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 .
Claim Status
Applicant’s specification, drawing, and claim amendments in the response filed 17 March 2026 are acknowledged.
Claims 1-3, 5, 8, 9, 12-14, 16, 17, 20-22, 26-30 & 33 are pending.
Claims 4, 6, 7, 10, 11, 15, 18, 19, 23-25, 31 & 32 are cancelled.
Claims 1, 12, 13, 17 20 & 21 are amended.
Claims 16, 26-30 & 33 are withdrawn.
Claims 1-3, 5, 8, 9, 12-14, 17 & 20-22 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 January 2026 has been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Drawings
The drawings were received on 17 March 2026. These drawings are accepted.
Withdrawn Objections/Rejections
The objection to the drawing is withdrawn due to amendments which correct the figure label.
The objection to the disclosure is withdrawn due to amendments to refer to the singular figure as "The Figure".
The rejection of claims 12, 13 & 17 under 35 USC 112(b)-lack of antecedent basis is withdrawn due to amendments which provide antecedent basis by reciting the “shell composition”.
The rejection of claims 1-3, 5, 8, 9, 12-14, 17 & 20-22 under 35 U.S.C. 103 over Tanner in view of Kondo is withdrawn due to amendments which recite the water soluble polymer is present in an amount of about 0.5 wt% to about 12 wt.%.
The provisional rejection of claims 1-3, 5, 8, 9, 12-14, 17 & 20-22 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18,940,147 in view of Tanner and Kondo is withdrawn due to amendments which recite the water soluble polymer is present in an amount of about 0.5 wt% to about 12 wt.%.
Objections/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 1-3, 5, 8, 9, 12-14, 17 & 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tanner (US 2002/0081331; Published: 06/27/2002; previously cited) in view of Huo (CN 101628117; Published: 01/20/2010).
*All references refer to the English language translation.
Claim Analysis: The instant specification at paragraph [0046] discloses “The starch can be modified starch or native starch…hydroxypropylated starch….” As such, the claim 1 recitation of “starch” is interpreted as encompassing modified starch.
*All references refer to the English language translation.
With regard to claims 1, 2, 8, 20 & 21, Tanner in Table VI Formulation #32 teaches a wet film for soft gel capsules comprising iota carrageen (i.e. non-animal gelling agent) and modified starch (i.e. Pure Cote B760-non-animal gelling agent; [0115]; [0118]). With regard to claims 3 & 17, Tanner in Table VI Formulation #32 teaches inclusion of the plasticizer, glycerin, in an amount of 21% of the wet film [0118]. With regard to claim 9, Tanner teaches the ratio of carrageenan to starch is 10.25 to 25.75 (i.e. 1: 2.51). With regard to claim 9, more broadly, Tanner teaches the ratio of iota-carrageenan to modified starch ranges from 1:1.5 to 1: 4.0 (Tanner’s claim 2). With regard to the dissolution properties as recited by claims 1 & 20, Tanner in Table VI Formulation #32 teaches the Formulation #32 is found to dissolve or disintegrate in about 5 minutes [0119]. With regard to claims 12 & 21, Tanner in Table 1 teaches a prototypic formulation for a wet film which comprises 6-12% iota-carrageenan and 12-30% modified starch position [0033]. With regard to claim 12, as such, Tanner teaches the non-animal gelling agent comprises 18-42% of the composition (Math: 6 + 12= 18; 12 + 30= 42). With regard to claims 13 & 14, the prototypic and Table VI Formulation #32 wet films do not contain animal derived gelling agents ([0033] & [0118]). With regard to claims 1, 20, 21 & 22, Tanner teaches the fill materials include oils and hydrophobic actives and in Example 7 teaches the fill is vitamin E (i.e. a lipophilic active which is encapsulated in the fill composition; [0091]; [0118]). With regard to claims 1, 20 & 21, Tanner teaches their capsules “are similar in appearance to traditional softgels” [0108]. Tanner teaches inclusion of other plasticizers in the films for soft capsules of their invention [0084]. Tanner in discussing the background art of their invention discusses comestible/edible capsules [0028].
