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 .
Response to Amendment
The amendments filed 10/31/2025 have been entered. Accordingly, claims 1-39 remain pending in the current application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-39 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9, 15-19, 20-24, 26-27, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al. (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), and in further view of Wagner et al. (US 2012/0226200 A1).
Regarding claim 1, Schwarz discloses a method of treatment of musculoskeletal conditions (methods and devices for a non-invasion treatment of soft tissue, Paragraph 0012 and Abstract; methods may be used to treat musculoskeletal pain, Paragraph 0088), the method comprising the steps of: treating an area of a body with a regimen comprising of treatment sessions (predefined number of treatments, Paragraph 0092), wherein each treatment session of the plurality of treatment sessions comprises a synergistic combination of a plurality of sequentially administered therapeutic modalities administered to the area (soft tissue of a body is treated using a combination of both mechanical stimulation therapies and electromagnetic field therapies, Paragraphs 0012-0016; the electromagnetic field therapy is first applied and then mechanical stimulation is applied in a subsequent time interval, therefore the therapies are applied in a sequential manner, Paragraph 0019), the plurality of therapeutic modalities being selected from the group consisting of laser therapy (electromagnetic field may be generated by an energy delivery element such as a laser diode, Paragraphs 0014-0015 and 0048), capacitive resistive electric transfer therapy (a bipolar electrode system may be used, wherein both capacitive and resistive electrodes are used, Paragraph 0044), shock wave therapy (mechanical stimulation may include generating shock waves, Paragraphs 0008-0009), and acoustical vibration therapy (mechanical stimulation may include acoustic waves, Paragraph 0012).
Although Schwarz teaches various therapy modalities configured to stimulate cells and promote blood circulation (Abstract), further teaching the combined therapy modalities being used to stimulate synthesis of new connective tissue in order to treat a wide variety of musculoskeletal conditions (Paragraph 0087), Schwarz doesn’t explicitly state and wherein the regimen collectively employs: (i) the laser therapy to a degree effective to stimulate release and activation of stem cells, (ii) at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells and (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells.
However, in regards to (i) the laser therapy being used to a degree effective to stimulate release and activation of stem cells, Porter teaches a method of transdermally treating tissue for facilitating the release and/or differentiation of stem cells through the use of exposing the tissue to laser light (Abstract, Col. 1 lines 54-66).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the laser therapy to a degree effective to stimulation the release and activation of stem cells, as taught by Porter, as the use of laser light to stimulate release and activation of stem cells may further enhance healing and provide therapeutic benefits in a wide variety of applications (Col. 1 lines 30-32 and Col. 6 lines 30-31).
In regards to (ii) the at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells, Jimenez Lozano teaches a method of treating a user’s skin (Abstract) comprising an applicator associated with at least one treatment unit, wherein the treatment unit provides acoustical vibration therapy to the user (applicator 1504 comprising treatment unit 1506 may provide mechanical energy to create a vibration, massage, and/or pulsatile effect, Paragraph 0084) wherein the vibrational therapy is used in order to stimulate activation of an extracellular matrix in order to promote viability of released stem cells (stimulated cells such as stem cells in subcutaneous fat releasing growth factors in turn stimulate neighboring connective tissue cells in the dermal fat and skin, in order to synthesize extracellular matrix components such as collagen and elastin, Paragraphs 0077-0078).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that activation of an extracellular matrix is stimulated, as taught by Jimenez Lozano, as the promotion of an extracellular matrix would therefore promote healing by increasing collagen content, increase skin firmness, smoothness, increased dermal hydration, dermal remodeling, and fibrous septae thickening (Paragraph 0006).
In regards to (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells, Wagner teaches a method of stimulating tissue (Abstract) utilizing capacitive resistive electric transfer therapy (stimulation may include electromagnetic energy consisting of capacitive and resistive components, Paragraph 0067) such that the electric stimulation is used to promote growth of stem cells (levels of stimulation may control stem cell growth factors, Paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that stem cell growth is promoted, as the growth of stem cells may further enhance the healing process of the treated tissue.
Regarding claim 2, Schwarz further discloses wherein the regimen collectively employs all four of the laser therapy (electromagnetic field may be generated by an energy delivery element such as a laser diode, Paragraphs 0014-0015 and 0048), the capacitive resistive electric transfer therapy ( bipolar electrode system may be used, wherein both capacitive and resistive electrodes are used, Paragraph 0044), the shock wave therapy (mechanical stimulation may include generating shock waves, Paragraphs 0008-0009), and acoustical vibration therapy (mechanical stimulation may include acoustic waves, Paragraph 0012).
