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 .
Preliminary Amendment
As directed by the amendment filed on 12 May 2026: claim(s) 1-27 have been cancelled, claim(s) 28-35 have been added. Thus, claims 28-35 are presently pending.
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 31-33 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.
Claim 31 recites the limitation " laparoscopic instrument" that lacks antecedent basis.
The remaining claim(s) is/are rejected due to dependency upon a rejected claim.
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.
Claim(s) 28-30 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foote et al. (US 20170360550 A1) in view of Shelton et al. (US 20230101750 A1) and Baker et al. (US 20100030017 A1).
Regarding Claim 28, Foote discloses an intraluminal device to the cardiac region of the stomach ("intraluminal device … cardiac portion of the stomach" [0004]),
the device comprising a wall ("wall 12" [0057]; FIG. 1) defining a surface and an open portion said wall that is alignable with the gastroesophageal (GE) junction ("esophageal portion 14 that is configured to the size and shape of a portion of a mammalian lumen or hollow organ, namely, the esophagus" [0057]),
said surface and the cardiac portion of the stomach conformable with each other ("cardiac portion 16 that is configured to the size and shape of a separated portion of mammalian lumen or hollow organ, namely, the cardiac portion of the stomach" [0057]), the intraluminal device retained in the stomach in contact with the cardiac portion of the stomach with the open portion generally aligned with the GE junction ("intraluminal device 10 is positioned at the gastroesophageal region with the esophageal portion 14 in the esophagus, the cardiac portion 16 at the cardiac portion of the stomach and at least a portion of connector 18 extending through the gastroesophageal (GE) junction" [0058]; FIG. 1).
Foote fails to specify the intraluminal device is deployed by a surgical robot system said system comprising: an esophageal robotic portion an abdominal robotic portion and a robotic controller; said esophageal portion comprising at least one esophageal end-of-arm tool that is adapted to deploying the intraluminal device trans-orally to the stomach and visualizing the intraluminal device within the stomach with an endoscope; said abdominal robotic portion comprising at least one abdominal end-of-arm tool that is adapted to fastening the retained intraluminal device to the cardiac portion of the stomach through a wall of the stomach from within the abdominal cavity with an attachment fastener; and said robot control adapted to control said esophageal robotic portion and said abdominal robotic portion including adjusting relative position between said at least one abdominal robotic portion and the intraluminal device to ensure proper engagement between said attachment fastener and said intraluminal device from within the stomach while the attachment fastener is being applied from the abdomen. However, Shelton teaches a robotic surgical system ([0133]) comprising: an esophageal robotic portion ("second robotic arm 114 is configured to maneuver the imaging device 120" [0152]), an abdominal robotic portion ("first robotic arm 112 is configured to maneuver the surgical device 102" [0152]) and a robotic controller ("control circuit 170" [0168]);
said esophageal portion comprising at least one esophageal end-of-arm tool ("imaging device 120 configured to provide real-time views of the surgical site" [0145]) that is adapted to deploying the intraluminal device trans-orally to the stomach and visualizing the intraluminal device within the stomach with an endoscope ("passes an endoscope down the throat and into the stomach of the patient" [0255]);
said abdominal robotic portion comprising at least one abdominal end-of-arm tool ("first robotic arm 112 is configured to maneuver the surgical device 102" [0152]) that is adapted to operate from within the abdominal cavity (“abdominal wall is pierced and a straight tubular cannula or trocar” [0256]); and
said robot control adapted to control said esophageal robotic portion and said abdominal robotic portion including adjusting relative position between said at least one abdominal robotic portion and the intraluminal device to ensure proper engagement between said attachment fastener and said intraluminal device from within the stomach while the attachment fastener is being applied from the abdomen ("position of the surgical device 102 and the imaging device 120 can be registered relative to a particular coordinate system" [0160]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Foote to incorporate the teachings of Shelton to suitably “provide improved visualization of the patient's anatomy and/or the surgical procedure, and/or use visualization to provide improved control of a surgical tool” ([0132]).
Foote/Shelton fails to specify fastening the retained intraluminal device to the cardiac portion of the stomach through a wall of the stomach with an attachment fastener. However, Baker teaches a bariatric device (see Abstract) comprising an intraluminal device (“endoluminal bariatric device 10” [0101]) and fastening the retained intraluminal device to the cardiac portion of the stomach through a wall of the stomach with an attachment fastener ("passing tether 26 through wall 18 of esophageal member 12 through the wall of the esophagus, through the wall of the stomach at the cardiac region, and through body 21 of the cardiac member" [0101]). Therefore, it would be obvious to modify Foote/Shelton to combine with Baker to suitably “resist distal migration of bariatric device 10 while causing satiety and thereby weight loss in the recipient” ([0107]).
Regarding Claim 29, Foote discloses aligning the intraluminal device in the stomach in order to generally align the open portion with the GE junction ("intraluminal device 10 is positioned at the gastroesophageal region with the esophageal portion 14 in the esophagus" [0058]) but fails to specify the alignment is adapted to be done by at least one esophageal robotic portion. However, Shelton teaches alignment using at least one esophageal robotic portion ([0026-0027]). Therefore, it would have been obvious to modify Foote as taught by Shelton to suitably “provide improved visualization of the patient's anatomy and/or the surgical procedure, and/or use visualization to provide improved control of a surgical tool” ([0132]).
Regarding Claims 30 and 34-35, Foote discloses a retaining device adapted to retain the intraluminal device during fastening, the retaining device comprising at least one retention filament connected with the wall and the retention filament passing through the esophagus ("connector 18 extending through the gastroesophageal (GE) junction. In the illustrated embodiment, connector 18 is made up of two elongated filaments 20a, 20b" [0058]); said wall includes an involute collar around said open portion ("mesh 32 that provides a structure to bariatric device 10" [0061]); said intraluminal device comprises one chosen from a bariatric device, a metabolic disease treatment device, a gastric reflux treatment device and a hiatal hernia treatment device ("bariatric device and/or a metabolic device" [0001]).
Claim(s) 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foote/Shelton/Baker in view of Badylak et al. (US 20070166396 A1).
Regarding Claims 31-33, Foote discloses said wall has a mean radius measured from said open portion (inherent physical property of the "wall 12" [0057]; FIG. 1). Foote/Shelton/Baker teaches said laparoscopic instrument that is adapted to fasten the intraluminal device but fails to specify the intraluminal device is fastened within a half of the radius closest to said open portion; the intraluminal device is fastened within a third of the radius closest to said open portion; the intraluminal device is fastened within a quarter of the radius closest to said open portion. However, Badylak teaches an “extracellular matrix shaped into a conformation that more closely approximates the geometry of the native gastro-esophageal junction” (Abstract) wherein the intraluminal device is fastened within a half of the radius closest to said open portion; the intraluminal device is fastened within a third of the radius closest to said open portion; the intraluminal device is fastened within a quarter of the radius closest to said open portion ([0027]; FIGs. 4B-4C). Therefore, it would have been obvious to modify Foote/Shelton/Baker to suitably secure the implant to the stomach ([0026-0027]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights