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 of Group I in the reply filed on 08/28/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-18, 24, 28, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/28/2025.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al (US 4432768).
Regarding Claim 1, Brown discloses an ampule fracture device (10, Figs. 1-3) comprising:
a body (frame 12, Figs. 1-3) having a first end (proximal end 16, Figs. 1-3) and a second end (distal end 14, Figs. 1-3); and
a support (combination of hand grip 24 and guard surface 42, Figs. 1-3) configured to incline the first end (16, Figs. 1-3) of the body (12, Figs. 1-3) at a first height vertically above a second height of the second end (14, Figs. 1-3) of the body (12, Figs. 1-3) when the ampule fracture device (10, Figs. 1-3) is rested on a flat surface and while the device is actuated to fracture an ampule (20, Figs. 1-3; if the device is placed on a surface such that both the hand grip and the guard surface are touching the surface, the device will be inclined as claimed).
Regarding Claim 2, Brown discloses the body (12, Figs. 1-3) is configured to hold a medicament applicator having an ampule (20, Figs. 1-3; the device is fully capable of holding a medicament application that contains an ampule inside it rather than just the ampule itself) within a cavity (recess defined by walls 18, Figs. 1-3) of the body (12, Figs. 1-3) at an incline based at least in part on the difference between the first and second heights (Figs. 1-3; if the device is placed on a surface such that both the hand grip and the guard surface are touching the surface, the device will be inclined as claimed).
Regarding Claim 3, Brown discloses a cover (arm 26, Figs. 1-3) moveable relative to the body (12, Figs. 1-3; Col. 2 lines 23-29), wherein the cover (26, Figs. 1-3) includes at least one rib (protuberance 38, Figs. 1-3) configured to crush an ampule (20, Figs. 1-3) when the cover (26, Figs. 1-3) is moved towards the body (12, Figs. 1-3; Col. 2 lines 23-29 and 38-43).
Regarding Claim 4, Brown discloses the support (combination of 42 and 24, Figs. 1-3) includes a first tower portion (hand grip 24, Figs. 1-3) and a second flanged portion (guard surface 42, Figs. 1-3), wherein the first tower portion (24, Figs. 1-3) is disposed on the first end (16, Figs. 1-3) of the body (12, Figs. 1-3) and the second flanged portion (42, Figs. 1-3) is disposed on the second end (14, Figs. 1-3) of the body (12, Figs. 1-3).
Regarding Claim 5, Brown discloses the first tower portion (24, Figs. 1-3) reaches a third height vertically above a fourth height of the second flanged portion (42, Figs. 1-3) relative to the surface (Figs. 1-3; if the device is placed on a surface such that both the hand grip and the guard surface are touching the surface, the parts of the device will have the heights as claimed).
Regarding Claim 11, Brown discloses a cavity (recess formed by walls 18, Figs. 1-3) configured to receive a medicament applicator having an ampule (20, Figs. 1-3; the device is fully capable of holding a medicament application that contains an ampule inside it rather than just the ampule itself), wherein the cavity (recess formed by walls 18, Figs. 1-3) includes a first portion (tip opening 21, Figs. 1-3) and a second portion (main portion of recess, Figs. 1-3), the first portion (21, Figs. 1-3) shaped and positioned to receive a dispensing end (tip 22, Figs. 1-3) of the medicament applicator, and the second portion (main portion of recess, Figs. 1-3) shaped an positioned to receive a tube end (main portion of ampule 20, Figs. 1-3) of the medicament applicator; the first portion (21, Figs. 1-3) having a tapered shape, and the second portion (main portion of recess, Figs. 1-3) having a cylindrical shape (Figs. 1-3).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (US 4432768) in view of Hensel (US 2012/0103203).
Regarding Claims 6-8, Brown is silent whether the body includes a plurality of ribs having curved edges configured to crush the ampule, further comprising a cover, wherein the cover includes a plurality of ribs having flat edges configured to crush an ampule, and wherein the plurality of ribs having curved edges are disposed on the second end of the body.
Hensel teaches a citrus press, thus being in the same problem solving field of maximizing fluid removal from an item, with a body (reamer 50, Figs. 2 and 5) that includes a plurality of ribs (53, Figs. 2 and 5) having curved edges (as seen in Fig. 5, the ribs have curved edges) configured to crush an item, a cover (dome 90, Figs. 2 and 5), wherein the cover (90, Figs. 2 and 5) includes a plurality of ribs (182, Fig. 7b) having flat edges (flat face 183, Fig. 7b; ¶ [0054]) configured to crush an item. These ribs improve the juicing ability of the device (¶ [0047, 0061]).
