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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/03/25, 01/26/26, and 02/10/26 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
The amendment filed 01/05/26 has been entered. Claims 1-6, have been amended. Claims 21-27 are in the original/ previously presented form. Claims 11 and 15 are withdrawn. Claims 7-10, 12-14, and 16-20 are cancelled. Thus, claims 1-6 and 21-27 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 09/04/25.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson et al. (U.S. PGPUB No. 2019/0069973), hereinafter Isaacson.
Regarding claim 1, Isaacson discloses a catheter system, comprising:
an outer catheter adapter (12, see FIG. 6 and [0026]: outer catheter 22 operatively coupled to hub 12) configured for placement external to a vasculature of a patient (see [0033-0034]: locking collar 72 is actuatable on hub 12 and therefore the hub 12 must be configured for placement external to a vasculature to enable user actuation), the outer catheter adapter (12) comprising a distal end and a proximal end (see ‘Modified FIG. 6’ below);
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an outer catheter (22), comprising a distal end (24, see [0026]) configured for placement within the vasculature of the patient (see [0028]: assembly including inner and outer catheter placed in a vessel), a proximal end (26, see [0026]), an outer catheter lumen (30) extending through the distal end of the outer catheter and the proximal end of the outer catheter (see [0026]: lumen 30 extends from distal to proximal end of catheter 22), and an inner surface (see inner surface of catheter wall in cross-sectional view of FIG. 6) forming the outer catheter lumen (30), wherein the proximal end (26) of the outer catheter (22) is connected to (see [0026] and additionally, FIG. 3, for visual clarity) the outer catheter adapter (12) and extends distally from the distal end (see ‘Modified FIG. 6’ above) of the outer catheter adapter (12), and the distal end (24) of the outer catheter (22) comprises a distal opening (see [0028]: distal end opening as shown in FIG.4, houses inner catheter 42 for selectively opening a fluid flow path 54);
an inner catheter adapter (46), comprising a distal end, a proximal end, and an inner catheter lumen (52) extending through (see [0027]: channel 52 provides fluid communication with lumen 30 and extends proximally to central passage 14, the proximal-most structure in FIG. 6. Therefore, the inner catheter lumen extends through the entire inner catheter adapter from proximal to distal end) the distal end of the inner catheter adapter (46) and to the proximal end of the inner catheter adapter (46); and
an inner catheter (40) comprising a distal end (42, see [0027]) configured for placement within the vasculature (see [0028]: distal end 42 for providing fluid communication with vessel of patient), the inner catheter (40) connected to (see [0027]: 40 extends proximally to 46/48/50 which form channel 52. Therefore, the structures are connected) the inner catheter lumen (52) of the inner catheter adapter (46) and extending distally from the distal end (see ‘Modified FIG. 6’ above) of the inner catheter adapter (46),
wherein the inner catheter adapter (46) is contained within (as seen in ‘Modified FIG. 6’ above) the outer catheter adapter (12), the inner catheter (40) is disposed within the outer catheter lumen (30, see FIG. 6 and [0029]: obturator assembly extends through lumen 30), the inner catheter (40) is movable with respect to the outer catheter (22) between an inner catheter proximal position (see FIG. 6 with tip 42 contained within outer catheter and [0029]: distal tip 42 of obturator positioned within fluid path) and an inner catheter distal position (see FIG. 7 and [0029]: inner catheter 40 is moved distally until distal end 42 extends distally from lumen 30), and the inner catheter adapter (46) is movable within the outer catheter adapter (12) between an inner catheter adapter proximal position (see position of inner catheter adapter 46 in FIG. 6) and an inner catheter adapter distal position (see position of inner catheter adapter 46 in FIG. 7).
Regarding claim 2, Isaacson discloses the catheter system of claim 1, and Isaacson further discloses wherein in response to the inner catheter (40, see FIG. 7) being in the inner catheter distal position (see FIG. 7) and the inner catheter adapter (46) being in the inner catheter (see inner catheter adapter position in FIG. 7) and inner catheter adapter (see inner catheter adapter position in FIG. 7) distal positions (see FIG. 7), the distal end (42) of the inner catheter (40) is disposed distal to the distal end (see FIG. 7 and [0029]: inner catheter 40 is moved distally until distal end 42 extends distally from lumen 30) of the outer catheter (22).
