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 .
Receipt is acknowledged of IDS filed on 03/16/2026
Claims 1, 4, 8, 9, 11, 14, 17, 19, and 22 are amended.
Claims 1-2, 4, 8-9, 11, 14, 17-22 and 25-28 are pending.
Claims 25-27 are withdrawn.
Claim 28 has been added
Claims 3, 5-7, 10, 12, 13, 15, 16, 23, and 24 are cancelled.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to 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:
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.
Claims 1, 2, 4, 8, 11, 14, 17-22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over ZHU (WO 2019/238068 A1) in view of LI (US 2019/0218172).
Regarding claim 1, ZHU teaches a pregabalin sustained-release composition comprising:
An active ingredient, pregabalin, that is present in a percentage of 25% to 30% by weight (page 4, paragraph 6).
A matrix-forming agent, such as Kollidon (page 4), which according to Applicant’s specification is a polyvinyl acetate-povidone copolymer(page 4, paragraph 4), in a concentration of 20% to 30% (page 5, paragraph 1).
Swelling agents, such as polyoxyethylene (page 5, paragraph 1) and crospovidone, also known as polyvinylpolypyrrolidone, can be added to the composition (page 5, paragraph 1). The swelling agnent is used to cause the size of the composition to swell which affects the drug release rate (page 5, paragraph 1).
A gelling agent, such as carbomer, which present in a concertation of 3% to 10% (claims).
ZHU does not teach a compound with structure formula (I).
Regarding claim 1 and 2, LI teaches a sustained release pharmaceutical formulation comprising the following compound
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(claim 5), which is a benzene sulphonate and reads on the structure shown in claim 1.
LI further teaches that pregabalin is effective in the treatment of pain, however it is less safe and may be abused or induce drug dependance in patients and the compound taught has better efficacy (page 1, paragraph 0003-0004). The compound in LI is used to treat pain (page 6, paragraph 0016) and has excellent pharmacokinetic properties (page 26, paragraph 0239).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the compound shown in LI. The person of ordinary skill in the art would have been motivated to make those modifications, because it has excellent pharmacokinetic properties and pregabalin can be considered not safe, and reasonably would have expected success because both references are in the same field of endeavor, such as compounds for treating pain and LI explicitly states that the purpose of the compound taught is to have a better alternative to pregabalin (page 1, paragraph 0004).
Regarding claim 4, ZHU teaches that the active ingredient is present in a percentage of 25% to 30% by weight (page 4, paragraph 6).
Regarding claim 14, ZHU teaches carbomer is present in a concertation of 3% to 10% (claims).
Regarding claims 17-18, the filler is optional and is listed as can have a percent weight of 0%, and therefore is not a limitation.
Regarding claim 19-21, ZHU teaches the composition further comprises magnesium stearate as a lubricant, in a concentration of 0.1% to 1.5% (claims)
Regarding claim 22, ZHU teaches the composition is a sustained release tablet (claims).
Additional disclosure: Polyoxyethylene allows the composition to have a faster volume expansion rate (page 6, paragraph 2) and effects the drug release rate (page 5, paragraph 1).
Regarding claims 1, 8, 11 and 28, The reference does not specifically teach the concentration of the swelling agent or polyoxyethylene as claimed by the Applicant. The concentration of the swelling agent is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration of the swelling agent and polyoxyethylene in order to best achieve desired results, such as controlling the drug release rate and the volume expansion rate. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentration of the swelling agent and polyoxyethylene would have been obvious at the time of Applicant’s invention.
Claims 1, 2, 4, 14, 17-22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over ZHU (WO 2019/238068 A1) and LI (US 2019/0218172), in view of VRANIKOVA (Experimental Design for Determination of Effects of Superdisintegrant Combinations on Liquisolid System Properties. Journal of Pharmaceutical Sciences. 2017.).
ZHU and LI teach Applicant’s invention as discussed above. ZHU does teach that crospovidone can have a certain effect on the stability of the composition (page 5, paragraph 1).
VRANIKOVA teaches that crospovidone, when used in a tablet, improves disintegration, wetting time, enhances drug release, and improves tablet disintegration (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate crospovidone. The person of ordinary skill in the art would have been motivated to make those modifications, because it improves disintegration, wetting time, enhances drug release, and improves tablet disintegration, and reasonably would have expected success because the references are in the same field of endeavor, such drugs delivered in tablet form that have a specific rate of release.
Claims 1, 2, 4, 8, 9, 11, 14, 17-22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over ZHU (WO 2019/238068 A1), LI (US 2019/0218172) and VRANIKOVA (Experimental Design for Determination of Effects of Superdisintegrant Combinations on Liquisolid System Properties. Journal of Pharmaceutical Sciences. 2017.) in view of MEDAREVIC (POLYETHYLENE OXIDES AS MATRIX FORMING AGENTS: DIRECT COMPRESSION VS. WET GRANULATION. 2012.).
ZHU, LI and VRANIKOVA teach Applicant’s invention as discussed above.
Regarding claim 9, ZHU, LI and VRANIKOVA do no teach using a specific polyoxyethylene, such as Polyox Coagulant, polyoxyethylene coagulant.
Regarding claim 9, MEDAREVIC teaches polyethylene oxide, also known as polyoxyethylene, is commonly used in the formulation of extended release, which reads on sustained release, tablets (abstract). Brands on polyethylene oxide that are used are Polyox N-12K and Polyox Coagulant (abstract). Polyox Coagulant slowed the release time of the drug (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate Polyox Coagulant. The person of ordinary skill in the art would have been motivated to make those modifications, because it is commonly used in the formulation of sustained release tablets and can slow the release of the drug, and reasonably would have expected success because the references are in the same field of endeavor such as sustained release tablet utilizing polyoxyethylene.
Response to Arguments
Applicant argues, the claimed ratios of components achieves unexpected results.
The examiner does not find the argument persuasive. In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the unexpected results are not commensurate in scope with the breadth of the claims. The results provided, examples 2-5, 11 and 13, are only towards the specific species compound IV, which correlates to
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, which is not the two compounds listed in instant claim 1,
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. Furthermore, in the examples provided, the matrix agents are in concentrations ranging from 29-33% vs instant claim 1 with the range of 20-40%, the swelling agents are in the ranges of 48-58% vs instant claim 1 with the range of 15-70%, and the gelling agent is in a concentration of 2%, whereas instant claim 1 does not recite a range. Furthermore, ZHU teaches all concentrations claimed with the exception of the swelling agent as discussed above.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Applicant argues, that ZHU teaches away from using cross-linked polyvinylpyrrolidone due to stability.
Examiner does not find the argument persuasive because as discussed above cross-linked polyvinylpyrrolidone/crospovidone can still be added to the composition and the formulations can be used promptly after formulation so as to not need to be stored for long periods of time. Furthermore, VRANIKOVA teaches that crospovidone, when used in a tablet, improves disintegration, wetting time, enhances drug release, and improves tablet disintegration (abstract). This benefit of adding crospovidone can outweigh the negative effects on storage noted by ZHU.
Conclusion
No claims are allowable.
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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