DETAILED ACTION
This action is pursuant to the claims filed on 06/29/2021. Claims 1-12 are pending. Claims 1-4 are withdrawn. A first action on the merits of claims 5-12 is as follows.
Election/Restrictions
Applicant’s election without traverse of claims 5-12 in the reply filed on 04/08/2025 is acknowledged.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/08/2025.
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 5-12 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 5 recites the limitation "non-ionizing, non-ablating electromagnetic or mechanical energy" in limitation a, “adequate localized energy” in limitation c, “the energy” in limitation d, and “focused, enhanced and localized heating or other energy” in limitation f. It is unclear if these variations of claimed energy are intended to recite unique energies or if the limitations are attempting to claim antecedent basis to a previously recited energy. For example, it is unclear if limitation f is a further narrowing of the localized energy of limitation c or if these limitations recite two distinct applications of localized energy. For examination purposes, these energies will be interpreted to be further narrowing limitations of the same energy delivery. Claims 6-12 inherit this deficiency.
Claim 5 recites “counteracting environmental stresses and forces … consisting of but not limited to, increased temperature, 38°-43°C or greater, and reduced pH, < 7.4, by inducing chaperone molecules, such as HSPs, for refolding denatured proteins and antigen presentation to dendritic cells and reversing aggregation” in limitation e. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, use of “consisting of but not limited to” does not clearly set forth the metes and bounds of the claim. It is unclear what the scope of this limitation is intended to be when it simultaneously recites “consisting of” (i.e., a closed term) directly followed by “but not limited to” (i.e., an open term).
Regarding claims 5, 7, 10, and 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites “radiating an energy that is non-ionizing, non-ablating electromagnetic or mechanical”. It is unclear if this claimed energy is intended to recite antecedent basis to the same term of claim 5 or is intended to recite a distinct energy application. Claims 7-9 inherit this deficiency.
Claim 6 recites multiple limitations that repeat prior limitations of parent claim 5 and limitations within claim 6. These limitations are “employing a phased array … for discrete and localized delivery of energy dose …” It is unclear if this energy dose is the same energy that is radiated in step b of claim 6. The same indefiniteness occurs with “depositing energy dose” in step i of claim 6. For examination purposes, these energies will be interpreted to be further narrowing limitations of the same energy dose.
Claim 7 recites “focusing the output of an array of microwave antennas”. It is unclear if this step recites a new step or is further limiting one of the many energy delivery steps of claims 5-6 stated above. Furthermore, it is unclear if the array of microwave antennas is a narrowing of the energy radiating sources of claim 6, step a. For examination purposes, these limitations will be interpreted to be further narrowing limitations of the previous energy delivery steps.
Claim 7 recites “targeting a lesion by employing volumetrically discrete energy dose deposition” in step d. It is unclear if a lesion is intended to claim antecedent basis to the pathologic lesions recited in claim 6. Similarly, the same dilemma exists with the energy dose that is recited in this limitation.
Claim 7 recites limitations in steps e and f that appear to be repeated steps that do not possess either antecedent basis or clear differentiation from the previously recited limitations.
Claim 8 recites limitations in steps a-d that appear to repeat previously recited limitations from parent claims 5-7. These limitations all lack either clear antecedent basis or clear differentiation from the previously recited steps.
Claim 9 recites “a lesion”. It is unclear if a lesion is intended to claim antecedent basis to the pathologic lesions recited in claim 6.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation 40° C or greater, and the claim also recites 38°-43° C which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 recites “volumetrically discrete energy dose deposition” in step d. It is unclear if this energy dose is a further narrowing of the energy dose recited in step d of claim 5 or if this limitation is reciting a new and distinct energy dose.
Claim 11 recites “transferring energy … wherein a radiated energy comprises” in steps a-b. It is unclear if the energy recited in step a is intended to be the same radiated energy in step b or if these energies are distinctly different.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “or greater”, and the claim also recites “38°-43° C” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12 appears to repeat steps a-c of parent claim 5 without proper antecedent basis, thus making these limitations indefinite.
