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 .
Claim Objections
Claims 5 and 13 are objected to because of the following informalities:
In claim 5, line 1, “…the clamp pad includes proximal clamp…” should read “…the clamp pad includes a proximal clamp…”’
In claim 13, line 3, “…less than a second thickness…” should read “less than [[a]] the second thickness”
Appropriate correction is required.
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 16-20 are 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.
Claims 16 and 20 each recite “a guide” in line 6 and again in line 8. It unclear if the second recitation of “a guide” is intended to refer to the earlier recited structure or is a separate element. For examination purposes, each recitation of a guide has been interpreted as a reference to the same feature.
Claims 17-19 are rejected by virtue of their dependency from claim 16.
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.
Claims 1-4, 6-7, 9-11, 13-15, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawaguchi et al. (US 2013/0303949).
Regarding claims 1 and 16, Kawaguchi discloses a surgical instrument (see Fig. ), comprising: a shaft (26); and an end effector (end effector formed by blade 52 and arm 60) located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration (see Fig. 8-9), wherein the end effector comprises: an ultrasonic blade (52) extending from a guide (51, see Fig. 3) and operable to treat tissue with ultrasonic energy, a clamp arm (60) movable relative to the ultrasonic blade, a clamp pad (61) disposed on the clamp arm and extending from a proximal end to a distal end, a tissue stop (see Fig. 14) defining an interior channel, wherein the guide is disposed in the interior channel (see Fig. 3), wherein the proximal end of the clamp pad is disposed in the interior channel when the end effector is in the closed configuration (see Fig. 9). Further regarding claim 1, Kawaguchi teaches the tissue stop encircling the guide (the proximal portion of the tissue stop completely encircles the guide, see Fig. 3 and 14).
Regarding claim 2, Kawaguchi discloses the surgical instrument of claim 1, wherein the tissue stop abuts the clamp arm when the end effector is in the closed configuration (the stoppers 70 of the tissue stop are set to always be superimposed onto the proximal end portion of the arm, see [0059]).
Regarding claim 3, Kawaguchi discloses the surgical instrument of claim 1, wherein the clamp arm includes a gap surface, wherein the tissue stop abuts the gap surface when the end effector is in the closed configuration (the portion of the arm that stoppers 70 are superimposed onto can be considered a gap surface, see [0059]).
Regarding claim 4, Kawaguchi discloses the surgical instrument of claim 1, wherein 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 (the portion of the arm that stoppers 70 are superimposed onto can be considered a proximal clamp arm surface, see [0059]).
Regarding claim 6, Kawaguchi discloses the surgical instrument of claim 1, wherein the tissue stop includes a first portion and a second portion (see annotated Fig. 16 below), wherein the second portion extends from the first portion, wherein the first portion extends entirely around the ultrasonic blade (see Fig. 3), wherein the second portion extends partially around the ultrasonic blade (see Fig. 8).
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Regarding claim 7, Kawaguchi discloses the surgical instrument of claim 6, wherein the second portion includes a U-shaped profile (probe cover 72 and stoppers 72 make a u-shaped profile, see Fig. 14).
Regarding claims 9, 10 and 18, Kawaguchi discloses the surgical instrument of claims 1 and 16, wherein the tissue stop includes a pair of deflectable flaps (stoppers 70 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. 8), wherein the pair of deflectable flaps abut the clamp arm when the end effector is in the closed configuration (the stoppers 70 of the tissue stop are set to always be superimposed onto the proximal end portion of the arm, see [0059]).
Regarding claims 11 and 19, Kawaguchi discloses the surgical instrument of claims 9 and 18, wherein the pair of deflectable flaps are formed from a first material, wherein a remainder of the tissue stop is formed from a second material (it is noted that the claim does not require the second material to be different than the first material; the deflectable flaps 70 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 13, Kawaguchi discloses the surgical instrument of claim 9, wherein 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 stoppers 70 is less than the wall-to-wall thickness of the cylindrical section 71, see Fig. 14).
Regarding claim 14, Kawaguchi discloses the surgical instrument of claim 9, wherein the tissue stop includes a deflectable flap (stoppers 70 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 (stoppers 70 remain distal of the proximal end of the clamp pad 61, see Fig. 8-9).
Regarding claim 15, Kawaguchi discloses the surgical instrument of claim 9, wherein the pair of deflectable flaps abut the clamp arm as the end effector moves between the open configuration and the closed configuration (the stoppers 70 of the tissue stop are set to always be superimposed onto the proximal end portion of the arm, see [0059]).
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Messerly et al. (US 2018/0078268).
