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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 March 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 11, 16, 18-19, and 21, as well as the addition of new claim 24. Claims 1, 4-6, 11-19, and 21-24 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “22” is used to label two different elements between Figs. 1A [advancement element] and 1B [a distal end of extension tube 35]; “26” is used to label two different elements in Fig. 1B [advancement element, distal end of tube 20]; “28” is used to label two different elements between Figs. 1B [proximal end of tube 20] and 1D [proximal end of catheter adapter 42].
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 Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 11 and those dependent therefrom is/are 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 11 recites the limitation “a proximal end of the coil is coupled to a distal end of the tube” [lines 11-12], which is considered indefinite, as it is unclear whether the instant recited distal end of the tube is meant to refer to a different particular portion/area of the distal end of the tube from the previously recited distal end of the tube that includes the opening centered about a longitudinal axis of the tube [lines 4-5] or refer to the same portion/area. For examination purposes, the Examiner has interpreted the indefinite limitation to refer to either identified interpretation in light of any prior art applied under § 102 or § 103.
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 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190321590-A1, previously presented) in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1).
Regarding claim 1, Burkholz teaches
A blood collection device configured to couple to a catheter assembly [catheter assembly 52 (Burkholz Figure 5A)], the blood collection device comprising:
a housing, comprising a distal end, a proximal end, and a slot [a delivery device 10 for delivering a catheter 12 into an intravenous catheter assembly and/or the vein may include a housing 14, which may include a distal end 16, a proximal end 18, and a slot 20 (Burkholz ¶0039, Figs. 1-4)];
a tube disposed within the housing [the delivery device 10 may include the catheter 12 (Burkholz ¶0039, Figs. 1-4)];
an advancement element configured to move along the slot, wherein in response to distal movement of the advancement element along the slot, the tube may be configured to advance distally beyond the distal end of the housing [the guidewire hub 42 may include another advancement tab 46, which may be coupled to the portion of the guidewire hub 42 that extends through the slot 20 (Burkholz ¶0050, Fig. 1A); the catheter hub 26 and the guidewire hub 42 may be fully advanced, according to some embodiments… In some embodiments, the guidewire hub 42 may contact a proximal end of the catheter hub 26 in response to the guidewire hub 42 being fully advanced (Burkholz ¶0054, Figs. 2-4); movement of the guidewire hub 42 in the distal direction may also move the catheter hub 26 in the distal direction, advancing both the guidewire 36 and the catheter 12 (Burkholz ¶0055)];
a core wire disposed within the tube, with a proximal end of the core wire secured within the advancement element [the guidewire 36 may be disposed within the catheter 12 (Burkholz ¶0047, Figs. 1-4); the guidewire 36 may be secured to the guidewire hub 42. In some embodiments, the proximal end 38 of the guidewire 36 may be secured to the guidewire hub 42, as illustrated, for example, in FIG. 1B (Burkholz ¶0048, Fig. 1B); Burkholz ¶0050, Fig. 1A].
However, Burkholz fails to explicitly disclose wherein a distal end of the core wire is coupled to a proximal end of a coil.
Murayama discloses a guidewire to be inserted in a tube, wherein the guidewire comprises a coil at a distal end of the guidewire [A guide wire 1 shown in FIG. 1 is of a type used to be inserted in a catheter, and includes a wire member 10 and a spiral coil 4 (Murayama Col 5:26-28, Figure 1)].
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 guidewire of Burkholz to employ wherein the guidewire comprises a coil, to allow the guidewire to exhibit X-ray contrast performance to confirm a position of the guidewire under fluoroscopy [The coil 4 may be made from a metal material such as a stainless steel, a superelastic alloy, a cobalt alloy, a noble metal such as gold, platinum, or tungsten, or an alloy containing such a noble metal. In particular, the coil 4 is preferably made from a radiopaque material such as a noble metal. If the coil 4 is made from such a radiopaque material, the guide wire 1 can exhibit an X-ray contrast performance. This makes it possible to insert the guide wire 1 in a living body while confirming the position of the distal end portion of the guide wire 1 under fluoroscopy (Murayama Col 6:36-45)] and impart flexibility, restoring performance, and mitigate reforming [Superelastic alloys are relatively flexible, good in restoring performance, and less susceptible to reforming. Accordingly, if the first wire 2 is made from a superelastic alloy, the guide wire 1 including such a first wire 2 has, at its distal portion, a high flexibility and a high restoring performance against bending, and a high trackability to a blood vessel complicatedly curved or bent, to thereby enhance the operationality of the guide wire 1 (Murayama Col 6:20-27), wherein the cited portion is directed towards the guidewire itself, but the previously cited portion of Murayama Col 6:36-45 discloses the coil as being formed of the same/similar materials].
However, Burkholz in view of Murayama fails to explicitly disclose wherein the coil extends distal to the tube.
