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
Applicant’s information disclosure statements, filed June 14, 2024 and December 4, 2025 have been entered and the references cited therein have been considered by the examiner.
Specification
The specification contains section headings that do not align with the section headings used in U.S. applications. The section headings utilized in U.S. applications are below. Correction is required.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
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 4, 10 and 15 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.
In claims 4, 10 and 15, the phrase “wherein the fixation portion is not provided in any one or more of. . .” is vague and confusing. The use of “not” and “any one or more of” is contradictory. Is applicant claiming that the fixation portion is not in any of the first section, second section or third section? Or is applicant claiming that there is at least one fixation portion but not in all three sections? Correction is required.
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.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim(s) 1, 3, 6-9 and 17-19 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Koike et al. (PCT Publication No. WO 2020/246037).
In regard to claims 1 and 3, Koike et al. teaches a guide wire 1 that is a medical device inserted into a biological lumen such as a blood vessel or organ that is configured as a radio frequency guide wire (for RF ablation) that discharges RF or plasma (see Fig. 1 and page 2 of the attached translation). The guide wire 1 includes a core shaft 10 and a first coil body 30 wound around the core shaft 30 so as to cover the outer periphery of the tip side of the core shaft 10 (see Fig. 2 and page 2 of the attached translation). A tip tube 80 (first tube) is a resin tube that covers a distal end side of the core shaft 10 and a protective tube 70 is a resin tube that covers a proximal end side of the core shaft 10 (see Fig. 2 and page 3 of the attached translation). An insulation film 40 (third tube) covers an intermediate portion of the core shaft 10 located between the distal end side and the proximal end side (see Fig. 2 and pages 2-3 of the attached translation). Figure 2 shows that the insulation film 40 has a distal end portion joined to a proximal end portion of the tip tube 80 and a proximal end portion joined to a distal end portion of the protective tube 70. As shown in Figure 2, there is a space between the outer surface of the core shaft 10 and the inner surface of the protective tube 70. The outer diameter of the core shaft 10 is in the range of 0.1 mm to 1 mm and the outer diameter of the protective tube is in the range of 0.2 mm to 1.2 mm (see pages 2-3 of the attached translation). Thus, the space between the outer surface of the core shaft 10 and the inner surface of the protective tube 70 is in the range of 0.1 mm (100 µm) to 0.2 mm (200 µm). Koike does not specifically state that there is a gas in this space thus constituting a gas layer. However, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that there is at least air in this space as tube 70 is described as a “protective” tube for the core shaft 10 and, in order to properly protect the core shaft, there would be a cushion or buffer of air. In regard to claims 6 and 17, Figure 2 of Koike shows that the outer diameter of the intermediate portion of the core shaft 10 is smaller than an outer diameter of the distal end side of the core shaft 10 (including coil 30) and is smaller than an outer diameter of the proximal end side of the core shaft 10. Furthermore, Figure 2 of Koike shows that the outer diameter of the insulation film 40 is smaller than an outer diameter of the tip tube 80 and smaller than an outer diameter of the protective tube 70. In regard to claims 7 and 18, Figure 2 of Koike shows that the distal end portion of the insulation film 40 is overlapped with the proximal end portion of the tip tube 80 and the proximal end portion of the insulation film 40 is overlapped with the distal end portion of the protective tube 70. Furthermore, Figure 2 of Koike shows that the outer peripheral surface of the distal end portion of the insulation film 40 is joined to an inner peripheral surface of the proximal end portion of the tip tube 80 and the outer peripheral surface of the proximal end portion of the insulation film 40 is joined to an inner peripheral surface of the protective tube 70. In regard to claims 8 and 19, Figure 2 of Koike shows that an intermediate portion of the insulation film 40 is not covered with the tip tube 80 or the protective tube 70 and is exposed to an outside.
Claim(s) 4, 5, 15 and 16 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Koike et al. (PCT Publication No. WO 2020/246037) in view of Miyata et al. (U.S. Patent Application Publication No. 2013/0131642).
In regard to claims 4, 5, 15 and 16, Koike is silent as to a fixation member that fixes any of the tip tube 80, insulation film 40 or protective tube 70 to the core shaft 10. However, Miyata et al. teach a similar guidewire 1A where an inner coil body 6 is connected to a resin layer 6 on a cylindrical body 16 with a first (proximal) fixing portion 7 and a second (distal) fixing portion 10 (see Fig. 2 and paras. 0030 and 0033). Miyata et al. thus demonstrate that fixing portions for connecting and securing the inner body 16 and the resin layer 6 are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide proximal and distal fixing portions on the device of Koike to connect the tip tube 80, insulation film 40 or protective tube 70 with the core shaft 10, in the manner disclosed by Miyata et al., in order to properly connect and secure the structures together. As shown by Figure 2 of Koike, fixing portions, as applied to the device of Koike, would serve to block flow of gas between an inside and an outside of the guide wire.
Allowable Subject Matter
Claims 2, 9 and 11-14 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.
Claim 10 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or fairly suggest a guidewire with a gas layer formed between the first tube and the guide wire main body, as recited in claim 2 (claims 9-14 depend from claim 2). Koike (discussed above), only teaches a gas layer between the second tube (protective tube 70) and the core shaft 10 (see Fig. 2).
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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