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 .
Response to Amendment
The amendment filed 08/15/2025 has been entered. Claims 11-16 and 18-25 remain pending in the application. Claim 17 has been cancelled. Applicant’s amendments to the claims 12 have overcome the 112(b) rejection previously set forth in the Non-final Office Action mailed 05/21/2025.
Response to Arguments
Applicant’s arguments, see page 1 lines 9-10, filed 08/15/2025, with respect to claim 12 have been fully considered and are persuasive. The 112(b) rejection of claim 12 has been withdrawn.
Regarding applicant’s arguments with respect claim 11 rejections under 102(a)(2), see page 6 lines 20-23 and page 7 line 1-5. The argument has been considered but is unconvincing. Applicant states that Johnson does not discloses forming an incision on a mucosal surface and injecting fluid. However, Johnson discloses the use of a needle, which is seen as creating a incision, and injecting a bio compatible fluid below the mucosa, which is seen as submucosal, to form a blister ([Column 10 lines 48-53])
Applicant’s arguments, see page 7 lines 6-8, filed 08/15/2025, with respect to the rejection(s) of claim(s) 19 under 10 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tang.
Applicant’s arguments with respect to claim(s) 11-12 amendments with regards to 102(a)(2) rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Further, rejection of dependent claims 2-16 and 18 is maintained.
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.
Claims 11-15 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha (US 20210330977 A1) herein referred to as “Sinha” in view of Tang et al. (US 12035960 B2) herein referred to as “Tang”.
Regarding claim 11, Sinha discloses: A treatment method comprising: inserting an endoscopic treatment device into a body cavity ([0088] Specifically, Sinha teaches inserting the catheter into the patient), the treatment device comprising: an electrode having a hole([Figure 6]; Specifically, Sinha teaches an electrode 30 which has a hole); and a having a needle and being freely movable with respect to the electrode ([0054];Specifically, Sinha teaches a needle 112 that extends beyond the distal end and is movable with respect to the electrode); Sinha does not disclose: forming an incision from a mucosal surface to a submucosa layer by the needle; and inflating the mucosal surface by injecting fluid directly into the submucosa layer from the hole of the electrode inserted in the incision.
However, Tang discloses: forming an incision from a mucosal surface to a submucosa layer by the needle ([Column 10 lines 34-37]; “During the traditional operation, the surgeon marks the lesion with a needle knife first, then injects normal saline in the lesion with an injection needle to elevate the mucosal tissue, and cuts the lesion in the last.”); and inflating the mucosal surface by injecting fluid directly into the submucosa layer from the hole of the electrode inserted in the incision. ([Column 4 lines 58-63];” The invention provides a dual-channel injection bipolar high frequency electrosurgical knife, the active electrode of the electrosurgical knife consists of the metallic material with hollow tubular portion, and form the first liquid passageway. Liquid can flow out from the hollow tubular portion of the active electrode”)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the device as disclosed by Sinha with the method of submucosa fluid mediated inflation the motivation being to elevate the mucosal tissue or clean hemorrhage site ([Column 4 lines 64-65])
Regarding claim 12, Sinha in view of Tang discloses: The treatment method according to claim 11. Sinha does not disclose: further comprising inserting the needle into the incision and injecting the fluid to the submucosa layer via the incision when the needle provided in the incision.
However, Tang discloses: further comprising inserting the needle into the incision and injecting the fluid to the submucosa layer via the incision when the needle provided in the incision. ([Column 10 lines 34-37]; “During the traditional operation, the surgeon marks the lesion with a needle knife first, then injects normal saline in the lesion with an injection needle to elevate the mucosal tissue, and cuts the lesion in the last.”);
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the device as disclosed by Sinha with the method of submucosa fluid mediated inflation the motivation being to elevate the mucosal tissue or clean hemorrhage site ([Column 4 lines 64-65])
Regarding claim 13, Sinha in view of Tang discloses the treatment method according to claim 11. Sinha further teaches: wherein the liquid is supplied toward the incision from the hole. ([0050]; Specifically, Sinha teaches medication of liquid exiting through the catheter tip 106)
Regarding claim 14, Sinha in view of Tang discloses the treatment method according to claim 11. Sinha further teaches: wherein the hole opens at a distal end of the electrode and the liquid is supplied toward the incision from the hole ([0050]; Specifically, Sinha teaches medication or liquid exiting through the catheter tip 106 which is located at the distal end of electrode 30) in a state in which the distal end of the electrode is pressed on the incision. ([Figure 6] Specifically, Sinha teaches the electrode being at the distal end of the apparatus which is seen as being pressed on the incision)
Regarding claim 15, Sinha in view of Tang discloses the treatment method according to claim 11. Sinha further teaches: wherein forward movement the needle is restricted in a state in which the distal end of the electrode is positioned at the distal end side of the distal end of the needle. ([0090]; Specifically, Sinha teaches the electrode is extended beyond the needle tip and the needle is restricted via 114 as shown in figure 6)
Regarding claim 19, Sinha discloses: A treatment method comprising: inserting an endoscopic treatment device into a body cavity ([0088] Specifically, Sinha discloses inserting the catheter into the patient), the treatment device comprising: an electrode having an opening; ([Figure 6]; Specifically, Sinha discloses an electrode 30 which has a hole) and a needle having a needle tip;([Figure 6]; Specifically, Sinha discloses a needle 110 having a needle tip 112) forming an incision in a wall of the body cavity by the needle tip; ([0087];Specifically, Sinha discloses that the tip of the needle be inserted into tissue). Sinha does not disclose: and inflating the wall of the body cavity by injecting fluid into the wall from the opening of the electrode inserted in the incision.
