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Applicant elected Group I in the reply filed 5/8/2025 and, accordingly, the claims of Group II (claims 24,25) were withdrawn from consideration in the non-final Office Action dated 8/21/2025. At this time, the restriction requirement was deemed proper and, therefore, made FINAL.
Applicant’s remarks filed 11/13/2025 assert that the amendment to claim 1 (of Group I) render Groups I and II no longer restrictable from each other and requires rejoinder of claims 24 and 25 (of Group II). This is not persuasive for the following reasons: (1) Although claim 1 (of Group I) now requires “a catheter assembly comprising a catheter adapter and an intravenous catheter”, the method of Group II does not require the catheter assembly to include an intravenous catheter as required by Group I (instead, the method of Group II could be used with a urinary catheter, for example) and (2) the assembly of Group I could be used in a manner that does not require a “button” and a “spring” mechanism as required by Group II (instead, the device of Group I could be operated by manual rotation). Accordingly, the restriction between Groups I and II remains proper and claims 24 and 25 remain withdrawn from consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first embodiment of Lundquist et al. (US Pat 5,195,968).
Re claim 1, Lundquist et al. discloses a catheter traction system and a catheter assembly arrangement (Fig 35, wherein the controller 15 has the configuration of controller 410 of Fig 7-10; it is noted that all reference characters cited below refer to Fig 7-10 unless otherwise noted), the arrangement comprising: a catheter assembly 40+44 (Fig 35) comprising a catheter adapter 44 (Fig 35; Col 4, Lines 47-48) and an intravenous catheter 40 (Fig 35; Col 3, Lines 65-67 set forth that the catheter is an “angioplasty catheter” which is known in the art as being a type of intravenous catheter); and a catheter traction system (the entire mechanism seen Fig 7) for applying traction to the intravenous catheter (Col 8, Lines 10-29), the catheter traction system comprising: a rotary device 410; and an extension member 320+350+360+370+400 extending from the rotary device and configured to couple to a proximal end of the catheter adapter (as seen in Fig 35, all components of the arrangement are coupled to each other either directly or indirectly; in this instance, the extension member is indirectly coupled to the proximal end of the catheter adapter), wherein in response to activation of the rotary device, the extension member is configured to apply traction to the catheter assembly, to pull the intravenous catheter in a proximal direction (as seen in Fig 7 and described in Col 8, Lines 10-29).
Re claim 2, Lundquist discloses that the rotary device comprises: a base 420; a groove (within which shaft 550 resides in Fig 9); and a rotary element 450+540+550 comprising a peg 550, wherein the rotary element is configured to rotate with respect to the base (Col 8, Lines 10-14), wherein in response to the peg being forced into the groove, rotation of the rotary element with respect to the base is reduced (Col 9, Lines 11-17), and wherein, in response to rotation of the rotary element with respect to the base, the extension member is configured to apply traction to the catheter assembly (Col 8, Lines 10-14).
Re claim 3, Lundquist discloses that the groove is disposed within the base (as seen in Fig 9).
Re claim 4, Lundquist discloses that the groove is circular (as seen in Fig 7).
Re claim 7, Lundquist discloses that the groove is disposed within the base (as seen in Fig 9), wherein the rotary element comprises a disc-shaped body 540 (as seen in Fig 7), and wherein the peg extends downwardly from a bottom of the disc-shaped body (as seen in Fig 9).
Re claim 10, Lundquist discloses that the rotary device further comprises a lid 570 coupled to the base (as seen in Fig 9), wherein the rotary element comprises a neck portion 560 extending through the lid (as seen in Fig 9), and wherein the lid holds the peg in the groove (as seen in Fig 9; Col 9, Lines 3-4, 11-17).
Re claim 17, Lundquist discloses that the extension member is rigid (at ferrule 400).
Re claim 18, Lundquist discloses that the extension member is flexible (at wire 360).
Claims 1-3, 7, 17, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second embodiment of Lundquist et al. (US Pat 5,195,968).
