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 with traverse of Group III (claims 12-15) in the reply filed on 9/30/25 is acknowledged. The traversal is on the ground(s) that (1) there is no search burden and the examiner made no showing of search burden, and (2) the groups require the same technical features. This is not found persuasive because (1) unity analysis does not require a showing of search burden and (2) the claims do not all require the grip pad as argued, at least because the pads of claims 1 and claim 8 are different pads with different structural limitations (grip pad that extends over proximal facing surface of plunger of claim 1 vs. grip pad on syringe assembly through which a plunger can extend of claim 8). Thus, there is not one unifying technical feature across the groups. Claims 1-11 are withdrawn from consideration.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 14 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 14 not been further treated on the merits.
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 12, 13, and 15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, it is unclear what the intended scope of the transitional phrase “comprising at least” is relative to the traditional phrase “comprising”. Furthermore, the phrase “the finger grip is a finger grip” is indefinite, and appears redundant at best.
Regarding claim 15, the phrase “or a kit thereof” is indefinite. It is not possible to determine what meaning or scope is intended by this phrase.
Claim 13 is rejected as dependent on rejected claim 12.
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.
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mandaroux et al. (US 20170290987).
Regarding claim 12, a syringe assembly 100 (fig. 1-8) for administering a liquid composition to a human or animal body (abstract), comprising at least: a longitudinal syringe barrel 104 having an inner lumen 152 for receiving and storing a liquid composition to be administered (abstract; par. 0040), a finger grip 108 coupled to a proximal end of said barrel (see fig. 1-8), and a plunger 106 having a plunger rod 202 and a plunger head 204, the plunger rod being disposed at least partly within the inner lumen of the barrel with a distal end thereof (see fig. 3), wherein the finger grip is a finger grip comprising a finger grip body 302 through which the plunger of a syringe assembly can be inserted (via 310; par. 0089).
Regarding claim 15, Mandaroux et al. discloses a product comprising a syringe assembly according to claim 12 (see claim 12 above) for therapeutic application (abstract), wherein said product comprises an effective amount of a liquid composition which is adapted to be administered to a subject (abstract; par. 0034).
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.
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mandaroux et al. in view of Heinz et al. (US 20040116858).
Regarding claim 13, Mandaroux et al. discloses the syringe barrel comprises a luer fitting at a distal end thereof integrally formed with the syringe barrel (par. 0038; fig. 1-2), but fails to specifically disclose that the fitting is a luer lock connector, wherein the syringe assembly further comprises a tip cap, the tip cap covering and sealing the distal end of the syringe barrel, wherein the tip cap is a two-part tip cap comprising a rigid part and an elastomeric part, wherein the maximum outer diameter (Dmax) of the rigid part is less or equal to the outer diameter of the Luer lock connector of the syringe barrel. However, Heinz et al. teaches, in combination with a syringe barrel 1 having a luer lock connector integrally formed therewith (fig. 3; par. 0031), a tip cap (comprising 13 and 15) covering and sealing the distal end of the barrel (see fig. 3) which is two-part (13 and 15) comprising a rigid part 13 and an elastomeric part 15 (see fig. 3; par. 0015), wherein the maximum outer diameter of the rigid part is less or equal to that of the luer lock connector (see fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mandaroux et al. to utilize a luer lock and corresponding tip cap, such as the one taught by Heinz et al., for the purpose of accommodating needles that utilize luer lock style fittings and to provide sufficient structure to close the syringe prior to use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. These references disclose similar tip cap arrangements: Jansen et al. (US 6196998); Arai et al. (US 6004299); Grabenkort (US 5779668; fig. 5A); Imbert (US 5624402); Fischer et al. (US 20140358078); Okhara (US 20220008660); Chou et al. (US 20220160972).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783