DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 9 July 2026. The Examiner acknowledges the amendments to claims 1, 11, and 19, as well as the addition of new claims 25-27. Claims 1, 4-6, 11-19, and 21-27 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) 16 and 27 is/are objected to because of the following informalities:
The Examiner notes that a remnant of the previously presented amendments to claim 16 is still present [underline between “is” and “in” (line 5)].
Claim 27 should read “wherein the extension tube extends through [lines 1-2].
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 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20200016374-A1), hereinafter Burkholz ‘374, in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1, previously presented).
Regarding claim 1, Burkholz ‘374 teaches
A blood collection device configured to couple to a catheter assembly [the catheter 12 may be used for fluid infusion and/or blood withdrawal (Burkholz ‘374 ¶0040); the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14. In some embodiments, the connector 40 may be configured to couple the delivery device 10 to the intravenous catheter assembly (as illustrated, for example, in FIG. 6) (Burkholz ‘374 ¶0044, Fig. 6)], the blood collection device comprising:
a housing, comprising a distal end, a proximal end, and a slot [the delivery device 10 may include a housing 14. In some embodiments, the housing may include a distal end 16, a proximal end 18, and a slot 20 (Burkholz ‘374 ¶0033, Fig. 1A)];
a tube disposed within the housing [the instrument may include the catheter 12, and the second end 30 of the instrument may be coupled to extension tubing 32. In some embodiments, the extension tubing 32 may be coupled to a blood collection device… a fluid pathway of the delivery device 10 may include the catheter 12 and the extension tubing 32 (Burkholz ¶0039, Fig. 1C)];
an advancement element configured to move along the slot, wherein in response to distal movement of the advancement element along the slot, the tube is configured to advance distally beyond the distal end of the housing [the guide feature 22 may extend through the slot 20. In some embodiments, the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. In some embodiments, the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25 (Burkholz ‘374 ¶0034, Figs. 1C, 2C)]; and
a core wire disposed within the tube, with a proximal end of the core wire secured within the advancement element [a guidewire 34 may be disposed within the catheter 12 (Burkholz ‘374 ¶0040); the guidewire 34 and the catheter 12 may be advanced and/or retracted together… the second end 38 of the guidewire may be fixed inside the catheter 12 (Burkholz ¶0041); in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, the guidewire 34 may move through the channel 24 with the catheter 12 (Burkholz ‘374 ¶0051), wherein the guidewire 34 being fixed inside the catheter 12, which is in turn secured to the advancement element (Burkholz ¶0034), is considered to read on the guidewire 34 being secured within the advancement element],
wherein both of the tube and the coil wire are secured to or within the advancement element, such that distal movement of the advancement element causes distal movement of all of the tube and the core wire [Burkholz ¶¶0034, 0041, Figs. 1C, 2C].
However, Burkholz ‘374 fails to explicitly disclose a coil, with a distal end of the core wire coupled to a proximal end of the 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)]. Murayama further discloses that the coil may comprise a material 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].
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 ‘374 to employ a coil, with a distal end of the core wire coupled to a proximal end of the coil, to allow the guidewire to exhibit X-ray contrast performance to confirm a position of the guidewire under fluoroscopy and impart flexibility, restoring performance, and mitigate reforming. Based on the modification in view of Murayama to employ a coil, Burkholz ‘374 in view of Murayama is considered to render obvious wherein distal movement of the advancement element further causes distal movement of the coil.
However, while Burkholz ‘374 discloses that the core wire may extend to a distal end of the tube [the guidewire 34 may provide support to the catheter 12 along a full or partial length of the catheter 12 (Burkholz ¶0052)], Burkholz ‘374 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)]. Galgano further discloses wherein the distal end of the guidewire extending distally out past a distal end of the tube facilitates placement of the catheter assembly in the body when the tube and the guidewire are advanced into a 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)].
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 ‘374 in view of Murayama to employ wherein a distal end of the core wire 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. Based on the present modification, as Burkholz ‘374 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 ‘374 in view of Murayama and Galgano teaches
The blood collection device of claim 1, wherein the coil extends into the tube [See § 103 modification of claim 1 above; Galgano discloses that the guidewire may extend past the tube by 0.739 inches (18.771 mm) (Galgano ¶0093), and as Murayama discloses that the entire length of the coil is in a range of 5-500 mm (Murayama Col 8:51-52), the coil as modified may be considered to extend into the tube].
