DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed August 04, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informality:
Claim 1 requires a comma after the word hour in line 8 (“…about one hour, the capsule disintegrates…”). Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph (New, Necessitated by Amendment)
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-9, 11, 13-17, 19, 27-29, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it recites that the “pH dependent shell composition does not substantially dissolve or disintegrate in a basic environment for a time period of at least about one hour” and “the capsule disintegrates in at least about one hour in a basic medium”. These statements appear to be contradictory as the pH dependent shell is the shell of the capsule and for the capsule to disintegrate one would reasonably expect that the shell would need to disintegrate in the same (basic) environment. It is not clear how the shell composition can both disintegrate and not disintegrate in a basic environment. To overcome this rejection, the last limitation of the claim “and the capsule disintegrates in at least about one hour in a basic medium based on a disintegration test performed in a basket-rack assembly NT-40H model apparatus in a 1000 mL beaker at about 37°C ± 20°C” can be removed from the claim.
Claim Rejections - 35 USC § 112(a) (New, Necessitated by Amendment)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-9, 11, 13-17, 19, 27-29, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the present instance, claim 1, from which all claims depend, is drawn to a soft gel capsule, comprising a fill material and a pH dependent shell composition. Claim 1, as amended, recites both that the “pH dependent shell composition does not substantially dissolve or disintegrate in a basic environment for a time period of at least about one hour” and “the capsule disintegrates in at least about one hour in a basic medium”. These statements appear to be contradictory as the pH dependent shell is the shell of the capsule and for the capsule to disintegrate one would reasonably expect that the shell would need to disintegrate in the same (basic) environment. The specification provides no guidance on how the capsule would disintegrate in the basic environment while the pH dependent shell does not substantially dissolve or disintegrate, therefore, it is understood that the specification does not provide sufficient written support to support the claim limitations of both the “pH dependent shell composition does not substantially dissolve or disintegrate in a basic environment for a time period of at least one hour” and “the capsule disintegrates in at least about one hour in a basic environment”.
Furthermore, the specification does not provide sufficient written support to support the claimed limitations of “a pH dependent polymer that solubilizes at a pH of less than 6.0” and “the capsule disintegrates in at least about one hour in a basic medium”. It is not clear whether all potential combinations of the pH dependent shell which comprises a pH dependent polymer that solubilizes at a pH of less than 6.0 allowed by claim 1 would possess the property of disintegrating in at least about one hour in a basic medium. In the instant specification, examples of the capsules are given [0074]-[0086] with Eudragit E PO as the amino methacrylate copolymer, however, no solubility data is given. As previously noted by the Examiner, EUDRAGIT ® E PO is soluble below pH 5.0 (Eudragit, pg. 2). One of ordinarily skill in the art would expect EUDRAGIT ® E PO (and the pH dependent polymers as claimed) to dissolve in an acidic environment. Therefore, it is not clear whether all potential combinations of the pH dependent shell which comprises a pH dependent polymer that solubilizes at a pH of less than 6.0 would possess the property of disintegrating in at least about one hour in a basic medium and the specification does not provide sufficient written support to describe all embodiments of the claimed compositions.
Claim Interpretation/Response to Arguments
The U.S. 35 USC § 112(a) and U.S. 35 USC § 112(b) rejection(s) are newly applied based on the amended claims and have not been traversed.
As discussed above, the claim language is indefinite because it is not clear how the capsule can both dissolve and not dissolve in a basic medium.
The closest prior art, Vamvakas et al. (US 2015/0108033 A1) would meet the claim limitations of claim 1 if the last limitation of the claim “and the capsule disintegrates in at least about one hour in a basic medium based on a disintegration test performed in a basket-rack assembly NT-40H model apparatus in a 1000 mL beaker at about 37°C ± 20°C” were to be removed from the claim because Vamvakas discloses the soft capsule shell comprises gelatin and a methacrylic acid copolymer, such as EUDRAGIT ® E PO [0102] [0106], which is soluble below pH 5.0 (Eudragit, pg. 2). This capsule with the EUDRAGIT ® E PO copolymer would be reasonably expected to dissolve in an acidic environment.
Because the Examiner must consider all claim limitations when applying art, Vamvakas cannot be applied as a prior art rejection because the capsules of Vamvakas would not be expected to both dissolve and not dissolve in a basic medium. However, as discussed in detail above, this combination of claim limitations does not appear to be possible and the indefinite language in the claim as amended forbids the application of the prior art (even though the rejection over Vamvakas would apply if the last limitation were to be removed from the claim).
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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