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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 7, 10-13, 15 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re claims 1 and 12, these claims have been amended to recite “the catheter support defining a passageway therein that is configured to receive the catheter to provide support to a length of the catheter that extends between the actuator and the distal end portion of the introducer, such that the catheter support is provided at a length of the catheter defining a first portion positioned between the distal end portion of the introducer and the catheter support and a second portion positioned between the catheter support and the actuator” on lines 12-17 and “the catheter support comprising a bracket portion and a hub portion, the hub portion defining a passageway therein that is configured to receive the catheter to provide support to a length of the catheter that extends between the actuator and the distal end portion of the introducer, such that the catheter support is provided at a length of the catheter defining a first portion positioned between the distal end portion of the introducer and the catheter support and a second portion positioned between the catheter support and the actuator” on lines 12-18, respectively.
The phrase “such that the catheter support is provided at a length of the catheter” in each of these passages positively recites the “catheter” which is only functionally recited earlier in the claims. Therefore, it is unclear if the “catheter” is intended to be a part of the claimed “fluid transfer device” or not. For the sake of examination, the catheter is not interpreted as being part of the claimed invention.
Additionally, reciting that the catheter support is (configured to be) provided at “a length of the catheter defining a first portion positioned between the distal end portion of the introducer and the catheter support and a second portion positioned between the catheter support and the actuator” renders the claim indefinite since it is unclear how the catheter support can be positioned at location that is “between” the distal end portion of the introducer and itself or at a location that is “between” the actuator and itself. This limitation is not recited in the Specification nor did Applicant’s remarks filed with the amendment explain what is meant by this amendment. At most, the Specification states that the catheter support is positioned within the introducer housing at a location between the actuator and the distal end of the housing (Para 5,7,12,17,22). For the sake of examination, this limitation is interpreted as not defining the position of the catheter support relative to the “first portion” and the “second portion” but, rather, requiring the catheter support to be configured to be positioned on the catheter between the actuator and the distal end of the housing and defining the catheter as having the “first portion” and the “second portion”.
Additionally, “a first portion” is introduced twice in each of claims 1 and 12 – first on line 9 of each of the claims and second on line 15 of claim 1 and line 16 of claim 12. It is unclear if the “first portion” of lines 15 and 16 is intended to be the same as or different than the “first portion” of line 9. for the sake of examination, they are interpreted as being the same.
In order to overcome all of the above rejections, it is suggested to amend this passage in each of claims 1 and 12 to recite “such that the catheter support is configured to be provided at a position on the catheter between the actuator and the distal end of the housing, wherein the catheter has a length defined by the first portion, which is positioned between the distal end portion of the introducer and the catheter support, and a second portion positioned between the catheter support and the actuator”.
Claims 2, 3, 5, 7, 10, 11, 13, 15 and 17 are rejected due to their dependence on claims 1 and 12.
Re claim 13, the claim recites “wherein the catheter is encouraged to bow down” on line 6. This limitation positively recites the “catheter” which is only functionally recited in claim 12. Therefore, it is unclear if the “catheter” is intended to be a part of the claimed “fluid transfer device’ or not. For the sake of examination, the catheter is not interpreted as being part of the claimed invention. In order to overcome this rejection, it is suggested to amend line 6 to recite “the open slotted passageway is configured to encourage the catheter It is noted that this rejection was set forth in the last Office Action, but the claim was not amended to overcome this rejection nor was this rejection argued in the 2/18/2026 reply.
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, 2, 10-12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehrenreich et al. (PG PUB 2018/0272107).