Regarding claim 3, Schwarz further discloses wherein at least one of the treatment session comprises administering the laser therapy to the area followed by administering at least one of the capacitive resistive electric transfer therapy, the shock wave therapy, and the acoustical vibration therapy to the area (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), is used in a subsequent time interval of 6-10 seconds, Paragraph 0019)).
Regarding claim 4, Schwarz further discloses wherein at least one of the treatment session comprises administering the laser therapy to the area followed by administering at least two of the capacitive resistive electric transfer therapy, the shock wave therapy, and the acoustical vibration therapy to the area (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), is used in a subsequent time interval of 6-10 seconds, Paragraph 0019; electrodes may be used in coordination with the electromagnetic field, therefore at least two therapies being applied, Paragraph 0044)).
Regarding claim 5, Schwarz discloses the method of claim 1, further teaching wherein the treatment session comprises administering the laser therapy to the area followed by administering at least one of the capacitive resistive electric transfer therapy and the shock wave therapy to the area (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), is used in a subsequent time interval of 6-10 seconds, Paragraph 0019)), however doesn’t explicitly state this is then followed by administering the acoustical vibration therapy to the area.
However, as Schwarz’s device and method further teaches the application of acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, to include laser therapy followed by shock wave therapy followed by acoustical vibration, as there are a finite number of sequences in which the therapies generated by the device may provide to the area. Furthermore, applying vibrational therapy following shock wave therapy may offer the benefit of providing additional and/or supplemental massaging effects to the user after receiving the shock wave therapy.
Regarding claim 6, Schwarz discloses the method of claim 1, further teaching wherein the treatment session comprises administering the laser therapy to the area followed by shock wave therapy to the area (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), is used in a subsequent time interval of 6-10 seconds, Paragraph 0019)), however doesn’t explicitly state followed by administering the capacitive resistive electric transfer therapy to the area, and followed by administering the acoustical vibration therapy to the area.
However, as Schwarz’s device and method further teaches the application of resistive electrical transfer therapy to the area (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044) and acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, to capacitive resistive electric transfer therapy followed by acoustical vibrational therapy, as there are a finite number of sequences in which the therapies generated by the device may provide to the area. Furthermore, applying vibrational therapy following electric transfer therapy may offer the benefit of providing additional and/or supplemental massaging effects to the user after receiving the shock wave therapy.
Regarding claim 7, Schwarz discloses the method of claim 1, further teaching for a first predetermined number of treatment sessions of the plurality of treatment sessions (predefined number of treatments, Paragraph 0092), and laser therapy applied first (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), however doesn’t explicitly state administering the laser therapy to the area followed by administering the capacitive resistive electric transfer therapy to the area.
However, as Schwarz’s device and method further teaches the application of resistive electrical transfer therapy to the area (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, to include laser therapy followed by electric transfer therapy, as there are a finite number of sequences in which the therapies generated by the device may provide to the area.
Regarding claim 8, Schwarz teaches method of claim 7, however doesn’t explicitly state administering the acoustical vibration therapy to the area following the capacitive resistive electric transfer therapy.
However, as Schwarz’s device and method further teaches the application of resistive electrical transfer therapy to the area (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044) and acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, to include vibrational therapy following capacitive resistive transfer therapy, as there are a finite number of sequences in which the therapies generated by the device may provide to the area. Furthermore, applying vibrational therapy following electric transfer may offer the benefit of providing additional and/or supplemental massaging effects to the user after receiving the shock wave therapy.
Regarding claim 9, Schwarz teaches method of claim 7, however doesn’t explicitly state the step of treating further comprises: administering the acoustical vibration therapy to the area following the capacitive resistive electric transfer therapy every other sequential treatment session.
However, as Schwarz’s device and method further teaches the application of resistive electrical transfer therapy to the area (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044) and acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, to vibration therapy to the area following the capacitive resistive electric transfer therapy every other sequential treatment session, as there are a finite number of sequences in which the therapies generated by the device may provide to the area.
