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 .
Status of the Claims
Claims 1-10 and 12-21 are currently pending. Claim 1 is currently amended. Claim 11 is cancelled. Claims 13-20 are withdrawn. Claims 1-10, 12, and 21 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/09/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fiser et al (US 20080065015 A1).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “200” has been used to designate both a “broad tab” (see at least figs. 9a-d, [0065]) and a “catheter insertion device” (see at least fig. 17 and [0084]).
Reference character “202” has been used to designate both a “narrow recess” (see at least figs. 9a-d, [0065]) and a “housing” (see at least fig. 17 and [0084]).
Reference character “204” has been used to designate both a “broad recess” (see at least figs. 9a-d, [0065]) and a “slider” (see at least fig. 17 and [0084]).
Reference character “206” has been used to designate both “compression ribs” (see at least fig. 11a, [0071]) and a “release” (see at least fig. 17 and [0084]).
Reference character “208” has been used to designate both a “smooth region” (see at least fig. 11b, [0072]) and a “catheter hub” (see at least fig. 17 and [0084]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
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 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) 1-9 and 21 is/are rejected under 35 U.S.C. 103 as being obvious over Blanchard et al (US-20110282285-A1; hereafter Blanchard) in view of Fiser et al (US-20080065015-A1).
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 (needle safety component 56, fig. 2B),
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]).
Blanchard is silent to the needle safety clip having a first end configured to removably engage an exterior portion of the catheter group.
Fiser, directed to a locking clip, teaches a needle safety clip (clip 628, fig. 1, [0046]) having a first end (distal part 636 of first leg 632 of clip 628, fig. 1, [0046]) configured to removably engage an exterior portion (flange 72 of the catheter hub noted in [0052]) of the catheter group (catheter 38 shown in fig. 1; [0046] “first leg 632 has a distal part 636 that is configured to engage the catheter 38; see fig. 1 which shows engagement of distal part 636 with exterior of catheter 38”; [0052] “The hook portion 670 also rotates away from the catheter hub or needle cannula 22, as shown in FIG. 2A, to release the flange 72 of the catheter hub. The catheter 38 is then separable from the housing 644.”),
wherein the first end (distal part 636 of first leg 632 of clip 628, fig. 1) of the needle safety clip (clip 628) 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 (628) relative to the catheter group (38) when the first end of the needle safety clip engages the exterior portion of the catheter group (see fig. 1) ([0050] “the distal part 636 defines an arm 668 that is configured to releasably retain the catheter hub with the outer surface of the housing 644. In the sliding orientation, the arm 668 is disposed such that a hook portion 670 thereof captures a flange 72 of the catheter hub”), and
wherein the needle safety clip (628) 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 (distal end 26 of the needle cannula 22, fig. 2a shows distal tip 26 covered by the needle clip 628, [0056]) of the needle cannula (needle cannula 22, fig. 2a) following removal of the needle cannula ([0052] describes movement of needle safety clip “As shown in FIG. 2A, when the needle cannula 22 is withdrawn”) from the catheter hub (see difference between fig. 1 and fig. 2a which shows needle has been withdrawn from the catheter).
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 safety housing 54 and needle safety component 56 (Blanchard: fig. 10a/b and [0051]) in view of the similarly functioning housing 644 and clip 628 (Fiser: fig. 1-2b and [0048]) such that the needle safety clip has a first end which removably engages the catheter group, as taught by Fiser, since both references deal with needle safety devices which receive a sharp needle tip after removal from a catheter, and both references deal with engagement between the needle safety device and the catheter group. One would have been motivated to make the modification because the rotatable needle safety clip 628 of Fiser provides additional protection from needle sticks since, as shown in fig. 2c and described in [0058] of Fiser, the sharp tip of the needle is prevented from moving forward by direct contact between the needle tip and the clip itself. Additionally, having the releasable engagement of the catheter group and needle safety clip directly between an arm of the needle safety clip itself and the exterior of the catheter group ensures that the needle safety clip and catheter group do not detach prematurely, but only when the needle has been withdrawn into and triggered movement of the needle safety clip can the catheter group detach. This configuration thus better helps to reduce the risk of needle sticks.
Regarding claim 2, Blanchard as modified discloses the catheter insertion device according to claim 1, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 2, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 1, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 4, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 1, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 6, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 6, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 6, as described above, and Blanchard 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 as modified discloses the catheter insertion device according to claim 1, as described above, including wherein the first end (Fiser: distal part 636 of first leg 632 of clip 628, fig. 1, [0046]) of the needle safety clip (Fiser: 628) 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 (Fiser: 628 fig. 1) relative to the catheter group (Fiser: 38 fig. 1) when the first end of the needle safety clip engages the catheter group (see Fiser fig. 1) ([0050] “the distal part 636 defines an arm 668 that is configured to releasably retain the catheter hub with the outer surface of the housing 644. In the sliding orientation, the arm 668 is disposed such that a hook portion 670 thereof captures a flange 72 of the catheter hub”).
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard modified by Fiser, as applied to claim 1 above, and further in view of a second embodiment of Blanchard (hereafter Blanchard2).
Regarding claim 10, Blanchard as modified discloses the catheter insertion device according to claim 1, as described above, and Blanchard 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 as modified 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 as modified 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thorne (US-6972002-B2) – part 220 latches onto catheter assembly 50 until needle is withdrawn, see figs. 29 and 30
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 ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/17/2026
Prosecution Insights