Re claim 1, Enrenreich discloses a fluid transfer device 300 (Fig 33; it is noted that all reference characters cited below refer to Fig 31-34 unless otherwise noted) for advancing a catheter into an indwelling catheter of a vascular access device (it is noted that the italicized text constitutes functional language and, therefore, “a catheter” and “a vascular access device” are not a part of the claimed invention; this limitation is met in view of catheter 360+365 and in view of Para 134 that discloses an indwelling PIV), the fluid transfer device comprising: an introducer 310 having a proximal end portion 311 and a distal end portion 312, the distal end portion coupleable to the vascular access device (as seen in Fig 33; Para 134), the introducer defining an inner volume 313 configured to movably receive the catheter (as seen in Fig 33); an actuator 371 movably coupled to the introducer and configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, such that at least a first portion 360 of the catheter is configured to be disposed within the indwelling catheter (Para 135); and a catheter support (the entirety of 370 minus actuator 371) movably coupled to the introducer (as seen in Fig 34, the introducer and the catheter support are integrally formed), and positioned between the actuator and the distal end portion of the introducer (as seen in Fig 33, nose 375 extends distally further than actuator 371 and, therefore, is between actuator 371 and the distal end portion 312), the catheter support defining a passageway (within which catheter 360+365 resides in Fig 33,34) therein that is configured to receive the catheter to provide support to a length of the catheter that extends between the actuator and the distal end portion of the introducer (as seen in Fig 33), such that the catheter support is configured to be provided at a position on the catheter between the actuator and the distal end of the housing (as explained above, because nose 375 extends distally further than actuator 371, the catheter support is provided between the actuator 371 and the distal end 312 of the housing), wherein the catheter has a length defined by the first portion, which is positioned between the distal end portion of the introducer and the catheter support (as seen in Fig 33), and a second portion 365 positioned between the catheter support and the actuator (as seen in Fig 33); wherein the passageway in the catheter support is configured to encourage a downward bowing of the catheter in the catheter support and/or pre-bias a downward bowing of the catheter (as seen in Fig 34; Para 138).
Re claim 2, Enrenreich discloses that the catheter support comprises a bracket portion (the portion of 370 extending between the actuator 371 and the hub portion 375) and a hub portion 375, the hub portion including a top surface (facing upward in Fig 34 and directly connected to the bracket portion) and a bottom surface (facing downward in Fig 34), with a center axis of the hub portion extending lengthwise between a proximal end and a distal end of the hub portion (as seen in Fig 33).
Re claim 10, Enrenreich discloses that the proximal end of the hub portion is configured to engage the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end to move the catheter support with respect to the introducer (because the hub portion and the actuator are integrally formed, as seen in Fig 17).
Re claim 11, Enrenreich discloses that the distal end portion of the introducer comprises a lock 340 configured to couple the introducer to the vascular access device (Para 134).
Re claim 12, Enrenreich discloses a fluid transfer device 300 (Fig 33; it is noted that all reference characters cited below refer to Fig 31-34 unless otherwise noted) for advancing a catheter into an indwelling catheter of a vascular access device (it is noted that the italicized text constitutes functional language and, therefore, “a catheter” and “a vascular access device” are not a part of the claimed invention; this limitation is met in view of catheter 360+365 and in view of Para 134 that discloses an indwelling PIV), the fluid transfer device comprising: an introducer 310 having a proximal end portion 311 and a distal end portion 312, the distal end portion coupleable to the vascular access device (as seen in Fig 33; Para 134), the introducer defining an inner volume 313 configured to movably receive the catheter (as seen in Fig 33); an actuator 371 movably coupled to the introducer and configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, such that at least a first portion of the catheter 360 is configured to be disposed within the indwelling catheter (Para 135); and a catheter support (the entirety of 370 minus actuator 371) movably coupled to the introducer (as seen in Fig 34, the introducer and the catheter support are integrally formed), and positioned between the actuator and the distal end portion of the introducer (as seen in Fig 33, nose 375 extends distally further than actuator 371 and, therefore, is between actuator 371 and the distal end portion 312), the catheter support comprising a bracket portion (the portion of 370 extending between the actuator 371 and the hub portion 375) and a hub portion 375, the hub portion defining a passageway (within which catheter 360+365 resides in Fig 33,34) therein that is configured to receive the catheter to provide support to a length of the catheter that extends between the actuator and the distal end portion of the introducer (as seen in Fig 33), such that the catheter support is configured to be provided at a position on the catheter between the actuator and the distal end of the housing (as explained above, because nose 375 extends distally further than actuator 371, the catheter support is provided between the actuator 371 and the distal end 312 of the housing), wherein the catheter has a length defined by the first portion, which is positioned between the distal end portion of the introducer and the catheter support (as seen in Fig 33), and a second portion 365 positioned between the catheter support and the actuator (as seen in Fig 33); wherein the passageway is a slotted passageway (as seen in Fig 34, wherein the lumen forming the passageway is considered to be a “slot” since a slot is defined as “a narrow opening or groove”1) and comprises: a proximal opening (facing right in Fig 33) and a distal opening (facing left in Fig 33); wherein the slotted passageway extends between the proximal and distal openings, the slotted passageway configured to encourage a downward bowing of the catheter within the slotted passageway (as seen in Fig 34; Para 138).
Re claim 17, Ehrenreich discloses that a proximal end of the catheter support is configured to engage the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end to move the catheter support with respect to the introducer (because the catheter support and the actuator are integrally formed, as seen in Fig 17).
