for example dabrafenib (page 30, lines 8-25), and imatinib (page 33, line 13).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have treated lymphoma expressing a KRAS mutation by administering neocuproine in combination with dabrafenib or imatinib, as taught by Mohindru and Coffey et al.
A person of ordinary skill in the art would have been motivated to have treating lymphoma expressing a KRAS mutation because Mohindru et al. teach that neocuproine is useful in treating lymphoma, in general. Therefore, one of ordinary skill in the art would have expected a similar reasonable expectation of success for treating a specific type of lymphoma, specifically lymphoma expressing a mutation. Furthermore, a person of ordinary skill in the art would have been motivated to combine neocuproine with dabrafenib or imatinib because both are individually known to be useful for treating lymphoma. Therefore, the skilled artisan would have had a reasonable expectation of success in treating lymphoma by the therapeutically additive effect of two active agents used for the same purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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