` 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
Response to Amendments
The Amendment filed 03/10/2026 has been entered.
Claims 13 and 16-19 have been cancelled.
Claims 1-12, 14, 15, 20, and 21 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 12/23/2025.
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.
Claims 1-5, 7, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. (U.S. Patent Pub. 20140188003), hereinafter Belson, in further view of Madin et al. (U.S. Patent Pub. 20090198194), hereinafter Madin.
Regarding claim 1, Belson discloses an instrument advancement device (blood draw device 1d; see FIG. 37A; the Examiner notes that all reference characters cited below refer to FIGS. 37A-42 unless otherwise stated), comprising:
a housing (housing 5, see [0156]), comprising a distal end (distal end of housing 5) and a proximal end (proximal end 6 of housing 5);
an instrument (guide wire 10) disposed within the housing; and
an advancement element (guide wire advancement lever 14), wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]),
wherein the distal end of the housing comprises a compressible portion (flexible tube 195) proximate a chamber (interior of tube 195) configured to hold blood. However, Belson does not expressly state wherein the distal end of the housing including a distal connector configured to couple with a catheter assembly, the distal connector including a blunt cannula or a male luer with the compressible portion and the chamber being positioned proximal from the blunt cannula or male luer, the compressible portion is actuatable to a compressed state to reduce a volume of the chamber, and wherein with the compressible potion in the compressed state, at least a portion of any blood held in the chamber is dispensed distally from the chamber through the distal end of the housing.
Madin teaches a syringe and barrel with resilient part for aspiration (Abstract) the distal end of the housing (outlet 6) including a distal connector (luer slip design, see [0016]) configured to couple with a catheter assembly (“The liquid outlet 6 can be arranged in a variety of ways as needed to attach a needle”, [0016]), the distal connector including a blunt cannula or a male luer (see [0016])
with the compressible portion and the chamber being positioned proximal from the blunt cannula or male luer (see FIG. 2)
wherein the compressible portion (resilient portions 13) is actuatable to a compressed state (see FIG. 4) to reduce a volume of the chamber, and wherein with the compressible potion in the compressed state, at least a portion of any blood held in the chamber is dispensed distally from the chamber through the distal end of the housing (“resilient portions 13 are resiliently deformed such that the volume of chamber 12 is slightly reduced, [0023]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Belson wherein the distal end of the housing including a distal connector configured to couple with a catheter assembly, the distal connector including a blunt cannula or a male luer with the compressible portion and the chamber being positioned proximal from the blunt cannula or male luer, the compressible portion is actuatable to a compressed state to reduce a volume of the chamber, and wherein with the compressible potion in the compressed state, at least a portion of any blood held in the chamber is dispensed distally from the chamber through the distal end of the housing. Doing so provides a method for affixing a needle assembly to a syringe housing and for manual operation to perform aspirations, as taught by Madin (see [0016; 0023]).
Regarding claim 2, Belson in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 1, and Belson further teaches wherein the instrument comprises a guidewire (guide wire 10; see FIG. 37A).
Regarding claim 3, Belson in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 2, and Belson further teaches comprising another instrument (needle 20) coupled to the advancement element, wherein the other instrument comprises a tubing (needle lumen 23), wherein blood is configured to flow proximally through the tubing, wherein the guidewire is disposed within the tubing (see [0157]).
Regarding claim 4, Belson in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 1, and Belson further teaches wherein the distal end of the housing comprises a distal connector (a luer fitting, valve or a seal 386), wherein the distal connector comprises the compressible portion and the chamber (“flexible tube 195 is within an outer flexible tube 195 rather than the distal end of the housing.”, [0156]; see FIG. 37A).
Regarding claim 5, Belson in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 4, and Belson further teaches the compressible portion (flexible tube 195) further comprises a tab (flaps 384) forming an upper surface of the compressible portion (see FIG. 37A).
Regarding claim 7, Belson in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiment of Belson FIGS. 37A-42 does not expressly state wherein the housing comprises a slot, wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position, wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing.
