DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 7/7/2026.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/7/2026 has been entered.
Status of the Claims
Claim 1 has been amended. Claims 2 and 3 are cancelled. No claims are newly added. Accordingly, claim 1 remains pending in the application and is currently under examination.
Information Disclosure Statement
The IDS filed 5/28/2026 has been considered. A signed copy is enclosed herewith.
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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnaeve et al. (JP 2012/071141 A, Apr. 12, 2012, machine translation, hereafter as “Sinnaeve”).
The instant claim is drawn to a hard capsule comprising a cap and a body, wherein each of the cap and the body is in a cylindrical shape, wherein the cap has a first end and a second end and extends from the first end to the second end in a longitudinal direction, and the body has a first end and a second end and extends from the first end of the body to the second end of the body in the longitudinal direction, wherein the cap includes: a first cap lock spaced apart from the first end of the cap and formed in a concave shape around the cap in a circumferential direction, and a second cap lock spaced apart from the first cap lock by a first distance and formed in the concave shape around the cap in the circumferential direction, wherein the body includes: a single body lock spaced apart from the first end of the body by a second distance and formed in the concave shape around the body in the circumferential direction, wherein each of the first cap lock, the second cap lock, and the single body lock has an inner circumferential surface with a convex arc-shaped longitudinal cross-section extending toward a center line of the hard capsule, and an outer peripheral surface with an concave-shaped longitudinal cross-section recessed toward the center line, wherein the first cap lock and the single body lock are in a first joint-locked state coupled to each other along the entire periphery when the first end of the body is inserted into the cap through the second end of the cap, wherein the second cap lock and the single body lock are in a second joint-locked state coupled to each other along the entire periphery when the first end of the body is further inserted into the cap through the second end of the cap, and wherein a first overall length of the hard capsule in the first joint-locked state and a second overall length of the hard capsule in the second joint-locked state are each selected from the group consisting of 26.1 mm, 25.3 mm, 23.3 mm, 23.6 mm, 21.7 mm, 20.4 mm, 19.4 mm, 16.7 mm, 19.3 mm, 18.0 mm, 16.0 mm, 15.9 mm, 14.3 mm, and 11.1 mm, wherein the first and the second overall lengths are different from each other.
It is noted the language “single body lock”, however it is also noted the “comprising” open-ended language which allows for additional unrecited elements (MPEP 2111.03). Giving the claim it’s broadest most reasonable interpretation, the term “single” in the presence of “comprising” does not preclude the inclusion of additional locks.
Regarding instant claim 1, Sinnaeve teaches a container (cylindrical capsule) 200 including a cap 210 (cylindrical), a body 240 (cylindrical) slidably engageable with an inner side of the cap, and the fluid gap located between the cap and the body adjacent to one end of the cap, a first groove 220 of the cap (first cap lock) and a first groove 250 of the body (body lock) form a snap type joint 270 (joint-locked state), and a second groove 222 of the cap (second cap lock) and a second groove 252 of the body (body lock) form a fluid stop joint (joint-locked state) (abstract; page 2, 2nd paragraph; Fig. 2). Sinnaeve also teaches additional embodiments having a capsule comprising a body having three grooves and a cap having two grooves allowing for two adjustable locked joints (page 9, 3rd paragraph – page 10, 3rd paragraph; Figures 5, 9A-10B). The abovementioned Figures illustrate that the cap has a first end and a second end and extends from the first end to the second end in a longitudinal direction, and the body has a first end and a second end and extends from the first end of the body to the second end of the body in the longitudinal direction, wherein the cap includes: a first cap lock spaced apart from the first end of the cap and formed in a concave shape around the cap in a circumferential direction, and a second cap lock spaced apart from the first cap lock by a first distance and formed in the concave shape around the cap in the circumferential direction, wherein each of the first cap lock, the second cap lock, and the single body lock has an inner circumferential surface with a convex arc-shaped longitudinal cross-section extending toward a center line of the hard capsule, and an outer peripheral surface with an concave-shaped longitudinal cross-section recessed toward the center line, wherein the body includes: a single body lock spaced apart from the first end of the body by a second distance and formed in the concave shape around the body in the circumferential direction, wherein the first cap lock and the single body lock are in a first joint-locked state coupled to each other along the entire periphery when the first end of the body is inserted into the cap through the second end of the cap, wherein the second cap lock and the single body lock are in a second joint-locked state coupled to each other along the entire periphery when the first end of the body is further inserted into the cap through the second end of the cap. Sinnaeve also teaches capsule materials including the well-known hard capsule material, HPMC (page 11, 4th paragraph). It is noted that the instant specification discloses HPMC as a hard capsule material (page 1, lines 19-23; Example 1). Sinnaeve further teaches that the container has a length of, for example, 18 mm when closed (i.e. locked state) and also teaches lengths of the fluid stop junction being between about 0.2 mm and about 3.5 mm (page 4, last paragraph – page 5, 2nd paragraph). Sinnaeve further teaches that other dimensions are possible (page 5, 2nd paragraph).
