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 Amendments
The amendments overcome the previous claim objections.
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) 1-6, 8, 11-12, 16 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 4999210 A].
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 fluid conduit is configured to be antithrombogenic and the second conduit portion coated with an antithrombogenic composition.
However, Solomon teaches, in a catheter capable of use in a blood draw device [Col. 4 lines 3-8], wherein at least a portion of a fluid conduit is configured to be antithrombogenic, at least a portion of a fluid conduit is coated with an antithrombogenic composition [Col. 10 lines 47-58: “provide an ionically bonded heparin coating to both the inner and outer tubing surfaces, thus yielding a catheter tube with both antimicrobial and antithrombogenic properties,”].
The advantage of the conduit configured to be antithrombogenic is that this inhibits clot formation [Col. 1 lines 13-16] and allows fluid to flow freely by preventing blockage by debris such as clots. 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 coating the fluid conduit of Burkholz with an antithrombogenic composition as taught by Solomon in order to prevent blockage and provide antimicrobial properties.
Solomon teaches coating an entire conduit with an antithrombogenic composition. Thus, one of ordinary skill would reasonably be motivated, when applying the coating of Solomon to the invention of Burkholz, to apply the antithrombogenic to the entire fluid conduit of Burkholz, including the second conduit. Thus, one of ordinary skill would reasonably be apprised of the benefits of coating the second conduit as claimed.
Re. claim 2, Burkholz fails to teach the composition of the fluid conduit. However Solomon further teaches the fluid conduit comprises a polyurethane and/or a silicone material [polyurethane, Col. 3 lines 1-5]. 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 polyurethane as taught by Solomon because medical articles are frequently formed of polyurethane [Solomon Col. 1 lines 35-36] and thus this amounts to a simple substitution of one conduit material known in the art for another, with predictable results (polyurethane is known in the art as suitable for use in fluid conduits, as evidenced above).
Re. claim 3, Burkholz-Solomon teach the second conduit portion is coated with the antithrombogenic composition as set forth with respect to claim 1 above.
Re. claim 4, Solomon further teaches the antithrombogenic composition is heparin [Col. 10 lines 47-58]. 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 coating the fluid conduit of Burkholz with heparin as taught by Solomon in order to prevent blockage.
Re. claims 5-6, because the triblock polymer was not selected, these limitations are trivially met.
Re. claim 8, Burkholz fails to teach the antithrombogenic composition. However, Solomon further teaches at least a portion of a fluid conduit comprises the antithrombogenic composition [Col. 10 lines 47-58] The advantage of the conduit comprising an antithrombogenic composition is that this inhibits clot formation [Col. 1 lines 13-16] and allows fluid to flow freely by preventing blockage by debris such as clots (that is, it solves the problem of blockage recognized by Burkholz by inhibiting clot formation). 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 second fluid conduit of Burkholz to comprise an antithrombogenic composition as taught by Solomon in order to prevent blockage in the second fluid conduit.
Re. claim 11, Solomon further teaches the second conduit portion is coated, on an inner and outer surface thereof, with the antithrombogenic composition [heparin, Col. 10 lines 47-58]. 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 coating the inner and outer surface of the second conduit portion of the fluid conduit of Burkholz with an antithrombogenic composition as taught by Solomon in order to prevent blockage.
Re. claim 12, Solomon further teaches the entire fluid conduit comprises and/or is coated with the antithrombogenic composition [heparin, Col. 10 lines 47-58]. 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 entire fluid conduit of Burkholz to comprise/ be coated with an antithrombogenic composition as taught by Solomon in order to prevent blockage.
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 fluid conduit is configured to be antithrombogenic and the second conduit portion coated with an antithrombogenic composition.
However, Solomon teaches, in a catheter capable of use in a blood draw device [Col. 4 lines 3-8], wherein at least a portion of a fluid conduit is configured to be antithrombogenic, at least a portion of a fluid conduit is coated with an antithrombogenic composition [Col. 10 lines 47-58: “provide an ionically bonded heparin coating to both the inner and outer tubing surfaces, thus yielding a catheter tube with both antimicrobial and antithrombogenic properties,”].
The advantage of the conduit configured to be antithrombogenic is that this inhibits clot formation [Col. 1 lines 13-16] and allows fluid to flow freely by preventing blockage by debris such as clots. 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 coating the fluid conduit of Burkholz with an antithrombogenic composition as taught by Solomon in order to prevent blockage and provide antimicrobial properties.
Solomon teaches coating an entire conduit with an antithrombogenic composition. Thus, one of ordinary skill would reasonably be motivated, when applying the coating of Solomon to the invention of Burkholz, to apply the antithrombogenic to the entire fluid conduit of Burkholz, including the second conduit. Thus, one of ordinary skill would reasonably be apprised of the benefits of coating the second conduit as claimed.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Solomon, as applied to claim 3, and further in view of Wan et al. [US 2004/0048021 A1, hereinafter “Wan”].
Re. claim 7, the modified Burkholz teaches the device above including the composition comprising heparin but is silent regarding PEG and sulfate/sulfonate. However, Wan teaches a medical device comprising a composition of poly(ethylene glycol), one or more sulfate and/or sulfonate groups, and heparin [Par. 0011]. 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 forming the composition to include, in addition to heparin, PEG and a sulfate group as taught by Wan because this improves the compatibility of the device/material with human blood [Wan Par. 0011].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Solomon, as applied to claim 8, 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, 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 3/2/26 have been fully considered but they are not persuasive. The examiner agrees as previously stated that Burkholz fails to teach the antithrombogenic coating. In the Remarks, Applicant argues that Burkholz fails to teach the element 12 as being susceptible to clots. However, whether or not Burkholz finds this to be a problem, Solomon recognizes and addresses the advantage of preventing clotting (and also providing antimicrobial properties). The combination does not actually rely on Burkholz recognizing the problem of clotting and need not in order to be improved by the antithrombogenic coating.
Regarding the arguments re. claims 5-6, the examiner notes that the antithrombogenic composition need not comprise a triblock copolymer as that is but one of the options of claim 4. If the antithrombogenic composition does not comprise a triblock copolymer then it does not need to comprise on e of the specific compounds. For the sake of compact prosecution, the examiner notes that limiting the antithrombogenic compound to one of those in claims 5 or 6 is unlikely on its own to result in patentability.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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