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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Species 7 (Figs 7a-b; claims 1-4, 14-22) in the reply filed on 05 January 2026 is acknowledged.
Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 1-6 and/or 8-9, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 January 2026.
Claim Objections
Claims 2-4 and 14-22 are objected to because of the following informalities:
Cl.2-4, and 14-22: “An administration device as claimed in claim…” is believed to be in error for –The administration device as claimed in claim--
Appropriate correction is required.
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 1-4 and 14-22 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, the recitation(s) “a sidewall disposed radially within the hollow body” (emphasis added) renders the claim indefinite because it seems to require a wall within the hollow body (e.g. a plate or rib extending from the boundary of the hollow body towards the longitudinal centerline), whereas Applicant’s Specification and Drawings describes/shows the sidewall as extending cylindrically to define at least a portion of the hollow body. Thus, it is unclear whether Applicant’s intention is to claim subject matter that is not shown or described in the Drawings/Specification, or whether the claim language should be amended to correspond to the Specification/Drawings.
Regarding claim 2, “a first position” and “a second position” are unclear because a first and second position were previously recited in claim 1, and it is unclear whether these new recitations are referring to the same positions or new and different positions.
Dependent Claims 2-4 and 14-22 are also rejected for relying on at least one rejected claim above.
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) 1-4, 14-16, 18-19, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinz 20130116627.
Regarding Claim 1, Heinz teaches an administration device (syringe of Figs 4-5; [0039]) configured to transition between a static state (left side of Figs 4 and 5) and an advancing state (right side of Figs 4-5), comprising:
a hollow body (incl.10) including a sidewall (10) disposed radially within the hollow body along a longitudinal length of the hollow body (see 112b discussion above; just as Applicant considered the cylindrical sidewall 704 defining the hollow body 702 to satisfy this claim limitation, the cylindrical wall 10 defining the hollow body of the syringe in Figs 4-5 satisfies this claim limitation);
a post (11) configured to move axially within the hollow body (Figs 4-5); and
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a stopper (17) comprising a primary wall (at and between 24, 25) and an interior cavity (shaded regions in Figs 4-5 above), the primary wall configured to seal against the sidewall when the post is in a first position (Figs 4-5), wherein the stopper is configured to apply a first radial pressure against the sidewall when the post is in the first position and configured to apply a second radial pressure less than the first radial pressure against the sidewall when the post is in a second position (Figs 4-5 show less radial pressure in a second translating position – on the right - relative to a first stationary position – on the left).
Regarding claim 2, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the interior cavity distally terminates in a distal wall (26, 20), the post being configured to transition from a first position in the static state in which no axial force is applied by the post to the distal wall into a second position in the advancing state in which an axial force is applied to the distal wall by the post (Figs 4-5; the left side of Figs 4-5 is a “rest state”; [0039, 41]).
Regarding claim 3, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the primary wall is configured to radially contract into the interior cavity in response to axial stretching of the distal wall caused by the axial force applied to the distal wall in the advancing state (right side of Figs 4-5 show 24, 25 moving radially inward towards the cavity to exert less pressure against the sidewalls as the stopper is stretched in the axial direction by the post moving axially in the advancing state against the distal wall).
Regarding claim 4, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the axial force is applied distally and the axial stretching is in a distal direction (Figs 4-5).
Regarding claim 14, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches a flange (21 in Fig 4 and analogous feature in Fig 5) disposed proximally of the stopper (Figs 4-5), the flange having a radial cross-section greater than a radial cross-section of a proximal end of the interior cavity (Figs 4-5), the flange configured to axially engage the stopper in the advancing state (Figs 4-5).
Regarding claim 15, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the post longitudinally extends an axial distance greater than an axial depth of the interior cavity (Figs 4-5), and engagement of the flange with the stopper limits distal stretching of the distal wall to a predefined amount from the axial force applied to the distal wall (Figs 4-5).
Regarding claim 16, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the post further comprising a skirt (21 in Fig 4, and analogous feature in Fig 5; skirt defined as a part or attachment serving as a rim, border, or edging per Merriam Webster Dictionary) extending radially from the post (Figs 4-5).
Regarding claim 18, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the post being more rigid than the stopper (in order for the post to deform the stopper per Figs 4-5).
Regarding claim 19, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches the first radial pressure applied by the stopper against the sidewall provides an aseptic barrier (the hermetic seal of the stopper against the sidewall is sufficient to establish an aseptic barrier).
Regarding claim 21, Heinz teaches all the limitations of the claimed invention as discussed above.
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Heinz further teaches an interior surface of the primary wall includes raised surface features (Figs 4-5 above; including 27 in Fig 5) protruding radially inwardly into the interior cavity (Figs 4-5).
Regarding claim 22, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz further teaches a longitudinal extent of the post is an axial length greater than an axial depth of the interior cavity (Figs 4-5).
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.
Claims 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heinz in view of Cupicha 20160243309.
Regarding claim 17, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz does not teach the skirt is configured to seal against the sidewall (the skirt in Figs 4-5 depicted as being spaced from the syringe hollow body sidewall).
However, Cupicha teaches a syringe (Fig 22) with a shortened post (122) having proximal sealing skirts (110) on the post, separate from the stopper sealing function (130, 134), in order to enable pneumatic actuation of the syringe (via 202, 204, 302, 320; Fig 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe post of Heinz to be a shortened post with sealing skirts at the proximal end as taught by Cupicha, in order to enable the syringe to be actuated pneumatically (Figs 22-24) instead of using a manually operated plunger arrangement, thereby providing more uniform, consistent, and controlled injections while preventing contamination of the medication being administered ([0003]).
Regarding claim 20, Heinz teaches all the limitations of the claimed invention as discussed above. Heinz does not teach the post is actuated from a first position to a second position by an increase in pressure of a proximal volume.
However, Cupicha teaches a syringe (Fig 22) having a post (122) that is actuated from a first position to a second position by an increase in pressure of a proximal volume (302, 320), instead of using a manually operated plunger arrangement, thereby providing more uniform, consistent, and controlled injections while preventing contamination of the medication being administered ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manually operated plunger syringe of Heinz to be pneumatically operated as taught by Cupicha in order to provide more uniform, consistent, and controlled injections while preventing contamination of the medication being administered (Cupicha, [0003]).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741