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 .
Response to Amendment
The amendment filed July 24, 2025 has been entered. Claims 1-12 remain pending in the application. Claim 12 has been withdrawn from consideration. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed April 15, 2025.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blanchard et al. (US 20110282285).
Regarding claim 1, Blanchard discloses a catheter assembly (insertion tool 10) comprising:
a catheter (catheter tube 44);
a catheter hub (catheter hub 46) fixed to the catheter (Figure 2B);
an inner needle (needle 16) inserted through the catheter (Figure 1A);
a grip (needle hub 14) fixed to and holding the inner needle (Figure 2A);
a first support portion (catheter advancement assembly 40), which is a member separate from the grip (Figure 2B), the first support portion comprising a support structure (teeth 50C) configured to support an outer side of the catheter (via hub 46: “The teeth 50C engage corresponding raised surfaces on the hub 46 so as to removably connect the handle 48 to the catheter 42.” [0050]); and
a second support portion (housing 12, formed by top housing portion 12A and bottom housing portion 12B), which is a member separate from the grip (Figure 2A), has at least a part that is located at a position facing the first support portion, and is configured to support the outer side of the catheter (Figure 1A);
wherein the first support portion and the second support portion are releasably engaged with each other (“FIGS. 6A and 6B show that, as the catheter is advanced via the handle 48, the housing portions 12A and 12B are easily separated so as to enable the catheter hub 46 to exit the distal end of the housing 12 and for the catheter to be inserted into the patient vasculature to a suitable degree.” [0058], wherein the handle 48 of the catheter advancement assembly 40 separates from the housing as shown in Figure 7A); and
wherein, in a state in which the first support portion and the second support portion are engaged with each other (Figures 3A-5B), the first support portion (catheter advancement assembly 40), including the support structure (teeth 50C), is slidable along an extending direction of the catheter (Figures 5A; “As seen in FIGS. 5A and 5B, once the guidewire 22 has been fully extended within the vessel of the patient (FIGS. 4A and 4B), the catheter advancement assembly 40 is actuated, wherein the handle 48 is distally advanced by the user to cause the catheter tube 44 to slide over distal portions of the needle 16 and guidewire 22 and into the patient's vasculature via the insertion site.” [0058]).
Regarding claim 2, Blanchard discloses the catheter assembly according to claim 1, wherein: the first support portion is an operation unit (catheter advancement assembly 40) configured to be operated to cause relative movement of the catheter with respect to the grip (“catheter advancement assembly 40 for selectively advancing in a distal direction a catheter 42” [0049]).
Regarding claim 3, Blanchard discloses the catheter assembly according to claim 2, wherein: in the state in which the first support portion and the second support portion are engaged with each other (Figures 3A-5B) the operation unit (catheter advancement assembly 40) is not separable from the second support portion in a direction in which the operation unit and the second support portion overlap each other (Figures 3A-5B, the catheter advancement assembly 40 is only able to move along the longitudinal axis of the catheter assembly and cannot move horizontally in a direction that the catheter advancement assembly 40 is overlapped by the housing 12).
Regarding claim 4, modified Blanchard discloses the catheter assembly according to claim 2, wherein: at least a part of the operation unit (safety housing 54 of catheter advancement assembly 40) is engaged with the grip (needle hub 14, via connection to needle 16; “the catheter slides distally along the needle 16 until the distal needle tip is received into the safety housing 54 and engaged with the needle safety component 56.” [0059]) such that the operation unit is not detachable from the grip in a direction in which the operation unit and the second support portion overlap each other (Figures 3A-5B, the catheter advancement assembly 40 is only able to move along the longitudinal axis of the catheter assembly and cannot move horizontally in a direction that the catheter advancement assembly 40 is overlapped by the housing 12).
Regarding claim 5, Blanchard discloses the catheter assembly according to claim 2, wherein: the operation unit (catheter advancement assembly 40) comprises a reinforcing portion (base 48A) on a distal side (Figure 2B), the reinforcing portion inhibiting deflection of the operation unit in a direction away from the catheter (Figure 7A).
Regarding claim 6, Blanchard discloses the catheter assembly according to claim 1, wherein: the first support portion comprises:
an extending portion (handle 48) extending along the catheter (Figure 7A, extending along at least the hub 46 of catheter 42),
a protruding portion (finger grabs 50B) that protrudes from the extending portion beyond the catheter (Figure 2B), and
a holding portion (arms 50) that extends from the protruding portion toward the second support portion (Figure 2B and 3A) and, in the state in which the first support portion and the second support portion are engaged with each other, engages the second support portion (Figure 3A, wherein the arms 50 are engaged between the upper and lower housing portion (12A, 12B).