Regarding claim 4, Isaacson discloses the catheter system of claim 1, and Isaacson further discloses wherein the inner catheter adapter (46, see FIG. 6) is slidable (see [0029]: inner catheter is pushed/pulled==slidable at the inner catheter adapter 46, see FIG.6, to move the inner catheter distally and proximally) relative to the outer catheter adapter (12) to move the inner catheter adapter (46) and the inner catheter (40) between the inner catheter adapter and inner catheter proximal positions (see inner catheter adapter 46 and inner catheter 40 proximal positions in FIG. 6) and the inner catheter adapter and inner catheter distal positions (see inner catheter adapter 46 and inner catheter 40 distal positions in FIG. 7).
Regarding claim 27, Isaacson discloses the catheter system of claim 1, and Isaacson further discloses wherein at least one seal (56, see FIG. 6 and [0030]: O-ring seals 56) is disposed between (see FIG. 6) the outer catheter adapter (12) and the inner catheter adapter (46) to seal a fluid path between (see [0030]: O-ring seals 56 positioned on outer periphery of inner catheter adapter to provide fluid-tight seal) the outer catheter adapter (12) and the inner catheter adapter (46).
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wisman (U.S. PGPUB No. 2020/0094025).
Regarding claim 1, Wisman discloses a catheter system, comprising:
an outer catheter adapter (12 & 22, see FIG.1, [0051] & [0053]. ‘Modified FIG. 1’ provided below for ease of reference)
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configured for placement external to a vasculature of a patient (see [0050]), the outer catheter adapter (12 & 22) comprising a distal end (32) and a proximal end (60);
an outer catheter (14, see [0056]), comprising a distal end (40) configured for placement within the vasculature of the patient (see [0052]: 14 advanced into vasculature), a proximal end (38), an outer catheter lumen (42, see FIG. 2 and [0056]) extending through (see [0063]) the distal end (40) of the outer catheter (14) and the proximal end (38) of the outer catheter (14), and an inner surface (see [0056]) forming the outer catheter lumen (42), wherein the proximal end (38) of the outer catheter (14) is connected to (see [0057]) the outer catheter adapter (12 & 22) and extends distally (leftward in FIG.1) from the distal end (32) of the outer catheter adapter (12 & 22), and the distal end (40) of the outer catheter (14) comprises a distal opening (see [0063]: dilator extends through entire sheath 14 and out distal end such as shown in FIG.1);
an inner catheter adapter (intermediary structure such as tube, see [0066] and ‘Modified FIG. 3’ below),
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comprising a distal end (tube as in [0066] inherently has distal end), a proximal end (tube as in [0066] inherently has proximal end), and an inner catheter lumen extending through the distal end of the inner catheter adapter and to the proximal end of the inner catheter adapter (see [0066]: guidewire housed within tube and therefore a lumen of the tube must extend throughout entirety of tube from distal to proximal end of the inner catheter adapter); and
an inner catheter (56, see FIG. 5) comprising a distal end (distal end seen in FIG. 5) configured for placement within the vasculature (see [0082-0083]), the inner catheter (56) connected to the inner catheter lumen of the inner catheter adapter and extending distally from the distal end of the inner catheter adapter (see [0066]),
wherein the inner catheter adapter (intermediary structure such as tube, see [0066]) is contained within (such as shown in ‘Modified FIG. 1’ and ‘Modified FIG. 3’ above, see also [0070]) the outer catheter adapter (12 & 22), the inner catheter (56) is disposed within (see FIG. 5 and [0085]: 56 coaxially deployed through needle and dilator and therefore circumferentially within lumen 42) the outer catheter lumen (42), the inner catheter (56) is movable with respect to the outer catheter (14) between an inner catheter proximal position (see FIG. 4 and [0082]) and an inner catheter distal position (see FIG. 5 and [0083] and [0074]: guidewire can be locked in place), and the inner catheter adapter (see [0066] and ‘Modified FIG. 3’ above) is movable within the outer catheter adapter (12&22) between an inner catheter adapter proximal position (proximal end 72 of slot 66, see [0070] and [0073]) and an inner catheter adapter distal position (distal end 74 of slot 66, see [0070] and [0073]).
