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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/06/2025 has been entered.
Response to Amendment
Applicant’s amendments and remarks, filed 10/06/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 10/06/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Status of Claims
Claims 1-20 are currently under examination.
Priority
The instant application is a national stage entry under §371 of the international application PCT/IL2021/051301 which was filed on 11/03/2021.
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) to provisional application 63/109,091, filed 11/03/2020, are acknowledged.
Response to Arguments
Applicant’s responses and arguments filed 10/06/2025 regarding claim rejections under 35 USC 103 have been fully considered.
Regarding the claim rejections under 35 USC 103, Applicant argues that the combination of Schaer and Miller does not teach the HIFU treatment to be applied as claimed through the perineal region or perineum of the patient while sitting.
In response, the examiner had considered the teaching of Miller for combining the ultrasound imaging and HIFU treatment from the outside the patient body to the region of treatment within the body of the patient and therefore as teaching in combination with Schaer already teaching the imaging of a region within the body of a patient through the perineal region therefore teaching the treatment with HIFU and imaging with ultrasound using the same probe for a treatment through the perineal region of the patient. In order to clarify the position of the examiner, the examiner is modifying the rejection with an additional reference teaching the HIFU treatment through the perineal region as being known in the art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004).
Regarding independent claim 1, Schaer teaches an apparatus for use with a subject (Title and abstract with an ultrasound apparatus with specific designs and function for a subject sitting on a chair with the ultrasound waves directed through the perineum region of the subject in Fig.1 with the subject seating on the ultrasound probe 1 with the seating chair 6), the apparatus comprising:
a treatment head (Fig.1 with 2 force sensor on the treatment head having a holder for holding the ultrasound probe 1) comprising:
an ultrasound imaging probe configured to generate a sonogram of internal anatomy of the subject by generating an imaging acoustic field (Fig.1 imaging transducer probe 1 and p.298 col.2 2nd ¶); and
[…a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject…];
a chair comprising a chair-frame and a seat, wherein the chair-frame, the seat, and the treatment head are arranged such that when the subject is sitting in the chair a perineum of the subject is acoustically coupled to the treatment head (Fig.1 micturition chair 6 having a chair frame and seat and the treatment head with the ultrasound probe in contact with the subject p.298 col.1 2nd ¶); and
a control circuitry (p.298 col.1 2nd ¶ with main control microprocessor controlling the robot system) configured to
(a) control movement of the treatment head relative to the seat (Fig.1 microprocessor controlling the positioning of the ultrasound probe under a range of force against the subject (p.298 col.1 2nd ¶),
(b) operate the ultrasound imaging probe to generate at least one sonogram of internal anatomy of the subject through the perineum of the subject (p.298 col.2 2nd ¶ “urethrovesical anatomy was visualized sonographically with a 5 MHz linear curved array transducer (Aloka SSD 2000; Aloka Ltd., Tokyo, Japan)… The ultrasound video signal was digitalized by a frame grabber card and displayed on the computer screen”) , and
[…(c) operate the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject...].
Schaer does not specifically teach a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject and the control (c) operate the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject as in claim 1.
However, Wu teaches within the same field of endeavor of medical field using ultrasound emissions including imaging (Title and abstract and p.500 col.2) the treatment of prostate with a HIFU treatment while the patient is sitting and the treatment being performed using HIFU through the perineal region of the patient to reach the prostate (p.500-501 ¶ HIFU therapy) with the therapy being tracked and directed using ultrasound imaging performed using the same probe combining imaging and treatment, as Wu refers to Jun-Qun as using the same device (ref.8) with Jun-Qun describing the ultrasound/HIFU device of Wu as the combined imaging-HIFU treatment probe (Fig.1 and p.57 col.2 last ¶ - p.58 col.1 1st ¶ for ¶ Equipment) therefore teaching a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject and Wu teaches also the imaging being used for tracking the therapy with the computer controlling the imaging and sending results to the therapy array controller (p.500) therefore teaching the control (c) operate the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer such that the system further comprises: a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject and the control (c) operate the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject, since one of ordinary skill in the art would recognize that using a HIFU/therapy transducer as coupled to the ultrasound imaging transducer for treating specific urologic diseases such as prostate cancer and monitoring the treatment under imaging guidance was known in the art as taught by Wu as evidenced by Jun-Qun. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Wu and Schaer both teach ultrasound imaging within the patient. The motivation would have been to ideally provide treatment to specific urologic diseases by using a therapy transducer with an alignment between the imaging and therapy beams in order to avoid complex registration between imaging and therapy beams for guiding and monitoring the therapy, as suggested by Wu (p. 500-501) and Jun-Qun as discussed above.
