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 .
Election/Restrictions
Applicant’s election of Invention I in the reply filed on 12/31/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 13-24 are objected to because of the following informalities:
Claim 13, line 12, “be” should be inserted after “configured to”.
Claim 21, line 1, “Nitional” should read “Nitinol”.
Appropriate correction is required.
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.
Claim(s) 13-18 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,713,907 (Hogendijk).
13. Hogendijk discloses a device (deployment catheter 45) for treating tissue (Abstract), comprising:
a cap configured to be coupled to a distal end of a flexible insertion device, the cap including a wall (wall of outer sheath 52 or “introducer”) defining a chamber with an open distal end (FIG. 5; col 8, lns. 45-55);
a patch deployment mechanism slidably received within the chamber in an insertion configuration (FIG. 5; col. 8, lns. 45-55), the patch deployment mechanism including a proximal member (cup 58) coupled to a distal member (nose 57) by a plurality of bowing members (arms 52; col. 8-9, lns. 65-14), the bowing members being configured to expand radially outward relative to the insertion configuration when longitudinally compressed via movement of the distal member toward the proximal member (FIG. 6a-6b; col. 8-9, lns. 56-42); and
a first therapeutic patch (graft 1) wrapped around the patch deployment mechanism, the first therapeutic patch being configured to be forced radially outward into contact with and adhere to a first target portion of tissue when the patch deployment mechanism is longitudinally compressed and the bowing members are radially expanded (FIG. 6b; col. 8-9, lns. 56-14), the patch deployment mechanism being configured to radially retracted after the first therapeutic patch has been adhered to the first target portion of tissue, from a deployed configuration to the insertion configuration to separate the first therapeutic patch from the patch deployment mechanism leaving the first therapeutic patch in a desired position adhered to the first target portion of tissue (FIG. 6b; col. 8-9, lns. 56-14 and col. 10, lns. 6-17).
14. The device has a control wire (deployment shaft 46) coupled to the distal member of the patch deployment mechanism, movement of the control wire proximally relative to the patch deployment mechanism compressing the patch deployment mechanism along a longitudinal axis thereof and expanding the bowing members radially away from the longitudinal axis (FIG. 6a-6b; col. 8-9, lns. 43-26.
15. The device has a tube (coil 59) slidably receiving the control wire, wherein the tube is coupled to the proximal member of the patch deployment mechanism so that movement of the control wire within the tube moves the distal member of the patch deployment mechanism relative to the distal member of the patch deployment mechanism to move the patch deployment mechanism between the insertion configuration and a radially expanded configuration (FIG. 6a-6b; col. 9, lns. 14-26).
16. The device has a handle (grip 75 with grip body 76) including a slider (deployment knob 85) coupled to the control wire, the slider being configured so that movement of the slider relative the tube moves the control wire through the tube to move the patch deployment mechanism between the insertion configuration and the radially expanded configuration (FIG. 8-9; col. 9-10, lns. 55-17).
17. The handle includes a handle body (body 76) and a spool (deployment shaft 83) slidably mounted on the handle body, the spool being coupled to the tube so that movement of the spool relative to the handle body moves the patch deployment mechanism relative to the cap (FIG. 8-9; col. 9-10, lns. 55-17).
18. Each of the bowing members is coupled to a distal surface of the proximal member and wherein each of the bowing members is coupled to a proximal surface of the distal member, the bowing members being arranged, in the insertion configuration, in a cylinder extending about a longitudinal axis of the patch deployment mechanism (FIG. 6a-6b; col. 8-9, lns. 65-14).
23. The first therapeutic patch has a width extending along a longitudinal axis of the patch deployment mechanism and a length transverse to the width, the first therapeutic patch being wrapped around the patch deployment mechanism so that the length of the first therapeutic patch extends circumferentially around the patch deployment mechanism, the length of the first therapeutic patch being configured to be at least as great as a diameter of the patch deployment mechanism in the deployed configuration (FIG. 1, 6a-6b, and 7b).
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.
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.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over US 5,713,907 (Hogendijk), as applied to claim 13 above, and further in view of US 7,771,452 (Pal).
Hogendijk discloses the invention substantially as claimed as discussed above and further discloses the bowing members serving the function of expansion (FIG. 6a-6b) but is silent on their material such that it does not disclose the members being Nitinol. Pal teaches a device in the same field of endeavor having bowing members (struts 14) of Nitinol (col. 3, lns. 54-65) in order to have superelastic bowing members (col. 3, lns. 54-65). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the Nitinol bowing members of Pal in place of the bowing members of Hogendijk in order to have superelastic bowing members and since all the claimed elements were known in the prior art such that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results to one of ordinary skill in the art (MPEP 2143).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over US 5,713,907 (Hogendijk), as applied to claim 13 above, and further in view of US 2021/0162185 (Smith).
Hogendijk discloses the invention substantially as claimed as discussed above but does not disclose an adhesive. Smith teaches a device in the same field of endeavor having an adhesive for the purpose of curing the adhesive once the patch is properly positioned (P0063 and P0065). The adhesive having a predetermined cure time and wherein the first therapeutic patch is configured to be removable from tissue against which it has been pressed before the predetermined cure time has elapsed since the first therapeutic patch was pressed against the tissue (P0063 and P0065). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hogendijk to include an adhesive as taught by Smith in order to cure the adhesive once the patch is properly positioned.
Allowable Subject Matter
Claims 19-20 and 22 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771