Regarding claim 15, Schwarz further discloses wherein the laser therapy includes treating at least a portion of the area using a near infrared laser therapy treatment device (laser diode module or LED may generate near infrared waves in the range of 600 nm to 1200 nm, Paragraph 0050).
Regarding claim 16, Schwarz further discloses wherein the laser treatment device supplies a 1064 nm laser to the portion of the area (laser diode module or LED may generate near infrared waves in the range of 600 nm to 1200 nm, therefore the claimed wavelength is within the range, Paragraph 0050).
Regarding claim 17, Schwarz further discloses wherein the laser treatment device comprises a 1w to 12w laser (emission output power of laser diode in the range of 10 mW to 10 W, Paragraph 0050).
Regarding claim 18, Schwarz further discloses wherein the laser treatment device is operated at a maximum power density for the laser treatment device throughout the duration of supplying light energy to the area (laser diode may operate various maximum power densities such as 450 mW, Paragraph 0052).
Regarding claim 19, Schwarz further discloses wherein the laser treatment device is operated at a maximum power density of 450 mw/cm² (Laser power density maximum flux between 0.005 mw/cm² 500 mw/cm², therefore the claimed maximum power density within the stated range, Paragraph 0048).
Regarding claim 20, Schwarz further discloses wherein the capacitive resistive electric transfer therapy includes treating at least a portion of the area using a capacitive resistive electric transfer therapy device, and wherein the capacitive resistive electric transfer therapy device is configured to operate in a capacitive mode and a resistive mode (both capacitive and resistive electrodes may be used, therefore operating in both a capacitive and resistive mode, Paragraph 0044).
Regarding claim 21, Schwarz teaches method of claim 20, further teaching wherein the capacitive resistive electric transfer therapy includes treating at least the portion of the area using the capacitive mode (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044), however doesn’t explicitly state followed by treating at least the portion of the area using the resistive mode.
However, as Schwarz’s device and method further teaches the application of resistive and capacitive electrical transfer therapy to the area (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044) it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to try any order of the applied therapies, capacitive transfer therapy followed by resistive transfer therapy, as there are a finite number of sequences in which the therapies generated by the device may provide to the area.
Regarding claim 22, Schwarz further discloses wherein the capacitive resistive electric transfer therapy device is configured to supply capacitive and resistive radio frequency currents from 300 kHz to 1 MHz to at least a portion of the area (radio frequencies in the range of 0.1 MHZ to 435 MHz, therefore within the claimed range, Paragraph 0043).
Regarding claim 23, Schwarz further discloses wherein the shock wave therapy includes treating at least a portion of the area using a shock wave device (applicator head generates shock waves to be applied to the tissue, Paragraph 0013 and Figure 3A).
Regarding claim 24, Schwarz further discloses wherein the shock wave device has a frequency of from 1Hz to 12Hz (the frequency of the mechanicals stimulation may be in the range of 0.1 Hz to 100 Hz, preferably 1 Hz to 40 Hz, therefore within the claimed range, Paragraph 0037).
Regarding claim 26, Schwarz further discloses wherein the acoustical vibration therapy includes treating at least a portion of the area using an acoustical vibration device configured to supply a plurality of frequencies and a plurality of amplitudes of mechanical vibration to the portion of the area (the repetition rate and/or frequency of the mechanical stimulation, which may be in the form of acoustic waves, may be in the range of 0.1 Hz to 100 Hz, therefore configured to supply a plurality of frequencies, Paragraph 0037; amplitudes of up to 150 MPa).
Regarding clam 27, Schwarz further discloses wherein the acoustical vibration device is configured to supply acoustical vibration having a frequency of 0-300 Hz and plurality of amplitudes (the repetition rate and/or frequency of the mechanical stimulation, which may be in the form of acoustic waves, may be in the range of 0.1 Hz to 100 Hz, therefore producing frequencies in the claimed range, Paragraph 0037; amplitudes of up to 150 MPa).
