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 .
Applicant’s election without traverse of Group I claims 1-6 and 8-13 in the reply filed on 01 December 2025 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-6 and 8-13 is contained herein below.
Group II Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application claims foreign priority to JAPAN JP 2022-097328 filed 06/16/2022, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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.
Claims 1-6 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Curtis
Fisk et al. (WO2015/047762A1).
Curtis-Fisk et al teaches a composition comprising an aqueous liquid diluent, and 0.1 to 6 weight percent of a cellulose ether (Abstract). The preferred cellulose ether is hydroxypropyl methylcellulose (HPMC) (page 4, lines 19 – 20; component recited in claim 1). The cellulose ether utilized in the composition has a viscosity of from 2.4 to 1000 mPa∙s measured as a 2 weight-% solution in water at 20 ⁰C (page 6, lines 15 – 18; limitation of claim 1 regarding viscosity) and it has a MS of 0.05 to 0.35 and a DS of from 1.6 to 2.5 (page 5, line 25; page 5, line 18; limitation of claims 1 and 3 regarding MF, and limitation of claim 2 regarding DS). The molar fraction of the 26-Me-3-HA, which is the HPMC type with two hydroxy groups in the 2- and 6-positions of the anhydroglucose unit are substituted with methyl groups and the 3-position is substituted with hydroxyalkyl is 0.0211 with an MS of 0.23 (page 16, lines 18 – 20; page 20, Table 3). The composition may additionally comprise an organic liquid diluent (page 8, lines 31 – 32; as in claims 4, 6, 8, 10, 11 and 13), wherein an organic liquid diluent as used means an organic solvent (page 9, line 9). The organic liquid diluent is preferably pharmaceutically acceptable, such as ethanol (page 9, lines 16 – 17) and at least 55 percent of the weight of the liquid diluent is water (page 10, lines 15 – 18). The water/diluent is preferably present up to at least 90% (page 9, line 2). This means that a liquid composition can have more than 0% by mass and up to 20% by mass of hydroxypropyl methyl cellulose content as in claims 5, 9 and 12.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the HPMC as taught by Curtis-Fisk et al to achieve the claimed HPMC with a ratio (MF at 3-position/MS) of 0.12 or more because Curtis-Fisk et al teaches that the MF of one HPMC is 0.0211 and the MS of the HPMC may be 0.05 to 0.35. One would have performed routine experimentation to discover the best MF and MS for the optimal HPMC characteristics. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to modify the HPMC as taught by Curtis-Fisk et al to achieve the claimed HPMC with a MF/MS ratio of 0.12 or more, as such modifications involve routine optimization of known parameters within the disclosed ranges to achieve desirable polymer properties.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6 and 8-13 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 12-14, and 17-20 of copending Application No. 18/334,457 (‘457) in view of Curtis-Fisk et al. (WO2015/047762A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant Claims are drawn to a hydroxypropyl methyl cellulose (HPMC) having a MS of hydroxypropoxy groups of from 0.1 to 0.5; a ratio (MF at 3-position/MS) of 0.12 or more, as calculated by dividing a molar fraction of anhydroglucose units in which only a hydroxy group at the 3-position carbon is substituted with a hydroxypropoxy group and none of hydroxy groups at the 2-position and 6-position carbons is substituted with a hydroxypropoxy group by the MS of hydroxypropoxy groups; and a viscosity at 20 ⁰C of more than 50 mPa∙s and not more than 15000 mPa∙s, as determined in a 2% by mass aqueous solution (claim 1). The HPMC has a degree of substitution (DS) of methoxy groups of from 1.0 to 2.0 (claim 2). The HPMC has a molar fraction of 0.027 or more (claim 3). ‘456 teaches a liquid composition comprising the HPMC and an organic solvent (claims 4, 8, and 11). The liquid composition has a content of HPMC more than 0% by mass and not more than 20% by mass (claims 5, 9, and 12). The organic solvent is miscible with water and the liquid composition further comprises water (claims 6, 10, and 13).
The copending claims of ‘457 are drawn to hydroxypropyl methyl cellulose having the same molar substitution, degree of substitution and liquid compositions having an organic solvent and further comprising water, and the liquid composition having a content of HPMC of more than o% by mass and not more than 20% by mass,
The copending claims of ‘457 differ from the instant claims in that the instant claims are drawn to HPMC that has a viscosity at 20oC of more than 50 mPa.s and not more than 150000 mPa.s as determined in a 2% by mass aqueous solution whereas the copending claims are drawn to HPMC that has a viscosity at 20oC of from 1.0 to 50 mPa.s as determined in a 2% by mass aqueous solution.
Curtis-Fisk teaches HPMC compositions having a viscosity of form 1.2 to 8000mPa.s (page 6, lines 15-16) which is very useful for transmucosal delivery of physiologically active agents (page 3, lines 14-19). In view of Curtis-Fisk one of ordinary skill in the art will adjust the viscosity to the claimed range for such applications.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the HPMC as taught by ‘457 to a HPMC with the claimed viscosity in view of Curtis-Fisk because it teaches that the HPMC having viscosity in the claimed range are useful for delivery of physiologically active agents. One would have been motivated to modify the HPMC as taught by ‘457 to a HPMC with the claimed viscosity in view of Curtis-Fisk because of the intended application. Such modification will yield a HPMC with improved characteristics for the application taught by Curtis-Fisk. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to modify the HPMC as taught by ‘457 to a HPMC with the claimed viscosity in view of Curtis-Fisk.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
1. Elected claims 1-6 and 8-13 (Group I) are rejected.
2. Group II, claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693