DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 04/16/2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 18 is 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.
Regarding claim 18, the claim recites “a third actuator”, however claim 17 (from which claim 18 depends) previously introduces “a third actuator” – therefore it is unclear whether the “third actuator” of claim 18 is the same third actuator of claim 17 or a different and separate third actuator, therefore rendering the claim indefinite. For examination purposes, the claim 18 recitation will presume to read as “a fourth actuator”.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 8-9, 11, and 22-25 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 2010/0241139 A1 to Harshman (hereinafter “Harshman”) (previously of record).
Regarding claim 8, Harshman discloses (see abstract; Figs. 1-8; and [0016]-[0024]) a tissue shaping device (see at least [0016]), comprising: a distal end configured to be inserted into a stomach of a patient (as shown in Fig. 3, see [0022]) , the distal end comprising: a shaft (shaft connected to tissue engaging element 6 shown in Fig. 3); an outer wall (4) disposed around the shaft (see Fig. 3), wherein the outer wall comprises a plurality of slits (lateral openings 18, see Fig. 3 and [0019]) that extend from a proximal end toward a distal end of the wall (as shown in Fig. 3); a recess disposed between the shaft and the outer wall (see Fig. 3, defining recess 16 as per [0019]); a first displacing element (6) disposed within the recess and configured to extend from and retract to the recess (see Fig. 3 and [0017]); an engaging element (8) disposed at a longitudinal end of the displacing element (see Fig. 3 and [0017]); a fastener (22) disposed within the recess (see [0020]), the fastener configured to fasten folds of reshaped tissue (see [0024]); a control handle proximally connected to the distal end (as shown in Fig. 1), the control handle comprising: a first actuator (23, see Fig. 1) configured to extend and retract the first displacing element from within the recess (see [0021]-[0022]); a second actuator (13, see Fig. 1) configured to cause the engaging element to engage the tissue (see [0017]).
Harshman further discloses (claim 9) wherein the control handle further comprises: a third actuator (19, see Fig. 1) configured to move the fastener between a stored position and a deployed position (see [0020]); (claim 11) a suction lumen configured to provide suction to vacuum orifices disposed on an outer circumferential surface of the shaft (see [0023]).
Regarding claim 22, Harshman discloses (see abstract; Figs. 1-8; and [0016]-[0024]) a device for forming a fold of tissue at the intersection between the esophagus and the stomach (see [0022]), comprising: a distal end configured to be inserted into the stomach of a patient (as shown in Fig. 3, see [0022]), the distal end comprising: a shaft (shaft connected to tissue engaging element 6 shown in Fig. 3); an outer wall (4) disposed around the shaft (see Fig. 3); a recess disposed between the shaft and the outer wall (see Fig. 3, defining recess 16 as per [0019]); a displacing element (6) disposed within the recess and configured to extend from and retract to the recess and configured to reshape the stomach tissue (see Fig. 3 and [0017]); a slot (indicated by #13 in Fig. 3) configured to allow radial movement of the displacing element relative to the shaft (see Figs. 3-5 and [0017]), wherein the slot is transverse to the length of the shaft (the slot is transverse to the length of the shaft as it passes through the slot, see e.g. Fig. 5); and a control interface proximally connected to the distal end (a shown in Fig. 1), the control interface comprising: a first actuator (13, see Fig. 1) configured to initiate radial movement of the displacement element relative to the shaft (see Fig. 1 and [0017]).
Harshman further discloses (claim 23) wherein the slot is further configured to allow longitudinal movement of the displacing element relative to the shaft (see Fig. 3, the slot is elongated in the longitudinal direction thus allowing longitudinal movement); (claim 24) wherein the control interface further comprises a second actuator (23, see Fig. 1) configured to initiate longitudinal movement of the displacement element relative to the shaft (see [0021]-[0022]); and (claim 25) wherein the control interface further comprises: a locking mechanism ("lock", see [0017]) configured to fix the displacing element in a fixed position relative to the shaft (see [0017]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 12-13, 15-16, 20-21, and 26-27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harshman in view of US 6,736,828 B1 to Adams et al. (hereinafter “Adams”) (previously of record).
