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
Claims 1-20 are canceled. Claims 21-37 are added. Claims 21-37 are pending and now evaluated on its merit.
Priority
This application is a divisional to application 18/420,370, with a filing date of 01/23/2024.
Information Disclosure Statement
The information disclosure statement (IDS) dated 01/17/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
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 29 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.
Regarding claim 29, the phrase "free from a permeation enhancer" renders the claim indefinite because claim 21, which claim 29 is dependent on, recites the limitation of propylene glycol, which is a known permeation enhancer.
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.
Claims 21-28 and 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (CN 107281094 A).
Regarding claims 21-28 and 30-37, Lu teaches a topical gel pharmaceutical composition and the preparation thereof for the administration of timolol maleate to infant patients suffering from hemangioma (relevant to claim 28) (abstract, para. 0009). The gel composition comprising timolol maleate and pharmaceutical auxiliary material and water, according to weight percentage, timolol maleate is 0.1 to 2.0%, the medicine auxiliary material is carbomer 0.1 to 6%, triethanolamine 0.05 to 3.0%, propanediol 1 to 4% and ethyl hydroxy benzoate 0.05 to 2%, propylene glycol and the rest is water (abstract, para. 0008). Lu teaches the propylene glycol as an organic solvent, wherein the quantity of propylene glycol in the topical preparation product is 5 %-80 % (relevant to claims 21, 27, 30 and 36) (para. 0027).
The process for preparing the gel composition comprises the steps:
1) adding carbomer into proper purified water, stirring to make it fully swelling to obtain the uniformly dispersed solution I;
2) dissolving the timolol maleate in the partially purified water, stirring and dissolving to obtain clarified transparent solution II;
3) adding ethyl hydroxy benzoate in propylene glycol, stirring and dissolving to obtain clarified transparent solution III;
4) after mixing solution I and solution II, stirring uniformly to obtain the solution IV. After the solution III is diluted n times by purified water to dilute glycol quantity, adding the solution IV, under the stirring state, stirring and mixing uniformly.
5) adding the triethanolamine in the mixed liquid, adding the rest purified water, fully stirring to obtain the semi-transparent gel, gel pH should be 5.5-7.5. (relevant to claims 31-35) (para. 0032-0037).
In terms of claims 22-26 and 37, the limitation of “when the formulation is administered twice a day to a human subject at a daily dose of from about 0.4 to about 10mg/cm2/day, a steady mean timolol blood Cmax of lower than 3ng/ml and ratio of less than 2 for Cmax/Cmin are achieved” is of intended use for the claimed formulation, thus would be anticipated by the prior art teaching of Lu per MPEP 2111.02 (II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have formulated a composition comprising timolol maleate ranging from about 0.5% to about 2.0%, propylene glycol ranging from 5% to 7%, carbomer ranging from 1.6% to 2.5%, triethanolamine ranging from 0.6% to 1.0% and ethyl hydroxybenzoate ranging from 0.05% to 2% from the teachings of Lu. One would have been motivated to do so because Lu teaches the formulation comprising the claimed ingredients within the claimed desired ranges. Additionally, Lu teaches propylene glycol from a range of 5% to 80%, thus producing the claimed formulation with propylene glycol ranging from 5% to 7% would be of routine experimentation to determine the effective amounts of propylene glycol employed in the composition. There is a reasonable expectation of developing the claimed formulation comprising the range limitations from the teachings of Lu.
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 21-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8-10, 12, 14-15 and 19 of U.S. Patent No. 12257255. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4, 8-10, 12, 14-15 and 19 of U.S. ‘255 is of the same subject matter of a formulation comprising timolol maleate ranging from about 0.5% to about 2.0%, propylene glycol ranging from 5% to 7%, carbomer ranging from 1.6% to 2.5%, triethanolamine ranging from 0.6% to 1.0% and ethyl hydroxybenzoate ranging from 0.05% to 2% for administration twice a day to a human subject ages 3-12 at a dosage from about 0.5 to about 8 mg/cm2/day.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
