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 .
Applicants' arguments, filed 07/22/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claim Rejections - 35 USC § 102
New Rejection
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 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) 1, 6, 50 and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fassihi et al. (US Patent Pub. 2002/0061332).
Fassihi et al. disclose a composition comprising the active agent, verapamil at a concentration of 120 mg and glycine at a concentration of 120 mg (Example 1). The weight ratio meets the limitation of instant claim 1. The reference anticipates the instant claims.
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:
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, 2, 6, 15, 17, 18, 22, 24, 25, 46, 47-49 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (US Patent Pub. 2023/0133326).
Khan et al. disclose a stable formulation comprising an active agent, including varenicline, and at least one pharmaceutical excipient (ABSTRACT and [0036]). Khan et al. disclose the amount of nitrosamine impurity after exposure of the pharmaceutical composition to 40°C/75% RH for a period of six months is less than about 50 ppm when packed in high density polyethylene bottle, blister pack or any other finished container ([0008]). Khan et al. disclose a formulation comprising an excipient/glidant, a lubricant and an antioxidant, butylated hydroxytoluene, which meets the limitation of instant claim 15 (TABLE 9, Formulation 2). Khan et al. disclose excipients include, diluents, disintegrants and lubricants and are present in the composition in a range from 1 to 95% w/w ([0014] and [0070]).
Khan et al. differs from the instant claims insofar as they do not specifically disclose a composition comprising 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant; based on the total weight of the composition.
The prior art discloses the use of 1 to 95% excipients. Thus, the prior art differs from the instant claims insofar as it does not disclose the particular endpoints recited therein, i.e. 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning of the Peterson decision.
Applicant’s Arguments
Applicant argues the reference does not disclose a stable pharmaceutical composition comprising a therapeutically active agent selected from the group recited in Applicant’s claim 1, one or more stabilizing agents, and one or more pharmaceutically acceptable excipients wherein the weight ratio of the therapeutically active agent to the stabilizing agent is 1:0.01 to 1:25. Applicant argues there would have been no motivation to modify the reference. Applicant argues unexpected results are directly attributable to the claimed composition and ranges.
Examiner’s Response
As previously disclosed Khan et al. differs from the instant claims insofar as they do not specifically disclose a composition comprising 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant; based on the total weight of the composition.
The prior art discloses the use of 1 to 95% excipients. Thus, the prior art differs from the instant claims insofar as it does not disclose the particular endpoints recited therein, i.e. 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning of the Peterson decision.
Claim(s) 1, 2, 6, 15, 17, 18, 22, 24, 25, 46, 47-49 and 52 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Khan et al. (US Patent Pub. 2023/0148226).
Khan et al. disclose a stable formulation comprising varenicline and at least one pharmaceutical excipient (ABSTRACT). Khan et al. disclose the amount of nitrosamine impurity after exposure of the pharmaceutical composition to 40°C/75% RH for a period of six months is less than about 50 ppm when packed in high density polyethylene bottle, blister pack or any other finished container ([0010]). Khan et al. disclose a formulation comprising an excipient/glidant, a lubricant and an antioxidant, butylated hydroxytoluene, which meets the limitation of instant claim 15 (TABLE 6, Formulation 1). Khan et al. disclose excipients include antioxidants at a concentration of 0.001 to 5% and diluents, disintegrants and lubricants ([0021] and [0069]). Khan et al. disclose the weight ratio of the varenicline to the pharmaceutical excipient is from 1 to 99 to 99 to 1% w/w ([0023]).
Khan et al. differs from the instant claims insofar as they do not specifically disclose a composition comprising a ratio of the therapeutically active agent to the stabilizing agent is 1:0.1 to 1:25 or 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant; based on the total weight of the composition.
The prior art discloses the use of 0.001 to 5% antioxidant and a ratio of 1 to 99% to 99 to 1% ratio of varenicline to the pharmaceutical excipients. Thus, the prior art differs from the instant claims insofar as it does not disclose the particular endpoints recited therein, i.e. the ratio of the therapeutically active agent to the stabilizing agents is 1:0.01 to 1:25 and 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning of the Peterson decision.
Applicant’s Arguments
Applicant argues the reference fails to disclose or suggest the critical relationship between the therapeutical active agent and stabilizing agent as required by the present claims. Applicant argues the reference does not disclose or suggest the specific composition comprising the ranges of the claims nor does it provide any reason why a person of skilled in the art would have selected these particular ranges. Applicant's arguments have been fully considered but they are not persuasive.
Examiner’s Response
The reason or motivation to modify a reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144, IV. Therefore, the reference need not disclose or suggest the critical relationship between the active and stabilizing agents.
The prior art discloses the use of 0.001 to % antioxidant and a ratio of 1 to 99% to 99 to 1% ratio of varenicline to the pharmaceutical excipients. Thus, the prior art differs from the instant claims insofar as it does not disclose the particular endpoints recited therein, i.e. the ratio of the therapeutically active agent to the stabilizing agents is 1:0.01 to 1:25 and 10% w/w -80% w/w of diluent; 0.1% w/w – 10% w/w of disintegrant, and 0.1% w/w – 5% w/w of lubricant. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning of the Peterson decision.
In regard to the alleged unexpected results of compositions prepared within the claimed ranges consistently provided reduced nitrosamine impurity formation and improved stability across multiple active pharmaceutical ingredients. The reference appears to similar properties since it teaches the amount of nitrosamine impurity after exposure of the pharmaceutical composition to 40°C/75% RH for a period of six months is less than about 50 ppm when packed in high density polyethylene bottle, blister pack or any other finished container ([0010]).
Even, assuming, purely arguendo, that unexpected results had been shown, Applicant’s claims encompass more compounds, i.e. stabilizing agents and pharmaceutically acceptable excipients, than that disclosed by Examples 5-12 in the specification, therefore the examples are not commensurate in scope with the instant claims.
Claim(s) 1, 2, 6, 15, 17, 18, 22, 24, 25, 46 and 47-54 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (US Patent Pub. 2023/0133326) in view of Fassihi et al. (US Patent Pub. 2002/0061332).
Khan et al. differs from the instant claims insofar as they do not disclose a composition comprising an amino acid.
Fassihi et al. disclose a composition comprising an active agent at a concentration of 120 mg and glycine at a concentration of 120 mg (Example 1). The weight ratio meets the limitation of instant claim 1. Fassihi et al. disclose the amino acid may be used to modulate the solubility and release of the active agent ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used amino acid in the composition of Khan motivated by the desire to modulate the solubility and release of the active agent as taught by Fassihi.
Double Patenting
The double patenting rejection is withdrawn since application 18/063460 is abandoned.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612
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