Galgano discloses devices for facilitating placement of a catheter assembly, wherein Galgano discloses a needle assembly comprising a housing having a distal end [needle body 40 is fixed to cap 20, which is in turn fixed over flash chamber 25 of handle body 20 (Galgano ¶0067, Figs. 1A-B), wherein as the handle body 20 is fixed to needle body 40, the combination of both defines the claimed housing, wherein distal end 41 is considered to be the distal end of the housing]; wherein a tube and a guidewire disposed within the tube are contained within a distal end of the housing in a retracted position [In home or fully retracted position for HSC tube 50 and guide wire 60, both are coaxial and proximal of the distal end 41 of needle 40 (Galgano ¶0092, Figs. 3E, H)]; and wherein in an advanced position, the tube and guidewire extend past the distal end of the housing, wherein a distal end of the guidewire is positioned to extend distally out past a distal end of the tube [FIGS. 4A-4H show the intermediate position. Importantly, as shown in FIG. 4A, after the user pushes both slide controls 54 and 64 forward (Galgano ¶0105, Figs. 4A, H); FIGS. 5A-H shows the third (fully extended) position. Slide control 64 is pushed until the end of slot 72 (which functions as a mechanical stop). As shown in FIG. 5A, guide wire 60 then extends further out of HSC tube 50 an additional distance down the blood vessel (Galgano ¶0106, Figs. 5A, H)].
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 Murayama to employ wherein a distal end of the guidewire extends distally to the tube, so as to facilitate placement of the catheter assembly in the body when the tube and core wire comprising the coil are advanced into the body [While this precise arrangement is not necessarily required, in this example it is selected such that upon full deployment of guide wire 60 and HSC 50 (FIG. 5A), catheter sheath 30 need only then be slid a short distance forward to pass distal end of needle 40 and then the user would have both the extended section of HSC 50 and guide wire 60 to guide that sheath to a fully extended distal end of guide wire 60. This can guide and support that sheath to an intended location (Galgano ¶0093, Figs. 5A, 6); Thereafter, as indicated in FIG. 6, the user can manually push, slide, thread or otherwise manipulate the catheter assembly 17 distally. The catheter cannula 30, typically a thin wall flexible tube (such as known in the art), will follow the outside of the needle and then the extended portion of HSC tube 50 and then the extended portion of guide wire 60. In this embodiment, the length of cannula 30 will be enough that it can be pushed to the end of the extended guide wire 60 while leaving a hub portion 36 outside the patient and available for connection for other use (Galgano ¶0107, Fig. 6)]. Based on the present modification, as Burkholz was previously modified to employ a coil at the distal end of the guidewire, the coil as modified is considered to extend distal to the tube.
Regarding claim 4, Burkholz in view of Murayama and Galgano teaches
The blood collection device of claim 1, wherein the coil extends into the tube [wherein as depicted in Burkholz Fig. 1B, as the distal end of the guidewire 36 (core wire) is disposed within catheter 12 (tube), the coil as modified above is considered to extend into the tube, as core wire and tube are slidably movable relative to one another (Burkholz ¶¶0050, 0054-0055)].
Regarding claim 5, Burkholz in view of Murayama and Galgano teaches
The blood collection device of claim 1, wherein a proximal end of the coil is distal to a distal end of the tube, wherein a distal end of the core wire is distal to the distal end of the tube [see § 103 modification above; Galgano ¶¶0093, 0106-0107, Figs. 5A-6, wherein as the distal end of the core wire (guidewire 36 of Burkholz) has been modified to extend distally beyond a distal end of the tube (catheter 12), the coil is considered to be distal to the tube].
Regarding claim 6, Burkholz in view of Murayama and Galgano teaches
The blood collection device of claim 1, wherein the tube comprises a plurality of sections, wherein the plurality of sections comprises a first section and a second section proximal to the first section, wherein the first section is a distalmost section of the plurality of sections, wherein the first section comprises a first inner diameter and a first outer diameter that are constant along the first section [the catheter 12 may include a first portion 28 and a second portion 30. In some embodiments, the first portion 28 may include a first inner diameter along an entire length of the first portion 28 and a first outer diameter along the entire length of the first portion 28 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein the second section comprises a second inner diameter and a second outer diameter that are constant along the second section [the second portion 30 may be disposed proximal to the first portion 28. In some embodiments, the second portion 30 may include a second inner diameter and a second outer diameter along an entire length of the second portion 30 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein the coil extends distal to the first section [see § 103 modification above; Galgano ¶¶0093, 0106-0107, Figs. 5A-6, wherein as the distal end of the core wire (guidewire 36 of Burkholz) has been modified to extend distally beyond a distal end of the tube (catheter 12), the coil is considered to be distal to the first section of the tube].
