DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 06/17/2026.
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 § 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 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) 1-2, 4-7, 8, and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0351910 A1 to Gilmore et al. (hereinafter “Gilmore”).
Regarding claim 1, Gilmore discloses (see abstract; Figs. 1A-7D; and [0237]-[0399]) a grasping device (20) for use with a tissue recruiting device, the grasping device comprising: a grasping portion (30) near a distal end of the grasping device, the grasping portion including a tip (34) and a plurality of helical coils (at 106 + 110, see Figs. 1A-1B); a coupling portion (40 + 114 + 116) near a proximal end of the grasping device (see Figs. 1A-B), the coupling portion being configured to couple with an actuation element (624, see Fig. 7B) of the tissue recruiting device (622); and a flexible portion (see [0247]-[0273], flexible portion is at portion 102 in Fig. 1A and portion immediately proximal thereto spanning between 102 and 116) configured to permit the grasping device to flex (see [0247]-[0273]); wherein the grasping device is translatable and rotatable via the actuation element to insert the grasping portion into tissue (see Figs. 5A-7D and [0352]-[0360]); wherein the flexible portion is configured to allow the coupling portion to flex when the grasping portion is inserted into tissue (see [0247]-[0273]); and wherein the coupling portion is operably decoupled from the actuation element such that the grasping device may remain deployed grasping tissue within a body when the actuation element is retracted from the body (see Figs. 5A-7D and [0352]-[0360]).
Gilmore further discloses (claim 2) wherein the flexible portion comprises a plurality of flexible slots (as best shown in Fig. 4A, the portion mentioned as the flexible portion above shows a first flexible slot and the cross section in Fig. 4B shows a corresponding opposing second flexible slot); (claim 4) wherein the grasping portion includes a proximal portion (two distal-most coils of 160, Fig. 2A) and a distal portion (150, Fig. 2A), wherein the helical coils of the proximal portion are narrower than the helical coils of the distal portion (see Figs. 2A-B); (claim 5) wherein the grasping portion includes a proximal portion (two distal-most coils of 160, Fig. 2A) and a distal portion (150, Fig. 2A), wherein a pitch of the helical coils of the proximal portion is lower than a pitch of the helical coils of the distal portion (see Figs. 2A-B and [0036]); (claim 6) further comprising two flutes (see [0299]); (claim 7) further comprising detents (shown near #42 in Figs. 1A-1B) in the coupling portion fully capable of operably coupling with prongs of a coupler (see Figs. 1A-1B).
Regarding claim 8, Gilmore discloses (see abstract; Figs. 1A-7D; and [0237]-[0399]) a grasping device (20) for use with a tissue recruiting device, the grasping device comprising: a grasping portion (30) near a distal end of the grasping device, the grasping portion including a tip (34) and a plurality of helical coils (at 106 + 110, see Figs. 1A-1B); a coupling portion (40 + 114 + 116) near a proximal end of the grasping device (see Figs. 1A-B), the coupling portion being configured to couple with an actuation element (624, see Fig. 7B) of the tissue recruiting device (622);wherein the grasping portion includes a proximal portion (two distal-most coils of 160, Fig. 2A) and a distal portion (150, Fig. 2A), the helical coils of the proximal portion having a pitch less than a pitch of the helical coils of the distal portion (see Figs. 2A-B and [0036]); wherein the grasping device is translatable and rotatable via the actuation element to insert the grasping portion into tissue (see Figs. 5A-7D and [0352]-[0360]); wherein the coupling portion is operably decoupled from the actuation element such that the grasping device may remain deployed grasping tissue within a body when the actuation element is retracted from the body (see Figs. 5A-7D and [0352]-[0360]), and wherein the proximal portion is configured to prevent the grasping portion from being inserted into tissue past the distal portion (see [0250]/[0279] and Figs. 3F/6).
Gilmore further discloses (claim 10) further comprising a flexible portion (see [0247]-[0273], flexible portion is at portion 102 in Fig. 1A and portion immediately proximal thereto spanning between 102 and 116) configured to permit the grasping device to flex when the distal portion is inserted into tissue (see [0247]-[0273]); (claim 11) wherein the grasping portion comprises a plurality of barbs (104, see Fig. 1A and [0281]); (claim 12) wherein the coupling portion comprises a receiving portion (114) configured to couple with the actuation element; (claim 13) wherein a proximal end of the coupling portion is tapered (see Figs. 1A-B); and (claim 14) further comprising two flutes (see [0299]).
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.
