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 .
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 1-27 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.
In claim 1, the limitation “reduce, reverse or stop cell senescence or aging and apoptosis” renders the claim indefinite. The use of the terms “or” “and” should be clarified. It is unclear what combination of the elements “senescence, “aging”, and “apoptosis” are required. It is unclear if the claim requires only one of senescence, or aging, or apoptosis. It is unclear if the claim requires one of 1) senescence or aging, in combination with 2) apoptosis. It is unclear if the claim requires one of 1) senescence or 2) aging in combination with apoptosis.
In claim 7, the limitation “wherein subjecting the reflexology zone to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the reflexology zone stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in cells wherein the cells are positioned within a path of the emitted shock waves or pressure pulses; and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the skin or beyond the skin thereby passing the emitted waves or pulses through the skin while avoiding having any localized focal point within the skin, wherein shortened telomeres at ends of chromosomes are lengthened, thereby regenerating the telomeres reversing senescence in cells” renders the claim indefinite.
The claim language is grammatically incorrect. The claim language is a run on sentence. It is unclear what is meant by “evidenced by not experiencing the sensation of hemorrhaging”, it is unclear how a sensation may be considered evidence. It is unclear what “evidence” and “experience” have to do with the acoustic shock waves. It is unclear what is meant by the use of a semicolon and the language “; and away from”. It is unclear what is intended to be described in regards to the language “away from”, it is unclear what aspects of the shockwaves are “away from”. Furthermore, the language “wherein shortened telomeres at ends of chromosomes are lengthened, thereby regenerating the telomeres reversing senescence in cells” appears to refer to an intended effect of the shockwave therapy, however it is unclear what aspects of the shockwaves achieve the desired effects.
In claim 21, the language beginning the claim with “is repeated” renders the claim indefinite.
In claim 26, the limitation “treating the cellular substance” renders the claim indefinite. The bounds and scope of the term “treating” is unclear, it is unclear what this step entails. It is unclear what may be considered “treating”. It is unclear how the step of “treating” differs from the steps of activating the shock wave generator to achieve the desired effects in the patient’s tissue.
In claim 26, the limitation ““wherein subjecting the reflexology zone to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the reflexology zone stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in cells wherein the cells are positioned within a path of the emitted shock waves or pressure pulses; and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the skin or beyond the skin thereby passing the emitted waves or pulses through the skin while avoiding having any localized focal point within the skin” renders the claim indefinite. The claim language is grammatically incorrect. The claim language is a run on sentence. It is unclear what is meant by “evidenced by not experiencing the sensation of hemorrhaging”, it is unclear how a sensation may be considered evidence. It is unclear what “evidence” and “experience” have to do with the acoustic shock waves. It is unclear what is meant by the use of a semicolon and the language “; and away from”. It is unclear what is intended to be described in regards to the language “away from”, it is unclear what aspects of the shockwaves are “away from”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 and 12-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warlick et al. (US 2018/0296432; hereinafter Warlick) in view of Narodden (US 2019/0374623; Narodden).
Warlick shows a method of treating a reflexology zone using pressure pulses or shock waves ([0062]) comprises the steps of: placing an applicator head of an acoustic shock wave or pressure pulse generator or source at a reflexology zone ([0062]); coupling the applicator head directly or indirectly to an exposed surface of the skin near the reflexology zone ([0062]); and activating the generator or source to emit pressure pulses or acoustic shock waves through the skin to the reflexology zone ([0062]).
Warlick shows a method of stimulating a cellular substance wherein the cellular substance is a patient having senescent cells or a culture of senescent cells ([0062]) comprises the steps of: treating the cellular substance ([0062]); activating an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves directed toward the substance to impinge the substance with pressure pulses or shock waves having a low energy density in the range of 0.00001 mJ/mm 2 to 1.0 mJ/mm 2 ([0062]); the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second, rise times of the positive part of the first pressure cycle in the range of nano-seconds (ns) up to some milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 100's of ns, the duration of the shock wave is typically below 1-3 micro-seconds (ps) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle ([0035]); and subjecting the cellular substance to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the substance stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging caused by the emitted waves or pulses in the substance wherein the cellular substance is positioned within a path of the emitted shock waves or pressure pulses and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the cellular substance or beyond the cellular substance thereby passing the emitted waves through the cellular substance while avoiding having any localized focal point within the cellular substance wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm2 to a high end of below 1.0 mJ/mm2 ([0063], [0065], [0067]).
