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Claims 38-40, 47-48, 50 are withdrawn.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, and 49 are pending and represent all claims currently under consideration.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks (pages 8-9), filed 05/19/2026, with respect to the rejection(s) of claim(s) 1-12, 15, 19, 29-31, 33-34, 49, and 54 under 35 U.S.C. 103 have been fully considered and are persuasive due to the amendment. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zhao (US 20160361320 A1), further in view of Hu (US 10357467 B2; IDS reference, 04/13/2023).
New 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 1-12, 15, 19, 29-31, 33-34, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20160361320 A1), further in view of Hu (US 10357467 B2; IDS reference, 04/13/2023). Hu was cited previously by the Examiner.
Regarding claim 1, Zhao teaches a slow-releasing (i.e., modified release) pharmaceutical composition (Zhao, claim 44), and teaches a matrix composition is encapsulated within a soft shell composition (Zhao, page 5, paragraph 0057). Zhao exemplifies a matrix fill composition comprising active pharmaceutical ingredients and release modifiers (i.e., a controlled release material; Zhao, table 1). Zhao teaches pharmaceutical excipients to include dextrose and pectin (Zhao, page 13, paragraph 0115), and exemplifies a shell composition comprising gelatins in 5-70% by weight of the shell, and excipients in 0-10% by weight of the shell (Zhao, table 4). Zhao teaches about 10% of the mass is lost as water during drying (Zhao, page 18, paragraph 0148). Therefore, it would be reasonable to expect the final mass of each individual component based on a dry weight of the shell composition would be about 10% higher, resulting in an amount of gelatins of 5.5-77% and an amount of excipients of 0-11% by dry weight of the shell composition, which each encompass the claimed ranges of gelatin and dextrose. 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).
While Zhao does not specifically state that the shell is pH dependent, Zhao teaches the shell composition comprises optional excipients (Zhao, table 4), and teaches additional pharmaceutical ingredients which are useful to the composition to include coating agents such as hydroxypropylmethylcellulose phthalate (Zhao, page 13, paragraph 0115).
Hu teaches an enteric soft shell capsule comprising a gelatin composition (Hu, column 3, lines 5-6) wherein the enteric shell dissolves under specific pH conditions (i.e., a pH dependent shell; Hu, column 3, lines 30-33), and further teaches hydroxypropylmethylcellulose phthalate is an enteric (i.e., pH dependent) polysaccharide (Hu, column 10, line 64 - column 11, line 4).
Zhao and Hu are considered to be analogous to the claimed invention, because Zhao, Hu, and the instant invention are all 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 modified the shell of Zhao to be enteric as taught by Hu, by selecting hydroxypropylmethylcellulose phthalate which is taught by both references, because both teach reducing peptic ulcers (Zhao, claim 65; Hu, column 36, lines 1-20) and Hu teaches enteric dosage forms provide slow, controlled, or delayed release of a substance (Hu, column 1, lines 48-49).
Regarding claim 2, Zhao and Hu together teach all the elements of the current invention as applied to claim 1. Zhao teaches the matrix fill can further comprise polyethylene oxide as a release modifier (i.e., a controlled release material according to the instant claim 2; Zhao, table 2).
Regarding claim 3, Zhao and Hu together teach all the elements of the current invention as applied to claim 2. Zhao teaches the matrix fill can further comprise polyethylene oxide as a release modifier with a molecular weight of 6x10-7 – 7x106 (i.e., 0.0000006 to 7M Dalton; Zhao, table 2), 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).
Regarding claim 4, Zhao and Hu together teach all the elements of the current invention as applied to claim 1. Zhao teaches the matrix fill comprises film-forming polymers (Zhao, table 1), and teaches film-forming polymers include methylcellulose, cellulose, and hydroxypropylmethylcellulose (i.e., cellulose derivatives from the claimed list; Zhao, page 7, paragraph 0067).
Regarding claim 5, Zhao and Hu together teach all the elements of the current invention as applied to claim 2. Zhao the shell composition comprises optional excipients (Zhao, table 4), and teaches additional pharmaceutical ingredients which are useful to the composition to include guar gum and xanthan gum (i.e., gums from the claimed list; Zhao, page 13, paragraph 0115).
Regarding claim 6, Zhao and Hu together teach all the elements of the current invention as applied to claim 1. Zhao teaches release modifiers (i.e., controlled release materials) in 0.5-10% by weight of the fill composition (Zhao, table 1), 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).
Regarding claim 7, Zhao and Hu together teach all the elements of the current invention as applied to claim 1. Zhao teaches the fill composition comprises plasticizers (Zhao, table 1), and teaches plasticizers to include low molecular weight polyethylene glycols (i.e., a hydrophilic carrier as defined by the instant claim 8; Zhao, page 7, paragraph 0070), but does not specify a molecular weight range. Hu, however, 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. It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of Zhao to include the specific polyethylene glycol of Hu, because Zhao does not define “low molecular weight” and Hu teaches polyethylene glycol of this molecular weight to enhance solubility (Hu, column 4, lines 32-33).
Regarding claim 8, Zhao and Hu together teach all the elements of the current invention as applied to claim 7. As above, Zhao teaches the fill composition comprises plasticizers (Zhao, table 1), and teaches plasticizers to include low molecular weight polyethylene glycols (Zhao, page 7, paragraph 0070).
