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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-12 and 21-22 in the reply filed on 26 March 2026 is acknowledged. The traversal is on the ground(s) that there would be no search and/or examination burden. This is found persuasive because the same art described in detail in this action has been found to teach the limitations of both groups.
The requirement for restriction dated 1 December 2025 is withdrawn. Claims 1-22 are pending and examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 104.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities: "connecter" in paragraph 0024 should be -connector--.
Appropriate correction is required.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities:
Claim 1, line 4 “the connecter” should be “the connector”.
Claim 21, line 10 “the connecter” should be “the connector”.
Appropriate correction is required.
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) 1-2, 4-5, 12-13, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190021640 A1) in view of US 20190167855 A1 to Burkholz, henceforth referred to as BD.
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…);
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.
BD, in the same field of endeavor of a catheter assembly, discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass at least a portion of the second conduit portion being coated with an antimicrobial coating (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Regarding claim 2, the combination of Burkholz and BD teaches the blood draw device of claim 1. BD additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (antimicrobial lube 104; Paragraph 0011, 0028, 0033, 0042).
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 lubricant as an antimicrobial coating as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Regarding claim 4, the combination of Burkholz and BD teaches the blood draw device of claim 1. BD additionally teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0028-- the antimicrobial agent used to form the antimicrobial coating can be chlorhexidine including chlorhexidine diacetate (CHA) and/or chlorhexidine gluconate (CHG)).
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 utilize the particular antimicrobial composition of BD in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Regarding claim 5, the combination of Burkholz and BD teaches the blood draw device of claim 1. BD 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 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 connector as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0003-0004, 0011, 0042).
Regarding claim 12, the combination of Burkholz and BD teaches the blood draw device of claim 1. BD additionally wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
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 which releases one or more antimicrobial compositions as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway and surrounding area of the catheter system (Paragraph 0003-0004, 0011, 0042).
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…);
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.
BD, in the same field of endeavor of a catheter assembly, discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass at least a portion of the second conduit portion being coated with an antimicrobial coating (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 connector as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Regarding claim 20, the combination of Burkholz and BD teaches the blood draw device of claim 13. BD additionally wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
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 which releases one or more antimicrobial compositions as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway and surrounding area of the catheter system (Paragraph 0003-0004, 0011, 0042).
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…);
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.
BD, in the same field of endeavor of a catheter assembly, discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass at least a portion of the second conduit portion being coated with an antimicrobial coating (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Regarding claim 22, the combination of Burkholz and BD 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of BD, further in view of Ma (US 20170056639 A1).
Regarding claim 3, the combination of Burkholz and BD teaches the blood draw device of claim 2. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and BD to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Claim(s) 6-9 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of BD, further in view of Devgon (US 20170216564 A1).
Regarding claim 6, the combination of Burkholz and BD 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, BD, 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, BD, and Devgon teaches the blood draw device of claim 7. BD additionally discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0003-0004, 0011, 0042).
Regarding claim 9, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 8. BD additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (antimicrobial lube 104; Paragraph 0011, 0028, 0033, 0042).
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 lubricant as an antimicrobial coating as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Regarding claim 14, the combination of Burkholz and BD 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, BD, 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, BD, and Devgon teaches the blood draw device of claim 15. BD additionally discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0003-0004, 0011, 0042).
Regarding claim 17, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 18. BD additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (antimicrobial lube 104; Paragraph 0011, 0028, 0033, 0042).
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 lubricant as an antimicrobial coating as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0003-0004, 0011, 0042).
Claim(s) 10-11 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of BD, further in view of Devgon, further in view of Ma.
Regarding claim 10, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 9. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz, BD, and Devgon to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Regarding claim 11, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 10. BD additionally teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0028-- the antimicrobial agent used to form the antimicrobial coating can be chlorhexidine including chlorhexidine diacetate (CHA) and/or chlorhexidine gluconate (CHG)).
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 utilize the particular antimicrobial composition of BD in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Regarding claim 18, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 17. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz, BD, and Devgon to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Regarding claim 19, the combination of Burkholz, BD, and Devgon teaches the blood draw device of claim 18. BD additionally teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0028-- the antimicrobial agent used to form the antimicrobial coating can be chlorhexidine including chlorhexidine diacetate (CHA) and/or chlorhexidine gluconate (CHG)).
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 utilize the particular antimicrobial composition of BD in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Claim(s) 1-2, 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 US 20190022367 A1 to Burkholz, henceforth referred to as Becton.
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…);
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.
Becton, in the same field of endeavor of an instrument for use with a catheter assembly, discloses “any of the components of the catheter system, including any component of the introducer 42 and/or any component of the catheter assembly 10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant” (Paragraph 0067).
