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 .
Allowable Subject Matter
Claims 5-9, 16-19 are allowed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenreich (US 11090461) (Fig 1-2) in view of Ehrenreich (US 20180272107) (Fig 5-20)
Regarding Claim 1, Ehrenreich (Fig 1-2) discloses a blood draw device for use with a peripheral intravenous catheter (PVC) (abstract) comparing: a catheter (catheter 160, Fig. 1) having a proximal end (161, Fig. 1), a distal end (162, Fig. 1), and a sidewall therebetween defining a lumen (catheter 160 has a sidewall between 161 and 162 to define lumen 163, Col. 9, lines 15-18, Fig. 1); an introducer (110, Fig. 1} having a proximal end (111, Fig. 1), a distal end (112, Fig 1}, and a.sidewall therebetween defining an inner volume (introducer 110 has a sidewall between (111 and 112 defining inner volume 113, Fig. 1) configured to movably receive the catheter (inner volume 113 movably receives catheter 160, col. 9, lines 18-20, Fig, 1), the introducer (110) having a top surface (introducer 110 has a top surface near actuator 170, Fig. 1) and a bottom surface positioned opposite to the top surface (introducer 110 has a bottom surface near first portion 171 opposite the first surface, Fig. 1); and an actuator (170) movably coupled to the introducer (actuator 170 is movably coupled the introducer 110, Figs. 1-2), the actuator (170) is configured to move relative to the introducer (110) to move the catheter (160) between a first position (actuator 170 moves relative to introducer (110) to move catheter 160 between a first position and a second position, Col, 9, Lines. 22-25, Figs, 1-2), in which the distal end of the catheter is disposed within the introducer (at least the distal end portion 162 of the catheter 160 is disposed within the second portion 115 of the Inner volume 113 when the catheter 160 is in the first position”, Col. 9 lines. 26-29, Fig. 1), and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer ("at least a portion of the catheter 160 extends through the PV 105 to place a distal end of the catheter 160 in a distal position relative to a portion of the PIV 105 when the catheter 160 is in the second position", col. 9, lines 29-32, Fig. 2).
Ehrenreich (Fig 1-2) disclose all of the claimed limitations except wherein the introducer defines a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer, the groove is positioned within the inner volume of the introducer and closer to the bottom surface than the top surface, the groove is configured to receive and engage a portion of the catheter to prevent the catheter from bowing in an upward direction during use of the blood draw device. Ehrenreich (Fig 5-20) teaches wherein the introducer (210) defines a groove (226/234) extending in a direction extending from the proximal end of the introducer to the distal end of the introducer (paragraph 0080), the groove (226/234) is positioned within the inner volume of the introducer (Fig 6-7) and closer to the bottom surface than the top surface (Fig 6-7), the groove (226/234) is configured to receive and engage a portion of the catheter (260/265) to prevent the catheter from bowing in an upward direction during use of the blood draw device (paragraph 0080-0081, 0088) (Fig 6-7). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding 2, Ehrenreich discloses The blood draw device of claim 1, wherein the groove extends from the distal end of the introducer to the proximal end of the introducer (the outer surface of the introducer 110 can include grooves along which the tab, protrusion, and/or surface of the first portion 171 advances when the actuator 170 is moved relative to the introducer 110, col. 10, lines 58-62, Fig 1-2).