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.
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) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenna (U.S. PGPub No. 2012/0190911) in view of Mukhopadhaya (Mukhopadhaya, Arunika et al., “Localized Hyperthermia Combined with Intratumoral Dendritic Cells Induces Systemic Antitumor Immunity”, Cancer Res, August 15, 2007).
Regarding claim 5, McKenna teaches A method comprising:
a. effective and deliberate targeting to non-invasively deliver non-ionizing, non-ablating electromagnetic or mechanical energy to specific volumes of tissue, locations, fluid collections, airways or microorganisms inside a body or head, wherein the energy targeting is measured and evaluated in real time with imaging, thermometry or other functional metrics (Figs 15-17, [0061-0062] disclose real time feedback to control energy);
b. wherein the non-ionizing energy output is effectively directed towards a desired location, specific or selected volume, and energy waves traveling towards undesired locations, such as healthy tissue, are quenched (see Figs 15-17);
c. obtaining an original condition, state, conformation, functionality or phase in the body by introducing adequate localized energy to an altered process, network or system ([0063-0064] method treats invasive agents (i.e., cancer) to obtain original condition of system);
d. wherein the energy is focused, enhanced and localized energy, and reverses prion-like mechanisms, wherein misfolded, or unfolded proteins, which may be unaggregated or aggregated, are subjected to a permissible temperature or energy dose, thereby enabling restoration to their native, normal conformation ([0010-0020] heat shock proteins are minimized in cancer tissue, but still present; furthermore, HSPs would necessarily be present in inadvertently heated healthy tissue to reverse prion-like mechanisms);
e. counteracting environmental stresses and forces, which alter protein conformation, consisting of but not limited to, increased temperature, 38°-43°C or greater (Fig 14 step 1530 temp rise to 42 degrees C), and reduced pH, < 7.4 (Fig 13 step 1430 and [0102] disclose reduced pH to destroy cancer cells), by inducing chaperone molecules, such as HSPs, for refolding denatured proteins and reversing aggregation (heating of tissues to said temperatures and acidification necessarily induces HSPs );
f. employing focused, enhanced and localized heating or other energy deposition to induce refolding itself or chaperone molecules for refolding (heating of tissues to said temperatures and acidification induces HSPs) or antigen presentation and reversing aggregation (this limitation is recited in the alternative and need not be mapped to the prior art to read upon the claim);
g. inducing an effect in a diseased tissue wherein the effects comprise a combination of refolding, reversing aggregation, promoting fragmentation, enhancing degradation, elimination, enhancing immune processing and antigen presentation of peptide elements, each having a detrimental impact selected from the group consisting of misfolded proteins, their large polymers, fibrils, tangles and protein aggregates (heating of tissues to said temperatures and acidification induces HSPs, even in minimally, which provide refolding, [0013] discloses release of cytotoxin within tissue which is an elimination technique); and
h. wherein the induced effects of focused, enhanced and localized energy deposition further compromise a combination of enhancing fluid circulation to repair and remove toxic metabolites in bodies (Fig 12 and [0102] re-oxygenation 1380 and increased vessel pore size 1330 enhances fluid circulation to remove toxic metabolites in body), each having a diseased tissue selected from the group consisting of the CNS, the peripheral nervous system, the musculoskeletal system, the genitourinary system, the gastrointestinal system, the integument and other anatomy (disease tissue of McKenna falls under at least one of these categories).
McKenna fails to teach antigen presentation to dendritic cells.
In related prior art, Mukhopadhaya teaches a similar method wherein e. counteracting environmental stresses and forces, which alter protein conformation, consisting of but not limited to, increased temperature, 38°-43°C or greater, and reduced pH, < 7.4, by inducing chaperone molecules, such as HSPs, for refolding denatured proteins and antigen presentation to dendritic cells and reversing aggregation (Pg 7804 right column; LTH induces release of HSP from dying tumor cells that provide antigen presentation to dendritic cells). Therefore 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 method of McKenna in view of Mukhopadhaya to incorporate the step of antigen presentation to dendritic cells with the increased temperature and reduced pH as claimed. Doing so would be obvious to one of ordinary skill in the art to advantageously attack tumor cells (Pg 7804).