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 Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (See Becton, paragraph 0067).
Regarding claim 2, the combination of Burkholz and Becton teaches the blood draw device of claim 1. Becton additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (Paragraph 0067—antimicrobial lubricant).
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 lubricant as an antimicrobial coating as disclosed by Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Becton, paragraph 0067).
Regarding claim 5, the combination of Burkholz and Becton teaches the blood draw device of claim 1. Becton 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 0067).
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 connector as disclosed by Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0067).
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…);
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.
Becton, in the same field of endeavor of an instrument for use with a catheter assembly, discloses “any of the components of the catheter system, including any component of the introducer 42 and/or any component of the catheter assembly 10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant” (Paragraph 0067).
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 Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (See Becton, paragraph 0067).
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…);
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.
Becton, in the same field of endeavor of an instrument for use with a catheter assembly, discloses “any of the components of the catheter system, including any component of the introducer 42 and/or any component of the catheter assembly 10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant” (Paragraph 0067).
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 Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (See Becton, paragraph 0067).
Regarding claim 22, the combination of Burkholz and Becton 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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Becton, further in view of Ma.
Regarding claim 3, the combination of Burkholz and BD teaches the blood draw device of claim 2. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Regarding claim 4, the combination of Burkholz and Becton teaches the blood draw device of claim 1. While Becton teaches an antimicrobial coating, it does not explicitly disclose the antimicrobial coating is one or more of chlorhexidine gluconate and chlorhexidine diacetate.
Ma in the same field of endeavor of a catheter assembly having an antimicrobial coating, teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0039-0044, 0060-0064-- chlorhexidine gluconate…chlorhexidine diacetate…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to utilize the particular antimicrobial composition of Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Claim(s) 6-9 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Becton, further in view of Devgon (US 20170216564 A1).
Regarding claim 6, the combination of Burkholz and Becton 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, Becton, and Devgon teaches the blood draw device of claim 6.
Becton additionally teaches a connector comprises a proboscis (54) configured to pierce a septum of a needless connector (Septum 18; paragraphs 0068-0069).
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 Becton or 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, Becton, and Devgon teaches the blood draw device of claim 7. Becton additionally discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition (Paragraph 0067--any of the components of the catheter system, including any component of the introducer 42 and/or any component of the catheter assembly 10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant).
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 Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0067).
Regarding claim 9, the combination of Burkholz, Becton, and Devgon teaches the blood draw device of claim 8. Becton additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (paragraph 0067—antimicrobial lubricant).
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 lubricant as an antimicrobial coating as disclosed by Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0067).
Regarding claim 14, the combination of Burkholz and Becton 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, Becton, and Devgon teaches the blood draw device of claim 14.
Becton additionally teaches a connector comprises a proboscis (54) configured to pierce a septum of a needless connector (Septum 18; paragraphs 0068-0069).
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 Becton or 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, Becton, and Devgon teaches the blood draw device of claim 15. Becton additionally discloses any portion of the catheter assembly may include an antimicrobial coating, which would encompass coating the proboscis at least partially with the antimicrobial composition (Paragraph 0067--any of the components of the catheter system, including any component of the introducer 42 and/or any component of the catheter assembly 10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant).
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 Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system (Paragraph 0067).
Regarding claim 17, the combination of Burkholz, Becton, and Devgon teaches the blood draw device of claim 16. Becton additionally teaches wherein the antimicrobial coating is an antimicrobial lubricant (paragraph 0067—antimicrobial lubricant).
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 lubricant as an antimicrobial coating as disclosed by Becton in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and additionally provides lubrication to the device (Paragraph 0067).
Claim(s) 10-11 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Becton, further in view of Devgon, further in view of Ma.
Regarding claim 10, the combination of Burkholz, Becton, and Devgon teaches the blood draw device of claim 9. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz, Becton, and Devgon to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Regarding claim 11, the combination of Burkholz, Becton, Devgon, and Ma teaches the blood draw device of claim 10. While Becton teaches an antimicrobial composition, it does not explicitly disclose the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.
Ma in the same field of endeavor of a catheter assembly having an antimicrobial coating, teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0039-0044, 0060-0064-- chlorhexidine gluconate…chlorhexidine diacetate…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to utilize the particular antimicrobial composition of Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Regarding claim 18, the combination of Burkholz, Becton, and Devgon teaches the blood draw device of claim 17. However, the combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz, Becton, and Devgon to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
Regarding claim 19, the combination of Burkholz, Becton, and Devgon teaches the blood draw device of claim 18. While Becton teaches an antimicrobial composition, it does not explicitly disclose the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate.
