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 .
Claims 6, 8, 11-15, 20, 21, 23, 25-45, and 48 are cancelled. A complete action on the merits of pending claims 1-5, 7, 9, 10, 16-19, 22, 24, 46, 47, and 49-58.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Applicant argues “according to MPEP 2141.02 VI, "a prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention". Galen appears to show in figures 1 and 2, indicated by the Examiner, a specific design of a treatment tip in which the energy delivery elements of the treatment tip appear to project forward from the hand piece. Furthermore, Galen appears to explain in paragraph 47 that the specific non-cylindrical structure of the device provides a functional advantage, "the midsection of the treatment tip provides a functional advantage in that it allows the energy delivery elements to be projected forward from the body of the hand piece" (emphasis added).”
Examiner respectfully contends that Galen teaching a functional advantage to the energy delivery elements being projected forward from the body of the hand piece does not necessarily mean one of ordinary skill in the art would be unable to find a functional advantage, and therefore be unmotivated, to a cylindrical shaped distal end. For example, a cylindrical shaped distal end may be useful when a user does not want to ablate tissue distal to the instrument, and only wants to target tissue radially surrounding said distal end.
Applicant further argues “one of ordinary skill in the art, upon reviewing Figures 1 and 2 of Galen, which illustrate forward-facing energy-delivery elements, and considering paragraph 47 of Galen describing that the presence of a midsection of the treatment tip provides a functional advantage, would not have been motivated to modify Galen to employ a cylindrical body lacking such a midsection. Altering Galen's design in this manner would eliminate the specific structural feature that Galen identifies as providing a functional benefit, and thus would run counter to the explicit teaching of Galen. Accordingly, such a modification would not have been obvious to one of ordinary skill in the art.”
Examiner respectfully contends that, as discussed above, Galen teaching a functional advantage to the energy delivery elements being projected forward from the body of the hand piece does not necessarily mean one of ordinary skill in the art would be unable to find a functional advantage, and therefore be unmotivated, to a cylindrical shaped distal end. For example, a cylindrical shaped distal end may be useful when a user does not want to ablate tissue distal to the instrument, and only wants to target tissue radially surrounding said distal end.
Applicant further argues “one of ordinary skill in the art would not be motivated to modify Galen to include the cylindrical shape taught by Govari, because the device of Govari is distinct from the device of Galen, for example in shape, size, treatment type and treatment location. The device of Govari appears to be shaped and sized to be introduced into the pulmonary vein within the heart, and therefore is much smaller than the device of Galen. In addition, the device of Govari does not appear to include any cooling, and appears to be used is for electrical isolation of the pulmonary vein.”
Examiner respectfully contends that the device of Govari, as further discussed in the rejection to claim 1 below, is similar to the device of Galen at least in that both devices deliver ultrasound energy to a target tissue in order to treat said tissue. Govari was not relied on to teach cooling, and was instead merely used to teach a cylindrical shaped ultrasound transducer array. Even if the device of Govari is sized differently than the device of Galen, and configured to treat a different area of tissue, one of ordinary skill in the art would still be able to understand possible benefits from a cylindrical shaped array and incorporate said shape into various ultrasound devices, including the device of Galen.
Applicant further argues “an ordinary skill in the art would not think to modify the device of Galen which appears to have a size and shape suitable for treating vagina tissue located at least partly outside a subject body, to include a shape of the device of Govari which appears to have a size and shape suitable for positioning the device inside a subject heart, ad that appears to lack a cooling feature, which appears to be a key component in the device of Govari.”
Examiner respectfully contends that, as further discussed above, Govari was not used to teach a cooling feature, and was merely used to teach a cylindrical shaped ultrasound transducer array. Both the devices of Galen and Govari are directed towards treating a target tissue with ultrasound energy delivered from an ultrasound transducer array. One of ordinary skill in the art would be able to recognize possible benefits from a cylindrical shaped transducer array, such as when only tissue immediately surrounding said array is to be targeted, and would be able to modify the device of Galen to incorporate said cylindrical shape instead of a conical shape.