Figures 4 and 5 explicitly illustrate grooves around the periphery of the body of the capsule. While Sinnaeve does not explicitly teach that grooves are also present around the periphery of the cap, a skilled artisan would reasonably expect that a cap without a groove would allow for space between the groove of the body and non-grooved cap, thereby, permitting the contents of capsule to potentially leak out or a foreign substance to penetrate the void between the body and the cap. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to also include grooves around the periphery of the cap with a reasonable expectation of success because having both the cap and the body with matching grooves around the periphery of said cap and said body would improve the seal between cap and body and, thereby, avoid leakage or contamination.
While Sinnaeve does not explicitly teach the limitation, a second overall length of the hard capsule in the second joint-locked state is selected from the group consisting of 26.1 mm, 25.3 mm, 23.3 mm, 23.6 mm, 21.7 mm, 20.4 mm, 19.4 mm, 16.7 mm, 19.3 mm, 18.0 mm, 16.0 mm, 15.9 mm, 14.3 mm, and 11.1 mm, Sinnaeve teaches a first overall length in one locked position being 18 mm, provides a length range of the fluid stop junction, states that other dimensions are possible and illustrates Figures that provide spatial inferences.
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 optimize the length of each locking joint (two or three depending on the embodiment) and thereby the first and second overall lengths of the capsule in each locked position by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Sinnaeve teaches a first overall length in one locked position being 18 mm, provides a length range of the fluid stop junction, states that other dimensions are possible and illustrates Figures that provide spatial inferences and "[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" (MPEP 2144.05). It is the normal desire of scientists or artisans to improve upon what is already generally known and determine the optimum dimensions. One of ordinary skill would have reasonably expected the capsule of Sinnaeve with optimized dimensions depending on desired parameters.
Thus, the teachings of Sinnaeve render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 7/7/2026, regarding the 103 rejection over Sinnaeve have been fully considered but they are not persuasive.
Applicant argues that the claim has been amended to recite that the body includes a single body lock which distinguishes the claimed hard capsule from Sinnaeve. Remarks, page 4.
In response, it is respectfully submitted that the claim recites “comprising” open-ended language which allows for additional unrecited elements (MPEP 2111.03). Giving the claim it’s broadest most reasonable interpretation, the term “single” in the presence of “comprising” does not preclude the inclusion of additional body locks or joints. Applicant’s argument is unpersuasive.
Applicant argues that Sinnaeve is directed to a dual-joint structure that requires multiple grooves in the body to separate mechanical locking from fluid sealing functions whereas the claimed hard capsule employs a single body lock designed to engage with either the first or second cap locks to achieve stepwise length adjustment for variable standardized sizes. Remarks, pages 4-5.
In response, it is respectfully submitted that Sinnaeve teaches embodiments having a capsule comprising a body having three grooves and a cap having two grooves allowing for two adjustable locked joints (page 9, 3rd paragraph – page 10, 3rd paragraph; Figures 5, 9A-10B). The purpose of the locks is immaterial to the rejection as the claims are drawn to a product and the structure of the prior art reads on the structure of the invention as it is currently claimed. Thus, applicant’s argument is not found persuasive.
Applicant argues that the claim has been amended to define that each lock has an “inner circumferential surface with a convex longitudinal cross-section” and Sinnaeve’s “fluid stop joint” is explicitly taught as having a different strength or gap compared to its “snap-fit joint” which does not suggest the entirely coupled geometric structures claimed. Remarks, page 5.
In response, it is respectfully submitted that Figures 4 and 5 explicitly illustrate grooves around the periphery of the body of the capsule. While Sinnaeve does not explicitly teach that grooves are also present around the periphery of the cap, a skilled artisan would reasonably expect that a cap without a groove would allow for space between the groove of the body and non-grooved cap, thereby, permitting the contents of capsule to potentially leak out or a foreign substance to penetrate the void between the body and the cap. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to also include grooves around the periphery of the cap with a reasonable expectation of success because having both the cap and the body with matching grooves around the periphery of said cap and said body would improve the seal between cap and body and, thereby, avoid leakage or contamination. With respect to the geometry of the joints, the Figures in Sinnaeve illustrate convex and concave portions that form a snap fit lock and a fluid stop lock. While Sinnaeve teaches that there can be differences between the dimensions of snap fit joints and the fluid stop joints, the teachings of Sinnaeve nonetheless meet the limitations of the claim. Applicant’s argument is unpersuasive.
Thus, for these reasons, the rejection has been modified to account for the newly added claim limitations, but does not overcome said rejection.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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