Claim(s) 11-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190321590-A1, previously presented) in view of Buydenok (US-20130085468-A1, previously presented).
Regarding claim 11, Burkholz teaches
A catheter system, comprising:
a blood collection device, comprising:
a housing, comprising a distal end, a proximal end, and a slot [a housing 14, which may include a distal end 16, a proximal end 18, and a slot 20 (Burkholz Figures 1-4)];
a tube disposed within the housing, the tube having a distal end including an opening centered about a longitudinal axis of the tube and into and through which fluid may flow [the delivery device 10 may include the catheter 12 (Burkholz ¶0039, Figs. 1-4); fluid may flow into through the catheter 12 (Burkholz ¶0047); wherein as depicted in Burkholz Fig. 8, the tube (catheter 12) includes an opening centered about a longitudinal axis of the tube];
an advancement element configured to move along the slot from a retracted position to an advanced position, wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the tube is configured to advance distally beyond the distal end of the housing [the catheter hub 26 may include an advancement tab 44, which may be coupled to the portion of the catheter hub 26 that extends through the slot 20 (Burkholz ¶0050, Figure 1A); the catheter hub 26… may be fully advanced, according to some embodiments. In some embodiments, when the catheter hub 26 is fully advanced in the distal direction to fully advance the catheter 12, the catheter hub 26 may contact a distal end of the slot 20 and/or an inner surface of the housing 14, which may act as a stop (Burkholz ¶0054, Figures 2A-B)]; and
wherein the blood collection device does not include any core wire or guidewire therein [the delivery device 10 may include a guidewire 36 (Burkholz ¶0046), wherein the Examiner notes that as disclosed in Burkholz, the guidewire 36 is considered to be optional, such that the delivery device 10 of Burkholz may be employed without the guidewire 36]; and
a catheter assembly [catheter assembly 52 (Burkholz Figure 5A)], comprising:
a catheter, comprising a distal tip and a proximal end [catheter 55 (Burkholz Figure 5A); the tip 75 of the catheter 55 (Burkholz ¶0062, Figure 5A); wherein the catheter 55 being defined by a body 77 is considered to have a proximal end as depicted in Burkholz Figures 5A-B].
However, Burkholz fails to explicitly disclose a coil extending distal to the tube, wherein a proximal end of the coil is coupled to a distal end of the tube and a distal end of the coil extends distally out past the distal end of the tube, with the coil not obstructing the opening at the distal end of the tube, thereby allowing fluid to flow into and through the opening.
Buydenok discloses a tubular instrument comprising a tube [Shaft (102) is a hollow member defined by a shaft wall surrounding a lumen that permits fluids to flow freely through shaft (102) and exit out an outflow opening (not shown) located at proximal end (101) (Buydenok ¶0025, Fig. 1)] with a coil extending distal to the tube [One skilled in the art will appreciate that body wall separator (103) may be connected to distal end (104) by any suitable connection means including, but not limited to, threads, interlocking components (e.g. a locking mechanism), welding, adhesive, or combinations thereof (Buydenok ¶0025)], wherein Buydenok discloses embodiments wherein a distal end of the tube includes an opening centered about a longitudinal axis of the tube and into and through which fluid may flow [FIG. 2 depicts an embodiment of a catheter of the invention wherein body wall separator (103) is in a stretched, open configuration… Body wail separator (103) preferably comprises a flexible material that is manufactured to have the shape memory of a coil. Body wall separator (103) may comprise, for example a solid (or tubular) linear member having the shape memory of a coil (Buydenok ¶0027, Fig. 2); While the catheter of the invention is depicted as having a particular shape and design, one skilled in the art will appreciate that the catheter of the invention may assume any shape and design that permits it to prevent the occlusion of openings (105a-n) white the catheter occupies a body space as disclosed herein… It is also contemplated that terminal end may be open, wherein body wall separator (103) connects to the side of shaft (102), for example (Buydenok ¶0035); Thus having described preferred embodiments of the invention, alterations and modifications that do not depart from the spirit of the invention may occur to others (Buydenok ¶0040)].
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 system of Burkholz to employ a coil extending distal to the tube, wherein a proximal end of the coil is coupled to a distal end of the tube and a distal end of the coil extends distally out past the distal end of the tube, with the coil not obstructing the opening at the distal end of the tube, thereby allowing fluid to flow into and through the opening, so as to prevent occlusion of any opening(s) in the tube configured to allow for fluid collection or infusion by any surrounding tissues [In its natural state, body wall separator (103) prevents tissues within the body from contacting openings (105a-n) thereby permitting the free passage of fluids through shaft (102) (Buydenok ¶0031)].