Regarding claim 5, Burkholz ‘374 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].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘374, as applied to claim 1 above, and U.S. Patent Application No. 62/660,646, filed 20 April 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS”, hereinafter Burkholz ‘646 [NPL attached], as incorporated by reference by Burkholz ‘374 [See Burkholz ‘374 ¶0042], in view of Murayama and Galgano.
Regarding claim 6, Burkholz ‘374 and Burkholz ‘646 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, wherein the second section comprises a second inner diameter and a second outer diameter that are constant along the second section [the catheter 12 may include a multi-diameter catheter, such as described, for example, in U.S. Patent Application No. 62/660,646, filed Apr. 20, 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS,” which is incorporated herein by reference (Burkholz ‘374 ¶0042); See ¶0040 of the Specification and Fig. 1B of the Drawings of attached Provisional Application 62/660,646, which defines a catheter that comprises a distalmost first portion 28 (first section) having a constant first inner diameter and first outer diameter, and a second portion 30 (second section) proximal to the first portion 28 and having a constant second inner diameter and second outer diameter], 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 of Burkholz ‘374 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), hereinafter Burkholz ‘590, in view of Buydenok (US-20130085468-A1, previously presented).
Regarding claim 11, Burkholz ‘590 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 ‘590 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 ‘590 ¶0039, Figs. 1-4); fluid may flow into through the catheter 12 (Burkholz ‘590 ¶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 ‘590 ¶0050, Fig. 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 ‘590 ¶0054, Figs. 2A-B)];
wherein the blood collection device does not include any core wire or guidewire therein [the delivery device 10 may include a guidewire 36 (Burkholz ‘590 ¶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 ‘590 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 ‘590 ¶0062, Fig. 5A); wherein the catheter 55 being defined by a body 77 is considered to have a proximal end as depicted in Burkholz ‘590 Figs. 5A-B].
However, Burkholz ‘590 fails to explicitly disclose a coil extending distal to the tube, wherein a proximal end of the coil is coupled to the 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), wherein the Examiner notes that the use of “proximal” and “distal” is considered to be relative, such that there is not any specifically imposed limit to how much of the length of the tube the “distal” end is meant to comprise, such that the body wall separator 103 of Buydenok is considered to be attached to the shaft 102 at the “distal” end (Buydenok ¶0035)].
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 ‘590 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 ‘590 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 ‘590 ¶0041, Figs. 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 ‘590 ¶0041, Figs. 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 ‘590 ¶0054, Figs. 2A-B].
Regarding claim 13, Burkholz ‘590 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 ‘590 ¶0062), wherein as depicted in Fig. 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 ‘590 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 ‘590 ¶0053, Fig. 2B)].
Regarding claim 15, Burkholz ‘590 in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter [catheter adapter 54 (Burkholz ‘590 Fig. 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 ‘590 ¶0057)], and a side port between the distal end and the proximal end in fluid communication with the lumen [side port 62 (Burkholz ‘590 Fig. 5A)]; and
an extension tube integrated within the side port [extension tubing 66 (Burkholz ‘590 Fig. 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 ‘590 Fig. 5B].
Regarding claim 16, Burkholz ‘590 in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter [catheter adapter 54 (Burkholz ‘590 Fig. 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 ‘590 ¶0057)], and a side port located between the distal end and the proximal end that is in fluid communication with the lumen [side port 62 (Burkholz ‘590 Fig. 5A)]; and
an extension tube integrated within the side port [extension tubing 66 (Burkholz ‘590 Fig. 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 ‘590 ¶¶0041, 0062, and Fig. 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 ‘590 in view of Buydenok teaches
The catheter system of claim 12, wherein the catheter assembly further comprises:
a catheter adapter [catheter adapter 54 (Burkholz ‘590 Fig. 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 ‘590 ¶0057)], and a side port located between the distal end and the proximal end that is in fluid communication with the lumen [side port 62 (Burkholz ‘590 Fig. 5A)]; and
an extension tube integrated within the side port [extension tubing 66 (Burkholz ‘590 Fig. 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 ‘590 ¶¶0041, 0062, and Fig. 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 ‘590 in view of Buydenok, as applied to claim 16 above, and in further view of Burkholz (US-20190022357-A1, previously presented), hereinafter Burkholz ‘357 [previously presented as Burkholz II].