Applicant further argues “the Examiner has not shown in any of the cited prior-art or their combination an elongated hollow body of an ultrasound applicator that has at least one side acoustic window positioned to face body tissue surrounding the elongated hollow body, and ’one or more ultrasound transducers comprises an emitting surface facing said at least one side acoustic window’, as claim 49 now describes.”
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 49 below, Thapliyal teaches an elongated hollow body of an ultrasound applicator (Fig. 3-5, Char. 16: distal housing) that has at least one side acoustic window positioned to face body tissue surrounding the elongated hollow body, (Fig. 3-5 and Par. [0043]: The energy beam (20) exits the end portion of the housing through a window.) and one or more ultrasound transducers comprises an emitting surface facing said at least one side acoustic window. (Fig. 1: the emitting surface of energy source (12) faces at least some of the window in housing (16) configured to let beam (20) pass through)
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7, 9, 10, 16, 17, 22, 51, 53-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of Govari (US 2005/0215990 A1), in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1).
Regarding claim 1, Galen teaches
an ultrasound applicator (Fig. 1) shaped and sized to be at least partially inserted into a vagina, (Par. [0005]) comprising:
a body with a non-planar surface, (Fig. 1, Char. 1: treatment tip//Fig. 1-2, Char. 2, 3, and 5) wherein said body is shaped and sized to be at least partly introduced into a vagina; (Par. [0018])
a plurality of ultrasound transducers distributed on said non-planar surface of said ultrasound applicator body, (Fig. 1, Char. 4: energy delivery elements; Par. [0049]: the energy delivery elements may be ultrasound emitters) wherein at least some of said plurality of ultrasound transducers are configured to contact a surface of a wall of said vagina during the generation of ultrasonic waves, (Par. [0020]: Energy delivery elements (4) comprise an epithelium-contacting surface) wherein said plurality of ultrasound transducers are spaced-apart (Fig. 8A: there is a gap between each of the energy delivery elements (4)) and are arranged side-by-side along at least a portion of a circumference of said body, on said non-planar surface; (Fig. 8A)
at least one cooler configured to apply cooling to prevent overheating of said vagina wall surface being contacted by said transducers by applying said cooling to said plurality of ultrasound transducers; (Par. [0035]-[0037]: Coolant is applied to the internal surface of the energy delivery elements via cooling chamber (5), which then causes the cooling of epithelium tissue in contact with said delivery elements)
a control unit, (Par. [0036] and [0064]: controller) comprising:
a control circuitry electrically connected to said ultrasonic transducers, (Par. [0049] and [0064]) wherein said control circuitry signals at least some of said ultrasound transducers to generate ultrasonic waves to heat said tissue volume. (Par. [0040]: Tissue is heated by applying energy from energy delivery elements; Par. [0049]: energy delivery elements may be ultrasound emitters.)
Galen, as applied to claim 1 above, is silent regarding said body being cylindrical; the at least one cooler having at least one surface in contact with said plurality of ultrasound transducers; said cooling to said plurality of ultrasound transducers occurring via said at least one surface; the ultrasound transducers being configured to simultaneously generate the ultrasonic waves.
Govari, in a similar field of endeavor, teaches a cylindrical ultrasound transducer array. (Fig. 2, Char. 32: ultrasound array)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the body with a non-planar surface (Fig. 1, Char. 1: treatment tip//Fig. 1-2, Char. 2, 3, and 5) of Galen to comprise whatever form or shape was desired or expedient, including the cylindrical shape taught by Govari. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore,
The combination of Galen/Govari, as applied to claim 1 above, is silent regarding the at least one cooler having at least one surface in contact with said plurality of ultrasound transducers; said cooling to said plurality of ultrasound transducers occurring via said at least one surface; the ultrasound transducers being configured to simultaneously generate the ultrasonic waves.
Choi, in a similar field of endeavor, teaches a plurality of ultrasound transducers (Fig. 5B, Char. 41: ultrasound transducer) configured to apply ultrasound energy either sequentially or simultaneously. (Par. [0065])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari, as applied to claim 1 above, to incorporate the teachings of Choi, and configure the energy delivery elements (4) of Galen to deliver ultrasound waves either sequentially or simultaneously. Doing so would allow for more treatment protocols, and options for energy delivery.
