DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 38-40, 47-48, 50 are withdrawn.
Claims 1-12, 15, 19, 29-31, 33-34, 49, and 54 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 11/07/2025 has been entered.
Claims 18 and 20 were canceled. Claims 1-2, 11, and 19 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the claims, specification, and drawing, and the rejections of claims 11 and 19 under 35 U.S.C. 112(b).
The previous rejections of claims 18 and 20 are moot, because the claims were canceled.
The rejections of claim 2 under 35 U.S.C. 112(b) and claims 1-12, 15, 19, 29-31, 33-34, 49, and 54 under 35 U.S.C. 103 have been modified to address the amendments and maintained.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
Regarding the rejection of claim 2 under 35 U.S.C. 112(b), Applicant argues that “a cellulose derivative” is clear and definite to one of skill in the art, and refers to a class of polymeric substances chemically modified from native cellulose (Remarks, page 10). This argument is not persuasive, because this definition also does not provide a requisite degree, and therefore it is unclear how far one can deviate from the parent compound “cellulose” without the “derivative” being so far removed therefrom as to be considered a different compound. The Examiner suggests modifying the claim to list specific examples in place of “cellulose derivatives”, as listed in the instant specification (paragraph 0096).
Applicant argues that Hu fails to teach or suggest an amount of gelatin above 40% as stated in the amended claim 1 (Remarks, pages 10-11). This argument is not persuasive, because as previously stated, Hu teaches the shell composition can comprise a combination of two gelatins in 25-37% and 32-37% by weight each (Hu, column 12, table 1), resulting in a gelatin content of 57-74%, which lies within the newly amended claimed range.
Applicant argues that Hu teaches the total plasticizer in the shell can be included in an amount of 8-20%, and fails to teach or suggest dextrose as an excipient for the shell composition (Remarks, page 11). Applicant further states that Hu fails to recognize the effect that dextrose may have on the gel strength and dissolution properties of the shell composition and therefore there would be no reason for one of skill in the art to modify the amount of dextrose to arrive at the claimed invention (Remarks, page 12). This argument is not persuasive, because Hu teaches the shell composition comprises excipients in 1-5% by weight (Hu, column 16, table 2) and specifies the shell can comprise flavorings and other conventionally accepted pharmaceutical excipients (Hu, column 10, lines 31-32). Hu teaches dextrose as an excipient and sweetening agent (Hu, column 26, line 28), suggesting dextrose is a conventionally accepted pharmaceutical excipient. Therefore, it would be obvious to one of ordinary skill in the art to use dextrose as the excipient in the shell composition. Further, Hu teaches the final enteric capsule composition provides films of increased strength (Hu, column 19, lines 65-66), and describes enteric as resistant to dissolution in certain fluids (Hu, column 7, lines 53-59). Therefore, it would be reasonable to expect the composition of Hu would display such properties.
Information Disclosure Statement
The information disclosure statements filed 10/28/2025 and 01/08/2026 have been considered.
New Claim Objections
Claims 1, 11, and 19 are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1, “the amount of gelatin” should read “an amount of gelatin”, “the amount of dextrose” should read “an amount of dextrose”, “dry weight” should read “a dry weight”, and "dry pH dependent shell weight" should read "a dry pH dependent shell weight".
Regarding claim 11, “USP Apparatus II” should read “a USP Apparatus II”.
Regarding claim 19, "dry pH dependent shell weight" should read "a dry pH dependent shell weight".
Modified/Maintained 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 2 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.
Regarding claim 2, term “derivative” is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from the parent compound “cellulose” without the “derivative” being so far removed therefrom as to be considered a different compound.
Modified/Maintained 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, 4-12, 15, 19, 29-31, 33-34, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 10357467 B2; IDS reference, 04/13/2023). The references were cited previously by the Examiner.
Regarding claim 1, Hu teaches an enteric soft shell capsule comprising a gelatin composition (Hu, column 3, lines 5-6) having a matrix fill, wherein the matrix fill includes an active pharmaceutical ingredient (i.e. active agent; Hu, column 36, lines 31-34) and teaches the structured internal matrix provides controlled drug release (i.e., a controlled release fill composition; Hu, column 27, lines 65-67). Hu teaches the enteric shell dissolves under specific pH conditions (i.e., a pH dependent shell; Hu, column 3, lines 30-33), and can comprise gelatin, pectin, and a plasticizer (Hu, column 3, lines 8-11), Hu teaches the matrix fill can further comprise polyethylene oxide (i.e., a controlled release material according to the instant claim 2; Hu, column 26, line 25). Hu teaches the shell composition comprises excipients in 1-5% by weight (Hu, column 16, table 2), and teaches dextrose is an excipient, a sweetening agent (Hu, column 26, line 28). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize dextrose as the excipient in 1-5% by weight, which overlaps 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. See MPEP §2144.05(I). Hu teaches the shell composition can comprise a combination of two gelatins in 25-37% and 32-37% by weight each (Hu, column 12, table 1), resulting in a gelatin content of 57-74%, which lies within the claimed range.
