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 .
Response to Amendment
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
The amendment filed 20 July 2026 has been entered. Claim(s) 1-22 remain pending in the application. Applicant’s amendments to the specification and claims have overcome each and every objection to the specification and claims, and the rejections under 35 U.S.C. 103 in view of BD and Becton previously set forth in the Office Action mailed 21 April 2026.
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.
Claim(s) 1, 5, 13, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190021640 A1) in view of Ofek (US 20200000972 A1).
Regarding claim 1, Burkholz teaches a blood draw device (Paragraph 0006-0007-- an extension or introducer that may house an instrument, such as, for example, a probe or an intravenous catheter…the extension may include a blood collection device, which may be used to obtain a blood sample… may be used for needle-free blood collection and/or fluid infusion…; Figs. 2A-D; NOTE: this is the intended use of the device, and not given further patentable weight), the blood draw device comprising:
a housing (28) comprising a proximal end, a distal end, and a sidewall therebetween defining an interior (See annotated Fig. 2D, below), the housing comprising a connecter (30) at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly (Paragraph 0048-0049--the distal end of the housing 28 may include a coupling mechanism 30, which may couple the extension 10 with the catheter assembly 14. In some embodiments, the coupling mechanism 30 may be a luer fitting, such as, for example, a male luer fitting or a luer lock threaded collar…);
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a fluid conduit (12) displaceably received within the housing interior and having a proximal end (Paragraph 0055--the instrument 12 may include the proximal end and the distal tip 42) and a distal end (42), the fluid conduit comprising:
a first conduit portion at the proximal end of the fluid conduit (See annotated Fig. 2D); and
a second conduit portion (See annotated Fig. 2D) at the distal end of the fluid conduit, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly (Fig 2A shows a first position wherein the second conduit portion does not extend beyond the connector and thus does not extend beyond a distal end of a catheter connected to the connector) to a second, distal position in which the second conduit portion extends beyond the connector and/or beyond a distal end of a catheter of the intravenous catheter assembly (Fig. 2D--The second conduit portion may be advanced until it extends beyond the connector; Paragraph 0065-- the instrument 12 may be advanced to the distal position beyond a distal end of the sleeve 55 and/or the catheter 16).
However, Burkholz does not explicitly disclose at least a portion of the second conduit portion coated with an antimicrobial coating.
Ofek, in the same field of endeavor of a catheter assembly including an extension-leg portion and a hub, teaches at least a portion of the second conduit portion coated with an antimicrobial coating (Paragraph 0013, 0024, 0070, 0078, 0099-- the antimicrobial coating is on the internal surface of the catheter assembly including the extension-leg lumen defining the corresponding extension-leg portion of the fluid pathway through the catheter assembly).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to provide an antimicrobial coating on at least a portion of the second conduit portion as disclosed by Ofek in order to predictably improve the device by reducing a risk of bacterial colonies that can migrate into the blood in parts of the assembly which are typically difficult for traditional antimicrobial treatments to reach (Paragraph 0069, 0078 of Ofek).
Regarding claim 5, the combination of Burkholz and Ofek teaches the blood draw device of claim 1. Ofek additionally discloses wherein the connector is at least partially coated with an antimicrobial composition (Paragraph 0016, 0025, 0089-- the antimicrobial catheter assembly further includes at least one Luer connector connected to the extension leg. The antimicrobial coating is on the internal surface of the catheter assembly including an internal surface of the Luer connector in fluid communication with the fluid pathway, an external surface of the catheter assembly including an external surface of the Luer connector, or a combination thereof…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to provide an antimicrobial coating on the connector as disclosed by Ofek in order to predictably improve the device by reducing a risk of bacterial colonies that can migrate into the blood in parts of the assembly which are typically difficult for traditional antimicrobial treatments to reach (Paragraph 0069, 0078 of Ofek).
Regarding claim 13, Burkholz teaches a blood draw device (Paragraph 0006-0007-- an extension or introducer that may house an instrument, such as, for example, a probe or an intravenous catheter…the extension may include a blood collection device, which may be used to obtain a blood sample… may be used for needle-free blood collection and/or fluid infusion…; Figs. 2A-D; NOTE: this is the intended use of the device, and not given further patentable weight), the blood draw device comprising:
a housing (28) comprising a proximal end, a distal end, and a sidewall therebetween defining an interior (See annotated Fig. 2D, below), the housing comprising a connecter (30) at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly (Paragraph 0048-0049--the distal end of the housing 28 may include a coupling mechanism 30, which may couple the extension 10 with the catheter assembly 14. In some embodiments, the coupling mechanism 30 may be a luer fitting, such as, for example, a male luer fitting or a luer lock threaded collar…);
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a fluid conduit (12) displaceably received within the housing interior and having a proximal end (Paragraph 0055--the instrument 12 may include the proximal end and the distal tip 42) and a distal end (42), the fluid conduit comprising:
a first conduit portion at the proximal end of the fluid conduit (See annotated Fig. 2D); and
a second conduit portion (See annotated Fig. 2D) at the distal end of the fluid conduit, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly (Fig 2A shows a first position wherein the second conduit portion does not extend beyond the connector and thus does not extend beyond a distal end of a catheter connected to the connector) to a second, distal position in which the second conduit portion extends beyond the connector and/or beyond a distal end of a catheter of the intravenous catheter assembly (Fig. 2D--The second conduit portion may be advanced until it extends beyond the connector; Paragraph 0065-- the instrument 12 may be advanced to the distal position beyond a distal end of the sleeve 55 and/or the catheter 16).
