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 § 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 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.
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 1-5, 8, 10-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Goto, US 20190290325, herein referred to as “Goto”, in view of Rahmani, US 20070260112, herein referred to as “Rahmani”.
Regarding claim 1, Goto discloses an endoscopic treatment method for resecting a full thickness of a gastrointestinal wall under an endoscope (Figures 1-14), the method comprising: fixing a traction device to a first location positioned further outside a target tissue (Figures 6 and 8); pulling the first location using the traction device so that a first region and a second region approach each other (Figure 9), to lift the full thickness of the gastrointestinal wall including the target tissue toward a gastrointestinal lumen side (Figure 10); and resecting the target tissue placed in the lumen side of the sutured area (Figures 11-13). Goto does not explicitly teach a method comprising pulling the first location using the traction device so that a first region and a second region are folded and approach each other along a fold line that passes through the first location and divides the target tissue into the first region and the second region; and suturing the lifted gastrointestinal wall positioned further outside the target tissue.
However, Rahmani teaches a method (Figures 1a-6) comprising pulling the first location using the traction device so that a first region and a second region are folded and approach each other along a fold line that passes through the first location and divides the target tissue into the first region and the second region (Figure 2 and [0056]: “Suction is provided in the beveled barrel 25 of the ligator, thereby causing tissue of the mucosa layer 17 and the submucosa layer 18 to pull away from muscle 20 and be drawn into the barrel 25.”); and suturing the lifted gastrointestinal wall positioned further outside the target tissue (Figure 3 and [0056]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes pulling the first location using the traction device so that a first region and a second region are folded and approach each other along a fold line that passes through the first location and divides the target tissue into the first region and the second region; and suturing the lifted gastrointestinal wall positioned further outside the target tissue as taught by Rahmani so that the size of the wound produced at each treatment site can be estimated (Rahmani [0063]) so that a software program can be beneficially used to guide the physician as to what percentage of the tissue wall should be treated and/or what pattern of tissue removal should be utilized (Rahmani [0065]).
Regarding claim 2, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Goto further discloses a method further comprising: making a full circumferential incision in tissue around the target tissue up to a submucosal layer (Goto Figure 4-5), wherein the first location is further inside the incised site (Goto Figure 6), and Rahmani further discloses a method wherein the sutured area of the gastrointestinal wall is the submucosal layer exposed by incision (Rahmani Figures 3 and 6: submucosal layer 18).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that the sutured area of the gastrointestinal wall is the submucosal layer exposed by incision as taught by Rahmani so that the healing can cause a beneficial thickening of underlying muscle tissue (Rahmani [0058]).
Regarding claim 3, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Rahmani further discloses a method further comprising: moving the endoscope so that an endoscope optical axis is substantially parallel to the fold line after bringing the first region and the second region closer together and before suturing the submucosal layer (Figure 2: multi-band ligator 22 is substantially parallel to the fold line).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes moving the endoscope so that an endoscope optical axis is substantially parallel to the fold line after bringing the first region and the second region closer together and before suturing the submucosal layer as taught by Rahmani so that the size of the wound produced at each treatment site can be estimated (Rahmani [0063]) so that a software program can be beneficially used to guide the physician as to what percentage of the tissue wall should be treated and/or what pattern of tissue removal should be utilized (Rahmani [0065]).
Regarding claim 4, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Rahmani further discloses a method further comprising: performing pressing so that the first region and the second region are in close contact with each other after lifting the target tissue using the traction device and before suturing the submucosal layer (Figure 2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes performing pressing so that the first region and the second region are in close contact with each other after lifting the target tissue using the traction device and before suturing the submucosal layer as taught by Rahmani so that the size of the wound produced at each treatment site can be estimated (Rahmani [0063]) so that a software program can be beneficially used to guide the physician as to what percentage of the tissue wall should be treated and/or what pattern of tissue removal should be utilized (Rahmani [0065]).
Regarding claim 5, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 4, and Rahmani further discloses a method further comprising: performing pressing so that the first region and the second region are in close contact with each other using a pinching device capable of pinching tissue (Figure 2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes performing pressing so that the first region and the second region are in close contact with each other using a pinching device capable of pinching tissue by Rahmani so that the size of the wound produced at each treatment site can be estimated (Rahmani [0063]) so that a software program can be beneficially used to guide the physician as to what percentage of the tissue wall should be treated and/or what pattern of tissue removal should be utilized (Rahmani [0065]).
