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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 24, 2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/077,760, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application does not show support for a shield with a mounting protrusion and a clip with a mounting cavity as claimed.
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.
Claim 19 is 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 19 recites the mounting protrusion is interlocked to the needle shield. Claim 1, from which 19 depends, recites the mounting protrusion is integrated into the needle shield to form a unitary and monolithic structure. It is not clear how a structure which is monolithic is “interlocked.” For purposes of examination the Examiner is considering a monolithic structure to be interlocked.
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) 1, 3, 5-9, 16, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howell et al. (US 6,749,588 B1).
With regard to claims 1, 3, 5, 16, and 19, Howell et al. teach a catheter assembly comprising: a catheter (exemplary Fig. 1 member 21); a needle disposed in the catheter and having a distal tip (Fig. 74 member 31 with tip 32); a catheter hub attached to the catheter and enclosing the needle (exemplary Fig. 1 member 24); a needle shield configured to be connected to the catheter hub (Figs. 1 and 74 member 40), the needle shield having a mounting protrusion including a projection extending from an inner surface of the needle shield, the mounting protrusion is integrated into the needle shield to form a unitary and monolithic structure (see Reference Figure 1 below); a clip including a mounting cavity, the clip being disposed in the needle shield (Fig. 74 member 896, cavity within 896 and as illustrated in Reference Figure 2 below); wherein the clip has a first position that exposes the distal tip of the needle, the needle biases the clip in the first position (Fig. 74), the clip includes a second position that shields the distal tip of the needle within the clip (Fig. 75); and when the needle retracts, the clip transitions into the second position and while the clip substantially maintains an axial position, the needle unbiases the clip, causing the clip to deflect and shield the distal tip of the needle and causing a periphery of the mounting cavity to move into engagement with the mounting protrusion to secure the clip to the needle shield and avoid undesired movement or tampering of the clip, the periphery of the mounting cavity surrounds the mounting protrusion to engage the mounting protrusion; wherein the periphery of the mounting cavity does not engage the mounting protrusion in the first position whereby the periphery of the mounting cavity does not surround the mounting protrusion (see transition from Fig. 74 to 75).
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With regard to claim 6, see Reference Figure 1 above.
With regard to claims 7 and 8, see Reference Figure 1 above.
With regard to claims 9 and 17, see Reference Figure 2 below.
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Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783