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 .
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 05/14/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 recites the limitation “the at least one reflective material is a conformable material defining an exterior surface of the body”. There is insufficient written description for the limitation. In this instance, it is noted that while [0013] of applicant’s originally filed specification discloses that the gaseous filled membrane has an elastomeric conformable exterior surface that conforms to the shape of the surface of the appendage when pressed against the appendage and [0050] which discloses the gaseous filled membrane 300 can have a reflective interior appendage side surface 310 and a reflective interior opposite side surface 308, 312 of the gaseous filled membrane 300. The balloon or bag also has interior surfaces 310, 308 and 312 that can have a reflective coating to better reflect and redirect the acoustic shock waves 200. Thus it is noted that the membrane, balloon, or bag may have interior reflective surfaces or are filled with air which is a reflective material, there is no disclosure of the material of the membrane, balloon, or bag (which define the exterior surface of the body) being reflective themselves. It is therefore noted that there is insufficient written description as to the nature of the reflective material that is also conformable and defines and exterior surface of the body.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation “the at least one reflective material is a conformable material defining an exterior surface of the body”. The limitation is unclear as to what the reflective material is that is conformable and defines an exterior surface of the body. In other words, it is unclear what reflective material is envisioned to be conformable. For examination purposes, it has been interpreted to mean a conformable material (such as a membrane) is associated with the reflective material, however, clarification is required.
Claim 25 recites the limitation “the body includes opposing layers of material defining an enclosed space”, “the at least one reflective material include a gas and a gaseous-filled membrane”, and “the gas and the gaseous-filled membrane are within the enclosed space”. The limitation is unclear as it appears to contradict elements recited in claim 22. For example, claim 22 recites that the reflective material is a conformable material defining an exterior surface of the body, however claim 25 contradicts this by reciting that the at least one reflective material include a gas and a gaseous-filled membrane which are enclosed within a space defined by opposing layers of the body, where such elements of the reflective material being within an enclosed space cannot define an exterior surface of the body. It is further unclear if the claim is attempting to define that the gas and gaseous-filled membrane are the conformable material or if these are different elements, however, due to the language that the reflective material is a conformable material they would appear to be one in the same, however, this is not made clear by the language. It is further unclear if the opposing layers of material include the conformable material or if these are different elements. For examination purposes, it has been interpreted that the conformable material defines an exterior surface of the body and may be one of the layers of material defining the enclosed space that is associated with the reflective material, however, clarification is required.
Claim 27 recites the limitation “a surface of at least one of the exterior walls”. It is unclear if the at least one of the exterior walls is the same or includes the one or the exterior walls recited in claim 26 or if this is a different at least one of the exterior walls. In other words, it is unclear if the claim is attempting to define that the layer of coating material is on a surface of the one of the external walls engaging the appendix or if the layer of coating is on a different one of the exterior walls excluding the wall engaging the appendix. For examination purposes, it has been interpreted that the at least one of the exterior walls is any of the exterior walls and may include the one of the exterior walls engaging the appendage, however, clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17 and 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azhari et al. (US 20110251524 A1), hereinafter Azhari.