Ma in the same field of endeavor of a catheter assembly having an antimicrobial coating, teaches wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0039-0044, 0060-0064-- chlorhexidine gluconate…chlorhexidine diacetate…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to utilize the particular antimicrobial composition of Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating where antimicrobial compounds are known in the art.
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Becton further in view of BD.
Regarding claim 12, the combination of Burkholz and Becton teaches the blood draw device of claim 1. While Becton teaches an antimicrobial composition, it does not explicitly disclose the antimicrobial coating is configured to release one or more antimicrobial compositions.
BD, in the same field of endeavor of a catheter assembly having an antimicrobial coating, additionally wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to additionally provide an antimicrobial coating which releases one or more antimicrobial compositions as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway and surrounding area of the catheter system (Paragraph 0003-0004, 0011, 0042).
Regarding claim 20, the combination of Burkholz and Becton teaches the blood draw device of claim 13. While Becton teaches an antimicrobial composition, it does not explicitly disclose the antimicrobial coating is configured to release one or more antimicrobial compositions.
BD, in the same field of endeavor of a catheter assembly having an antimicrobial coating, additionally wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Burkholz and Becton to additionally provide an antimicrobial coating which releases one or more antimicrobial compositions as disclosed by BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway and surrounding area of the catheter system (Paragraph 0003-0004, 0011, 0042).
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 1-2, 4-5, 6-7, 8-9, 12-17, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, and 14-17 of copending Application No. 18/371,181 in view of BD (US 20190167855 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, whereas the reference application instead discloses an antithrombogenic composition.
BD, in the same field of endeavor of a catheter assembly including a coating, teaches any portion of the catheter assembly may include an antimicrobial coating, which would encompass at least a portion of the second conduit portion (instant claim 1), the connector (instant claim 5 and 13), and the proboscis (instant claim 8) being at least partially coated with an antimicrobial coating (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…), wherein the antimicrobial coating is an antimicrobial lubricant (antimicrobial lube 104; Paragraph 0011, 0028, 0033, 0042), wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0028-- the antimicrobial agent used to form the antimicrobial coating can be chlorhexidine including chlorhexidine diacetate (CHA) and/or chlorhexidine gluconate (CHG)), wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and surrounding area and additionally providing lubrication to the device using compositions which are well-known and available in the art (Paragraph 0003-0004, 0011, 0042).
This is a provisional nonstatutory double patenting rejection.
Claims 3, 10-11, 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, and 14-17 of copending Application No. 18/371,181 in view of BD (US 20190167855 A1, cited above), further in view of Ma (US 20170056639 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, whereas the reference application instead discloses an antithrombogenic composition.
BD, in the same field of endeavor of a catheter assembly including a coating, teaches any portion of the catheter assembly may include an antimicrobial coating, which would encompass at least a portion of the second conduit portion (instant claim 1), the connector (instant claim 5 and 13), and the proboscis (instant claim 8) being at least partially coated with an antimicrobial coating (Paragraph 0011, 0028, 0033, 0042-- an antimicrobial lube 104 can be applied to any portion of the catheter that does not include the antimicrobial coating…), wherein the antimicrobial coating is an antimicrobial lubricant (antimicrobial lube 104; Paragraph 0011, 0028, 0033, 0042), wherein the antimicrobial composition is one or more of chlorhexidine gluconate and chlorhexidine diacetate (Paragraph 0028-- the antimicrobial agent used to form the antimicrobial coating can be chlorhexidine including chlorhexidine diacetate (CHA) and/or chlorhexidine gluconate (CHG)), wherein the antimicrobial coating is configured to release one or more antimicrobial compositions (Paragraph 0007, 0010, 0013, 0025, 0036, 0038, 0042-- The antimicrobial coating is applied to at least a portion of the catheter adapter and comprises a base material that releases one or more antimicrobial agents).
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 BD in order to predictably improve the device by reducing a risk of contamination of a fluid pathway of the catheter system and surrounding area and additionally providing lubrication to the device using compositions which are well-known and available in the art (Paragraph 0003-0004, 0011, 0042).
However, this combination fails to explicitly disclose wherein the antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition.
Ma, in the same field of endeavor of a catheter assembly device, teaches an antimicrobial lubricant comprises a silicone-based lubricant and an antimicrobial composition (Paragraph 0039-0044, 0060-0064-- lubricant 60 comprises a microbial agent…the antimicrobial lubricant 60 may include a silicone lubricant…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined reference application and BD to utilize aa silicone-based lubricant as described by Ma in order to predictably improve the system by reducing a risk of contamination of a fluid pathway of the catheter system via the antimicrobial coating and additionally reducing friction between components of the system via the lubricant which can improve the smooth use of the device and prevent damage to components (see Ma, paragraph 0011).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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