Regarding the dependent claims 2-5 all the elements of these claims are instantly disclosed or fully envisioned by the teachings of Schaer, Wu and Jun-Qun.
Regarding claim 2, Schaer teaches the treatment head is moveably coupled to the chair-frame (Fig.1 with the chair immobile during the setting and use of the ultrasound probe as part of the treatment head wherein the treatment head also include the HIFU transducer as modified by Miller).
Regarding claim 3, as discussed above, Schaer as modified by Wu teaching the HIFU transducer and the ultrasound imaging probe teach the probe as fixed to the treatment head such that movement of the treatment head relative to the seat moves the HIFU transducer and the ultrasound imaging probe relative to the seat, as discussed above for claim 1 with Wu describing the probe as modified as including both therapy and imaging transducers as being coaxially set as described by Jun-Qun (Fig.1) and therefore being oriented using the robotic arm (Schaer Fig.1) shows the motion of the treatment head as a whole with the coaxial placement of the imaging and treatment transducers on the treatment head as both transducers are attached to the head treatment and are moving relative to the seat as the head treatment is moved (Schaer Fig.1).
Regarding claim 4, Schaer teaches also the control circuit for positioning the treatment head so that the ultrasound probe is in contact with the subject within a range of contact pressure (p.298 col.1 2nd ¶ including a translation along the X-axis and a translation along the Y-axis with one of them corresponding to the longitudinal axis of the treatment head, Fig.1) therefore teaching the control circuitry is configured to control translation of the treatment head along a longitudinal axis of the treatment head, and along an axis that is perpendicular to the longitudinal axis as claimed.
Regarding claim 5, Schaer also teaches the control circuitry is configured to control rotation of the treatment head about an axis that is perpendicular to a longitudinal axis of the treatment head (Fig.1 and p.298 col.1 2nd ¶ with the control of the tilt of the probe).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) as applied to claims 1-3 and further in view of Watson et al. (USPN 20190290939 A1; Pub.Date 09/26/2019; Fil.Date 06/07/2019).
Schaer, Wu and Jun-Qun teach an apparatus as set forth above.
Schaer, Wu and Jun-Qun do not specifically teach to control rotation of the treatment head about a longitudinal axis of the treatment head as in claim 6.
However, Watson teaches within the same field of endeavor of performing HIFU treatment under ultrasound imaging guidance for a person sitting on a chair (Title and abstract with an ultrasound therapeutic and scanning apparatus with specific designs and function for treating a subject in Figs.7C and 8C and [0157] with the subject seating on the apparatus with the seating place/saddle 704 or 804), the apparatus comprising a treatment head ([0177] and Fig.12B transducer holder 1203 with transducers 1201 and 1202 wherein one of the transducers is an HIFU transducer 1201 for performing the ultrasound treatment as in [0008] and a imaging transducer 1202 to image the treatment region both independently orientable one from each other to allow their proper functions) the apparatus comprising: an ultrasound imaging probe configured to generate a sonogram of internal anatomy of the subject by generating an imaging acoustic field ([0177]-[0181] imaging transducer 1202 providing as in [0178] an image of the prostate by scanning up through the perineum before, during or after the irradiation with the treating HIFU transducer) ) and a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject ([0177]-[0181] HIFU transducer 1201 as therapeutic transducer emitting waves within the range or 5MHz to 20MHz) defining a treatment head with the support wherein Watson teaches also the control circuitry is configured to control rotation of the treatment head about a longitudinal axis of the treatment head ([0025] for control and Fig.10 showing the rotation of the probe around the longitudinal z axis of the treatment head ([0169])).
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu and Jun-Qun such that the system further comprises: the control circuitry is configured to control rotation of the treatment head about a longitudinal axis of the treatment head, since one of ordinary skill in the art would recognize that controlling the rotation of the treatment head around the treatment head longitudinal axis was known in the art as taught by Watson. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Watson, Wu and Schaer both teach ultrasound imaging of the perineum region of the subject. The motivation would have been to ideally provide sufficient degrees of freedom to the probe to be positioned rightfully towards the targeted organ for proper treatment under imaging guidance, as suggested by Watson ([0178]-[0180]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) as applied to claims 1-3 and further in view of Vaezy et al. (USPN 20050203399 A1; Pub.Date 09/15/2005; Fil.Date 10/29/2004).
Schaer, Wu and Jun-Qun teach an apparatus as set forth above. As discussed above, both Schaer, Wu and Jun-Qun teach the computer control for positioning the imaging and treatment transducers.
Schaer, Wu and Jun-Qun do not specifically teach to rotate relative to the treatment head about a longitudinal axis of the treatment head, and wherein the control circuitry is further configured to control the rotation of the ultrasound imaging probe relative to the treatment head as in claim 7.
However, Vaezy teaches within the same field of endeavor of combining HIFU treatment under ultrasound imaging guidance (Title and abstract) the positioning of the imaging transducer with the transducer rotating about the longitudinal axis of its support to align the imaging beam to the target for treatment (Fig.7A-7B and [0071] rotation around the axis of the support 208) therefore teaching to rotate relative to the treatment head about a longitudinal axis of the treatment head, and wherein the control circuitry is further configured to control the rotation of the ultrasound imaging probe relative to the treatment head as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu and Jun-Qun such that the system further comprises: to rotate relative to the treatment head about a longitudinal axis of the treatment head, and wherein the control circuitry is further configured to control the rotation of the ultrasound imaging probe relative to the treatment head, since one of ordinary skill in the art would recognize that controlling the rotation of the imaging transducer relative to the longitudinal axis of the treatment head in order to align the imaging beam to the target for treatment was known in the art as taught by Vaezy. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Vaezy, Wu and Schaer both teach ultrasound imaging of the perineum region of the subject. The motivation would have been to ideally provide sufficient degrees of freedom to the probe to be positioned rightfully towards the targeted organ for proper treatment under imaging guidance and to improve the imaging focusing, as suggested by Vaezy ([0089]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) as applied to claim 1 and further in view of Miller (2014 PhD thesis BME University of Michigan 173 pages; Pub.Date 2014).
Schaer, Wu and Jun-Qun teach an apparatus as set forth above.
Regarding claim 8, Wu as evidenced by Jun-Qun teaches as discussed above the coaxial positioning of the therapy and the imaging transducer for better registration (Fig.1 and p.57-58 from Jun-Qun). The examiner notes that the imaging transducer is cylindrical and is capable to be translated along the longitudinal axis of the therapy transducer.
Schaer, Wu and Jun-Qun do not teach specifically the ultrasound imaging probe is configured to rotate within a central bore of the HIFU transducer as in claim 8.