Regarding claim 17,
Azhari discloses a method of treating an appendage of a patient ([0292] which discloses to allow the treatment of limbs or other curved body parts) comprises the steps of:
Placing an acoustic shock wave applicator (at least fig. 1 (42 and 32) and corresponding disclosure in at least at least [0206]-[0209] or fig. 4 (42 and 32) and corresponding disclosure in at least [0271] and [0232] which discloses in the treatment mode, acoustic elements 40 and/or 42 transmit high intensity ultrasound waves, shock waves, sharp negative pressure pulses, continuous waves (CW), pulse sequences that cause cavitation, any other form of acoustic radiation that affects the tissue in a desired manner, or any combination of the above. See also fig. 2) on a surface (see at least fig. 4) of the appendage ([0292] which discloses the housing described herein coupled to the first and second support structures is flexible, e.g., to allow the treatment of limbs or other curved body parts. Examiner thus notes that the first and second support structures (i.e. 32 and 30 of fig. 4)), wherein said placing the acoustic shock wave applicator (42 and 32) includes manually retaining the acoustic shock wave applicator in contact with the skin of the appendage (additionally/alternatively [0293] which discloses for some applications, the apparatus does not comprise a housing; rather, the first and second support structures comprise hand-held devices resembling wands, which are placed by the user, e.g., a physician or the subject, at two different portions of the skin of the subject. Examiner thus notes that placing the acoustic shock wave applicator 42 in such applications includes manually retaining the acoustic shock wave applicator in contact with the skin of the appendage (i.e. limb))
Placing a wave energy treatment device (at least fig. 1 (30 and 40) and corresponding disclosure in at least [0209] or at least fig. 4 (30 and 120 and/or 30, 120) and corresponding disclosure in at least [0271]. Examiner notes that the wave energy treatment device may further comprise the housing as disclosed in at least [0292] and [0206]) at a location on an opposite surface of the appendage relative to a location of the acoustic shock wave applicator (see at least fig. 4), wherein wave energy treatment device includes a body (at least fig. 1 (30 and/or 40) and at least fig. 4 (30 and/or 120) and at least one reflective material integral with the body (at least fig. 1 (40) and corresponding disclosure in at least [0216] or at least fig. 4 (120) or (123 and/or 123 and polyurethane coupler) and corresponding disclosure in at least [0272]), wherein the body is a hand-held article held by a hand ([0293] which discloses for some applications, the apparatus does not comprise a housing; rather, the first and second support structures (30 and 32) comprise hand-held devices resembling wands, which are placed by the user, e.g., a physician or the subject, at two different portions of the skin of the subject. Examiner further notes that the apparatus including the housing is considered to be a hand-held article in that a person having ordinary skill in the art would have recognized the ability to hold the c-shaped clamp as depicted in fig. 1) wherein the at least one reflective material reflects acoustic shock waves impinged thereupon, wherein said placing includes holding the appendage in contact with the wave energy treatment device for enabling acoustic shockwave emitted by the acoustic shock wave applicator to impinge upon the at least one reflective material ([0216] which discloses acoustic element 42 also transmits energy toward acoustic element 40, which either receives and/or reflects the through-transmitted energy back in the direction of the acoustic element 42 and [0222] which discloses The reflected energy is then refocused toward the center of portion 122 of tissue 25 so as to supplement the confocal acoustic radiation provided by acoustic elements 40 and 42. In such an application, the arrays are capable of varying their respective focal points in response to an electronic system which electronically reconfigures the transducers in the arrays. Additionally, each of the first and second arrays reflects through-transmitted energy back toward the respective opposing array and toward the center of the portion of the skin and underlying tissue that is drawn between the first and second support structures. See also [0271] which discloses reflector 120 is disposed with respect to acoustic element 42 in a manner in which at least a portion of beams 45 transmitted from acoustic element 42 are reflected from acoustic reflector 120 toward a focal zone 110 which is typically in the center of tissue portion 122, e.g., equidistant from (a) an interface between reflector 120 and skin 24 of tissue portion 122, and (b) from an interface between acoustic element 42 and skin 24 of tissue portion 122. Typically, such reflection generates nonconfocal transmission of energy toward focal zone 110. See also [0272]-[0273] which discloses the acoustic element 42 may be replaced with a focused ultrasound transducer having a curved surface that faces and is in acoustic communication with the lateral surface of the support structure, which interfaces with tissue of portion 122 and acoustic element 42 comprises an annular phased array of ultrasound transducers which can steer its focal zone electronically to align with the focal zone 110 of reflector 120. Examiner thus notes that the reflective material 40 or 123 reflects acoustic energy (thus shock waves when the transmission from 42 is shock waves as noted in [0232])