Regarding claim 9, Zhao and Hu together teach all the elements of the current invention as applied to claim 7. Zhao teaches the fill composition comprises plasticizers in 5-20% by weight of the fill composition (Zhao, table 1), and teaches plasticizers to include low molecular weight polyethylene glycols (Zhao, page 7, paragraph 0070), which lies within the claimed range. Further, 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, Zhao and Hu together teach all the elements of the current invention as applied to claim 1. Zhao teaches two active pharmaceutical ingredients in 1.001-11% by weight of the fill composition (Zhao, table 1), 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).
Regarding claim 11, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao does not measure a dissolution as claimed, and Hu does not specifically state the dissolution test is fiber optic or the paddle speed. However, Hu 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, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao teaches casting the shell gel mass into shell films using heat-controlled drums (an annealing step is a final heating step of the dried capsule as defined by the instant specification, page 26, paragraph 00120; Zhao, page 23, paragraph 0168). Further, Hu teaches the formed and dried capsules are then dried on trays in a temperature controlled oven (Hu, column 48, lines 57-59).
Regarding claim 15, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao teaches the fill composition comprises plasticizers (Zhao, table 1).
Regarding claim 19, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao teaches pharmaceutical excipients to include pectin (Zhao, page 13, paragraph 0115), and exemplifies a shell composition comprising excipients in 0-10% by weight of the shell (Zhao, table 4), Zhao teaches about 10% of the mass is lost as water during drying (Zhao, page 18, paragraph 0148). Therefore, it would be reasonable to expect the final mass of each individual component based on a dry weight of the shell composition would be about 10% higher, resulting in an amount of excipients of 0-11% by dry weight of the shell composition, which overlaps the claimed range of pectin. 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).
Regarding claim 29, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao teaches a composition which can comprise hydroxypropylmethylcellulose phthalate (Zhao, page 13, paragraph 0115), which is an enteric (i.e., pH dependent) polysaccharide according to Hu (Hu, column 10, line 64 - column 11, line 4). Zhao 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 Zhao.
Regarding claim 30, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao and Hu do not teach a viscosity of the shell composition. Hu does, however, teach a viscosity of the gelatin (Hu, claim 1) and teaches 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 Zhao and Hu would also result in the viscosity as claimed.
Regarding claim 31, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao does not teach a specific ratio of gelatin to pectin. Hu, however, 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. It would have been prima facie obvious to one of ordinary skill in the art to utilize the ratio taught by Hu, because Zhao does not specify, while Hu demonstrates the claimed ratio is known in the art.
Regarding claim 33, Zhao and Hu together all the elements of the current invention as applied to claim 1. Zhao does not teach a specific ratio of the controlled release material to the active agent as claimed. Hu, however, 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. It would have been prima facie obvious to one of ordinary skill in the art to utilize the ratio taught by Hu, because Zhao teaches it will be apparent to one of ordinary skill that suitable modifications to the formulation can be made (Zhao, page 18, paragraph 0147), and Hu demonstrates the claimed ratio is known in the art.
Regarding claim 34, Zhao and Hu together all the elements of the current invention as applied to claim 1. As above, Zhao teaches the composition comprises active pharmaceutical ingredients (Zhao, table 1).
Regarding claim 49, Zhao teaches a slow-releasing (i.e., modified release) pharmaceutical composition (Zhao, claim 44), and teaches a matrix composition is encapsulated within a soft shell composition (Zhao, page 5, paragraph 0057). Zhao exemplifies a matrix fill composition comprising active pharmaceutical ingredients, release modifiers (i.e., a controlled release material), and no recitation of a hydrophilic carrier, which is an optional embodiment, and therefore reads on the composition as claimed (Zhao, table 1). Zhao teaches the matrix fill can further comprise polyethylene oxide as a release modifier with a molecular weight of 6x10-7 – 7x106 (i.e., 0.0000006 to 7M Dalton; Zhao, table 2), which overlaps the claimed range. Zhao teaches pharmaceutical excipients to include dextrose and pectin (Zhao, page 13, paragraph 0115), and exemplifies a shell composition comprising plasticizers, gelatins in 5-70% by weight of the shell, and excipients in 0-10% by weight of the shell (Zhao, table 4). Zhao teaches about 10% of the mass is lost as water during drying (Zhao, page 18, paragraph 0148). Therefore, it would be reasonable to expect the final mass of each individual component based on a dry weight of the shell composition would be about 10% higher, resulting in an amount of gelatins of 5.5-77% and an amount of excipients of 0-11% by dry weight of the shell composition, which each encompass the claimed ranges of gelatin and dextrose. 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).
While Zhao does not specifically state that the shell is pH dependent, Zhao teaches the shell composition comprises optional excipients (Zhao, table 4), and teaches additional pharmaceutical ingredients which are useful to the composition to include coating agents such as hydroxypropylmethylcellulose phthalate (Zhao, page 13, paragraph 0115).
Hu teaches an enteric soft shell capsule comprising a gelatin composition (Hu, column 3, lines 5-6) wherein the enteric shell dissolves under specific pH conditions (i.e., a pH dependent shell; Hu, column 3, lines 30-33), and further teaches hydroxypropylmethylcellulose phthalate is an enteric (i.e., pH dependent) polysaccharide (Hu, column 10, line 64 - column 11, line 4). As above, 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 shell of Zhao to be enteric as taught by Hu, by selecting hydroxypropylmethylcellulose phthalate which is taught by both references, because both teach reducing peptic ulcers (Zhao, claim 65; Hu, column 36, lines 1-20) and Hu teaches enteric dosage forms provide slow, controlled, or delayed release of a substance (Hu, column 1, lines 48-49).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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