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 .
Priority
The instant application was filed 06 November 2023 and is the continuation of several applications, earliest is 01 July 2019. The Applicant claims priority to provisional application 62/693,503 filed 03 July 2018 and 62/693,502 filed 03 July 2018. The effective filing date of the instant application is 03 July 2018.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gjorstrup (WO 2014/134184 A1) and Lichter et al. (US 2010/0004225 A1).
Gjorstrup teaches compositions and methods for treating ototoxicity (entire teaching; abs) that may comprise sodium thiosulfate (para. 147), tromethamine (other name: tris(hydroxymethyl)aminomethane, pg. 5 of instant specification) (para. 179), preservatives (para. 175), and sodium hydroxide as a pH adjuster (para. 155), addressing claims 3 and 4 and partially addressing claim 1. The compounds in the composition may be in their anhydrous form (para. 100) and as aqueous solutions (para. 166), addressing claim 2. The compounds in the composition may be in an amount of about 0.0001 to 100 mg, 0.0001 micrograms to 10 mg, etc. (para. 157).
Gjorstrup does not specifically teach a concentration for the tris buffer in claims 1 and 5-12. Gjorstrup also does not specifically teach a concentration of sodium thiosulfate or a pH range in claim 1.
Lichter teaches compositions and methods for treating otic diseases and conditions (entire teaching; abs). The composition may include sodium thiosulfate (para. 213), tromethamine (para. 385), and sodium hydroxide (para. 418, 419). To treat the perilymph, the pH of the formulation, with the use of buffers, should be around 5.5 to 9.0 (para. 21), addressing the pH range in claim 1. The amount of buffer may be in an amount of 10 Micromolar to about 200 Millimolar (para. 292), addressing the concentrations in claims 1 and 5-12.
In regards to selecting the combination of sodium thiosulfate, tris(hydroxymethyl)aminomethane, preservatives, and sodium hydroxide, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
In regards to the concentration of sodium thiosulfate in claim 1, Gjorstrup teaches that the compounds in the composition may be in an amount of about 0.0001 to 100 mg, 0.0001 micrograms to 10 mg, etc. (para. 157). That being said and in lieu of objective evidence of unexpected results, the concentration can be viewed as a variable that achieves the recognized result of successfully making the sodium thiosulfate composition. The optimum or workable range of concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of sodium thiosulfate as nonobvious.
Since Gjorstrup does not specifically teach a concentration for the tris buffer in claims 1 and 5-12, a concentration of sodium thiosulfate or a pH range in claim 1, one of ordinary skill in the art would have been motivated to use Lichter’s teaching of a pH range of 5.5 to 9.0 and an amount of buffer of 10 Micromolar to about 200 Millimolar. A skilled artisan would have been led to use both teachings since Gjorstrup and Lichter teach methods of treating otic conditions, such as ototoxicity.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/111,849 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a pharmaceutical composition comprising anhydrous sodium thiosulfate (claims 1, 2, 13), a buffer (claims 5-11, 14-25), and a sodium hydroxide base (claims 3 and 4). The claims include concentrations of sodium thiosulfate (claims 12 and 26). The reference claims do not specify the tris buffer, but one of ordinary skill in the art would have been led to use any buffer that would achieve a pH of 6.5-8.9 (specification, pg. 7). All of the claims correspond to instant claims 1-12.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/503,027 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a pharmaceutical composition comprising anhydrous sodium thiosulfate (claims 1 and 2), a buffer (claims 5-12), and a sodium hydroxide base (claims 3 and 4). The claims include concentrations of sodium thiosulfate and the buffer (claims 1, 5-12). The reference claims do not specify the tris buffer, but one of ordinary skill in the art would have been led to use any buffer that would achieve a pH of 6.5-8.9 (specification, pg. 5). All of the claims correspond to instant claims 1-12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613