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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on February 6, 2026 has been entered. Claims 22, 25-29, 31-35, and 38-41 are pending in the application. Response to applicant's arguments can be found at the end of this office action.
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 22, 25, 26, 28, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Stringham et al. (U.S. Patent Application Publication No. 20130023866; hereinafter “Stringham”) in view of Olichney et al. (U.S. Patent No. 5421829; hereinafter “Olichney”), Chen et al. (U.S. Patent Application Publication No. 20140009891; hereinafter “Chen”), and Toda (U.S. Patent Application Publication No. 20170007855).
Regarding claim 22, Stringham discloses a surgical handpiece (Figs. 2A-4), comprising:
a housing (32) including an inner surface (annotated fig. 4 below), and a distal shoulder on the inner surface, the distal shoulder formed radially about a longitudinal axis of the housing;
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an electrical component (20; para. [0096]) within the housing (Fig. 4); and
a thermal diffuser (36) comprising a thermal conductive layer (para. [0106]), wherein the thermal conductive layer is radially disposed between the housing and the electrical component (Fig. 4), wherein the thermal conductive layer is in direct contact with the housing (Fig. 4);
wherein the distal shoulder forms a space that sits the thermal diffuser (annotated Fig. 4 above); and
wherein the housing (32) has an elongated body and the thermal diffuser is disposed adjacent along the elongated body of the housing and in a direction parallel to the longitudinal axis and is radially spaced outward from the electrical component (20; Fig. 4).
The device of Stringham discloses the invention substantially as claimed, except for the housing including a proximal shoulder that also forms the space that sits the thermal diffuser.
Olichney, a reference in the ultrasonic handpiece field of endeavor, teaches providing a housing (17) with a proximal shoulder and a distal shoulder (i.e., at respective ends of circumferential recess (34); Fig. 2), the proximal shoulder and the distal shoulder formed radially about a longitudinal axis of the housing; and wherein the proximal shoulder and the distal shoulder form a space (34) that sits a cylinder (35) to fix the cylinder to the housing (Fig. 2; col. 7, ll. 14-35).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the inner surface of the housing of Stringham to also include a proximal shoulder formed radially about a longitudinal axis of the housing such that the proximal shoulder and the distal shoulder form a space that sits the thermal diffuser, in view of Olichney, to fix the heat diffuser within the housing in order to promote cooling at the proper location in the housing.
The modified device discloses the invention substantially as claimed, except for the thermal diffuser including a thermal conductive layer and an electrical insulating layer. However, Stringham discloses that the thermal diffuser (36) operates by convection to dissipate heat (para. [0106]).
Chen, a reference in the electronics enclosure field of endeavor, teaches providing a housing (140) with a thermal diffuser (combination of heat dissipation structures (200, 200’); Fig. 6) comprising a thermal conductive layer (130) and an electrical insulating layer (120), wherein both the thermal conductive layer and the electrical insulating layer are radially disposed between the housing and the electrical component (115; Fig. 6), wherein the thermal conductive layer is radially closer to the housing than the electrical insulating layer and in direct contact with the housing (Fig. 6).
Chen also teaches configuring the thermal conductive layer (130) comprising a plurality of thermal conductive material pieces (respective metal layers (130) of each heat dissipation structure (200, 200’); Fig. 6), wherein there is a first overlapping area between a first thermal conductive material piece (metal layer (130) of structure (200)) and a second thermal conductive material piece (metal layer (130) of structure (200’)) that extends longitudinally on the thermal diffuser (Figs.4-6).
Chen teaches that such a configuration facilitates heat dissipation through thermal convection (paras. [0077]-[0080]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the thermal diffuser (36) of Stringham to include a thermal conductive layer and an electrical insulating layer, wherein both the thermal conductive layer and the electrical insulating layer are radially disposed between the housing and the electrical component; wherein the thermal conductive layer is radially closer to the housing than the electrical insulating layer and in direct contact with the housing; wherein the thermal conductive layer comprises a plurality of thermal conductive material pieces; and wherein there is a first overlapping area between a first thermal conductive material piece and a second thermal conductive material piece that extends longitudinally on the thermal diffuser, in view of Chen, in order to facilitate heat dissipation to cool the handpiece.
The modified device is not explicitly disclosed with the electrical component comprising an ultrasonically powered transducer and the thermal diffuser being radially spaced from the transducer. However, Stringham teaches an ultrasonic surgical handpiece (440) of a surgical cutting tool to include a cooling system (Fig. 15B; paras. [0164]-[0165]).