Regarding claim 8, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Rahmani further discloses a method wherein suture and resection of the target tissue are performed multiple times ([0045]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that suture and resection of the target tissue are performed multiple times as taught by Rahmani to ensure that the treatments result in the desired reshaping of the body lumen when a subsequent tissue healing process occurs (Rahmani [0045]).
Regarding claim 10, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Goto further discloses a method wherein the first location is positioned proximal to the target tissue when viewed from the endoscope (Figure 6).
Regarding claim 11, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 10, and Goto further discloses a method further comprising: lifting a second location positioned on a distal side when viewed from the endoscope in addition to the first location (Figure 8).
Regarding claim 14, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Goto further discloses a method wherein the traction device is a needle-attached suture (Figures 7A-B).
Regarding claim 15, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, and Goto further discloses a method wherein the traction device includes at least one of a penetration member that penetrates tissue (Figures 7A-B: needle 44) and a gripping member that grips the tissue (Figure 6: grasping portion 31), and a connection member connected to the one of them (Figures 7A-B: suture thread 40).
Claims 6-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Goto in view of Rahmani, further in view of Calvo et al., US 20230248346, herein referred to as “Calvo”.
Regarding claim 6, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 5, but does not explicitly disclose a method wherein the pinching device is a linear stapler or a clip.
However, Calvo teaches an endoscopic treatment method (Figure 1-2) wherein the pinching device is a linear stapler or a clip (Figure 1-2 and [0044]: “the tissue-engagement member 200, 202 is an adjustable clip (such as a hemostatic clip) with first and second grasper arms 210 (which may be alternately referenced herein as jaws without intent to limit) movable with respect to each other between an open configuration and a closed configuration.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that the pinching device is a linear stapler or a clip as taught by Calvo so that the pinching device may be configured to allow for the clip to be releasably engaged (e.g., closed, but not locked, into engagement) with tissue when in a first configuration, and locked against opening out of engagement with tissue when in a second closed configuration (Calvo [0032]).
Regarding claim 7, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 5, but does not explicitly disclose a method wherein, when the target tissue is lifted by the traction device, the pinching device is movable regardless of the position of the traction device.
However, Calvo teaches an endoscopic treatment method (Figure 1-2) wherein, when the target tissue is lifted by the traction device, the pinching device is movable regardless of the position of the traction device (Figures 1-2: tissue engagement member 200 is movable regardless of the position of tissue-engagement member 202).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that when the target tissue is lifted by the traction device, the pinching device is movable regardless of the position of the traction device as taught by Calvo so that the pinching device may be configured to allow for the clip to be releasably engaged (e.g., closed, but not locked, into engagement) with tissue when in a first configuration, and locked against opening out of engagement with tissue when in a second closed configuration (Calvo [0032]).
Regarding claim 12, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 11, but does not explicitly disclose a method further comprising: attaching the traction device to a third location between the first location and the second location in addition to the first location and the second location to assist in lifting the target tissue.
However, Calvo teaches an endoscopic treatment method (Figure 1-2) further comprising: attaching the traction device to a third location between the first location and the second location in addition to the first location and the second location to assist in lifting the target tissue (Figure 2: tissue-engagement members 200, 202, and 204).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes attaching the traction device to a third location between the first location and the second location in addition to the first location and the second location to assist in lifting the target tissue as taught by Calvo so that the traction devices can be releasably engaged (e.g., closed, but not locked, into engagement) with tissue when in a first configuration, and locked against opening out of engagement with tissue when in a second closed configuration (Calvo [0032]).
Claims 9 and 13are rejected under 35 U.S.C. 103 as being unpatentable over Goto in view of Rahmani, further in view of Binmoeller et al., US 20210298739, herein referred to as “Binmoeller”.
Regarding claim 9, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, but does not explicitly disclose a method further comprising: fixing the traction device through a muscle layer when the traction device is fixed to the first location.
