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 statements (IDS) submitted on 8/22/24;6/12/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Rejections - 35 USC § 102
3. 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 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.
4. 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.
5. Claims 1-4, 8, 10-13, 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 2012/0118088) (“Smith”).
(claims 1, 11, 18): Smith discloses: A catheter deployment system and method (Figs. 25-27 [0095-0100]) comprising: a first catheter 664 having a body with a distal end and a proximal hub 666; gripping features 620 (Fig. 27 [0101]) on the catheter body distal of the proximal hub; a free-standing support structure (frame of Fig. 27 [0094],[0047]; being a universal element capable of interacting with the geared central support structure of 610) having at least one support post 606; and a clamp structure (614,616,618, Fig. 27 [0100-0103]) on the support structure, the clamp structure having an opened position (allowing normal axial and rotational movement, Fig. 27 [0105-0107]), a closed position (not allowing axial and rotational movement, Fig. 27 [0105-0107]), and a plurality of intermediate positions between the opened and closed positions, Fig. 27; wherein (a) the gripping features of the catheter body may be inserted into and removed from the clamp structure when the clamp structure is in its opened configuration (Fig. 27 [0098] [0105-0107]), (b) the gripping features of the catheter body may be rotated and axially translated within the clamp structure when the clamp structure is in a first intermediate position (Fig. 27, [0097] [0105-0107]: at least when only 618 partially engaged), and (c) the gripping features of the catheter body may be rotated but not axially translated within the clamp structure when the clamp structure is in a second intermediate position (via action of 616 only; Fig. 27 [0106]).
Claim 19: Smith further discloses: wherein the gripping features of the catheter body are prevented from both rotation and axial translation within the clamp structure when the clamp structure is its closed position (engagement of 616 and 614 stopping rotational and axial translation; Fig. 27 [0098] [0105-0106]).
Claims 2, 12, 20: Smith further discloses: wherein the gripping features comprise circumferential ribs (teeth of 604 [0102]) and valleys (between teeth, Fig. 26 [0102]) and the clamp structure has an engaging element located adjacent to the gripping features when the first catheter in the clamp structure 602 [0102].
Claims 3, 21: Smith further discloses: wherein the engaging element does not engage the gripping features when the clamp structure is in the first intermediate position such that the first catheter is free to both rotate and axially translate relative to the support structure 614,616,618; Fig 26-27 [0102, 0104-0106]).
Claims 4, 13, 22: Smith further discloses: wherein the engaging element is advanced into the valley between adjacent ribs when the clamp structure is in the second intermediate position such that the catheter is free to rotate as the engaging element travels in the valley but is constrained from axial movement by the ribs (movement of extending member of 616; Fig 26-27; [0106]).
Claim 8: Smith further discloses wherein the clamp structure comprises a biasing member configured to advance the gripping features toward the engaging element (100; Fig 26; [0097-0099]; utilization of 100 to actuate locking mechanisms).
Claim 10: Smith further discloses wherein the engaging element comprises a ribbed structure that mates with the ribs of the gripping features, see Fig. 28 (gears)
Claim Rejections - 35 USC § 103
6. 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 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.
7. 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.
8. 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.
9. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith.
Smith discloses wherein the biasing member comprises a threaded shaft (screw [0096]). Combination of disclosed embodiments is within the ordinary skill of one in the art. 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 have employed the set screw of Smith upon the system of Smith in order to provide more intermediate settings for the fixation of the catheter within the system.
10. Claims 5-7, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Evalve, Inc. (WO 2017/062637) (“Evalve”).
As pertaining to claims 5, 14, Smith teaches the catheter deployment system of claim 1, but is silent wherein further comprising a second catheter configured to be introduced through a lumen of the first catheter while the first catheter is held by the clamp structure.
However, Evalve, in the analogous art, teaches a catheter deployment system (collectively Fig. 8; para [(0055]) comprising a first catheter (706, 702, collar immediately rightmost of 702; Fig. 8; para [0055]-[0058}) further comprising a second catheter configured to be introduced through a lumen of the first catheter while the first catheter is held by a clamp structure (708 entering through collar immediately rightmost of 702; Fig. 8).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have employed the second catheter nesting of Evalve upon the system of Smith, in order to introduce further tools into a surgical area without needing to remove an already placed assembly.
As pertaining to claim 6, Smith in view of Evalve teaches the catheter deployment system of claim 5, and Evalve further discloses wherein the second catheter has a rigid proximal shaft region (704; Fig. 8) that self-supports a handle of the second catheter when extending proximally from a proximal end of the first catheter (rightmost handle end extending from 704; Fig. 8).
As pertaining to claim 7, Smith in view of Evalve teaches the catheter deployment system of claim 5, and Evalve discloses further comprising a second support post on the support structure (304; Fig. 8), wherein the second support post supports a handle of the second catheter when extending proximally from a proximal end of the first catheter (rightmost end of 704 supported by 304; Fig. 8).
As pertaining to claim 15, Evalve further teaches supporting a hub on the second catheter in tandem with the hub on the first catheter. (rightmost portion of 704; Fig. 8)
As pertaining to claim 17, Evalve further teaches wherein supporting the hub on the second catheter in tandem with the hub on the first catheter comprises placing the hub on a second support post on the support structure. (rightmost portion of 704 supported upon 304; Fig. 8)
As pertaining to claim 16, the support of Evalve supporting the hub on the second catheter in tandem with the hub on the first catheter comprises self-supporting the hub on a rigid proximal shaft region of the second catheter because the second end at support block 316 need not necessarily be used and thus would only be self-supporting by the stabilizer body 300 at the other end (Fig. 8).
Conclusion
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/DEANNA K HALL/ Primary Examiner, Art Unit 3783