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's election with traverse of Species A in the reply filed on 7/23/2025 is acknowledged. The traversal is on the grounds that no serious burden exists in examining the claims of Species A-F in a single application. Specifically, Applicant argues that examining of Species A will encounter subject matter of Species B-F regardless of the configuration of the passageway. Additionally, Applicant argues that if the Restriction Requirement among Species A-F is maintained, no serious burden exists for examining the claims of Species B and C along with the claims of Species A because Species A and B share a passageway aligned with a tubing path while Species A and C share an open slotted passageway. Neither of these arguments are found persuasive. Although the Examiner may agree with the Applicant that “any search and examination would include a fluid transfer device with an introducer, an actuator and a catheter support with a bracket portion and a hub portion”, this is not the complete search that would be required. Rather, each of the Species has a different structural configuration that results in a different result and each of these different structural configurations would need to be searched if not restricted. Additionally, although Species A and B may share a passageway aligned with a tubing path, Species A and B differ in the passageway being closed or open; therefore, the search of the open passageway of Species A may not necessarily encounter the closed passageway of Species B. Similarly, although Species A and C may share an open passageway, Species A and C differ in the vertical positioning of the passageway; therefore, the search of the aligned passageway of Species A may not necessarily encounter the offset passageway of Species C.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 4, 6, 8, 9, 14, 16 and 18-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
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, each of these claims recite “such that at least a first portion of the catheter may be disposed within the indwelling catheter” on line 9. The use of the phrase “may be” renders the claims indefinite since the term “may” expresses a possibility, not a definitive. In order to overcome this rejection, it is suggested to replace the phrase “may be” in each of these claims with the term “is”. Claims 2, 3, 5, 7, 10, 11, 13, 15 and 17 are rejected due to their dependence on claims 1 and 12.
Re claims 1 and 12, each of these claims recite “the catheter support defining a passageway therein that receives the catheter” on lines 12-13. This limitation positively recites the “catheter” which is only functionally recited in the rest of the claim. 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 a part of the claimed invention. In order to overcome this rejection, it is suggested to amend lines 12-13 to recite “the catheter support defining a passageway therein that is configured to receive the catheter”. Claims 2, 3, 5, 7, 10, 11, 13, 15 and 17 are rejected due to their dependence on claims 1 and 12.
Re claim 12, lines 16-20 recite “wherein the passageway comprises: a proximal opening and a distal opening; a slotted passageway extending between the proximal and distal openings”. It is unclear if this recitation is intended to recite that the passageway is a slotted passageway or that the passageway includes an additional passageway that is slotted. For the sake of examination, the former is the interpreted applied to the claims. Therefore, it is suggested to amend lines 16-20 to recite “wherein the passageway is a slotted passageway and comprises: a proximal opening and a distal opening; wherein the [[a]] slotted passageway extends between the proximal and distal openings”. Claims 13, 15 and 17 are rejected due to their dependence on claim 12.
Re claim 3, lines 1-5 recite “wherein the passageway comprises: a proximal opening and a distal opening; an open slotted passageway extending between the proximal and distal openings”. It is unclear if this recitation is intended to recite that the passageway is a slotted passageway or that the passageway includes an additional passageway that is slotted. For the sake of examination, the former is the interpretation applied to the claim. Therefore, it is suggested to amend claim 3 to recite “wherein the passageway is an open slotted passageway and comprises: a proximal opening and a distal opening; wherein the [[an]] open slotted passageway extends
Re claims 3 and 13, each of these claims recite “the catheter is encouraged to bow downward” on lines 9 and 7, respectively. This limitation positively recites the “catheter” which is only functionally recited in claims 1 and 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 lines 9 and 7, respectively, to recite “the open slotted passageway is configured to encourage the catheter
Re claims 5 and 15, each of these claims recite “a tubing path along which the length of the catheter extends” on lines 2-3. This limitation positively recites the “catheter” which is only functionally recited in claims 1 and 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 a part of the claimed invention. In order to overcome this rejection, it is suggested to amend lines 2-3 to recite “a tubing path along with the length of the catheter is configured to extend”.
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 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 may 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 resides in Fig 33,34) therein that receives 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); 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 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 may 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 resides in Fig 33,34) therein that receives 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); wherein the passageway comprises a proximal opening (facing right in Fig 33) and a distal opening (facing left in Fig 33), a slotted passageway extending 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 comprises: a proximal opening (to the right in Fig 33) and a distal opening (to the left in Fig 33); a slotted passageway extending between the proximal and distal openings (the passageway itself), 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 open 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 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 extends 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 open 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 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 extends 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 rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 7 could either not be found or was not suggested in the prior art of record. Claim 7 requires the fluid transfer device of claim 3 to allow the catheter to only bow downward at a location of the catheter support. As seen in Fig 33 and 34, Ehrenreich’s bowing is not at a location of the catheter support, but rather is distal to the catheter support. Although US Pat 10,806,901 to Burkholz discloses bowing down both distal to the catheter support and at a distal portion of the catheter support (as seen in Fig 5), the bowing is not limited to being only at a location of the catheter support. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ehrenreich to include the catheter support such that it is configured to allow downward bowing of the catheter only at a location of the catheter support as doing so would render Enrenreich inoperable for its intended purpose (since the catheter is intended to be held fixedly in position within the catheter support).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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