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
The office acknowledges Applicants filing of the claim amendments on 5/31/2024 and the response to the restriction election on 5/12/2026. Claims 1-4, 6, 8-15, 17, 19-20, 22-24 are pending. Claims 5, 7, 16, 18, 21 have been cancelled. Applicants have elected Group I, claims 1-4, 13-15 with traverse. Applicants have elected provisionally with traverse compound (c) of formula I and compound (f) of formula II with traverse. Claims 1-4, 13-15 read on the elected group and species. Claims 6, 8-12, 17, 19-20, 22-24 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The restriction requirement is made Final. The elected compounds compound (c) and compound (f) are free of prior art. Therefore the scope of the subject matter was extended or broadened pursuant to MPEP 803.02. The following species will be examined: compound (d) and compound (b). The claims corresponding to the elected subject matter are 1-4, 13-15 and are herein acted on the merits.
Application Priority
This application filed on 05/31/2024 is a National Stage entry of PCT/CN2022/ 136153, International Filing Date: 12/02/2022, 18715132 Claims Priority from Provisional Application 63286100, filed 12/06/2021.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel-Hoffmann et al. (J Antimicrob Chemother 2012; 67: 2165–2172) and Tung (Future Medicinal Chemistry, 2016, 85, 491-494).
Daniel-Hoffmann et al. teaches organo-tellurium compound AS 101 and its bactericidal activity on Enterobacter cloacea (see title, objectives, methods and results, p 2165, Figure 1). The reference teaches the pharmaceutical composition of AS101 as solution in PBS at pH 7.4 (see p 2166, col. 1, para 3).
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The instantly claimed compound (d) is (in particular, in the proviso wherein the Z is not H, while the X is O) wherein Z is D when X is O. However in compound, AS101 it is H in all the Z position.
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The difference between the two compounds is the substitution of Z (in the claimed formula I) and the deuterated substitution is not tuaght.
Daniel-Hoffmann do not disclose the deuterated compound(s) of claim 1.
Tung teaches that deuterium modified or deuterated compounds retain the potency and selectivity of their hydrogen analogs. Starting with an existing drug, hydrogen can be replaced by deuterium at specific sites without otherwise modifying the drug scaffold. Selectively incorporating deuterium as a targeted hydrogen replacement substituent in otherwise unchanged drug molecules, has been adopted by several companies, and has seen considerable progress in recent years. A number of deuterated compounds have shown several advantages. For example, AVP-786, due to its deuterium stabilization, a much lower amount of quinidine was needed to reach an equivalent plasma exposure of the active species. For SD-809, deuterium incorporation markedly altered pharmacokinetics, increasing the half-life from 4.8 to 8.6 hours and approximately doubling the AUC exposure. As a result, SD-809 is dosed less frequently, twice- versus three-times daily, and has a substantially smaller peak/trough ratio, which provides a much more benign side effect profile. Similarly, deuterated CTP-656 provided about 3.5-fold greater AUC exposure and about a third longer plasma half-life. Tung concludes that deuterium is now a validated component of the medicinal chemistry repertoire (pages 491-493).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have performed deuterium substitution, as taught by Tung, at position Z, as taught by Daniel-Hoffmann. A person of ordinary skill in the art would have been motivated to substituted deuterium at position Z because of the reasonable expectation of maintaining or enhancing the potency and selectivity of their hydrogen analogs. Thus claims 1, 3 are obvious over the prior art teachings. As to claim 2, Daniel-Hoffmann teach a pharmaceutical composition comprising AS101 and further teaches its bactericidal activity. Hence a skilled artisan would have found it obvious to arrive at the claimed pharmaceutical composition of the similar compound, herein compound (d) with a reasonable expectation of success and to check its bactericidal activity.
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(s) 13-15 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Dutton et al. (Chem Eur J 2009, 15, 10263-10271) as evidenced by Rowe et al. (Pharmaceutical Excipients, Edited by Rowe et al, 2009).
Dutton et al. teach the following tellurium compound.
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(p 12866).
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(See p 10265, col. 2, last para).
Rowe et al. teach the applications of acetone in pharmaceutical formulation or technology. Further disclosed is that it is used as a solvent in topical preparations, formulating tablets etc. (See p 7, col. 1, bullet point 7).
Dutton anticipates claims 13 and 15 by teaching the tellurium bipyridine substituted compound (b) of claim 15 (See above Dutton, compound 8Cl). As to claim 14, Dutton teaches a composition comprising compound (b) in acetone. As evidenced by Rowe et al., acetone is a pharmaceutical excipient. Hence Dutton’s teaching of compound (b) in acetone addresses the pharmaceutical composition of the compound.
Note: Dutton also teaches the compound,
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and the structure is:
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Claim(s) 13, 15 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Couch et al. (Inorganic, Physical, Theoretical (1967), (11), 1813-17).
Couch teaches the following compound Tecl4bipy, TeBr4bipy (See compounds 5, 10 in Tables 3 and 4).
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Thus claims 13 and 15 are anticipated.
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 2, 3, 14 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.
Claims 2 and 14 recite the limitation of ‘’wherein the compound further forms a pharmaceutical composition by combining with its pharmaceutical salts” (lines 2-3).
The preamble is to a compound and the compound cannot further comprise to form pharmaceutical composition by combination. A claim to a chemical compound cannot be open-ended, but must be claimed with precision. This rejection can be overcome by amending the claim to ‘A pharmaceutical composition comprising the compound of claim 1”.
Note: For examination purposes the claims have been examined based on the interpretation that the claims are to a pharmaceutical composition comprising the compound.
Claim 3 is directed to:
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.
Claim 3 depends on claim 1 recites the limitation of ‘wherein the compound is compound (a)” in line 2. It is noted compound (a) is not a compound of formula I of claim 1, see claim 1 below.
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There is insufficient antecedent basis for this limitation in the claim.
Note: Compound (a) is taught by Lee et al. (Main Group Chemistry, 2010, see page 119, 2.2, preparation of C6H4N2H2TeCl2, compound 11, Table 2)
Allowable Subject Matter
Claim 4 is 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. The elected compounds compound (c) of formula I and compound (f) of formula II are free of prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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