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 Statements
The information disclosure statements (IDSs) filed March 28, 2025, December 20, 2024 and October 31, 2023 have been entered and the references citer therein have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3 and 12 recite “and/or” which renders the claims vague and indefinite as the metes and bounds of the claims cannot be determined. Similarly, claim 16 recites “signal transceiver/power supply” and “actuator/sensor” and claim 17 recites “sensing/executing element” and “control/computing/power supply element” which also render the claims vague and indefinite as the metes and bounds of the claims cannot be determined. Claim 6 recites “the metal wire” which lacks proper antecedent basis in claims 1-6. As claims 4, 5, 7-11 and 13-15 depend either directly or indirectly from claim 1, they are likewise rejected.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Howat et al. (U.S. Patent Application Publication No. 2015/0032104).
In regard to claims 1-3, Howat et al. teach a catheter 10 with a shaft 12 that has an inner layer 26, a braid assembly 28 (intermediate layer) and an outer layer 30 (see Figs. 1 and 8 and para. 0033). Figure 8 shows that the braid assembly 28 covers an outer peripheral surface of the inner layer 26 and the outer layer 30 covers an outer peripheral surface of the braid assembly 38. The braid assembly 28 is comprised of braid members 46 that include a conductive element 40, a first coating 42 and a second coating 44 (see Figs. 2 and 3 and para. 0034). The conductive element 40 constitutes a core body and is formed from an electrically conductive metallic material, such as copper (see para. 0034). First coating 42 constitutes an insulation layer arranged between the conductive element 40 and the second coating 44 and it is formed from a flexible, non-electrically conductive polymer that insulates the conductive wire 40 (see Figs. 2 and 3 and para. 0038). Second coating 44 constitutes an isolation layer on the outer side of the code body adapted to isolate the conductive wire 40 (see Figs. 2 and 3). In regard to claim 8, Figures 1 and 8 show that inner layer 26 is formed as a tube with a cavity and openings at both ends and that braid assembly 28 is a mesh structure.
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) 4-7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howat et al. (U.S. Patent Application Publication No. 2015/0032104) in view of Steen et al. (U.S. Patent No. 6,213,995).
In regard to claim 4, Howat et al. are silent as to second coating 44 being comprised of a plurality of metal wires arranged in a crossing manner. However, Steen et al. teach a medical grade tubing 10 having a plurality of braid elements 14 that include signal transmitting elements 18 and structural elements 20 having structural properties different from the signal transmitting elements 20 (see Figs. 1 and 2 and col. 3, lines 14-24). Steen et al. thus demonstrate that the use of braid elements in a medical tubing is well known in the art as they provide a stronger structure. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the second coating 44 of Howat et al. as a braid structure, in the manner disclosed by Steen et al. In regard to claim 5, see the above rejection for claims 1-3. In regard to claim 6, Figure 1 of Steen et al. and Figures 2 and 3 of Howat et al. show that the conductive wire 40 of Howat et al. has a much larger diameter than the braid assembly elements 18, 20 of Steen et al. and thus, the combined device would meet the ratio relationship recited in claim 6. In regard to claim 7, Figures 2 and 3 of Howat et al. show that the conductive wire 40 has a much larger diameter than the first coating 42 and thus, the combined device would meet the ratio relationship recited in claim 7. In regard to claim 16, since both Howat et al. and Steen et al. teach conductive wires, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide a power supply and a sensor at the end of the catheter.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howat et al. (U.S. Patent Application Publication No. 2015/0032104) in view of Leeflang et al. (U.S. Patent Application Publication No. 2007/0074805).
In regard to claim 9, Howat et al. are silent as to a coating on the inner wall of the inner layer 26. However, Leeflang et al. teach a catheter with an inner liner 20 that includes a thin film on its inner surface 21 having one or more desired properties (such as lubricity) (see para. 0047). Leeflang et al. thus demonstrate that providing a coating on the inner surface of a catheter is well known in the art to achieve desired properties. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the inner wall of inner layer 26 of Howat et al. with the coating disclosed by Leeflang et al., in order to provide lubricity to the inner layer 26.
Allowable Subject Matter
Claims 10-15 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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