Toda, a reference in the ultrasonic handpiece field of endeavor, teaches providing an ultrasonic surgical handpiece with an ultrasonically powered transducer (1) and arranging a thermal diffuser (2) radially spaced outward from the ultrasonically powered transducer (Fig. 1A; para. [0029]) to suppress overheating of the transducer during use (para. [0041]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrical component to include an ultrasonically powered transducer and arrange the thermal diffuser to be radially spaced outward from the ultrasonically powered transducer, in view of Toda, to enable the handpiece to provide desired ultrasonic treatment without overheating during a procedure.
Regarding claim 25, the modified device is not explicitly disclosed with the thermal diffuser in a cylindrical or partially cylindrical form.
However, Stringham teaches heat spreader (36) having a cylindrical or partially cylindrical form (Fig. 4) to fit in the elongated body around the electrical component (para. [0106]).
Additionally, Toda teaches heat-radiation tube (2) having a cylindrical or partially cylindrical form (para. [0038]) to diffuse heat from the ultrasonic transducer (para. [0041]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the thermal diffuser to be in a cylindrical or partially cylindrical form that fits in the elongated body around the electrical component in order for the thermal diffuser to fit within the housing to dissipate heat.
Regarding claim 26, Chen teaches wherein the thermal conductive layer is made of a material selected from the group consisting of copper, aluminum, nickel, silver, gold and alloys thereof (para. [0036]).
Regarding claim 28, Chen teaches wherein the thermal conductive layer and the electrical insulating layer are bonded with an adhesive (160; Fig. 6; para. [0039]).
Regarding claim 41, Chen teaches wherein the thermal conductive layer (130) includes a gap (either the spacing/gap between metal layers (130, 130) or the spacing/gap between vertical portions of layer (130); annotated Fig. 6 below) between a first end and a second end thereof.
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Claims 27, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Stringham in view of Olichney, Chen, and Toda, as applied to claim 22 above, and further in view of Okada et al. (U.S. Patent Application Publication No. 20050004589; hereinafter “Okada”).
Regarding claim 27, the modified device disclose the invention substantially as claimed except for a specific material for the electrical insulating layer. Okada, a reference in the surgical cutting instrument field of endeavor, teaches that polytetrafluoroethylene to be a suitable insulating material preventing undesired current leakage from the device (paras. [0218]-[0219]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the electrical insulating layer be made of polytetrafluoroethylene, in view of Okada, in order to prevent current from leaking to other parts of the device during use.
Additionally or alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to form the electrical insulating layer of polytetrafluoroethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 29, the modified device discloses the invention substantially as claimed, except for the housing being made of an electrical insulating material. Okada teaches providing a housing with an electrical insulating material to prevent current leakage from reaching an operator (para. [0291]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the housing to be made of an electrical insulating material, in view of Okada, in order to protect on operator from electrocution during use of the device.
Regarding claim 31, the modified device is not explicitly disclosed with an ultrasonic horn contained within the housing. However, Stringham teaches an ultrasonic surgical handpiece (440) of a surgical cutting tool to include a cooling system (Fig. 14B; paras. [0164]-[0165]). Okada teaches providing an ultrasonic surgical cutting tool with an ultrasonic horn (121) contained within a housing (102) for conveying vibrations to a cutting element to effectuate ultrasonic cutting (paras. [0331]-[0339])
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the modified device as an ultrasonic surgical cutting tool further comprising an ultrasonic horn contained within the housing in order to dissipate heat generated in the housing (102) to keep it cool during use.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Stringham, Olichney, Chen, Toda, and Okada, as applied to claim 31 above, and further in view of Schulte et al. (U.S. Patent Application Publication No. 20150080925; hereinafter “Schulte”).
Regarding claim 32, Okada teaches wherein the housing (102) includes an inner surface and a longitudinal axis, and wherein the ultrasonic horn includes an outer surface (Figs. 28-29). The modified device is not explicitly disclosed with a housing engagement portion and a horn engagement portion.