Regarding claim 12, Burkholz in view of Buydenok teaches
The catheter system of claim 11, wherein the tube comprises a plurality of sections, wherein the plurality of sections comprises a first section and a second section proximal to the first section, wherein the first section is a distalmost section of the plurality of sections, wherein the first section comprises a first inner diameter and a first outer diameter that are constant along the first section [the catheter 12 may include a first portion 28 and a second portion 30. In some embodiments, the first portion 28 may include a first inner diameter along an entire length of the first portion 28 and a first outer diameter along the entire length of the first portion 28 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein the second section comprises a second inner diameter and a second outer diameter that are constant along the second section [the second portion 30 may be disposed proximal to the first portion 28. In some embodiments, the second portion 30 may include a second inner diameter and a second outer diameter along an entire length of the second portion 30 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein the coil extends distal to the first section [see § 103 modification of claim 11 above; Buydenok ¶0035], wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, first section and the second section are configured to advance distally beyond the distal end of the housing [Burkholz ¶0054, Figures 2A-B].
Regarding claim 13, Burkholz in view of Buydenok teaches
The catheter system of claim 12, wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the first section extends through the distal tip and the second section is at least partially disposed within the catheter [when the catheter 12 is fully and/or partially advanced, the transition portion 32 may be disposed within the catheter 55 proximal and/or proximate the tip 75 of the catheter 55, which may be narrowed compared to a body 77 of the catheter 55 (Burkholz ¶0062), wherein as depicted in Figure 2B, the transition portion 32 defines the distal end of the second section, such that the transition portion 32 being disposed within the catheter 55 is considered to read on the second section being at least partially disposed within the catheter].
Regarding claim 14, Burkholz in view of Buydenok teaches
The catheter system of claim 12, wherein the blood collection device comprises a septum, wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the first section and the second section move through the septum [the delivery device 10 may include a blood control septum 51, which may be disposed within a lumen of the delivery device 10. In some embodiments, the septum 51 may be disposed proximate or towards the distal end 16 of the delivery device 10. In some embodiments, the catheter 12 may penetrate the septum 51 in response to the catheter 12 being advanced (Burkholz ¶0053, Figure 2B)].
Regarding claim 15, Burkholz in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter [catheter adapter 54 (Figure 5A)], wherein the catheter adapter comprises a distal end, a proximal end, a lumen extending through the distal end and the proximal end [the catheter adapter 54 may include a distal end 56, a proximal end 58, and a lumen 60 extending between the distal end 56 and the proximal end 58 (Burkholz ¶0057)], and a side port between the distal end and the proximal end in fluid communication with the lumen [side port 62 (Burkholz Figure 5A)]; and
an extension tube integrated within the side port [extension tubing 66 (Figure 5A)], wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, a distal end of the first section is disposed within the catheter [Burkholz Figure 5B].
Regarding claim 16, Burkholz in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter, wherein the catheter adapter comprises a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port located between the distal end and the proximal end that is in fluid communication with the lumen [Burkholz ¶0057, Fig. 5A]; and
an extension tube integrated within the side port [extension tubing 66 (Figure 5A)], wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, a distal end of the first section is disposed within the catheter adapter proximal to the catheter [wherein based off of Burkholz ¶¶0041, 0062, and Figure 5B, the tubing (catheter 12) is considered to advance from the housing 14 through the catheter adapter 54 to reach the catheter 55, the first section is considered to have been disposed within the catheter adapter as the first section was advanced distally].
Regarding claim 18, Burkholz in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter, wherein the catheter adapter comprises a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port located between the distal end and the proximal end that is in fluid communication with the lumen [Burkholz ¶0057, Fig. 5A]; and
an extension tube integrated within the side port [extension tubing 66 (Figure 5A)], wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, a distal end of the first section is disposed within the extension tube or within the side port distal to the extension tube [wherein based off of Burkholz ¶¶0041, 0062, and Figure 5B, the tubing (catheter 12) is considered to advance from the housing 14 through the extension tubing 66, wherein as the first section may reach the catheter (catheter 55) as depicted in Figure 5B, the first section is considered to have been disposed within the extension tube or the side portion distal to the extension tube as the first section was advanced distally].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Buydenok, as applied to claim 16 above, and in further view of Burkholz (US-20190022357-A1, previously presented), hereinafter Burkholz II.
Regarding claim 17, Burkholz in view of Buydenok teaches
The catheter system of claim 16.
However, while Burkholz discloses that the catheter is secured within the catheter adapter [the catheter 55 may be secured to the catheter adapter 54 (Burkholz ¶0057, Figures 5A-B)], wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the distal end of the first section is disposed within the portion of the catheter secured to the catheter adapter [wherein based off of Burkholz ¶¶0041, 0062, and Figure 5B, the tubing (catheter 12) is considered to advance from the housing 14 through the catheter adapter 54 to reach the catheter 55, the first section is considered to have been disposed within the catheter adapter proximal to the catheter], Burkholz fails to explicitly disclose wherein the catheter assembly further comprises a wedge securing the catheter within the catheter adapter, and wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the distal end of the first section is disposed within the wedge proximal to the catheter.
