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 .
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (US 2003/0060454; published March 27, 2003).
Applicant claims a formulation comprising an enteric capsule and black seed oil contained therein.
Kandil teach Nigella sativa L. lipid fraction which is oil extracted from seeds and purified (abstract; Figure 1). Solid dosage forms for oral administration include capsules and tablets that can be prepared with enteric or film coatings [0042]. Soft gelatin capsules comprising black seed oil were used in clinical trials and the found to reduce the frequency of asthma attacks in adults when administered at a dose of 400 mg twice daily [0081-86].
With respect to claims 1-3, 5, 12 and 13, Kandil teaches tablets and capsules that can include enteric or film coatings. The Examples only disclose gelatin capsules, however capsules with enteric components are taught. With respect to claims 12 and 13, Kandil teach the lipid fraction comprises 1-4% volatile oils which contain thymoquinone [0013-18]. Therefore, one of ordinary skill would have been able to optimize the black seed oil to be comprised of at least 1.5-2wt% thymoquinone with a reasonable expectation of success.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Kandil and form a black seed oil formulation comprising at least 2wt% thymoquinone and an enteric capsule before the time of filing with a reasonable expectation of success because Kandil teach solid dosage forms can include capsules and enteric components and the lipid fraction comprises 1-4% volatile oils which contain thymoquinone.
Claim(s) 4, 6-11 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (US 2003/0060454; published March 27, 2003), as applied to claims 1-3, 5, 12 and 13 above in combination with of Teles (CA 2940203; published December 23, 2015).
Applicant claims a formulation comprising an enteric capsule and black seed oil contained therein (claim 1).
Applicant also claims a formulation comprising an enteric capsule comprising HPMC, HPMCP coating and black seed oil comprising at least 1.5wt% thymoquinone (claim 18).
The teachings of Kandil are addressed in the above 103 rejection.
With respect to claim 4, Kandil do not teach that the enteric capsule includes an acid-insoluble polymer. With respect to claim 6, Kandil do not teach that the enteric capsule includes an hydroxypropyl methylcellulose phthalate (HPMCP). With respect to claims 7, 11 and 18, Kandil do not teach that the enteric capsule includes an hydroxypropyl methylcellulose (HPMC) substrate layer. With respect to claim 8, 9 and 19, Kandil does not teach a banding solution which may comprise a second enteric component. With respect to claim 10, Kandil does not teach the enteric component and the second enteric component are the same. With respect to claims 14-18, Kandil do not teach that the formulation remains intact in gastric acid having a pH of 3 or lower and disintegrates at pH greater than 5.5, 6-7 or above 7. It is for this reason that Teles is joined.
Teles et al. teach enteric soft capsules comprising gastric resistant polymers and gelatin which have enteric and elastic properties and are simpler to manufacture (abstract). The capsules are able to protect the contents of the dosage form from gastric conditions and prevent mouth odor resulting from ingestion of different oil substances (page 1, paragraph 1). The capsules comprise at least one or more film forming polymers selected from gelatin, hydroxypropyl methylcellulose (HPMC), or carrageenan, at least one or more acid-insoluble polymers selected from hydroxypropyl methylcellulose phthalate (HPMCP) (page 2, paragraph 3). The enteric soft capsule shell does not dissolve in simulated gastric fluid (pH 1.2) for at least 2 hours and begins dissolution in simulated intestinal fluid (pH 6.8) within about 10 minutes (page 5, paragraph 2; limitation of claims 14-17). The active ingredient can be any compound that has a beneficial effect including nutraceuticals (page 7a, paragraph 2). Other useful nutraceuticals include seed oils (page 31, paragraph 2). The enteric capsule and enteric shell can comprise gelatin with the acid-insoluble polymers which may also include one or more film forming polymers (7b, paragraphs 1-6). Examples of enteric polymers include acrylic and methacrylate acid copolymers, CAP, HPMCP and shellac and mixtures (page 8, lines 9-23). The enteric soft capsule shells can be made by dissolving the acid-insoluble polymers in an aqueous solution and the film forming polymer can then be added to make a homogenous mixture (page 9, paragraphs 2-3). Another embodiment includes preparing a gel mass composition comprising the film forming polymers and the enteric acid-insoluble polymer and a matrix that is liquid, semi-solid or solid that release the composition at a specific rate (page 19, paragraph 3; limitation of claims 2 and 3). Additional coating polymers include HPMC and HPMCP (hydroxypropyl methylcellulose phthalate) (page 22, lines 6-9; limitation of claims 4 and 6-11). The matrix comprises hygroscopic polymers selected from HPMC (substrate layer) (page 27, lines 1-4; limitation of claim 7). The capsules comprise the active ingredients at dosages of about 500 mg or more (page 43, lines 12-21; limitation of claim 20).
The specification defines the banding solution as a liquid formulation of HPMCP (Example 1). Since Teles teach the enteric component are included in the matrix and the coating and include HPMC and HPMCP and mixtures the limitations of claims 4 and 6-11 are taught.
Both Kandil and Teles teach seed oils with enteric capsules. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Kandil and Teles to form a black seed formulations with an enteric capsule comprising gelatin, HPMC and HPMCP with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine the teachings of Kandil and Teles before the time of filing because Teles teaches forming enteric capsules comprising at least one or more film forming polymers selected from gelatin, hydroxypropyl methylcellulose (HPMC), or carrageenan and at least one or more acid-insoluble polymers selected from hydroxypropyl methylcellulose phthalate (HPMCP) which protect different seed oil formulations contained therein from gastric pH.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
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