Regarding claim 4, Wisman discloses the catheter system of claim 1, and Wisman further discloses wherein the inner catheter adapter (intermediary structure such as tube, see [0066] and ‘Modified FIG. 3’ above) is slidable (see [0066]: inner catheter adapter attached to slidable actuator 24 by tube and [0070]: 24 slidable) relative to the outer catheter adapter (12 & 22) to move the inner catheter adapter (intermediary structure such as tube, see [0066]) and the inner catheter (56) between the inner catheter adapter (proximal end 72 of slot 66, see [0070] and [0073]) and inner catheter proximal positions (see FIG. 4 and [0082]) and the inner catheter adapter (distal end 74 of slot 66, see [0070] and [0073]) and inner catheter distal positions (see FIG. 5 and [0083] and [0074]: guidewire can be locked in place).
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.
Claims 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (U.S. PGPUB No. 2019/0069973).
Regarding claim 3, Isaacson discloses the catheter system of claim 1, and Isaacson discloses further comprising a gap (54, see FIG. 7 and FIG. 4) disposed between an outer surface (see ‘Modified FIG. 4’ below) of the inner catheter (40) and the inner surface (see ‘Modified FIG. 4’ below) of the outer catheter (22),
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wherein when the inner catheter (40) is in the inner catheter distal position (see FIG. 7) and the inner catheter adapter (46) is in the inner catheter adapter distal position (as seen in FIG. 7), the inner catheter (40) is disposed within the distal opening (see opening at distal end of outer catheter in Fig. 4) of the outer catheter (22) and allows flow distally into the gap (see FIG. 4 where fluid can move in==proximally or out==distally of gap and [0028]), and in response to movement (selective movement described in [0029]) of the inner catheter (40) from the inner catheter distal position (as seen in FIG. 7) to the inner catheter proximal position (as seen in FIG. 6), the inner catheter (40) is disposed proximal (see [0028-0029]: in proximal position, inner catheter is at least partially disposed within lumen. [0029]: obturator 40 can be pulled proximally toward hub a suitable distance to provide fluid path) to the distal opening (see opening of distal end of catheter 22 in at least FIG.4) of the outer catheter (22) and the gap (54) is in fluid communication with the distal opening (see [0029]: fluid path can be formed while inner catheter is in a proximal position when pulled ‘a suitable distance’) of the outer catheter (22).
Isaacson (in the embodiment of FIGs. 6-8) is silent to when the inner catheter and the inner catheter adapter are in the inner catheter and the inner catheter adapter distal positions, the inner catheter is disposed within the distal opening of the outer catheter and “restricts flow” distally into the gap.
However, Isaacson teaches that, in other embodiments, the inner catheter distal end (42, see FIG. 4 & FIG. 7) may have ANY suitable profile configuration (see [0031]: any suitable configuration, such as asymmetric/ other geometric configurations and [0032]: different profiles for obtaining certain cross-sectional areas of the fluid path).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the profile of the distal end of the inner catheter disclosed in the first embodiment of Isaacson such that fluid flow is restricted when the inner catheter is positioned at the inner catheter distal position as taught by other embodiments of Isaacson for the purpose of providing a specific fluid flow profile best suited for the administration or drawing of fluids through the catheter assembly (see [0031-0032]), thus achieving when the inner catheter and the inner catheter adapter are in the inner catheter and the inner catheter adapter distal positions, the inner catheter is disposed within the distal opening of the outer catheter and “restricts flow” distally into the gap.
Regarding claim 21, the modified system of Isaacson teaches the catheter system of claim 3, and Isaacson further discloses wherein a diameter of the outer catheter lumen (see ‘Modified FIG. 4i’ below)
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tapers at the distal end (24) of the outer catheter (22), such that the diameter of the outer catheter lumen at the distal end of the outer catheter is reduced (see ‘Modified FIG. 4i’ above).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson as applied to claim 1 above, and further in view Breindel et al. (U.S. PGPUB No. 2020/0230368), hereinafter Breindel.
Regarding claim 26, Isaacson discloses the catheter system of claim 1, but Isaacson is silent to “further comprising an extension tube in fluid communication with the inner catheter lumen, and extending through a slot in the outer catheter adapter.”
