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 .
Election/Restrictions
Newly submitted claims 16-20 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 16 is tissue manipulation system and claim 1 is directed to a tool to pass through a working channel of an endoscope. There claims are only capable of examining together if they become eligible for a rejoinder. Currently, no claims have been allowed, therefore these claims are not eligible for examining.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The amendment filed on 8/7/2025 has been entered. Claims 1-3, 5-15 are pending.
Claim 4 is cancelled. Applicant’s amendment to the claims have overcome objections
previously set forth in the Non-Final Office Action notified on 5/8/2025.
Claim Rejections - 35 USC § 102
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, 3, 5, 7-9, 11, 12-14, is/are rejected under 35 U.S.C. 102 as being anticipated by Lee (US 20090171147).
Regarding claim 1, Lee discloses a device for use through a working channel of an endoscope (FIG. 1; instrument 10), comprising:
a shaft (portion 38A; FIGS. 1, 12) having a proximal end and a distal end;
a tool (end effector 16; FIGS. 1-2; para [0057]) at the distal end of the shaft capable of anchoring the shaft to tissue at a target site; and
a detachable handle (portion 38A is detachable from the handle; FIGS. 2, 4, 12; Para [0070]) at the proximal end of the shaft; wherein the detachable handle comprises an inner collet (See attached FIG. 17) and an outer sleeve (See attached FIG. 17), and wherein the outer sleeve is operable to tighten the inner collet around the shaft so as to removably attach the detachable handle to the shaft (sleeve 386 tightens the grasping fingers 392. Para [0094]); and
wherein the tool and the shaft are sized to pass through a working channel of an endoscope (instrument 10 is used through a cannula; para [0057]) when the detachable handle is removed from the shaft (FIGS. 15-17).
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Regarding claim 3, Lee discloses wherein the tool comprises a clamp (jaws 44; FIGS. 1-2).
Regarding claim 5, Lee discloses wherein the proximal end of the shaft comprises threads (Note the rotational constrains of knob 24 in FIG. 1).
Regarding claim 7, Lee discloses wherein the tool comprises a grasper (jaws 44: FIGS. 1-2).
Regarding claim 8, Lee discloses wherein the grasper comprises a pair of jaws (jaws 44; FIGS. 1-2).
Regarding claim 9, Lee discloses a locking mechanism (rotation knob 24; FIG. 1) for selectively locking the tool (Any rotation of the rotation knob 24 while the instrument is locked (or unlocked) maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). FIG. 1; Para [0060]).
Regarding claim 10, Lee discloses wherein the detachable handle is operable to activate or deactivate the locking mechanism (Any rotation of the rotation knob 24 while the instrument is locked (or unlocked) maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). FIG. 1; Para [0060], [0091]).
Regarding claim 11, Lee discloses wherein the locking mechanism (rotation knob 24; FIG. 1) is comprised of a twist-lock mechanism (Any rotation of the rotation knob 24 while the instrument is locked (or unlocked) maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). FIG. 1; Para [0060]).
Regarding claim 12, Lee discloses a sheath (shaft 314 is around portion 38A; FIG. 12) positioned around at least a portion of a length of the shaft.
Regarding claim 13, Lee discloses wherein the shaft is movable within the sheath (Portions 3A, 38B are moveable within the shaft. FIG. 12).
Regarding claim 14, Lee discloses wherein the shaft includes a projection, wherein the sheath includes a slot (The slots and tapers guide and capture the four lugs 544 with their tapers 546 that are on the circumference of each of the cable lug 544. Para [0100]), and wherein the shaft is movable with respect to the sheath only when the projection is aligned within the slot (The slots and taper allows for connection of the cable portions which allows the movement of the cable during use).
Regarding claim 15, Lee discloses wherein the detachable handle is operable to deactivate the locking mechanism (Any rotation of the rotation knob 24 while the instrument is locked (or unlocked) maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). FIG. 1, 17; Para [0060], [0091]).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20090171147) in view of Swanstrom (US 20050251176).
Regarding claim 2, Lee does not expressly disclose wherein the tool comprises a sharpened helix.
Swanstrom is directed to a system for treating gastroesophageal reflux disease (GERD) (Abstract) and teaches wherein the tool comprises a sharpened helix (tissue engagement member 18; para [0055]; FIG. 3C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s tool to have a tissue engagement member in accordance with the teaching of Swanstrom so that helix could be used for drawing muscularis tissue layer (para [0055]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20090171147) in view of Swanstrom (US 20050251176).
Regarding claim 6, Regarding claim 2, Lee does not expressly disclose wherein the tool comprises a balloon.
Swanstrom is directed to a system for treating gastroesophageal reflux disease (GERD) (Abstract) and teaches wherein the tool comprises a balloon (The endoscope my comprise a balloon. Expandable members may comprise a balloon. FIGS. 8A-8B; Para [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee to include a balloon with the tool of Lee so that balloon could be used in surgical space to provide spacing between the tissue.
Response to Arguments
Applicant' s arguments filed with respect to the claims have been fully considered. However, the arguments are not persuasive for the reasons stated below.
The newly recited feature – “wherein the detachable handle comprises an inner collet and an outer sleeve, and wherein the outer sleeve is operable to tighten the inner collet around the shaft so as to removably attach the detachable handle to the shaft,” is disclosed by Lee.
Lee discloses a detachable handle (Portion 38A is detachable from the handle; FIGS. 2, 4, 12; Para [0070]) at the proximal end of the shaft; wherein the detachable handle comprises an inner collet (See attached FIG. 17) and an outer sleeve (See attached FIG. 17), and wherein the outer sleeve is operable to tighten the inner collet around the shaft so as to removably attach the detachable handle to the shaft (sleeve 386 tightens the grasping fingers 392. Para [0094]).
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See rejection set forth above.
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 SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 9/18/25