Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/6/26 has been entered.
Claim Objections
Claims 1 and 16 are objected to because of the following informalities: these claims refer to both “a polymeric material” and “the polymer material.” The same language should be used throughout. 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, 8, 16, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. [US 2019/0021640 A1, hereinafter “Burkholz”] in view of Solomon et al. [US 4521564 A, hereinafter “Solomon ‘564,” newly cited].
Re. claim 1, Burkholz teaches a blood draw device [“blood collection device,” Par 0007, Figs. 2A-D] (“for withdrawing blood through an intravenous catheter assembly” is the intended use of the device, and not given further patentable weight; however, Burkholz’s device is capable of such use, see Par. 0007), the blood draw device comprising:
a housing [28] comprising a proximal end, a distal end, and a sidewall therebetween [Annotated Fig. 2A] defining an interior, the housing comprising a connecter [30] at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly [“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,” Par. 0048];
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a fluid conduit [12] displaceably received within the housing interior and having a proximal end [Par. 0055] and a distal end [42], the fluid conduit comprising:
a first conduit portion at the proximal end of the fluid conduit [Annotated Fig. 2D]; and
a second conduit portion [Annotated Fig. 2D] at the distal end of the fluid conduit,
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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. 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 extends beyond the connector. It may also extend beyond the catheter; see Par. 0065].
Burkholz fails to teach the material of the fluid conduit, the fluid conduit is configured to be antithrombogenic and the antithrombogenic composition integrated into the polymer material of the fluid conduit.
However, Solomon ‘564 teaches, in a fluid conduit [“cannula” or “catheter”] suitable for use in a blood draw device [Col. 1 lines 17-19], the fluid conduit comprising a polymeric material [“polyurethane polymer” Col. 1 lines 7-8], wherein at least a portion of the fluid conduit is configured to be antithrombogenic [Col. 2 lines 12-14], wherein an antithrombogenic composition is integrated into the polymer material of the fluid conduit [Col. 2 lines 18-27].
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 forming the fluid conduit to comprise a polymeric material (polyurethane) as taught by Solomon because polyurethane is known as having suitable properties for medical devices (see Previously cited Solomon reference Col. 1 lines 35-36) and thus this amounts to a simple substitution of one medical conduit material known in the art for another (the original unspecified material of Burkholz), with predictable results.
The advantage of the conduit being configured to be antithrombogenic is that this inhibits clot formation [Col. 1 lines 20-31] and allows fluid to flow freely by preventing blockage by debris such as clots. Further, forming the antithrombogenic composition to be integrated into the polymer material of the conduit allows the device to “retain[] its antithrombogenic agent in a permanent and non-leachable fashion when in contact with blood” [Solomon 564 Col. 2 lines 12-14]. Thus, 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 forming at least a portion of the fluid conduit of Burkholz with an antithrombogenic composition as taught by Solomon in order to prevent blockage by clot formation, and specifically to integrate the antithrombogenic composition into the polymer of the conduit in order to allow the device to permanently retain this antithrombogenic quality.
Re. claim 2, as set forth with respect to claim 1 above, Solomon ‘564 teaches the polymeric material of the fluid conduit comprising polyurethane.
Re. claim 8, Burkholz fails to teach the antithrombogenic composition. However, Solomon ‘564 further teaches the antithrombogenic composition is included as a moiety in a polymeric backbone and/or as a pendant group of the polymeric material of the fluid conduit [a moiety in a polymeric backbone, Col. 6 lines 21-39 and Col. 7 Fig. (G)] 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 to configured the antithrombogenic composition is included as a moiety in a polymeric backbone in order to allow the device to permanently retain this antithrombogenic quality [see claim 1 above].
Re. claim 16, Burkholz discloses a catheter system [Fig. 1A], comprising:
a catheter assembly [14] comprising:
a catheter adapter [20], comprising a distal end [that connected to catheter 16], a proximal end [in the vicinity of 26], a lumen extending between the distal end and the proximal end [Par. 0043]; and
a catheter [16] secured to the catheter adapter and extending distally from the catheter adapter, wherein the catheter comprises a distal end [18] and a proximal end [opposite 18]; and
a blood draw device [“blood collection device,” Par 0007, Figs. 2A-D] comprising:
a housing [28] comprising a proximal end, a distal end, and a sidewall therebetween [Annotated Fig. 2A] defining an interior, the housing comprising a connecter [30] at the distal end thereof for reversibly connecting the blood draw device to the intravenous catheter assembly [“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,” Par. 0048];
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a fluid conduit [12] displaceably received within the housing interior and having a proximal end [Par. 0055] and a distal end [42], the fluid conduit comprising:
a first conduit portion at the proximal end of the fluid conduit [Annotated Fig. 2D]; and
a second conduit portion [Annotated Fig. 2D] at the distal end of the fluid conduit,
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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. 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 extends beyond the connector. It may also extend beyond the catheter; see Par. 0065].