Regarding claim 7, Blanchard discloses the catheter assembly according to claim 6, wherein: the second support portion includes an insertion target portion (gap between upper and lower housing portions 12A, 12B) into which the holding portion is slidably insertable such that the insertion target portion, in the state in which the first support portion and the second support portion are engaged with each other, engages the holding portion (Figures 3A-6B).
Regarding claim 8, Blanchard discloses the catheter assembly according to claim 7, wherein: the holding portion and the insertion target portion extend along the extending direction of the catheter (Figures 3A-6B).
Regarding claim 9, Blanchard discloses the catheter assembly according to claim 6, wherein: the protruding portion is a first protruding portion (left finger grab 50B);
the holding portion is a first holding portion (left arm 50);
the first support portion further comprises:
a second protruding portion (right finger grab 50B) that protrudes from the extending portion beyond the catheter (Figure 2B), and
a second holding portion (right arm 50B) that extends from the protruding portion toward the second support portion (Figure 2B and 3A) and, in the state in which the first support portion and the second support portion are engaged with each other, engages the second support portion (Figure 3A, wherein the arms 50 are engaged between the upper and lower housing portions 12A, 12B); and the catheter (catheter 42) is positioned between (i) the first protruding portion and the first holding portion and (ii) the second protruding portion and the second holding portion (Best shown in Figure 8, with at least hub 46 positioned between opposing sides of the handle 48).
Regarding claim 10, Blanchard discloses the catheter assembly according to claim 1, wherein: at least one of the first support portion and the second support portion is configured to support the catheter at a location frontward of a distal end of the grip (Figure 1A).
Regarding claim 11, Blanchard discloses a catheter assembly (insertion tool 10) comprising:
a catheter (catheter tube 44);
a catheter hub (catheter hub 46) fixed to the catheter (Figure 2B);
an inner needle (needle 16) inserted through the catheter (Figure 1A);
a grip (needle hub 14) fixed to and holding the inner needle (Figure 2A);
a catheter operation member (guidewire advancement assembly 20, catheter advancement member 40) which is a member separate from the grip (Figures 2A-B), the catheter operation member comprising:
an operation plate portion (slide 28) extending in an axial direction of the catheter (Figure 1A),
a support structure (catheter advancement member 40) connected to the operation plate portion (via top housing 12A; Figure 1B), the support structure configured to support an outer side of the catheter (via hub 46; Figure 8, for example), and
a hub engagement portion (teeth 50C) connected to a proximal end of the operation plate portion (connected via top housing 12A) and engaged with the catheter hub (“The teeth 50C engage corresponding raised surfaces on the hub 46 so as to removably connect the handle 48 to the catheter 42.” [0050]); and; and
a lower support member (bottom housing portion 12B) that is rotatably attached to the grip (Figure 7B showing lower housing portion rotated away from needle hub 14), has at least a part that is located at a position facing the catheter operation member (Figure 1B), and is configured to support the outer side of the catheter (Figure 1B), wherein the lower support member comprises:
a shaft (axially extending body of bottom housing portion 12B) extending in a direction in which the catheter operation member and the lower support member overlap (Figure 1B), and
a supporting body portion (engagement features 68) protruding in a direction orthogonal to the direction in which the shaft extends (Figure 2A);
wherein the catheter operation member and the lower support member are releasably engaged with each other (“FIGS. 6A and 6B show that, as the catheter is advanced via the handle 48, the housing portions 12A and 12B are easily separated so as to enable the catheter hub 46 to exit the distal end of the housing 12 and for the catheter to be inserted into the patient vasculature to a suitable degree.” [0058], wherein the handle 48 of the catheter advancement assembly 40 separates from the housing as shown in Figure 7A); and
wherein in a state in which the catheter operation member and the lower support member are engaged with each other (Figures 3A-5B), the catheter operation member (guidewire advancement assembly 20 and catheter advancement assembly 40), including the support structure (catheter advancement member 40), is slidable along the axial direction of the catheter (Figures 5A; “As seen in FIGS. 5A and 5B, once the guidewire 22 has been fully extended within the vessel of the patient (FIGS. 4A and 4B), the catheter advancement assembly 40 is actuated, wherein the handle 48 is distally advanced by the user to cause the catheter tube 44 to slide over distal portions of the needle 16 and guidewire 22 and into the patient's vasculature via the insertion site.” [0058]).
Response to Arguments
Applicant’s arguments with respect to claims 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights