DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 4-8, 12, 14-16, 19, 25, and 30) in the reply filed on October 21, 2025 is acknowledged.
Claims 33, 53, 61, 65, 70, and 75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-IV, there being no allowable generic or linking claim.
Status of Application
Receipt of Applicant’s amended claims filed on October 21, 2025 is acknowledged. Claims 1-2, 4-8, 12, 14-16, 19, 25, 30, 33, 53, 61, 65, 68, 70, and 75 are pending in this application.
As noted above, claims 33, 53, 61, 65, 70, and 75 have been withdrawn.
Claim 30 has been amended.
As noted, claims 1-2, 4-8, 12, 14-16, 19, 25, and 30 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on May 10, 2023 and October 21, 2025 is acknowledged. Signed copies are attached to this office action.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (US 10,357,467).
Hu discloses a method for tuning the pH dependent dissolution profile of a delayed release soft-gel capsule (providing a soft capsule that as modified release profile and modified properties to dissolve in a target location; abstract; column 9, lines 1-10; column 36, lines 10-20) comprised of a fill material encapsulated in a pH dependent shell composition (a matrix fill composition for controlled release is encapsulated by a shell which is responsive to a pH; abstract; column 3, lines 5-10, 30-33; column 8, lines 50-52; column 9, lines 1-10).
The method comprising adjusting an amount of pectin (modifying the pH sensitive shell by adjusting pectin from about 2 to 7 wt.% of pectin to the gelatin in the pH sensitive shell; column 3, lines 3-10; column 11, lines 5-41; column 14, lines 6-10; column 48, table 10; claim 1) and an amount of synthetic polymer in the pH dependent shell (modifying the pH sensitive shell by adjusting acrylate polymer present as an anionic polymer to the pH sensitive shell comprising gelatin, adjusting gelatin to acrylate polymer ratio from 4:1 to 9:1, and 2 to 7 wt.% of pectin to the gelatin, thus adjusting; column 3, lines 3-10; column 11, lines 5-41; column 14, lines 6-10; column 48, table 10; claim 1) composition to attain a target pH dependent dissolution profile in acidic medium and/or in buffer medium (in order to attain the modified release profile of the soft capsule at a target pH 1.2 in acidic medium and at a target pH 6.8 in phosphate buffer; abstract; column 3, lines 26-33, 64-67; column 9, lines 1-10; column 36, lines 10-20; column 49, lines 4-7; column 52, lines 1-21).
Hu, therefore, anticipates the rejected claim.
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.
Claims 1-2, 4-8, 12, 14-16, 19, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan (US 2012/0301546) in view of Coulter et al. (US 2016/0213611).
Hassan discloses acid resistant soft gel composition. The soft gel shell comprises a gelatin-based water soluble film forming polymer, an acid insoluble polymer and at least one reducing sugar and water (abstract).
The shell matrix can contain a fill that is liquid, semi-solid or solid (paragraph 0040). The fill can comprise pharmaceutical active/nutritional supplement or nutraceutical ingredients to be delivered to the gastro-intestinal tract of a human (paragraph 0037).
The reducing sugar is present in the matrix in the amount of 0.5 to 20% (w/w) (paragraph 0016).
Regarding clam 2, the soft gel shell is disclosed to optionally include a plasticizer (paragraph 0014).
Regarding claim 4, the soft gel shell matrix additionally comprises pectin. The pectin is not disclosed to be amidated, therefore, it is the Examiner’s position that it would be non-amidated.
Regarding claim 5, the matrix includes about 15-55 % (w/w) gelatin (paragraph 0015).
Regarding claim 6, the acid insoluble polymer (pectin) is present at about 0.5% to about 30% (w/w) (paragraph 0043).
Regarding claim 8, the plasticizer is present in the amount of about 5-30% (w/w) (paragraph 0019).
Regarding claim 12, the plasticizer can include sorbitol or glycerol (paragraph 0018).
Regarding claim 14, the acid insoluble polymer can include copolymers of methacrylic acid and ethyl acrylate (paragraph 0017).
Regarding claims 15-16, the films do not dissolve or disintegrate in acids, such as 0.1M hydrochloric acid (paragraph 0039). It is noted that said solution has a pH of about 1.0. Example 4 discloses the dry capsules resisted mechanical and acid stress of 0.1N HCl yet dissolved in pH 6.8 buffer. Capsules were intact after one hour in acidic environment and disintegrated in pH 6.8 buffer within 5 minutes.
Regarding claim 19, as noted above, the shell matrix can contain a fill that is liquid, semi-solid or solid (paragraph 0040).
Regarding claim 30, the only active method step of the is the administration of the capsule. Therefore, the oral administration of the capsule would necessarily result in the method recited.
Hassan does not disclose the use of dextrose as the reducing sugar. However, he does disclose the reducing sugar can be glucose, fructose or a combination thereof.
Coulter discloses a shell comprising dextrose (paragraphs 0366; 0376).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the composition of Hassan to include dextrose as the reducing sugar in order to have provided a shell for the benefit of providing a controlled release soft capsule comprising a pH sensitive shell to further modify release control by increasing permeability of a polymeric material (Coulter; paragraphs 0254, 0348, 0382). Additionally, dextrose is considered a functional equivalent of glucose and fructose in a capsule shell according to the disclosure of Coulter (paragraph 0366).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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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.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615