Hu is considered to be analogous to the claimed invention, because both Hu and the instant invention are in the field of soft shell gelatin capsules. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Hu under the meaning of 35 U.S.C. 103.
Regarding claim 2, Hu teaches all the elements of the current invention as applied to claim 1. As above, Hu teaches the matrix fill can further comprise polyethylene oxide (i.e., a controlled release material according to the instant claim 2; Hu, column 26, line 25).
Regarding claim 4, Hu teaches all the elements of the current invention as applied to claim 2. Hu teaches the matrix fill can further comprise microcrystalline cellulose (i.e., a controlled release material from the claimed list; Hu, column 26, lines 21-22).
Regarding claim 5, Hu teaches all the elements of the current invention as applied to claim 2. Hu teaches the matrix fill can further comprise guar gum (i.e., a controlled release material from the claimed list; Hu, column 26, line 22).
Regarding claim 6, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the matrix fill comprises a hydrophilic polymer such as Carbopol or guar gum (i.e., a suitable controlled release material according to the instant claim 5; Hu, column 27, lines 25-32) and exemplifies a matrix fill formulation comprising 9% by weight of Carbopol (Hu, column 51, table 14, example 6). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use guar gum in the same amount, which lies within the claimed weight range.
Regarding claim 7, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the matrix fill may include one or more hydrophilic carriers, such as polyethylene glycol (Hu, column 27, lines 17-18) and teaches a polyethylene glycol having a molecular weight of about 200-800 Dalton (Hu, column 4, lines 32-33), which lies within the claimed range.
Regarding claim 8, Hu teaches all the elements of the current invention as applied to claim 7. Hu teaches the matrix fill may include one or more hydrophilic carriers, such as polyethylene glycol (Hu, column 27, lines 17-18).
Regarding claim 9, Hu teaches all the elements of the current invention as applied to claim 7. Hu teaches the matrix fill may include one or more hydrophilic carriers, such as polyethylene glycol (Hu, column 27, lines 17-18), and teaches polyethylene glycol in 10% by weight of the matrix fill formulation (Hu, column 51, table 15, example 2), which lies within the claimed range.
Regarding claim 10, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the active pharmaceutical ingredient comprises about 60% of the matrix fill mass (Hu, column 5, lines 5-6).
Regarding claim 11, Hu teaches all the elements of the current invention as applied to claim 1. Hu does not specifically state the dissolution test is fiber optic or the paddle speed, but teaches a measurement of the release of the active pharmaceutical ingredients in buffered media at a pH of 6.8 in USP paddle disintegration tests (Hu, column 49, lines 4-7), resulting in about 0% active ingredient released at 0.5 hours (Hu, figure 1), which lies within the claimed range of less than about 85%. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 12, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the formed and dried capsules are then dried on trays in a temperature controlled oven (an annealing step is a final heating step of the dried capsule as defined by the instant specification, page 26, paragraph 00120; Hu, column 48, lines 57-59).
Regarding claim 15, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the shell comprises adding a plasticizer (Hu, column 3, lines 38-41).
Regarding claim 19, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the shell composition comprises 2-7% by weight of an anionic polysaccharide such as pectin (Hu, column 12, table 1), which lies within the claimed range. As above, Hu teaches a step of combining dry shell components (Hu, column 3, lines 38-40), suggesting the weight percentage is based on the dry components.
Regarding claim 29, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the capsule comprises pectin and gelatin (Hu, claim 1) and can comprise plasticizers such as dextrose (Hu, column 11, lines 52-57), but does not teach any other required pH dependent polymers. Therefore, a composition free of additional pH dependent polymers would be prima facie obvious based on the teachings of Hu.
Regarding claim 30, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches a viscosity of the gelatin (Hu, claim 1), but does not teach a viscosity of the shell composition. Hu does, however, teach the enteric shell comprising gelatin, pectin, and a plasticizer (Hu, column 3, lines 8-11), such as dextrose (Hu, column 11, line 57), as claimed. As evidenced by the instant specification, pectin and gelatin interact with each other to increase the viscosity (specification, page 50, paragraph 00208) and a formulation comprising pectin in a range of 7-12% by weight and gelatin in a range of 45-65% by weight results in a viscosity of 115,000 cPs (specification, page 44, table 3, lot 1). Hu teaches the shell composition can comprise pectin in 2-7% by weight (Hu, column 12, table 1) and two gelatins with a Bloom strength ranging from 30-400 (Hu, column 10, lines 61-63), which includes 250 and 150 Bloom gelatin (i.e., suitable gelatins as defined by the instant specification, paragraph 00125), in 25-37% and 32-37% by weight each (Hu, column 12, table 1), resulting in a gelatin content of 57-74%. The ranges for pectin and gelatin taught by Hu each overlap the range demonstrated in the instant specification to result in the claimed viscosity. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Therefore, it would be reasonable to expect the composition taught by Hu would also result in the viscosity as claimed.
