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, 8-15, 20-21, 23, 25-45, and 48 are cancelled. A complete action on the merits of pending claims 1-5, 7, 16-19, 22, 24, 46, 47, and 49-61 appears herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/02/2026 has been entered.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
Applicant argues “Galen explains that "the energy delivery elements can be turned on and off in a specific sequence, or in a clockwise or counter-clockwise direction." Galen at [0024]. In other words, Galen's treatment scheme is using an on/off sequence. Galen, however, does not teach selecting which regions within the vagina to treat. Therefore, Galen does not teach a control circuitry configured to control the plurality of ultrasound transducers to selectively treat different regions within the vagina based on position of the ultrasound applicator inside the vagina. Neither of the other cited references discloses vaginal treatments and more specifically selectively treating different regions of a vagina based on position of the ultrasound applicator inside the vagina. Thus, Galen, Govari, Choi, and Sverdlik, alone or in combination, fail to teach or suggest the recitations of claim 1, and claim 1 is allowable over the art of record for this reason.”
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 1 below, Galen teaches control circuitry (at least the controller in Par. [0064] configured to control energy delivery, including selectively activating the energy delivery elements of Galen in a specific sequence, or in a clockwise/counter-clockwise direction, (Par. [0024] and [0064]) would selectively treat different regions within the vagina based on a position of the ultrasound applicator inside the vagina at least in that only the regions within the vagina facing the activated energy delivery elements would be treated.
Applicant further argues “Moreover, independent claim 1 further recites that "selectively treat involves adjusting a simultaneous emission of ultrasonic waves in different directions to heat two or more vaginal regions spaced apart from each other." Galen turns its energy delivery elements on and off in a sequence, or in a clockwise or counter-clockwise direction (Galen at [0024], [0055]), rather than adjusting a simultaneous emission of ultrasonic waves in different directions to heat two or more spaced-apart vaginal regions. None of the other cited references teaches or suggests adjusting a simultaneous emission of ultrasonic waves in different directions to heat two or more spaced-apart regions, let alone two or more spaced-apart regions within a vagina.”
Examiner respectfully contends that, as further discussed in the rejection to claim 1 below, Galen teaches activating the energy delivery elements in any pattern. (Par. [0055]) Choi, as further discussed in the rejection to claim 1 below, teaches activating ultrasound elements either sequentially or simultaneously. Being able to sequentially or simultaneously activate the energy delivery elements of Galen in any sequence or pattern would allow for more treatment protocols, and options for energy delivery and would allow the resulting combination to adjust a simultaneous emission of ultrasonic waves in different directions to heat two or more spaced-apart regions within the surrounding vagina.
Applicant further argues “each of claims 2-5, 7, 9, 10, 16, 17, 22, 51, 53-56, and 58 recites a unique combination that includes elements not expressly or inherently described in the cited references. For example, claim 16 recites that a thickness of the plurality of ultrasound transducers is in a range of 0.1-2 mm, a feature the Office rejected merely as an obvious "matter of design choice," Office Action at 11, without identifying any disclosure of the recited thickness range in Galen, Govari, Choi, or Sverdlik.”
Examiner respectfully contends that applicant has failed to provide any statements of criticality AND unexpected results from the claimed thickness of 0.1-2 mm. The ultrasound transducers of Galen would have a thickness, even if said thickness isn’t explicitly stated in the disclosure of Galen. Merely changing the size of the energy delivery elements of Galen would an obvious matter of design choice, since such a modification would have involved a mere change in the size of a component and the energy delivery elements would be expected to perform equally as well with the claimed thickness of 0.1-2mm as they would with their original thickness. 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).
Claim Objections
Claims 1, 46, and 49 are objected to because of the following informalities:
Regarding claims 1, 46, and 49: the phrase “based on position” should read --based on a position--
Appropriate correction is required.
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, 16, 17, 22, 50, 51, 53, 56 and 58-60 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).
