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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on June 3, 2026 is acknowledged.
Claims 1-2, 5-8, 12, 14-16, 19, 25, 30, 33, 53, 61, 65, 68, 70, and 75 are pending in this application. Claims 1, 6, and 25 have been amended.
Claims 3, 9-11, 13, 17-18, 20-24, 26-29, 31-32, 34-52, 62-64, 66-67, 69, 71-74, and 76-82 have been cancelled.
Claims 33, 53, 61, 65, 68, 70, and 75 remain withdrawn from consideration.
Therefore, claims 1-2, 5-8, 12, 14-16, 19, 25, and 30 remain under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 102
The rejection of claim 25 under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (US 10,357,467) has been withdrawn in view of the amendment to recite “low methoxyl pectin”.
Claim Rejections - 35 USC § 103
The rejection of claims 1-2, 4-8, 12, 14-16, 19, and 30 under 35 U.S.C. 103 as being unpatentable over Hassan (US 2012/0301546) in view of Coulter et al. (US 2016/0213611) has been withdrawn in view of the amendment to claim 1 to recite “low methoxyl pectin”.
Newly Applied Rejections
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.
Claims 1-2, 5-8, 12, 14-16, 19, 25, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan (US 2012/0301546) in view of Srivastava et al. (Sources of in Pectin, extraction, and its applications in pharmaceutical industry- An overview, Indian Journal of Natural Products and Resources, Vol 2(1), March 2011. Pp. 10-18) 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 acid insoluble polymer is disclosed to include pectin and copolymers of methacrylic acid and ethyl acrylate (paragraph 0017), which are synthetic polymers.
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, as noted above, the acid insoluble polymer can include copolymers of methacrylic acid and ethyl acrylate.
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 25, as noted above, the shell can include pectin and synthetic polymers. The recitation of “to attain a target pH dependent dissolution profile in acidic medium and/or in a buffer medium” is regarded as a necessary result of the shell matrix.
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.
While Hasan discloses the use of pectin, he does not recite low methoxyl pectin.
Srivastrava discloses sources of pectin used in pharmaceutical formulations. Pectin is divided not two major groups on the basis of their degree of esterification. The pectin, by itself or by its gelling properties, is employed in pharmaceutical industry as a carrier for drug delivery to the gastrointestinal tract, such as matrix tablets, gel beads, and film coated dosage forms (abstract).
Pectins are classified as high-ester or low-ester pectins; rather in short, HM (high-methoxy) versus LM (low-methoxy) pectins, with more or less than half of all the galacturonic acid esterified (Chemistry).
Powdered HM-pectins slowly lose their ability to form gels if stored under humid or warm conditions while LM-pectins are more stable and loss should not be significant after one year storage at room temperature (general properties of pectin).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used LM-pectin as the pectin recited in Hassan since it is disclosed the use of LM-pectin allows for the drug release pattern to be modified (pectin in medicine and pharmaceutical industry).
Hassan, additionally, 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
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 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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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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