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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Claims 1-40, 68-72, 74 and 101-105 are pending. Claims 1-11, 14-23, 28-39, 68, 69, 71, 74, 102 and 104 were under consideration in the prior Office action to the extent that they encompassed elected species “C”. Claims 12, 13, 24-27, 40, 70, 72, 101, 103 and 105 were withdrawn from consideration in the prior Office action as not reading on the elected species “C”. Claims 9-11, 14-23, 28-39 were 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 in the previous Office action.
The rejection of claims 1, 2, 3, 4, 5-8, 68, 69, 71, 74, 102 and 104 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The rejection of claims 1-8, 68, 69, 71, 74, 102 and 104 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of applicant’s amendment.
As all rejections have been overcome in claims 1-11, 14-23, 28-39, 68, 69, 71, 74, 102 and 104 to the extent that they encompass elected species “C”, the next species will be examined: “(vi) free compound of claim 40”. Thus, claims 1-39, 68, 69, 71, 74, 102, 104 and 105, directed in part to non-elected species, are withdrawn from consideration. Claims 40, 70, 72, 101, 103 and 105 are examined on the merits.
Claims 72 and 105 are objected to because of the following informalities: the typographical error of “castrate-resistant prostrate cancer” rather than “castration resistant prostate cancer”. Appropriate correction is required.
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 40, 70, 72, 101, 103 and 105 are 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.
(A)Claim 40 is vague and indefinite in the recitation of a “first N-terminal amino acid residue”. It is unclear how “first” as modifying the “N-terminal amino acid residue” affects the metes and bound of the claim. It is further noted that “N-terminal amino acid residue” does not provide structural information for how the amino acid is connected to the ring.
(B) The recitation of “T” in the last phrase of claim 40 lacks specific antecedent basis within the claim. For purpose of examination, the last phrase of claim 40 will be read as “wherein Formula I” rather than “wherein T”.
(C)Claim 40 recites, in part, that “T” (formula I) is not tubulysin A-I, The specification fails to provide any structural information about tubulsin A-I. The prior art (Toader et al, JMC, 2016, Vol. 59, pp. 10781-10787, reference of the IDS filed 11/02/2021) refers to tubulysin A-I as
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wherein R1 is alkyl or alkenyl and R2 is H or OH (Figure 1), Thus tubulysin A-I refers to a genus of compounds, not a specific compound. Claim 40 recites “tubulysin A-I” in the singular. It unclear if applicant intends on excluding the entire genus of compounds, or just a sub-set or a single compound from the genus of tubulysin A-I.
(D)Claims 72 and 105 are vague and indefinite in the recitation of malignant gliomas, astrocytomas, leimyosarcomas and lymphomas. It is unclear if the subject must have multiple cancers of malignant gliomas, astrocytomas, leimyosarcomas or lymphomas because these species are listed in the plural, in contrast to renal cell carcinoma, pancreatic carcinoma, head and neck cancer, prostate cancer, castrate-resistant prostate cancer, osteosarcoma, colorectal cancer, gastric cancer, mesothelioma, malignant mesothelioma, multiple myeloma, ovarian cancer, lung cancer, small cell lung cancer, non-small cell lung cancer, synovial sarcoma, thyroid cancer, breast cancer, PRLR positive (PRLR+) breast cancer, melanoma, acute myelogenous leukemia, adult T-cell leukemia, bladder cancer, cervical cancer, cholangiocarcinoma, endometrial cancer, esophageal cancer, glioblastomata, Kaposi's sarcoma, kidney cancer, liver cancer, MFH/fibrosarcoma, nasopharyngeal cancer, rhabdomyosarcoma, colon cancer, stomach cancer, uterine cancer, residual cancer, and Wilms' tumor which are recited in the singular.
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 40, 70, 72, 101, 103 and 105 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.
Claim 40 requires, in part that the compounds of formula I do not include “tubulysin U-X”. Neither the specification nor the prior art provides a written description of tubulysin U-X. The prior art describes the structures of tubulysins A, B, C, D, E, F, G, H, I, U, V, W, X and Z, but not tubulysin “U-X”. One of skill in the art would not be able to envisage the structure of tubulysin U-Z and thus, would not be able to determine if a given tubulysin of formula I belonged in the genus of compounds claimed. One of skill in the art would reasonably conclude that applicant was not in possession of the compounds of formula I at the time of filing.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 40, 70, 72, 101, 103 and 105 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gingipalli et al (WO2015/157594, reference of the IDS filed 3/02/2022).
Gingipalli et al disclose compounds Ii to Iiii (claims 6-8 of ‘594):
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Compounds Ii-Iiii meet the limitations of claim 40 wherein R1 is C1-C10 alkyl, R10 is C1-C5 alkyl, Q is CH2; R2 is alkyl; R3 is -OC(O)C1-C5 alkyl; R4 is hydrogen, R5 is C1-C5 alkyl and R6 is -OH. Gingipalli et al disclose and pharmaceutical compositions comprising said compounds (claim 34 of ‘594), wherein the pharmaceutical compositions comprise pharmaceutically acceptable carriers, including, e.g., water, ion exchangers, proteins, buffer substances, and salts; and that the carrier can be a solvent or dispersion medium (page 18, lines26-31) which meets the limitations of instant claim 101.
Gingipalli et al disclose a method of treating cancer by administering to a subject in need thereof an effective amount of the compounds of Ii-Iiii, (claim 36 of ‘594) or the pharmaceutical composition of the compounds Ii-Iiii (page 5, lines 1-2 and page 18, lines 22-26) which meets the limitations of claims 70, and 103, wherein the cancer is renal papillary carcinoma, pancreatic cancer, head and neck cancer, prostate cancer, colorectal cancer, gastrointestinal cancer, esophageal cancer, or endometrial carcinoma which meets the limitations of claims 72 and 105.
Claims 40, 70, 72, 101, 103 and 105 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cong et al (US 2014/0227295, reference of the IDS filed 11/02/2021).
Cong et al disclose compounds comprising a structure of formula I, including compounds I-8 and I-9 (claim 1 of ‘295 and page 10):
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Compounds I-8 and I-9 meet the limitations of claim 40 for R1= C1-C6 alkyl; Q= CH2; R2 is alkyl; R7 is NRaR7b, wherein R7a and R7b are hydrogen; R3 is -OC(O)N(H)C1-C10 alkyl; R4 is hydrogen, R5 is C1-C5 alkyl and R6 is -OH.
Cong et al disclose a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (claim 19 of ‘295) which meets the limitation of claim 101. Cong et al disclose a method of treating a cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a compound of claim 1 (claim 15 of ‘295) which meets the limitation of instant claim 72. Cong et al disclose practice of the methods and use of compositions described herein will result in a reduction in the size or number of the cancerous growth and/or a reduction in associated symptoms (where applicable) (paragraph [0170]) which meets the limitations of claim 103. Cong et al disclose that the cancer can be renal, lung, gastric, or ovarian cancer which meets the limitations of claim 105.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643