Causing one or more acoustic shock waves to be transmitted from the acoustic shock wave applicator through the appendage by activating an acoustic shock wave generator or source coupled to the acoustic shock wave applicator ([0232] which discloses acoustic elements 40 and/or 42 are switched to a treatment mode. In the treatment mode, acoustic elements 40 and/or 42 transmit high intensity ultrasound waves, shock waves, sharp negative pressure pulses, continuous waves (CW), pulse sequences that cause cavitation, any other form of acoustic radiation that affects the tissue in a desire d manner or any combination of the above. See also [0233]. Examiner notes that such transmission of acoustic shock waves requires activation of an acoustic shock wave generator or source coupled to the acoustic shock wave applicator otherwise such transmissions would not occur), wherein the one or more acoustic shock waves impinge upon the at least one reflective material thereby reflecting the one or more of the acoustic shock waves back into the appendage ([0216] which discloses acoustic element 42 also transmits energy toward acoustic element 40, which either receives and/or reflects the through-transmitted energy back in the direction of the acoustic element 42 and [0222] which discloses The reflected energy is then refocused toward the center of portion 122 of tissue 25 so as to supplement the confocal acoustic radiation provided by acoustic elements 40 and 42. In such an application, the arrays are capable of varying their respective focal points in response to an electronic system which electronically reconfigures the transducers in the arrays. Additionally, each of the first and second arrays reflects through-transmitted energy back toward the respective opposing array and toward the center of the portion of the skin and underlying tissue that is drawn between the first and second support structures. See also [0271] which discloses reflector 120 is disposed with respect to acoustic element 42 in a manner in which at least a portion of beams 45 transmitted from acoustic element 42 are reflected from acoustic reflector 120 toward a focal zone 110 which is typically in the center of tissue portion 122, e.g., equidistant from (a) an interface between reflector 120 and skin 24 of tissue portion 122, and (b) from an interface between acoustic element 42 and skin 24 of tissue portion 122. Typically, such reflection generates nonconfocal transmission of energy toward focal zone 110. See also [0272]-[0273] which discloses the acoustic element 42 may be replaced with a focused ultrasound transducer having a curved surface that faces and is in acoustic communication with the lateral surface of the support structure, which interfaces with tissue of portion 122 and acoustic element 42 comprises an annular phased array of ultrasound transducers which can steer its focal zone electronically to align with the focal zone 110 of reflector 120. Examiner thus notes that the reflective material 40 or 123 reflects acoustic energy (thus shock waves when the transmission from 42 is shock waves as noted in [0232]).
Regarding claim 26,
Azhari further discloses the body is a hand-held article having exterior walls defining an enclosed space of the hand-held article (see at least fig. 4 and disclosure in at least [0272] which discloses a concave reflecting portion coupled to a non-refracting coupling medium, comprising polyurethane where the walls are considered to be the side portions and back portion of the acoustic reflector 120 and the polyurethane. See also at least fig. 2 where the hand-held article has exterior walls defined by case 50));
The at least one reflective material (at least fig. 4 reflecting portion. See also fig. 2 and disclosure in [0251] which discloses the focused transducer defining element 62 is replaced by a curved acoustic reflector) is within the enclosed space (see at least fig. 4 in which the at least one reflective material is within a space enclosed by walls (i.e. sides of acoustic reflector 120) and the polyurethane. See also at least fig. 2 in which the element 62 when replaced by acoustic reflector is enclosed in the case 50); and
Holding the appendage in contact with the wave energy treatment device includes engaging the appendage with one of the exterior walls (see at least 4 and at least fig. 2).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Azhari in view of Schultheiss et al. (US 20070239082 A1), hereinafter Schultheiss.
Regarding claim 18,
Azhari teaches the elements of claim 17 as previously stated. Azhari further teaches wherein the body has a flexible conformable exterior surface that conforms to the shape of the surface of the appendage when holding the appendage in contact with the wave energy treatment device ([0292] which discloses the housing described herein coupled to the first and second support structures is flexible, e.g., to allow the treatment of limbs or other curved body parts), Azhari further teaches wherein the body has a polyurethane exterior surface ([0272] which discloses the reflecting portion is coupled to a generally non-refracting coupling medium, comprising polyurethane).
It is unclear if the flexible conformable exterior surface or if the polyurethane coupling medium is elastomeric. Nonetheless, Schultheiss in a similar field of endeavor involving shock wave treatment, teaches a wave energy treatment device (at least fig. 4 (2) and corresponding disclosure in at least [0059]) including a body (at least fig. 4 (16 and/or 40) and corresponding disclosure in at least [0057]-[0059]) and at least one reflective material (at least fig. 4 (15) and corresponding disclosure in at least [0059]) integral with the body (see at least fig. 4), wherein the body has a flexible conformable exterior surface that conforms to the shape of the surface of the appendage when holding the appendage in contact with the wave energy treatment device (and [0016] which discloses the external housing is hermetically sealed in a non-electrically conductive insulating skin membrane. The membrane being made of a polymer material, preferably silicone rubber or polyurethan rubber and [0058] which discloses the reflector cover 3 (i.e. an exterior surface of the body 16/40) is made of a flexible silicone membrane).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Azhari to include an elastomeric conformable exterior surface as taught by Schultehiess in order to provide a flexible coupling material having an integral shielding which would insure that only reflected shock wave energy was directed outward from a reflector cover and the covering through skin membrane overlying these components of the device. Such a modification would further provide a resilient cushion thick enough along at least the back and preferably the sides of the wave energy treatment device to dissipate any transmitted acoustic energy (Shultehiess [0018]).