Belson teaches an embodiment in FIGS. 43A-43C wherein the housing comprises a slot (slot 390), wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position (see FIGS. 43A-43C), wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing (“Here the guide wire advancement lever 14 is moved distally and the guide wire 10 is moved relative to the access needle lumen 23”, [0079]; “ a slot in the housing; a handle within the slot coupled to the guidewire wherein movement of the handle along the slot moves the guidewire relative to the access needle lumen.”, [Claim 47]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing in Belson’s embodiment of FIGS. 37A-42 to include a slot, wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position, wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing. Doing so provides a mechanical stop to allow for inspection of the guidewire tip, as taught by the embodiment of Belson in FIGS. 43A-43C (see [0162]).
Regarding claim 10, Belson discloses an instrument advancement device (blood draw device 1d; see FIG. 37A; the Examiner notes that all reference characters cited below refer to FIGS. 37A-42 unless otherwise stated), comprising:
a housing (housing 5, see [0156]), comprising a proximal end (proximal end 6 of housing 5), a distal end (distal end of housing 5), the housing defining a lumen (lumen 44) therein and including a proximal connector (hub 45) at the proximal end (see FIG. 1);
an extension tube (tube 43) positioned within and extending through the lumen of the housing, coupled to the proximal connector (see FIG. 1), wherein blood is configured to flow through the extension tube (the Examiner notes the devices is a catheter with needle 21 meant to be inserted into blood vessels for fluid communication),
wherein the housing comprises a compressible portion (flexible tube 195) proximate the lumen and proximal to the distal connector.
However, the embodiment of Belson FIGS. 37A-42 does not expressly state wherein the housing comprises a slot, an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; an instrument comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing,
Belson teaches an embodiment in FIGS. 43A-43C wherein the housing comprises a slot (slot 390, see 43A-43C),
an advancement element (guide wire advancement lever 14) extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and
an instrument (guide wire 10) comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing in Belson’s embodiment of FIGS. 37A-42 to include a slot, an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and an instrument comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing. Doing so provides a mechanical stop to allow for inspection of the guidewire tip, as taught by the embodiment of Belson in FIGS. 43A-43C (see [0162]).
However, the embodiments of Belson do not expressly state a distal connector at the distal end, with the distal connector configured to couple with a catheter assembly, with the extension tube coupled to, extending between, fluidly connecting the distal connector and the proximal connector, and in response to compression of the compressible portion, the lumen is deformed, which causes the extension tube to be pinched and the housing to dispense blood distally from the extension tube through the distal end of the housing.
Madin teaches a syringe and barrel with resilient part for aspiration (Abstract) comprising a distal connector at the distal end (luer slip design, see [0016]), with the distal connector configured to couple with a catheter assembly (“The liquid outlet 6 can be arranged in a variety of ways as needed to attach a needle”, [0016]), with the extension tube coupled to, extending between, fluidly connecting the distal connector and the proximal connector (see FIGS. 1-2; the Examiner notes Madin teaches chamber 12 which fluidly connects proximal and distal ends of barrel 2)
the housing comprises a compressible portion (resilient portions 13) proximate the lumen, wherein in response to compression of the compressible portion, the lumen is deformed, which causes the extension tube to be pinched and the housing to dispense blood distally from the extension tube through the distal end of the housing (“resilient portions 13 are resiliently deformed such that the volume of chamber 12 is slightly reduced, [0023]; see FIG. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Belson to include a distal connector at the distal end, with the distal connector configured to couple with a catheter assembly, with the extension tube coupled to, extending between, fluidly connecting the distal connector and the proximal connector, and in response to compression of the compressible portion, the lumen is deformed, which causes the extension tube to be pinched and the housing to dispense blood distally from the extension tube through the distal end of the housing. Doing so provides a method for affixing a needle assembly to a syringe housing and for manual operation to perform aspirations, as taught by Madin (see [0016; 0023]).
Regarding claim 11, the combination of Belson’s embodiments in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the instrument comprises a guidewire (guide wire 10).
