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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Status of the Claims
Claims 1-10 and 12-21 are currently pending. Claims 13-20 are currently withdrawn. Claim 1, 10, and 12 are currently amended. Claim 11 is cancelled. Claim 21 is newly added. Claims 1-10, 12, and 21 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/30/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered but are moot because the new ground of rejection does not rely on the same interpretation of the prior art used in the previous rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that “The extension 74 does not prevent longitudinal movement of the needle safety housing 54 or the needle safety component 56 relative to the catheter 42 and the valve 52 when the extension 74 is inserted into the valve 52.” See the representations of the cylindrical extension 74 and the cylindrical valve 52, both shown in fig. 2b of Blanchard, and [0060] “the extension 74 of the safety housing 54 in the present embodiment extends into the valve 52 so as to open the valve during use of the insertion tool 10”. Examiner notes that when the extension 74 is inserted into valve 52, the engagement of these pieces would prevent further longitudinal movement of the catheter group 42/52 and the needle safety clip 54/46 towards each other. The claim language, as currently written, does not require that the engagement prevents longitudinal movement in both directions, only that some longitudinal movement is prevented when the noted elements are engaged.
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.
Claim(s) 1-9 and 21 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Blanchard et al (US-20110282285-A1; hereafter Blanchard).
Regarding claim 1, Blanchard discloses a catheter insertion device (insertion tool 10, [0043], fig. 7B), comprising: a handle (housing 12 and needle hub 14, fig. 2A, [0043]) comprising a top arm (top housing portion 12A) and a bottom arm (bottom housing portion 12B), the top arm and the bottom arm formed in a distal region of the handle (fig. 7B shows that the arms 12A and 12B are formed in the distal end of the housing, where the sides of the housing are separable);
a needle cannula (hollow needle 16, [0045], fig. 1B) having a sharp distal tip (sharp tip shown in fig. 2A), the needle cannula (16) held within the handle (12/14) and at least partially disposed between the top arm (12A) and the bottom arm (12B) ([0043] hollow needle 16 is supported by the needle hub 14 and interposed between the top and bottom housing portions 12A and 12B, fig. 1B);
a guidewire (guidewire 22, fig. 1B, [0045]) at least partially disposed within a lumen of the needle cannula (16), the guidewire (22) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to slide within the lumen of the needle cannula ([0045] guidewire 22 is advanced through the lumen of hollow needle 16, fig. 1B);
a first actuator (slide 28 and guidewire lever 24, fig. 1B, [0046]) connected to the guidewire, the first actuator (28/24) being movable relative to the handle (12/14) ([0046] slide 28 is slidably attached to housing 12) to move the guidewire relative to the handle ([0046] movement of slide 28 leads to movement of guidewire 22);
a catheter group (catheter 42, base 48A, and valve 52; fig. 2B; respectively see [0049], [0051], and [0059]) comprising a catheter (catheter tube 44) and a catheter hub (hub 46, fig. 2B), the catheter hub connected to a proximal end of the catheter ([0049] hub 46 located at proximal end of the catheter tube 44, fig. 2B), the catheter (44) and the catheter hub (46) at least partially disposed between the top arm and the bottom arm ([0049] fig. 1B shows catheter hub 46 and catheter tube 44 pre-disposed within the housing 12), and the catheter and the catheter hub are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to move relative to the handle ([0058] catheter advancement assembly 40 slides distally relative to the handle) and slide over the cannula (hollow needle 16; see 112b interpretation above) during deployment of the catheter into vasculature of a patient ([0058] catheter advancement assembly slides over the hollow needle 16 during catheter insertion into the vasculature);