Regarding claim 31, Hu teaches all the elements of the current invention as applied to claim 1. Hu exemplifies a capsule formulation comprising 35.4% by weight of gelatin and 2.87% by weight of pectin (Hu, column 48, table 10, example 1), resulting in a ratio of 12.3:1 of gelatin to pectin, which lies within the claimed range.
Regarding claim 33, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the structured internal matrix provides controlled drug release (i.e., a controlled release fill composition; Hu, column 27, lines 65-67) and exemplifies a capsule matrix comprising a ratio of diclofenac (i.e., an active pharmaceutical ingredient) to matrix fill of 0.3:1 (Hu, column 51, table 16, example 1), resulting in a ratio of 3.3:1 of controlled release material to active ingredient, which lies within the claimed range.
Regarding claim 34, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the composition comprises an active pharmaceutical ingredient or a nutraceutical (Hu, column 4, lines 1-17).
Regarding claim 54, Hu teaches an enteric soft shell capsule comprising a gelatin composition (Hu, column 3, lines 5-6) having a matrix fill, wherein the matrix fill includes an active pharmaceutical ingredient (i.e. active agent; Hu, column 36, lines 31-34) and teaches the structured internal matrix provides controlled drug release (i.e., a controlled release fill composition; Hu, column 27, lines 65-67). Hu teaches the enteric shell dissolves under specific pH conditions (i.e., a pH dependent shell; Hu, column 3, lines 30-33). Hu teaches the matrix fill can further comprise polyethylene oxide (i.e., a controlled release material according to the instant claim 2; Hu, column 26, line 25).
Claims 3 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 10357467 B2; IDS reference, 04/13/2023) as applied to claims 1-2, 4-12, 15, 19, 29-31, 33-34, and 54, further in view of Oshlack (US 20030068371 A1). The references were cited previously by the Examiner.
Regarding claim 3, Hu teaches all the elements of the current invention as applied to claim 1. Hu teaches the matrix fill can further comprise polyethylene oxide (i.e., a controlled release material according to the instant claim 2; Hu, column 26, line 25), but does not teach a polyethylene oxide of a specific molecular weight. Oshlack teaches an oral dosage form which can be a soft gelatin capsule (Oshlack, page 13, paragraphs 0146-0147) for modified release (Oshlack, page 2, paragraph 0031) which comprises polyethylene oxide having an average molecular weight of 1M Dalton (Oshlack, page 16, paragraph 0179), which lies within the claimed range.
Hu and Oshlack are considered to be analogous to the claimed invention, because Hu, Oshlack, and the instant invention are all in the same field of modified release softgel capsules. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Hu to utilize the specific polyethylene oxide taught by Oshlack, because Hu does not specify a suitable molecular weight, while Oshlack teaches the polyethylene oxide of the claimed size to be a pharmaceutically acceptable polymer (Oshlack, page 16, paragraph 0183) for use in softgel capsules.
Regarding claim 49, Hu teaches an enteric soft shell capsule comprising a gelatin composition (Hu, column 3, lines 5-6) having a matrix fill, wherein the matrix fill includes an active pharmaceutical ingredient (i.e. active agent; Hu, column 36, lines 31-34) and teaches the structured internal matrix provides controlled drug release (i.e., a controlled release fill composition; Hu, column 27, lines 65-67). Hu teaches the enteric shell dissolves under specific pH conditions (i.e., a pH dependent shell; Hu, column 3, lines 30-33), and can comprise gelatin, pectin, and a plasticizer (Hu, column 3, lines 8-11), such as dextrose (Hu, column 11, line 57). Hu teaches the matrix fill can further comprise polyethylene oxide (i.e., a controlled release material according to the instant claim 2; Hu, column 26, line 25), but does not teach a polyethylene oxide of a specific molecular weight. Oshlack teaches an oral dosage form which can be a soft gelatin capsule (Oshlack, page 13, paragraphs 0146-0147) for modified release (Oshlack, page 2, paragraph 0031) which comprises polyethylene oxide having an average molecular weight of 1M Dalton (Oshlack, page 16, paragraph 0179), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Hu to utilize the specific polyethylene oxide taught by Oshlack, because Hu does not specify a suitable molecular weight, while Oshlack teaches the polyethylene oxide of the claimed size to be a pharmaceutically acceptable polymer (Oshlack, page 16, paragraph 0183) for use in softgel capsules.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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