The combination of Galen/Govari/Choi, as applied to claim 1 above, is silent regarding the at least one cooler having at least one surface in contact with said plurality of ultrasound transducers; said cooling to said plurality of ultrasound transducers occurring via said at least one surface.
Sverdlik, in a similar field of endeavor, teaches using at least one cooler (Fig. 15A, Char. 2010, 2012, and 2014 and associated generator) comprising at least one heat conducting base Fig. 15A, Char. 2012 and 2010; Par. [0256]) and at least one surface (Fig. 15A: The outer surface of thermoelectric cooler (2010)) in contact with at least one energy delivery element (Fig. 15A, Char. 102 and 104) to apply cooling to said at least one energy delivery element via said at least one surface; (Par. [0255])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Choi, as applied to claim 1 above, to incorporate the teachings of Sverdlik, and include the braid (2012) and at least one thermoelectric cooler (2010) of Sverdlik, such that the at least one thermoelectric cooler (2010) of Sverdlik is attached to each energy delivery element (4) of Galen in place of the liquid cooling system of Galen to cool said energy delivery elements (4). Doing so would be a simple substitution of one cooling system for another for the predictable result of cooling and controlling the temperature of the energy delivery elements (4) of Galen.
Regarding claim 2, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said non-planar surface has a radius of curvature smaller than 5 cm.
However, absent a statement of criticality and unexpected results, it would have been an obvious matter of design choice to configure the treatment tip (1) of Galen to have a radius of curvature smaller than 5 cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 3 and 4, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said plurality of ultrasound transducers are axially and circumferentially distributed on at least a portion said non-planar surface. (Galen: Fig. 1: Energy delivery elements (4) are distributed axially and circumferentially on treatment tip (1))
Regarding claim 5, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said body being a tubular body. (In the rejection to claim 1 above, the energy delivery elements (4) of Galen were arranged in a cylindrical array, which would make said body a tubular body)
Regarding claim 7, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said control circuitry signals at least some of said ultrasound transducers to generate said ultrasonic waves at different angular directions larger than 90 degrees, relative to another ultrasound transducer, to heat said tissue volume. (Galen: Par. [0040]: Tissue is heated by applying energy from energy delivery elements; Par. [0049]: energy delivery elements may be ultrasound emitters; Fig. 1: Some of the energy delivery elements on treatment tip (1) are positioned about 180 degrees from each other about the longitudinal axis of treatment tip (1))
Regarding claim 9, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said control circuitry is electrically connected to said at least one cooler, (Galen: Par. [0069]) and wherein said control circuitry signals said at least one cooler to apply said cooling prior to or during or after signaling said at least some of said ultrasound transducers to generate said ultrasonic waves, or any combination of the aforesaid. (Galen: Par. [0040]: The cooling may occur before, during and/or after the heating)
Regarding claim 10, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said at least one cooler is configured to cool said surface of a wall of said vagina being contacted by said transducers through said transducers or between said transducers, or a combination of the aforesaid. (Galen: Par. [0039]-[0040])
Regarding claim 16, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said plurality of ultrasound transducers having a thickness in a range of 0.1 - 2mm.
However, absent a statement of criticality and unexpected results, it would have been an obvious matter of design choice to configure the energy delivery elements (4) of Galen to have a thickness in a range of 0.1 - 2mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 17, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said body comprises a plurality of visual depth markings on an external surface of said body, wherein said visual depth markings are configured to deliver a visual indication regarding a penetration depth of the ultrasound applicator into said vagina. (Galen: Par. [0060]: The treatment tip (1) may include markers that indicate how deep into the vagina the device has entered)
Regarding claim 22, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said control circuitry is configured to modify one or both of intensity and frequency of said ultrasonic waves according to one or both of a position of said ultrasound applicator within the vagina and a relation between said calculated position and a selected target location within the vagina wall. (Galen: Par. [0088]-[0090])
Regarding claim 51, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said ultrasound applicator comprises at least one contact sensor configured to sense contact of said at least some of said plurality of ultrasound transducers with said vagina wall. (Galen: Par. [0077]: there may be more than one pair of temperature measuring junctions placed on the energy delivery elements in contact with the target tissue; Par. [0038]: Confirming contact of the energy delivery elements with the tissue based on the temperature at the energy delivery elements)
Regarding claim 53, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said non-planar surface defines an arc having an angle of at least 10 degrees.
