DETAILED ACTION
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/2026 has been entered.
Previous Rejections
Applicants' arguments, filed 02/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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 1-4, 6-9, 11, 13-16, 19, 25, 27, 29, and 32 are rejected under 35 U.S.C. 103 as being as being obvious over Vamvakas et al. (US 2015/0108033 A1) and as evidenced by (EUDRAGIT).
Regarding claim 1, Vamvakas discloses an oral pharmaceutical composition comprising a matrix fill [0009] [0069] encapsulated in a soft capsule shell [0106] where the matrix fill includes at least one solubility enhancing agent, water, and at least one active pharmaceutical ingredient, [0009] [0069]. The soft capsule shell comprises gelatin and a methacrylic acid copolymer, such as EUDRAGIT ® E PO [0102] [0106]. Water comprises about 1% to about 7% of the matrix fill mass and the solubility enhancing agent, such as polyethylene glycol, is present in an amount of about 40% to about 85% of the matrix fill mass [0009] [0069].
Vamvakas is not believed to be anticipatory because Vamvakas could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to include EUDRAGIT ® E PO taught at [0102] within the shell composition taught at [0106].
Nevertheless, claim 1 is rendered prima facie obvious over the teachings of Vamvakas, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., liquid fill material with water; gelatin shell with methacrylic acid copolymer; EUDRAGIT E PO) were known in the prior art (e.g., Vamvakas) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a soft gel capsule) to one of ordinary skill in the art. MPEP 2143.A.
As evidenced by EUDRAGIT, EUDRAGIT ® E PO is soluble below pH 5.0 (Eudragit, pg. 2). Therefore, the pH dependent polymer, EUDRAGIT ® E PO, in the shell of the capsule would result in a pH dependent shell composition that dissolves in acidic gastric fluid.
Regarding the amount of the liquid medium comprising water. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Claim 2 is rendered prima facie obvious because Vamvakas discloses an active agent dissolved or suspended in the liquid medium fill (depends on drug type and pH value of fill) [0009] [0062]-[0063] [0125]-[0143] and that the fill material has a pH value of 3.5 to 8.5 [0061]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 3 is rendered prima facie obvious because Vamvakas taught EUDRAGIT ® E PO [0102] and as evidenced by EUDRAGIT, EUDRAGIT ® E PO is soluble below pH 5.0 (Eudragit, pg. 2).
Claims 4 and 6 are rendered prima facie obvious because Vamvakas taught the amino methacrylate copolymer, EUDRAGIT ® E PO [0102].
Claim 7 is rendered prima facie obvious because Vamvakas discloses the methacrylic acid copolymer is present in the shell composition in an amount of 8-20 wt.% [0106]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 8 is rendered prima facie obvious because Vamvakas discloses gelatin is present in the shell composition in an amount of 20-36 wt.% [0106]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 9, 11, and 13 are rendered prima facie obvious because Vamvakas discloses the shell includes a pH modifier in an amount of 0.5-2 wt.% [0106] and Vamvakas teaches pH modifiers include succinic acid [0013]. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In regards to the amount recited in claim 13, a prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 14-16 are rendered prima facie obvious because Vamvakas discloses the shell includes a plasticizer, such as glycerol, in an amount of 15-22 wt.% [0106] [0119]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 19 and 32 are rendered prima facie obvious because Vamvakas discloses the matrix includes the solubility enhancing agent, polyethylene glycol [0009] [0069].
Regarding claim 25, Vamvakas does not explicitly disclose that the soft-gel capsule disintegrates in less than about 60 minutes in a gastric environment based on the claimed test. While this time for disintegration is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the teachings of the prior art disclose a capsule shell with the same components (e.g., pH dependent polymer that solubilizes at a pH less than 6.0, gelatin), the properties the applicant discloses and/or claims would reasonably be expected to be necessarily present.
Claim 27 is rendered prima facie obvious because Vamvakas discloses the matrix fill includes an active ingredient that is at least sparingly/slightly soluble in water [0009] [0127] [0033].
Claim 29 is rendered prima facie obvious because Vamvakas discloses that the fill material has a pH value of 3.5 to 8.5 [0061]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 17 is rejected under 35 U.S.C. 103 as being as being obvious over Vamvakas et al. (US 2015/0108033 A1) as evidenced by (EUDRAGIT) and further in view of Hu et al. (US 2015/0366814 A1).
The 35 U.S.C. 103 rejection over Vamvakas as evidenced by EUDRAGIT was previously discussed.
Vamvakas does not disclose the gelatin comprises Type A or B gelatin as recited in claim 17.
Hu discloses a soft capsule gelatin shell with Type A and Type B gelatin and a matrix fill [abstract] [0078].
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Vamvakas generally taught a soft capsule gelatin shell, it is prima facie obvious to select Type A or Type B gelatin for use in a gelatin shell based on its recognized suitability for the intended use as type of gelatin for use in a soft capsule shell, as taught by Hu.
Claim 28 is rejected under 35 U.S.C. 103 as being as being obvious over Vamvakas et al. (US 2015/0108033 A1) as evidenced by (EUDRAGIT) and further in view of in view of Coulter (WO 2006/035418 A2).
The 35 U.S.C. 103 rejection over Vamvakas as evidenced by EUDRAGIT was previously discussed.
Vamvakas does not disclose that the capsule comprises levothyroxine or a pharmaceutically acceptable salt thereof, as recited in claim 28.
Coulter discloses a capsule with a gelatin shell and liquid core (Claim 89; pg. 30, lines 5-6) where the core contains at least one active ingredient (Claim 6), such as levothyroxine (pg. 102, lines 18-19).
It is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., liquid fill material with active ingredient; levothyroxine as active ingredient in liquid core) were known in the prior art (e.g., Vamvakas and Coulter) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a soft gel capsule) to one of ordinary skill in the art. MPEP 2143.A.
Response to Arguments
Applicant' s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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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