Burkholz II discloses a catheter adapter, wherein a wedge secures a catheter within the catheter adapter [Catheter 103 (not shown) is anchored in catheter adapter 101 with catheter wedge 202 (Burkholz II ¶0069, Figures 1-3)].
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 system of Burkholz in view of Buydenok to employ a wedge to secure the catheter within the catheter adapter, as this modification would amount to mere simple substitution of one known element for another to obtain predictable results [secure the catheter within the catheter adapter] [MPEP § 2143(I)(B)]. Based on the modification by Burkholz II, the combination of Burkholz in view of Buydenok and Burkholz II is considered to further teach wherein in response to movement of the advancement element along the slot from the retracted position to the advanced position, the distal end of the first section is disposed within the wedge proximal to the catheter [wherein based off of Burkholz ¶¶0041, 0062, and Figure 5B, the tubing (catheter 12) is considered to advance from the housing 14 through the catheter adapter 54 to reach the catheter 55, the first section is considered to have been disposed within the portion of the catheter secured to the catheter adapter (by a wedge as modified) proximal to the catheter].
Claim(s) 19 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190321590-A1, previously presented) in view of Murayama (US-7547288-B2, previously presented).
Regarding claim 19, Burkholz teaches
A blood collection device, configured to couple to a catheter assembly [catheter assembly 52 (Burkholz Figure 5A)], the blood collection device comprising:
a housing, comprising a distal end, a proximal end, and a slot [a delivery device 10 for delivering a catheter 12 into an intravenous catheter assembly and/or the vein may include a housing 14, which may include a distal end 16, a proximal end 18, and a slot 20 (Burkholz ¶0039, Figs. 1-4)];
a tube disposed within the housing [the delivery device 10 may include the catheter 12 (Burkholz ¶0039, Figs. 1-4)];
a guidewire [the delivery device 10 may include a guidewire 36 (Burkholz ¶0046, Figs. 1-4)];
a distal advancement element configured to move along the slot and coupled to the tube, wherein in response to distal movement of the distal advancement element along the slot, the tube is configured to advance distally beyond the distal end of the housing [the catheter hub 26 may include an advancement tab 44, which may be coupled to the portion of the catheter hub 26 that extends through the slot 20 (Burkholz ¶0050, Fig. 1A); the catheter hub 26 and the guidewire hub 42 may be fully advanced, according to some embodiments. In some embodiments, when the catheter hub 26 is fully advanced in the distal direction to fully advance the catheter 12, the catheter hub 26 may contact a distal end of the slot 20 and/or an inner surface of the housing 14, which may act as a stop (Burkholz ¶0054, Figs. 2-4)]; and
a proximal advancement element configured to move along the slot and coupled to the guidewire, wherein in response to distal movement of the proximal advancement element along the slot, a distal end of the guidewire is configured to advance distally beyond the distal end of the housing [the guidewire hub 42 may include another advancement tab 46, which may be coupled to the portion of the guidewire hub 42 that extends through the slot 20 (Burkholz ¶0050, Fig. 1A); the catheter hub 26 and the guidewire hub 42 may be fully advanced, according to some embodiments… In some embodiments, the guidewire hub 42 may contact a proximal end of the catheter hub 26 in response to the guidewire hub 42 being fully advanced (Burkholz ¶0054, Figs. 2-4)];
wherein each of the distal advancement element and the proximal advancement element are movable from an initial, retracted position to an advanced position, with movement of the distal advancement element from the initial, retracted position to the advanced position causing a distal end of the tube to move from within the housing to a position distally beyond the distal end of the housing, and with movement of the proximal advancement element from the initial, retracted position to the advanced position causing the distal end of the guidewire to move from within the housing to a position distally beyond the distal end of the housing [Burkholz ¶¶0050, 0054, Figs. 1-4]; and
wherein when the distal advancement element and the proximal advancement element are each in the initial, retracted position, the distal advancement element is distal and spaced apart from the proximal advancement element [Burkholz Figs. 1A-B; see Annotated Fig. 1].
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Annotated Fig. 1. The Examiner has annotated Fig. 1A of Burkholz to clearly identify “the initial, retracted position” of the distal advancement element [advancement tab 44] and the proximal advancement element [advancement tab 46], wherein as depicted in the encircled portion of the Examiner’s annotation, the distal advancement element and the proximal advancement element are spaced apart; and wherein as further depicted in the entirety of Fig. 1A of Burkholz [not presently reproduced due to the annotation being a zoomed in portion of Fig. 1A to emphasize the annotated encircled portion], each of a distal end of the tube [catheter 12] and a distal end of the guidewire [guidewire 36] are entirely housed within the housing [housing 12] in “the initial, retracted position”.