Re claim 1, Lundquist et al. discloses a catheter traction system and a catheter assembly arrangement (Fig 35, wherein the controller 15 has the configuration of controller 1240 of Fig 18,19; it is noted that all reference characters cited below refer to Fig 18,19 unless otherwise noted), the arrangement comprising: a catheter assembly 40+44 (Fig 35) comprising a catheter adapter 44 (Fig 35; Col 4, Lines 47-48) and an intravenous catheter 40 (Fig 35; Col 3, Lines 65-67 set forth that the catheter is an “angioplasty catheter” which is known in the art as being a type of intravenous catheter); and a catheter traction system (the entire steering mechanism seen in Fig 18,19) for applying traction to the catheter (Col 12, Lines 65-68; Col 8, Lines 14-29), the catheter traction system comprising: a rotary device 1240; and an extension member 1285+1290+1300+350+400 (wherein 300+400 are shown in Fig 8; Col 12, Lines 44-46) extending from the rotary device and configured to couple to a proximal end of the catheter adapter (as seen in Fig 35, all component of the arrangement are coupled to each other either directly or indirectly; in this instance, the extension member is indirectly coupled to the proximal end of the catheter adapter), wherein in response to activation of the rotary device, the extension member is configured to apply traction to the catheter assembly, to pull the catheter in a proximal direction (as seen in Fig 7 and described in Col 8, Lines 14-29 and Col 12, Lines 65-68).
Re claim 2, Lundquist discloses that the rotary device comprises: a base 1270; a groove 1380; and a rotary element 1310+1410+1420 comprising a peg 1310, wherein the rotary element is configured to rotate with respect to the base (Col 12, Lines 65-68), wherein in response to the peg being forced into the groove, rotation of the rotary element with respect to the base is reduced (because the longitudinal length of the groove 1380 limits the degree to which the rotary element can rotate) and wherein, in response to rotation of the rotary element with respect to the base, the extension member is configured to apply traction to the catheter assembly (Col 12, Lines 65-68).
Re claim 3, Lundquist discloses that the groove is disposed within the base (as seen in Fig 18).
Re claim 7, Lundquist discloses that the groove is disposed within the base (as seen in Fig 18), wherein the rotary element comprises a disc-shaped body 1420, and wherein the peg extends downwardly from a bottom of the disc-shaped body (as seen in Fig 19).
Re claim 10, Lundquist discloses that the rotary device further comprises a lid 1260 coupled to the base (as seen in Fig 18), wherein the rotary element comprises a neck portion 1370+1450 extending through the lid (as seen in Fig 18,19), and wherein the lid holds the peg in the groove (Col 13, Lines 9-12).
Re claim 17, Lundquist discloses that the extension member is rigid (at ferrule 400).
Re claim 18, Lundquist discloses that the extension member is flexible (at wire 1290).
Re claim 20, Lundquist discloses that the rotary device comprises a cutaway portion 1320, wherein the cutaway portion comprises a sector (labeled in Fig A below, located distally to the channel) and a channel (labeled in Fig A below, located proximal to the sector), wherein the extension member is flexible and secured within the channel of the cutaway portion (Col 12, Lines 48-54), and wherein, in response to rotation of the rotary device, the extension member contacts an edge of the sector and applies traction to the catheter assembly (as seen in Fig 19).
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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.
Claims 1-3, 6, 7, 10, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (PG PUB 2014/0336573) in view of Lundquist et al. (US Pat 5,195,968).
Re claim 1, Yu discloses a catheter traction system and catheter assembly arragnement 10 (Fig 1-3; it is noted that all reference characters cited below refer to Fig 1-3 unless otherwise noted), the arrangement comprising: a catheter assembly 14+16 comprising a catheter adapter 16 (Para 32, “strain relief”) and a catheter 14; and a catheter traction system (all components shown in Fig 1-3 except for catheter assembly 14+16) for applying traction to the catheter (Para 31), the catheter traction system comprising: a rotary device (all components shown in Fig 2,3 except for extension member 30+32+34+36+40 and catheter shaft 14+16); and an extension member 30+34+36 extending from the rotary device and configured to couple to a proximal end of the catheter adapter (as seen in Fig 1, all component of the arrangement are coupled to each other either directly or indirectly; in this instance, the extension member is indirectly coupled to the proximal end of the catheter adapter), wherein, in response to activation of the rotary device, the extension member is configured to apply traction to the catheter assembly, to pull the catheter (Para 31,55). Although Yu discloses that the extension member applies traction to the catheter assembly to pull the catheter to cause it to deflect, Yu does not explicitly disclose that this deflection is in a proximal direction; additionally, Yu does not explicitly disclose that the catheter is an intravenous catheter.
Lundquist, however, teaches a substantially similar arrangement (seen in Fig 35 with the controller 410 of Fig 7 instead of controller 15) comprising a catheter assembly 40+44 (Fig 35) comprising an intravenous catheter 40 (Col 3, Lines 65-67 disclose that the catheter is an “angioplasty catheter” that is known in the art to be a type of intravenous catheter) and a catheter traction system (Fig 7-10) comprising a rotary device 410 (Fig 7) and an extension member 320+350+360+370+400 (Fig 8), wherein, in response to rotation of the rotary device (like how Yu’s rotary device is rotated), the extension member is configured to apply traction to the catheter assembly to pull the intravenous catheter in a proximal direction (as seen in Fig 7; Col 8, Lines 10-29). By utilizing an intravenous catheter that can be pulled in a proximal direction, the arrangement can be used to maneuver to a location in the vasculature (Col 3, Lines 55-57) where blood vessels are blocked or narrowed and open these vessels (which is what an angioplasty catheter is known in the art to be used for). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Yu to include the catheter as an intravenous catheter that, when deflected, is pulled in a proximal direction, as taught by Lundquist, or the purpose of maneuvering to a location in a vasculature where blood vessels are blocked or narrowed and open these vessels (Col 3, Lines 55-57 and 65-67).