However, Breindel teaches a catheter system (100, see FIG. 1a) with an inner catheter adapter (310 housing needle 302, see [0021]: needle hub 310) for an inner catheter (302) and an outer catheter adapter (204) for an outer catheter (208), further comprising an extension tube (205) in fluid communication with an inner catheter lumen (see [0018]: side port fluidly coupled into catheter hub which includes hub 310), and extending through a slot (214, see FIG. 2) in the outer catheter adapter (204, see [0018]: side port 214 extends through hub 204).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer catheter adapter disclosed in Isaacson to include an extension tube extending through a slot and in fluid communication with the inner catheter lumen as taught by Breindel for the purpose of providing a fluid pathway for an IV fluid supply (see [0018]), thus achieving “further comprising an extension tube in fluid communication with the inner catheter lumen, and extending through a slot in the outer catheter adapter”
Allowable Subject Matter
Claims 5-6 and 22-25 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant arguments on pages 8-10 in relation to claim 5 are persuasive (see remarks filed 01/05/26). The examiner agrees that a modification of the toggle joint of Isaacson in view of Esch may result in the loss of the locking mechanism disclosed in Isaacson. Further, a modification of the supplementary reference, Wisman, in view of Esch to obtain the features of claim 5 such as “a toggle joint comprising a distal end coupled to the outer catheter adapter and a proximal end coupled to the inner catheter adapter” would be impermissible hindsight because Esch teaches a toggle joint with the proximal end (378, see FIG. 27) on a stationary hub portion (see [0427] and FIG. 25B for visual with a proximal end 352 attached to a stationary hub 359), similar to the outer catheter adapter of the current invention, and the distal end (380) on a catheter (see [0428] and FIG. 25B for visual with a distal end 354 on a catheter 358). Therefore, Esch teaches a proximal end coupled to the outer catheter adapter. Thus, a modification of Wisman in view of Esch would not result in the claimed invention unless impermissible hindsight were applied to achieve “a toggle joint comprising a distal end coupled to the outer catheter adapter and a proximal end coupled to the inner catheter adapter”. Therefore, claim 5 is indicated as having allowable subject matter and is objected to as being dependent upon a rejected base claim.
Response to Arguments
Applicant's arguments filed 01/05/26 have been fully considered but they are not persuasive.
On pages 6-7, Applicant argues that the proximal end of the inner catheter adapter of Isaacson is improperly identified and therefore the 35 U.S.C. § 102 claim rejections of claim 1 and the subsequent depending claims should be withdrawn. The examiner disagrees. Isaacson discloses in [0027], previously cited in the rejection of claim 1 in the non-final office action mailed 09/04/25, the tip/ distal end of inner catheter adapter 46 transitions into a body 48 and the body 48 forms a channel 52. Therefore, the inner catheter adapter extends to form the lumen/ channel 52. Therefore, the proximal end as identified in Isaacson Modified FIG. 6 is appropriately identified because the inner catheter adapter is disclosed as terminating at the end of the lumen 52. Thus, the proximal end should not extend to further include the lumen associated with the connector 14 as argued by Applicant.
Further, the breadth of the claims as argued by Applicant on pages 6-7 does not align with the claims as recited. Claim 1 only requires that the inner catheter adapter is “contained within” the outer catheter adapter. Even if the connector portion 14 were identified as the proximal end of the inner catheter adapter in Isaacson (as argued by Applicant), the majority of the inner catheter adapter of Isaacson is “contained within” the outer catheter and therefore meets the limitation as claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., an entirety of the inner catheter adapter being contained within/ completely circumferentially surrounded by the outer catheter adapter) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the examiner was not persuaded by the arguments as presented by Applicant on pages 6-8 and has maintained the 35 U.S.C. § 102 claim rejections under Isaacson.
However, in order to expedite prosecution, the examiner has also provided a supplementary 35 U.S.C. § 102 claim rejection of claim 1 under a new reference, Wisman. Another reference has also been cited in the conclusion section below. Thus, whether the arguments against Isaacson are persuasive or not, claim 1 does not appear to have allowable subject matter in view of the prior art and Applicant is encouraged to amend the claims to further distinguish the invention from the prior art of record (such as incorporating claim 5 into claim 1, see Allowable Subject Matter section above).
The arguments presented on pages 8-10 were found persuasive and therefore claim 5 has been objected to for depending from a rejected base claim (see allowable subject matter section above for further explanation).
Because no further arguments were presented, all subsequent depending claim rejections (from claim 1) were maintained by the examiner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Muse et al. (20180339131) teaches an outer catheter adapter with an inner catheter adapter contained entirely within (See FIG. 1) and several embodiments thereof
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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783