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 3, 5, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenreich et al. (PG PUB 2018/0272107) in view of Auth (US Pat 4,829,999).
Re claim 3, Ehrenreich discloses that the passageway is an slotted passageway (as seen in Fig 34, wherein the lumen forming the passageway is considered to be a “slot” since a slot is defined as “a narrow opening or groove”2) and comprises: a proximal opening (to the right in Fig 33) and a distal opening (to the left in Fig 33); wherein the slotted passageway extends between the proximal and distal openings, the slotted passageway including: a top portion (facing upward in Fig 33) generally aligned with the distal opening (as seen in Fig 33,34); and a bottom portion (facing downward in Fig 33) vertically below the top portion (as seen in Fig 33,34); wherein the catheter is encouraged to bow downward within the slotted passageway, from the top portion down toward the bottom portion (as seen in Fig 33; it is noted that the language of the claim does not require the bowing to occur within the passageway, but rather requires the bowing to be encouraged by the passageway). Ehrenreich does not disclose that the slotted passageway is an “open” slotted passageway such that it is open along the bottom surface of the hub portion. Auth, however, teaches providing a catheter support 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) with a hub portion 12 with a slotted passageway 14 extending between a proximal opening (to the right in Fig 1) and a distal opening (to the left in Fig 1), wherein the slotted passageway is open along a bottom surface of the hub portion (when rotated 180 degrees from the view in Fig 2, the opening will be along a bottom surface of the hub portion) for the purpose of providing a means for inserting the tubular member within the hub portion (Col 1, Lines 56-58). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ehrenreich to include the slotted passageway such that it is open along the bottom surface of the hub portion, as taught by Auth, for the purpose of providing a means for inserting the catheter into the hub portion (Col 1, Lines 56-58).
Re claim 5, Ehrenreich discloses that the proximal opening, the distal opening, and the top portion are aligned with a tubing path along which the length of the catheter is configured to extend between the actuator and the distal end portion of the introducer (as seen in Fig 33).
Re claim 13, Ehrenreich discloses the slotted passageway including: a top portion (facing upward in Fig 33) generally aligned with the distal opening (as seen in Fig 33,34); and a bottom portion (facing downward in Fig 33) vertically below the top portion (as seen in Fig 33,34); wherein the catheter is encouraged to bow downward within the slotted passageway, from the top portion down toward the bottom portion (as seen in Fig 33; it is noted that the language of the claim does not require the bowing to occur within the passageway, but rather requires the bowing to be encouraged by the passageway). Ehrenreich does not disclose that the slotted passageway is an “open” slotted passageway such that it is open along the bottom surface of the hub portion. Auth, however, teaches providing a catheter support 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) with a hub portion 12 with a slotted passageway 14 extending between a proximal opening (to the right in Fig 1) and a distal opening (to the left in Fig 1), wherein the slotted passageway is open along a bottom surface of the hub portion (when rotated 180 degrees from the view in Fig 2, the opening will be along a bottom surface of the hub portion) for the purpose of providing a means for inserting the tubular member within the hub portion (Col 1, Lines 56-58). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ehrenreich to include the slotted passageway such that it is open along the bottom surface of the hub portion, as taught by Auth, for the purpose of providing a means for inserting the catheter into the hub portion (Col 1, Lines 56-58).
Re claim 15, Ehrenreich discloses that the proximal opening, the distal opening, and the top portion are aligned with a tubing path along which the length of the catheter is configured to extend between the actuator and the distal end portion of the introducer (as seen in Fig 33).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Because claim 7 was indicated as containing allowable subject matter in the last Office Action, please see the last Office Action for a detailed statement of reasons for the indication of allowable subject matter.
Response to Arguments
Applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive.
Applicant argues that Ehrenreich does not teach the amended subject matter of the independent claims. In the arguments, Applicant equates Ehrenreich’s item 370 to the claimed “catheter support”, but this is not the mapping set forth by the Examiner in the prior or current rejections. Rather, the prior and current rejections explicitly state that the “catheter support” is the “entirety of 370 minus actuator 371”. Because Applicant misinterprets the mapping of Ehrenreich onto the claim elements, their arguments are not 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.
Any inquiry concerning this communication or earlier communications from the examiner 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
1 “slot”. Merriam Webster Online Dictionary. <<http://www.merriam-webster.com/dictionary/slot>>
2 “slot”. Merriam Webster Online Dictionary. <<http://www.merriam-webster.com/dictionary/slot>>
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