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 Rejections - 35 USC § 112
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 43 is 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), regards as the invention.
Regarding claim 1, the phrase "a compound depicted in any one of FIG. 1-4" renders the claim indefinite because it is unclear the structural limitations of figures 1-4. It is improper referring to figures to represent compound structures or names in a claim. Ultimately, the metes and bounds of the claim is unclear.
Regarding claim 43, the phrase "n" renders the claim indefinite because it is unclear what are the limitations of n. It is unclear if n is an integer of o or and integer above 0, as being above 0 and 0 changes the structure of Formula (IV). Ultimately the metes and bounds of the claim is unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 12 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bompiani et al. High-Throughput Screening Uncovers Novel Botulinum Neurotoxin Inhibitor Chemotypes, ACS Comb. Sci., June 2017, Pages 461-474.
Regarding claim 12, Bompiani teaches classes of inhibitory compounds for the treatment of botulism comprising compound
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and a pharmaceutically acceptable excipient (abstract, Pg. 464), wherein for the Benzimidazole scaffold R is a substituted aryl and substituted arylalkyl as shown in table 5 compounds 42-68 (relevant to claim 12).
Claim 20 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Durrenberger et al. (US 20120196853 A1).
Regarding claim 20, Durrenberger teaches pharmaceutical compositions that are hepcidin antagonists for the treatment of disorders in iron metabolism, such as, in particular, iron deficiency diseases and anemias comprising Formula (I)
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and a pharmaceutically acceptable excipient (para. 0051 and 0302). Of the above compound Durrenberger teaches embodiment
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,
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,
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. The above compounds read to claim invention of R1 as aryl, substituted aryl, heteroaryl, R2-R3 and R5-R6 as H, R4 as H or alkoxy and R7 as H or a halogen.
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 1-8, 11, 58-63 and 68-71 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2021102370 A1).
Regarding claims 1-8, 11, 58-63 and 68-71, Chen teaches a method for the treatment of diseases, disorders and conditions selected from a list which consist of adenocarcinoma (relevant to claims 58-59) and diabetes (relevant to claims 62-63) by route of oral, intramuscular, intraperitoneal and intravenous (relevant to claims 61 and 69) (Pg. 19-20, 204) comprising administration of Formulas
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(relevant to claim 3-8 and 11) (Pg. 9) and
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(Pg. 12) and a pharmaceutically acceptable carrier (Pg. 203). Chen additionally teaches the above compounds in combination with an additional agent of insulin or cancer chemotherapeutic agent to treat the above conditions (relevant to claims 60 and 70-71) (Pg. 209), and the effective dose of the compound varies based depending on the diseases being treated, the severity of the disease, the route of administration, the sex, age and general health condition of the subject, excipient usage, the possibility of co-usage with other therapeutic treatments (Pg.208).
Therefore, I would have been obvious to someone of ordinary kill in the art at the time of filling to have developed the claimed structure of claim 1 in which R1 is a thiophene to an individual who has a body mass index greater than 30kg/m2. One would have been motivated to do so from the teachings of Chen of Formula (IIIh), in which R9 is a 5–10-member heteroaryl which consist of thiophene. One would also be motivated to treat an individual who has a body mass index greater than 30kg/m2 to test the effectiveness of the therapeutic on different patient populations. There is a reasonable expectation of treating the above conditions comprising the above compound Formula (IIIh) taught by Chen wherein to claimed invention R1 is a thiophene to an individual who has a body mass index greater than 30kg/m2.
Allowable Subject Matter
Claims 9-10, 55-57 and 73-74 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627