Schulte, a reference in the surgical cutting instrument field of endeavor, teaches providing a housing with
a housing engagement portion on the inner surface of a housing (para. [0130]), the housing engagement portion having a transverse section that includes a central recess (para. [0130]), a plurality of pointed recesses (between teeth; Fig. 38A) pointing radially outward from the central recess and spaced evenly about the longitudinal axis, and convex arcs (i.e., part of the circumference of the circle defined by the cross-section of locking members (720, 722); annotated Fig. 38B below) joining adjacent pointed recesses;
and a horn engagement portion on the outer surface of a horn (702), the horn engagement portion having a transverse section that includes a central portion, a plurality of pointed protrusions (teeth (704); Fig. 38A) extending radially outward and spaced evenly about the longitudinal axis, and concave arcs (i.e., part of the circumference of the circle defined by the cross-section of horn (702); annotated Fig. 38A below) joining adjacent pointed protrusions; and
wherein each of the pointed protrusions corresponds in shape and is engageable with each of the pointed recesses (Fig. 38B)
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to prevent undesired relative rotation between the horn (702) and the housing (para. [0130]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to:
provide the housing with a housing engagement portion on the inner surface, the housing engagement portion having a transverse section that includes a central recess (receiving , a plurality of pointed recesses pointing radially outward from the central recess and spaced evenly about the longitudinal axis, and convex arcs joining adjacent pointed recesses; and
provide the ultrasonic horn with a horn engagement portion on the outer surface, the horn engagement portion having a transverse section that includes a central portion, a plurality of pointed protrusions extending radially outward and spaced evenly about the longitudinal axis, and concave arcs joining adjacent pointed protrusions; and
such that wherein each of the pointed protrusions corresponds in shape and is engageable with each of the pointed recesses
in view of Schulte, in order to maintain the desired position of the waveguide relative the housing to cut tissue during a procedure.
Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Stringham, Olichney, Chen, Toda, Okada, and Schulte, as applied to claim 32 above, and further in view of Masuda et al. (U.S. Patent Application Publication No. 20080171938; hereinafter “Masuda”).
Regarding claim 33, the modified device discloses the invention substantially as claimed except for at least one pointed recess having a recess tip portion that is pointed (Schulte Figs. 38A-38B) to prevent undesired rotation between the horn (702) and the housing (Schulte para. [0130]) instead of being rounded or curved. Masuda, a reference in the surgical cutting instrument field of endeavor, teaches configuring a recess tip portion (48a) to be rounded or curved to prevent undesired rotation of a horn (83) and a housing (48).
Thus, a person having ordinary skill in the art would recognize a pointed recess tip portion and a rounded or curved recess tip portion to be equivalents for preventing undesired rotation of a horn and a housing.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a recess tip portion that is rounded or curved for the pointed recess tip portion to achieve the predictable result of preventing undesired rotation of a horn and a housing and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Regarding claim 34, the modified device discloses the invention substantially as claimed except for at least one pointed protrusion having a protrusion tip portion that is pointed (Schulte Figs. 38A-38B) to prevent undesired rotation between the horn (702) and the housing (Schulte para. [0130]) instead of being rounded or curved. Masuda teaches configuring a protrusion tip portion (83b) to be rounded or curved to prevent undesired rotation of a horn (83) and a housing (48).
Thus, a person having ordinary skill in the art would recognize a pointed recess tip portion and a rounded or curved recess tip portion to be equivalents for preventing undesired rotation of a horn and a housing.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a protrusion tip portion that is rounded or curved for the pointed protrusion tip portion to achieve the predictable result of preventing undesired rotation of a horn and a housing and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Claims 35 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Stringham, Olichney, Chen, and Toda.
Regarding claim 35, Okada discloses a surgical handpiece (Figs. 27-29), comprising:
a housing (102) having an elongated body along a longitudinal axis (Fig. 27); and
an ultrasonically powered transducer positioned within the elongated body of the housing (para. [0331]).
The device of Okada is not explicitly disclosed with a thermal diffuser.
Stringham, a reference in surgical cutting instrument field of endeavor, teaches providing an ultrasonic cutting instrument (para. [0164]-[0165]) with a thermal diffuser (36; Figs. 2-4A) to dissipate heat from within the housing (para. [0106]).
Chen, a reference in the electronics enclosure field of endeavor, teaches providing a housing (140) with a thermal diffuser (combination of heat dissipation structures (200, 200’); Fig. 6) comprising a thermal conductive layer (130) and an electrical insulating layer (120), wherein both the thermal conductive layer and the electrical insulating layer are disposed between the elongated body of the housing and an electrical component (115; Fig. 6), wherein the thermal conductive layer is radially closer to the elongated body of the housing than the electrical insulating layer (Fig. 6); and wherein the thermal conductive layer of the thermal diffuser is disposed directly against the elongated body of the housing (Fig. 6) and both the thermal conductive layer and the electrical insulating layer are radially spaced radially away from the transducer (Fig. 6).
Chen also teaches configuring the thermal conductive layer (130) comprising a plurality of thermal conductive material pieces (respective metal layers (130) of each heat dissipation structure (200, 200’); Fig. 6), wherein there is a first overlapping area between a first thermal conductive material piece (metal layer (130) of structure (200)) and a second thermal conductive material piece (metal layer (130) of structure (200’)) that extends longitudinally on the thermal diffuser (Figs. 4-6).