However, Burkholz does not explicitly disclose wherein the connector is at least partially coated with an antimicrobial coating.
Ofek, in the same field of endeavor of a catheter assembly including an extension-leg portion and a hub, discloses wherein the connector is at least partially coated with an antimicrobial composition (Paragraph 0016, 0025, 0089-- the antimicrobial catheter assembly further includes at least one Luer connector connected to the extension leg. The antimicrobial coating is on the internal surface of the catheter assembly including an internal surface of the Luer connector in fluid communication with the fluid pathway, an external surface of the catheter assembly including an external surface of the Luer connector, or a combination thereof…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to provide an antimicrobial coating on the connector as disclosed by Ofek in order to predictably improve the device by reducing a risk of bacterial colonies that can migrate into the blood in parts of the assembly which are typically difficult for traditional antimicrobial treatments to reach (Paragraph 0069, 0078 of Ofek).
Regarding claim 21, Burkholz teaches a catheter system, comprising: a catheter assembly (catheter assembly 14) comprising:
a catheter adapter, comprising a distal end, a proximal end, a lumen extending between the distal end and the proximal end (Catheter adapter 20, having a distal and proximal end and a lumen extending therebetween; paragraph 0043--the catheter adapter 20 may include a distal end, a proximal end, and a lumen extending therebetween); and
a catheter secured to the catheter adapter and extending distally from the catheter adapter, wherein the catheter comprises a distal end and a proximal end (Catheter 16, having a distal end and a proximal end; paragraph 0043-- the catheter 16 may be secured within and extend distally from the catheter adapter 20); and
a blood draw device for withdrawing blood through an intravenous catheter assembly (Paragraph 0006-0007-- an extension or introducer that may house an instrument, such as, for example, a probe or an intravenous catheter…the extension may include a blood collection device, which may be used to obtain a blood sample… may be used for needle-free blood collection and/or fluid infusion…; Figs. 2A-D; NOTE: this is the intended use of the device, and not given further patentable weight), the blood draw device comprising:
a housing (28) comprising a proximal end, a distal end, and a sidewall therebetween defining an interior (See annotated Fig. 2D, below), the housing comprising a connecter (30) at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly (Paragraph 0048-0049--the distal end of the housing 28 may include a coupling mechanism 30, which may couple the extension 10 with the catheter assembly 14. In some embodiments, the coupling mechanism 30 may be a luer fitting, such as, for example, a male luer fitting or a luer lock threaded collar…);
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a fluid conduit (12) displaceably received within the housing interior and having a proximal end (Paragraph 0055--the instrument 12 may include the proximal end and the distal tip 42) and a distal end (42), the fluid conduit comprising:
a first conduit portion at the proximal end of the fluid conduit (See annotated Fig. 2D); and
a second conduit portion (See annotated Fig. 2D) at the distal end of the fluid conduit, wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter of the intravenous catheter assembly (Fig 2A shows a first position wherein the second conduit portion does not extend beyond the connector and thus does not extend beyond a distal end of a catheter connected to the connector) to a second, distal position in which the second conduit portion extends beyond the connector and/or beyond a distal end of a catheter of the intravenous catheter assembly (Fig. 2D--The second conduit portion may be advanced until it extends beyond the connector; Paragraph 0065-- the instrument 12 may be advanced to the distal position beyond a distal end of the sleeve 55 and/or the catheter 16).
However, Burkholz does not explicitly disclose at least a portion of the second conduit portion coated with an antimicrobial coating.
Ofek, in the same field of endeavor of a catheter assembly including an extension-leg portion and a hub, teaches at least a portion of the second conduit portion coated with an antimicrobial coating (Paragraph 0013, 0024, 0070, 0078, 0099-- the antimicrobial coating is on the internal surface of the catheter assembly including the extension-leg lumen defining the corresponding extension-leg portion of the fluid pathway through the catheter assembly).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to provide an antimicrobial coating on at least a portion of the second conduit portion as disclosed by Ofek in order to predictably improve the device by reducing a risk of bacterial colonies that can migrate into the blood in parts of the assembly which are typically difficult for traditional antimicrobial treatments to reach (Paragraph 0069, 0078 of Ofek).
