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 .
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.
Response to Amendment
This Action is responsive to the Reply filed on 22 January 2026 (“Reply”). As directed in the Reply:
no claims have been amended;
Claims 38-51 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-37 are presently pending in this application, with Claims 1 (in part), 3, 4, 6, 7, 9, 10, 12-14, 18 (in part), 20, 21, 23, 24, 26, 27, and 29-31 are withdrawn from consideration (see below).
Election/Restrictions
Applicant’s election without traverse of species I, II, and VIII in the Reply is acknowledged.
Claims 1 (in part), 3, 4, 6, 7, 9, 10, 12-14, 18 (in part), 20, 21, 23, 24, 26, 27, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sealing module is configured to separately seal around . . . the distal portion of the access guidewire when compressed in the sealing-module cavity” of Claim 35 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because of the following additional informalities:
in Fig. 3, hatching is required of solid elements, as correctly done in Fig. 4;
in Figs. 9A-9E, #152 has been used to indicate an unknown structure, already used for the tip bevel (maybe should be #150?); and
in Fig. 11, section lines 12-12 and 13-13 are not described in the Specification, and 13-13 is used twice for different sections.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities.
Generally, much of the Specification refers to reference numerals without specifying in which drawing figure(s) they can be found, and thus the reader is left to hunt for them to understand the drawing disclosure viz. the Specification; see, e.g., Fig. 1, #196, 198 are not shown (cf. [0090], lines 3, 5; suggest referencing Figs. 3 and 4);
Appropriate correction is required.
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, 5, 8, 11, 16-19, 22, 25, 28, 33, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2009187147, by Kurth et al. (“Kurth”).
Kurth describes a device as claimed by Applicant, as follows.
Claim 1: An introducer needle, comprising:
a needle shaft (16) including a needle slot (23) extending from a proximal portion of the needle shaft through a distal needle tip having a bevel with a tip bevel (26) and a heel (proximal end of the bevel), the needle shaft including one or more features selected from a group of features consisting of:
a) (elected species) opposite needle-slot walls face each other and are parallel to each other consistent with the needle slot being cut into the needle shaft (see Fig. 7, showing walls as claimed);
b) (non-elected species) the opposite needle-slot walls face each other but are oblique to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
c) (non-elected species) the opposite needle-slot walls face away from a bottom of the needle slot consistent with the needle slot being ground into the needle shaft;
d) (non-elected species) the opposite needle-slot walls face toward the bottom of the needle slot consistent with opposite needle-slot walls being bent in toward the bottom of the needle slot; and
e) (non-elected species) the opposite needle-shaft walls are parallel to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
a sheath (22) over the needle shaft sealing the needle slot thereunder but for a sheath opening in a proximal portion of the sheath (Figs. 4-5 and [0053]: ”A slit (not shown) can be provided in the sleeve 22 to ease the start of the tear as well if needed.”); and
a needle hub (24) around both the proximal portion of the needle shaft and a proximal portion of the sheath (Fig. 5; the hub 24 surrounds the sheath).
Claim 2: (The introducer needle of claim 1,) wherein the needle slot extends along at least a portion of a top of the needle shaft, the top of the needle shaft including the heel of the bevel (Figs. 4, 7).
Claim 5: (The introducer needle of claim 1,) wherein the needle slot bisects the heel of the bevel (Figs. 4, 7).
Claim 8: (The introducer needle of claim 1,) wherein the needle slot is linear from the proximal portion of the needle shaft through the needle tip (Fig. 7).
Claim 11: (The introducer needle of claim 1,) wherein the needle slot has a constant needle-slot width (Fig. 7).
Claim 16: (The introducer needle of claim 1,) wherein the needle slot extends through a proximal end of the needle shaft ([0060], “slot 30 is continuous through needle 16”).
Claim 17: (The introducer needle of claim 1,) wherein edges of the needle-slot walls are finished, thereby minimizing or eliminating sharp, access guidewire-fraying edges of the needle slot (slot is machined, which “minimizes” as claimed).
Claim 18: A rapidly insertable central catheter ("RICC") insertion assembly, comprising:
a RICC including a catheter tube and a primary lumen therethrough ([0004], description of additional ‘introducer’ used with the slotted needle);
an introducer needle (16) including:
a needle shaft (16) including a needle slot (23) extending from a proximal portion of the needle shaft through a distal needle tip having a bevel with a tip bevel (26) and a heel (proximal end of the bevel), the needle shaft including one or more features selected from a group of features consisting of:
a) (elected) opposite needle-slot walls face each other and are parallel to each other consistent with the needle slot being cut into the needle shaft (see Fig. 7, showing walls as claimed);
b) (non-elected species) the opposite needle-slot walls face each other but are oblique to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
c) (non-elected species) the opposite needle-slot walls face away from a bottom of the needle slot consistent with the needle slot being ground into the needle shaft;
d) (non-elected species) the opposite needle-slot walls face toward the bottom of the needle slot consistent with opposite needle-slot walls being bent in toward the bottom of the needle slot; and
e) (non-elected species) the opposite needle-shaft walls are parallel to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
a sheath (22) over the needle shaft sealing the needle slot thereunder but for a sheath opening in a proximal portion of the sheath (Figs. 4-5 and [0053]: ”A slit (not shown) can be provided in the sleeve 22 to ease the start of the tear as well if needed.”); and
a needle hub (24) around both the proximal portion of the needle shaft and a proximal portion of the sheath (Fig. 5; the hub 24 surrounds the sheath).
an access guidewire (#8 in Fig. 1) including a proximal portion disposed in the primary lumen of the RICC ([0058], describing location of the guidewire relative to the ‘larger medical device’) and a distal portion disposed in the needle shaft through both the sheath opening and needle slot (id.); and
a coupler coupling the RICC and the introducer needle together (24 in Fig. 11).