and a needle safety clip (safety housing 54 and needle safety component 56, fig. 2B) having a first end (see end of safety housing 54 which includes extension 74 shown in fig. 2b and discussed in [0060]) configured to removably engage the catheter group (42/48A/52, fig. 2B) ([0060] the extension 74 of the safety housing 54 extends into the valve 52; [0059] upon removal of the needle 16 and safety housing 54 from the catheter 42, the valve 52 occludes the catheter lumen so as to prevent inadvertent blood spillage from the catheter hub 46; Examiner notes that the needle safety clip 54/56 removably engages the catheter group 42/52),
wherein the first end (see end of safety housing 54 which includes extension 74 shown in fig. 2b and discussed in [0060]) of the needle safety clip (54/56) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent longitudinal movement of the needle safety clip (54/56) relative to the catheter group (42/48A/52, fig. 2b) when the first end of the needle safety clip engages the catheter group ([0060] Note that the extension 74 of the safety housing 54 in the present embodiment extends into the valve 52; see fig. 2b and note that the 350 degree engagement of the cylindrical first end 74 into the valve 52 through base 48A of the catheter group would prevent further longitudinal movement once engaged, since the extension 74 and face of the safety housing 54 facing the base 48A would engage with and through base 48A thus preventing further longitudinal movement of the catheter group 42/48A/52 toward the needle safety clip 54/56 once engaged), and
wherein the needle safety clip (54/56) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cover the sharp distal tip (see fig. 1A) of the needle cannula (16) following removal of the needle cannula from the catheter hub ([0059] distal tip of needle 16 is received in safety housing 54 when the hollow needle 16 is retracted from the catheter hub 46, see fig. 7A/7B, see fig. 10A/10B and [0060]).
Regarding claim 2, Blanchard discloses the catheter insertion device according to claim 1, as described above, and further discloses wherein the first actuator (28/24, fig. 1B) comprises an arm (lever tab 26, fig. 1B) secured to the guidewire ([0045] guidewire lever 24 includes lever tab 26 that engages the guidewire 22 to push the guidewire through the lumen of needle 16), the arm (26) extending from a bottom surface of the first actuator (see fig. 1B).
Regarding claim 3, Blanchard discloses the catheter insertion device according to claim 2, as described above, and further discloses wherein the arm (26, fig. 1B) is connected to a proximal end of the guidewire (22, fig. 1B) (fig. 1B, [0045] lever tab 26 engages proximal end of guidewire 22).
Regarding claim 4, Blanchard discloses the catheter insertion device according to claim 1, as described above, and further discloses wherein the first actuator (28/24, fig. 1B) is a slider (slide 28) operable to slide over a portion of the handle (12/14) ([0046] slide 28 selectively slides along track 34 in top housing portion 12A).
Regarding claim 5, Blanchard discloses the catheter insertion device according to claim 4, as described above, and further discloses wherein the slider (28, fig. 1B) is operable to slide over the top arm (12A, fig. 1B) formed in the distal region of the handle (see fig. 1B, slide 28 is located in distal portion of the handle; [0046] slide 28 selectively slides along track 34 in top housing portion 12A).
Regarding claim 6, Blanchard discloses the catheter insertion device according to claim 1, as described above, and discloses further comprising a second actuator (arms 50, fig. 1A, fig. 2B, [0050]) connected to the handle (see fig. 1A, second actuator/arms 50 attached to handle/housing 12), the second actuator (50) being movable relative to the handle (12/14, fig. 1A) to push the catheter group (42, fig. 2B) relative to the handle ([0050] pushing second actuator/arms 50 of catheter advancement assembly 40 allows a user to selectively advance the catheter group 42; movement shown through figs. 4-6).
Regarding claim 7, Blanchard discloses the catheter insertion device according to claim 6, as described above, and further discloses wherein the second actuator (50, fig. 2B) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive a portion of the catheter hub (46) (fig. 8 and 9 show that the second actuator 50 receives a portion of catheter hub 46; [0050] teeth 50C engage corresponding raised surfaces on the hub 46, see fig. 2B).