Regarding claim 11, in view of the combination of claim 5 above, McKenna further teaches a. transferring energy from outside a virally or microbe infected cell, tissue, organ or body, into a volume, partly or entirely encompassing and localizing to an affected structure thereof (Figs 1-2, 15-17, energy is transferred from outside an infected portion of a body into a volume encompassing an affected structure thereof);
b. wherein a radiated energy comprises a combination of non-ionizing output or beams selected from the group consisting of microwave radiation, radiofrequency radiation, long radio waves, laser emissions, visible, ultraviolet and solar light, infrared and far infrared light, thermal chambers, or incubators, diathermy or high-frequency electric currents, pulsed, mechanical or acoustic waves, ultrasound and high-intensity focused ultrasound (HIFU), heat from nano-devices and warm water ([0049]);
c. delivering the energy non-invasively without employing a device or mechanism to cut, puncture or traumatically penetrate skin or other surface (energy is delivered non-invasively);
d. inducing high local temperature in the encompassing volume and affected structure, in a range of 380-430C or greater, therein heating subcellular organelles, cells, tissue and anatomic sites and rendering them more resistant to viral penetration and escape (Fig 14 step 1530 temp rise to 42 degrees C necessarily renders the claimed function);
e. wherein the high local temperature raises endosomal pH and inhibiting IL-6, a mediator of viral reproduction (temperature rise to 42 degrees C of McKenna necessarily achieves a raised endosomal pH and inhibited IL-6 mediator; examiner notes applicant’s PGPub 2021/0401288 discloses this function as being caused by heating to 39-43 deg C in [0049]);
f. wherein the high local temperature induces heat shock protein promoters, such as those of Hsp70, initiating global gene expression of antiviral proteins, thereby inactivating or counteracting virality (temperature rise to 42 degrees C of McKenna necessarily achieves a release of Hsp70 as claimed; examiner notes applicant’s PGPub 2021/0401288 discloses this function as being caused by heating to 39-43 deg C in [0049]); and
g. wherein the transferred energy reduces viral replication and function (temperature rise to 42 degrees C of McKenna necessarily achieves reduced viral replication and function as claimed; examiner notes applicant’s PGPub 2021/0401288 discloses this function as being caused by heating to 39-43 deg C in [0049]).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenna in view of Mukhopadhaya, and in further view of Zastrow (U.S. PGPub No. 2012/0172954).
Regarding claim 6, McKenna teaches a. distributing energy radiating sources, externally and around a body to treat and image pathologic lesions (see Figs 15-17; [0051-0055] disclosing imaging and treating lesions),
b. radiating an energy that is non-ionizing, non-ablating electromagnetic or mechanical (Fig 2, generators 153-155 generate non-ionizing, non-ablating EM or mechanical energy);
c. wherein the radiated energy comprises a combination of non-ionizing output or beams selected from the group consisting of microwave radiation, radiofrequency radiation, long radio waves, laser emissions, visible, ultraviolet and solar light, infrared and far infrared light, thermal chambers, or incubators, diathermy or high-frequency electric currents, pulsed, mechanical or acoustic waves, ultrasound and high-intensity focused ultrasound (HIFU), heat from nano-devices and warm water ([0049]);
d. delivering the energy non-invasively without employing a device or mechanism to cut, puncture or traumatically penetrate skin or other surface, and without an open surgical procedure (energy is delivered non-invasively);
h. controlling the sources electronically or with computers, and operating with a connected power supply with cooling (Fig 2, LTH system 150 is controlled with electronics and computers that have power supply and cooling); and
i. depositing energy dose locally by shifting and contouring energy output, or beams, for treatment comprising a combination of pathologic lesions, each having a detrimental impact selected from the group consisting of infectious agents, protein misfolding, temperature and pH imbalances; cancer, cancerous and benign tumors and mass effects, demyelination, autoimmunity, loss of immunity, loss of normal mitochondrial and other organelle function; loss of neurotransmitters and neurotransmitter-degrading enzymes, vascular abnormalities and abnormal cerebral blood flow, aneurysms, atherosclerosis, arteriosclerosis, hemorrhage, blood clots, microvascular angiopathy, retinopathy, excess hemoglobin AIc, diabetic angiopathy; abnormalities of the cerebrospinal fluid (CSF) and its production and movement, hormonal imbalances, trauma and traumatic encephalopathy, mental illnesses, neuroses, addiction, depression, mania, schizophrenia and psychoses (method and system treats cancers and tumors).
