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 1-3, 5-8, 10-11, 14-15, 17-18, 21, 23, 34-35, 47-53 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed September 1, 2023. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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).
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 (as required by instant claims 10) and therefore will have a glass transition of at least 30ºC, 40 ºC and 50 ºC (as required by instant claims 7-8 as further limited and via incorporation of EP1663183, wherein the glass transition is at least 50 ºC, see pg 5, lines 13+).
Claim(s) 1-2, 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).
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 incorp[orated by reference), wherein the polymer is polyvinylpyrrolidone vinyl acetate co-polymer (PVPVA64) (see pg 2, lines 9+ as incorporated, as required by instant claims 17-18 and 21) with a ratio of 1:0.2 to 1:10 (see pg 5, lines 35+, as required by instant claim 23)
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) 1-3, 5-8, 10-11, 14-15, 17-18, 21, 23, 34-35, 47-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lulla et al. (WO 2009/087410) in view of Berndl et al. (WO 2012/085236) and Noriega et al. (WO 2016/111725).
Lulla is applied here as above. Additionally, although Lulla teaches the polymer used is polyvinylpyrrolidone and can also be a polyvinylpyrrolidone-vinyl acetate (PVPVA) as required by instant claims 17-18, 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).
However, Lulla fails to teach per-se the first and second polymer and also fails to teach instant claims 5-6, 14-15.
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 incorp[orated by reference), wherein the polymer is polyvinylpyrrolidone vinyl acetate co-polymer (PVPVA64) (see pg 2, lines 9+ as incorporated, as required by instant claims 17-18 and 21) with a ratio of 1:0.2 to 1:10 (see pg 5, lines 35+, as required by instant claim 23), wherein the polymer is 600-6,000 Da (see claim 3 , as required in part by instant claim 48) although the reference did not per-se teach that the second polymer has a molecular weight average of 45, 000, nonetheless teaches that preferred polymers have an average weight of 45,000 (see pg 6, lines 20+, as required by instant claim 48) thus one of ordinary skill in the art would have been obvious to use the teaching for selecting the co-polymer within the average molecular weight. The reference teaches the extrude is from 70-200 ºC (see pg 156, lines 9+).
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 pH 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.
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 12/3/25