Regarding claim 1, Galen teaches a system for delivery of ultrasonic waves for vaginal treatment, (Claim 1) comprising:
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 the body is shaped and sized to be at least partly introduced into a vagina; (Par. [0018])
a plurality of ultrasound transducers distributed on the non-planar surface of the body, (Fig. 1, Char. 4: energy delivery elements; Par. [0049]: the energy delivery elements may be ultrasound emitters) wherein at least some of the plurality of ultrasound transducers are configured to contact a surface of a wall of the vagina during the generation of ultrasonic waves, (Par. [0020]: Energy delivery elements (4) comprise an epithelium-contacting surface) wherein the 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 the body, on the non-planar surface; (Fig. 8A) and
a control circuitry electrically connected to the plurality of ultrasonic transducers, Par. [0049] and [0064]) wherein the control circuitry is configured to control the plurality of ultrasound transducers arranged side-by-side along at least a portion of the circumference of the body to selectively treat different regions within the vagina (Par. [0024]: The energy delivery elements can be turned on in a specific sequence, including in a clockwise or counter-clockwise direction) based on position of the ultrasound applicator inside the vagina. (The different regions within the vagina would be treated based on the position of the ultrasound applicator within the vagina at least in that the different regions within the vagina would be treated based on what energy delivery elements (4) said regions are facing)
Galen further teaches adjusting emission of ultrasonic waves based on the position/location of the device within the treatment area. (Par. [0088]-[0090])
Galen, as applied to claim 1 above, is silent regarding the body being a cylindrical body; and wherein selectively treat involves adjusting a simultaneous emission of ultrasonic waves in different directions to heat two or more vaginal regions spaced apart from each other.
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.
The combination of Galen/Govari, as applied to claim 1 above, is silent regarding selectively treat involving adjusting a simultaneous emission of ultrasonic waves in different directions to heat two or more vaginal regions spaced apart from each other.
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.
In this combination, simultaneously activating energy delivery elements (4) of Galen disposed on opposite ends of treatment tip (1) of Galen would heat at least two vaginal regions spaced apart from each other. (Galen: Par. [0055]: specific electrodes can be activated in any sequence or pattern)
Regarding claim 2, the combination of Galen/Govari/Choi, as applied to claim 1 above, is silent regarding the 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, as applied to claim 1 above, teaches the plurality of ultrasound transducers are axially and circumferentially distributed on at least a portion of the 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, as applied to claim 1 above, teaches the body is 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, as applied to claim 1 above, teaches the control circuitry controls at least some of the ultrasound transducers to generate the ultrasonic waves at different angular directions larger than 90 degrees, relative to another ultrasound transducer, to heat the two or more vaginal regions spaced apart from each other. (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 16, the combination of Galen/Govari/Choi, 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, as applied to claim 1 above, teaches the body comprises a plurality of visual depth markings on an external surface of the body, wherein the visual depth markings are configured to deliver a visual indication regarding a penetration depth of the ultrasound applicator into the 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 the control circuitry is configured to modify one or both of intensity and frequency of the ultrasonic waves according to one or both of a position of the ultrasound applicator within the vagina and a relation between the calculated position and a selected target location within the vagina wall. (Galen: Par. [0088]-[0090])
Regarding claim 50, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches the ultrasound applicator includes at least one sensor configured to sense one or both of a position and an orientation of the ultrasound applicator within the vagina. (Galen: Par. [0029] and [0088])
Regarding claim 51, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches the ultrasound applicator includes at least one contact sensor configured to sense contact of the at least some of the plurality of ultrasound transducers with the 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, as applied to claim 1 above, is silent regarding the 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 56, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches at least some of the plurality of ultrasound transducers are configured to contact directly or indirectly the surface of a wall of the vagina during the generation of ultrasonic waves. (Galen: Claim 1)
Regarding claim 58, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches the plurality of ultrasound transducers are arranged on the non-planar surface of the body to emit ultrasound energy sideways towards tissue of the vagina wall surrounding the body. (Govari: Fig. 3A – it is implicit that this feature be present in the Galen/Govari/Choi combination based on the rejection to claim 1 above.)
Regarding claim 59, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches the control circuitry is configured to adjust at least one parameter of ultrasonic waves emitted by each transducer based on the vaginal region facing that transducer. (Galen: Par. [0088]-[0090])
Regarding claim 60, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches the control circuitry selectively deactivates one or more of the plurality of ultrasound transducers while activating others to avoid thermal treatment of a selected vaginal region. (Par. [0055] and Par. [0088]-[0090])
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), 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, as applied to claim 1 above, teaches a handle coupled to a proximal end of the body, (Galen: Fig. 1, Char. 2: handle) wherein the handle comprises one or more gripping members. (Galen: Fig. 1: the surface of handle (2))
The combination of Galen/Govari/Choi, 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, 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/Wang, as applied to claim 18 above, teaches the ultrasound applicator includes one or more visual rotation orientation markings on one or both of the body and on the handle, wherein the 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), 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, as applied to claim 1 above, is silent regarding the ultrasonic waves generated by the 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/Govari/Choi, 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) 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), 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, as applied to claim 1 above, is silent regarding the body includes a hinge, and at least two movable portions interconnected by the 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, 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) 54 and 55 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), as applied to claim 1 above, and further in view of Sverdlik (US 2014/0039477 A1).
Regarding claim 54, the combination of Galen/Govari/Choi, as applied to claim 1 above, teaches at least one cooler is configured to apply cooling to the plurality of spaced-apart ultrasound transducers. (Galen: 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)
The combination of Galen/Govari/Choi, as applied to claim 1 above, is silent regarding at least one heat conducting base interconnecting the at least one cooler with the plurality of spaced-apart ultrasound transducers; and wherein the cooling is applied via the heat conducting base.
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.
In this combination, the cooler (2010) of Sverdlik would connect each energy delivery element (4) of Galen with at least their respective wires (2014) of Sverdlik and the generator for thermoelectric cooler (2010).
Regarding claim 55, the combination of Galen/Govari/Choi/Sverdlik, as applied to claim 54 above, teaches the 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 54 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 54 above.) and wherein the plurality of ultrasound transducers are in contact with the plurality of spaced apart protrusions. (In the rejection to claim 54 above, the thermoelectric cooler (2010) of Sverdlik was attached to the energy delivery elements (4) 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), 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, as applied to claim 56 above, is silent regarding at least some of the plurality of ultrasound transducers are configured to indirectly contact the surface of a wall of the 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, 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) 61 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), as applied to claim 1 above, and further in view of Emery (US 2019/0142380 A1)
Regarding claim 61, the combination of Galen/Govari/Choi, as applied to claim 1 above, is silent the control circuitry is configured to cause different transducers to emit ultrasonic waves with different parameter values to treat tissue at different depths in the two or more vaginal regions.
Emery, in a similar field of endeavor, teaches an ultrasonic treatment system configured to control energy delivery parameters to deliver ultrasound at various tissue locations and at various depths. (Par. [0013] and [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 control circuitry of Galen to control the energy parameters of each energy delivery element (4) of Galen, such that the energy delivery elements are capable of simultaneously treating different tissue areas at different depths. Doing so would allow for greater control over the energy delivery and resulting ablation pattern.
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) in view of Choi (US 2008/0027423 A1).
Regarding claim 46, Galen teaches a system for delivery of ultrasonic waves to a tissue volume, (Claim 1) comprising:
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 the non-planar surface of the body, (Fig. 1, Char. 4: energy delivery elements; Par. [0049]: the energy delivery elements may be ultrasound emitters) wherein the plurality of ultrasound transducers are configured to contact a surface of a wall of the vagina during the generation of ultrasonic waves, (Par. [0020]: Energy delivery elements (4) comprise an epithelium-contacting surface) wherein the plurality of ultrasound transducers are spaced-apart on the 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)and
a control circuitry electrically connected to the ultrasonic transducers, (Par. [0049] and [0064]) wherein the control circuitry is configured to control signals at least some of the ultrasound transducers arranged side-by-side along at least a portion of a circumference of the body to selectively treat different regions within the vagina (Par. [0024]: The energy delivery elements can be turned on in a specific sequence, including in a clockwise or counter-clockwise direction) based on position of the ultrasound applicator inside the vagina., (The different regions within the vagina would be treated based on the position of the ultrasound applicator within the vagina at least in that the different regions within the vagina would be treated based on what energy delivery elements (4) said regions are facing).
Galen, as applied to claim 46 above, is silent regarding the body being a cylindrical body; 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; and wherein selectively treat involves adjusting a simultaneous emission of ultrasonic waves at different angular directions with parameter values sufficient to deliver ultrasonic energy to heat two or more vaginal regions spaced apart from each other.
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.
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; and wherein selectively treat involves adjusting a simultaneous emission of ultrasonic waves at different angular directions with parameter values sufficient to deliver ultrasonic energy to heat two or more vaginal regions spaced apart from each other.
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; and wherein the selectively treat involving adjusting a simultaneous emission of ultrasonic waves at different angular directions with parameter values sufficient to deliver ultrasonic energy to heat two or more vaginal regions spaced apart from each other.
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.
The combination of Galen/Govari/Sverdlik/Spooner, as applied to claim 46 above, is silent regarding the selectively treat involving adjusting a simultaneous emission of ultrasonic waves at different angular directions with parameter values sufficient to deliver ultrasonic energy to heat two or more vaginal regions spaced apart from each other.
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/Sverdlik/Spooner, as applied to claim 46 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.
In this combination, simultaneously activating energy delivery elements (4) of Galen disposed on opposite ends of treatment tip (1) of Galen would heat at least two vaginal regions spaced apart from each other. (Galen: Par. [0055]: specific electrodes can be activated in any sequence or pattern)
Regarding claim 47, the combination of Galen/Govari/Spooner/Choi, as applied to claim 46 above, teaches the one or more cooling elements comprises at least one cooler, and at least one heat-conducting base interconnecting the at least one cooler and the plurality of ultrasound transducers, (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 combination of Galen/Govari/Sverdlik/Spooner/Choi 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 the at least one cooler is configured to apply the cooling via the heat conducting base to the plurality of ultrasound transducers, and via the plurality of ultrasound transducers to the vagina wall surface being contacted by said the transducers, to prevent overheating of the vagina wall surface. (Sverdlik: Fig. 15A, and Par. [0255]-[0256] – it is implicit that this feature be present in the Galen/Govari/Sverdlik/Spooner/Choi combination based on the rejection to claim 46 above.)
Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 2005/0215990 A1) in view of Merchant (US 2008/0014627 A1), in view of Thapliyal (US 2010/0016762 A1), in view of Galen (US 2013/0245728 A1) in view of Choi (US 2008/0027423 A1).
Regarding claim 49, Govari teaches an ultrasound applicator (Fig. 1) comprising:
an elongated hollow body having a non-planar surface, (Fig. 1, Char. 10: catheter) wherein the elongated body comprises at least one side acoustic window in said non-planar surface positioned to face body tissue surrounding the elongated hollow body; (Fig. 1 and 3A: The portion of catheter (10) configured to allow the ultrasound energy to pass therethrough to the target tissue)
a plurality of ultrasound transducers (Fig. 1 and 2, Char. 34: transducers) connected to a shaft passing through an inner lumen of the elongated hollow body, (Fig. 1 and 2, Char. 22: lead) wherein the plurality of ultrasound transducers comprises an emitting surface facing the at least one side acoustic window (Fig. 1 and 3A) wherein the plurality of ultrasound transducers are configured to transmit ultrasound waves from the emitting surface through the at least one side acoustic window (Claim 1 and Fig. 3A) with at least one of, frequency and intensity, suitable for generating thermal damage lesion in deep tissue layers of a subject body; (Claim 1 and Par. [0068])
a control circuitry electrically connected to the plurality of ultrasonic transducers, (Par. [0022]: Control unit) wherein the control circuitry is configured to control the plurality of ultrasonic transducers arranged side-by-side along at least a portion of a circumference of the body to selectively treat different regions within the subject body based on position of the ultrasound applicator inside the vagina, (Claim 5 and Par. [0022]) wherein selectively treat involves adjusting an emission of ultrasonic waves in different directions to heat two or more regions of the subject body spaced apart from each other. (Claim 6 and Par. [0022])
Govari, as applied to claim 49 above, is silent regarding the transmitted ultrasound waves being unfocused ultrasound waves; a cooling liquid bath for circulating cooling liquid in the inner lumen between the plurality of ultrasound transducers and the at least one side acoustic window; wherein circulating cooling liquid reduces temperature levels of the non-planar surface during the activation of the plurality of ultrasound transducers; and the emission of ultrasonic waves being simultaneous.
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 Govari, as applied to claim 49 above, to incorporate the teachings of Merchant, and configure the transducers (34) of Govari 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 Govari/Merchant, as applied to claim 49 above, is silent regarding a cooling liquid bath for circulating cooling liquid in the inner lumen between the plurality of ultrasound transducers and the at least one side acoustic window; wherein circulating cooling liquid reduces temperature levels of the non-planar surface during the activation of the plurality of ultrasound transducers; and the emission of ultrasonic waves being simultaneous.
Thapliyal, in a similar field of endeavor, teaches a cooling liquid bath for circulating in an inner lumen between one or more ultrasound transducers and 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 the circulating cooling liquid reduces temperature levels of a non-planar surface of an ultrasound catheter. (Claim 61)
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 Govari/Merchant, as applied to claim 49 above, to incorporate the teachings of Thapliyal, and configure the catheter (10) of Govari to circulate the cooling fluid (28) of Thapliyal between the catheter (10) and the transducers (34) of Govari. Doing so would minimize the risk of the transducers (34) and catheter (10) from overheating thereby minimizing any potential damage to said transducers (34) and catheter (10) caused by said overheating.
The combination of Govari/Merchant/Thapliyal, as applied to claim 49 above, is silent regarding the circulation of cooling fluid occurs during activation of said one or more ultrasound transducers; and the emission of ultrasonic waves being simultaneous.
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 Govari/Merchant/Thapliyal, 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 transducers (34) of Govari. Doing so would ensure that every part of the ultrasonic apparatus of Govari was maintained within safe operating temperatures.
The combination of Govari/Merchant/Thapliyal/Galen, as applied to claim 49 above, is silent regarding the emission of ultrasonic waves being simultaneous.
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 Govari/Merchant/Thapliyal/Galen, as applied to claim 49 above, to incorporate the teachings of Choi, and configure the transducers (34) of Govari to deliver ultrasound waves either sequentially or simultaneously. Doing so would allow for more treatment protocols, and options for energy delivery, as well as potentially shorten treatment time.
Conclusion
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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