However, Miller teaches within the same field of endeavor for coupling HIFU therapeutic device with an ultrasound imaging through the perineum of the subject for biomedical applications (Title and abstract) the HIFU transducer and imaging transducer as being coaxially disposed for better registration (p.57 1st ¶ and Fig.6-11 and Fig.6-22 with the cylindrical imaging transducer sliding along the longitudinal axis of the therapy transducer using O-ring to maintain the coupling water within the enclosure in front of the transducer (Fig. 6-23, 6-24)), therefore is capable to rotate about the longitudinal axis as claimed. Applicant is reminded that while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. See MPEP 2112 (Section III) and MPEP 2114. Therefore Miller teaches the ultrasound imaging probe is configured to rotate within a central bore of the HIFU transducer as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu and Jun-Qun such that the system further comprises the ultrasound imaging probe is configured to rotate within a central bore of the HIFU transducer, since one of ordinary skill in the art would recognize that having a cylindrical imaging transducer placed axially within a therapy transducer and capable to slide along this axis using O-rings was known in the art as taught by Miller. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Miller and Schaer both teach ultrasound imaging of the internal region of the subject. The motivation would have been to ideally provide an alignment between the imaging and therapy beams in order to avoid complex registration for guiding and monitoring the therapy, as suggested by Miller (p.134 2nd ¶).
Regarding claim 9, Jun-Qun teaches the use of a cushion/reservoir filled with degassed water for coupling the imaging and HIFU therapy probe to the skin of the patient (Jun-Qun Fig.1, p.57-58) the reservoir appearing to be part of the probe with a flexible membrane. Miller provide a better description for the treatment head which comprises: a housing, in which the ultrasound imaging probe and the HIFU transducer are disposed (Fig.6-22 rectangular housing and Fig. 6-23); and a flexible membrane sealably coupled to a perimeter of the housing, the flexible membrane and the housing forming an internal cavity that is configured to be filled with a liquid such that, when the internal cavity of the housing is filled with the liquid the ultrasound imaging probe and the HIFU transducer are in direct contact with the liquid (Fig.6-23 and 2-1 and p.14 last ¶ to p.15 1st ¶ with plastic membrane sealing the enclosure with O-rings with degassed water within the enclosure in contact with the transducers), wherein: the flexible membrane is configured to inflate outwards from the perimeter of the housing due to pressure from the liquid within the internal cavity (the presence of the water will physically inflate outwardly the plastic membrane as being flexible as seen in Fig.2-1), and when the subject is sitting in the chair the perineum of the subject is acoustically coupled to the treatment head via the flexible membrane, the flexible membrane being pressed against the perineum of the subject due to the pressure (Fig.2-1 with Miller teaching that the contact of the plastic membrane with the skin of the subject will couple the transducer with the body of the subject therefore since Schaer taches already the placement of the probe against the perineum region of the subject Miller teaches when the subject is sitting in the chair the perineum of the subject is acoustically coupled to the treatment head via the flexible membrane, the flexible membrane being pressed against the perineum of the subject due to the pressure as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu and Jun-Qun such that the system further comprises: the treatment head comprises: a housing, in which the ultrasound imaging probe and the HIFU transducer are disposed; and a flexible membrane sealably coupled to a perimeter of the housing, the flexible membrane and the housing forming an internal cavity that is configured to be filled with a liquid such that, when the internal cavity of the housing is filled with the liquid the ultrasound imaging probe and the HIFU transducer are in direct contact with the liquid, wherein: the flexible membrane is configured to inflate outwards from the perimeter of the housing due to pressure from the liquid within the internal cavity, and when the subject is sitting in the chair the perineum of the subject is acoustically coupled to the treatment head via the flexible membrane, the flexible membrane being pressed against the perineum of the subject due to the pressure, since one of ordinary skill in the art would recognize that sealing the enclosure containing the imaging and therapy transducer with degassed water using a flexible plastic membrane with O rings around the periphery of the housing was known in the art, and since bringing the flexible membrane having the water bulging the membrane outward in contact with the patient for coupling the transducer with the patient tissue was known in the art, as taught by Miller and since the positioning of the probe against the perineum region of patient was also know in the art as taught by Schaer. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Miller and Schaer both teach ultrasound imaging of the perineum region of the subject. The motivation would have been to ideally provide an alignment between the imaging and therapy beams with the most direct coupling between the transducer and the sensor in order to avoid noise formation, as suggested by Miller (p.134 2nd ¶).
Regarding the dependent claim 10, all the elements of these claims are instantly disclosed or fully envisioned by the teachings of Schaer, Wu, Jun-Qun and Miller.
