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 11 June 2026. As directed by the amendment: claims 16, 20 and 21 have been amended, claims 1-15 have been or remain canceled. Thus claims 16-29 are presently pending in this application and claims 24-29 remain withdrawn.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “from a location that is radially inwardly from the outer perimeter of the proximal wall” twice, in lines 6 and 9. These should instead recite “from a location that is radially inward from the outer perimeter of the proximal wall”.
Appropriate correction is required.
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.
(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.
Claims 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulli (US 2007/0149928).
Regarding claim 16, Kulli discloses a needle guard (64’, 10’ Fig 10, with components equivalent to the embodiment shown in Fig 9) comprising: a proximal wall (20 Fig 11) having a distally facing surface, a proximally facing surface (See the proximal and distal facing surfaces in annotated Fig 10 below), and an inner perimeter defining a through opening (See the inner perimeter in annotated Fig 10, equivalent to 22 in Fig 9), and an outer perimeter of the proximal wall (See the outer perimeter in annotated Fig 10 below), the proximal wall being made of a first material ([0031] “support member 20 may be metal or may be plastic, especially if housing 64 is formed of plastic” in the embodiment relied upon, the support member 20 and housing 64 forming the proximal wall are plastic); a first arm (26 and 30 Fig 9) extending distally from the distally facing surface of the proximal wall, from a location that is radially inwardly from the outer perimeter of the proximal wall (As shown in Figs 9 and 10 the arms 24 and 26 are radially inward from the outer perimeter of the proximal wall), the first arm comprising an arm section (26 Fig 9) and a distal wall (30 Fig 9); a second arm (24 and 28 Fig 9) extending distally from the distally facing surface of the proximal wall, from a location that is radially inwardly from the outer perimeter of the proximal wall (See Figs 9 and 10), the second arm comprising an arm section (24 Fig 9) and a distal wall (28 Fig 9); wherein the first arm, the second arm, or both the first arm and the second arm are made of a second material different from the first material of the proximal wall ([0031] “Tip protector 10 and 10' may be of metal and/or plastic. For example, members 28, 30 or 28', 30' and spring arms 24, 26 may be metal, and support member 20 may be metal or may be plastic, especially if housing 64 is formed of plastic.”, in the embodiment relied upon the first and second arms are metal, and the proximal wall is plastic).
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Regarding claim 17, Kulli discloses the needle guard according to claim 16, wherein the first arm and the second arm are made of the same second material ([0031] “members 28, 30 or 28', 30' and spring arms 24, 26 may be metal”).
Regarding claim 18, Kulli discloses the needle guard according to claim 16, further comprising an adaptor (housing 64’ and resilient fingers 70 and 72 Fig 10) attached to the proximal wall (the cylindrical housing and the attached components extend from the proximal wall as shown in Fig 10).
Regarding claim 19, Kulli discloses the needle guard according to claim 18, wherein the adaptor comprises at least one engagement tab (70 and 72 Fig 10), the engagement tab comprising a locating protrusion (76 Fig 10) for contacting a catheter hub (As shown in Fig 10, the detents 76 contact recess 58 of catheter hub 56).
Regarding claim 20, Kulli discloses the needle guard according to claim 19, wherein the at least one engagement tab extends from a side surface of an adaptor body (As shown in Fig 10, 70 and 72 extend from the outer surface of the cylinder of the housing 64’) of the adapter and comprises a bend (See the bend 77 in Fig 11) such that the at least one engagement tab extends in a proximal direction or a distal direction (70 and 72 extend distally as shown in Fig 10 and with the bend in Fig 11).
Regarding claim 21, Kulli discloses the needle guard according to claim 19, wherein the at least one engagement tab comprises a locating projection (76 Fig 10, this is the same element as the locating protrusion in claim 19, the locating protrusion and the locating projection are described in the specification of the instant application as referencing the same element [0186] “Each of the engagement tabs 358 may have at least one locating protrusion or projection 362”) projecting from a surface of the engagement tab (detents project from the outer surface of 70 and 72 Fig 10).
Regarding claim 22, Kulli discloses the needle guard according to claim 18, wherein the adaptor comprises two or more engagement tabs (70 and 72 Fig 10).
Regarding claim 23, Kulli discloses the needle guard according to claim 22, wherein at least two of the two or more engagement tabs are diametrically opposed around an adaptor body (the cross section shown in Fig 10 shows the tabs 70 and 72 diametrically opposed around the body 64’).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Holm et al. (US 20150126931 A1) discloses a needle guard with a catheter adapter having many of the claimed elements.
Tan et al. (US 20160354539 A1) discloses a needle guard with a catheter adapter having separate construction and materials.
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.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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