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 .
Specification
The replacement Abstract filed 2/17/2026 is acceptable and has been entered.
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 4-6 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 4 recites “said incision” on line 2. With claim 1 being amended to recite “a pair of upper incisions”, it is unclear if “said incision” is intended to refer to the “lower incision” introduced on line 2 of claim 4 or to one of the “upper incisions” now introduced in claim 1. For the sake of examination, the phrase “said incision” is interpreted as referring to the “lower incision” introduced in claim 4; accordingly, it is suggested to amend line 2 of claim 4 to recite “said lower incision”. Claims 5 and 6 are rejected due to their dependence on claim 4.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 has been amended to recite that “the catheter hub comprises a pair of upper incisions, each upper protrusion [of the high pressure clip] engages a respective one of the upper incisions of the catheter hub” on lines 11-13. Due to this amendment, claim 6 (which recites “wherein the catheter hub further comprises upper incisions and wherein the high pressure clip is arranged in said upper incisions”) fails to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-3 and 10 are allowed, claims 4-5 would be allowable if amended to overcome the 112(b) rejection set forth above, and claim 6 would be allowable if amended to overcome the 112(d) rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: Independent claim 1 has been amended to incorporate the subject matter of previously-pending dependent claim 8 which was indicated as allowable in the 11/18/2025 Office Action; please see that Office Action for a detailed statement of reasons for allowance.
As set forth above, claim 1 is allowable. The restriction requirement between Groups I and II, as set forth in the Office action mailed on 8/13/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is maintained because the nonelected claims do not require all the limitations of an allowable claim. Independent claim 11 only requires the needle shielding device to (a) have a proximal end and (b) comprise a needle protection clip; it does not require the proximal end to comprise the needle protection clip as required by claim 1. Additionally, independent claim 11 only requires the catheter hub to (a) have a distal end and (b) have a high pressure clip inserted within the catheter hub; it does not require the distal end to comprise the high pressure clip as required by claim 1. It is suggested to cancel the non-elected claims or take other appropriate action (37 CFR 1.144).
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 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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