Regarding claim 17, Burkholz ‘590 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 ‘590 ¶0057, Figs. 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 ‘590 ¶¶0041, 0062, and Fig. 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 ‘357 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 ‘590 in view of Buydenok to employ wherein the catheter assembly further comprises a wedge securing 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 [one means for secure the catheter within the catheter adapter for another] [MPEP § 2143(I)(B)].Based on the modification of the combination of Burkholz ‘590 in view of Buydenok and Burkholz ‘357, the combination 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 ‘590 ¶¶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, 21-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190321590-A1, previously presented), hereinafter Burkholz ‘590, in view of Murayama (US-7547288-B2, previously presented).
Regarding claim 19, Burkholz ‘590 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 ‘590 ¶0039, Figs. 1-4)];
a tube disposed within the housing [the delivery device 10 may include the catheter 12 (Burkholz ‘590 ¶0039, Figs. 1-4)];
a guidewire [the delivery device 10 may include a guidewire 36 (Burkholz ‘590 ¶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 ‘590 ¶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 ‘590 ¶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 ‘590 ¶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 ‘590 ¶0054, Figs. 2-4)]; and
an extension tube including a distal end and a proximal end, with the distal end of the extension tube coupled to the distal advancement element and with the extension tube extending proximally out from the distal advancement element [the portion of the catheter hub 26 that extends through the slot 20 may be coupled to the blood collection device via extension tubing 34, which may include a connector on a proximal end of the extension tubing for connecting the blood sampling device to the extension tubing 34… a fluid pathway of the catheter system 50 may include the catheter 12, the catheter hub 26, and the extension tubing 34 (Burkholz ‘590 ¶0045, Fig. 1B)];
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 ‘590 ¶¶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 ‘590 Figs. 1A-B; see Annotated Fig. 1]; and
wherein with each of the distal advancement element and the proximal advancement element in the advanced position and the distal advancement element adjacent the proximal advancement element, the extension tube extends proximally through or past the proximal advancement element [In some embodiments, the blood collection device 78 may move distally as the catheter hub 26 is moved distally and/or proximally as the catheter hub 26 moves proximally. In these and other embodiments, the delivery device 10 may or may not include the guidewire 36 and/or the guidewire hub 42 (Burkholz ‘590 ¶0076, Fig. 7B); a proximal end of the guidewire 36 may extend parallel to and/or next to the extension tubing 34 such that the proximal end 38 of the guidewire 36 is disposed external to the extension tubing 34 and the blood collection device 78 (Burkholz ‘590 ¶0077), wherein as depicted in Fig. 7B, the extension tube 34 extends proximally past the housing 14, which contains the guidewire hub 42 and defines the proximal position of the advancement tab 46 (proximal advancement element), such that the extension tube 34 extends proximally past the proximal advancement element].
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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 ‘590 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)]. Murayama further discloses that the coil may comprise a material 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].
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 a coil at a distal end of the guidewire, to allow the guidewire to exhibit X-ray contrast performance to confirm a position of the guidewire under fluoroscopy and impart flexibility, restoring performance, and mitigate reforming. Based on the present modification, as the guidewire of Burkholz ‘590 in view of Murayama comprises a coil at a distal end of the guidewire, 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 ‘590 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 ‘590 ¶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 ‘590 ¶0055)].
Regarding claim 22, Burkholz ‘590 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 ‘590 ¶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 ‘590 ¶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 ‘590 ¶0054, Figures 2A-B].
Regarding claim 23, Burkholz ‘590 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 ‘590, 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)].
Regarding claim 25, Burkholz ‘590 in view of Murayama teaches
The blood collection device of claim 19, wherein with each of the distal advancement element and the proximal advancement element in the advanced position, the distal advancement element and the proximal advancement element couple to each other, such that the distal advancement element and the proximal advancement element may be collectively moved back to the initial, retracted position via a single motion retraction [movement of the catheter hub 26 in the proximal direction may also move the guidewire hub 42 in the proximal direction, retracting the guidewire 36 and the catheter 12 (Burkholz ‘590 ¶0055)].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘590 in view of Murayama, as applied to claim 19 above, in further view of Galgano (US-20160045715-A1, previously presented).
