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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2025 has been entered.
Status of claims
The amendment filed on 07/14/2025 is acknowledged. Claims 2-4 and 6 have been canceled, claims 9-13 have been withdrawn, and new claim 14 has been added. Claims 1, 5, 7, 8, and 14 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 07/14/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. 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.
New ground of rejections necessitated by Applicant’s amendment
The amendments in claim 1 and new claim 14 necessitate the following new ground of rejections.
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.
Claims 1, 5, 7, and 8 are 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 1 recites the limitation “at least one inert film-forming polymer carrier” before the recitation of “the inert polymer carrier”. Thus, there is insufficient antecedent basis for “the inert polymer carrier” in the claim. Claims 5, 7, and 8 are rejected as dependent claims of a rejected claim.
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 recitations of “the inert polymer carrier” and “the film forming polymers”. Thus, there is insufficient antecedent basis for “the inert polymer carrier” and “the film forming polymers” in the claim.
To expedite the prosecution “the inert polymer carrier” and “the film forming polymers” are given their broadest reasonable interpretations by the examiner in light of the specification in the 112(b) and 103 rejection 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 said 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", “said inert (film-forming) polymer carrier”, and “the (inert) film forming polymers” herein are interpreted.
Rejections maintained
The following rejection of the claims is maintained for reasons of record and the following.
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, with or without a bittering agent such as denatonium benzoate, coated with an acid labile coating containing at least one acid labile substance including polyvinyl pyridine polymers and copolymers (the same polymer recited in the instant claims 1 and 14 and thus the claimed inert film-forming polymer in the instant claims 1 and 14) (paragraph 429-431 and claims 101-103), i.e., the release of the bittering agent is controlled by the acid labile coating (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 acid labile coating 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:
Applicants’ argument based on the amendments of “film-forming polymer” is addressed in the modifies rejection above.
Applicants argue that Oddi is not an analogous art.
However, this argument is not deemed persuasive. The instant claims are directed to “a composition” while Odidi teaches drug delivery formulations which is within the scope of the claimed “a composition” and thus is an analogous art.
Applicants argue that there is benefit of reducing or eliminating of careful handling of the embittering compound.
However, this argument is not deemed persuasive. Odidi teaches the claimed polyvinyl pyridine polymers/copolymers coated denatonium benzoate; thus, the polyvinyl pyridine polymers/copolymers coated denatonium benzoate taught by Odidi would have the alleged benefit. Please refer to MPEP 2145.II:
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
Correspondence
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.
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, 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