Regarding claim 38, Schwarz discloses a method of treatment of musculoskeletal conditions (methods and devices for a non-invasion treatment of soft tissue, Paragraph 0012 and Abstract; methods may be used to treat musculoskeletal pain, Paragraph 0088), the method comprising the steps of: treating an area of a body with a plurality of treatment sessions, wherein each treatment session of the plurality of treatment sessions comprises a synergistic combination of a plurality of of sequentially administered therapeutic modalities administered to the area (soft tissue of a body is treated using a combination of both mechanical stimulation therapies and electromagnetic field therapies, Paragraphs 0012-0016; the electromagnetic field therapy is first applied and then mechanical stimulation is applied in a subsequent time interval, therefore the therapies are applied in a sequential manner, Paragraph 0019), wherein, in a first subset of the plurality of treatment sessions, the therapeutic modalities comprise laser therapy followed by at least one of capacitive resistive electric transfer therapy, shock wave therapy, and acoustical vibration therapy (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), is used in a subsequent time interval of 6-10 seconds, Paragraph 0019)), wherein, in a second subset of the plurality of treatment sessions, the therapeutic modalities comprise laser therapy followed by at least one of capacitive resistive electric transfer therapy, shock wave therapy, and acoustical vibration therapy, and wherein the therapeutic modalities of the first subset are different from the therapeutic modalities of the second subset (in the overlapping method of applying the combined therapies, the electromagnetic field (generated by the laser, Paragraph 0048) is first applied for a period of 1-7 seconds, and then mechanical stimulation (using shock and/or acoustic waves, see Paragraph 0008) is used in a second overlapping time interval of 4-10 seconds, wherein during the second time interval the electromagnetic field and mechanical stimulation are simultaneously applied over the second interval starting at 4 seconds, therefore having a different therapeutic modality as compared to the first time interval, Paragraph 0019)).
Although Schwarz teaches various therapy modalities configured to stimulate cells and promote blood circulation (Abstract), further teaching the combined therapy modalities being used to stimulate synthesis of new connective tissue in order to treat a wide variety of musculoskeletal conditions (Paragraph 0087), Schwarz doesn’t explicitly state and wherein the regimen collectively employs: (i) the laser therapy to a degree effective to stimulate release and activation of stem cells, (ii) at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells and (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells.
However, in regards to (i) the laser therapy being used to a degree effective to stimulate release and activation of stem cells, Porter teaches a method of transdermally treating tissue for facilitating the release and/or differentiation of stem cells through the use of exposing the tissue to laser light (Abstract, Col. 1 lines 54-66).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the laser therapy to a degree effective to stimulation the release and activation of stem cells, as taught by Porter, as the use of laser light to stimulate release and activation of stem cells may further enhance healing and provide therapeutic benefits in a wide variety of applications (Col. 1 lines 30-32 and Col. 6 lines 30-31).
In regards to (ii) the at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells, Jimenez Lozano teaches a method of treating a user’s skin (Abstract) comprising an applicator associated with at least one treatment unit, wherein the treatment unit provides acoustical vibration therapy to the user (applicator 1504 comprising treatment unit 1506 may provide mechanical energy to create a vibration, massage, and/or pulsatile effect, Paragraph 0084) wherein the vibrational therapy is used in order to stimulate activation of an extracellular matrix in order to promote viability of released stem cells (stimulated cells such as stem cells in subcutaneous fat releasing growth factors in turn stimulate neighboring connective tissue cells in the dermal fat and skin, in order to synthesize extracellular matrix components such as collagen and elastin, Paragraphs 0077-0078).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that activation of an extracellular matrix is stimulated, as taught by Jimenez Lozano, as the promotion of an extracellular matrix would therefore promote healing by increasing collagen content, increase skin firmness, smoothness, increased dermal hydration, dermal remodeling, and fibrous septae thickening (Paragraph 0006).
In regards to (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells, Wagner teaches a method of stimulating tissue (Abstract) utilizing capacitive resistive electric transfer therapy (stimulation may include electromagnetic energy consisting of capacitive and resistive components, Paragraph 0067) such that the electric stimulation is used to promote growth of stem cells (levels of stimulation may control stem cell growth factors, Paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that stem cell growth is promoted, as the growth of stem cells may further enhance the healing process of the treated tissue.