However, Burkholz fails to explicitly disclose wherein the guidewire comprises a coil, such that in response to distal movement of the proximal advancement element along the slot, the coil is configured to advance distally beyond the distal end of the housing; and with movement of the proximal advancement element from the initial, retracted position to the advanced position causing a distal end of the coil to move from within the housing to a position distally beyond the distal end of the housing.
Murayama discloses a guidewire to be inserted in a tube, wherein the guidewire comprises a coil at a distal end of the guidewire [A guide wire 1 shown in FIG. 1 is of a type used to be inserted in a catheter, and includes a wire member 10 and a spiral coil 4 (Murayama Col 5:26-28, Figure 1)].
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 guidewire of Burkholz to employ wherein the guidewire comprises a coil, to allow the guidewire to exhibit X-ray contrast performance to confirm a position of the guidewire under fluoroscopy [The coil 4 may be made from a metal material such as a stainless steel, a superelastic alloy, a cobalt alloy, a noble metal such as gold, platinum, or tungsten, or an alloy containing such a noble metal. In particular, the coil 4 is preferably made from a radiopaque material such as a noble metal. If the coil 4 is made from such a radiopaque material, the guide wire 1 can exhibit an X-ray contrast performance. This makes it possible to insert the guide wire 1 in a living body while confirming the position of the distal end portion of the guide wire 1 under fluoroscopy (Murayama Col 6:36-45)] and impart flexibility, restoring performance, and mitigate reforming [Superelastic alloys are relatively flexible, good in restoring performance, and less susceptible to reforming. Accordingly, if the first wire 2 is made from a superelastic alloy, the guide wire 1 including such a first wire 2 has, at its distal portion, a high flexibility and a high restoring performance against bending, and a high trackability to a blood vessel complicatedly curved or bent, to thereby enhance the operationality of the guide wire 1 (Murayama Col 6:20-27), wherein the cited portion is directed towards the guidewire itself, but the previously cited portion of Murayama Col 6:36-45 discloses the coil as being formed of the same/similar materials]. Based on the present modification, as the guidewire comprises a coil at a distal end of the guidewire [Murayama Fig. 1], the combination of Burkholz in view of Murayama is considered to teach that in response to distal movement of the proximal advancement element along the slot, the coil is configured to advance distally beyond the distal end of the housing; and with movement of the proximal advancement element from the initial, retracted position to the advanced position causing a distal end of the coil to move from within the housing to a position distally beyond the distal end of the housing.
Regarding claim 21, Burkholz in view of Murayama teaches
The blood collection device of claim 19, wherein the proximal advancement element is configured to move distally along the slot a first distance from the initial position to contact the distal advancement element [Burkholz ¶0054, Figures 1-2], wherein in response to movement of the proximal advancement element distally along the slot a second distance greater than the first distance from the initial position, the distal advancement element and the proximal advancement element move distally along the slot together [movement of the guidewire hub 42 in the distal direction may also move the catheter hub 26 in the distal direction, advancing both the guidewire 36 and the catheter 12 (Burkholz ¶0055)].
Regarding claim 22, Burkholz in view of Murayama teaches
The blood collection device of claim 19, wherein the tube further comprises a plurality of sections, wherein the plurality of sections comprises a first section and a second section proximal to the first section, wherein the first section is a distalmost section of the plurality of sections, wherein the first section comprises a first inner diameter and a first outer diameter that are constant along the first section [the catheter 12 may include a first portion 28 and a second portion 30. In some embodiments, the first portion 28 may include a first inner diameter along an entire length of the first portion 28 and a first outer diameter along the entire length of the first portion 28 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein the second section comprises a second inner diameter and a second outer diameter that are constant along the second section [the second portion 30 may be disposed proximal to the first portion 28. In some embodiments, the second portion 30 may include a second inner diameter and a second outer diameter along an entire length of the second portion 30 (Burkholz ¶0041, Figures 1B, 2B, 3B, 4B)], wherein in response to distal movement of the distal advancement element along the slot, the first section and the second section are configured to advance distally beyond the distal end of the housing [Burkholz ¶0054, Figures 2A-B].
Regarding claim 23, Burkholz in view of Murayama teaches
The blood collection device of claim 19, wherein with the distal advancement element distal to and spaced apart from the proximal advancement element, the proximal advancement element is distally advanceable prior to advancement of the distal advancement element [wherein as depicted in Figs. 1-3 of Burkholz, each of advancement elements 44 and 46, which are considered to read on the distal and proximal advancement elements respectively, being positionable anywhere along the slot 20, would allow for an initial configuration wherein advancement element 44 is positioned such that advancement element 46 is distally advanceable prior to advancement of advancement element 44 (as starting in the initial configuration)].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Murayama, as applied to claim 19 above, in further view of Galgano (US-20160045715-A1).