However, absent a statement of criticality and unexpected results, it would have been an obvious matter of design choice to make the different portions of the treatment tip (1) of whatever form or shape was desired or expedient, including defining an arc having an angle of at least 10 degrees. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 54, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches at least one heat conducting base interconnecting said at least one cooler with said plurality of spaced-apart ultrasound transducers, (Merriam webster defines the term “interconnect” as “to connect with one another;” Sverdlik: Fig. 15A: Cooler (2010) connects the ultrasound element (102) with at least the wires (2014) and generator for thermoelectric cooler (2010) – it is implicit that this feature be present in the Galen/Govari/Choi/Sverdlik combination based on the rejection to claim 1 above; In the rejection to claim 1 above, each energy delivery element (4) of Galen was attached to its own cooler (2010) of Sverdlik) and wherein said at least one cooler is configured to apply said cooling to said plurality of spaced-apart ultrasound transducers via said heat conducting base. (Sverdlik: Fig. 15A, and Par. [0255]-[0256] – it is implicit that this feature be present in the Galen/Govari/Choi/Sverdlik combination based on the rejection to claim 1 above.)
Regarding claim 55, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 54 above, teaches said at least one heat conducting base comprises a round portion (Sverdlik: Fig. 15A, Char. 2012: braid – it is implicit that this feature be present in the Galen/Choi/Sverdlik combination based on the rejection of claim 1 above.) with a plurality of spaced apart protrusions, (Sverdlik: Fig. 15A, Char. 2010: thermoelectric cooler – it is implicit that this feature be present in the Galen/Choi/Sverdlik combination based on the rejection of claim 1 above.) and wherein said plurality of ultrasound transducers are in contact with said plurality of spaced apart protrusions. (In the rejection to claim 1 above, the thermoelectric cooler (2010) of Sverdlik was attached to the energy delivery elements (4) of Galen.)
Regarding claim 56, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said at least some of said plurality of ultrasound transducers are configured to contact directly or indirectly said surface of a wall of said vagina during the generation of ultrasonic waves. (Galen: Claim 1)
Regarding claim 58, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches said plurality of ultrasound transducers are arranged on said non-planar surface of said cylindrical body to emit ultrasound energy sideways towards tissue of said vagina wall surrounding said cylindrical body. (Govari: Fig. 3A – it is implicit that this feature be present in the Galen/Govari/Choi/Sverdlik combination based on the rejection to claim 1 above.)
Claim(s) 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of Govari (US 2005/0215990 A1), in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1), as applied to claim 1 above, and further in view of Wang (US 2009/0024039 A1).
Regarding claim 18, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, teaches a handle coupled to a proximal end of said body, (Galen: Fig. 1, Char. 2: handle) wherein said handle comprises one or more gripping members. (Galen: Fig. 1: the surface of handle (2))
The combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding the one or more gripping members being shaped and sized to allow holding of the handle with a single hand.
Wang, in a similar field of endeavor, teaches a handheld ultrasound device sized and shaped to allow holding of the device with a single hand. (Par. [0010]: The handheld ultrasound device comprises a casing configured and dimensioned for single-handed manipulation and a mechanically oscillated ultrasound transducer disposed therewithin.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, to incorporate the teachings of Wang, and configure handle (2) to be sized and shaped to allow holding of the handle (2) with one hand. Doing so would be a mere change in size well within the ability of one of ordinary skill in the art and would allow for the user to use their free hand to hold other instruments, perform other procedural tasks, etc.
