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Claims 10-20 are withdrawn.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 21-27 are canceled.
Claims 1-9 are presently pending in this application.
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 9 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 9 recites the limitation "the tear line" in line 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets claim 9 to be dependent on claim 8.
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, and 5-9 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.
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.
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).
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 as taught by Kraus in order to allow the needle and flashback assembly to be moved independent of the housing (Kraus: para. 0047).
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. 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)
Regarding claim 3, Hall in view of Kraus and Blanchard 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 6, Hall in view of Kraus and Blanchard disclose the device above.
Hall in view of Kraus do not expressly disclose the anchor hub includes an arm configured to engage a cleaver portion of the housing and configured to deflect the arm radially outward.
Blanchard teaches a device (Blanchard: Fig. 6B, insertion tool 10), wherein an anchor hub (Fig. 6B, needle hub 14) includes an arm (Fig. 6B, top housing 12A and bottom housing 12B) configured to engage a cleaver portion (Fig. 6B, catheter hub 46) of the housing (Fig. 4B, catheter advancement assembly 40) and configured to deflect the arm (Fig. 6B, top housing 12A and bottom housing 12B) radially outward (Fig. 6B, when catheter hub 46 is advanced forward, top and bottom housing 12A and B separate outward radially; para. 0058).
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 the anchor hub includes an arm configured to engage a cleaver portion of the housing and configured to deflect the arm radially outward as taught by Blanchard in order to allow for the catheter to be inserted into patient vasculature to a suitable degree (para. 0058).
Regarding claim 7, Hall in view of Kraus and Blanchard discloses the device above.
Hall does not expressly disclose 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, wherein an anchor hub (Kraus: 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 anchor hub and anchor sheath of Hall such that 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 removal of the sheath without damaging the instruments (Kraus: para. 0037).
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 10 December 2025, with respect to the rejection of claim 9 under 35 USC 112(b) has been fully considered but is not persuasive. Applicant did not properly amend the claim as stated in their arguments. Therefore, the rejection is maintained.
Applicant’s arguments, see page 6-8, filed 10 December 2025, with respect to the rejections of claims 1-9 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Hall in view of Kraus and Blanchard cited above.
Applicant argues:
“The Office Action alleges that Hall discloses a needle supported by the flashback assembly because 'dilator hub base 22A can operate as a flashback.' (Office Action, p. 3). However, Hall only teaches that "a flash window can be provided in or near the dilator hub base 22A" (par. [0021]), and is silent regarding a flashback assembly configured to draw a blood flow through the needle lumen.”
The dilator base hub 22A of Hall is clearly a flash window can be provided in the dilator base hub 22A (para. 0021). Examiner interprets the broadest reasonable interpretation of “a flash assembly” to describe an assembly capable of drawing blood flow. Therefore, the dilator base hub 22A of Hall can be considered a flash assembly.
Applicant also argues:
“But even assuming arguendo, that dilator hub base 22A can be considered a flashback assembly, Hall is silent as to the needle supported by such an assembly.
The dilator body 24 forms an outer 'tubular member,' while the hollow needle 30 is independently disposed therein. Thus, there is no reason to construe the dilator body 24 as part of the needle. Further, the Office Action asserts that Hall teaches that the dilator body 24 and hollow needle 30 are supported by dilator hub 22. However, a needle extending distally from the needle hub 32 through the bore does not equate to that needle being supported by the hub 22 and body 24, which only serve to define the bore. And with continued reference to FIG. 1A, Hall teaches, that the "proximal end 30A of the needle 30 is connected to a needle hub 32."(Hall, par. [0021]). Stated differently, the needle is connected to and supported by the needle hub, not the dilator hub base (e.g., a flashback assembly). Because needle hub 32 is not a flashback assembly, and the needle is connected thereto, it follows that the needle cannot be supported by a flashback assembly.”
The broadest reasonable interpretation of the term “needle” implies a long, thin, sharp implement for piercing. It is reasonable to interpret the dilator body 24 and the needle 30 as the needle, as they work in tandem to be inserted and pierce into the skin 62 of a subject (para. 0034-0036). Therefore, it is proper to construe the needle 30 and the dilator body 24 as parts of a needle. It is clear, then, that the dilator body 24 is supported by the dilator hub base 22A). Furthermore, the broadest reasonable interpretation of the word “support” would still result in the dilator hub base 22A providing support to the needle 30, as the base 22A provides support to the entire distal implement.
Applicant also argues:
“Further, Applicant submits that Hall does not recite "an anchor hub configured to split the anchor sheath axially and remove the anchor sheath proximally." The Office Action alleges that Hall teaches that "hub 14 and sheath 16 are configured to be splitable by hub 14 axially." (Office Action, p. 4). However, the cited sections merely describe that the sheath itself "is configured to be peeled apart" and does not disclose any structure configured to perform the splitting, nor that the splitting is axial.”
The broadest reasonable interpretation of the limitation would be that the anchor hub would be acting upon the anchor sheath to split the anchor sheath axially. If the hub 14 were peeled apart, this would be considered being split axially and, further, the hub 14 would act upon the sheath 16 to split it as well by transferring the action of splitting to the sheath 16.
Applicant further argues:
“A person of ordinary skill would understand that such devices are removed by tearing the sheath open and peeling it away from the insertion site, not by withdrawing it proximally. To emphasize this distinction, Applicant has amended claim 1 to recite "an anchor hub slidably engaged with the housing." It is appreciated that such a limitation requires proximal removal, because the anchor hub moves (e.g., retracts) with the housing as it is withdrawn.”
During the action of placement, splitting of the anchor hub of Hall is done by peeling away, but would also require removal of the anchor hub by proximal withdrawal. As seen in Fig. 4E, the introducer is left in the skin after the insertion procedure, and can be left until a desired time (para. 0037). Removal of the anchor hub would require proximal removal. The limitation need not require the anchor hub be removed proximally relative to the device. Furthermore, as seen based on the alternative interpretation of Hall cited above, the anchor hub is shown to be slidably engaged with the housing (Fig. 4D and E, hub 14 is seen releasably sliding out of engagement with cap portion 22B; para. 0020).
Applicant also argues:
“If dilator hub base 22A were modified to be "slidably engaged with the housing," as the Office Action proposes by importing Kraus, the actuation of handles 44 would no longer retract the needle relative to a fixed, proximal assembly. Instead, the entire dilator/flashback assembly (including dilator body 24) would move with the needle hub 32.”
The slidable engagement of the proximal end 302 of Kraus into the dilator hub 126 (Fig. 1 and 2, proximal end 302 is designed to be slotted into the dilator hub 126) does not preclude fixing of the proximal end 302 once assembled. In fact, the proximal end 302 is fixed to the dilator hub 126 axially via engagement of a shoulder 364 with a flange 366 (Fig. 10-12, proximal end 302 is fixed within hub 126 in the standard configuration; para. 0047).
Applicant further argues:
“Moreover, such a modification would preclude a configuration in which "the flashback assembly includes a syringe barrel in fluid communication with a lumen of the needle," as recited by claim 4. Hall teaches that the needle lumen terminates at needle hub 32 and is silent as to a needle in fluid communication with a syringe barrel or other flashback assembly. Nothing in Hall suggests incorporating a syringe barrel within the housing, nor does Hall provide a fluid-communication interface to which such a barrel could connect.”
Applicant does not provide an argument for the combination with Kraus, as Kraus was relied upon for the rejection of dependent claim 4.
Conclusion
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783