However, Binmoeller teaches a method comprising fixing the traction device through a muscle layer when the traction device is fixed to the first location ([0073]: “The relatively loose configuration 44 is designed to utilize rotational forces to embed the second helical anchor 42 into the mucosal, submucosal or muscle tissues.” And [0084]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes fixing the traction device through a muscle layer when the traction device is fixed to the first location as taught by Binmoeller so that a defect in intestinal mucosal, submucosal or muscle tissues can be closed (Binmoeller [0084]).
Regarding claim 13, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 1, but does not explicitly disclose a method further comprising: lifting the target tissue to a position where a muscle layer of the target tissue is sufficiently retracted to the gastrointestinal lumen side when performing lifting.
However, Binmoeller teaches a method comprising lifting the target tissue to a position where a muscle layer of the target tissue is sufficiently retracted to the gastrointestinal lumen side when performing lifting ([0073]: “The relatively loose configuration 44 is designed to utilize rotational forces to embed the second helical anchor 42 into the mucosal, submucosal or muscle tissues.” And [0084]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes lifting the target tissue to a position where a muscle layer of the target tissue is sufficiently retracted to the gastrointestinal lumen side when performing lifting as taught by Binmoeller so that a defect in intestinal mucosal, submucosal or muscle tissues can be closed (Binmoeller [0084]).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goto in view of Rahmani, further in view of Mitelberg et al., US 20200178956, herein referred to as “Mitelberg”.
Regarding claim 16, Goto in view of Rahmani discloses the endoscopic treatment method according to claim 15, but does not explicitly disclose a method further comprising: fixing the traction device to a fourth location in tissue of the gastrointestinal wall facing the target tissue to connect the first location to the fourth location via the connection member.
However, Mitelberg teaches an endoscopic treatment method comprising: fixing the traction device to a fourth location in tissue of the gastrointestinal wall facing the target tissue to connect the first location to the fourth location via the connection member (Figures 22-23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes fixing the traction device to a fourth location in tissue of the gastrointestinal wall facing the target tissue to connect the first location to the fourth location via the connection member as taught by Mitelberg so that a gastric defect, like a submucosal resection site or a tissue perforation can be treated (Mitelberg [0091]).
Regarding claim 17, Goto in view of Rahmani and Mitelberg discloses the endoscopic treatment method according to claim 16, and Mitelberg further discloses a method further comprising: pulling the connection member to apply tension to the connection member that connects the first location to the fourth location (Figures 22-27 and [0091]: “The defect 700 is closed by positioning four suture anchors such that the suture extends in a zig-zag configuration about the defect. Then, the suture is cinched and secured with cinch 702 to approximate the surrounding tissue, as shown in FIG. 24. In another example, shown in FIGS. 25 through 27, the defect 710 can be closed by placing anchors about a periphery of the defect and cinching the suture like a ‘purse string’.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that it includes pulling the connection member to apply tension to the connection member that connects the first location to the fourth location as taught by Mitelberg so that a gastric defect, like a submucosal resection site or a tissue perforation can be treated (Mitelberg [0091]).
Regarding claim 18, Goto in view of Rahmani and Mitelberg discloses the endoscopic treatment method according to claim 16, and Mitelberg further discloses a method wherein the fourth location is placed at a position facing the first location (Figures 22-23 and Figures 25-26).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Goto so that the fourth location is placed at a position facing the first location as taught by Mitelberg so that a gastric defect, like a submucosal resection site or a tissue perforation can be treated (Mitelberg [0091]).
Regarding claim 19, Goto in view of Rahmani and Mitelberg discloses the endoscopic treatment method according to claim 16, and Goto further discloses a method further comprising: applying tension to the connection member that connects the first location to the other location by delivering air endoscopically and dilating the lumen ([0011] and [0073]). In combination with Mitelberg, the other location is the fourth location.
Regarding claim 20, Goto in view of Rahmani and Mitelberg discloses the endoscopic treatment method according to claim 16, and Goto further discloses a method further comprising: adjusting a tension of the connection member that connects the first location to the other location in the middle of resection when resecting the target tissue ([0073] and [0087]). In combination with Mitelberg, the other location is the fourth location.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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, Joanne Rodden can be reached on 3032974276. 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.
/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
Prosecution Insights