Regarding claim 22, the combination of Burkholz and Ofek teaches the blood draw device of claim 21. Burkholz additionally teaches wherein the catheter assembly comprises a needleless access connector, and wherein the distal end of the blood draw device housing is reversibly coupleable to the needleless access connector (Coupler element 32; paragraph 0049-- the extension tube 22 of the catheter assembly 14 may include an adapter or coupler element 32, which may be coupled to the corresponding coupling mechanism 30 of the extension 10… the coupler element 32 may include a luer fitting…).
Claim(s) 6-8 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Ofek, further in view of Devgon (US 20170216564 A1).
Regarding claim 6, the combination of Burkholz and Ofek teaches the blood draw device of claim 1. Burkholz additionally teaches the connector may be any of a variety needle-free connections (Paragraph 0013, 0017, 0041, 0048-0049-- the coupler element may include a luer fitting and a removable or non-removable needle-free connector…the extension 10 may be used for needle-free blood collection).
However, the combination fails to explicitly disclose the connector comprises a plurality of arms configured to engage a needleless connector.
Devgon, in the same field of endeavor of a catheter assembly having a blood draw device, teaches a device having a connector which comprises a plurality of arms (Arms 243, 250; Figs. 13-15) configured to engage a needleless connector (Paragraph 0073-0078-- the lock 240 is configured to be physically and fluidically coupled to the introducer 210 and configured to couple the introducer 210 to the PIV and/or any suitable intermediate device or adapter coupled to the PIV. The lock 240 has a coupler 241, a proboscis 242, a first arm 243, and a second arm 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Burkholz by configuring the connector to have arms for engaging a needleless connector as taught by Devgon because this structure allows for easy locking engagement (see Devgon, paragraph 0073-0078).
Regarding claim 7, the combination of Burkholz, Ofek, and Devgon teaches the blood draw device of claim 6. Devgon further teaches the connector comprises a proboscis (242) configured to pierce a septum of the needleless connector (Paragraph 0073-0078-- the proboscis 242 can be sufficiently long to extend through the adapter and at least partially into or through the PIV…).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Burkholz by configuring the connector to have a proboscis as taught by Devgon in order to predictably improve the device by allowing it to cooperate with and provide structural support for the element to which it is attached simultaneously (Devgon, paragraph 0047-- the shape, size, and/or arrangement of the lock is such that the lock forms three points of contact with the PIV 105. In some embodiments, such an arrangement can provide structural rigidity and/or support to the PIV 105 as a portion of the lock (e.g., a proboscis or the like) is inserted into a portion of the PIV 105, as described in further detail herein).
Regarding claim 8, the combination of Burkholz, Ofek, and Devgon teaches the blood draw device of claim 7. Ofek additionally discloses the connector may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition upon modification of the device to use a connector described by Devgon(Paragraph 0016, 0025, 0089-- the antimicrobial catheter assembly further includes at least one Luer connector connected to the extension leg. The antimicrobial coating is on the internal surface of the catheter assembly including an internal surface of the Luer connector in fluid communication with the fluid pathway, an external surface of the catheter assembly including an external surface of the Luer connector, or a combination thereof…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to additionally provide an antimicrobial coating at least partially coating the proboscis as disclosed by Ofek in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (0059, 0078 of Ofek).
Regarding claim 14, the combination of Burkholz and Ofek teaches the blood draw device of claim 13. Burkholz additionally teaches the connector may be any of a variety needle-free connections (Paragraph 0013, 0017, 0041, 0048-0049-- the coupler element may include a luer fitting and a removable or non-removable needle-free connector…the extension 10 may be used for needle-free blood collection).
However, the combination fails to explicitly disclose the connector comprises a plurality of arms configured to engage a needleless connector.
Devgon, in the same field of endeavor of a catheter assembly having a blood draw device, teaches a device having a connector which comprises a plurality of arms (Arms 243, 250; Figs. 13-15) configured to engage a needleless connector (Paragraph 0073-0078-- the lock 240 is configured to be physically and fluidically coupled to the introducer 210 and configured to couple the introducer 210 to the PIV and/or any suitable intermediate device or adapter coupled to the PIV. The lock 240 has a coupler 241, a proboscis 242, a first arm 243, and a second arm 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Burkholz by configuring the connector to have arms for engaging a needleless connector as taught by Devgon because this structure allows for easy locking engagement (see Devgon, paragraph 0073-0078).
