DETAILED ACTION
This action is responsive to claim amendments and Applicant’s Remarks filed 22 December 2025. The Examiner acknowledges the amendments to claims 1, 3, 5-8, and 16, and the cancelation of claims 2, 4, 9-15, and 17-18. Claims 1, 3, 5-8, 16, and 19-22 are pending.
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 .
Claim Objections
Claim(s) 6 is/are objected to because of the following informalities:
Claim 6 should read “The blood collection device of claim 1” [line 1].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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) 1, 3, 5-6, 8, 16, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20200316346-A1, previously presented) in view of Devgon (US-20140364766-A1, previously presented).
Regarding claim 1, Burkholz teaches
A blood collection device comprising:
a distal end portion [distal end 52 (Burkholz Fig. 1D); a housing 50, which may include a distal end 52, a proximal end 54 (Burkholz ¶0082)];
a proximal end portion [proximal end 54 (Burkholz ¶0082, Fig. 1D)];
an actuator [guidewire hub 62 (Burkholz Fig. 1D)]; and
a probe operably coupled to the actuator [guidewire 48 (Burkholz Figs. 1A, C-E, G-H); the guidewire hub 62 may be configured to move along the slot 56 to advance the guidewire 48 in a distal direction and distal to the distal end 52 of the housing 50 (Burkholz ¶0083)],
wherein the actuator is configured to selectively advance the probe through a catheter of a vascular access device when the blood collection device is coupled to the vascular access device [the guidewire 48 may be advanced beyond the distal tip 70 of the catheter 24, which may move or push away anything within the vasculature of the patient that might otherwise occlude the catheter 24 during a blood draw (Burkholz ¶0086, Figs. 1D-E)],
wherein the probe comprises a distal portion and a proximal portion, with the proximal portion of the probe comprising a wire section [the fluid permeable structure 64 may include an elongated core 66 (Burkholz ¶0085, Fig. 1H)] and the distal portion of the probe comprising:
a tubular section joined with the wire section and extending distally therefrom [the guidewire 48 may include a tube 118 in addition to or as an alternative to the coil 68. In some embodiments, the tube 118 may include the fluid permeable structure 64. For example, in some embodiments, the tube 118 may be porous (Burkholz ¶0115), wherein as depicted in at least Burkholz Fig. 1G, the fluid permeable structure is positioned at a distal end of guidewire 48], and
a distal coil positioned at a distal end of the tubular section and extending distally therefrom [the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66 (Burkholz ¶0085, Fig. 1H), wherein as the tube 118 may comprise the fluid permeable structure (coil 68), and the coil 68 is positioned at a distal end of the guidewire 48, the coil 68 is considered to be positioned at a distal end of the tubular section and extend distally therefrom],
wherein only the distal portion of the probe is configured to extend at least partially beyond a distal tip of the catheter of the vascular access device when the probe is in a fully advanced position [wherein as depicted in Burkholz Fig. 1E, the proximal portion 58 does not extend beyond a distal tip of the catheter].
However, Burkholz fails to explicitly disclose wherein the distal portion and the proximal portion of the probe are formed of different materials.
Devgon discloses a blood collection device comprising a probe advanced into a patient’s vasculature [the fluid transfer device 15000 includes an introducer 15100, a catheter 15200, an actuator 15570, and an adapter 15450 (Devgon ¶0155, Fig. 47); the bodily fluid (e.g., blood) is drawn through the lumen 15209 of the cannula 15200 and the lumen 15253 of the secondary cannula 15250 and into the fluid container. In this manner, a phlebotomist can collect (e.g., draw) a given amount of blood through an existing peripheral intravenous line without the need for additional needle sticks (Devgon ¶0192)], wherein Devgon discloses wherein the probe comprises a distal portion and a proximal portion, wherein the distal portion and the proximal portion of the probe are formed of different materials [the first portion 15205 of the catheter 15200 can have a Shore durometer that is greater than a Shore durometer of the second portion 15210. For example, in some embodiments, the first portion 15205 can be formed from a first material or first blend of materials and the second portion can be formed from a second material or second blend of materials having a durometer less than a durometer of the first material or first blend of materials… As such, the first portion 15205 can have a stiffness and/or durometer that is sufficient to inhibit a kinking, a pinching, a breaking, and/or an undesirable plastic deformation of the first portion 15205 while being advanced, for example, through the introducer 15100, as described in further detail herein. The second portion 15210 can have a stiffness and/or durometer that is less than the stiffness and/or durometer of the first portion 15210 and as such, can be configured to bend, flex, elastically deform, and/or otherwise reconfigure, which, in some instances, can reduce a likelihood of the second portion 15210 puncturing a vascular tissue when disposed therein and/or allow the second portion 15210 to be advanced through a kink, bend, turn, valve, and/or obstruction in, for example, a lumen defined by a PIV, as described in further detail herein (Devgon ¶0178, Fig. 56)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ wherein the distal portion and the proximal portion are formed of different materials, so as to impart mechanical properties to the proximal portion of the probe to inhibit kinking, pinching, breaking, or undesirable plastic deformation as the probe is advanced and impart mechanical properties to the distal portion of the probe to reduce a likelihood of puncturing a vascular tissue as the probe is advanced.
