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 .
Status of Claims
Claims 1, 5-6,11, 18, 21, 23, 34, 49-51, 53, 63-65 are pending and under examination in this office action.
Response to Amendment and argument
The response filed on 4/9/26 has been entered.
Applicant’s arguments filed 4/9/26 have been fully considered but they are not deemed to be persuasive.
The rejection of Claim(s) 1-2, 7-8, 10, 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lulla et al. (WO 2009/087410) is withdrawn due to the amendment of the claims.
The rejection Claim(s) 1, 7-8, 10, 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Berndl et al. (WO 2012/085236) is withdrawn due to the amendment of the claims.
Modified Claim Rejections - 35 USC § 103
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, 5-6,11, 18, 21, 23, 34, 49-51, 53, 63-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berndl et al. (WO 2012/085236 in view of Bi et al. (WO 2014/081581 from IDS) and Lulla et al. (WO 2009/087410) and Noriega et al. (WO 2016/111725).
Berndl teaches solid melt dispersion comprising an active agent (see pg 1, lines 5+) wherein the active agent is ibuprofen, diclofenac (see pg 7, lines5+, as required by instant claim 1) in combination of at least 2 polymers (see pg 3, lines 15+, as required by instant claims 1-3) wherein the extrudate comprises 20% of the active agent (see pg 1, lines 35+ as required by instant claims 5-6, as incorporated by reference or upto 40%, see the active agent i.e., ibuprofen see pg 6, lines 31+, as required by instant claim 53), wherein the polymer is polyvinylpyrrolidone vinyl acetate co-polymer (PVPVA64) (see pg 2, lines 9+ as incorporated, as required by instant claims 18 and 21) with a ratio of 1:0.2 to 1:10 (see pg 5, lines 35+, as required by instant claim 23), and polyethylene glycol (see pg 6, lines 17+, as the other polymer)
However Berndl failed to specifically teach first and second polymer. Nonetheless teaches the presence of two polymers, which is dependent on the purview of the skilled artisan on the release rate/profile of the drug.
Bi teaches solid dispersion of amorphous efavirenz comprising a composition comprising a first polymer i.e., polyvinyl pyrrolidone (see 0011) and a second polymer ie., polyvinylpyrrolidone/vinyl acetate copolymer(see 0054) and also teaches that the polymer dimethylaminoethyl methacrylate as the polymer. As used here first polymer is based on the dissolution rate for increase bioavailability, therefore based on the purview of the skilled artisan to determine the dissolution rate and choose the appropriate polymer to use (as required by instant claims 63-65).
Lulla with regards to instant claim 1, teaches a solidified melt extrude comprising a pharmaceutical composition (see tittle, pg 1 lines 5+ ) comprising an amorphous form (see pg. 8, lines 8+) and active agent ie., paracetamol (see pg 9, lines 10+ as required by instant claims 1-2) combined with at least 2 polymers (see pg 1, lines 5+) wherein the polymers are croscamelloes sodium, crospovidone
Additionally, although Lulla teaches the polymer used is polyvinylpyrrolidone and can also be a polyvinylpyrrolidone-vinyl acetate (PVPVA) as required by instant claims 18, 21) wherein the polymer is preferably present in the range wherein the ratio of drug to polymer is 1 :0.5 to 1:6 (as required by instant claim 23).
Noriega teaches solid amorphous drug (see pg 2, lines 19+) wherein the active is a NSAID ie., ketoprofen (as required by instant claim 1-3) wherein the extrudant comprises at least 35%-50% (as required by instant claims 5-6, see Example IB) having the first polymer by weight from 25-50% and the second polymer from 0-32% (as required by instant claim 51) and the NSAID can be combined with dimethylaminoethyl methacrylate as the polymer (see pg 20, lines 20+) and polyvinylpyrrolidone-co-vinyl acetate. Although Noriega did not per se teach a first and second polymer, one of ordinary skill in the art would have been motivated to use based on the controlled release pattern of the drug (as required by instant claim 53).
It would have been obvious to one of ordinary skill in the art to have combined the cited prior art to result in the instant claimed invention because One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a). With regards to the and varying ratios, this is within the purview of the skilled artisan to determine based on the end product of the composition and the drug used, since the polymer and release pattern would be considered.. It should be noted that Berndl teaches the use of pH regulators, intrinsically, one of ordinary skill in the art would adjust the pH based on the polymer release , drug used as the pH of each drug will vary. Although Bi teaches another drug, Berndl teach the solidified melt extrude can comprise drugs such as antiviral drugs such as efavirenz (see pg 9, lines 1). Therefore it would have been obvious to one of ordinary skill in the art to substitute Bi’s efavirenz for a NSAID such as ibuprofen with a reasonable expectation of success as the actives taught can be used in the instant claimed method.
The recitation first and second polymer depends on the dissolution rate of the drug, since all the listed polymers are taught by the cited prior art it is well within the purview of the skilled artisan to determine the first and second polymer.
Applicant argues that “none of these exemplary compositions contain a first and second polymer or ibuprofen as the active ingredient as required by the claims-and because that document mentions dimethylaminoethyl methacrylate and polyvinylpyrrolidone-co-vinyl acetate amongst a two page list of pharmaceutical acceptable polymers and excipients starting on page 19 and ending on page 21 of the document.3 Applicant respectfully disagrees. Noriega provides no motivation to choose.
In response, Applicant’s argument have been considered but found unpersuasive based on the rejection above. Additionally, the claims do not recite a release profile , arguing what is not claimed is improper. In arguendo even if Noriega's exemplary compositions exhibit extended release profiles, taking multiple hours to achieve this same level of dissolution and that the data demonstrates that the art is unpredictable with respect to at least the selection of specific polymers for achieving a desired release profile, Applicant should note that these polymer’s release rate is based on the drug and the polymer used one of ordinary skill in the art recognizes that the choice of polymer is based on the active, as different actives would need a different first and second polymer.
Applicant argument is found unpersuasive, Applicant can be its own lexicographer by choosing and naming the polymers as first and second and the art merely reciting the first and second polymer is based on the choice of drug.
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 5/1/26
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