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 .
Response to Amendment
In the amendment filed on 11/05/2025 Applicant cancelled claims 2 and 3 and amended claims 1 and 4-10. Claims 1 and 4-10 are currently examined.
Withdrawn claim rejections
Claim Rejections - 35 USC § 102
The rejection of claims 1-10 under 35 U.S.C. 102(a)(1) as being anticipated by Yamano et al. is withdrawn in view of the amendments to the claims.
The rejection of claims 1-10 under 35 U.S.C. 102(a)(1) as being anticipated by Kurosawa et al. is withdrawn in view of the amendments to the claims.
New and maintained claim rejections necessitated by amendment
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 and 6-10 remain 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention for reasons of record.
The independent claim 1 is drawn to a method for treating therapeutic drug for carcinomatous peritonitis in a patient, comprising administering to the patient a therapeutic drug comprising an antibody which recognizes the amino acids at positions 629 to 633 of a human transferrin receptor.
The analysis made in the previous Office action is pertinent to the amended claims because still, by defining the antibody used in a method of treatment just shifts the focus on the lack of the problem of lacking a representative number of species from the genus of antibodies to the genus of methods of treatment. Thus, by describing a method of treatment using just a fubnctionally described antibody and presenting just one antibody to be used (the monoclonal antibody TfR436), is not representative for the genus of methods of treatment claimed with all the antibodies that potentially bind, inter alia, to the amino acids at positions 629 to 633 of a human transferrin receptor.
One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 1 and 4-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the administration regimen, the dosage, the route of administration, length of treatment and metrics to assess the efficacy of the treatment.
As such, the metes and bounds of the claims could not be determined.
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.
Claims 1 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kurosawa et al. (U.S. Pat. 9,593,165, which represents the Natl. Stage entry of the WO2014/073641 cited previously) in view of Castro-Mesa et al. (Bases and foundations of the treatment of peritoneal carcinomatosis: Review article. Medicina Universitaria 18, 98-104, 2016).
The claims are drawn to a method for treating therapeutic drug for carcinomatous peritonitis in a patient, comprising administering to the patient a therapeutic drug comprising an antibody which recognizes the amino acids at positions 629 to 633 of a human transferrin receptor. In dependent claims the antibody is further described by exact structure and the method is claimed for treatment of carcinomatous peritonitis that occurs in combination with cancer which causes the carcinomatous peritonitis. The route of administration of the drug is intraperitoneally.
The reference describe using an anticancer drug that targets a transferrin receptor to treat a disease caused by cancer cells that express said receptor. Antibody TfR436 (same as the antibody instantly claimed) and other fully humanized anti-human transferrin receptor antibodies were used to treat cancer by inhibiting the survival and growth of TfR expressing cancer cells (examples 8 and 10). Also, the reference indicated that the administration may be done intraperitoneally (col. 20, line 67).
The reference is silent about treating carcinomatous peritonitis per se.
Castro-Mesa et al. disclosed that peritoneal carcinomatosis refers to a shedding or tumor that spreads to the peritoneal serosa and structures of the abdominal cavity. It is an entity with a poor prognosis. Several conditions can cause this, the most common being colon, rectum, ovary, stomach or appendix cancers, including peritoneal pseudomyxoma, among others. The abdominal cavity invasion is considered a clinical stage IV. For a long time life expectancy of this entity was very short.
Given the fact that peritoneal carcinomatosis refers to a shedding or tumor that spreads to the peritoneal serosa and structures of the abdominal cavity and because Kurosawa et al. showed that their antibody TfR436 was used to treat cancer by inhibiting the survival and growth of TfR expressing cancer cells, it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have combined the teachings of the two reference and treat carcinomatous peritonitis with the TfR436 with a reasonable expectation of success. This is because the etiology of the peritoneal carcinomatosis was underscored by Castro-Mesa et al. By inhibiting the survival and growth of cancer cells within the peritoneum using the antibody of Kurosawa et al. a skilled artisan would have achieved the method of treatment instantly claimed.
Conclusion
No claims are 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 ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647