Burkholz fails to teach the material of the fluid conduit, the fluid conduit is configured to be antithrombogenic and the antithrombogenic composition integrated into the polymer material of the fluid conduit.
However, Solomon ‘564 teaches, in a fluid conduit [“cannula” or “catheter”] suitable for use in a blood draw device [Col. 1 lines 17-19], the fluid conduit comprising a polymeric material [“polyurethane polymer” Col. 1 lines 7-8], wherein at least a portion of the fluid conduit is configured to be antithrombogenic [Col. 2 lines 12-14], wherein an antithrombogenic composition is integrated into the polymer material of the fluid conduit [Col. 2 lines 18-27].
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 forming the fluid conduit to comprise a polymeric material (polyurethane) as taught by Solomon because polyurethane is known as having suitable properties for medical devices (see Previously cited Solomon reference Col. 1 lines 35-36) and thus this amounts to a simple substitution of one medical conduit material known in the art for another (the original unspecified material of Burkholz), with predictable results.
The advantage of the conduit being configured to be antithrombogenic is that this inhibits clot formation [Col. 1 lines 20-31] and allows fluid to flow freely by preventing blockage by debris such as clots. Further, forming the antithrombogenic composition to be integrated into the polymer material of the conduit allows the device to “retain[] its antithrombogenic agent in a permanent and non-leachable fashion when in contact with blood” [Solomon 564 Col. 2 lines 12-14]. Thus, 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 forming at least a portion of the fluid conduit of Burkholz with an antithrombogenic composition as taught by Solomon in order to prevent blockage by clot formation, and specifically to integrate the antithrombogenic composition into the polymer of the conduit in order to allow the device to permanently retain this antithrombogenic quality.
Re. claim 18, the modified Burkholz teaches the device as set forth with respect to claims 2 and 16 above.
Re. claim 19, the modified Burkholz teaches the device as set forth with respect to claim 8 above.
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Solomon ‘564, as applied to claim 8 or 19 above, and further in view of Unger [US 2007/0185009 A1].
Re. claim 9, the modified Burkholz teaches the device above but fails to disclose the claimed moieties. However, Unger teaches, in a coated medical device (catheter), an antithrombogenic [Par. 007, 0019] composition comprises a fluoro-containing moiety, a silicone moiety, and/or a poly(ethylene glycol)-containing moiety [PEG moiety, Par. 0026]. 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 the modified Burkholz by configuring the composition to include a PEG containing moiety as taught by Unger because this allows a composition to readily attach to a substrate [Par. 0029] and thus amounts to a simple substitution of one manner of attaching an active component to a substrate known in the art for another.
Claim(s) 14-15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Solomon ‘564, as applied to claim 1, and further in view of Devgon et al. [US 10300247 B2, hereinafter “Devgon”].
Re. claim 14, Burkholz teaches the device being used for needle-free connection [Par. 0041] but fails to disclose the details of the connection. However, Devgon teaches a blood draw device having a housing, wherein the connector comprises a plurality of arms [243, 250; Figs 13-15] configured to engage a needleless connector [via proboscis 242. Note the needleless connector is not itself positively recited.] 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 [Devgon Col. 16 lines 28-46].
Re. claim 15. Devgon further teaches the connector comprises a proboscis [242]configured to pierce a septum of the needleless connector [Col. 15 lines 25-55. Note that the septum of the needleless connector is not positively recited]. 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 because this allows for the device to cooperate with and be in contact/provide structural support for the element to which it is attached [Devgon col 15 lines 35-50].
Re. claim 17, Burkholz teaches the device being used for needle-free connection [Par. 0041] but fails to disclose the details of the connection.. Devgon teaches a catheter assembly comprises a needleless access connector [105, Fig. 2], and wherein the distal end of the blood draw device housing is reversibly coupleable to the needleless access connector [via 240, which may be locked or unlocked by manipulating the arms; Col. 16 lines 28-46]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of the modified Burkholz by adding a needleless access connector as taught by Devgon in order to allow the device to be used in a more efficient, less painful and labor intensive process [Col. 1 lines 13-30].
Response to Arguments
Applicant's arguments filed 7/6/26 have been fully considered but they are not persuasive. The examiner agrees as previously stated that Burkholz fails to teach the antithrombogenic agent, and furthermore agrees that previously cited Solomon fails to teach the amended feature of the antithrombogenic composition being integrated into the polymer material of the fluid conduit. However, Solomon ‘564 has been introduced to teach said antithrombogenic composition being integrated into a polymer material of a fluid conduit.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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