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the polyurethane of Azhari to be or include a flexible silicone rubber and/or flexible polyurethane rubber as taught by Schulteheiss in order to provide for a flexible material which conforms to the surface of the skin. Such a modification would provide enhanced coupling of the wave energy treatment device to the patient especially during treatment on an appendage (i.e. limbs) by ensuring contact along the entire face of the device. Finally, such a modification amounts to merely a simple substation of one known coupling material for another yielding predictable results with respect to ultrasound energy transmission thereby rendering the claim obvious (MPEP 2143).
Regarding claim 22,
Azhari teaches the elements of claim 17 as previously stated. Azhari further teaches wherein the at least one reflective material is a material defining an exterior surface of the body ([0272] which discloses the reflecting portion is coupled to a generally non-refracting coupling medium, comprising polyurethane).
It is unclear if the polyurethane coupling medium is elastomeric. Nonetheless, Schultheiss in a similar field of endeavor involving shock wave treatment, teaches a wave energy treatment device (at least fig. 4 (2) and corresponding disclosure in at least [0059]) including a body (at least fig. 4 (16 and/or 40) and corresponding disclosure in at least [0057]-[0059]) and at least one reflective material (at least fig. 4 (15 and 3 and/or skin membrane) and corresponding disclosure in at least [0059]) integral with the body (see at least fig. 4), wherein the reflective material is a conformable material defining an exterior surface of the body ([0016] which discloses the external housing is hermetically sealed in a non-electrically conductive insulating skin membrane. The membrane being made of a polymer material, preferably silicone rubber or polyurethane rubber and [0058] which discloses the reflector cover 3 (i.e. an exterior surface of the body 16/40) is made of a flexible silicone membrane).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Azhari to include a reflective material that is a conformable material as taught by Schultehiess in order to provide a flexible coupling material having an integral shielding which would insure that only reflected shock wave energy was directed outward from a reflector cover and the covering through skin membrane overlying these components of the device. Such a modification would further provide a resilient cushion thick enough along at least the back and preferably the sides of the wave energy treatment device to dissipate any transmitted acoustic energy (Shultehiess [0018]).
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the polyurethane of Azhari to be or include a flexible silicone rubber and/or flexible polyurethane rubber as taught by Schulteheiss in order to provide for a flexible material which conforms to the surface of the skin. Such a modification would provide enhanced coupling of the wave energy treatment device to the patient especially during treatment on an appendage (i.e. limbs) by ensuring contact along the entire face of the device. Finally, such a modification amounts to merely a simple substation of one known coupling material for another yielding predictable results with respect to ultrasound energy transmission thereby rendering the claim obvious (MPEP 2143).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Azhari in view of NPL Reisman (“Initial experience with linear focused shockwave treatment for erectile dysfunction…”), hereinafter Reisman.
Regarding claim 19,
Azhari teaches the elements of claim 17 as previously stated. Azhari further teaches wherein the appendage is a limb, however, fails to explicitly teach wherein the appendage is one of a hand, a foot, a penis, and a scrotum.
a method of treating a penis (pg. 1 right column which discloses the inclusion criteria for the study included heterosexual men aged 20-80 years with vascular ED (erectile dysfunction). See also Results on pg. 3 which disclose fifty-eight middle-aged men ranging from 33-84 years old were recruited for the study. Where ages 20-80 years old and/or 33-84 years old is post-pubertal),
comprising steps of placing an acoustic shock wave applicator on a surface of the penis (see at least fig. 3), and causing one or more acoustic shock waves to be transmitted from the acoustic shock wave applicator through the appendage by activating an acoustic shock wave generator or source coupled to the acoustic shock wave applicator (pg. 1 right column which discloses shocks were applied at the penis shaft at right corpus cavernosum and left corpus cavernosum),
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the appendage of Azhari to be a penis in order to provide a method which would allow for treating erectile dysfunction (Reisman pg. 1 left column which discloses the recently published study showed that low-energy shock wave therapy significantly restored erectile function to levels similar to normal levels of control) which would allow for patients suffering therefrom to have increased recruitment of mesenchymal stem cells (MSCs) that promote the regeneration of DM-damaged erectile tissues (Reisman pg. 2 first column), thereby providing additional therapeutic uses of the method of Azhari. Furthermore, such a modification would amount to merely applying the known method of Azhari while providing a simple substitution of one known appendage for another yielding predictable results with respect to shock wave treatments to the body.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Azhari in view of Reisman and Paz (US 20220331142 A1), hereinafter Paz.