Regarding claim 19, the combination of Galen/Govari/Choi/Sverdlik/Wang, as applied to claim 18 above, teaches said ultrasound applicator comprises one or more visual rotation orientation markings on one or both of said body and on said handle, wherein said one or more visual orientation markings are configured to deliver a visual indication regarding a rotation of the ultrasound applicator within the vagina. (Galen: Fig. 8A: Depth markers (8) would indicate a rotation of treatment tip (1) at least in that depth markers (8) are disposed at the top of treatment tip (1) and would rotate with treatment tip (1))
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of Govari (US 2005/0215990 A1) in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1), as applied to claim 1 above, and further in view of Merchant (US 2008/0014627 A1).
Regarding claim 24, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said ultrasonic waves generated by said plurality of ultrasound transducers are non-converging ultrasonic waves.
Merchant, in a similar field of endeavor, teaches a transducer apparatus comprising a flat transducer for producing unfocused ultrasound waves. (Par. [0153])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Choi/Sverdlik, as applied to claim 1 above, to incorporate the teachings of Merchant, and configure the energy delivery elements (4) of Galen to comprise the flat transducers of Merchant, such that the generated ultrasound waves are unfocused waves. Doing so would be a simple substitution of one ultrasound transducer for another for the predictable result of generating and delivering ultrasound to tissue.
Claim(s) 50 is rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of Govari (US 2005/0215990 A1), in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1), as applied to claim 1 above, and further in view of Heimbecher (US 2014/0364848 A1).
Regarding claim 50, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said ultrasound applicator comprises at least one sensor configured to sense a position and/or orientation of the applicator within the vagina.
Heimbecher, in a similar field of endeavor, teaches a catheter configured to deliver ultrasound to tissue; (Fig. 1, Char. 20: catheter) and Par. [0069]) wherein said catheter comprises at least one position sensor. (Par. [0069]: Catheter (20) may comprise one or more position sensors (60))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, to incorporate the teachings of Heimbecher, and include the position sensor (60) of Heimbecher on the treatment tip (1) of Galen. Doing so would allow for a user to easily determine the position of tip (1), providing easy navigation and placement of the device of Galen.
Claim(s) 52 is rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of Govari (US 2005/0215990 A1), in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1), as applied to claim 1 above, and further in view of Lacoste (US 5,170,790).
Regarding claim 52, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, is silent regarding said body comprising a hinge, and at least two movable portions interconnected by said hinge.
Lacoste, in a similar field of endeavor, teaches an assembly comprising a hinge, (Fig. 1, Char. 18: hinge axis) and at least two movable portions interconnected by said hinge; (Fig. 1, Char. 14 and 15: arms) wherein said assembly supports/holds a support member in place. (Claim 3)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 1 above, to incorporate the teachings of Lacoste, and configure the hand piece (2) of Galen to include the arms (14 and 15) and hinge axis (18 and 24) of Lacoste, such that the arms and hinge axis support and hold the hand piece (2) of Galen in place when a user finishes positioning the instrument or removes their hand from said instrument. Doing so would allow a user to freely interact with other instruments and/or aspects of the procedure as needed without worrying about dropping or moving the device of Galen.
Claim(s) 57 is rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1), in view of in view of Govari (US 2005/0215990 A1) in view of Choi (US 2008/0027423 A1), in view of Sverdlik (US 2014/0039477 A1), as applied to claim 56 above, and further in view of Thapliyal (US 2010/0016762 A1)
Regarding claim 57, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 56 above, is silent regarding at least some of said plurality of ultrasound transducers are configured to indirectly contact said surface of a wall of said vagina via a coating.
Thapliyal, in a similar field of endeavor, teaches coating an ultrasound transducer with a metallic coating. (Par. [0036])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 56 above, to incorporate the teachings of Thapliyal, and configure the energy delivery elements (4) of Galen to comprise the metallic coating of Thapliyal. Doing so would increase the efficiency of coupling of the energy delivery, as suggested in Thapliyal. (Par. [0036])
Claim(s) 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Galen (US 2013/0245728 A1) in view of Govari (US 2005/0215990 A1) in view of Sverdlik (US 2014/0039477 A1) in view of Spooner (US 2008/0195000 A1).