Chen teaches that such a configuration facilitates heat dissipation through thermal convection (paras. [0077]-[0080]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the housing (102) of Okada with a thermal diffuser comprising a thermal conductive layer and an electrical insulating layer; wherein both the thermal conductive layer and the electrical insulating layer are disposed between the elongated body of the housing and the transducer; wherein the thermal conductive layer is radially closer to the elongated body of the housing than the electrical insulating layer; wherein the thermal conductive layer of the thermal diffuser is disposed directly against the elongated body of the housing and both the thermal conductive layer and the electrical insulating layer are radially spaced radially away from the transducer; wherein the thermal conductive layer comprises a plurality of thermal conductive material pieces; and wherein there is a first overlapping area between a first thermal conductive material piece and a second thermal conductive material piece that extends longitudinally on the thermal diffuser, in view of Chen, in order to facilitate heat dissipation to cool the handpiece, in view of Stringham and Chen, in order to dissipate heat and keep the transducer cool during use.
The modified device discloses the invention substantially as claimed, except for the housing including an inner surface with proximal and distal shoulders forming a space that sits the thermal diffuser.
Olichney, a reference in the ultrasonic handpiece field of endeavor, teaches providing a housing (17) with a proximal shoulder and a distal shoulder (i.e., at respective ends of circumferential recess (34); Fig. 2), the proximal shoulder and the distal shoulder formed radially about a longitudinal axis of the housing; and wherein the proximal shoulder and the distal shoulder form a space (34) that sits a cylinder (35) to fix the cylinder to the housing (Fig. 2; col. 7, ll. 14-35).
Stringham teaches providing a housing (32) with a distal shoulder on an inner surface of the housing, the distal shoulder formed radially about a longitudinal axis of the housing such that the distal shoulder forms a space that sits the thermal diffuser along the inner surface (annotated Fig. 4 below).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the housing with an inner surface including a proximal shoulder and a distal shoulder on the inner surface, the proximal shoulder and the distal shoulder formed radially about the longitudinal axis of the housing such that the proximal shoulder and the distal shoulder form a space that sits the thermal diffuser, in view of Olichney and Stringham, to fix the heat diffuser within the interior of the housing in order to promote cooling at the proper location in the housing.
The modified device is not explicitly disclosed with the thermal diffuser being disposed adjacent along the elongated body of the housing and in a direction parallel to the longitudinal axis and is radially spaced outward from the ultrasonically powered transducer.
Toda, a reference in the ultrasonic handpiece field of endeavor, teaches arranging a thermal diffuser (2) adjacent along the elongated body of a housing (14) and in a direction parallel to the longitudinal axis of an ultrasonically powered transducer (1) and radially spaced outward from the ultrasonically powered transducer (Fig. 1A; para. [0029]) to suppress overheating of the transducer during use (para. [0041]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to arrange the thermal diffuser to be disposed adjacent along the elongated body of the housing and in a direction parallel to the longitudinal axis and is radially spaced outward from the ultrasonically powered transducer, in view of Toda, to enable the handpiece to provide desired ultrasonic treatment without overheating during a procedure.
Regarding claim 38, Chen teaches wherein the thermal conductive layer is made of at least copper (para. [0036]). However, the modified device is no explicitly disclosed with the electrical insulating layer is made of at least polytetrafluoroethylene.
Okada teaches polytetrafluoroethylene to be a suitable insulating material preventing undesired current leakage from the device (paras. [0218]-[0219]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the electrical insulating layer be made of polytetrafluoroethylene, in view of Okada, in order to prevent current from leaking to other parts of the device during use.
Additionally or alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to form the electrical insulating layer of polytetrafluoroethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 39, Chen teaches wherein the thermal conductive layer and the electrical insulating layer are radially bonded with an adhesive (160; Fig. 6; para. [0039]).
Regarding claim 40, the modified device is not explicitly disclosed with the thermal diffuser being in a cylindrical or partially cylindrical form. However, Okada discloses the housing (102) being cylindrical (Figs. 28-29).
Stringham teaches shaping a heat spreader (36) to be cylindrical or partially cylindrical form (Fig. 4) to fit in the elongated body around an electrical component (para. [0106]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to shape the thermal diffuser such that the thermal diffuser is in a cylindrical or partially cylindrical form that fits in the elongated body of the housing around the longitudinal axis in order for the thermal diffuser to fit within the housing to dissipate heat.
Response to Arguments
Applicant’s arguments with respect to claims 22, 25-29, 31-35, and 38-41 (Response pp. 6-9) 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. Specifically, the new grounds of rejection over Toda address the claimed subject matter newly amended into independent claims 22 and 35.
Conclusion
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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