Regarding claim 20,
Azhari teaches the elements of claim 17 as previously stated. Azhari further teaches wherein the appendage is a limb, however, fails to explicitly teach wherein the appendage is a penis of an adult post pubertal male;
The patient exhibits erectile dysfunction; and
The method further comprises the step of administering a medication to the patient prior to said activating for causing the penis to be erect during said activating.
Reisman, in a similar field of endeavor involving shock wave treatment of an appendage teaches,
a method of treating a penis of an adult post pubertal male (pg. 1 right column which discloses the inclusion criteria for the study included heterosexual men aged 20-80 years with vascular ED (erectile dysfunction). See also Results on pg. 3 which disclose fifty-eight middle-aged men ranging from 33-84 years old were recruited for the study. Where ages 20-80 years old and/or 33-84 years old is post-pubertal),
comprising steps of placing an acoustic shock wave applicator on a surface of the penis (see at least fig. 3), and causing one or more acoustic shock waves to be transmitted from the acoustic shock wave applicator through the appendage by activating an acoustic shock wave generator or source coupled to the acoustic shock wave applicator (pg. 1 right column which discloses shocks were applied at the penis shaft at right corpus cavernosum and left corpus cavernosum),
wherein the penis exhibits erectile dysfunction (pg. 1 right column which discloses the inclusion criteria for the study included heterosexual men aged 20-80 years with vascular ED (erectile dysfunction). See also Results on pg. 3 which disclose fifty-eight middle-aged men ranging from 33-84 years old having vascular ED were recruited for the study).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the appendage of Azhari to be a penis of a post-pubertal male in order to provide a method which would allow for treating erectile dysfunction (Reisman pg. 1 left column which discloses the recently published study showed that low-energy shock wave therapy significantly restored erectile function to levels similar to normal levels of control) which would allow for patients suffering therefrom to have increased recruitment of mesenchymal stem cells (MSCs) that promote the regeneration of DM-damaged erectile tissues (Reisman pg. 2 first column), thereby providing additional therapeutic uses of the method of Azhari. Furthermore, such a modification would amount to merely applying the known method of Azhari while providing a simple substitution of one known appendage for another yielding predictable results with respect to shock wave treatments to the body.
Azhari, as currently modified, fails to explicitly teach administering a medication to the patient prior to said activating for causing the penis to be erect during said activating.
Paz, in a similar field of endeavor involving ultrasound treatment, teaches a method of treating an appendage of a patient comprising the steps of placing an acoustic applicator on a surface of the appendage, and causing one or more acoustic waves to be transmitted from the acoustic applicator through the appendage, and administering a medication to the patient prior to said activating for causing the penis to be erect during said activating ([0092] which discloses creating penis engorgement may be achieved, for example, by any, some or all of the methods: of using a drug such as a PDE5 inhibitor such: SINDENAFIL, VARDENAFIL, TADALFIL, AVANFIL, or using vasoactive agents injected into the cavernous body or applied to mucosa of the urethra [0115] which discloses at least part of the engorged penis (e.g. corpora cavernosa 834 and/or penis crura or roots) optionally come in intimate contact and/or vibrational communication with the LIPUS transducers. While in communication with tissue, the LIPUS transducers are activated in order to treat erectile dysfunction and [0116] which discloses a partial erection may be maintained during treatment by continuously applying vacuum or suction. Alternatively or additionally, erection may be maintained by applying a band 944 at the base of the penis after achieving full and/or partial erection. For example, erection may be achieved using drugs, devices, penile injection, and/or stimulation (e.g. self stimulation and/or applied vibration).)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Azhari, as currently modified, to include a step of administering a mediation to the patient prior to said activating for causing the penis to be erect during said activating as taught by Paz in order to improve the efficacy of the treatment by increasing the treated volume, by stretching the cavernous tissue and/or increasing its susceptibility to the non-thermal effects of the ultrasonic waves and/or by acting on the trapped blood cells in the cavernous tissue to release neo-angiogenic and/or trophic factors (PAZ [0091]). Furthermore, such a modification would improve contact with the transducers and/or improve penetration of ultrasound signals (PAZ [0126])
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Azhari in view of Ogden et al. (US 6368292 B1), hereinafter Ogden.