Regarding claim 3, Burkholz in view of Devgon teaches
The blood collection device of claim 1, wherein the proximal portion of the probe further comprises at least one coil section [the coil 68 may extend into the catheter 24. In some embodiments, the coil 68 may extend through all or a portion of the catheter 24 (Burkholz ¶0098), wherein the portion of the probe (guidewire 48) inside the catheter when extended is considered to be part of the proximal portion; wherein as the distal end 60 of the guidewire 48 comprises the fluid permeable structure 64 (see Burkholz ¶0085, defined as coil 68), and as noted in the § 103 rejection of claim 1 above the guidewire 48 may include a tube 118 in addition to the coil 68 and the tube 118 may comprise the fluid permeable structure 64 (see Burkholz ¶0115), the arrangement of the distal coil relative to the tubular section as recited in claim 1 is still considered applicable].
Regarding claim 5, Burkholz in view of Devgon teaches
The blood collection device of claim 1, wherein a distal end of the distal coil is capped [the distal end of the coil 68 may be directly coupled to the rounded distal tip 72 (Burkholz ¶0091)].
Regarding claim 6, Burkholz in view of Devgon teaches
The blood collection of claim 1, wherein the tubular section comprises at least one perforation formed in a sidewall thereof [As illustrated in FIG. 7E, in some embodiments, the tube 118 may include multiple holes 120, which may be arranged in various patterns and numbers and may include various sizes. In some embodiments, the holes 120 may be disposed on a distal end 122 of the tube 118 (Burkholz ¶0115, Figs. 7E-F); As illustrated in FIG. 7G, in some embodiments, the tube 118 may include multiple slits 124, which may be arranged in various patterns and numbers and may include various sizes. In some embodiments, the slits 124 may be disposed on the distal end 122 of the tube 118 (Burkholz ¶0117, Figs. 7G-H)].
Regarding claim 8, Burkholz in view of Devgon teaches
The blood collection device of claim 1.
The Examiner notes that while the limitation “wherein the tubular section and the wire section are co-extruded” is considered to refer to a product-by-process limitation [being “co-extruded” is considered to refer to the process by which the tubular section and the wire section are coupled together (MPEP § 2113)], such that the tubular section and the wire section as presently coupled in Burkholz in view of Devgon may be considered to read on the claimed product itself [as any coupled tubular section and wire section are considered to be similarly coupled as a tubular section and a wire section coupled via co-extrusion].
However, for the sake of compact prosecution, the Examiner notes that Devgon discloses the use of co-extrusion to couple separate elements of a probe together [the first portion 15205 can be formed from a first material or first blend of materials and the second portion can be formed from a second material or second blend of materials having a durometer less than a durometer of the first material or first blend of materials. In some embodiments, the first portion 15205 and the second portion 15210 can be, for example, co-extruded (Devgon ¶0178)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Devgon to employ wherein the tubular section and the wire section are co-extruded, as this modification would amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [form elements of the probe] [MPEP § 2143(I)(D)].