Warlick also shows wherein the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure ([0035]); wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second ([0035]); wherein the rise times of the positive part of the first pressure cycle in the range of nanoseconds (ns) up to some milliseconds (ms) ([0035]); wherein the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 1000 ns ([0035]) ; wherein the duration of the shock wave is typically below 1-3 microseconds (ps) for the positive part of a cycle and typically above some microseconds for the negative part of a cycle ([0035]); wherein subjecting the reflexology zone to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the reflexology zone stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in cells wherein the cells are positioned within a path of the emitted shock waves or pressure pulses; and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the skin or beyond the skin thereby passing the emitted waves or pulses through the skin while avoiding having any localized focal point within the skin, wherein shortened telomeres at ends of chromosomes are lengthened, thereby regenerating the telomeres reversing senescence in cells (while silent as to telomeres, the application of ultrasound at the operating parameters set forth will achieve this effect and other beneficial effects such stimulating cellular responses, releasing healing agents and growth factors; [0063], [0065], [0067]-[0069], [0078]-[0079], [0102]); wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm2 to a high end of below 1.0 mJ/mm2 ([0062], [0072]-[0074]); wherein subjecting the cells directly to the acoustic shock waves having a low energy density of less than 1.0 mJ/mm2 per shock wave stimulates said reflexology zone wherein the reflexology zone is positioned directly within a path of the emitted pressure pulses or acoustic shock waves in the absence of any focal point or if a focal point exists, the reflexology zone being treated is positioned away from any focal point ([0062], [0072]-[0074]); wherein treating the reflexology zone stimulates by accelerating and increasing cell growth or regeneration or repair ([0067]-[0068]), [0071]); wherein the acoustic shock waves or pressure pulses are directed to one or more reflexology zones of the hands, feet or ears to cause a positive biologic response to treat the cells ([0102], Fig. 11); wherein the acoustic shock waves or pressure pulses are directed to an entire surface of one or both hands or feet or ears ([0102]; Fig. 11); wherein the shock wave or pressure pulse generator is acoustically coupled to the patient's skin using a coupling gel or liquid ([0102]); wherein the stimulating the one or more reflexology zones or the one or more reflexology zones and the cells causes a release of growth factors including, but not limited to VEGF ([0067]); wherein the stimulating the one or more reflexology zones or the one or more reflexology zones and the cells causes new blood vessels to be created increasing vascularization and reversing senescence ([0010]); is repeated one or more times to treat and reverse the senescence condition ([0011]); wherein the emitted acoustic shock waves or pressure pulses are low energy soft waves ([0010], [0079]); wherein the low energy soft waves have an energy density in the range of 0.01 mJ/mm2 to 1.0 mJ/mm2 ([0010], [0062]); wherein each subjected reflexology zone receives between 100 and 100,000 acoustic shock waves or pressure pulses per therapy session ([0011]); wherein the number of repeated treatments occur on a schedule over a period of one or more weeks, and treatments can be repeated over time as an anti-aging protocol over longer durations of time between repeated treatments ([0011]).
Warlick fails to show to reduce, reverse or stop cell senescence or aging and apoptosis.
Warlick also fails to show wherein the positive biologic response reduces or eliminates systemic or local inflammation and reverses senescence in cells; wherein the positive biologic response initiates, activates or recruits cells reversing senescence; wherein stimulating the one or more reflexology zones or the one or more reflexology zones and the cells causes a stimulation or modulation of adrenergic receptors α and β and one or more of a release of nitric oxide, secretion of digestive enzymes, inflammation reduction, hormonal regulation and peptide recruitment and activation; wherein the shock waves stimulate the senescent cells enhancing replication.
Narodden discloses methods and apparatus for shockwave treatments. Narodden teaches using shockwave treatments to reduce, reverse or stop cell senescence or aging and apoptosis (shockwave therapy alone or in combination with drugs to inhibit, prevent, minimize apoptosis, [0010]-[0014]; where apoptosis and senescence represent cell activity states, apoptosis representing a final state of cell death, minimizing apoptosis will similarly minimize senescence cell activity).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Warlick to provide additional therapeutic protocols to treat/prevent additional diseases, such as by preventing or minimizing cell apoptosis as taught by Narodden, as shockwave therapy may provide numerous benefits to the patient, and as it would be within the level of one of ordinary skill in the art, without undue experimentation, to apply shockwaves or to modify shockwave parameters to achieve a desired therapeutic effect depending on the patient’s disease state.
Furthermore, applying shockwaves at the particular operating parameters described Warlick will produce a variety of different natural effects within the patient’s body related to cell senescence, aging and, apoptosis, including: wherein the positive biologic response reduces or eliminates systemic or local inflammation and reverses senescence in cells; wherein the positive biologic response initiates, activates or recruits cells reversing senescence; and wherein stimulating the one or more reflexology zones or the one or more reflexology zones and the cells causes a stimulation or modulation of adrenergic receptors α and β and one or more of a release of nitric oxide, secretion of digestive enzymes, inflammation reduction, hormonal regulation and peptide recruitment and activation; wherein the shock waves stimulate the senescent cells enhancing replication.
The shockwave system and methods, when operated at the parameters described by Warlick, will produce the claimed effects within the patient’s body. Warlick teaches the claimed operating parameters described above: with pressure pulses or shock waves having a low energy density in the range of 0.00001 mJ/mm 2 to 1.0 mJ/mm 2; the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second, rise times of the positive part of the first pressure cycle in the range of nano-seconds (ns) up to some milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 100's of ns, the duration of the shock wave is typically below 1-3 micro-seconds (ps) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle; and subjecting the cellular substance to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the substance stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging caused by the emitted waves or pulses in the substance wherein the cellular substance is positioned within a path of the emitted shock waves or pressure pulses and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the cellular substance or beyond the cellular substance thereby passing the emitted waves through the cellular substance while avoiding having any localized focal point within the cellular substance wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm2 to a high end of below 1.0 mJ/mm2.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warlick et al. (US 2018/0296432; hereinafter Warlick) in view of Narodden (US 2019/0374623; Narodden) as applied to claim 1 above, and further in view of Capelli et al. (US 2018/0116905; hereinafter Capelli).
Warlick fails to show wherein the frequency of the emitted pressure pulses or shock waves is in the range of .5 Hz to 15 MHz; wherein the frequency of the emitted pressure pulses or shock waves has a preferred range of 70 Hz to 150 Hz.
Capelli discloses methods of shockwave treatment. Capelli teaches wherein the frequency of the emitted pressure pulses or shock waves is in the range of .5 Hz to 15 MHz ([0057], [0062], [0064]); wherein the frequency of the emitted pressure pulses or shock waves has a preferred range of 70 Hz to 150 Hz ([0057], [0062], [0064]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Warlick and Narodden to utilize a frequency in a range of 70 Hz to 150 Hz as taught by Capelli, in order to produce the desired therapeutic effects while inducing minimal or no detectable transient cavitation as described by Capelli ([0057]). It would be within the level of one of ordinary skill in the art, without undue experimentation, to select a desired operating frequency for the shockwave device.
Conclusion
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797