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) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0165842 A1 to Stokes et al. (hereinafter “Stokes”), optionally in view of US 2015/0065938 A1 to Zeiner et al. (hereinafter “Zeiner”), and in view of US 2005/0251160 A1 to Saadat et al. (hereinafter “Saadat”) (all references previously of record)
Regarding claim 15, Stokes discloses (see abstract; Figs. 1-5; and [0063]-[0089]) a tissue recruiting device (10, Fig. 1) comprising: a tissue recruiting assembly comprising a first grasping device (42/44) and a second grasping device (42/44) (see Fig. 5 and [0075]-[0076]), each grasping device including a coupling portion (42) and a grasping portion (44) having a plurality of helical coils (see Figs. 2-5 and [0074]-[0077]); and an actuation assembly ("actuating assembly", see [0076]) comprising a first control actuator coupled with the first grasping device by a first actuation element ("control wire(s)", see [0076]) and a second control actuator coupled with the second grasping device by a second actuation element ("control wire(s)", see [0076]); wherein the coupling portion of the first grasping device is coupled with a distal end of first actuation element and the coupling portion of the second grasping device is coupled with a distal end of the second actuation element (see [0076]); wherein the first control actuator is operable to translate and rotate the first grasping device to grasp tissue on a first side of a defect and the second control actuator is operable to translate and rotate the second grasping device to grasp tissue on a second side of the defect (see Figs. 2-5, [0074]-[0077], and [0083]-[0084]), wherein the first grasping device includes a flexible portion (42)configured to allow the coupling portion of the first grasping device to flex when the grasping portion of the first grasping device is inserted into tissue (see [0076]).
Stokes further discloses (claim 16) wherein the coupling portion of each grasping device is coupled to the distal end of the actuation element with a coupler (see [0076]); (claim 17) wherein the first grasping device may be rotated and translated independently from the second grasping device (see [0074]-[0077], and [0083]-[0084]); (claim 19) wherein the first control actuator is operable to retract the first grasping device and the second control actuator is operable to retract the second grasping device when the grasping devices grasp tissue (see [0076]); and (claim 20) wherein the tissue recruiting assembly extends through a catheter (20) inserted through an endoscope (2) (see [0064]-[0068]).
With respect to claim 15 and the limitation wherein the coupling portion is operably decoupled from the actuation element, Stokes discloses that the device, comprising an actuation element (e.g., handle assembly 14) is operatively coupled to the coupling portion (e.g., end effector 20) – see [0066]; and that the tissue manipulator 40 can be coupled to an actuator for actuating the tissue manipulator – see [0076]. Therefore, because the tissue manipulator 40 is operatively coupled to the actuator, and there is no disclosure that the manipulator and actuator are permanently coupled, fused, irreversibly bonded, etc. to each other, it is apparent that these structures, being operatively coupled to each other, are also configured to be operatively decoupled from each other.
Nonetheless, in the interests of compact prosecution, and in accordance with MPEP 2112-2112.02, an alternate 103 rejection is set forth providing a rationale for making the coupling portion operably decoupled from the actuation element. Zeiner discloses, in the same field of endeavor of transoral stomach treating devices (see abstract), an instrument comprising an actuation assembly (handle 110) and an end effector (see Fig. 3, handle assembly 110 and structures showing end effector on right side of Figure near #s 20/30 including shaft assembly 130), wherein the actuation assembly is operably coupled to the end effector (via deployment cables 140/142, see [0043]), wherein the actuation assembly is operably decoupled to the end effector (see [0042]) for the purpose of decoupling the handle from the rest of the device so the handle may be re-sterilized and reused with the rest of the device is disposed of after a single use. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Stokes’ device by operably decoupling the tissue manipulator and the actuation element, as taught by Zeiner, in order to re-sterilize the handle and allow it be reused while the rest of the device is disposed of after a single use.
Stokes, although disclosing that the distal tip can have a variety of configurations to enable the tissue manipulator to engage, penetrate, and/or grip tissue (see [0077]), fails to specifically disclose, with respect to claim 18, wherein the grasping portion of each grasping device includes a proximal portion and a distal portion, wherein the helical coils of the proximal portion having a pitch less than a pitch of the helical coils of the distal portion. Saadat discloses (see abstract; Figs. 1B and 4A-F; and [0128]-[0131] & [0149]-[0153]), in the same field of endeavor, an apparatus for manipulating tissue comprising a grasping device (20 + 30) comprising grasping portion (30) being a helical coil (see Figs. 1B and 4A-F); wherein the grasping portion includes a proximal portion and a distal portion, wherein a pitch of the helical coils of the proximal portion is lower than a pitch of the helical coils of the distal portion (see Fig. 4C and [0150], the proximal portion has a lower pitch than the distal portion). Given that Stokes discloses that the distal tip can have a variety of configurations to enable the tissue manipulator to engage, penetrate, and/or grip tissue, and Saadat discloses several helical coil variations which enable a tissue manipulator to engage, penetrate, and/or grip tissue, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of combining prior art elements according to known methods to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a tissue manipulator which can engage, penetrate, and/or grip tissue.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-7, 8, and 10-14 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.
Applicant’s arguments with respect to claim(s) 15-20 have been fully considered but they are not persuasive. Applicant alleges that the tissue manipulator shaft 42 is part of the actuation elements, and not part of the claimed grasping device. This is not persuasive because as shown in the rejection, other elements in Stokes represent the claimed actuation elements. The rejection specifically identifies element 42 as being part of the claimed grasping device. The claimed grasping device is not merely the helical coil portion 40 of Stokes, but rather can include other structures as well based on the claim language where the grasping portion has a plurality of helical coils – thus the claimed grasping portion would correspond to element 40 of Stokes, but it is within the BRI of the claims as set forth to interpret element 42 of Stokes as part of the grasping device and which includes a flexible portion fully capable of allowing the coupling portion to flex. Therefore, Applicant’s arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0028180 to Binmoeller et al. is made of record as being relevant to the claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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