Regarding claim 46, Galen teaches
an ultrasound applicator (Fig. 1) shaped and sized to be at least partially inserted into a vagina, (Par. [0005]) comprising:
a body with a non-planar surface; (Fig. 1, Char. 1: treatment tip)
a plurality of ultrasound transducers axially distributed on said non-planar surface of said ultrasound applicator body, (Fig. 1, Char. 4: energy delivery elements; Par. [0049]: the energy delivery elements may be ultrasound emitters) wherein said plurality of ultrasound transducers are configured to contact a surface of a wall of said vagina during the generation of ultrasonic waves, (Par. [0020]: Energy delivery elements (4) comprise an epithelium-contacting surface) wherein said plurality of ultrasound transducers are spaced-apart on said non-planar surface; (Fig. 3C-D)
one or more cooling elements configured to apply cooling to prevent overheating of said vagina wall surface being contacted by said transducers, (Par. [0035]-[0037]: Coolant is applied to the internal surface of the energy delivery elements via cooling chamber (5), which then causes the cooling of epithelium tissue in contact with said delivery elements);
a control unit, (Par. [0036] and [0064]: controller) comprising:
a control circuitry electrically connected to said ultrasonic transducers, (Par. [0049] and [0064]) wherein said control circuitry signals at least some of said ultrasound transducers to generate ultrasonic waves at different angular directions with parameter values sufficient to deliver ultrasonic energy to said tissue volume. (Par. [0040]: Tissue is heated by applying energy from energy delivery elements; Par. [0049]: energy delivery elements may be ultrasound emitters; Fig 1, Energy delivery elements (4) are arranged about the longitudinal axis of treatment tip (1), and would therefore generate ultrasonic waves at different angular directions about said axis.)
Galen, as applied to claim 46 above, is silent regarding said body being cylindrical; at least one of said one or more cooling elements comprises at least one surface in contact with two or more of said plurality of transducers;
Govari, in a similar field of endeavor, teaches a cylindrical ultrasound transducer array. (Fig. 2, Char. 32: ultrasound array)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the body with a non-planar surface (Fig. 1, Char. 1: treatment tip//Fig. 1-2, Char. 2, 3, and 5) of Galen to comprise whatever form or shape was desired or expedient, including the cylindrical shape taught by Govari. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore,
The combination of Galen/Govari, as applied to claim 46 above, is silent regarding at least one of said one or more cooling elements comprises at least one surface in contact with two or more of said plurality of transducers.
Sverdlik, in a similar field of endeavor, teaches using at least one cooler (Fig. 15A, Char. 2010, 2012, and 2014 and associated generator) comprising at least one heat conducting base Fig. 15A, Char. 2012 and 2010; Par. [0256]) and at least one surface (Fig. 15A: The outer surface of thermoelectric cooler (2010)) in contact with at least one energy delivery element (Fig. 15A, Char. 102 and 104) to apply cooling to said at least one energy delivery element via said at least one surface; (Par. [0255])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari, as applied to claim 46 above, to incorporate the teachings of Sverdlik, and include the braid (2012) and at least one thermoelectric cooler (2010) of Sverdlik, such that the at least one thermoelectric cooler (2010) of Sverdlik is attached to each energy delivery element (4) of Galen in place of the liquid cooling system of Galen to cool said energy delivery elements (4). Doing so would be a simple substitution of one cooling system for another for the predictable result of cooling and controlling the temperature of the energy delivery elements (4) of Galen.
The combination of Galen/Govari/Sverdlik, as applied to claim 46 above, is silent regarding at least one of said one or more cooling elements comprises at least one surface in contact with two or more of said plurality of transducers.
Spooner, in a similar field of endeavor, teaches a cooling element (Fig. 9, Char. 110: cooling element) comprising at least one surface in contact with two or more of a plurality of transducers. (Fig. 9: The outer surface of cooling element (110) contacts two or more of ultrasound transducers (108))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Galen/Govari/Sverdlik, as applied to claim 46 above, to incorporate the teachings of Spooner, and configure at least one of the thermos electric coolers (2010) of Sverdlik to contact two or more of the energy delivery elements (4) of Galen. Doing so would minimize the number of coolers (2010) required, saving space and making the device lighter.