Regarding claim 24, Burkholz ‘590 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 [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 [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 [Galgano ¶¶0105-0106, Figs. 4A, 5A, H]. Galgano further discloses wherein the distal end of the guidewire extending distally out past a distal end of the tube facilitates placement of the catheter assembly in the body when the tube and the guidewire are advanced into a body [Galgano ¶¶0093, 0107 Figs. 5A, 6)].
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 ‘590 in view of Murayama to employ 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.
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘374 in view of Murayama and Galgano, as applied to claim 1 above, in further view of Devgon (US-20170216564-A1).
Regarding claim 26, Burkholz ‘374 in view of Murayama and Galgano teaches
The blood collection device of claim 1, further comprising an extension tube including a distal end and a proximal end, wherein the extension tube is in fluid communication with the tube, such that the tube and the extension tube form a blood collection pathway through the blood collection device [Burkholz ‘374 ¶0039, Fig. 1A].
However, Burkholz ‘374 in view of Murayama and Galgano fails to explicitly disclose wherein the distal end of the extension tube coupled to the advancement element, wherein the distal end of the extension tube and the proximal end of the tube are sealed within the advancement element, wherein the extension tube is in fluid communication with the tube via a channel formed through the advancement element, such that the tube, the advancement element, and the extension tube form a blood collection pathway through the blood collection device.
Devgon discloses a blood collection device comprising a advancement element configured to advance a tube and an extension tube, wherein a distal end of the extension tube is coupled to the advancement element, wherein the distal end of the extension tube and a proximal end of the tube are sealed within the advancement element, and wherein the extension tube is in fluid communication with the tube via a channel formed through the advancement element, such that the tube, the advancement element, and the extension tube form a blood collection pathway through the blood collection device [As shown in FIG. 16, the catheter 260 has a proximal end portion 261 and a distal end portion 262 and defines a lumen 263 (see e.g., FIG. 24). The proximal end portion 261 of the catheter 260 is coupled to a second portion 275 of the actuator 270. In this manner, the actuator 270 can be moved relative to the introducer 210 to move the catheter 260 between a first position, in which the catheter 260 is disposed within the introducer 210 (e.g., the entire catheter 260 is disposed within the introducer 210 or within the introducer 210 and the lock 240) and a second position, in which the distal end portion of the catheter 260 is at least partially disposed in a position distal to the lock 240 and/or the PIV (not shown) when the lock 240 is coupled to the PIV, as described in further detail herein (Devgon ¶0081, Fig. 24); As shown in FIG. 16, the proximal end portion 266 of the secondary catheter 265 is coupled to and/or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), pump, and/or the like. The distal end portion 267 of the secondary catheter 265 is at least partially disposed within the second portion 215 of the inner volume 213 defined by the introducer 210 and is coupled to the second portion 275 of the actuator 270… In this manner, when the coupler 269 is coupled to a fluid reservoir, fluid source, syringe, evacuated container, pump, etc., the secondary catheter 265 establishes fluid communication between the reservoir, source, pump, etc. and the catheter 260 (Devgon ¶0085, Figs. 16, 24)].
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 ‘374 in view of Murayama and Galgano to employ wherein the distal end of the extension tube coupled to the advancement element, wherein the distal end of the extension tube and the proximal end of the tube are sealed within the advancement element, wherein the extension tube is in fluid communication with the tube via a channel formed through the advancement element, such that the tube, the advancement element, and the extension tube form a blood collection pathway through the blood collection device, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [fluidically couple a catheter to an extension tube via an advancement element to enable blood collection therethrough] [MPEP § 2143(I)(D)].
Regarding claim 27, Burkholz ‘374 in view of Murayama, Galgano, and Devgon teaches
The blood collection device of claim 26, wherein the extension tube extends through extends through the proximal end of the housing and moves through the proximal end of the housing in response to distal movement of the advancement element along the slot [See § 103 modification of claim 26 above; Devgon ¶¶0081, 0085, Figs. 16, 24].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 10, filed 9 July 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 10, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 11 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 11-16, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 103 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-20200016374-A1), hereinafter Burkholz ‘374, in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1, previously presented).
