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 .
Response to Amendment
This office action is responsive to the amendment filed on 4/29/2024. As directed by the amendment: claim 1 has been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-11 are presently pending in this application.
Drawings
The Drawings filed 4/29/2024 have been accepted.
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 1-9 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.
Claim 1 recites “a majority of the length of the body is located between the female luer fitting and the male luer fitting”. It is unclear whether the length is entirely between the female luer fitting and the male luer fitting (as the claim recites the length as being "between first and second ends" which the claim further describes as defining the female luer fitting and male luer fitting respectively) or whether only a majority of the length (which implies less than the entirety of the length) is between the female luer fitting and the male luer fitting as the language in lines 9-10 of claim 1 would indicate.
Dependent claims are rejected by virtue of their dependency on the independent claims.
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.
Claims 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilson et al. (US 4369781 A).
Regarding claim 1, Gilson discloses a grip (10) for mounting to a syringe (84) having a luer tip (86) with a liquid outlet defined at a distal end thereof (Col 4, lines 5-7), the grip comprising:
an elongated body (12) extending a length (Image 1) along a longitudinal axis between first and second ends (Image 1), the first end defining a female luer fitting (28) configured for mounting onto the luer tip of the syringe (Fig. 4), an inlet opening (30) being defined in the female luer fitting formed to align with the liquid outlet of the luer tip with the female luer fitting mounted to the luer tip (Fig. 4), the second end defining a male luer fitting (14) defining an outlet opening (20) at a distal end thereof (Fig. 1), and, a liquid passageway (Passagewafy within 12 between 20 and 30) defined through the body between the inlet opening and the outlet opening to allow liquid flow therebetween (Col 4, lines 5-7), wherein, a majority of the length of the body is located between the female luer fitting and the male luer fitting (Image 1), and, wherein, the body defines an outer surface (32) encircling the longitudinal axis (Fig. 1), the outer surface being at least partially textured (Col 4, lines 30-32).
Image 1:
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Regarding claim 2, Gilson discloses the grip of claim 1, wherein the diameter of the body varies along the longitudinal axis (Fig. 1).
Regarding claim 3, Gilson discloses the grip of claim 2, wherein the body defines a concave shape (Spaces between two adjacent longitudinal ribs on the outer surface of wall define a concave shape, Col 4, lines 30-32).
Regarding claim 4, Gilson discloses the grip of claim 1, wherein the outer surface is textured by a plurality of spaced-apart discontinuities and/or raised elements (Col 4, lines 30-32).
Regarding claim 5, Gilson discloses the grip of claim 4, wherein the outer surface includes a plurality of intersecting ribs (Col 4, lines 30-32, merriam-webster defines “intersecting” as “to pierce or divide by passing through or across” and because the ribs are dividing the body by passing across the body, the ribs are intersecting the body) defining the spaced-apart discontinuities (Col 4, lines 30-32, Fig. 4).
Regarding claim 6, Gilson discloses the grip of claim 1, further comprising an internally-threaded collar (24/26) disposed about the male luer fitting (Fig. 1).
Regarding claim 8, Gilson discloses the grip of claim 1, wherein the outer surface is textured about a full circumference of the body (Col 4, lines 30-32, Figs. 1 and 4).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 4369781 A) in view of Kim et al. (US 20200155770 A1).
Regarding claim 7, Gilson discloses the grip of claim 1, but is silent regarding further comprising at least one thread protruding radially outwardly from the female luer fitting.
In analogous art, Kim teaches
further comprising at least one thread protruding radially outwardly from the female luer fitting (34, Fig. 1, Paragraph [0033], Claim 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the female luer fitting on Gilson to incorporate the teachings of Kim to incorporate at least one thread protruding radially outwardly from the female luer fitting in order to allow mating with a male luer connector of a syringe barrel (Paragraph [0033]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 4369781 A) in view of MH Eye Care (“OASIS® Formed Irrigating Cystotome”, 2020).
Regarding claim 9, Gilson discloses a syringe assembly (Figs. 1 and 4) for performing a capsulotomy on a patient's eye with a cystotome, the syringe assembly comprising:
a syringe (84) having a luer tip (86) with a liquid outlet defined at a distal end thereof (Col 4, lines 5-7);
a grip as in claim 1 (See rejection of claim 1 above) with the female luer fitting thereof mounted to the luer tip of the syringe (Fig. 4); and,
a cannula (88), distally extending from a hub (90), the hub having a secondary female luer fitting (92) mounted to the male luer fitting of the grip (Fig. 4, Cols 3-4, lines 67-5).
Gilson is silent regarding
a cystotome, distally extending from a hub, the cystotome configured for incising the lens capsule of the patient's eye, the hub having a secondary female luer fitting mounted to the male luer fitting of the grip.
In analogous art, MH Eye Care teaches
a cystotome (Image 2), distally extending from a hub (Image 2), the cystotome configured for incising the lens capsule of the patient's eye (Page 2, “OASIS’® Irrigating Cystotome is a crucial instrument in the capsulotomy of the eye to remove cataracts by surgery. With a formed bend, this is a reliable instrument during cataract procedures”, the hub having a secondary female luer fitting (Image 2).
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The substitution of one known material (irrigating cystotome as taught in MH Eye Care) for another (fluid delivering cannula as taught in Gilson) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since the substitution of the irrigating cystotome as taught in MH Eye Care would have yielded predictable results, namely, a delivering conduit of Gilson that would expel the contents within the syringe. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Response to Arguments
Applicant's arguments filed 4/29/2024 have been fully considered but they are not persuasive.
In response to applicant's arguments, on page 7, that Gilson does not teach “the majority of the length of the body is located between the female luer fitting and the male luer fitting”, the Examiner respectfully disagrees. Claim 1 recites that the elongated body extends "a length along a longitudinal axis between first and second ends" and the current rejection maps this length to the portion/length of the body 12 in Gilson that is between the female luer fitting 28 and the male luer fitting 14, see annotated figure below, thus since this length of the body is entirely between the female luer fitting and the male luer fitting , a majority of this length is also located between the female luer and the male luer. Examiner notes that a 112(b) rejection is given above as the claim is unclear as to whether the length is entirely between the female luer fitting and the male luer fitting (as the claim recites the length as being "between first and second ends" which the claim further describes as defining the female luer fitting and male luer fitting respectively) or whether only a portion/majority of the length is between the female luer fitting and the male luer fitting as the language in lines 9-10 of claim 1 would indicate.
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Conclusion
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 extension fee 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 date of this final action.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783