Regarding claim 21,
Azhari teaches the elements of claim 17 as previously stated. Azhari fails to explicitly teach wherein the method further comprises the step of lowering the temperature of the appendage being treated prior to said activating to change tissue impedance of the appendage to improve tissue stimulation.
Ogden, in a similar field of endeavor involving acoustic shock wave treatment, teaches in a method involving applying acoustic shock waves to tissue (Col. 6 lines 53-67 which discloses the process of freezing the tissue prior to application of the acoustic shock waves renders the tissue harder, thereby increasing the acoustic impedance, making the tissue easier to break up and destroy), the method further comprising lowering the temperature of a target being treated to change the tissue impedance to improve stimulation (Col. 6 lines 53-67 which discloses the process of freezing the tissue prior to application of the acoustic shock waves renders the tissue harder, thereby increasing the acoustic impedance, making the tissue easier to break up and destroy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Azhari to include lowering the temperature of the appendage as taught by Ogden in order to provide additional treatment abilities of the method of Azhari. For example, in a case where it is desired to treat the appendage by breaking up and/or destroying certain tissues within the appendage, such as occlusions, cancerous tissues, such a modification would enhance the treatment by making the tissue within the appendage harder thus making the tissue easier to break up and destroy.
Claim 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Azhari and Schultheiss, as applied to claim 22 above, and further in view of Krone et al. (US 20220249876 A1), hereinafter Krone.
Regarding claim 23,
Azhari, as modified, teaches the elements of claim 22 as previously stated. Azhari, as modified, fails to explicitly teach wherein: the body is a glove or a mitten;
The at least one reflective material covers at least a portion of a palm region of the glove or mitten; and
Holding the appendage in contact with the wave energy treatment device includes holding the appendage at the palm region.
Krone, in a similar field of endeavor involving ultrasound treatment, teaches a wave energy treatment device, comprising a body and ultrasound elements integral with the body ([0105] which discloses the ultrasound device may attach to (as opposed to being held by) the user’s hand such as in a glove-based device that may be worn by the user, wherein the ultrasound components are encompassed within the glove), wherein the body is a glove ([0105]) and the ultrasound elements and a conformable material (at least fig. 1A (114) and corresponding disclosure in at least [0087]) cover at least a portion of a palm region of the glove ([0105] which discloses the ultrasound components are encompassed within the glove (e.g. palm portion)) and holding a treatment target in contact with the wave energy treatment device includes holding the appendage at the palm region ([0076] which discloses the coupling pad including a deformable coupling structure adapted to contact external genital tissue around the subject's vagina and geometric features configured to mate the coupling pad with the ultrasound transducer assembly. Examiner notes that a person having ordinary skill in the art would have recognized that in the embodiment in which the ultrasound device includes ultrasound components encompassed within the palm portion of the glove that performing treatment would include holding the treatment target at the palm region (where the ultrasound components are)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the body of Azhari to be a glove as taught by Krone in order to provide an alternative wave energy treatment device which would be more comfortable for a user/physician. Such a modification would allow for enhanced ease of use of the system of Azhari especially when treating limbs (i.e. appendages) such that a user may merely place their hand on the subject or hold the subject’s limb while performing treatment.
Examiner notes that in the modified method, the reflective material of Azhari is an ultrasound element in combination with the conformable material, thus it is noted that the reflective material covers at least a portion of the palm region of the glove since Krone discloses the ultrasound elements in the palm region.
Regarding claim 24,
Azhari, as modified, teaches the elements of claim 24 as previously stated. Azhari, as modified, further teaches wherein the at least one reflective material includes a gaseous-filled membrane (Schultheiss [0058] which discloses the reflector cover 3 (i.e. an exterior surface of the body 16/40) is made of a flexible silicone membrane. Where a silicone membrane is considered a gaseous-filled membrane due to its permeability to gases).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Azhari in view of Tsoref et al. (US 20150119713 A1), hereinafter Tsoref and Brouillette et al. (US 2020038692 A1), hereinafter Brouillette.