Regarding claim 15, the combination of Burkholz, Ofek, and Devgon teaches the blood draw device of claim 14. Devgon further teaches the connector comprises a proboscis (242) configured to pierce a septum of the needleless connector (Paragraph 0073-0078-- the proboscis 242 can be sufficiently long to extend through the adapter and at least partially into or through the PIV…).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Burkholz by configuring the connector to have a proboscis as taught by Devgon in order to predictably improve the device by allowing it to cooperate with and provide structural support for the element to which it is attached simultaneously (Devgon, paragraph 0047-- the shape, size, and/or arrangement of the lock is such that the lock forms three points of contact with the PIV 105. In some embodiments, such an arrangement can provide structural rigidity and/or support to the PIV 105 as a portion of the lock (e.g., a proboscis or the like) is inserted into a portion of the PIV 105, as described in further detail herein).
Regarding claim 16, the combination of Burkholz, Ofek, and Devgon teaches the blood draw device of claim 15. Ofek additionally discloses the connector may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition upon modification of the device to use a connector described by Devgon (Paragraph 0016, 0025, 0089-- the antimicrobial catheter assembly further includes at least one Luer connector connected to the extension leg. The antimicrobial coating is on the internal surface of the catheter assembly including an internal surface of the Luer connector in fluid communication with the fluid pathway, an external surface of the catheter assembly including an external surface of the Luer connector, or a combination thereof…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Burkholz to additionally provide an antimicrobial coating at least partially coating the proboscis as disclosed by Ofek in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0069, 0078 of Ofek).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5, 6-7, 8, 13-16, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, and 14-17 of copending Application No. 18/371,181 in view of Ofek (US 20200000972 A1, cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application teach all limitations of the instant claims except for an antimicrobial coating applied to a second conduit portion, whereas the reference application instead discloses an antithrombogenic composition generally present on at least a portion of the fluid conduit.
Ofek, in the same field of endeavor of a catheter assembly including an extension-leg portion and a hub, teaches at least a portion of the second conduit portion coated with an antimicrobial coating (Paragraph 0013, 0024, 0070, 0078, 0099-- the antimicrobial coating is on the internal surface of the catheter assembly including the extension-leg lumen defining the corresponding extension-leg portion of the fluid pathway through the catheter assembly).
Ofek additionally discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass coating the connector at least partially with the antimicrobial composition (Paragraph 0016, 0025, 0089-- the antimicrobial catheter assembly further includes at least one Luer connector connected to the extension leg. The antimicrobial coating is on the internal surface of the catheter assembly including an internal surface of the Luer connector in fluid communication with the fluid pathway, an external surface of the catheter assembly including an external surface of the Luer connector, or a combination thereof…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the reference application to provide an antimicrobial coating on at least a portion of the second conduit portion and connector as disclosed by Ofek in order to predictably improve the device by reducing a risk of bacterial colonies that can migrate into the blood in parts of the assembly which are typically difficult for traditional antimicrobial treatments to reach (Paragraph 0069, 0078 of Ofek).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 2-4, 9, 10-12, 17-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “wherein the antimicrobial coating is an antimicrobial lubricant”, “wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition”, “wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate”, or “wherein the antimicrobial coating is configured to release one or more antimicrobial compositions”.
The most pertinent prior art, Ofek (US 20200000972 A1) explicitly teaches away from the antimicrobial coating comprising chlorhexidine gluconate (Paragraph 0061) or being configured to release compositions (Paragraph 0078-0079). Ofek additionally implicitly teaches away from the antimicrobial coating being an antimicrobial lubricant or comprising silicone-based lubricant as it describes the material being a copper-based layer including corrosion-preventing layers which are all described as metal-based compositions (Paragraph 0020-0022, 0087) which are deposited during manufacturing in a method incompatible with a lubricant-comprising coating (Paragraph 0031, 0090). Ofek additionally teaches that application of traditional antimicrobial coatings (such as chlorhexidine) to a hub, connector, or extension lumen is typically difficult (Paragraph 0078, 0105) which further teaches away from any modification of the coating of Ofek to utilize an alternative antimicrobial composition such as chlorhexidine gluconate or diacetate.
Thiagarajan (US 20160287758 A1) similarly discloses an antimicrobial coating may be applied to an extension lumen of a catheter assembly but teaches away from the antimicrobial coating comprising chlorhexidine gluconate or being configured to release compositions.
While BD (US 20190167855 A1—previously cited) describes a catheter assembly including an antimicrobial coating which is an antimicrobial lubricant comprising chlorhexidine gluconate and chlorhexidine diacetate, BD does not fairly teach and/or suggest applying this coating to a second conduit or connector.
Response to Arguments
Applicant’s arguments, see pages 10-15 of the applicant's response, filed 20 July 2026, with respect to the rejection(s) of claim(s) 1-22 under 35 U.S.C. 103 in view of BD and Becton 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 Ofek as described above in this action and applied to claims 1, 5-8, 13-16, and 21-22.
Additionally, the annotated Fig. 2D of Burkholz has been included in the new rejection under 35 U.S.C. 103 and the double patenting rejections of the claims have been updated to reflect the changes.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791