Re claim 2, Yu discloses that the rotary device comprises: a base 20; a groove 52; and a rotary element (22+24 and all of the components sandwiched therebetween) comprising a peg 48, wherein the rotary element is configured to rotate with respect to the base (Para 31), wherein in response to the peg being forced into the groove, rotation of the rotary element with respect to the base is reduced (since rotation is limited by the longitudinal extend of groove 52), and wherein, in response to rotation of the rotary element with respect to the base, the extension member is configured to apply traction to the catheter assembly (Para 31)
Re claim 3, Yu discloses that the groove is disposed within the base (as seen in Fig 3).
Re claim 6, Yu discloses that the peg is disposed within the groove (Para 33), and wherein an outer portion of the groove is narrower than an inner portion of the groove to create an interference fit with the peg in response to the peg being forced into the groove (as seen in Fig 3, the end portions of the groove 50 are rounded and, therefore, these “outer portions” of the groove are narrower than an “inner portion” of the groove that lies between these rounded end portions).
Re claim 7, Yu discloses that the groove is disposed within the base (as seen in Fig 3), wherein the rotary element comprises a disc-shaped body (the portion of 22 from which pegs 46,48 directly extend), and wherein the peg extends downwardly from a bottom of the disc-shaped body (peg 48 is shown extending upward in Fig 3, but the device could be used such that actuator 22 lies above knob 24).
Re claim 10, Yu discloses that the rotary device further comprises a lid 18 coupled to the base (as seen in Fig 1), wherein the rotary element comprises a neck portion 66 extending through the lid (as seen in Fig 3, Para 43), and wherein the lid holds the peg in the groove (Para 34,43).
Re claim 17, Yu discloses that the extension member is rigid (at crimp 34).
Re claim 18, Yu discloses that the extension member is flexible (at fiber 36).
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments directed to the Yu reference:
The argument that Yu’s extension member is not “configured to couple to a proximal end of the catheter adapter” is not persuasive because all components are arrangement are coupled to each other either directly or indirectly. In this instance, the extension member is coupled to the proximal end of the catheter adapter indirectly due to the engagement of the catheter adapter 16 and the actuator 12. If Applicant desires for the extension member to be directly coupled to the proximal end of the catheter adapter, further amendments would be necessary.
The argument that Yu’s extension member is not “configured to […] pull the intravenous catheter in a proximal direction” is moot in view of the above rejection that utilizes Lundquist to teach that traction pulls the catheter in a proximal direction.
Regarding Applicant’s arguments directed to the first embodiment of the Lundquist reference:
The argument that Lundquist’s extension member is not “configured to couple to a proximal end of the catheter adapter” is not persuasive because all components are arrangement are coupled to each other either directly or indirectly. In this instance, the extension member is coupled to the proximal end of the catheter adapter indirectly due to the engagement between the catheter adapter 44 and the controller 15/410. If Applicant desires for the extension member to be directly coupled to the proximal end of the catheter adapter, further amendments would be necessary.
The argument that Lundquist’s extension member is not “configured to […] pull the intravenous catheter in a proximal direction” is not persuasive in light of Fig 7 and 8 that explicitly shows that traction applied by the extension member to the catheter assembly causes the distal end of the catheter to pulled in a proximal direction.
Regarding Applicant’s arguments directed to the second embodiment of the Lundquist reference:
The argument that Lundquist’s extension member is not “configured to couple to a proximal end of the catheter adapter” is not persuasive because all components are arrangement are coupled to each other either directly or indirectly. In this instance, the extension member is coupled to the proximal end of the catheter adapter indirectly due to the engagement between the catheter adapter 44 and the controller15/1240 . If Applicant desires for the extension member to be directly coupled to the proximal end of the catheter adapter, further amendments would be necessary.
The argument that Lundquist’s extension member is not “configured to […] pull the intravenous catheter in a proximal direction” is not persuasive in light of Fig 7 and 8 that explicitly shows that traction applied by the extension member to the catheter assembly causes the distal end of the catheter to pulled in a proximal direction.
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 examineer should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783