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 Claims
This application is responsive to the amendment filed 10 December 2025.
Claims 10-20 are withdrawn.
Claims 6, 7, and 21-27 are canceled.
Claims 1-5, 8, and 9 are presently pending in this application.
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.
Claims 1, 3, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US Patent Publication No. 20120220942 A1), hereinafter Hall, in view of Kraus et al. (US Patent Publication No. 20040092879 A1), hereinafter Kraus, in further view of Blanchard et al. (US Patent Publication No. 20150119806 A1), hereinafter Blanchard, in further view of Gray et al. (US Patent Publication No. 20150231369 A1), hereinafter Gray.
Regarding claim 1, Hall discloses a catheter placement system (Hall: Fig. 1A, device 10), comprising: a housing (Fig. 1A, comprising housing 42 and dilator hub 22); a flashback assembly (Fig. 1A, dilator hub base 22A can operate as a flashback; para. 0021); a needle (Fig. 1A, comprised of dilator body 24 and hollow needle 30) supported by the flashback assembly (Fig. 1A, dilator body 24 and hollow needle 30 are supported by dilator hub 22 via base 22A); a catheter (para. 0038); an anchor sheath (Fig. 1A, sheath body 16) slidably engaged with an outer surface of the needle (Fig. 4D-4E, sheath body 16 can slidably release from dilator body 24), a portion of the anchor sheath (Fig. 4E, distal portion of sheath 16) configured to be advanced distally of the needle (Fig. 1A, comprised of dilator body 24 and hollow needle 30) to anchor an incision site (Fig. 4E, distal portion of sheath 16 is advanced into an incision site as an anchor); and an anchor hub (Fig. 1A, introducer hub 14) slidably engaged with the housing (Fig. 4D and E, hub 14 is seen releasably sliding out of engagement with cap portion 22B; para. 0020) configured to split the anchor sheath (Fig. 1A, sheath 16) axially (hub 14 and sheath 16 are “configured to be splittable” by hub 14 axially; para. 0019). Examiner interprets that removal of the anchor sheath via splitting would occur proximally.
Hall does not expressly disclose the flashback assembly is slidably engaged with the housing, wherein the anchor hub includes a first arm coupled to a first portion of the anchor sheath and a second arm coupled to a second portion of the anchor sheath.
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Kraus teaches a device (Kraus: Fig. 2, assembly 100) comprising a flashback assembly (Fig. 2 and 8, proximal end 302 comprises flashback chamber 180) that is slidably engaged with a housing (Fig. 1 and 2, proximal end 302 is designed to be slotted into the dilator hub 126), wherein an anchor hub (Fig. 6, valve assembly 150) includes a first arm (Fig. 7 shown above, arm A) coupled to a first portion (Fig. 7 shown above, portion C) of an anchor sheath (Fig. 7, sheath 140) and a second arm (Fig. 7 shown above, arm B) coupled to a second portion (Fig. 7 shown above, portion D) of the anchor sheath (Fig. 7, sheath 140).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall such that the flashback assembly is slidably engaged with the housing, wherein the anchor hub includes a first arm coupled to a first portion of the anchor sheath and a second arm coupled to a second portion of the anchor sheath as taught by Kraus in order to allow the needle and flashback assembly to be moved independent of the housing (Kraus: para. 0047) and to allow removal of the sheath without damaging the instruments (Kraus: para. 0037).
Hall in view of Kraus does not expressly disclose a catheter is supported by a catheter advancement assembly that is slidably engaged with the housing.
Blanchard teaches a catheter (Blanchard: Fig. 9, catheter tube 44) supported by a catheter advancement assembly (Fig. 5B, 7A, and 7B, insertion tool 10 supports the tube 44 with interface 72; para. 0053) that is slidably engaged with a housing (Fig. 6B-7B, insertion tool 10 slidably releases from engagement from the safety housing 54 during the insertion procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall in view of Kraus such that a catheter is supported by a catheter advancement assembly that is slidably engaged with the housing as taught by Blanchard in order to allow distal advancement of a catheter during insertion (para. 0050) and provide stabilization of the catheter tube to improve user accuracy (para. 0053).
Hall in view of Kraus and Blanchard does not expressly disclose the first arm and the second arm configured to engage a cleaver disposed at a distal end of the housing, the cleaver configured to deflect the first arm and the second arm radially outward as the anchor hub is urged proximally to split the anchor sheath.
Gray teaches anchor hub (Gray: Fig. 4, sleeve 12) comprising a first arm (Fig. 4, first portion 12a) and a second arm (Fig. 4, second portion 12b) configured to engage a cleaver (Fig. 2, separator 14) disposed at a distal end of a housing (Fig. 2, separator 14 is disposed at the distal end of hub 16), the cleaver (14) configured to deflect the first arm (12a) and the second arm (12b) radially outward as the anchor hub (12) is urged proximally to split the anchor sheath (Fig. 3, the separator 14 splits the portions 12a and b radially outward). Examiner interprets the entire device 10 excluding the separator 14 to be urged proximally.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall in view of Kraus and Blanchard such that the first arm and the second arm configured to engage a cleaver disposed at a distal end of the housing, the cleaver configured to deflect the first arm and the second arm radially outward as the anchor hub is urged proximally to split the anchor sheath as taught by Gray in order overcome the need to use both hands to remove the anchor hub (para. 0065-0066).
Regarding claim 3, Hall in view of Kraus, Blanchard, and Gray discloses the device above, wherein the catheter includes one of a CVC catheter or a PICC catheter (Hall: para. 0040).