Regarding claim 47, the combination of Galen/Govari/Sverdlik/Spooner, as applied to claim 46 above, teaches at least one heat conducting base interconnecting said at least one cooler with said plurality of spaced-apart ultrasound transducers, (Merriam webster defines the term “interconnect” as “to connect with one another;” Sverdlik: Fig. 15A: Cooler (2010) connects the ultrasound element (102) with at least the wires (2014) and generator for thermoelectric cooler (2010) – it is implicit that this feature be present in the Galen/Govari/Sverdlik/Spooner combination based on the rejection to claim 46 above; In the rejection to claim 46 above, each energy delivery element (4) of Galen was attached to its own cooler (2010) of Sverdlik) and wherein said at least one cooler is configured to apply said cooling to said plurality of spaced-apart ultrasound transducers via said heat conducting base. (Sverdlik: Fig. 15A, and Par. [0255]-[0256] – it is implicit that this feature be present in the Galen/Govari/Sverdlik/Spooner combination based on the rejection to claim 46 above.)
Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Thapliyal (US 2010/0016762 A1), in view of Merchant (US 2008/0014627 A1), in view of Galen (US 2013/0245728 A1).
Regarding claim 49, Thapliyal teaches
an elongated hollow body having a non-planar surface, (Fig. 3-5, Char. 16: distal housing) wherein said elongated body comprises at least one side acoustic window in said non-planar surface positioned to face body tissue surrounding said elongated hollow body; (Fig. 3-5 and Par. [0043]: The energy beam (20) exits the end portion of the housing through a side window positioned to face the surrounding tissue.)
one or more ultrasound transducers connected to a shaft passing through an inner lumen of said elongated hollow body, (Fig. 4-5: Energy source (12) is disposed on a cylindrical shaft extending within housing (16); Par. [0024]: The energy source (12) may be an ultrasound transducer) wherein said one or more ultrasound transducers comprises an emitting surface facing said at least one side acoustic window (Fig. 1: the emitting surface of energy source (12) faces at least some of the side window in housing (16) configured to let beam (20) pass through) wherein said one or more ultrasound transducers are configured to transmit ultrasound waves from said emitting surface through said at least one side acoustic window (Par. [0046]) with at least one of, frequency and intensity, suitable for generating thermal damage lesion (Par. [0047]) in deep tissue layers of a subject body; (Par. [0022])
a cooling liquid circulating in said inner lumen between said one or more ultrasound transducers and said at least one side acoustic window; (Fig. 3-5, Par. [0044], and Claim 61: Cooling fluid (28) is circulated around energy source (12) including the space between energy source (12) and the window) wherein said circulating cooling liquid reduces temperature levels of said non-planar surface. (Claim 61)
Thapliyal, as applied to claim 49 above, is silent regarding the transmitted ultrasound waved being unfocused ultrasound waves; or that the circulation of cooling fluid occurs during activation of said one or more ultrasound transducers.
Merchant, in a similar field of endeavor, teaches an ultrasound transducer apparatus configured to selectively produce focused and unfocused ultrasound. (Par. [0153])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Thapliyal, as applied to claim 49 above, to incorporate the teachings of Merchant, and configure the energy source (12) of Thapliyal to selectively produce both focused and unfocused ultrasound waves. Doing so would allow for the user to have greater control over the energy parameters delivered to the target tissue.
The combination of Thapliyal/Merchant, as applied to claim 49 above, is silent regarding the circulation of cooling fluid occurs during activation of said one or more ultrasound transducers.
Galen, in a similar field of endeavor, teaches applying a cooling fluid to an ultrasound apparatus during activation of ultrasonic transducers. (Galen: Par. [0040]: The cooling may occur before, during and/or after the heating)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Thapliyal/Merchant, as applied to claim 49 above, to incorporate the teachings of Galen, and apply the cooling fluid of Thapliyal whenever any part contacting the fluid flow path required cooling, including during activation of the energy source (12) of Thapliyal. Doing so would ensure that every part of the ultrasonic apparatus of Thapliyal was maintained within safe operating temperatures.
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.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794