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 .
Status of Claims
The amendments and arguments filed on 12/18/2025 are acknowledged and have been fully considered. Claim 1 has been amended. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1-9 will be examined on the merits herein.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Response to Arguments
Applicant does not appear to have acknowledged or responded to the indication that the Abstract does not meet the requirements set forth in the MPEP. Appropriate correction is required.
Withdrawn Rejections
Rejections under 35 USC 102/103 and 103
Applicants’ amendment to claim 1 is persuasive in overcoming the previously raised prior art rejections based on Kottayil et al (US 20060160888 A1) alone. Said rejections are withdrawn.
Applicants’ amendment to claim 1 is persuasive in overcoming the previously raised prior art rejections based on Brunn et al (US 20200330423 A1). Said rejections are withdrawn.
New Grounds of Rejection — Necessitated by Amendment
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) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al (US 20200155464 A1) and KOREN et al (US 20150057342 A).
Nishimura discloses capsules are widely used in the field of pharmaceuticals, quasi-drugs and the like ([0002]). A seamless capsule is one type of soft capsules, which is manufactured by utilizing a tension occurring in the oil-water interface and gelling properties of a shell base material ([0002]). Nishimura teaches the seamless capsule has various advantages such as a wide selection range of the particle size, a wide selection range of the film thickness or the film hardness of the shell of a capsule, and a wide selection range of the dissolution time of a capsule ([0002]). Nishimura discloses a problem of providing a high quality seamless capsule, with excellent uniformity of shell thickness and virtually no eyes in the shell (see entire document, for instance abstract). Nishimura teaches carrageenan (see entire document, for instance claim 1). Nishimura discloses a shell forming material to form a seamless capsule (a shell composition), gelatin is used, which has excellent solubility in the body, so that the rapid disintegration allows a content to be released ([0003]). Nishimura teaches a shell composition has high quality, with excellent uniformity of the shell thickness of the capsule and virtually no eyes in the shell, being useful in the fields of pharmaceuticals ([0063]). Nishimura, while teaching seamless capsule in the field of pharmaceuticals, does not directly disclose cannabinoids. KOREN discloses oral pharmaceutical compositions comprising sustained release or a combination of sustained and immediate release formulation of cannabinoids (see entire document, for instance abstract). KOREN teaches carrageenan ([0014]). KOREN discloses the composition is formulated as a soft gelatin capsules ([0018], [0040]). KOREN teaches Cannabidiol from about 0.1% to about 99.9% w/w (see entire document, for instance [0038], claims 1-2).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Nishimura with the composition of KOREN et al. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It would have been obvious to utilize soft capsules as taught in Nishimura in the composition of KOREN. One would have been motivated to do so Nishimura teaches a shell forming material to form a seamless capsule (a shell composition), gelatin is used, which has excellent solubility in the body, so that the rapid disintegration allows a content to be released.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al (US 20200155464 A1) and KOREN et al (US 20150057342 A) as applied to claims 1-3 above, and further in view of Nakamura et al (US 20030195246 A1).
The teachings of Nishimura and KOREN et al have been set forth above. However, they do not expressly disclose including thickness of a shell. Nakamura et al remedy this deficiency.
Nakamura discloses "soft capsule" is one wherein a compounded solution of the drug is enclosed in a capsule shell ([0030]). Nakamura teaches soft capsule may be produced as a soft capsule with no seam in the capsule shell by, for example, a dropping method ([0031]). Seamless soft capsules contain no seam in the capsule shell of the soft capsule, and therefore entail no risk of leakage of the filled drug ([0031]). Nakamura discloses capsule shell thickness of the seamless soft capsule is preferably 100-900 μm ([0036]). A capsule shell thickness below this range will tend to result in oxygen permeation and solution leakage, while a capsule shell thickness above this range will tend to restrict the volume of the filling substance and lengthen the disintegration time of the seamless soft capsule ([0036]). Nakamura teaches seamless capsule with a diameter of 8.54 mm ([0054]). Nakamura discloses sorbitol is preferably 2.5-15 parts by weight and more preferably 5-10 parts by weight of the sorbitol to 100 parts by weight of the gelatin ([0035]). If the sorbitol content is below this range, the seamless soft capsule will tend to rupture more readily by splitting ([0035]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Nishimura and KOREN with the composition of Nakamura et al. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It would have been obvious to utilize soft capsules as taught in Nakamura in the composition of Nishimura and KOREN. One would have been motivated to do so Nakamura teaches that capsule shell thickness of the seamless soft capsule is particularly useful for imparting to minimize oxygen permeation and solution leakage property to a composition, wherein Nishimura teaches a shell composition has high quality, with excellent uniformity of the shell thickness of the capsule and virtually no eyes in the shell, being useful in the fields of pharmaceuticals ([0063]).
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Conclusion
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.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611