Regarding claim 39, Schwarz discloses a system for treatment of musculoskeletal conditions (methods and devices for a non-invasion treatment of soft tissue, Paragraph 0012 and Abstract; methods may be used to treat musculoskeletal pain, Paragraph 0088, Figure 3A), the system comprising: a laser therapy device (the electromagnetic field may be generated using a laser emitting diode comprising any type of laser, Paragraph 0048); a capacitive resistive electric transfer therapy device (a bipolar electrode system may be used comprising both capacitive and resistive electrodes, Paragraph 0044); at least one of shock wave therapy device (a ballistic mechanism of shock wave generation may be used, comprising an applicator head for generating the shock wave, Paragraph 0013); and an acoustical vibration therapy device (mechanical stimulation may include acoustic wave generation, Paragraph 0012) wherein the system is configured to treat an area of a body with a plurality of treatment sessions (predefined number of treatments, Paragraph 0092; (the mechanical stimulation (generated by the shock and/or acoustic waves, see Paragraph 0008) and electromagnetic filed application (generated by the laser, Paragraph 0048) may be applied to the tissue in a simultaneously, successive, and/or overlapping manner, Paragraph 0019).
Although Schwarz teaches various therapy modalities configured to stimulate cells and promote blood circulation (Abstract), further teaching the combined therapy modalities being used to stimulate synthesis of new connective tissue in order to treat a wide variety of musculoskeletal conditions (Paragraph 0087), Schwarz doesn’t explicitly state and wherein the regimen collectively employs: (i) the laser therapy to a degree effective to stimulate release and activation of stem cells, (ii) at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells and (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells.
However, in regards to (i) the laser therapy being used to a degree effective to stimulate release and activation of stem cells, Porter teaches a method of transdermally treating tissue for facilitating the release and/or differentiation of stem cells through the use of exposing the tissue to laser light (Abstract, Col. 1 lines 54-66).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the laser therapy to a degree effective to stimulation the release and activation of stem cells, as taught by Porter, as the use of laser light to stimulate release and activation of stem cells may further enhance healing and provide therapeutic benefits in a wide variety of applications (Col. 1 lines 30-32 and Col. 6 lines 30-31).
In regards to (ii) the at least one of the shock wave therapy and the acoustical vibration therapy to a degree effective to stimulate activation of an extracellular matrix in order to promote viability of the released stem cells, Jimenez Lozano teaches a method of treating a user’s skin (Abstract) comprising an applicator associated with at least one treatment unit, wherein the treatment unit provides acoustical vibration therapy to the user (applicator 1504 comprising treatment unit 1506 may provide mechanical energy to create a vibration, massage, and/or pulsatile effect, Paragraph 0084) wherein the vibrational therapy is used in order to stimulate activation of an extracellular matrix in order to promote viability of released stem cells (stimulated cells such as stem cells in subcutaneous fat releasing growth factors in turn stimulate neighboring connective tissue cells in the dermal fat and skin, in order to synthesize extracellular matrix components such as collagen and elastin, Paragraphs 0077-0078).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that activation of an extracellular matrix is stimulated, as taught by Jimenez Lozano, as the promotion of an extracellular matrix would therefore promote healing by increasing collagen content, increase skin firmness, smoothness, increased dermal hydration, dermal remodeling, and fibrous septae thickening (Paragraph 0006).
In regards to (iii) the capacitive resistive electric transfer therapy to a degree effective to stimulate improved healing by causing increased cell metabolism and blood flow in order to promote growth of the released stem cells, Wagner teaches a method of stimulating tissue (Abstract) utilizing capacitive resistive electric transfer therapy (stimulation may include electromagnetic energy consisting of capacitive and resistive components, Paragraph 0067) such that the electric stimulation is used to promote growth of stem cells (levels of stimulation may control stem cell growth factors, Paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by utilizing the vibrational therapy to a degree such that stem cell growth is promoted, as the growth of stem cells may further enhance the healing process of the treated tissue.
Claim(s) 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), Wagner et al. (US 2012/0226200 A1), and in further view of Schwarz et al. (US 2022/0211997 A1).
Regarding claim 10, Schwarz in view of Porter, Jimenez Lozano, and Wagner teach the method of claim 7, with Schwarz further teaching the step of treating further comprises: administering the laser therapy to the area followed by administering the shock wave therapy to the area (the mechanical stimulation and electromagnetic filed application may be applied to the tissue in a successive manner, wherein the electromagnetic field (generated by the laser diode module, see Paragraphs 0014 and 0048), is first applied for a time interval of 1-5 seconds, then stopped, and then mechanical stimulation (generated by shock waves and/or acoustic waves, see Paragraph 0008), however, Schwarz doesn’t explicitly state a second predetermined number of treatment sessions of the plurality of treatment sessions.