McKenna fails to teach distributing the radiating sources around the head and central nervous system, aligning the energy-emitting sources in a localized, or circumferential, or ring or spherical distribution around a patient, as a stand-alone arrangement, or moved by a robot or a gantry, or in a surface conforming and adhering layout, as a wearable; f. employing a phased array of the non-ionizing energy sources, electronically or computer controlled, to shift and contour their output in different directions without moving the sources, for discrete and localized delivery of energy dose to a given depth or lateral position in the body with a narrow or focused distribution; g. contouring energy output or beams to concentric, converging electromagnetic energy beams and depositing energy dose in a localized volume of interest to treat pathologic tissue;
In related prior art, Zastrow teaches distributing the radiating sources around the head and central nervous system (see Fig 1-2),
aligning the energy-emitting sources in a localized, or circumferential, or ring or spherical distribution around a patient, as a stand-alone arrangement, or moved by a robot or a gantry, or in a surface conforming and adhering layout, as a wearable (see Figs 1-2);
f. employing a phased array of the non-ionizing energy sources, electronically or computer controlled, to shift and contour their output in different directions without moving the sources, for discrete and localized delivery of energy dose to a given depth or lateral position in the body with a narrow or focused distribution (Fig 1 and [0038] phased antenna array 14);
g. contouring energy output or beams to concentric, converging electromagnetic energy beams and depositing energy dose in a localized volume of interest to treat pathologic tissue (Fig 3-4 target tissue 68). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the radiating sources of McKenna in view of Zastrow to incorporate distributing the radiating sources around the head and CNS and employing a phased array of non-ionizing energy sources to arrive at claim 6. Providing the phased array would advantageously enable the system to target specific regions of tissue within a larger tissue space to avoid inadvertent treatment of non-target tissue.
Regarding claim 7, in view of the combination of claim 6 above, McKenna and Zastrow further teach focusing the output of an array of microwave antennas to raise the temperature of a diseased volume of anatomy to levels in a range of 38°-43° C, or of a fever such as 40°C or greater, for several seconds to 24-hour intervals (Fig 3B step 222, temp is raised to 42 C for a determined “bake” time depending on cancer type and location [0069]; [0049] disclosing microwave antennas); b. wherein the array is annular in a stand-alone or wearable layout (McKenna Fig 17 array is annular and wearable; Zastrow Fig 1 also teaches an annular array in a wearable layout); . targeting a lesion within a body by employing volumetrically discrete energy dose deposition to beneficially manipulate lesions (Figs 15-17, target lesion 502 is a lesion within body targeted with discrete volumetric energy dose); wherein the conforming, discrete volume is encompassing and customized to a detrimental phase or lesion within the body (target tissue 68), thereby enhancing restoration of control parameters to a normal physiologic range and thus enabling a healthy transition state (treatment of target tissue 502 enhances restoration of control parameters to normal physiologic range); wherein a resulting adjustable radiation field size covers an internal treatment volume having diameters ranging from nanometers to a plurality of centimeters (target tissue 68 that is treated by the adjustable radiation field is necessarily nanometers to a plurality of centimeters (e.g., a plurality of centimeters can be interpreted as 1,000 cm)); g. inducing hydrodynamic manipulation of intracellular or extracellular fluid with local and regional energy deposition or heating (McKenna [0012] increased vessel pore size and perfusion is interpreted as hydrodynamic manipulation of intra or extracellular fluid from the heating); and h. repairing, reversing or removing toxic materials and peptide aggregates (McKenna Fig 12 and [0102] re-oxygenation 1380 and increased vessel pore size 1330 enhances fluid circulation to remove toxic metabolites in body).