Regarding claim 1, Messerly discloses a surgical instrument (see Fig. 17-19), comprising: a shaft (9004); and an end effector (9030) located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration (see Fig. 18-19), wherein the end effector comprises: a guide (9058), an ultrasonic blade (9054) extending distally from the guide and operable to treat tissue with ultrasonic energy, a clamp arm (9008) movable relative to the ultrasonic blade, a clamp pad (9026) disposed on the clamp arm and extending from a proximal end to a distal end, a tissue stop (9170) encircling the guide (linkage 9170 is located around the guide, see Fig. 17), wherein the tissue stop includes a leading surface, wherein the leading surface of the tissue stop is located distally of the proximal end of the clamp pad when the end effector is in the closed configuration (see Fig. 19).
Regarding claim 5, Messerly discloses the surgical instrument of claim 1, wherein the clamp pad (9026) includes a proximal clamp pad surface, wherein the tissue stop abuts the proximal clamp pad surface when the end effector is in the closed configuration (see Fig. 19).
Claims 1, 12 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stokes et al. (US 2015/0148833).
Regarding claim 1, Stokes discloses a surgical instrument (see Fig. 4), comprising: a shaft (130); and an end effector (140) located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration (see Fig. 6A-6B), wherein the end effector comprises: a guide (138), an ultrasonic blade (142) extending distally from the guide and operable to treat tissue with ultrasonic energy, a clamp arm (142) movable relative to the ultrasonic blade, a clamp pad (146) disposed on the clamp arm and extending from a proximal end to a distal end, a tissue stop encircling the guide (the end effector can have shields 680, 682 which encircle the guide and blade since these parts are integral, see Fig. 10 and [0093]), wherein the tissue stop includes a leading surface, wherein the leading surface of the tissue stop is located distally of the proximal end of the clamp pad when the end effector is in the closed configuration (while the clamp pad is not shown in Fig. 10, it is understood that if shields 680, 682 extend past the distal end of the blade 672 , as shown, the shields would be located distally of the proximal end of the clamp bad when the end effector is in the closed position, see also Fig. 9A and 9B).
Regarding claim 12, Stokes discloses the surgical instrument of claim 9, wherein at least one of the pair of deflectable flaps (680, 682) defines one of a slit therethrough and a cut out portion (the pair of deflectable flaps meet a seam or slit 684, see Fig. 10).
Regarding claim 16, Stokes discloses a surgical instrument (see Fig. 11-13), comprising: a shaft (732); and an end effector (740) located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration (the embodiment of Fig. 11-13 is movable between an open and closed configuration similar to what is shown in Fig. 6A-6B), wherein the end effector comprises: an ultrasonic blade (742) extending from a guide (the blade extends from a guide similar to the embodiment in Fig. 6A which shows blade 142 extending from waveguide 138) and operable to treat tissue with ultrasonic energy, a clamp arm (744) movable relative to the ultrasonic blade, a clamp pad (746) disposed on the clamp arm and extending from a proximal end to a distal end, a tissue stop (700) defining an interior channel (see Fig. 11), wherein the guide is disposed in the interior channel (the guide is partially disposed in the interior channel of the shield 700, see Fig. 12), wherein the proximal end of the clamp pad is disposed in the interior channel when the end effector is in the closed configuration (the proximal end of the clamp pad 746 would be within the interior channel when the end effector is in the closed configuration, see Fig. 12).
Regarding claim 17, Stokes discloses the surgical instrument of claim 16, wherein the end effector comprises further comprises: a pad retention feature (the pin about which the clamp arm rotates is considered a pad retention features since it prevents the clamp arm and therefore the clamp pad from moving proximally, see Fig. 12) proximate the clamp pad (the pad retention feature is near the clamp pad in the assembled position), wherein the pad retention feature is configured to prevent the clamp pad from sliding proximally therebeyond (the pad retention feature prevents the clamp pad from sliding proximally by restricting longitudinal movement of the clamp arm); and a notch defined by the tissue stop (see annotated Fig. 11 below), wherein a portion of the pad retention feature is disposed within the notch when the end effector is in the closed configuration (in the assembled position, the pin about which the clamp arm rotates is within the notch in the shield, see Fig. 12-13).
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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, 6, 7, 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boudreaux et al. (US 2017/0105755).
Regarding claims 1, 6, 7, 8 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 therefor 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 abuts the clamp arm when the end effector is in the closed configuration (the flaps 1296 of the tissue stop abut the 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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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of documents cited in the attached PTO-892 teach related surgical instruments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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