However, Tang discloses: and inflating the wall of the body cavity by injecting fluid into the wall from the opening of the electrode inserted in the incision. ([Column 10 lines 34-37]; “During the traditional operation, the surgeon marks the lesion with a needle knife first, then injects normal saline in the lesion with an injection needle to elevate the mucosal tissue, and cuts the lesion in the last.” Wherein elevating the mucosal tissue is seen as inflating the wall of a body cavity);
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the device as disclosed by Sinha with the method of submucosa fluid mediated inflation the motivation being to elevate the mucosal tissue or clean hemorrhage site ([Column 4 lines 64-65])
Regarding claim 20, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: wherein the fluid is injected into the wall via the incision in a state in which the needle tip is positioned in the incision. (Specifically, Sinha discloses that the tip of the needle be inserted into tissue therefore the needle is seen as positioned in the incision)
Regarding claim 21, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: wherein the liquid is supplied toward the incision from the opening. ([0050]; Specifically, Sinha discloses medication or liquid exiting through the catheter tip 106 which is located at the distal end of electrode 30)
Regarding claim 22, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: wherein the opening is formed at a distal end of the electrode ([0050]; Specifically, Sinha discloses medication or liquid exiting through the catheter tip 106 which is located at the distal end of electrode 30), and the liquid is supplied toward the incision from the opening in a state in which the distal end of the electrode is pressed on the incision. ([Figure 6] Specifically, Sinha discloses the electrode being at the distal end of the apparatus which is seen as being pressed on the incision)
Regarding claim 23, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: wherein forward movement of the needle is restricted in a state in which the distal end of the electrode is positioned distally beyond the distal end of the needle. ([0090]; Specifically, Sinha discloses the electrode is extended beyond the needle tip)
Regarding claim 24, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: wherein: when the electrode is advanced, forward movement of the needle is restricted in a state in which the distal end of the electrode is positioned distally beyond the distal end of the needle, , ([0090]; Specifically, Sinha discloses an electrode extended beyond the needle tip) and when the electrode is retracted, backward movement of the needle is restricted in a state in which the distal end of the electrode is positioned more proximally than the distal end of the needle and the electrode abuts on a distal end of the sheath. ([Figure 11]; Specifically, Sinha discloses the electrode at the proximal end of the needle)
Regarding claim 25, Sinha in view of Tang discloses: The treatment method according to claim 19. Sinha further discloses: further comprising: peeling the submucosa layer while energizing the electrode with a high- frequency current in a state in which a distal end of the need is positioned more proximally than a distal end of the electrode. ([0048] Specifically, Sinha discloses the use of multiple types of energy which is seen as including high frequency energy)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sinha in view of Tang further in view of Johnson et al. (US 7185657 B1) herein referred to as “Johnson”.
Regarding claim 18, Sinha in view of Tang discloses: The treatment method according to claim 11. Sinha does not disclose: further comprising: peeling the submucosa layer. Sinha discloses: while energizing the electrode with a high- frequency current in a state in which the needle is positioned at a proximal end side of a distal end of the electrode. ([0048] Specifically, Sinha teaches the use of multiple types of energy which is seen as including high frequency energy)
However, Johnson discloses: further comprising: peeling the submucosa layer ([column 10 lines 9-18] Specifically, Johnson teaches the separation of the submucosa layer which is seen as peeling)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the device as disclosed by Sinha with the method of submucosa peeling as disclosed by Johnson. The motivation being to provide a submucosal pouch ([Column 10 line 18])
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sinha in view of Tang further in view of Lin et al (CN 209529285 U) herein referred to as “Lin”.
Regarding claim 16, Sinha in view of Tang discloses: The treatment method according to claim 11. Sinha does not disclose: wherein: when the electrode is advanced, movement of the position of the distal end of the needle is restricted in a state in which the distal end of the electrode is positioned at the distal end side of the distal end of the needle, and when the electrode is retracted, movement of the position of the distal end of the needle is restricted in a state in which the distal end of the electrode is positioned at the proximal end side of the distal end of the needle while the electrode abuts on a distal end of the sheath.
However, Lin discloses: wherein: when the electrode is advanced, movement of the position of the distal end of the needle is restricted in a state([Page 3 pp 8] Specifically, Lin discloses a hollow needle fixed to a handle and an extendable electrode inside the hollow needle) in which the distal end of the electrode is positioned at the distal end side of the distal end of the needle ([Figure 2], Specifically, Lin discloses the probe at the distal end of the needle), and when the electrode is retracted, movement of the position of the distal end of the needle is restricted in a state in which the distal end of the electrode is positioned at the proximal end side of the distal end of the needle while the electrode abuts on a distal end of the sheath ([Figure 1] Specifically, Lin discloses the probe retracted into the hollow needle which is seen as the proximal end side of the needle).
It would have been obvious to one of ordinary skill in the art to combine the invention as disclosed by Sinha with the extendable electrode as disclosed by Lin the motivation being to release electric stimulation near tissue and to monitor the tissue in ablation treatment.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794