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 .
DETAILED ACTION
Filing Receipt and Priority
The filing receipt mailed 10/03/2024 states that the instant application is a 371 of PCT/CN2022/132643, filed 11/17/2022.
The filing receipt also states that the application claims foreign benefit of CN 202111410807.9, filed 11/19/2021.
The certified copy submit 05/20/2024 supports the instant claims. Therefore, the effective filing date is 11/19/2021.
Information Disclosure Statement
The information disclosure statements submitted 05/20/2024 and 11/11/2025 have been considered.
Restriction/Species Election
Applicant’s election without traverse of the following Group and species is acknowledged.
Applicant has elected Group I, claims 16-23.
Applicant has further elected compound 5 in claim 20, and SGI-1027 as a second therapeutic component.
At examiner’s discretion, search and examination has been broadened to the follow structures.
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Claims 21 and 24-27 have been withdrawn being drawn to non-elected invention and species.
Claim Objections
Claim 16 is objected to as the compounds which are excluded (see below) are difficult to read. Examiner requests higher fidelity images.
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Rejections
Claim Rejections - 35 USC § 112(b)
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 22-23 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.
Indefiniteness
Claim 22 states “A pharmaceutical compositions, comprising (1) a compound according to claim 16, an optical isomer or a pharmaceutically acceptable salt thereof; and optional (2) pharmaceutically acceptable carriers, excipients or other active drugs.”
The use of “optional” here makes it unclear if the composition being claimed comprises just one component (1) and that component (2) is not required for the composition. A composition requires more than just the compound of claim 1. The pharmaceutically acceptable carriers, excipients or other active drugs cannot be “optional”.
Additionally, while the specification contemplates “pharmaceutically acceptable carriers, excipients, or other active drugs”, there is not an explicit listing of “carriers, excipients, or other active drugs.” There is not even an exemplary listing of possible “carrier, excipients, or other active drugs.” The specification does disclose the combination of compound 5 (AZT-A5) with SGI-1027 (ref). The instant specification also discloses compounds in DMSO (p. 48, para. 3). However, the terms “carriers”, “excipients” and “other active drugs” are undefined and one of ordinary skill would not know the metes and bounds of the claim.
Indefinite Language
Claim 23 states “The pharmaceutical composition according to claim 22, wherein, the pharmaceutical composition further comprises a second therapeutic component, and the second therapeutic component is a DNA methyltransferase inhibitor; preferably, the DNA methyltransferase inhibitor is SGI-1027.”
The phrase "preferably" renders the claim indefinite because it is unclear whether the limitations 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 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.
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.
Claim(s) 16-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vairavelu (Bioorganic Chemistry 54, 2014, 12-20) in view of Hu (Clin. Epigenet, 2021, 13:166, published 08/28/2021).
Regarding claims 16-20, Vairavelu on p. 14, table 1 teaches compound 3a, shown below.
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Compound 3a is most similar to instant compounds 1, 3, and 5, shown below.
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Compound 3a differs from compound 1 in that compound 3a is substituted with an ethoxy group where the instant compound 1 has a hydroxyl group. Similarly, compound 3a differs from compound 3 in that compound 3 has only hydroxyl groups where compound 3a has ethoxy groups. Compound 5 has a hydroxyl group and a methoxy group.
The compounds are homologs of each in that the difference amount to an addition or removal of 1-2 methylene groups. The MPEP section 2144.09, subsections I and II states:
I. REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In rePapesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In reDillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In reMay, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Regarding claim 22, Vairavelu in section 4.2.1 teaches solution for assay testing comprising the compound 3a and DMSO (“The compound were dissolved in DMSO and diluted in the respective medium containing 1% FBS”).
Additionally, Vairavelu on p. 17, Table 2 teaches that compound 3a has an IC50 value of 0.80 μM against HeLa (cervical) cancer cells.
Regarding claim 23, Hu on p. 4, sec. Nonnucleoside analogs, para 2 states “SGI-1027 can also impair cervical cancer cell and hepatocellular carcinoma cell propagation by dramatically increasing apoptotic cell death and cell cycle arrest.”
Both compound 3a above and SGI-1027 show efficacy as anti-cancer medications, specifically cervical cancer. Therefore, one of ordinary skill in the art would find it obvious to combine compound 3a or similar compounds with SGI-1027 in efforts to treat cervical cancer.
The MPEP section 2144.06 states:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to modify the compound 3a of Vairavelu to arrive at the instant compounds before the effective filing date with a reasonable assumption of success. One of ordinary skill could further combine the modified compound with SGI-1027 to treat cervical cancer or to induce apoptosis in cervical cancer cells with a reasonable assumption of success.
One of ordinary skill would be motivated to make the modification as one of ordinary skill would expect similar properties (efficacy in killing cervical cancer cells) for similar compounds. One of ordinary skill would be further motivated to make the combination with SGI-1027 as both the reference compound and SGI-1027 display efficacy against cervical cancer cells.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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