Regarding claim 8, Blanchard discloses the catheter insertion device according to claim 6, as described above, and further discloses wherein the second actuator (50, fig. 2B) comprises an enlarged proximal end (protrusions 60 on inner surfaces of arms 50, fig. 2B) operable to engage the handle (12/14, fig. 1A) to limit movement of the second actuator (48, fig. 1A) relative to the handle ([0051] protrusions 60 included on the inner surfaces of the handle arms 50 engage with corresponding recesses 62 defined in the safety housing 54 to removably secure the safety housing to the handle 48; see fig. 10A for recesses 62; see fig. 9 which shows that the safety housing 54 remains attached to the handle/housing 12).
Regarding claim 9, Blanchard discloses the catheter insertion device according to claim 6, as described above, and further discloses wherein the second actuator (50, fig. 2B) comprises a lip (finger grabs 50B, fig. 2B, [0050]) extending outward from a distal end of the second actuator (50, see also fig. 2B) , the lip (50B) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent a finger of a practitioner from slipping past the distal end of the second actuator (50) during operation (Examiner notes that a practitioner could push against the lip/finger grab 50B to safely advance the second actuator 50 without having to move their finger past the distal end of the second actuator 50.).
Regarding claim 21, Blanchard discloses the catheter insertion device according to claim 1, as described above. Blanchard further discloses wherein the first end (see end of safety housing 54 which includes extension 74 shown in fig. 2b and discussed in [0060]) of the needle safety clip (54/56) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent lateral movement of the needle safety clip (54/56) relative to the catheter group (42/48A/52, fig. 2b) when the first end of the needle safety clip engages the catheter group ([0060] Note that the extension 74 of the safety housing 54 in the present embodiment extends into the valve 52; see fig. 2B and note that the 350 degree engagement of the cylindrical first end 74 into the valve 52 of the catheter group through the base 48A of the catheter group would prevent lateral movement when engaged).
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.
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.
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) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard, as applied to claim 1 above, and further in view of a second embodiment of Blanchard (hereafter Blanchard2).
Regarding claim 10, Blanchard discloses the catheter insertion device according to claim 1, as described above, and discloses further comprising a needle support (support structure 70, fig. 5B) coupled to the top arm (12A) ([0053] support structure 70 includes an interface 72 of the top housing portion 12A and bottom housing portion 12B, see fig. 5A/5B), and wherein the needle support (support structure 70, fig. 5B) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to stabilize a portion of the needle cannula (16, fig. 4B) during insertion of the needle cannula into a patient ([0053] The interface 72 stabilizes the needle cannula 16 so as to prevent excessive "play" in the needle, thus improving user accuracy when initially accessing the vasculature of the patient).
Blanchard is silent to the movement of the needle support.
Blanchard2 teaches wherein the needle support (support structure 170 comprising two flaps 172, fig. 14C, [0068]) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to move relative to the handle (housing 112, fig. 14C) upon abutment of the catheter hub (catheter hub 46, fig. 14C) to the needle support ([0068] once opened the flaps 172 provide an opening enabling the catheter hub 46 to be removed from the distal end of the housing 112).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the needle support of Blanchard to move relative to the handle as taught by Blanchard2 since both embodiments deal with advancement of intravenous catheter assemblies. One would have been motivated to make the modification because constraining the movement of the catheter hub, and tying the constraint to an obvious motion such as the flaps opening, provides the practitioner with a clear indication that the device is functioning correctly during use.
Regarding claim 12, Blanchard modified by Blanchard2 discloses the catheter insertion device according to claim 10, as described above. Blanchard further discloses wherein the needle support (support structure 70, fig. 5B) comprises a top portion that abuts a bottom surface (arms 30, fig. 5B, [0047]) of the first actuator (28/24, fig. 5A, fig. 1B) to prevent movement of the needle support (70) relative to the handle (12/14, fig. 5A) ([0047] slide 28 includes two arms 30; fig. 5B shows support structure 70 contacting bottom portions of slide 28 which is part of the first actuator 24/28; Examiner notes that contact would prevent further movement perpendicular to the plane of contact).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/05/2026