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 .
Acknowledgments
This office action is in response to the reply filed on 3/27/26. In the reply, the applicant amended claims 1,12,14; canceled claim 11. Claims 1-10,12-19, 38-41 are pending with claims 16-19 and 38-41 being withdrawn.
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 1-10,12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt (US 2012/0210569) in view of Auth (US 4,829,999). Schmitt discloses:
(claim 1,12) A catheter placement system (Figs. 9,10), comprising: a catheter 1022 defining a catheter lumen 1028; and a guidewire loading device 900,800, comprising: a body 902,802 defining a first body portion having a first arm and a second body portion having a second arm (see 802 on either side of 120 (Figs. 6-8) (Fig. 9 has the same portions but shown in a different view); body having a device lumen 904 extending longitudinally; a funnel 908 disposed at a distal end of the body and communicating with the device lumen; a slot 906 extending longitudinally between the distal end and a proximal end of the body and communicating with the device lumen; and a protrusion 940 extending radially inwards from an inner surface of the device lumen and configured to engage a skive 1042 ([0031]) disposed in an outer surface of the catheter.
Schmitt discloses the invention as substantially claimed but does not directly disclose the first and second body portions hingedly coupled and pivotable through a plane extending perpendicular to a longitudinal axis upon rotation of the first arm relative to the second arm; the first body portion and the second body portion are transitionable between a closed position and an open position, a smallest diameter of the device lumen being larger than an outer diameter of the catheter when the device is in the open position. (claim 14) A living hinge configured to bias the first body portion and the second body portion towards a closed position. Auth, in the analogous art, teaches a similar side-loading guidewire loading device, Fig. 1. A first and second body 18,20 are coupled via a living hinge to bias in the closed position C1L59-63. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Schmitt with the side loading clamping mechanism as taught by Auth for the portability to easily move the gripping device to another location to grip a catheter/guidewire. It has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Claim 2: the device lumen includes a funnel section 914 disposed distally, a catheter section 910 disposed proximally, and an alignment section 912 disposed therebetween, the protrusion extending from an inner surface of the catheter section. Fig. 9
Claim 3: the funnel section 914 defines a tapered inner profile extending from a first diameter at a distal end of the funnel section, to a second diameter at a proximal end of the funnel section, the second diameter being less than the first diameter. Fig. 9
Claim 4: the alignment section 912 defines a tapered inner profile extending from the second diameter at a distal end of the alignment section, to a third diameter at a proximal end of the alignment section, the third diameter being equal to an inner diameter of the catheter lumen. Fig. 9 (no distinct cut-off for these sections as described)
Claim 5: the catheter section 910 defines a fourth diameter larger than the third diameter, a wall of the catheter section extending parallel to a longitudinal axis. Fig. 9
Claim 6: the fourth diameter is equal to or larger than an outer diameter of the catheter, the catheter section configured to slidably engage an outer surface of the catheter. Figs. 9,10 [0031]
Claim 7: the fourth diameter is equal to or less than an outer diameter of the catheter, the catheter section configured to engage the catheter in an interference fit. Figs. 9,10; [0031]
Claim 8: the catheter section further includes a tapered distal section, and inner profile of the tapered distal section mirrors an outer profile of a distal tip structure of the catheter. Figs. 9,10
Claim 9: the device lumen further includes an abutment (where 912/910 meet, Figs. 9,10) extending radially inwards from a wall of the device lumen and configured to engage a distal tip of the catheter to inhibit further distal movement of the catheter through the device lumen.
Claim 10: the skive includes an aperture communicating with a second catheter lumen (guidewire port 1028, [0031]).
Claim 13: the protrusion of Schmitt is configured to disengage the skive in the open position to allow the catheter to slide longitudinally relative to the body. [0021-0022]
Claim 15: a guidewire defining an outer diameter equal to or less than the third diameter. (guidewire is loaded in lumen 1028 [0031])
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Examiner maintains the combination.
Examiner disagrees with applicant’s remarks that “Auth addresses a different problem altogether”; both Schmitt and Auth grasp a guidewire securely. Examiner also disagrees that the combination as claimed would render the device of Schmitt unsuitable for its intended purpose. Both Schmitt and Auth require removal of the tool after use. Schmitt has to peel off or break through (rip apart) the area of weakness 120 whereas Auth simply opens the tool via its hinge for removal. Both slots of lumens of Schmitt and Auth are adapted to receive the guidewire (Auth C1L36-37). In addition to the rejection above, Auth has several advantages over Schmitt in that the device can be moved and reused; the way in which the tool is removed is a simple substitution of one method for another given the design needs (reuse, different sized guidewires, movement during the procedure). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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