Regarding claim 16, Burkholz teaches
A method of blood sample collection from a patient, the method comprising:
providing a vascular access device comprising a catheter adapter and a catheter [the catheter assembly 14 may include a catheter adapter 16… a catheter 24 may be secured to the catheter adapter 16 and may extend distally from the catheter adapter 16 (Burkholz ¶0076, Figs. 1A, D)];
inserting the catheter of the vascular access device into a vein of the patient [the instrument may allow blood to enter the catheter from a longer portion of a vein (Burkholz ¶0009, Fig. 1H)];
providing a blood collection device, the blood collection device comprising:
a distal end portion [distal end 52 (Burkholz Fig. 1D); a housing 50, which may include a distal end 52, a proximal end 54 (Burkholz ¶0082)];
a proximal end portion [proximal end 54 (Burkholz ¶0082, Fig. 1D)];
an actuator [guidewire hub 62 (Burkholz Fig. 1D)]; and
a probe operably coupled to the actuator [guidewire 48 (Burkholz Figs. 1A, C-E, G-H); the guidewire hub 62 may be configured to move along the slot 56 to advance the guidewire 48 in a distal direction and distal to the distal end 52 of the housing 50 (Burkholz ¶0083)],
wherein the probe comprises a distal portion and a proximal portion [the guidewire 48, which may include a proximal end 58 and a distal end 60 (Burkholz ¶0082)], with the proximal portion of the probe comprising a wire section [the fluid permeable structure 64 may include an elongated core 66 (Burkholz ¶0085, Fig. 1H)] and the distal portion of the probe comprising:
a tubular section joined with the wire section and extending distally therefrom [the guidewire 48 may include a tube 118 in addition to or as an alternative to the coil 68. In some embodiments, the tube 118 may include the fluid permeable structure 64. For example, in some embodiments, the tube 118 may be porous (Burkholz ¶0115), wherein as depicted in at least Burkholz Fig. 1G, the fluid permeable structure is positioned at a distal end of guidewire 48], and
a distal coil positioned at a distal end of the tubular section and extending distally therefrom [the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66 (Burkholz ¶0085, Fig. 1H), wherein as the tube 118 may comprise the fluid permeable structure (coil 68), and the coil 68 is positioned at a distal end of the guidewire 48, the coil 68 is considered to be positioned at a distal end of the tubular section and extend distally therefrom], and
coupling the blood collection device to the vascular access device [the catheter assembly 14 may include a needleless connector 39, and the delivery device 12 may be coupled to the first port 36 of the connector 34 via the needleless connector 39, which may be disposed between the delivery device 12 and the connector 34 (Burkholz ¶0080, Figs. 1D-E)];
advancing the probe of the blood collection device through the vascular access device such that only the distal portion of the probe extends beyond a distal tip of the catheter [the guidewire 48 may be advanced beyond the distal tip 70 of the catheter 24, which may move or push away anything within the vasculature of the patient that might otherwise occlude the catheter 24 during a blood draw (Burkholz ¶0086, Figs. 1D-E)]; and
drawing blood through the distal portion of the probe and into the catheter [the delivery device 12 may include a gap between an outer diameter of the guidewire 48 and the catheter 24, which may allow blood to flow proximally through the gap from the vasculature. In some embodiments, the delivery device 12 may include a gap between the outer diameter of the guidewire 48 and the distal tip 70 of the catheter 24, which may allow blood to flow proximally through the gap from the vasculature (Burkholz ¶0087)].
However, Burkholz fails to explicitly disclose wherein the distal portion and the proximal portion of the probe are formed of different materials.
Devgon discloses a blood collection device comprising a probe advanced into a patient’s vasculature [the fluid transfer device 15000 includes an introducer 15100, a catheter 15200, an actuator 15570, and an adapter 15450 (Devgon ¶0155, Fig. 47); the bodily fluid (e.g., blood) is drawn through the lumen 15209 of the cannula 15200 and the lumen 15253 of the secondary cannula 15250 and into the fluid container. In this manner, a phlebotomist can collect (e.g., draw) a given amount of blood through an existing peripheral intravenous line without the need for additional needle sticks (Devgon ¶0192)], wherein Devgon discloses wherein the probe comprises a distal portion and a proximal portion, wherein the distal portion and the proximal portion of the probe are formed of different materials [the first portion 15205 of the catheter 15200 can have a Shore durometer that is greater than a Shore durometer of the second portion 15210. For example, in some embodiments, the first portion 15205 can be formed from a first material or first blend of materials and the second portion can be formed from a second material or second blend of materials having a durometer less than a durometer of the first material or first blend of materials… As such, the first portion 15205 can have a stiffness and/or durometer that is sufficient to inhibit a kinking, a pinching, a breaking, and/or an undesirable plastic deformation of the first portion 15205 while being advanced, for example, through the introducer 15100, as described in further detail herein. The second portion 15210 can have a stiffness and/or durometer that is less than the stiffness and/or durometer of the first portion 15210 and as such, can be configured to bend, flex, elastically deform, and/or otherwise reconfigure, which, in some instances, can reduce a likelihood of the second portion 15210 puncturing a vascular tissue when disposed therein and/or allow the second portion 15210 to be advanced through a kink, bend, turn, valve, and/or obstruction in, for example, a lumen defined by a PIV, as described in further detail herein (Devgon ¶0178, Fig. 56)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Burkholz to employ wherein the distal portion and the proximal portion are formed of different materials, so as to impart mechanical properties to the proximal portion of the probe to inhibit kinking, pinching, breaking, or undesirable plastic deformation as the probe is advanced and impart mechanical properties to the distal portion of the probe to reduce a likelihood of puncturing a vascular tissue as the probe is advanced.
Regarding claim 19, Burkholz in view of Devgon teaches
The method of claim 16, further comprising drawing blood into a blood collection container [the delivery device 108 may include tubing 110, which may include a proximal end 112 and a distal end 114. In some embodiments, the proximal end 112 of the tubing 110 may be coupled to a connector 116, which may include a male or female luer connector with a luer-slip or luer-lock feature. In some embodiments, the connector 116 may be coupled to any suitable blood collection device (Burkholz ¶0111, Fig. 7B)].
Regarding claim 20, Burkholz in view of Devgon teaches
The method of claim 19, wherein the blood collection container is fluidly coupled to the blood collection device [Burkholz ¶0111, Figs. 7A-B].
Regarding claim 21, Burkholz in view of Devgon teaches
The method of claim 19, wherein the blood collection container is fluidly coupled to the catheter adapter [Burkholz ¶0111, Figs. 7A-B].
Regarding claim 22, Burkholz in view of Devgon teaches
The method of claim 16, further comprising advancing the probe through a first port in the catheter adapter and drawing a blood sample through a second port in the catheter adapter [Referring now to FIG. 4A, in some embodiments, the delivery device 12 may be coupled to a proximal port of a T-connector 91, which may include a needleless connector. In some embodiments, a distal port of the T-connector 91 may be coupled to the proximal end 20 of the catheter adapter 16. In these and other embodiments, the catheter adapter 16 may not include the side port 26 and/or an integrated extension tube. In some embodiments, the extension tube 28 may be coupled to a side port of the T-connector, which may be angled with respect to the proximal port and the distal port (Burkholz ¶0101, Fig. 4A), wherein the T-connector being coupled to the catheter adapter 16 is considered to allow the T-connector to read on comprising part of the catheter adapter].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Devgon, as applied to claim 1 above, in further view of Hayzelden (US-20210322730-A1, previously presented).
Regarding claim 7, Burkholz in view of Devgon teaches
The blood collection device of claim 1.
However, Burkholz in view of Devgon fails to explicitly disclose wherein the wire section is coupled to a proximal end portion of the tubular section via an adhesive.
Hayzelden discloses guidewires for intravascular use [the materials and methods of construction and the dimensions of conventional intracorporeal devices such as intravascular guidewires may be employed with a device embodying features of the present invention (Hayzelden ¶0038)], wherein Hayzelden discloses a guidewire comprising distal tubular section and a proximal wire section, wherein the wire section is coupled to a proximal end portion of the tubular section via an adhesive [The tubular member 24 is attached to the distal end 16 of the proximal core wire 12 and to the proximal end 20 of the distal core wire 18 by any suitable means such as by welding, brazing, bonding, and adhesive bonding (Hayzelden ¶0027, Figs. 1-2A)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz in view of Devgon to employ wherein the wire section is coupled to a proximal end portion of the tubular section via an adhesive, as this modification would amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [couple a wire element to a tubular element of a probe together] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5, filed 22 December 2025, with respect to the previously applied Non-Statutory Double Patenting rejection(s) have been fully considered and are persuasive. The previously applied Non-Statutory Double Patenting rejection(s) of claims 1 and 16 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 5-7, with respect to the previously applied rejections under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that the amendment to claims 1 and 16 “wherein the probe comprises a distal portion and a proximal portion, with the proximal portion of the probe comprising a wire section and the distal portion of the probe comprising a tubular section joined with the wire section and extending distally therefrom, and a distal coil positioned at a distal end of the tubular section and extending distally therefrom” is patentably distinct from that which is disclosed in the cited prior art, wherein the Applicant notes that the cited portions of Burkholz in view of Devgon applied to teach the subject matter of original claim 4 [Burkholz ¶0115] and corresponding analysis distorts what is disclosed in Burkholz [Applicant reproduces Fig. 7E of Burkholz as the configuration that best depicts the disclosure of Burkholz regarding tube 118]; and wherein the Applicant notes that there is no disclosure in Burkholz of a probe as claimed, particularly a “distal coil” positioned at a distal end of the tube 118 and that extends out distally from the tube 118. However, the Examiner disagrees with the Applicant’s analysis of Burkholz, as Burkholz is considered to teach the argued subject matter wherein the distal portion of the probe comprises a tubular section joined with the wire section and extending distally therefrom [the guidewire 48 may include a tube 118 in addition to or as an alternative to the coil 68. In some embodiments, the tube 118 may include the fluid permeable structure 64. For example, in some embodiments, the tube 118 may be porous (Burkholz ¶0115), wherein as depicted in at least Burkholz Fig. 1G, the fluid permeable structure is positioned at a distal end of guidewire 48, such that as tube 118 comprises the fluid permeable structure 64, tube 118 is positioned at the distal portion of the probe], and a distal coil positioned at a distal end of the tubular section and extending distally therefrom [the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66 (Burkholz ¶0085, Fig. 1H), wherein as the tube 118 may comprise the fluid permeable structure 64 (defined by coil 68; see Burkholz ¶0115), and the coil 68 is positioned at a distal end of the guidewire 48, the coil 68 is considered to be positioned at a distal end of the tubular section and extend distally therefrom].
Conclusion
THIS ACTION IS MADE FINAL. 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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791
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