Regarding claim 10, as discussed above, Jun-Qun teaches the use of degassed water for coupling the transducers and the skin of the patient (Fig.1 and p.57-58) and also Miller teaches the use of water for coupling agent and additionally, Miller teach the use of degassed water (p.14 last ¶) therefore teaching the liquid is degassed water as claimed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) in view of Miller (2014 PhD thesis BME University of Michigan 173 pages; Pub.Date 2014) as applied to claims 1 and 9 and further in view of Wang et al. (USPN 5494038 A; Pat.Date 02/27/1996; Fil.Date 04/25/1995).
Schaer, Wu, Jun-Qun and Miller teach an apparatus as set forth above.
Schaer, Wu, Jun-Qun and Miller do not specifically teach at least a portion of the flexible membrane is water permeable and is configured such that when the flexible membrane is pressed against the perineum of the subject, liquid from within the internal cavity of the housing seeps through the at least a portion of the flexible membrane such that the perineum is acoustically coupled to the flexible membrane via the liquid that seeped through the at least a portion of the flexible membrane as in claim 11.
However, Wang teaches within the same field of endeavor of ultrasound transducer apparatus (Title and abstract) the use of a flexible membrane for sealing a cavity in front of the transducer with a coupling liquid (Fig.9 col.8 2nd ¶ membrane 83 coupling liquid within cavity 90 in front of ultrasound probe 80) wherein the membrane under pressure becomes porous to the coupling liquid providing a seeping of the coupling liquid outside through the pores and forming a coupling liquid layer to improve the coupling between the skin and the ultrasound probe (col.7 1st ¶) therefore teaching at least a portion of the flexible membrane is water permeable and is configured such that when the flexible membrane is pressed against the perineum of the subject, liquid from within the internal cavity of the housing seeps through the at least a portion of the flexible membrane such that the perineum is acoustically coupled to the flexible membrane via the liquid that seeped through the at least a portion of the flexible membrane as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun and Miller such that the system further comprises: at least a portion of the flexible membrane is water permeable and is configured such that when the flexible membrane is pressed against the perineum of the subject, liquid from within the internal cavity of the housing seeps through the at least a portion of the flexible membrane such that the perineum is acoustically coupled to the flexible membrane via the liquid that seeped through the at least a portion of the flexible membrane, since one of ordinary skill in the art would recognize that sealing the enclosure of the ultrasound transducers with a flexible membrane becoming porous to the coupling liquid under increasing pressure was known in the art as taught by Wang. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Wang, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide the ultrasound probe with an extra coupling liquid layer in between the probe membrane and the skin of the patient to improve the acoustic coupling and provide better imaging, as suggested by Wang (col.7 1st ¶).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) in view of Miller (2014 PhD thesis BME University of Michigan 173 pages; Pub.Date 2014) as applied to claims 1 and 9 and further in view of Chapelon et al. (USPN 5720287 A; Pat.Date 02/24/1998; Fil.Date 06/06/1996).
Schaer, Wu, Jun-Qun and Miller teach an apparatus as set forth above.
Schaer, Wu, Jun-Qun and Miller do not specifically teach the flexible membrane is arranged such that a major axis of a projection of the uninflated flexible membrane taken along a longitudinal axis of the treatment head of is 6 - 12 cm as in claim 12.
However, Chapelon teaches within the same field of endeavor of combine imaging and HIFU treatment (Title and abstract) the use of a flexible membrane for providing an enclosure for the HIFU and imaging transducers (Fig.9 col.15 4th – 5th ¶ membrane 120’ imaging and therapy transducer 30’ and 40’). Additionally, Chapelon teaches that the diameter of the imaging transducer exemplified at 1cm diameter and the diameter of the treatment transducer exemplified at 2.5cm therefore rendering the length of the membrane along the longitudinal axis of the treatment head of around 4cm or higher when not under pressure (col.8 7th ¶ and Fig.9) therefore teaching the flexible membrane is arranged such that a major axis of a projection of the uninflated flexible membrane taken along a longitudinal axis of the treatment head of is 6 - 12 cm.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun and Miller such that the system further comprises: the flexible membrane is arranged such that a major axis of a projection of the uninflated flexible membrane taken along a longitudinal axis of the treatment head of is 6 - 12 cm, since one of ordinary skill in the art would recognize that sealing the enclosure of the ultrasound transducers with a flexible membrane that project along the main axis of the treatment head with a length or more than 4cm was known in the art as taught by Chapelon. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Chapelon, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide the ultrasound probe with a flexible membrane that sufficiently cover the transducers with sufficient coupling liquid to improve the imaging, as suggested by Chapelon (col.8 6th ¶).
Schaer, Wu, Jun-Qun and Miller do not specifically teach the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 2 - 8 cm longer than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled as in claim 13.
However, Chapelon teaches within the same field of endeavor the projection of the flexible membrane as discussed above of being more than 4cm and as considering the Fig.9 the major axis of the perimeter of the housing where the membrane is attached is around less than 1/3 of that projection, therefore Chapelon teaches the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 2 - 8 cm longer than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun and Miller such that the system further comprises the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 2 - 8 cm longer than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled, since one of ordinary skill in the art would recognize that sealing the enclosure of the ultrasound transducers with a flexible membrane that project along the main axis of the treatment head with a length or more than 4cm and that the major axis of the perimeter of the housing is less than 1/3 of that projection was known in the art as taught by Chapelon. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Chapelon, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide the ultrasound probe with a flexible membrane that sufficiently cover the transducers with sufficient coupling liquid to improve the imaging, as suggested by Chapelon (col.8 6th ¶).
Regarding claim 14, Schaer, Wu, Jun-Qun and Miller do not specifically teach the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 20 - 100% larger than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled.
However, similarly to claim 13, Chapelon teaches within the same field of endeavor the projection of the flexible membrane as discussed above of being more than 4cm and as considering the Fig.9 the major axis of the perimeter of the housing where the membrane is attached is around less than 1/3 of that projection, therefore Chapelon teaches also the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 20 - 100% larger than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun and Miller such that the system further comprises the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 20 - 100% larger than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled, since one of ordinary skill in the art would recognize that sealing the enclosure of the ultrasound transducers with a flexible membrane that project along the main axis of the treatment head with a length or more than 4cm and that the major axis of the perimeter of the housing is less than 1/3 or 30% of that projection was known in the art as taught by Chapelon. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Chapelon, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide the ultrasound probe with a flexible membrane that sufficiently cover the transducers with sufficient coupling liquid to improve the imaging, as suggested by Chapelon (col.8 6th ¶).
Claims 15-17, are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) in view of Miller (2014 PhD thesis BME University of Michigan 173 pages; Pub.Date 2014) as applied to claims 1 and 9 and further in view of Kunii (USPN 4681120 A; Pat.Date 07/21/1987; Fil.Date 01/29/1985).
Schaer, Wu, Jun-Qun and Miller teach an apparatus as set forth above.
Schaer, Wu, Jun-Qun and Miller do not specifically teach a pressure regulator coupled to the housing and configured to regulate the pressure within the internal cavity of the housing as in claim 15.
However, Kunii teaches within the same field of endeavor of using a flexible membrane as a cover for the ultrasound probe head (Title, abstract and Fig.4 membrane 34 and ultrasonic probe 80) the regulation performed by a driver (Fig.4 and col.5 2nd ¶ to col.6 5th water pressure adjusted to maintained the patient body at a defined height in contact with the flexible membrane, with the driver 68 adjusting the water pump and the mode of flow with the switch 58 with the water input port at 46 and output port 48 in fluid communication with the internal cavity of the housing 30, therefore reading on a pressure regulator) therefore teaching a pressure regulator coupled to the housing and configured to regulate the pressure within the internal cavity of the housing as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun and Miller such that the system further comprises a pressure regulator coupled to the housing and configured to regulate the pressure within the internal cavity of the housing, since one of ordinary skill in the art would recognize that using a pressure regulator to regulate the volume of water to maintain the contact pressure between the patient body and the flexible membrane to a certain level to place the body at the right place relative to the ultrasound transducer/probe was known in the art as taught by Kunii. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Kunii, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide a regulate position of the body in contact with the flexible membrane to optimize the imaging of the patient region of interest, as suggested by Kunii (col.5 2nd ¶ to col.6 5th).