Regarding claim 24, Burkholz in view of Murayama teaches
The blood collection device of claim 19.
However, Burkholz fails to explicitly disclose wherein with each of the distal advancement element and the proximal advancement element in the advanced position, the distal end of the coil is positioned to extend distally out past the distal end of the tube.
Galgano discloses devices for facilitating placement of a catheter assembly, wherein Galgano discloses a needle assembly comprising a housing having a distal end [needle body 40 is fixed to cap 20, which is in turn fixed over flash chamber 25 of handle body 20 (Galgano ¶0067, Figs. 1A-B), wherein as the handle body 20 is fixed to needle body 40, the combination of both defines the claimed housing, wherein distal end 41 is considered to be the distal end of the housing]; wherein a tube and a guidewire disposed within the tube are contained within a distal end of the housing in a retracted position [In home or fully retracted position for HSC tube 50 and guide wire 60, both are coaxial and proximal of the distal end 41 of needle 40 (Galgano ¶0092, Figs. 3E, H)]; and wherein in an advanced position, the tube and guidewire extend past the distal end of the housing, wherein a distal end of the guidewire is positioned to extend distally out past a distal end of the tube [FIGS. 4A-4H show the intermediate position. Importantly, as shown in FIG. 4A, after the user pushes both slide controls 54 and 64 forward (Galgano ¶0105, Figs. 4A, H); FIGS. 5A-H shows the third (fully extended) position. Slide control 64 is pushed until the end of slot 72 (which functions as a mechanical stop). As shown in FIG. 5A, guide wire 60 then extends further out of HSC tube 50 an additional distance down the blood vessel (Galgano ¶0106, Figs. 5A, H)].
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 Murayama to employ wherein with each of the distal advancement element and the proximal advancement element in the advanced position, the distal end of the coil is positioned to extend distally out past the distal end of the tube, so as to facilitate placement of the catheter assembly in the body [While this precise arrangement is not necessarily required, in this example it is selected such that upon full deployment of guide wire 60 and HSC 50 (FIG. 5A), catheter sheath 30 need only then be slid a short distance forward to pass distal end of needle 40 and then the user would have both the extended section of HSC 50 and guide wire 60 to guide that sheath to a fully extended distal end of guide wire 60. This can guide and support that sheath to an intended location (Galgano ¶0093, Figs. 5A, 6); Thereafter, as indicated in FIG. 6, the user can manually push, slide, thread or otherwise manipulate the catheter assembly 17 distally. The catheter cannula 30, typically a thin wall flexible tube (such as known in the art), will follow the outside of the needle and then the extended portion of HSC tube 50 and then the extended portion of guide wire 60. In this embodiment, the length of cannula 30 will be enough that it can be pushed to the end of the extended guide wire 60 while leaving a hub portion 36 outside the patient and available for connection for other use (Galgano ¶0107, Fig. 6)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 24 March 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 1 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously applied claim rejections under § 112(b) have been fully considered and are persuasive. The § 112(b) rejections of claims 16, 18, and 21 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-10, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 103 as being obvious over Burkholz in view of Sepetka 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 Burkholz (US-20190321590-A1, previously presented) in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1).
Regarding claim 1, the Applicant asserts that there is no teaching or suggestion provided by the combination of Burkholz in view of Sepetka to provide a specific construction/arrangement where a core wire and coil are provided in a manner/configuration where a distal end of the core wire coupled to a proximal end of the coil, as specifically recited in amended claim 1. The Applicant notes that: 1) as Burkholz fails to explicitly disclose “a coil extending distal to the tube”, Burkholz also cannot teach a specific arrangement of coil relative to a core wire; 2) there is no disclosure in Sepetka of a distal end of the guidewire 12 being coupled to a proximal end of the perfusion coil 35, and instead Sepetka explicitly disclose that the perfusion coil 35 is fixedly joined to the distal tip 15 of the catheter 11; as such, the modification of Burkholz in view of Sepetka would teach a coil fixedly joined to the distal tip of catheter 12, with the guidewire 36 [core wire] separate from and movable relative to the coil, and thus the distal end of the guidewire 36 would not be joined to the proximal end of the coil. Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Burkholz (US-20190321590-A1, previously presented) is presently modified in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1), as Murayama discloses a guidewire to be inserted in a tube, wherein the guidewire comprises a coil at a distal end of the guidewire [A guide wire 1 shown in FIG. 1 is of a type used to be inserted in a catheter, and includes a wire member 10 and a spiral coil 4 (Murayama Col 5:26-28, Figure 1)] as argued, and as Galgano discloses a guidewire disposed within a tube that are contained within a distal end of a housing in a retracted position [In home or fully retracted position for HSC tube 50 and guide wire 60, both are coaxial and proximal of the distal end 41 of needle 40 (Galgano ¶0092, Figs. 3E, H)]; and wherein in an advanced position, the tube and guidewire extend past the distal end of the housing, wherein a distal end of the guidewire is positioned to extend distally out past a distal end of the tube [FIGS. 4A-4H show the intermediate position. Importantly, as shown in FIG. 4A, after the user pushes both slide controls 54 and 64 forward (Galgano ¶0105, Figs. 4A, H); FIGS. 5A-H shows the third (fully extended) position. Slide control 64 is pushed until the end of slot 72 (which functions as a mechanical stop). As shown in FIG. 5A, guide wire 60 then extends further out of HSC tube 50 an additional distance down the blood vessel (Galgano ¶0106, Figs. 5A, H)].
