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 .
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) 1-2 and 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0232237 A1 to Yokota et al. (hereinafter “Yokota”).
Regarding claim 1, Yokota discloses (see abstract; Figs. 1-16; and [0040]-[0081]) a method for inserting a holding device (1) into a body (see [0050]-[0069]), the method comprising: switching the holding device from a first configuration (Fig. 1) to a second configuration (Fig. 3) to hold a guidewire ("W"), with the guidewire indwelled from one of a bile duct or a pancreatic duct to a duodenum through a duodenal papilla (see [0050]-[0055]); and inserting the holding device into the one of the bile duct or the pancreatic duct through the duodenal papilla along the held guidewire (see [0062]), wherein in the first configuration, a holder (22) of the holding device is positioned at a first position relative to a sheath (10) of the holding device (see Fig. 1), and wherein in the second configuration, the holder is positioned at a second position relative to the sheath, the second position is proximally relative to the first position in a longitudinal direction of the sheath (see Fig. 3 and [0041]-[0047], 22 is proximal in Fig. 3 versus Fig. 1 as compared to sheath 10).
Yokota further discloses (claim 2) further comprising: during the inserting, performing ERCP procedure (see [0068]); (claim 8) further comprising: switching the holding device from the second configuration to the first configuration (see [0066]); (claim 9) further comprising: releasing the guidewire in response to the switching the holding device from the second configuration to the first configuration (see [0066]); (claim 10) further comprising: after completion of ERCP procedure, switching the holding device from the second configuration to the first configuration to release the guidewire; (claim 11) wherein the switching comprises contacting the sheath and the holder to hold the guidewire at the second configuration (see Fig. 3); (claim 12) wherein the switching comprises retracting an operation wire (23) (see Figs. 1/3 and [0047]); (claim 13) further comprising: hooking a distal end side of the guide wire to the holder at the first configuration (see [0060]); (claim 14) further comprising: confirming the one of the bile duct or the pancreatic duct through an ultrasound image; and puncturing the one of the bile duct or the pancreatic duct (see [0053]); (claim 15) wherein: during the inserting of the holding device, switching a treatment tool between a first state and a second state, the treatment tool comprises a puncture needle, in the first state, the treatment tool is provided inside the sheath, and in the second state, the treatment tool is protruded from the sheath (see [0053]); (claim 16) wherein switching comprises moving the holder relative to the sheath only in the longitudinal direction (see Figs. 1/3); (claim 17) wherein switching comprises holding the guidewire in a direction intersecting the longitudinal axis (see Fig. 3); (claim 18) wherein holding the guidewire comprises keeping the guidewire into a slit of the holder (22B/10A, see Figs. 1/3 and [0043]); (claim 19) wherein the guidewire comprises a first guidewire, and wherein the method further comprises: inserting a second guidewire into the sheath after the releasing; and protruding the second guidewire from the sheath (see [0064]); and (claim 20) further comprising: indwelling the guidewire from one of the bile duct or the pancreatic duct to the duodenum through the duodenal papilla; and inserting the holding device into the duodenum (see [0050]-[0055] & [0062]).
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, 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) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yokota in view of US 2004/0049095 A1 to Goto et al. (hereinafter “Goto”).
Yokoto fails to specifically disclose (claim 3) further comprising: during the inserting, switching a treatment tool between a first state and a second state, wherein in the first state, the treatment tool is provided inside the sheath, and wherein in the second state, the treatment tool is protruded from the sheath; (claim 4) wherein switching the treatment tool comprises switching the treatment tool from the first state to the second state is conducted in response to the switching the holding device from the first configuration to the second configuration; (claim 5) wherein the protruding is conducted at the second configuration; (claim 6) wherein the treatment tool comprises a basket, and wherein the method further comprises: in the first state, expanding the basket; and in the second state, folding the basket; and (claim 7) wherein the holder comprises an electrode knife, and wherein the method further comprises: in the first state, powering off the electrode knife, and in the second state, powering on the electrode knife.
Goto discloses, in the same field of endeavor, a treatment method for the pancreatic or bile duct from a duodenal papilla using a guide wire (see [0005]-[0006]), and further discloses, during treatment, switching a treatment tool (130) between a first state (Fig. 19A) and a second state (Fig. 19B), wherein in the first state, the treatment tool is provided inside the sheath (136) (see [0147]), and wherein in the second state, the treatment tool is protruded from the sheath (see [0148]), wherein the treatment tool comprises a basket (141) and wherein the method further comprises: in the first state, expanding the basket; and in the second state, folding the basket (see [0146]-[0150]); and further comprising an electrode knife (endo-therapy accessory connected to power transmission wire 135), and wherein the method further comprises: in the first state, powering off the electrode knife, and in the second state, powering on the electrode knife (see [0141]) (see [0140]-[0152]) for the purpose of providing an endo-therapy accessory to be used when a calculus in a bile duct is discharged from a papilla into a duodenum that needs to be extracted (see [0147]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yokoto's method with the endo-therapy accessory taught by Goto in order to use it when a calculus in a bile duct is discharged from a papilla into a duodenum that needs to be extracted. In making the proposed combination, the tool of Goto could be switched from the first state to the second state either before, during, or after (and thus in response to, which would result in the protuding being conducted at the second configuration) switching the holding device from the first configuration to the second configuration, and thus it would be obvious to try which of these sequencing steps would be best suited for the inventive method since there are only three possible options and thus would not involve undue experimentation to determine the optimum sequencing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art teaching guidewire holders and/or methods involving treating the pancreatic or bile ducts using guidewires.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAUN L DAVID/Primary Examiner, Art Unit 3771