However, Schwarz (‘997) teaches a method of soft tissue treatment (Abstract) comprising various applicators providing various types of treatment therapy to including laser therapy, acoustic wave, shock wave therapy, vibrational therapy, and electric transfer therapy (treatment applicators may provide different types of treatment therapy e.g.: radio-frequency therapy (RF therapy), plasma therapy, ultra-sound therapy, acoustic wave, shock wave therapy, light (coherent, non-coherent) therapy, heating, cooling, electro-therapy, therapy by generated magnetic field (include muscle stimulation), positive or negative pressure therapy, vibration therapy and/or massage therapy, Paragraph 0207)), wherein the number of treatment sessions are predetermined, to include having a second predetermined number of treatment sessions (software enables the user to be able to select one or more predefined treatment protocols, Paragraph 0246; treatment patterns may be repeated more than one time, Paragraph 0416; multiple types of treatment patterns may be created by providing various patterns of the therapies applied, Paragraph 0218).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by including a second predetermine number of treatment sessions, as taught by Schwarz (‘997), as providing an additional number of predefined treatment sessions allow the various therapy modalities to deeply penetrate the tissue, and setting predetermined treatment sessions allow the method to be used completely in the absence of an operator (Paragraph 0207).
Regarding claim 11, Schwarz (‘997) further teaches wherein the second predetermined number of treatment sessions follows a completion of at least one of the first predetermined number of treatment sessions (when a treatment is complete, the process of the treatment is evaluated and can then be used to adjust therapy parameters for the following treatment, Paragraph 0238).
Regarding claim 12, Schwarz (‘997) further teaches wherein the second predetermined number of treatment sessions follows a completion of all of the first predetermined number of treatment sessions (when a treatment is complete, the process of the treatment is evaluated and can then be used to adjust therapy parameters for the following treatment, Paragraph 0238).
Regarding claim 13, Schwarz in view of Schwarz (‘997) teach the method of claim 10, however don’t explicitly state wherein, for the second predetermined number of treatment sessions of the plurality of treatment sessions, the step of treating further comprises: administering the acoustical vibration therapy to the area following the shock wave therapy.
However, as Schwarz’s device and method further teaches the application of shock wave therapy (Paragraph 0012) and acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to select any order of the applied therapies, to include applying acoustic vibration therapy following shock wave therapy, as this order of applied therapies would not yield any new or unexpected results.
Regarding claim 14, Schwarz in view of Schwarz (‘997) teach the method of claim 10, however don’t explicitly state wherein, for the second predetermined number of treatment sessions of the plurality of treatment sessions, the step of treating further comprises: administering the acoustical vibration therapy to the area following the shock wave therapy every other sequential treatment session.
However, as Schwarz’s device and method further teaches the application of shock wave therapy (Paragraph 0012) and acoustical vibration therapy to the area (mechanical stimulation may include acoustic wave generation, Paragraph 0012), it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to select any order of the applied therapies, to include applying acoustic vibration therapy following shock wave therapy every other sequential treatment session, as this order of applied therapies would not yield any new or unexpected results.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), Wagner et al. (US 2012/0226200 A1), and in further view of Zabar et al. (US 2017/0079718 A1).
Regarding claim 25, Schwarz in view of Porter, Jimenez Lozano, and Wagner teaches the method of claim 23, however is silent wherein a power and a frequency of the shock wave device is increased with each successive treatment session of the plurality of treatment sessions.
However, Zabar teaches a soft tissue treatment method (Abstract) comprising a shock wave generating device (laser catheter 63 used to generate shock waves intended for soft tissue, Paragraphs 0105-0106 and Figure 6A) wherein a power and frequency of the shock wave is increased with subsequent treatment sessions (a reduction in shock wave pulse duration, therefore resulting in higher peak power and frequency, may be used in treatment sessions, Paragraph 0039).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by including an increase in shock wave power and frequency with successive treatments, as taught by Zabar, as this increase in power and frequency may lead to an increased efficiency of the shock waves applied to the tissue (Paragraph 0039 of Zabar).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), Wagner et al. (US 2012/0226200 A1), and in further view of Gertner et al. (US 2019/0262225 A1).
Regarding claim 28, Schwarz in view of Porter, Jimenez Lozano, and Wagner teaches the method of claim 26, however is silent wherein a frequency and an amplitude of the acoustical vibration supplied by the acoustical vibration device is increased with each successive treatment sessions of the plurality of treatment sessions.