McKenna fails to teach c. wherein the anatomy comprises a combination of sites selected from the group consisting of CNS, hippocampus, substantia nigra, blood-brain barrier (BBB), CSF, cranial nerves and extracranial vagus nerve fibers.
Zastrow further teaches c. wherein the anatomy comprises a combination of sites selected from the group consisting of CNS, hippocampus, substantia nigra, blood-brain barrier (BBB), CSF, cranial nerves and extracranial vagus nerve fibers (Zastrow Fig 1); d. targeting a lesion within a body by employing volumetrically discrete energy dose deposition to beneficially manipulate lesions (Zastrow Figs 3-4 target tissue 68 is a lesion within body targeted with discrete volumetric energy dose); e. wherein the conforming, discrete volume is encompassing and customized to a detrimental phase or lesion within the body (target tissue 68), thereby enhancing restoration of control parameters to a normal physiologic range and thus enabling a healthy transition state (treatment of target tissue 68 enhances restoration of control parameters to normal physiologic range); f. wherein a resulting adjustable radiation field size covers an internal treatment volume having diameters ranging from nanometers to a plurality of centimeters (target tissue 68 that is treated by the adjustable radiation field is necessarily nanometers to a plurality of centimeters (e.g., a plurality of centimeters can be interpreted as 1,000 cm)). Therefore 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 phased array to be a stand alone or wearable device applied to the head and CNS of a user arrive at the method of claim 7. Doing so would advantageously allow for the system and method to be used on a user’s head and CNS as is known in the art to yield predictable results therein (see Figs 1-2 of Zastrow).
McKenna/Zastrow discloses substantially all the limitations of the claim(s) except for an explicit teaching of several seconds to 24-hour intervals of treatment. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the focused microwave energy to raise temperatures of diseased tissue for several second to 24 hour intervals, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to provide a maximally effective treatment to the targeted cancer and/or tumor. The McKenna reference establishes that the treatment time is a well-known result effective variable for treatment of specific tumors types and locations to provide more effective treatment (Fig 3B step 222, temp is raised to 42 C for a determined “bake” time depending on cancer type and location [0069])
Regarding claim 8, in view of the combination of claim 7 above, McKenna and Zastrow further teach arraying microwave antennas around a pathologic site to focus and enhance microwave range energy (see Figs 1-2 of Zastrow with MW antennas 14); b. treating by applying energy to pathology selected from the group consisting of non- healing wounds, infections with microorganisms, bacteria, mycoplasma, viruses, fungi, archaea, amoebae, prions, protein misfolding, unfolding abnormalities in the proteostasis network, abnormalities in the microbiome, microorganism or bacterial signaling and quorum sensing, and biofilms (target tissue 68 is a tumor which is at least an abnormality in the microbiome); c. enhancing immunity, vascular and lymphatic flow to expedite recovery from infections and contagion throughout portions of a body selected from a group comprising the lungs, liver, gut, musculoskeletal system and CNS, the vagus, olfactory, and ophthalmic nerves and eyes and other cranial nerves, the nose, sinuses, mouth, gums and teeth (McKenna [0102] discloses treatment includes increasing vessel pore size which improves circulation to expedite recovery; treatment locations include musculoskeletal system); and d. modifying inflammatory reflexes linking metabolism to immune function (McKenna discloses heating to minimize deployment of HSPs to tissue that function as an inflammatory reflex).
