DETAILED ACTION
This Office Action is in response to Restriction/Elected, filed on 07/02/2026, on the application filed on 10/28/2024. Claims 1-12 are presented for examination consideration.
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
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group 2. There being no allowable generic or linking claims. Election was made without traverse in the reply filed on 07/02/2026.
Drawings Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s):
The limitation phrases “first member” and “second member” in the limitations “arranging a first member to an outer surface of the frame; arranging a second member to an outer surface of the first member so that the wire is sandwiched between the first member and the second member; and cutting a first part of the wire exposing from the second member” claimed in independent claim 1 needs to be shown in order to make structural relation with the other limitation structures, as detailed in the 112(a) and 112(b) rejections.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification Objections
The disclosure is objected to because of the following informalities:
One skilled in the arts would not have full appreciation of the invention since the specification does not clearly define how the structures of the first member” and “second member” NOT having ITEM DESIGNATIONS and NOT having ITEM DESCRIPTIONS will meet the limitations in independent claim 1.
Appropriate correction is required as well as no new matter should be entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the Specification and the Drawings do not provide enablement support in the limitations in claims. The Drawings in conjunction with the Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope in the claim. See MPEP § 2166 and § 2164.
Independent Claim 1 recites the limitation phrases “first member” and “second member” in the limitations “arranging a first member to an outer surface of the frame; arranging a second member to an outer surface of the first member so that the wire is sandwiched between the first member and the second member; and cutting a first part of the wire exposing from the second member”, where the cited limitation phrase has an ENABLING issue within the claim. There is NO ENABLEMENT in the cited limitation phrases in RELATION to the filed disclosure. Specifically, there is NO DETAILS in the specification for “first member” and “second member” in RELATION to any of Figures, since the cited limitation phrases does NOT have an ITEM DESCRIPTION in the Specification and ITEM DESIGNATION in the Drawings. Then HOW can the limitation phrase “first member” and “second member” MEET the cited limitation in claim 1. Consequently, any person skilled in the art to which it pertains, would have an ENABLEMENT issue with the claim since there is NO structural limitations in relation to the Figures that details the limitation.
Claim 2-11 are rejected since base claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph.
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 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as the claims are incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2175 and § 2172.01.
Independent Claim 1 recites the limitation phrases “first member” and “second member” in the limitations “arranging a first member to an outer surface of the frame; arranging a second member to an outer surface of the first member so that the wire is sandwiched between the first member and the second member; and cutting a first part of the wire exposing from the second member”, where the cited limitation is confusing. Specifically, there is NO RELATION BETWEEN in the filed disclosure to indicate and/or show HOW the “first member” and “second member” is RELATED to the “frame” and the “wire”, resulting in a GAP in the cited limitations. Consequently, there is NO structural relationship in the Specifications and the Figures to support the cited limitations. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention of the “first member” and “second member” in RELATION to the “frame” and the “wire” in the cited limitations in conjunction with the Specifications and the Figures.
Claim 2-12 are rejected since base claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Yanuma et al. (US20150342633A1 and Yanuma hereinafter), in view of NPL “Current Induction In Fiberglass Guidewire During Papillotomy_O'Brien_493-497_Jun 1997” (NPL “Papillotomy” hereinafter).
Regarding claim 1, Yanuma discloses a grounding method used for manufacturing a medical device (item 6 of Figs. 15_26 and ¶[0132-0133] is interpreted to show and indicate grounding method 6 {papillotome 6 for an endoscope} used for manufacturing of a medical device endoscopy) comprising: fixing a wire to an outer surface of a frame (items 100, 99 of Figs. 15_19_25 and ¶[0117-0120_0122_0128 & 0147] shows and indicates grounding method 6 is comprised of a fixed wire 100 to the outer surface of frame 99 {blade 99}); arranging a first member to an outer surface of the frame (item 91, 91a, 91b, 91c of Figs. 15_19_25 and ¶[0107_0109_0122 & 0128] shows and indicates arranging first member 91 {member that is formed by multi-lumen tube 91 comprised of the following structures: transition section 91a; sheath main body 91b; and a knife support section 91c} to the outer surface of frame 99); arranging a second member to an outer surface of the first member so that the wire is sandwiched between the first member and the second member (item 101 of Fig. 15 & item 105 of Figs. 15_19_25 and ¶[0117_0119_0122 & 0128] shows and indicates arranging second member 101 {coating tube 101 member that is configured to coat the blade 99} to the outer surface of first member 91 so that wire 100 is sandwiched between first member 91 and second member 101 {clearly shown in Figs. 15 & 25 where the wire 100 is sandwiched between coating tube 101 and knife support section 91c}); and cutting a first part of the wire exposing from the second member (items 105, 92 of Figs. 15_25 and ¶[0117_0119_0122 & 0147] shows and indicates cutting first part 105_92_100_99 {wire 100 protruding from the torque lumen 92 to distal end side is fixed to the blade 99 by the welding section 105, where the wire 100 is then cut so may it maybe welded to the blade 99} of wire 100 exposing {wire 100 protruding from the torque lumen 92, as shown in Fig. 25} from second member 101 {wire 100 that is fixed by the welding section 105; where then the welding section 105 is sandwiched between the proximal end section of the blade 99 and the proximal end section of the coating tube 101; and where the coating tube 101 is configured to coat the blade 99}).
Yanuma discloses the claimed invention except to explicitly disclose a grounding method.
NPL “Papillotomy” discloses a grounding method (Fig. 1 on page 494 indicates grounding method 1000Ω-Papillotome {power is applied to the papillotome cutting wire (circuit in red) from the electrosurgical generator, and grounded through a 1000 Ω resistor}).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a grounding method into the method of Yanuma. One would have been motivated in the grounding method of Yanuma and have the grounding method, in order to design the power applied to the papillotome from the electrosurgical generator, as shown in Fig. 1 and indicated on page 494 by NPL “Papillotomy”, in the grounding method of Yanuma.
Regarding claim 3, modified Yanuma discloses a grounding method, further comprising exposing the wire from an inside of the first member to an outside the first member before the arranging the second member to the outer surface of the first member (Yanuma: Figs. 15_25 and ¶[0107_0109_0117-0120_0122_0128 & 0147] shows and indicates that grounding method 6 is further comprised of exposing wire 100 from the inside of first member 91 to the outside of first member 91 before the arranging the second member 101 to the outer surface of the first member 91; NPL “Papillotomy”: Fig. 1 on page 494 indicates grounding method 1000Ω-Papillotome).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO J EGOAVIL whose telephone number is (571)270-1325. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/GUILLERMO J EGOAVIL/Examiner, Art Unit 2847
/TIMOTHY J THOMPSON/Supervisory Patent Examiner, Art Unit 2847
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