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
Applicant’s election without traverse of group I, claims 1-17 and 20 in the reply filed on 6/25/25 is acknowledged.
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.
Claims 15 and 16 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation typically between 0.5% by weight and 75% by weight, and the claim also recites more typically 1% by weight and 20% by weight which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 16 recites the broad recitation typically 1% and 75%, and the claim also recites more typically between 3% by weight and 70% by weight which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 6-11, 17 and 20 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Fowler et al (WO 2021/076718A1 hereafter 718).
Fowler discloses an active ingredient delivery system comprising a container having an interior compartment and a liquid fill composition where the fill comprises an oily phase and an aqueous phase, where an active ingredient is present in at least the oil or aqueous phase and the phases are immersible in each other [abstract, 0012, Examples]. The active can be oil soluble such as DHA [0020]. The active is present 30-50% [0029]. The active agent can also be present in the aqueous phase [0047]. The oil and water phases are encapsulated in a hard capsule [0072]. The hard capsules have a hydroxypropyl methylcellulose shell [0073]. The hard capsules are further coated with enteric polymers to make them acid resistant [0074]. Active ingredients include black currant seeds or cinnamon which can color the filling material and can be present about 1% [0065, 0093, Table 4]. These disclosures render the claims anticipated.
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.
Claim(s) 1-17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Fowler et al (WO 2021/076718 A1 hereafter Fowler) in view of Madit (US 2007/0059355 A1 hereafter Madit).
As disclosed above, Fowler discloses an active ingredient delivery system comprising a container and a shell where the fill is a liquid and where the fill comprises an aqueous and lipid phase. The container is a hard capsule with a cellulose shell. The reference however does not disclose the further inclusion of polysaccharides like pullulan into the shell material. The use of these compounds is known in the art as seen in the Madit reference.
Madit discloses a hard capsule formulation comprising a liquid fill composition where the filling comprises a polar solvents like water and active agents [abstract, 0016-0019, 0041]. The liquid fill may also comprise non-polar solvents that are lipophilic [0040-0041]. The hard capsule have a cellulose shell such as a hydroxypropyl methylcellulose and a pullulan [0026-0027]. The capsules are further coated with enteric polymers [0036-0037]. The water content of the capsule is up to 20% [0056]. The active agent is present in the solvent [0054-0055]. The fill is not an emulsion and does not comprise an emulsifier [Examples]. It would have been obvious to include these components with the capsules of Fowler as they solve the same problem of delivering active agents in hard capsules.
It would have been obvious to combine the prior art with an expected result of a stable drug delivery system. It would have been obvious to combine the shell materials of Madit with the capsule of Fowler as they solve the same problem of delivering a drug to the body. Madit establishes the level of skill in the art that blending solvents in a liquid filling can work to deliver active agents. One of ordinary skill in the art would have been obvious to combine the components of the prior art with an expected result of stable hard capsule for drug delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618