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 .
Status of Claims
Claims 1-12 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 8/29/24 (2) and 9/13/24. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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.
Claim 1 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.
Claim 1 recites the composition has a “pH between about”. The claim language is unclear as to whether “between” modifies the unit of measurement or if “about” modifies the unit of measurement, both of which have different meanings and would render different ranges of measurement as a claim limitation.
Claim 2 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.
Claim 2 recites “the sodium thiosulfate is aqueous anhydrous sodium thiosulfate” This is not clear as the sodium thiosulfate is in an aqueous solution. Clarity is required.
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (RU 2021102245) in view of Koehler (DE 2851037).
Li teaches with regards to instant claim 1, a pharmaceutical composition (see claim 1,) comprising anhydrous sodium thiosulphate (see claim 1) at a concentration from 0.1-0.5 M(see claim 4), glycine (see claim 6) from 0.01 M to about 0.05 M see claim 16) at a pH of 5-9.5 ((see claims 7-8), wherein the composition comprises a base sodium hydroxide (as required by instant claims 3-4, see description). With regards to instant claim 2, Li teaches the composition comprises aqueous sodium thiosulfate (see claim 1), wherein the glycine is about 0.01M to 0.05 M (as required by instant claims 5-12 see claim 16).
However Li did not per-se teach the additional agents as recited in claim 1, but nonetheless teaches other agents such as buffers and solvent to be included in the formulation.
Koehler teaches an aqueous sodium thiosulfate comprising sodium hydroxide (as required by instant claim 1 (see (description) and glycine, at a pH from 9-9.5).
It would have been obvious to one of ordinary skill in the art to have formulated a pharmaceutical composition comprising sodium thiosulfate at a concentration of 0.5 M with a concentration of glycine at 0.01-0.05M to include a base sodium hydroxide as taught by Koehler with a reasonable expectation of doing so, because the combination of references makes it obvious to do so at the time the claimed invention was filed.. One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11998604; (claims 1, 3-24 of US . Patent No 11992530); (US Patent No. 12311026, 1-24) in view of Li et al. (RU 2021102245) above. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are directed to a method of reducing ototoxicity in a human patient receiving a platinum based chemotherapeutic for the treatment of cancer sensitive to the platinum based chemotherapeutic comprising administering an effective amount of a pharmaceutical composition comprising aqueous anhydrous sodium thiosulfate, wherein the aqueous anhydrous sodium thiosulfate is at a concentration of about 0.5 M and further comprising about 0.004 M boric acid and the instant claims are to a pharmaceutical composition comprising (1) sodium thiosulfate at a concentration of about 0.5 M;(2) glycine at a concentration between about 0.01 M and about 0.05 M; and (3) an additional excipient, wherein the additional excipient is an isotonicity modifier, preservative, antimicrobial, stabilizer, anti-adsorption agent, lyophilization agent, cryoprotectant, oxidation protection agent, viscosity enhancer, or a diffusion agent; wherein the pharmaceutical composition has a pH between about 8.5 and 8.9.
Differ in that the patent is to a method using the same composition and the instant is to a composition with an open term “comprising” which do not exempt other agents to be present such as boric acid.
Smit above teaches treating ototoxicity in patient having a cancer and receiving a platinum based chemotherapeutic comprising administering an effective amount of sodium thiosulfate to the patient when the specification of the patent is used as a dictionary. Therefore it would have been obvious using the instant application in practicing the patented claims with the instant composition with a reasonable expectation of success.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claim 1 - 12 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 22 of U.S. Patent No. 11617793; (claims 1-6 of US Patent No. 11510964);US Patent No. 11291728 claims 1-2, 5-9) in view of Smit Li et al. (RU 2021102245) above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both applications recite using the same compositions and/or derivatives thereof. Differ only in the patented claims recitation of Boric acid.
Smit teaches that the composition may comprise boric acid. Therefore it would have been obvious to use the instant claims in practicing the patented in view of Smit above with a reasonable expectation of success. compositions recited in the claims would have been an obvious variation of the patented claims as the term comprising does not exclude other agents from been present in the composition..
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claim 1 - 12 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 26 of U.S. Patent Application No. 18111849. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to pharmaceutical composition comprising a sodium thiosulfate at a concentration between about 0.3 M and about 0.6 M and further comprising a buffer at a concentration between about 0.01 M and about 0.05 M wherein the buffer is selected from carbonate, maleate, citrate, isocitrate, succinate, aspartate, and glutamate and pharmaceutical composition comprising (1) sodium thiosulfate at a concentration of about 0.5 M;(2) glycine at a concentration between about 0.01 M and about 0.05 M; and (3) an additional excipient, wherein the additional excipient is an isotonicity modifier, preservative, antimicrobial, stabilizer, anti-adsorption agent, lyophilization agent, cryoprotectant, oxidation protection agent, viscosity enhancer, or a diffusion agent; wherein the pharmaceutical composition has a pH between about 8.5 and 8.9. The claims of the copending and the instant overlap in scope and therefore it is reasonable to use the instant in practicing the copending claims.
In view of the foregoing, the copending application claims and the current application claims are obvious variations of each other.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 9/23/25