Applicant's arguments, see Applicant’s Remarks p. 10-13, with respect to the rejections of claims 11 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claim 11, the Applicant asserts that there is no teaching or suggestion in either of Burkholz or Buydenok of a coil coupled to a distal end of the tube, where the coil coupled is to a distal end of the tube such that the coil does “not obstruct the opening at the distal end of the tube, thereby allowing fluid to flow into and through the opening”, as recited in amended claim 11; wherein the Applicant notes that Burkholz explicitly discloses that a delivery device 10 includes a guidewire 36, contrary to what is called for in claim 11 regarding “wherein the blood collection device does not include any core wire or guidewire therein”; and wherein instead, the Applicant notes that Buydenok specifically discloses that coil 103 is joined to the distal end of shaft 102 such that the distal end 104 is closed [Applicant cited Buydenok Figs. 1-2], with the shaft 102 instead specifically including openings 105 a-n formed about a circumference thereof that place a lumen 102 of the shaft 102 in fluid communication with the vasculature of a patient. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Buydenok embodiments of the shaft 102 (tube) and body wall separator 103 (coil) wherein the coil is coupled to a distal end of the tube such that the coil does not obstruct an opening at the distal end of the tube, thereby allowing fluid to flow into and through the opening [FIG. 2 depicts an embodiment of a catheter of the invention wherein body wall separator (103) is in a stretched, open configuration… Body wail separator (103) preferably comprises a flexible material that is manufactured to have the shape memory of a coil. Body wall separator (103) may comprise, for example a solid (or tubular) linear member having the shape memory of a coil (Buydenok ¶0027, Fig. 2); While the catheter of the invention is depicted as having a particular shape and design, one skilled in the art will appreciate that the catheter of the invention may assume any shape and design that permits it to prevent the occlusion of openings (105a-n) white the catheter occupies a body space as disclosed herein… It is also contemplated that terminal end may be open, wherein body wall separator (103) connects to the side of shaft (102), for example (Buydenok ¶0035); Thus having described preferred embodiments of the invention, alterations and modifications that do not depart from the spirit of the invention may occur to others (Buydenok ¶0040); One skilled in the art will appreciate that body wall separator (103) may be connected to distal end (104) by any suitable connection means including, but not limited to, threads, interlocking components (e.g. a locking mechanism), welding, adhesive, or combinations thereof (Buydenok ¶0025)].
Applicant's arguments, see Applicant’s Remarks p. 13-15, with respect to the rejections of claims 19 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claim 19, the Applicant asserts that there is no teaching or suggestion in the combination of Burkholz in view of Murayama of an arrangement of a distal advancement element and a proximal advancement element as recited in amended claim 19, as claim 19 now explicitly recites that the distal advancement element and the proximal advancement element are spaced apart when the distal advancement element and the proximal advancement element are each in an initial, retracted position where a distal end of the tube is within the housing and a distal end of the coil is within the housing [see lines 12-21 of amended claim 19]; wherein the Applicant notes that in Burkholz, the only arrangement of the advancement tabs 44 and 46 of an “initial, retracted position” [interpreted by the Applicant to refer to a distal end of each of the catheter 12 and guidewire 36 being positioned within the housing 14] is depicted in Burkholz Fig. 1A, which the Applicant notes depicts the tabs 44/46 being in contact with each other, as opposed to being spaced apart as claimed; and wherein the Applicant further notes that were advancement tab 44 to be moved distally and “spaced apart” from another advancement tab 46, tab 44 would no longer be considered to be in an “initial, retracted” position, as a distal end of catheter 12 would then no longer be positioned within the housing 14. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that in the previously presented Response to Arguments [see Final Rejection dated 4 December 2025, p. 19-21] and presently reproduced as Annotated Fig. 1 above, Burkholz discloses and depicts a distal advancement element and a proximal advancement element that are spaced apart and not in contact with each other as argued when the distal advancement element and the proximal advancement element are each in an initial, retracted position where a distal end of the tube is within the housing and a distal end of the guidewire is within the housing as claimed [Burkholz ¶¶0050, 0054, Figs. 1A-B; the distal end of the coil is considered to be contained within the housing based on the modification by Murayama].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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