However, Gertner teaches a method and device of treating soft tissue (Abstract and Figure 1) configured to generate acoustical vibrations (an actuator moves mechanically at a frequency driven by an electric current and voltage to generate acoustic vibrational energy, Paragraph 0052), wherein a frequency and an amplitude of the acoustical vibration supplied by the acoustical vibration device is increased with each successive treatment sessions of the plurality of treatment sessions (stimulation levels may be increased by increasing the amplitudes and/or frequencies, Paragraph 0484).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by having the frequency and amplitude of the acoustical vibration increase with successive treatments, as taught by Gertner, as this increase in stimulation levels may aide in the efficiency of the successive treatments.
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), Wagner et al. (US 2012/0226200 A1), and in further view of Cioanta et al. (US 2018/0221688 A1).
Regarding claim 29, Schwarz in view of Porter, Jimenez Lozano, and Wagner teaches the method of claim 1, and although Schwarz further teaches the treatment sessions may be repeated (Paragraph 0046), Schwarz doesn’t explicitly state wherein the plurality of treatment sessions is one of equal to and greater than five treatments.
However, Cioanta teaches a device and method of soft tissue treatment (Abstract and Figure 1B) wherein acoustic shock waves are generated via laser sources (Figure 1B and Paragraph 0121) for the treatment of skin (Paragraph 0002), wherein the total number of treatments is completely customized/personalized to the patient (customized algorithms may be used to change the total number of treatments or the energy setting used during a treatment with acoustic pressure shock waves based on the certain patient, Paragraph 0029) such that the number of treatment sessions is greater than five treatments (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by having the plurality of treatments be greater than five treatments, or as many treatment sessions as the patient may need, as taught by Cioanta, as providing multiple successive treatment sessions allows the user to fully resolve his/her unique skin conditions in which treatment is applied for.
Regarding claim 30, Cioanta further teaches wherein the plurality of treatment sessions is one of equal to and greater than ten treatments (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, therefore resulting in greater than ten treatments, Paragraph 0144).
Regarding claim 31, Cioanta further teaches wherein the first predetermined number of treatment sessions is one of equal to and greater than five treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Claim(s) 32-37 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 2019/0030356 A1) in view of Porter (US 9,907,975 B1), Jimenez Lozano et al. (US 2020/0038234 A1), Wagner et al. (US 2012/0226200 A1), Schwarz et al. (US 2022/0211997 A1) and in further view of Cioanta et al. (US 2018/0221688 A1).
Regarding claim 32, Schwarz in view of view of Porter, Jimenez Lozano, and Wagner and Schwarz (‘997) teach the method of claim 10, however are silent wherein the first predetermined number of treatment sessions is one of equal to and greater than five treatment sessions.
However, Cioanta teaches a device and method of soft tissue treatment (Abstract and Figure 1B) wherein acoustic shock waves are generated via laser sources (Figure 1B and Paragraph 0121) for the treatment of skin (Paragraph 0002), wherein the total number of treatments is completely customized/personalized to the patient (customized algorithms may be used to change the total number of treatments or the energy setting used during a treatment with acoustic pressure shock waves based on the certain patient, Paragraph 0029) such that the number of treatment sessions is greater than five treatments (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Schwarz’s method by having the plurality of treatments be greater than five treatments, or as many treatment sessions as the patient may need, as taught by Cioanta, as providing multiple successive treatment sessions allows the user to fully resolve his/her unique skin conditions in which treatment is applied for.
Regarding claim 33, Cioanta further teaches wherein the second predetermined number of treatment sessions is one of equal to and greater than five treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Regarding claim 34, Cioanta further teaches wherein the first predetermined number of treatment sessions is one of less than and equal to eight treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Regarding claim 35, Cioanta further teaches wherein the second predetermined number of treatment sessions is one of less than and equal to eight treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Regarding claim 36, Cioanta further teaches wherein the first predetermined number of treatment sessions is one of equal to and greater than fourteen treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Regarding claim 37, Cioanta further teaches wherein the second predetermined number of treatment sessions is one of equal to and greater than fourteen treatment sessions (multiple sessions may be applied and spread over a period of time, with the initial number of treatment sessions in the range of 4 to 10 sessions for each application, and if an tissue condition is not resolved after the initial round of sessions, the therapy may be administered again in a second set of treatment rounds, Paragraph 0144).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785