Regarding claim 9, in view of the combination of claim 6 above, McKenna and Zastrow further teach a. treating diseased tissue with a non-ionizing-radiation, treatment-localizing agent ([0013] Fig 4, nanoparticles 420 are liposomes), wherein the agent becomes active in response to received non-ionizing-radiation energy ([0013] liposome shells are temperature sensitive and the liposome shell “melts” when it receives the non-ionizing radiation); b. wherein the non-ionizing-radiation, treatment-localizing agents are selected from the group consisting of thermolabile or thermosensitive liposomes ([0013]), which carry drugs, biologics, immune-modulating compounds, contrast agents; and microbubbles; and c. targeting a lesion within the body by employing volumetrically discrete energy dose deposition to beneficially manipulate the lesion with a therapeutic compound therein (see Fig 4).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenna in view of Mukhopadhaya, in view of Zastrow, and in further view of Foley (U.S. PGPub No. 2005/0240126).
Regarding claim 10, in view of the combination of claim 5 above, McKenna further teaches a. to raise the temperature of a diseased volume of anatomy to levels in a range of 38°-43° C, or of a fever such as 40°C or greater, for several seconds to 24-hour intervals (Fig 3B step 222, temp is raised to 42 C for a determined “bake” time depending on cancer type and location [0069]); b. wherein the array is annular in a stand-alone or wearable layout (McKenna Fig 17 array is annular and wearable; Zastrow Fig 1 also teaches an annular array in a wearable layout); d. targeting a lesion within a body by employing volumetrically discrete energy dose deposition to beneficially manipulate lesions (Figs 15-17, target lesion 502 is a lesion within body targeted with discrete volumetric energy dose); e. wherein a resulting adjustable radiation field size covers an internal treatment volume having diameters ranging from nanometers to a plurality of centimeters (target tissue 68 that is treated by the adjustable radiation field is necessarily nanometers to a plurality of centimeters (e.g., a plurality of centimeters can be interpreted as 1,000 cm)); f. inducing hydrodynamic manipulation of intracellular or extracellular fluid with local and regional energy deposition or heating (McKenna [0012] increased vessel pore size and perfusion is interpreted as hydrodynamic manipulation of intra or extracellular fluid from the heating); and g. repairing, reversing or removing toxic materials and peptide aggregates (McKenna Fig 12 and [0102] re-oxygenation 1380 and increased vessel pore size 1330 enhances fluid circulation to remove toxic metabolites in body).
McKenna fails to teach c. wherein the anatomy comprises a combination of sites selected from the group consisting of CNS, hippocampus, substantia nigra, blood-brain barrier (BBB), CSF, cranial nerves and extracranial vagus nerve fibers.
Zastrow further teaches c. wherein the anatomy comprises a combination of sites selected from the group consisting of CNS, hippocampus, substantia nigra, blood-brain barrier (BBB), CSF, cranial nerves and extracranial vagus nerve fibers (Zastrow Fig 1); d. targeting a lesion within a body by employing volumetrically discrete energy dose deposition to beneficially manipulate lesions (Zastrow Figs 3-4 target tissue 68 is a lesion within body targeted with discrete volumetric energy dose); e. wherein the conforming, discrete volume is encompassing and customized to a detrimental phase or lesion within the body (target tissue 68), thereby enhancing restoration of control parameters to a normal physiologic range and thus enabling a healthy transition state (treatment of target tissue 68 enhances restoration of control parameters to normal physiologic range); f. wherein a resulting adjustable radiation field size covers an internal treatment volume having diameters ranging from nanometers to a plurality of centimeters (target tissue 68 that is treated by the adjustable radiation field is necessarily nanometers to a plurality of centimeters (e.g., a plurality of centimeters can be interpreted as 1,000 cm)). Therefore 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 phased array to be a stand alone or wearable device applied to the head and CNS of a user. Doing so would advantageously allow for the system and method to be used on a user’s head and CNS as is known in the art to yield predictable results therein (see Figs 1-2 of Zastrow).’
McKenna fails to teach wherein the energy is applied via defocusing an array of HIFU transducers.