Regarding claim 12, the combination of Belson’s embodiments in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the lumen (lumen 44) is configured for blood to flow therethrough, and wherein the compressible portion is proximate the lumen (see FIG. 37A and 37B).
Regarding claim 14, the combination of Belson’s embodiments in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the compressible portion (flexible tube 195) is aligned with the slot along all or a portion of the slot (see FIG. 37A and 43A-43C; the Examiner notes placement of slot 390 and tube 195 are in axial alignment as they are positioned linearly on the same main axis of the housing 5. The Examiner is of the position this is sufficient disclosure to teach or suggest the compressible tube is aligned with the slot.), with the slot formed on a top side of the housing (see 43A).
Madin teaches wherein the compressible portion (portions 13) formed on the underside of the housing (the Examiner notes portions 13 comprise the external surface of the barrel 2 as well as the internal surface of chamber 12, therefore portions 13 are sufficient disclosure to teach or suggest the compressible portions formed on the underside of the housing; see FIG. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Belson to include the teachings of wherein the compressible portion is formed on the underside of the housing. Doing so provides manual operation for performing aspirations while permitting a change in chamber volume, as taught by Madin (see [0023]).
Regarding claim 21, the combination of Belson’s embodiments in view of Madin teaches the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the housing (housing 5) comprises an upper body (proximal end 6) and a lower body (distal end 7), with the compressible portion (flexible tube 195) forming the lower body, and wherein the compressible portion has a lower durometer than the upper body (see FIG. 39).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. (U.S. Patent Pub. 20140188003), hereinafter Belson, in further view of Madin et al. (U.S. Patent Pub. 20090198194), hereinafter Madin, and further in view of Burkholz et al. (U.S. Patent Pub. 20200170559), hereinafter Burkholz.
Regarding claim 8, Belson in view of Madin discloses the claimed invention as discussed above concerning the rejection of claim 1, and Belson further discloses wherein the housing comprises a slot (slot 390), wherein the advancement element extends through the slot and is configured to move linearly along the slot (see FIGS. 43A-43C), wherein the instrument comprises a guidewire (guide wire 10) having a first end and a second end (distal end 11 and proximal end 12), wherein in response to movement of the advancement element distally a first distance along the slot, the second end of the guidewire is configured to advance a second distance (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]), further comprising another instrument (needle 20), wherein the other instrument comprises a tubing (needle lumen 23) comprising a distal end and a proximal end, wherein in response to movement of the advancement element distally the first distance along the slot, the proximal end of the tubing is configured to advance the first distance. However, Belson does not expressly state wherein the second distance is at least twice the first distance.
Burkholz teaches a delivery device for delivering an instrument into a catheter assembly (Abstract) having a guidewire (guidewire 40) and advancement element (plunger 16), wherein in response to movement of the advancement element distally a first distance along the slot, the second end of the guidewire is configured to advance a second distance (“guidewire 40 may be advanced in the distal direction beyond the distal end of the syringe 12 in response to the plunger 16 being partially and/or fully depressed.”, [0072]); and wherein the second distance is at least twice the first distance (“In some embodiments, in response to depression of the plunger 16 and movement of the guide feature 18 the first distance, the first end 56 of the support tubing 54 may be advanced in the distal direction a distance equal to the first distance (a “1:1 advancement ratio”), while the first end 25 of the instrument 22 may be advanced a distance greater than that of the first distance, such as for example, twice the first distance”, [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the distance traveled by the guidewire of Belson to be twice as long as the distance traveled by the advancing element. Doing so would provide reliability and structural support as the instrument is distally advanced while also providing the instrument with longer reach, as taught by Burkholz (see [0077]).
Allowable Subject Matter
Claims 6 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 15 and 20 are allowed.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/10/2026, with respect to the rejection(s) of claim(s) 1-5, 7, 8, 10-15, and 20 under 35 U.S.C. 103 to Belson et al. (U.S. Patent Pub. 2014/0188003) in view of Madin et al. (U.S. Patent Pub. 20090198194) 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 Belson et al. (U.S. Patent Pub. 2014/0188003) and Madin et al. (U.S. Patent Pub. 20090198194).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
07/18/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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