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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 01/08/2026 is acknowledged. Claims 2-4 and 6 have been canceled and claims 9-13 have been withdrawn. Claims 1, 5, 7, 8, and 14 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 01/08/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112(b) rejection of claims 1, 5, 7, and 8 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. The rejections are modified based on the amendments.
Claim Rejections - 35 USC 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 14 recites the limitation “at least one inert film-forming polymer carrier” before the recitation of “the film forming polymers”. Thus, there is insufficient antecedent basis for “the film forming polymers” in the claim.
To expedite the prosecution “the film forming polymers” is given itsbroadest reasonable interpretations by the examiner in light of the specification in the 112(b) and 103 rejections as “the inert film-forming polymer carrier”.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitations of "at least one inert film-forming polymer carrier", “wherein the inert film-forming polymer carrier is selected from the group consisting of: homo-/crosslinked polymers of vinyl pyridine and derivatives thereof, a polymer of 2- vinylpyridine, a polymer of 3-vinylpyridine, a polymer of 4-vinylpyridine, and precursors thereof”, and “wherein the (inert) film forming polymers are polysaccharides and/or cyclodextrins” in claim 14 render claim 14 indefinite.
It is confusing to one of ordinary skill whether the "at least one inert film-forming polymer carrier" “is selected from the group consisting of: homo-/crosslinked polymers of vinyl pyridine and derivatives thereof, a polymer of 2- vinylpyridine, a polymer of 3-vinylpyridine, a polymer of 4-vinylpyridine, and precursors thereof” as recited in the 3rd wherein clause or the "the (inert) film forming polymers" “are polysaccharides and/or cyclodextrins” as recited in the 5th wherein clause. Thus, it is unclear and indefinite as to how the "at least one inert film-forming polymer carrier", “the inert film-forming polymer carrier”, and “the (inert) film forming polymers” herein are interpreted.
Response to Applicants’ arguments:
Applicants argue that claim 14 is amended to overcome the rejections.
However, this argument is not deemed persuasive. As indicated above, the amendments of claim 14 do not overcome the rejections of record.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 5, 7, and 8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Odidi (US 2016/0022590 A1).
Odidi teaches drug delivery formulations comprising
a core of homogenous mixture of an active and an acid labile substance (the claimed matrix) including polyvinyl pyridine polymers and copolymers (the same inert film-forming polymer claimed in the instant claim 1) (paragraph 87-89, 103, and 128), with or without a bittering agent such as denatonium benzoate (paragraph 429-431 and claims 101-103), i.e., the release of the bittering agent is controlled by the acid labile (matrix) in the core (the instant claim 8);
wherein the amount of bittering agent is about 0.00001-100 mg/tablet with a final concentration of 20-1000 ppm (0.002-0.1% by weight); and wherein the amount of the acid labile materials is about 0.5-500 mg and about 2-60% by total dosage weight (paragraph 148 and 444). The weight percentage of a bittering agent relative to the acid labile substance in the core (acid labile substance matrix) is calculated to be 20% (100/500=20%).
Oddi does not teach the same weight percentage of acid labile substance (the claimed polymer carrier in the instant claim 7).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art. In the instant case, the claimed range of polymer carrier is about 10-99.95% by weight and the range of acid labile substance taught in the prior art is about 2-60% by weight and therefor, overlaps with the claimed range.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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