Regarding claim 1, the Applicant asserts that Burkholz fails to teach or suggest the amended language of claim 1 to clarify that both of the tube and the coil wire are secured to or within the advancement element, such that distal movement of the advancement element causes distal movement of all of the tube, the core wire, and the coil. The Applicant further notes that neither of Murayama and/or Galgano address the asserted failure of Burkholz to teach or suggest the amended claim language. However, the Examiner notes that 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. Claim 1 is presently rejected under § 103 as being rendered obvious over Burkholz (US-20200016374-A1), hereinafter Burkholz ‘374, in view of Murayama (US-7547288-B2, previously presented) and Galgano (US-20160045715-A1, previously presented), wherein the Examiner notes that Burkholz ‘374 is considered to teach the argued elements wherein both of the tube and the coil wire are secured to or within the advancement element, such that distal movement of the advancement element causes distal movement of all of the tube and the core wire [and the coil based on modification by Murayama].
Applicant's arguments, see Applicant’s Remarks p. 11-16, with respect to the rejections of claims 11, 19, and those dependent therefrom have been fully considered but they are not persuasive.
Regarding claim 11, the Applicant asserts that there is no teaching 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 the opening at the distal end of the tube, thereby allowing fluid to flow into and through the opening”, as recited in claim 11, and the Applicant notes that Buydenok specifically discloses that coil 103 is joined to the distal end 104 of shaft 102, such that the distal end 104 is closed [Buydenok Fig. 2]. The Applicant further asserts that while Buydenok does make mention that “body wall separator may connect to terminal end (104), or the side of shaft (102)” and that “it is also contemplated that terminal end may be open, wherein body wall separator (103) connects to the side of shaft (102)”, that (1) in an embodiment where terminal end 103 is left open, the body wall separator 103 is no longer coupled to the “distal end” of shaft 102, as called for in claim 11, but is coupled to a sidewall of the shaft 102, and (2) conversely, in an embodiment where body wall separator 103 is coupled to the terminal end 104 of shaft 102, then the terminal end 104 is closed/obstructed by body wall separator 103, such that fluid cannot flow through the terminal end, as called for in claim 11. However, the Examiner disagrees with the Applicant’s arguments regarding the modification in view of the disclosure of Buydenok, as the Examiner notes that the use of “proximal” and “distal” is considered to be relative, such that there is not any specifically imposed limit to how much of the length of the tube the “distal” end is meant to comprise. As such, Buydenok disclosing that body wall separator 103 connects to the side of shaft 102 at a “distal” end [as the body wall separator extends distally beyond the end of the tube (Buydenok Fig. 2)], the body wall separator 103 [coil] is considered to extend distal to the shaft 102 [tube], wherein a proximal end of the coil is coupled to the 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 ¶0035].
Regarding claim 19, the Applicant asserts that the combination of Burkholz and Murayama fails to teach or suggest the amended arrangement of “an extension tube including a distal end and a proximal end, with the distal end of the extension tube coupled to the distal advancement element and with the extension tube extending proximally out from the distal advancement element” and “wherein with each of the distal advancement element and the proximal advancement element in the advanced position and the distal advancement element adjacent the proximal advancement element, the extension tube extends proximally through or past the proximal advancement element”, as the Applicant notes that the extension tube 34 of Burkholz cannot be said to extend proximally through or past a proximal advancement element [through or past guidewire hub 42 and advancement tab 46 (Burkholz Fig. 1)] and Murayama does nothing to address the failure of Burkholz to teach the argued elements. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Burkholz ‘590 is considered to teach the amended arrangement of “an extension tube including a distal end and a proximal end, with the distal end of the extension tube coupled to the distal advancement element and with the extension tube extending proximally out from the distal advancement element” [Burkholz ‘590 ¶0045, Fig. 1B] and “wherein with each of the distal advancement element and the proximal advancement element in the advanced position and the distal advancement element adjacent the proximal advancement element, the extension tube extends proximally through or past the proximal advancement element” [Burkholz ‘590 ¶¶0076-007, Fig. 7B, wherein as depicted in Fig. 7B, the extension tube 34 extends proximally past the housing 14, which contains the guidewire hub 42 (proximal advancement element), such that the extension tube 34 extends proximally past the proximal advancement element].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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