Regarding claim 27,
Azhari teaches the elements of claim 26 as previously stated. Azhari further teaches wherein the at least one reflective material includes an ultrasound element; the ultrasound element is within the enclosed space;
Azhari fails to explicitly teach wherein the at least one reflective material include a gas and a layer of coating material; the gas and the coating material are within the enclosed space; the layer of coating material is on a surface of at least one of the exterior walls, and the gas and the layer of coating material both are both configured to reflect acoustic shock waves impinged thereupon.
Tsoref, in a similar field of endeavor involving ultrasound treatment, teaches a wave energy treatment device (at least fig. 2H (12) and corresponding disclosure in at least [0078]) comprising a body (at least fig. 2H (12 and 122) and corresponding disclosure in at least [0078] and [0079] which discloses for some applications, inflatable element 122 is coupled to a double-channeled catheter) and at least one reflective material ([0078] which discloses a fluid having a lower density than water, such as a gas, or a mixture of fluid and gas. Ultrasound energy that is transmitted towards tissue is reflected due to the fluid-filled (e.g. gas-filled) balloon), wherein the a body is a hand-held article having exterior walls defining an enclosed space of the hand-held article (see at least fig. 2 where the body is a double-channel catheter with an inflatable element 122 (i.e. exterior walls)), holding the tissue in contact with the wave energy treatment device includes engaging the appendage with one of the exterior walls (see at least fig. 2H);the at least one reflective material includes a gas ([0078] which discloses the inflatable element is inflated with a fluid such as gas); the gas is within the enclosed space ([0078] which discloses the inflatable element is inflated with a fluid such as gas); and the gas is configured to reflect acoustic shock waves impinged thereon ([0078]-[0079] where gas such as carbon monoxide is configured to reflect acoustic shock waves impinged thereupon).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the wave energy treatment device of Azhuri to include exterior walls defining an enclosed space and at least one reflective material including gas as taught by Tsoref in order to provide an increase in the amount of energy that passes through the tissue accordingly. Furthermore, such a modification amounts to merely a simple substitution of one known body and reflective material of a wave energy treatment device for another yielding predictable results with respect to ultrasound treatment enhancement thereby rendering the claim obvious (MPEP 2143).
Azhuri, as modified fails to explicitly teach wherein the at least one reflective material includes a coating material within the enclosed space, the layer of coating material is on a surface of at least one of the exterior walls; and the layer of coating material is configured to reflect acoustic shock waves impinged thereupon.
Brouillette, in a similar field of endeavor involving shock wave reflection, teaches a wave treatment device (at least fig. 1 (18) and corresponding disclosure in at least [0067]) including a body (see at least fig. 1) and a layer of a coating material on a surface of an exterior wall of the body ([0007] which discloses the wave directing device is one of made of and coated with a reflective material having an acoustic impedance being greater that an acoustic impedance of water and [0077] which discloses the external or internal surface of the wave concentrator device 52 may be coated with a material adapted to reflect mechanical waves); the layer of coating material is configured to reflect acoustic shock waves impinged thereupon ([0077] which discloses the external or internal surface of the wave concentrator device 52 may be coated with a material adapted to reflect mechanical waves).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Azhuri, as currently modified, to further include a layer of coating material on a surface of an exterior wall of the body as taught by Azurin in order to provide further assurance of the reflection of the ultrasonic energy of Azhuri modified by Tsoref. Such a modification would thereby enhance the reflection of the acoustic shock waves by ensuring that the exterior wall is also provided with reflective material such that any acoustic shock waves which are not reflected by the gas and reach the wall are reflected back toward the tissue as desired.