Regarding the dependent claims 16, 17, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Schaer, Wu, Jun-Qun, Miller and Kunii.
Regarding claim 16, as discussed above, Kunii teaches the housing comprises a fluid port in fluid communication with the internal cavity of the housing (Fig.4 input port 46 and output port 48), and the pressure regulator is configured to regulate the pressure within the internal cavity of the housing by regulating a volume of the liquid within the internal cavity of the housing using the fluid port (col.5 2nd ¶ to col.6 5th regulating the water pressure for maintaining the level of contact between the body/breast of the patient with the flexible membrane, therefore maintaining a constant volume within the cavity of the housing 30 since the coupling liquid here water is incompressible at the sensitivity level of the regulation).
Regarding claim 17, as discussed above, Kunii teaches the fluid port is a first fluid port and the housing further comprises a second fluid port, (a) the first fluid port being a fluid inlet port through which the liquid is received into the internal cavity of the housing, (b) the second fluid port being a fluid outlet port through which the liquid is drained from the internal cavity of the housing Fig.4 input port 46 and output port 48), and the pressure regulator is configured to regulate the pressure within the internal cavity of the housing by regulating a volume of the liquid within the internal cavity of the housing using the fluid inlet port and the fluid outlet port (col.5 2nd ¶ to col.6 5th regulating the water pressure for maintaining the level of contact between the body/breast of the patient with the flexible membrane, therefore maintaining a constant volume within the cavity of the housing 30 since the coupling liquid here water is incompressible at the sensitivity level of the regulation).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (1998 Obstetrics and Gynecology 91:297-301; Pub.Date 1998) in view of Wu et al. (2011 Asian Journal of Andrology 13:499–504; Pub.Date 2011) with evidential reference of Jun-Qun et al. (2004 Ultrasound in Med & Biol 30:57–60; Pub.Date 2004) in view of Miller (2014 PhD thesis BME University of Michigan 173 pages; Pub.Date 2014) in view of Kunii (USPN 4681120 A; Pat.Date 07/21/1987; Fil.Date 01/29/1985) as applied to claim 16 and further in view of Chapelon et al. (USPN 5720287 A; Pat.Date 02/24/1998; Fil.Date 06/06/1996) and in view of Milkowski et al. (USPN 20160089110 A1; Pub.Date 03/31/2016; Fil.Date 09/29/2014).
Schaer, Wu, Jun-Qun, Miller and Kunii teach an apparatus as set forth above. As discussed above, Schaer teaches the contact force between the patient perineum and the probe is between 0 and 10N with Kunii teaching the flexible membrane is coupled to the housing such that (a) when the flexible membrane is inflated by the internal cavity of the housing being filled with a volume of liquid such that the pressure within the internal cavity is a given pressure.
Schaer, Wu, Jun-Qun, Miller and Kunii do not specifically teach the pressure is within the internal cavity is 1.2 atm, and (b) the subject is not sitting in the chair, an uncompressed height of the inflated flexible membrane along a longitudinal axis of the treatment head is 2-12 cm.