Regarding claims 12-13, and 26-27, Harshman discloses the invention substantially as claimed as discussed above, however, Harshman fails to specifically disclose wherein the displacing element is coupled to a tension sensor, the tension sensor configured to measure force exerted on tissue during reshaping, wherein the control interface further comprises: a tension indicator coupled to the tension sensor, the tension indicator configured to display a level of tension applied to the displacing element. Adams discloses a device capable of forming the intersection between the esophagus and the stomach (see abstract and Col. 1, line 14 - Col. 2, line 42) comprising a tension sensor coupled to a tissue displacing element (18), the tension sensor capable of measuring a tension force exerted on tissue during reshaping, and an indicator (the relative position of tissue grasping device 18 with respect to endoscope 16 provides a visual indication to the user as to the extent of the tension) coupled to the sensor which provides an indication to a user relating to the tension sensed by the tension sensor in the same field of endeavor for the purpose of allowing the practitioner to control the tension which the device applies to the engaged tissue (see Col. 4, lines 25-39). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Harshman's device with the tension sensor taught by Adams in order to allow the practitioner to control the tension which the device applies to the engaged tissue.
Regarding claims 15-16, Harshman fails to specifically disclose wherein the distal end further comprises: an inflatable balloon disposed within the recess, the inflatable balloon configured to apply a compressive force to clamp the reshaped tissue. Adams discloses a tissue shaping device (see abstract and Col. 1, line 14 - Col. 2, line 42) comprising a fastener for securing folds of gastric tissue (see Fig. 12 and Col. 6, lines 42-61), the fastener comprising an inflatable balloon (58) configured to apply a compressive force to clamp reshaped tissue (see Col. 6, lines 50-51), and an actuator configured to initiate inflation of the balloon (see Col. 6, lines 42-61, inherent that a user accessible actuator is present to initiate inflation flow through inflation tube) in the same field of endeavor for the purpose of providing a fastener for improved securing of gastric folds by providing balloon members which help to grasp the tissue (see Col. 6, lines 42-52). Given that Harshman merely discloses that any fastener is suitable for use (see [0020]), it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Harshman's fastener with the balloon-end fastener taught by Adams in order to provide a fastener for improved securing of gastric folds by providing balloon members which help to grasp the tissue. In making the proposed combination, the distal end of Harshman's device would have the inflatable balloon disposed within the recess (because that is where the fastener is), with the inflatable balloon on the fastener applying a clamping force to clamp the reshaped tissue, and further, Harshman's control handle would be modified to accommodate the necessary inflation lumen and actuator therefore.
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harshman in view of US 2012/0165842 A1 to Stokes et al. (hereinafter “Stokes”) (previously of record).
Regarding claim 10, Harshman discloses the invention substantially as claimed as discussed above, however, Harshman fails to specifically disclose wherein the control handle further comprises: a common retractor configured to simultaneously retract the first displacing element and a second displacing element to within the recess. Stokes discloses, in the same field of endeavor, a tissue shaping device (see abstract; Figs. 1-5; and [0063]-[0087]) comprising a displacing element (40) and an engaging element (44) disposed at a longitudinal end of the displacing element (see Fig. 4A and [0076]-[0077]); wherein multiple displacing elements are used (see [0075]), and a common retractor configured to simultaneously retract the multiple displacing elements into a recess (26) (see [0084]) for the purpose of simultaneously manipulating multiple displacing elements to create the tissue fold by allowing for the creation of a tissue fold "line" rather than a "tent" by grasping tissue at two spaced apart locations which increases the area to place a fastener, thus decreasing the number of acquisitions required for obtaining a fold of the desired length/depth (see [0075]/[0084]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Harshman's device with the common retractor taught by Stokes in order to simultaneously manipulate multiple displacing elements to create the tissue fold by allowing for the creation of a tissue fold "line" rather than a "tent" by grasping tissue at two spaced apart locations which increases the area to place a fastener, thus decreasing the number of acquisitions required for obtaining a fold of the desired length/depth.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 17 and 19-21 are allowed.
Claim 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Harshman, alone or in combination with Adams, fails to teach or suggest wherein the control handle comprises an actuator that locks a position of the first displacing element at a specific tension point (Adams does not teach or disclose any such tension lock). While tension locks are generally well known, the prior art fails to teach or suggest a tension lock for an actuator on a control handle at the proximal end of the device which is directed to the tension applied to a displacing element configured to draw tissue into a mold/shaper to create a tissue fold.
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 04/16/2026, with respect to independent claim 17 have been fully considered and are persuasive. The rejection of claim 17 and dependents has been withdrawn. Claim 17 was amended to include subject matter similar to previously indicated as allowable claim 14, and would be allowable for the same reasons.
Applicant's arguments filed 04/16/2026 with respect to independent claims 8 and 22 have been fully considered but they are not persuasive.
Harshman indeed discloses the outer wall comprising a plurality of slits that extend from a proximal end toward a distal end of the wall – these are shown as lateral openings 18 in Fig. 3 and discussed at [0019]. Further, Harshman discloses the slot being transverse to the length of the shaft - the slot is transverse to the length of the shaft as it passes through the slot, see e.g. Fig. 5. Accordingly, Applicant’s arguments are not persuasive.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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