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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-6, 8-10, 12, 13, 15, 16, 20 and 21, drawn to an aqueous film-forming composition.
Group II, claim(s) 25, 26, 29 and 30, drawn to a capsule shell.
Group III, claim(s) 32, drawn to a method for producing capsule film, capsule shell or capsule.
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising (a) alginate having a viscosity in the range of about 2-200 mPaS measured at 1 wt.% solution in water at 20oC and (b) a film forming polymer having a viscosity in the range of about 2-20 mPaS measured at 2 wt.% solution in water at 20oC, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Perrie et al (US 2010/0113620 A1) as discussed in detail in Paragraph 15 below.
During a telephone conversation with Mr. Rayn Douglas (applicant’s representative) on September 2, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-6, 8-10, 12, 13, 15, 16, 20 and 21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 25, 26, 29, 30 and 32 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 5 is objected to because of the following informalities: on line 3, applicant need to change “(CMC) and” to --- (CMC), ---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: on line 2, applicant need to insert --- consisting --- between “the group” and “of”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: on the last line, applicant need to insert --- film-forming --- between “the aqueous” and “composition”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: on lines 4-5, and also on the last two lines, applicant need to insert --- film-forming --- between “the aqueous” and “composition”. Appropriate correction is required.
Claims 20 and 21 are objected to because of the following informalities: on line 2 of claim 20 and also on line 4 of claim 21, applicant need to insert --- film-forming --- between “the aqueous” and “composition”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 21 is 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 21 recites the limitation "the gelling temperature" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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(s) 1-6, 8-10, 12, 15, 16, 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perrie et al (US 2010/0113620 A1) (with (i) “PharmacoatTR” (a product technical data sheet by ShinEtsu, obtained from the website: https://www.metolose.jp/en/pharmaceutical/tc-5.html, which is being cited here merely to support the Examiner’s assertion that Pharmacoat 606 is a HPMC substitution type 2910 polymer with a viscosity of 6 mPaS measured at 2 wt.% aqueous solution at 20oC); and (ii) Dettmar et al (US 2003/0176394 A1), which is being cited here merely to support the Examiner’s assertion that Protonal LFR 5/60 is a sodium alginate having a viscosity of 6 mPaS measured at 1 wt.% aqueous solution at 20oC).
Perrie teaches (abstract and [0017]) a hard enteric capsule material containing (a) a film-forming water-soluble polymer, (b) an acid-insoluble polymer, (c) a gelatinizing agent, (d) an auxiliary for gelation, (e) at least one plasticizer and (f) optionally, minor ingredients such as coloring agents and flavoring agents, the balance of the composition being water. Perrie teaches (claims 10, 11 and 15) that the film-forming water-soluble polymer (a) is hydroxypropylmethyl cellulose (HPMC) and the acid-insoluble polymer is alginate. More specifically, in its Example 1, Perrie teaches (see Formulations 1-4) its inventive enteric polymer compositions containing 15-18 wt.% of HPMC (available under the product name “Pharmacoat 606”) and 1-7.5 wt.% of Alginate (available under the product name “Protonal LFR 5/60”). As evidenced by “PharmacoatTR” (a product technical data sheet by ShinEtsu, obtained from the website: https://www.metolose.jp/en/pharmaceutical/tc-5.html), Pharmacoat 606 (HPMC used in Perrie) is a HPMC substitution type 2910 polymer (instant hypromellose 2910 of claim 8) with a viscosity of 6 mPaS measured at 2 wt.% aqueous solution at 20oC. As evidenced by Dettmar et al (see [0010], [0011], Table 1 and [0019]), Protonal LFR 5/60 (alginate used in Perrie) is a sodium alginate having a viscosity of 6 mPaS measured at 1 wt.% aqueous solution at 20oC.
Thus, Perrie teaches instant claims 1-6, 8, 15 and 16.
With respect to instant claims 9 and 10, Perrie teaches ([0052]-[0053]) that the formulations 1-4 of its Example 1 were cooled and cast to produce films, and puncture tests were carried out on the films. Perrie teaches ([0053]-[0054]) that addition of polyethylene glycol (instant polyol plasticizer of claim 10) as a plasticizer to its formulations improved the puncture resistance of the films. Thus, Perrie teaches instant claims 9 and 10.
With respect to instant claim 12, Perrie’s formulations of its Example 1 contain NaCl (instant cationic salt) as its auxiliary for gelation. Thus, Perrie teaches instant claim 12.
With respect to instant claims 20 and 21, since Perrie meets instant aqueous film-forming composition of claim 1, such composition would naturally or inherently have instant gelation temperature (Tgel) in the range of 15-45oC as well as a viscosity in the range of about 500 to about 6000 mPaS measured at a temperature in the range of 9oC-1oC below the gelling temperature of the aqueous composition measured by a Brookfield type RV viscometer using Brookfield spindle 2 as recited in claim 21. Thus, Perrie teaches instant claims 20-21.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Perrie et al (US 2010/0113620 A1).
As discussed above, Perrie’s formulations of its Example 1 contain NaCl (as its auxiliary for gelation). Perrie further teaches that for its auxiliary for gelation, divalent cations such as Ca2+ or Mg2+ can also be used. Thus, it would be obvious to one skilled in the art to use CaCl2 or MgCl2 (instant cationic salts of claim 13) as its auxiliary for gelation in Perrie’s formulations of Example 1 with a reasonable expectation of success. Thus, Perrie renders obvious instant claim 13.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public
PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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 .
/SIN J LEE/
Primary Examiner, Art Unit 1613
September 5, 2026
Prosecution Insights