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 (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.
Notice of Amendment
In response to the amendment(s) filed on 2/5/26, amended claim(s) 8 and 10, canceled claim(s) 1-7, 11-12, and 15-20, and new claim(s) 21 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Election/Restrictions
Newly submitted claim(s) 21 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Group 1, claim(s) 8-10 and 13-14, drawn to a protective needle housing system (a first apparatus).
Group 2, claim(s) 21, drawn to a protective needle housing system (a second apparatus).
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. The reasons for the holding of lack of unity are as follows:
Groups 1-2 share common subject matter such as a needle; a protective needle housing comprising: a needle passageway configured to receive at least a portion of the needle therein; and a needle block configured to move between a closed position and an open position. However, this common subject matter are not special technical features because they do not define a contribution over the prior art. For example, WO 2016/168737 to Stokes discloses a needle (470) (Fig. 30) (para [0128]); a protective needle housing (Examiner’s Note: made up of the elements it comprises) comprising: a needle passageway (cylindrical passageway in the center of 420) (Fig. 30) (para [0123]) configured to receive at least a portion of the needle therein (as can be seen in Fig. 30); and a needle block (460) (Fig. 30) (para [0128]) configured to move between a closed position (as can be seen in Fig. 33) and an open position (as can be seen in Fig. 32). Therefore, Groups 1-2 lack unity of invention a posterori.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 21 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 8-10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/168737 to Stokes in view of U.S. Patent Application Publication No. 2019/0160264 to Isaacson.
For claim 8, Stokes discloses a protective needle housing system (Abstract) comprising:
a needle (470) (Fig. 30) (para [0128]);
a protective needle housing (Examiner’s Note: made up of the elements it comprises) comprising:
a needle passageway (cylindrical passageway in the center of 420) (Fig. 30) (para [0123]) configured to receive at least a portion of the needle therein (as can be seen in Fig. 30); and
a needle block (460) (Fig. 30) (para [0128]) configured to move between a closed position (as can be seen in Fig. 33) and an open position (as can be seen in Fig. 32);
wherein:
in the closed position, the needle block prevents the needle from advancing distally through the needle passageway (as can be seen in Fig. 33) (also see para [0137]); and
in the open position, an aperture formed in the needle block is placed in alignment with the needle passageway to allow the needle to advance distally through the needle passageway (as can be seen in Fig. 32) (also see para [0128]), wherein the needle block comprises a first engagement surface (surface of 460); and
a catheter adapter (either 400 or 430, which both engage 460 on either side, see Figs. 30-33 and para [0128] and [0137]) comprising a second engagement surface (surface of 400 or 430), wherein in response to coupling the protective needle housing to the catheter adapter (as can be seen in Fig. 30, showing the protective needle housing being coupled to the catheter adapter), the second engagement surface of the catheter adapter engages the first engagement surface of the needle block (para [0128] and [0137]) (also see Fig. 32) and the needle block is configured to move from the closed position to the open position (para [0128] and [0137]) (also see Fig. 32), wherein after the needle block automatically moves from the closed position to the open position, the needle is configured to move distally through the aperture (as can be seen in Fig. 32) (also see para [0128] and [0137]).
Stokes does not expressly disclose that the movement from the closed position to the open position is automatic.
However, Isaacson teaches that a movement from a closed position to an open position is automatic (Examiner’s Note: construed in light of para [0075] of Applicant’s specification as originally filed) (para [0047]).
It would have been obvious to a skilled artisan to modify Stokes such that the movement from the closed position to the open position is automatic, in view of Isaacson, because automating a manual activity has been held to be within the purview of a skilled artisan, see In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). Additionally, a skilled artisan would have been motivated to make such a modification for the obvious advantage of giving a motive force to the needle in Stokes when the protective needle housing is attached to the catheter adapter so that the needle is advanced when it is protected and not advanced when unprotected.
For claim 9, Stokes further disclose a resilient member configured to bias the needle block in the closed position (para [0112] and [0137]) (also see 144 in Fig. 25A).
For claim 10, Stokes does not express wherein the resilient member comprises a spring clip.
However, Isaacson teaches a spring clip (40).
It would have been obvious to a skilled artisan to modify Stokes wherein the resilient member comprises a spring clip, in view of the teachings of Isaacson, because such a modification would be the simple substitution of one resilient structure for another resilient structure that would lead to the predictable result of providing a biasing force.
For claim 14, Stokes further discloses wherein the needle comprises a bumper (472) (Fig. 30) (para [0130]) configured to prevent the needle from moving proximally out of the protective needle housing (para [0130] and [0138]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stokes in view of Isaacson, and further in view of U.S. Patent No. 3,848,579 to Villa-Real.
For claim 13, Stokes and Isaacson do not expressly disclose wherein a distal end of the needle comprises: a closed tip; and an aspiration aperture formed in a sidewall of the needle proximate the closed tip.
However, Villa-Real teaches wherein a distal end of the needle comprises: a closed tip (see where reference numeral “17” is pointing in Fig. 13); and an aspiration aperture formed in a sidewall of the needle proximate the closed tip (either 15 or 16) (Fig. 13).
It would have been obvious to a skilled artisan to modify Stokes wherein a distal end of the needle comprises: a closed tip; and an aspiration aperture formed in a sidewall of the needle proximate the closed tip, in view of the teachings of Villa-Real, because such a modification would be the simple substitution of the position of the opening on the needle which would lead to the predictable result or removing and/or delivering fluid.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 2/5/26.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791