DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 2/4/2026.
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 .
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.
Withdrawn Rejections
Applicant' s amendment renders the rejection of claims 1-3 under 35 USC 102 over Sinnaeve moot. Specifically, Sinnaeve does not explicitly teach the newly added limitation, wherein 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. Thus, said rejection has been withdrawn. However, after further consideration, a new grounds of rejection is made under 35 USC 103 over Sinnaeve.
New Rejections
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 body lock spaced apart from the first end of the body by a second distance and formed in the concave shape around the cap in the circumferential direction, wherein the first cap lock and the body lock are in a first joint-locked state 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 body lock are in a second joint-locked state 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.
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 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 the body includes: a body lock spaced apart from the first end of the body by a second distance and formed in the concave shape around the cap in the circumferential direction, wherein the first cap lock and the body lock are in a first joint-locked state 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 body lock are in a second joint-locked state 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).
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 2/4/2026, regarding the 102 rejection over Sinnaeve have been fully considered and they are persuasive in part. As such, the 102 rejection has been replaced with a 103 rejection over the same reference. Applicants arguments are applicable to the new 103 rejection and are addressed below.
Applicant argues that Sinnaeve teaches two grooves that serve different purposes: one is for forming a snap-fit joint and the other is for forming a fluid stop joint and asserts that Sinnaeve is structurally different from the presently claimed hard capsule’s stepwise length-adjustment mechanism. Remarks, page 6.
In response, it is respectfully submitted that Sinnaeve teach an embodiment having two grooves, as applicant has described above. Sinnaeve also teaches another embodiment involving a capsule comprising a body having three grooves and a cap having two grooves allowing for two adjustable locked joints. In either embodiment, there are at least two grooves in the cap and the body that lock together. 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 and the structure of the claimed invention appear to be the same. Thus, applicant’s argument is not found persuasive.
Applicant also argues that Sinnaeve fails to teach or suggest the overall lengths of the capsule in the first joint-locked state and in the second joint-locked state. Remarks, page 6.
In response, it is respectfully submitted that 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. Thus, 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. For these reasons, applicant’s argument is found unpersuasive.
Conclusion
All claims have been rejected; no claims are allowed.
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.
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
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616