However, as discussed above for claim 12, Chapelon teaches the flexible membrane is arranged such that a major axis of a projection of the uninflated flexible membrane taken along a longitudinal axis of the treatment head of is 6 - 12 cm as in claim 12, therefore teaching (b) the subject is not sitting in the chair, an uncompressed height of the inflated flexible membrane along a longitudinal axis of the treatment head is 2-12 cm.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun, Miller and Kunii such that the system further comprises: (b) the subject is not sitting in the chair, an uncompressed height of the inflated flexible membrane along a longitudinal axis of the treatment head is 2-12 cm, since one of ordinary skill in the art would recognize that sealing the enclosure of the ultrasound transducers with a flexible membrane that project along the main axis of the treatment head with a length or more than 4cm was known in the art as taught by Chapelon. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Chapelon, Miller and Schaer both teach ultrasound imaging of the subject. The motivation would have been to ideally provide the ultrasound probe with a flexible membrane that sufficiently cover the transducers with sufficient coupling liquid to improve the imaging, as suggested by Chapelon (col.8 6th ¶).
Additionally, Milkowski teaches within the same field of endeavor on ultrasound probe with a flexible membrane as cover (Title and abstract and Fig.1 with flexible membrane 34 and fluid port 38 and pressure/force sensor 40) the operational pressure for the probe applied during function is a pressure above 1 atm ([0031], [0037] exemplified to be above 1 atm) therefore overlapping the range of 1.2-2atm as claimed for the pressure within the internal cavity..
One of ordinary skill in the art would have recognized as obvious before the effective filling date of the invention that performing the ultrasound imaging and therapy while maintaining a contact pressure higher than 1 atm. Therefore the choice of the contact pressure would have been obvious as an arbitrary design consideration to choose the level of contact to improve the acoustic coupling between the probe transducers and the body of the patient via the perineum region as taught by Kunii. One of ordinary skill in the art would have also recognized as obvious at the time of the invention that the choice of the pressure would have been an arbitrary design consideration for achieving the adequate performance of the transducer for imaging at least as taught by Kunii.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Schaer as modified by Wu, Jun-Qun, Miller and Kunii such that the system further comprises: the pressure is within the internal cavity is 1.2 atm, since one of ordinary skill in the art would recognize that applying a contact pressure above 1 atm on the ultrasound probe was commonly known in the art as taught by Milkowski. One of ordinary skill in the art would have expected this design could have been made with predictable results since Milkowski teaches the use of a contact flexible membrane to allow to place the body in position appropriate for the function of the ultrasound probe. The motivation would have been to optimize the acoustic coupling and optimize the imaging of the region of interest by optimizing the contact surface of the body with the flexible membrane as suggested by Kunii.
Therefore, as it is well known in the art to specify optimal conditions to optimize the contact between the probe and the body of the patient, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to specify the optimum pressure of contact between 1.2 and 2atm including 1.2 atm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Alter, 105 USPQ 233 (C.C.P.A. 1955).
Regarding the dependent claims 19, 20, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Schaer, Wu, Jun-Qun, Miller, Kunii, Chapelon and Milkowski.
Regarding claim 19, as discussed above, Schaer and Miller teaches to bring the probe via the flexible membrane in contact with the perineum of the patient for providing an optimum acoustic coupling between the ultrasound probe and the patient body with Schaer teaching to maintain a contact pressure between the probe and the patient between 0 and 10 N (Schaer p.298 col.1 2nd ¶) and Kunii teaches the pressure regulator maintaining the pressure/volume within the liquid enclosure at a given volume to maintain the level of contact between the body and the membrane at a given height (col.5 2nd ¶ to col.6 5th regulating the water pressure for maintaining the level of contact between the body/breast of the patient with the flexible membrane, therefore maintaining a constant volume within the cavity of the housing 30 since the coupling liquid here water is incompressible at the sensitivity level of the regulation) therefore teaching the pressure regulator is configured such that, when the subject is sitting in the chair, the pressure regulator maintains the flexible membrane pressed against the perineum of the subject by maintaining the pressure within the internal cavity at an operational pressure.
Regarding claim 20, as discussed above for claim 18, Schaer, Wu, Jun-Qun, Miller, Kunii, Chapelon and Milkowski teach the operational pressure is 1.2 - 2 atm since Schaer, Wu, Jun-Qun, Miller, Kunii, Chapelon and Milkowski teach the operational pressure is 1.2 atm.
Conclusion
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/PATRICK M MEHL/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798