Regarding 3, Ehrenreich (Fig 1-2) discloses all of the claimed limitations except The blood draw device of claim 1, wherein the groove extends only a portion of a length extending from the distal end of the introducer to the proximal end of the introducer. Ehrenreich (Fig 5-20) teaches wherein the groove (226/234) extends only a portion of a length extending from the distal end of the introducer to the proximal end of the introducer (paragraph 0080-0081, 0088) (Fig 6-7). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding claim 4, Ehrenreich (Fig 1-2) discloses all of the claim limitations except wherein the groove is semi-spherical. Ehrenreich (Fig 5-20) teaches wherein the groove (226/234) is semi-spherical (Fig 6-7). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding claim 12, Ehrenreich discloses a blood draw device for use with a peripheral intravenous catheter (PIVC} (abstract, Figs. 1-2) comprising: a catheter (catheter 160, Fig. 1) having a proximal end (161, Fig. 1), a distal end {162, Fig. 1), and a sidewall therebetween defining a lumen (catheter 160 has a sidewall between 161 and 162 to define lumen 163, Col. 9, lines, 16-18, Fig. 1); an introducer {introducer 110, Fig. 1} having a proximal end (111, Fig. 1), a distal end (112, Fig. 1), and a sidewall therebetween defining an inner volume (introducer 110 has a sidewall between 111 and 112 defining Inner volume 113, Fig. 1) configured to movably receive the catheter (inner volume 113 movably receives catheter 160, col. 9, lines 18-20, Fig. 1), the introducer having a top surface (introducer 110 has a top surface near actuator 170, Fig. 1 and a Bottom surface positioned below the top surface (introducer 110 has a bottom surface near first portion 171 opposite the first surface, Fig. 1); and an actuator (170) movably coupled to the introducer (actuator 170 is movably coupled to introducer 110, Figs. 1-2), the actuator is configured to move relative to the introducer to move the catheter between a first position (actuator 170 moves relative to Introducer 110 to move catheter 160 between a first position and a second position, Col. 9, Lines. 22-25, Figs, 1-2), in which the distal and of the catheter is disposed within the introducer (“at least the distal and portion 162 of the catheter 160 is disposed within the second portion 115 of the inner Volume 113 when the catheter 160 Is In the first position, Col. 9, Lines 26-29, Fig, 1), and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer ("at least a portion of the catheter 160 extends through the PIV 105 to place a distal end of the catheter 160 in a distal position relative to a portion of the PIV 105 when the catheter 160 is in the second position”, Col. 9, lines 29-32, Fig. 2). Ehrenreich (Figs 1-2) discloses all of the claimed limitations except the actuator having a first portion disposed outside of the introducer and a second portion disposed in the inner volume of the introducer, the second portion of the actuator comprising a lower body positioned within the actuator space, wherein at least a portion of the actuator surface is curved to conform conforms to a top surface of the lower body of the second portion of the actuator, wherein the actuator surface is configured to engage the catheter during use such that the catheter remains within the actuator space as the catheter is advanced. Ehrenreich (Fig 5-20) teach the actuator (270) having a first portion disposed outside of the introducer (210) (engagement member 272 is disposed outside of the introducer 210) (paragraph 0112) (Fig 18) and a second portion disposed in the inner volume of the introducer (portion 275 of the actuator 270 is disposed within inner volume 213 defined by the introducer 210) (paragraph 0113) (Fig 19-20), the second portion (275) of the actuator comprising a lower body positioned within the actuator space (Fig 20), wherein at least a portion of the actuator surface is curved to conform to a top surface of the lower body of the second portion of the actuator (the actuator surface that defines the actuator space confirms to a top surface of portion 275 of actuator 270, Fig 20); wherein the actuator surface is configured to engage the catheter during use such that the catheter remains within the actuator space as the catheter is advanced (paragraph 0113) (“the catheter 260 and the second catheter 265 can be maintained in a fixed position relative to the actuator 270, and thus, move concurrently with the actuator 270 as the actuator 270 is moved relative to the introducer 210”). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding 13, Ehrenreich (Fig 1-2) discloses all of the claimed limitations except wherein the lower body of the second portion of the actuator is circular in cross-section, and wherein at least a portion of the actuator surface is curved to conform to the top surface of the lower body of the second portion of the actuator. Ehrenreich (Fig 3-20) teaches wherein the lower body of the second portion of the actuator is circular in cross-section (the lower body of portion 275 is circular in cross-section, Fig 20), and wherein at least a portion of the actuator surface is curved to conform to the top surface of the lower body of the second portion of the actuator (a portion of the actuator surface that defines actuator space is curved to conform to the top surface of the lower body of portion 275 of actuator 270, Fig 19-20). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding 14, Ehrenreich (Fig 1-2) discloses all of the claimed limitations except wherein the actuator surface extends at least 225 degrees around the lower body of the second portion of the actuator. Ehrenreich (Fig 3-20) teaches wherein the actuator surface extends at least 225 degrees around the lower body of the second portion of the actuator (the actuator surface that defines actuator space extends at least 225 degrees around the lower body of portion 275 of actuator 270, Fig 20). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Regarding 15, Ehrenreich discloses all of the claimed limitations except wherein the actuator surface extends at least 300 degrees around the lower body of the second portion of the actuator. Ehrenreich (Fig 3-20) teaches The blood draw device of claim 13, wherein the actuator surface extends at least 300 degrees around the lower body of the second portion of the actuator (the actuator surface that defines actuator space extends at least 300 degrees around the lower body of portion 275 of actuator 270, Fig 19-20). Therefore, it would have been obvious at the effective filing date of the invention to modify Ehrenreich (Fig 1-2) by Ehrenreich (Fig 5-20) for the purpose of allowing for easy transition of the transfer device from a first configuration to a second configuration to advance a catheter through an existing, placed, and/or indwelling PIV.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new grounds of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments regarding claims 5-9, 16-19 were found persuasive.
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.
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 YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791