Tanner does not teach inclusion of a water soluble polymer which is polyvinyl alcohol or it’s amount.
In the same field of invention of soft capsules, with regard to claims 1, 5, 20 & 21, Huo teaches soft capsule shells promising 0.1-1 wt. carrageenan and 2-5wt.% polyvinyl alcohol (i.e. water soluble polymer; abstract). With regard to claim 20, Huo teaches the capsules of their invention are pharmaceutical capsules (i.e. active agent; pg. 2). Huo teaches their capsules have the advantages of small mechanical strength and toughness (abstract). With regard to claims 1, 5, 20 & 21, Huo teaches polyvinyl alcohol has hygroscopicity and it makes the water content of the soft capsule shell to suitably rise, but too much makes the capsules stick together (pg. 2). Huo teaches the addition of polyvinyl alcohol also reduces the mechanical strength and the toughness of the chewing soft capsule (pg. 6).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the capsule suggested by Tanner by adding 2-5% polyvinyl alcohol as suggested by Huo because Tanner and Huo are directed to soft capsules which comprise carrageenan and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to increase the water content of the capsule shell and reduce its mechanical strength and toughness through inclusion of 2-5% polyvinyl alcohol as taught by Huo.
With regard to the recited amounts of weight ratio of carrageenan to starch, non-animal gelling agent, animal derived gelling agent, water-soluble polymer/polyvinyl alcohol and plasticizer, the combined teachings of Tanner and Huo suggest these parameters with values that fall within or overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to the recitation that the shell composition completely dissolves in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddles at 75 RPM in 900 ml of 0.1 N HCL and deionized water at 37 degrees C, the soft capsules suggested by the combined teachings of Tanner and Huo necessarily dissolve in less than 30 minutes under the recited dissolution conditions because they comprise the recited reagents in the recited amounts. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This assertion is supported by Tanner’s teaching that the Table VI Formulation #32 dissolved or disintegrated in about 5 minutes [0119]. This assertion is further supported by the as-filed specification’s disclosure that links the dissolution rate to the “softgel capsule shell composition comprising a non-animal derived gelling agent and a water soluble polymer” at paragraph [0030]. The combined teachings of Tanner and Huo suggest a softgel capsule comprising carrageenan and starch as the non-animal derived gelling agent and polyvinyl alcohol as the water soluble polymer. As such, the formulation suggested by the combined teachings necessarily have the recited dissolution parameters.
Response to Arguments
In the traverse of the rejection of claims 1-3, 5, 8, 9, 12-14, 17, and 20-22 under 35 USC 103 as over Tanner in view of Kondo, Applicant argues Tanner and Kondo fail to teach the claimed amount of water soluble polymer of about 0.5 wt.% to about 12 wt.% based on total weight of the shell composition (reply, pg. 9). Applicant further argues there is no motivation to combine the teachings of Tanner and Kondo in that Kondo’s softgel capsule is chewable and a chewable soft gel would not be expected to have the same dissolution properties as that intended to rapidly dissolve in gastric fluid (reply, pg. 9-10).
Applicant’s arguments 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 8, 9, 12-14, 17 & 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 31-34 & 39 of copending Application No. 18/940,147 (hereinafter ‘147; claims filed: 06/03/2026) in view of Tanner (US 2002/0081331; Published: 06/27/2002) and Huo (CN 101628117; Published: 01/20/2010). Both the ‘147 and the instant application recite a softgel capsule comprising an oil/lipophilic fill material and comprises an active agent. The softgel composition comprises carrageenan and starch in a ratio that is about 1:1 to about 1:10. The soft gel comprises a polyvinyl alcohol, plasticizer, and surfactants. The ‘147 recites the softgel film dissolves in less than 15 minutes. The ‘147 does not teach the amount of plasticizer, the amount of polyvinyl alcohol/water soluble polymer or amount of gelling agent/carrageenan + starch. The teachings of Huo are described above with regard to the amount of water soluble polymer/polyvinyl alcohol. The teachings of Tanner are described above. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the shell composition of the ‘147 application by adjusting the amount of plasticizer to be 21% and the amount of non-animal gelling agent/carrageenan + starch to be 18-42% and adding 2-5% polyvinyl alcohol as suggested by combined teachings of Tanner and Huo because the ‘147 application, Tanner and Huo are directed to soft capsules and it is obvious to modify to similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide the capsule ingredients in quantities art recognized as suitable for soft capsules and alter the mechanical strength of the shell.