In related prior art, Foley teaches a similar device comprising an array of HIFU transducers ([0017] [0073] and Fig 2 disclosing array of HIFU transducers) and defocusing the HIFU transducers to provide treatment ([0073] disclosing transducers with variable focal lengths; [0168] disclosing defocusing beam to produce larger focal size). Therefore 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 radiating sources of McKenna in view of Mukhopadhaya, Zastrow, and Foley to incorporate the HIFU transducers and step of defocusing the output of the HIFU transducers. Doing so would be a simple substitution of one well-known non-ionizing energy output (McKenna disclosing E-field, H-field, EM-field energy outputs) for another well-known non-ionizing energy output (Foley HIFU transducers) to yield the predictable result of applying energy to tissue to be treated. Furthermore, defocusing an array of HIFU transducers would advantageously produce a slightly larger focal size and treatment area as needed by a physician ([0168] of Foley).
McKenna/Mukhopadhaya/Zastrow/Foley discloses substantially all the limitations of the claim(s) except for an explicit teaching of several seconds to 24-hour intervals of treatment. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the focused microwave energy to raise temperatures of diseased tissue for several second to 24 hour intervals, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to provide a maximally effective treatment to the targeted cancer and/or tumor. The McKenna reference establishes that the treatment time is a well-known result effective variable for treatment of specific tumors types and locations to provide more effective treatment (Fig 3B step 222, temp is raised to 42 C for a determined “bake” time depending on cancer type and location [0069]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenna in view of Mukhopadhaya, and in further view of Knight (U.S. PGPub No. 2014/0330353).
Regarding claim 12, in view of the combination of claim 5 above, McKenna further teaches focusing and enhancing non-ionizing energy deposition in a body, wherein energy output is effectively directed towards a desired location, specific or selected volume (Fig 2, 15-17, microwave antennas, [0020] [0049], are used to focus and enhance non-ionizing energy to a target location);
b. reversing or rectifying prion-like mechanisms in the volume, wherein misfolded, or unfolded proteins, which may be unaggregated or aggregated, are subjected to a permissible temperature or energy dose, thereby enabling restoration to their native, normal conformation ([0010-0020] heat shock proteins are minimized in cancer tissue, but still present; furthermore, HSPs would necessarily be present in inadvertently heated healthy tissue to reverse prion-like mechanisms);
c. obtaining an original condition, state, conformation, functionality or phase in the body by introducing adequate localized energy to a deleterious altered process, network or system and thereby overcoming an undesired transition ([0063-0064] method treats invasive agents (i.e., cancer) to obtain original condition of system);
d. wherein depositing energy into the discrete, conforming volume encompassing and customized to a detrimental phase or lesion within the body, thereby enhances restoration of control parameters to a normal physiologic range and enabling a healthy transition state (treatment of target tissue 502 enhances restoration of control parameters to normal physiologic range);
e. wherein elevated levels of mis-folded, aggregated or modified proteins, including p-Tau, are reversed and undone by restoration of lesion or core temperature (Fig 3B step 222 to “exit” step involves a temperature rise to 42 degrees C and reversion to normal core temperature after treatment; this necessarily achieves a reversion of mis-folded p-Tau; examiner notes applicant’s PGPub 2021/0401288 discloses this function as being caused by heating to 39-43 deg C and reversion to core temperature in [0041]).
McKenna fails to teach wherein inhibiting pathologic modifications of proteins, including phosphorylation of tau or supplanting cold inhibition of proteasomes, yields a desired effect.
In related prior art, Knight teaches that it is known that protein tau builds up inside cells and tangles nerve cells and is major cause of Alzherimer’s disease, dementia, and dementia-like symptoms ([0038-0039]). Therefore 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 method of McKenna in view of Knight to incorporate an inhibition of modifications of protein tau to yield the desired effect of preventing and/or treating Alzheimer’s disease, dementia, and/or dementia-like symptoms. Doing so would advantageously yield a well-known desired effect of preventing and/or treating Alzheimer’s disease, dementia, and/or dementia-like symptoms ([0038-0039]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794