Examiner’s note
Examiner notes that claim 25 is found to distinguish over the prior art collectively, however, patentability is not determinable at this time due to pending 112 issues. Specifically, it is noted that the closest prior art remains to be Azhari and Krone, as applied above, where Azhari and Krone in combination teach the body including opposing layers (i.e. glove layer) and coupling layer (114) defining an enclosed space; the enclosed space covers at least a portion of the palm region. The references fail to explicitly teach the at least one reflective material include a gas and gaseous filled-membrane within the enclosed space. Examiner notes that while there are references which teach a reflective material including gas and a gaseous-filled membrane such as Crum et al. (US 9198635 B2) which discloses reflectors can be implemented using an air-filled body or a layer of Styrofoam™ (or similar material) and Azhari et al. (US 20120296240 A1) both included in applicant’s IDS, examiner notes that a person having ordinary skill in the art would not have been motivated to have further modified the body of Azhari which is a glove as taught by Krone to include a reflective material including a gas and a gaseous-filled membrane within the enclosed space. Examiner notes that specifically Azhari is directed to an ultrasound element which reflects ultrasound energy and Krone teaches ultrasound elements enclosed within the glove, however, such ultrasound elements are understood to include transducer/circuitry components. Therefore, modifying Azhari and Krone such that the at least one reflective material includes a gas and a gaseous-filled membrane which are within the enclosed space would have required impermissible hindsight reasoning.
Furthermore, while there is prior art which teaches a glove containing a gas and a gaseous filled membrane such as Shiono (US 20050259269 A1) or Jaskiewics (US 5257418 A) it is noted that where Shiono uses the glove and air filling as a marker for representing an affected target part and Jaskiewics is directed to gas filled cushions on the palm to absorb shocks and impacts by an object gripped by the glove, where neither reference is considered analogous to the problem being solved by the invention of claim 1 which is to reflect treatment energy back into the treated appendage in order to improve the treatment effect.
For at least the reasons listed above, the combination of elements distinguishes over the prior art collectively.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12303721 (hereinafter referred to as “reference”). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims and the instant claims are merely an obvious broadening of the reference claims.
Regarding instant claim 17,
Reference claim 1 recites each of the elements of instant claim 17, except for the specific language of a wave energy treatment device including a body and at least one reflective material integral with the body, wherein the body is one of a hand-donnable article donned on a hand and a hand-held article held by a hand. It is noted however, that reference claim 1 recites placing a gaseous filled membrane integral at a location on an opposite surface of the appendage relative to a location of the acoustic shock wave applicator, wherein the gaseous filled membrane is integral with a mitten or a glove of reference claim 1 reads on a wave energy treatment device including a body (i.e. mitten or glove and/or membrane) and at least one reflective material (i.e. gaseous filled membrane or gas therein) integral with the body (i.e. mitten or glove and/or membrane), wherein the body (i.e. mitten or glove and/or membrane) is a hand-donnable article donned on a hand, wherein the at least one reflective material reflects acoustic shock wave impinged thereupon. Thus reference claim 1 anticipates each of the elements of instant claim 17.
Regarding instant claim 18,
Reference claim 12 recites wherein the body (i.e. gaseous filled membrane integral with the mitten/glove) has an elastomeric conformable exterior that conforms to the shape of the surface of the appendage when holding the appendage in contact with the wave energy treatment device.
Regarding instant claim 19,
Reference claims 6, 13, and 15-17 recite wherein the appendage is one of a hand, a foot, a penis, and a scrotum.
Regarding instant claim 20,
Reference claim 13 recites the elements of instant claim 20.
Regarding instant claim 21,
Reference claim 9 recites the elements of instant claim 21.
Regarding instant claim 22,
Reference claim 12 recites the at least one reflective material (i.e. gaseous filled membrane), is a conformable material defining an exterior surface of the body (i.e. mitten or glove); and
Holding the appendage in contact with the wave energy treatment device includes holding the appendage in contact with the exterior surface (i.e. holding the appendage in contact with the palm side of the mitten or glove is understood to be holding in contact with the exterior surface since the gaseous filled membrane is on the palm side of the mitten or glove as recited in reference claim 1).
Regarding instant claim 23,
Reference claim 1 recites the body is a glove or a mitten (“the gaseous filled membrane is integral with a mitten or a glove”); the at least one reflective material covers at least a portion of a palm region of the glove or mitten (“the gaseous filled membrane is on a palm side of the mitten or glove”); holding the appendage in contact with the wave energy treatment device includes holding the appendage at the palm region (“holding the appendage in contact with the palm side of the mitten or the glove”).
Regarding instant claim 24,
Reference claim 1 recites wherein the at least one reflective material includes a gaseous-filled membrane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights