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 .
Response to Amendment
This Office action is responsive to the amendment filed 06/25/2026. Claims 1, 5, 11-13, 16 and 20 have been amended. Claims 8 and 17 have been cancelled and claims 21-22 have been newly added. Claims 1-7, 9-16 and 18-22 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 06/25/2026, with respect to objection to claims 5 and 13 have been fully considered and are persuasive. The objections have been withdrawn.
Applicant’s arguments, see pg. 7, filed 06/25/2026, with respect to rejection of claims 16-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant’s arguments, see pg. 7-8, filed 06/25/2026, regarding the rejections of the claims under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The amendments to the claims overcome the rejections in view of Kawaguchi, Messerly and Stokes. Therefore, the rejections have been withdrawn. However, after further consideration, a new grounds of rejection is made in view of Boudreaux et al. (US 20170105755).
Applicant’s arguments, see pg. 9-12, filed 06/25/2026, regarding the rejections of the claims under 35 U.S.C. 103 as being unpatentable over Boudreaux have been fully considered but they are not persuasive.
Applicant argues that a notch and a boss are not functionally interchangeable and that the proposed reversal would alter the structural and functional relationship between the components.
The Examiner disagrees. The rejection does not propose replacing the claimed pad retention feature with an opening or aperture. Instead, the rejection proposes modifying Bourdeaux by reversing the locations of the boss 1172 and notch 1204. Further, the rejection does not rely on the boss and notch being functionally interchangeable. The boss and notch are cooperating structures and reversing their locations would merely change which component includes the projecting feature and which includes the receiving feature; the cooperative engagement between the structures would remain in tact.
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.
Claims 1-4, 6-7, 9-11, 13-16, 18-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Boudreaux et al. (US 2017/0105755).
Regarding claims 1, 6, 7, 16 and 20, Boudreaux discloses a surgical instrument (see Fig. 17A -18) configured to apply ultrasonic energy to tissue disposed therein, the surgical instrument comprising: a shaft (1130, see Fig. 17B); and an end effector (end effector formed by blade 1152 and clamp arm 1210, see Fig. 17C) located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration (the end effector moves between an open and closed configuration as shown in Fig. 16D and 16E), wherein the end effector comprises: an ultrasonic blade (1152) extending from a guide (1154) and operable to treat tissue with ultrasonic energy, a clamp arm (1210) movable relative to the ultrasonic blade, a clamp pad (1212) disposed on the clamp arm and extending from a proximal end to a distal end, a pad retention feature (opening 1204 is considered a clamp pad retention feature since it prevents longitudinal movement of the clamp arm and therefore the clamp pad, see Fig. 18) proximate the clamp pad (the opening 1204 is near the clamp pad, see Fig. 18), wherein the pad retention feature is configured to prevent the clamp pad from sliding proximally therebeyond (the opening 1204 prevents the clamp arm and therefore the clamp bad from moving proximally), a tissue stop (1170) encircling the guide (waveguide 1154 is encircled by the proximal portion of 1170, see Fig. 17D and 18), wherein the tissue stop is configured to prevent tissue from moving proximally past the clamp pad when the end effector moves into the closed configuration (see [0113]), wherein the tissue stop defines an interior channel, wherein the guide is disposed in the interior channel (member 1170 has an interior channel into which the blade 1152 and guide 1154 are inserted, see Fig 17A-17B), wherein a proximal portion of the clamp pad is disposed in the interior channel when the end effector is in the closed configuration (it is understood that a proximal portion of the clamp pad is disposed in the interior channel of member 1170 in order for the member to prevent tissue from traveling to those portions as intended, see [0113] and Fig. 17C and 17D), and wherein the tissue stop abuts the clamp arm when the end effector is in the closed configuration (flaps 1296 of the tissue stop abut flaps 1290 which are connected to the clamp arm 1210 in the closed configuration, see Fig. 17D and [0113]-[0114]), wherein the tissue stop includes a first portion and a second portion (see annotated Fig. 18 below), wherein the second portion extends from the first portion (see annotated Fig. 18), wherein the first portion extends entirely around the ultrasonic blade (in the assembled position the first portion extends entirely around the blade 1152, see Fig. 17D), wherein the second portion extends partially around the ultrasonic blade (in the assembled position, the second portion extends partially around the blade 1152, see Fig. 17D), and wherein the second portion includes a U-shaped profile (the second portion containing flaps 1296 has a u-shaped profile, see annotated Fig. 18).
Boudreaux fails to expressly teach “a notch defined by the tissue stop, wherein a portion of the pad retention feature is disposed within the notch when the end effector is in the closed configuration”. Boudreaux teaches the opposite configuration. The tissue stop includes a boss 1172 that engages a notch 1204 formed by the pad retention feature.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical instrument of Boudreaux so that the tissue stop comprises a notch and the pad retention feature comprises a boss since doing so would have been a mere reversal of parts and it has been held that a mere reversal of the essential working parts of a device involves only routine skill to yield predictable results. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). See MPEP 2144.04 IV A.
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Regarding claim 2, Bourdeaux further teaches the tissue stop abuts the clamp arm when the end effector is in the closed configuration (flaps 1296 of the tissue stop abut flaps 1290 which are connected to the clamp arm 1210 in the closed configuration, see Fig. 17D and [0113]-[0114]).
Regarding claim 3, Bourdeaux further teaches the clamp arm includes a gap surface, wherein the tissue stop abuts the gap surface when the end effector is in the closed configuration (flaps 1296 of the tissue stop abut a gap surface defined by flaps 1290 which are connected to the clamp arm 1210 in the closed configuration, see Fig. 17D and [0113]-[0114]).
Regarding claim 4, Bourdeaux further teaches the clamp arm includes a proximal clamp arm surface, wherein the tissue stop abuts the proximal clamp arm surface when the end effector is in the closed configuration (flaps 1296 of the tissue stop abut a proximal clamp arm surface defined by flaps 1290 which are connected to the clamp arm 1210 in the closed configuration, see Fig. 17D and [0113]-[0114]).
Regarding claims 9, 10 and 18, Bourdeaux further teaches the tissue stop includes a pair of deflectable flaps (flap 1296 are considered deflectable because they are necessarily capable of some measure of deflection before breaking), wherein the ultrasonic blade is disposed between the pair of deflectable flaps (see Fig. 17C), wherein the pair of deflectable flaps abut the clamp arm when the end effector is in the closed configuration (flaps 1296 of the tissue stop abut flaps 1290 which are connected to the clamp arm 1210 in the closed configuration, see Fig. 17D and [0113]-[0114]).
Regarding claims 11 and 22, wherein the tissue stop is formed from an elastomeric material (see [0078]).
Bourdeaux fails to expressly teach the material having a Shore A hardness between 30 and 90, inclusive.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the elastomeric material of Bourdeaux to have a Shore A hardness between 30 and 90, inclusive, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Bourdeaux would not operate differently and would function appropriately having the claimed hardness. Further, applicant places no criticality on the range claimed, indicating simply that the hardness “may” be within the claimed ranges (specification pp. [00058]).
Regarding the limitation “wherein a remainder of the tissue stop is formed from a second material” recited in claim 11, it is noted that the claim does not require the second material to be different than the first material. The deflectable flaps 1296 of Bourdeaux are necessarily made of a second material and the remainder of the tissue stop is also necessarily made of a first material; the materials are the same.
Regarding claim 19, Bourdeaux further teaches the pair of deflectable flaps are formed from a first material, wherein a remainder of the tissue stop is formed from a second material (the claim does not require the second material to be different than the first material; the deflectable flaps 1296 are necessarily made of a first material and the remainder of the tissue stop is also necessarily made of a second material; the materials are the same).
Regarding claim 13, Bourdeaux further teaches at least one of the pair of deflectable flaps includes a first thickness, wherein a remainder of the tissue stop includes a second thickness, wherein the first thickness is less than the second thickness (the thickness of one of the flaps 1296 is less than the wall-to-wall thickness of the portion of member 1170 proximal of flaps 1296, see Fig. 18).
Regarding claim 14, Bourdeaux further teaches the tissue stop includes a deflectable flap (flaps 1296 are considered deflectable because they are necessarily capable of some measure of deflection before breaking), wherein a portion of the deflectable flap remains distal of the proximal end of the clamp pad as the end effector moves between the open configuration and the closed configuration (it is understood that a portion of the flaps 1296 remain distal of the clamp pad in order for member 1170 to prevent tissue from traveling to those portions as intended, see [0113] and Fig. 17C and 17D).
Regarding claim 15, Bourdeaux further teaches the pair of deflectable flaps abut the clamp arm as the end effector moves between the open configuration and the closed configuration (flaps 1296 of the tissue stop abut flaps 1290 which are connected to the clamp arm 1210 as the end effector moves into the closed configuration, see Fig. 17D and [0113]-[0114]).
Allowable Subject Matter
Claims 5, 12 and 21 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the closest prior art document of record, Bourdeaux, teaches the surgical instrument of claim 1, but fails to teach the tissue stop abuts the proximal clamp pad surface when the end effector is in the closed configuration.
Messerly et al. (US 20180078268), in the same field of art, teaches a related surgical instrument (see Fig. 18-19) having a clamp pad (9026) including a proximal clamp pad surface and a tissue stop (9170), which abuts the proximal clamp pad surface when the end effector is in the closed configuration (see Fig. 19).
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the tissue stop of Bourdeaux in view of the teachings of Messerly to arrive at the technical solution of claim 5 since the structure and function of the tissue stops of each reference are different.
Regarding claim 12, Bourdeaux teaches the surgical instrument of claim 9 but fails to teach each deflectable flap defines a cut out portion therethrough.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the flaps of Bourdeaux to arrive at the technical solutions of claim 12 according to the prior art of record or any combination thereof.
Regarding claim 21, Bourdeaux teaches the surgical instrument of claim 1, wherein the tissue stop includes a pair of deflectable flaps (1296, see Fig. 18) but fails to teach the deflectable flaps deflect outwardly away from one another as the clamp arm moves from the open configuration to the closed configuration.
Stokes et al. (US 20150148833), in the same field of art, teaches a related surgical instrument (see Fig. 10) having a tissue stop including a pair of deflectable flaps (680, 682) which deflect outwardly away from one another as the end effector (670) moves from the open configuration to the closed configuration (see [0093]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical instrument of Bourdeaux in view of the teachings of Stokes to arrive at the technical solution of claim 21 since the structure and function of the tissue stops of each reference are different.
Conclusion
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.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