Claim 19: (The RICC insertion assembly of claim 18,) wherein the needle slot extends along at least a portion of a top of the needle shaft, the top of the needle shaft including the heel of the bevel (Fig. 7).
Claim 22: (The RICC insertion assembly of claim 18,) wherein the needle slot bisects the heel of the bevel (Fig. 7).
Claim 25: (The RICC insertion assembly of claim 18,) wherein the needle slot is linear from the proximal portion of the needle shaft through the needle tip (Fig. 7).
Claim 28: (The RICC insertion assembly of claim 18,) wherein the needle slot has a constant needle-slot width (Fig. 7).
Claim 33: (The RICC insertion assembly of claim 18,) wherein the needle slot extends through a proximal end of the needle shaft ([0060], “slot 30 is continuous through needle 16”).
Claim 34: (The RICC insertion assembly of claim 18,) wherein edges of the needle-slot walls are finished, thereby minimizing or eliminating sharp, access guidewire-fraying edges of the needle slot (slot is machined, which “minimizes” as claimed).
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.
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.
Claims 15 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth as applied to Claims 1 and 18 above, and further in view of U.S. Patent No. 5,380,290, granted to Makower et al. (“Makower”).
Kurth describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the needle slot is short of a proximal end of the needle shaft.
Makower relates to venipuncture needles having longitudinal slots that are sealed with a sleeve, used with guidewires, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Makower teaches (see Figs. 1, 2, and 9) that the needle slot (26) can be made to be short of a proximal end of the needle shaft (as at 36 in Fig. 9), so that the needle and slot can be used with a guidewire (24) which has a proximal portion with a larger outer diameter (col. 7, lines 21-35), such as at section 10 of Kurth’s guidewire 8.
It 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, to construct Kurth’s needle’s slot so that it is short of a proximal end of the needle shaft, because Makower teaches doing so in a closely related device, to allow it to be more easily used with a guidewire of Kurth’s construction.
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth as applied to Claim 18 above, and further in view of U.S. Patent App. Pub. No. 2022/0168548, by Dong et al. (“Dong”).
Kurth describes a device substantially as claimed by Applicant; see above. It does not, however, describe that it includes a coupler housing including a sealing-module cavity, and a sealing-module insert disposed in the sealing-module cavity, the sealing-module cavity and the sealing-module insert forming a sealing module of the RICC insertion assembly configured to separately seal around a proximal portion of the introducer needle including the sheath opening and the distal portion of the access guidewire when compressed in the sealing-module cavity.
Dong relates to venipuncture needles used with guidewires, and their proximal sealing hubs, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Dong teaches (see Figs. 1A-1F and [0078]-[0083]) that the proximal coupler of such a device can be constructed to include, for the purpose of sealing the needle and guidewire from the environment once they are passed through the hub, a coupler housing (23) including a sealing-module cavity (interior, see in Fig. 1B), and a sealing-module insert (25) disposed in the sealing-module cavity (Fig. 1B), the sealing-module cavity and the sealing-module insert forming a sealing module of the RICC insertion assembly configured to separately seal around a proximal portion of the introducer needle including the sheath opening (as needle is inserted distally into position shown in Fig. 1B, Kurth’s sheath opening will be sealed) and the distal portion of the access guidewire (311, Fig. 1B) when compressed in the sealing-module cavity ([0078]).
It 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, to construct the proximal coupler of Kurth’s device to further include the features of Claim 35, because Dong teaches doing so to seal the needle and guidewire from the environment once they are passed through the hub.
Claim 36: (The RICC insertion assembly of claim 35,) wherein the coupler housing includes a longitudinal coupler-housing slot (Kurth’s Fig. 5A, #23) configured to allow the access guidewire to escape from the coupler housing after a distal portion of the sealing-module insert is removed from the sealing-module cavity with withdrawal of the introducer needle from the coupler (Kurth [0053]; were Dong’s insert removed, as claimed, the guidewire would still be ‘allowed to escape’).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth and Dong as applied to Claim 35 above, and further in view of U.S. Patent No. 5,261,887, granted to Walker (“Walker”).
Kurth and Dong together describe a device substantially as claimed by Applicant; see above. They do not, however, describe that the coupler includes a blade extending into the sealing module such that the blade is disposed in the needle slot under a distal end of the sheath opening, the blade including a distal-facing blade edge configured to cut the sheath away from the needle shaft as the introducer needle is withdrawn from the coupler, thereby allowing the access guidewire to escape from the needle shaft by way of the needle slot.
Walker relates to sealed catheter hubs used with guidewires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Walker teaches that, in order to strip a covering (here, the catheter 12) off of the outer surface of a guidewire (14) while the guidewire is still within the patient (col. 8, lines 31-39), the coupler includes a blade (52 in Fig. 2) extending into the sealing module (blade 52 would be positioned in Dong’s sealing module in order to have access to the exterior of its needle, while still sterile) such that the blade is disposed in the needle slot under a distal end of the sheath opening (same), the blade including a distal-facing blade edge configured to cut the sheath away from the needle shaft as the introducer needle is withdrawn from the coupler (Walker Fig. 2), thereby allowing the access guidewire to escape from the needle shaft by way of the needle slot (Walker col. 8, lines 31-39).
It 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, to further include, in a Kurth-Dong device, the additional subject matter of Claim 37 (noted above), because Walker teaches doing so in closely related catheter guidewire proximal hub, in order to more easily strip off the covering of a vascular-indwelling medical device without the need to remove that medical device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2020/0197682 describes another over-the-needle catheter hub with a sealed guidewire.
The balance of the documents cited with this Office Action relate generally to over-the-needle, guidewire assisted venipuncture devices and their hubs.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783