Therefore, 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 body of Brown to include a plurality of ribs having curved edges and to modify the cover of Brown to include a plurality of ribs having flat edges, as taught by Hensel, to improve the efficiency of fluid removal from the ampule of Brown. This is motivated by Hensel who describes the enhanced efficiency of removing juice from a citrus fruit using the structure of Hensel (¶ [0047, 0061]). The combination of Brown/Hensel will have the plurality of ribs having curved edges be disposed on the second end of the body, as the cavity that holds the ampule is present on the second end of the body and therefore the ribs will also be on the second end of the body.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sestak et al (US 8173418) in view of Weinstein (US 4957385).
Regarding Claim 9, Sestak discloses an ampule fracture device (10, Fig. 1) comprising:
a body (lever arm 20, Fig. 1) having a first end (end connecting to hinge 30, Fig. 1) and a second end (end opposite to hinge end, Fig. 1); and
a support (hinge member 30, Fig. 1) configured to incline the first end (end connecting to hinge 30, Fig. 1) of the body (20, Fig. 1) at a first height vertically above a second height of the second end (end opposite to hinge end, Fig. 1) of the body (12, Fig. 1) when the ampule fracture device (10, Fig. 1) is rested on a flat surface (as seen in Fig. 1) and while the device is actuated to fracture an ampule (50, Fig. 1);
further comprising a cavity (28, Fig. 1) disposed on the first end (end connecting to hinge 30, Fig. 1) of the body (20, Fig. 1), the cavity (28, Fig. 1) configured to receive at least a distal end of a medicament applicator (50, Fig. 1), the distal end including a dispenser tip (the device of Sestak is fully capable of receiving an ampule/medicament applicator with a distal dispenser tip rather than the capped biological indicator as shown in Fig. 1), wherein the cavity (28, Fig. 1) includes a sidewall (34, Fig. 1).
Sestak is silent regarding a reservoir that is recessed relative to the sidewall, the reservoir being configured to collect a medicament expelled from an ampule during an ampule fracturing operation.
Weinstein teaches an ampule dispensing device, thus being in the same field of endeavor, comprising a cavity including a side wall and a reservoir (75, Fig. 5) that is recessed relative to the sidewall (as seen in Fig. 5, the recess is within the wall of the base 73), the reservoir (75, Fig. 5) being configured to collect a medicament expelled from an ampule (99, Fig. 5) during an ampule fracturing operation. This recess allows for easier breaking of the ampule (Col. 3 line 68 – Col. 4 line 2).
Therefore, it would have been obvious to modify the cavity of Sestak to have a reservoir recessed relative to the sidewall, the reservoir being configured to collect a medicament expelled from an ample during an ampule fracturing operation, as taught by Weinstein. Weinstein indicates that this reservoir makes breaking the end of the ampule easier (Col. 3 line 68 – Col. 4 line 2) and therefore one of ordinary skill in the art would be motivated to make this modification.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (US 4432768) in view of Chen (US 4637139).
Regarding Claim 10, Brown further discloses the body includes a base portion (12, Figs. 1-3) having a first cavity (recess formed by sidewalls 18, Figs. 1-3) and a cover portion (arm 26, Figs. 1-3), wherein the cover portion (26, Figs. 1-3) and the base portion (12, Figs. 1-3) are movable relative to one another (Col. 2 lines 23-29).
Brown is silent whether the cover portion has a second cavity, wherein the cover portion and the base portion are moveable relative to one another to form an open configuration and a closed configuration, wherein, in the closed configuration, the cover portion covers the base portion, and the first cavity and the second cavity form a closed enclosure.
Chen teaches an ampule cutting device, thus being in the same field of endeavor, with a base portion (shell 10, Fig. 1) having a first cavity (lower tapered slot 111, Fig. 1) and a cover portion (shell 13, Fig. 1) having a second cavity (upper tapered slot 111, Fig. 1), wherein the cover portion (13, Fig. 1) and the base portion (10, Fig. 1) are moveable relative to one another to form an open configuration (as seen in Fig. 5) and a closed configuration (as seen in Fig. 3), wherein, in the closed configuration (as seen in Fig. 3), the cover portion (13, Fig. 1) covers the base portion (10, Fig. 1), and the first cavity (lower 111, Fig. 1) and the second cavity (upper 111, Fig. 1) form a closed enclosure. This structure allows the tip of the ampule to be held in place and the neck to be scored by the blade 121 with only a rotation of the ampule or device (Col. 3 line 60 – Col. 4 line 9).
Therefore, it would have been obvious to modify the cover portion of Brown to include a second cavity, and to have the cover portion and the base portion moveable relative to one another to form an open configuration and a close configuration, wherein, in the closed configuration, the cover portion covers the base portion and the first cavity and the second cavity form a closed enclosure, as taught by Chen, as this structure allows the blade to score the neck of the ampule with only a rotation of the ampule (as motivated by Chen Col. 3 line 60 – Col. 4 line 9).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781