Regarding claim 5, Hall in view of Kraus and Blanchard discloses the device above, further including a guidewire (Hall: Fig. 3A-3C, guidewire 60) disposed within a lumen of the catheter (para. 0038 and 0039).
Regarding claim 8, Hall in view of Kraus and Blanchard discloses the device above.
Hall does not expressly disclose the anchor sheath includes a tear line extending axially therealong and configured to allow the first portion of the anchor sheath to separate from the second portion of the anchor sheath.
Kraus teaches a device (Kraus: Fig. 5, assembly 100), wherein an anchor sheath (Fig. 5, sheath 140) includes a tear line (Fig. 5, score line 141 extends axially along sheath 140) extending axially therealong and configured to allow the first portion (Fig. 7 shown above, portion C) of the anchor sheath (Fig. 5, sheath 140) to separate from the second portion (Fig. 7 shown above, portion D) of the anchor sheath (Fig. 5, sheath 140 is separated in two along the score line; para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall such that the anchor sheath includes a tear line extending axially therealong and configured to allow the first portion of the anchor sheath to separate from the second portion of the anchor sheath as taught by Kraus in order to allow removal of the sheath without damaging the instruments (Kraus: para. 0037).
Regarding claim 9, Hall in view of Kraus and Blanchard discloses the device above.
Hall does not expressly disclose the tear line includes one of a groove, a score-line, a perforation, or a laser cut line.
Kraus teaches a device (Kraus: Fig. 5, assembly 100), wherein a tear line (Fig. 5, score line 141) includes a score-line (Fig. 5, score line 141 is a score line; para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall such that the tear line includes one of a groove, a score-line, a perforation, or a laser cut line as taught by Kraus in order to allow removal of the sheath without damaging the instruments (Kraus: para. 0037).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hall, in view of Kraus and Blanchard, in further view of Pizzato (US Patent Publication No. 20230381481 A1).
Regarding claim 2, Hall in view of Kraus and Blanchard discloses the device above.
Hall in view of Kraus and Blanchard does not expressly disclose the anchor sheath is formed of a compliant material including one of a plastic, polymer, PTFE, or an elastomer.
Pizzato teaches a device comprising an anchor sheath (Pizzato: Fig. 4, sheath 102) formed from of a compliant material including a polymer (para. 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the anchor sheath of Hall in order to allow for folding or furling of the sheath (Pizzato: para. 0095).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hall, in view of Kraus and Blanchard, in further view of Bierman (US Patent Publication No. 20180296804 A1).
Regarding claim 4, Hall in view of Kraus and Blanchard discloses the device above.
Hall in view of Blanchard does not expressly disclose the flashback assembly includes a syringe barrel in fluid communication with a lumen of the needle and a plunger slidably engaged therewith, the flashback assembly configured to draw a blood flow through the needle lumen.
Kraus teaches a device, wherein a flashback assembly (Kraus: Fig. 2, proximal end 302 comprising flashback chamber 180) includes a syringe barrel (user can optionally attach a syringe to chamber 180; para. 0034) in fluid communication with a lumen of the needle (Fig. 8, flashback and attached syringe are in fluid communication with the needle 300; para. 0034), the flashback assembly configured to draw a blood flow through the needle lumen.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hall in view of Blanchard such that the flashback assembly includes a syringe barrel in fluid communication with a lumen of the needle and a plunger slidably engaged therewith, the flashback assembly configured to draw a blood flow through the needle lumen as taught by Kraus in order to aspirate the needle using the syringe (para. 0034).
Hall in view of Kraus and Blanchard do not expressly disclose that the syringe comprises a plunger slidably engaged therewith.
Bierman teaches a device (Bierman: Fig. 1, device 20), comprising a syringe (Fig. 1, syringe 24) comprising a plunger (Fig. 1, plunger 32) slidably engaged therewith (para. 0069).
It would have been obvious to one of ordinary skill in the art before the effective filing date for the syringe of Hall in view of Kraus and Blanchard to have a plunger slidably engaged therewith as taught by Bierman in order to allow aspiration of the syringe and the needle (para. 0096).
Response to Arguments
Applicant’s arguments, see page 6, filed 9 June 2026, with respect to the rejection of claim 9 under 35 USC 112(b) has been fully considered and are persuasive. The rejection of claim 9 has been withdrawn.
Applicant’s arguments, see pages 6-9, filed 9 June 2026, with respect to the rejections of claims 1-5, 8, and 9 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Hall in view of Kraus, Blanchard, and Gray as cited above.
Regarding claim 1, applicant argues that the flashback assembly of Kraus would not be construed as slidably engaged with the housing, and further, that the chamber 180 is coupled to the hub 126 of the dilator 120, thus preventing slidable engagement.
Kraus discloses that the flashback chamber 180 is located at the proximal end 302 of the needle 300. As shown in Fig. 1, the proximal end 302 of the needle 300 is meant to be slotted within hub 126. Only within a further embodiment is the chamber 180 coupled to the hub 126. Otherwise, it is clear that the proximal end 302 is meant to slot within hub 126. Furthermore, the broadest reasonable interpretation of the term “slidably engaged” implies that there be some form of interactive, sliding contact with two objects. In this case, the chamber 180 is meant to be slotted into hub 126, which, therefore, means it is slidably engaging with the interior surface of hub 126 as it is inserted or removed, both of which can occur during operation (needle 300 is movably disposed within dilator 120). It should be noted that, if the chamber 180 were coupled in the way the applicant describes, needle 300, as it is described in Kraus, would not be able to be movably disposed, as there would be no means by which it could retract or extend, as the chamber 180 is part of the proximal end 302 of the needle 300.
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.
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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