The pending claims are therefore an obvious variant of the conflicting, copending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5, 12, 17 & 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 9, 15, 19 & 34 of copending Application No. 18/031,669 (hereinafter ‘669; claims filed: 05/19/2026). Both the ‘669 and the instant application recite a softgel composition comprising about 2 wt.% to about 20 wt.% pectin and polyethylene glycol having a molecular weight from about 200 to about 5000 Daltons (i.e. high molecular weight polyethylene glycol) in an amount of above 0 wt% and up to about 70 wt%. The ‘669 further recites the composition comprises a plasticizer and pharmaceutically active ingredients (i.e. fill). With regard to the dissolution properties recited by the instant application, the ‘669 application necessarily has the recited dissolution properties because the ‘669 recites the same reagents in the recited amounts and "[p]roducts of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The pending claims are therefore an obvious variant of the conflicting, copending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5, 8, 9, 12-14, 17, 20 & 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,980,916 (hereinafter ‘916; Issued: 05/29/2018). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘916 and instant application recite soft capsules. The soft capsules of the ‘916 comprise at 6.3% glycerol/plasticizer, 3.1% carrageenan, 9.2% hydroxypropyl starch phosphate, and 2.4% polyvinyl alcohol-polyethylene glycol graft copolymer/water soluble polymer. Since the composition is a capsule is necessarily has a fill because capsules are made to envelope capsule fills. The capsule dissolves at a pH of 6.8 within 30 minutes.
The pending claims are therefore an obvious variant of the conflicting, patented claims.
Claims 1-3, 5, 8, 9, 12-14, 17, 20 & 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,182,989 (hereinafter ‘989; Issued: 01/22/2019). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘989 and instant application recite soft capsules which encapsulate a fill. The soft capsules of the ‘989 comprise at 6.3% glycerin/plasticizer, 3.1% carrageenan, 9.2% hydroxypropyl starch phosphate, and 2.4% polyvinyl alcohol-polyethylene glycol graft copolymer. Since the composition is a capsule is necessarily has a fill. The capsule dissolves at a pH of 6.8 within 30 minutes.
The pending claims are therefore an obvious variant of the conflicting, patented claims.
Response to Arguments
Applicant argues the present claims are patentably distinct over the claims of the ‘147 application in view of Tanner and the claims of the ‘669 application because they do not recite the claimed amount of water soluble polymer (reply, pg. 11).
This is not persuasive. With regard to the ‘147 application, Applicant’s arguments 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. In particular, Huo teaches inclusion of 2-5% polyvinyl alcohol to alter the water content of the shell and alter the mechanical strength of the shell.
With regard to the ‘669 application, the ‘669 recites inclusion of polyethylene glycol having a molecular weight from about 200 to about 5000 Daltons (i.e. high molecular weight polyethylene glycol/water soluble polymer) in an amount of above 0 wt% and up to about 70 wt%. This amount overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant argues the nonstatutory double patenting rejections of the pending claims over US Patent No. 9,980,916 and US Patent No. 10,182,989, requesting withdrawal of the rejections because these patents were not commonly owned (reply, pg. 11).
This is not persuasive. The ‘916, ‘989 and the instant application share a common inventor (i.e. Qi Fang). The nonstatutory double patenting are appropriate (See MPEP 804).
Conclusion
No claims are allowed.
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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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