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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/029,714, filed on 03/31/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Claims 72-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/03/2025. Applicant’s election without traverse of claims 54-71 and 89-95 in the reply filed on 10/03/2025 is acknowledged.
Drawings
The drawings are objected to because Figure 15 is blurry and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 54-71 and 89-95 are objected to because of the following informalities:
Regarding claim 54, in lines 1-2, the claim includes a minor grammatical error of missing a comma prior to “comprising” and reads “a biological object comprising a light”. Examiner suggests amending the claim to read “a biological object, comprising a light”.
Regarding claims 54-58, and 62, the claims include a minor grammatical error of missing a colon following “comprising”. Examiner suggests amending the claims such that the claims read “comprising:” to improve clarity.
Regarding claims 55-58, 62, and 89-95, the claims include a minor grammatical error of missing a comma following the claim number within the dependency statement. For example, claim 55 reads “Device according to claim 54 comprising”, but should read “Device according to claim 54, comprising”.
Regarding claims 55-71 and 89-95, the beginning of each claim is missing the article “the”. Examiner suggests amending claims 55-71 and 89-95 to add the article the, such that the claims read “The device…”, “The method…” , or “The use…”, to improve clarity.
Regarding claim 63, in line 3, the claim contains a typographical error and read “influences or modify an amplitude”. Examiner suggests amending the claim to read “influences or modifies an amplitude”.
Regarding claim 64, in line 2, “and/or irradiance” is missing the article “the”. Examiner suggests amending claim 64 to add the article “the” to improve clarity.
Regarding claims 89-95, the wording of these claims make it unclear as to whether the claims inherit all of the limitations of claim 54. Examiner suggests amending the claims to read “A method comprising the device of claim 54, wherein …” to improve clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
The “processing and/or light control unit” in claim 54.
The “Krebs cycle enzymes kinetics measurement means” in claim 57.
The “unit” in claim 58.
The “metabolic monitoring unit” in claim 62.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 54-71 and 89-95 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claims purport to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see claim limitations of the “processing and/or light control unit” in claim 54, “Krebs cycle enzymes kinetics measurement means” in claim 57, and “unit” in claim 58), but fail to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
Claims 54-71 and 89-95 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.
Regarding claims 54 and 57-58, the claim limitation “processing and/or light control unit” in claim 54, “Krebs cycle enzymes kinetics measurement means” in claim 57, and “unit” in claim 58 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The term “adequate” in claim 54 is a relative term which renders the claim indefinite. The term “adequate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what would be adequate and what the comparison is in relation to such as what threshold needs to be met to achieve adequacy. For the purposes of examination, Examiner interprets that adequate refers to “an illumination scheme protocol comprising at least a combined fluence rate and a time selected from the list comprising 3±2 mW/cm2 during 180+30 s, 11+9 mW/cm2 during 80±25 s, 16+10 mW/cm2 during 40±20 s, 25+10 mW/cm2 during 15+10 s and/or 10+9,7 mW/cm2 during 40+1 s” since this would achieve the requisite optical power.
Regarding claim 70, the limitation of “modulated in intensity ranging…” is unclear since mHz is not a proper measurement of intensity, where the claim reads “wherein the light is modulated in intensity ranging between 0.04 mHz and 1000 mHz or between 5 mHz and 500 mHz or between 10 mHz and 200 mHz”. For the purposes of examination, Examiner interprets “modulated in intensity” as “modulated in intensity at frequencies ranging…” since the disclosure refers to modulation in intensity at frequencies in these ranges.
Claims 89-95 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. These claims are an omnibus type claim since they claim “the use of the previous device or method as defined” without properly limiting the claims.
Regarding claims 54-71 and 89-95, there is insufficient antecedent basis for this limitations in these claims. Specifically, the limitations with insufficient antecedent basis are as follows:
Claim 54 recites the limitation “the total treatment time” in line 5, “the biological object optical coefficients” in lines 5-6, and “the light delivery geometry on/in the biological object” in line 6. There is insufficient antecedent basis for these limitations in the claim. For the purposes of Examination, “the total treatment time”, “the biological object optical coefficients”, and “the light delivery geometry on/in the biological object” will be interpreted as “a total treatment time”, “a biological object optical coefficient”, and “a light delivery geometry on/in the biological object”, respectively.
Claim 64 recites the limitations “and/or irradiance” in line 2 and “the frequency analysis of the at least one metabolic parameter” in lines 2-3. There is insufficient antecedent basis for these limitations in the claims. For the purposes of Examination, “and/or irradiance” will be interpreted as “and/or the irradiance,” referring to respective limitations in claim 62, and “the frequency analysis of the at least one metabolic parameter” will be interpreted as “a frequency analysis of the at least one metabolic parameter.”
Claim 66 recites the limitation “the optimal time” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the optimal time” will be interpreted as “an optimal time.”
Claim 71 recites the limitations “the pulmonary artery” and “the cava vein” in line 2. There is insufficient antecedent basis for these limitations in the claim. For the purposes of Examination, “the pulmonary artery” and “the cava vein” will be interpreted as “a pulmonary artery” and “a cava vein.”
Claim 89 recites the limitation “the treatment of myocardial infarction”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of myocardial infarction” will be interpreted as “a treatment of myocardial infarction.”
Claim 90 recites the limitation “the treatment of biological objects subjected to ischemia and/or hypoxia and/or anoxia”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of biological objects subjected to ischemia and/or hypoxia and/or anoxia” will be interpreted as “a treatment of biological objects subjected to ischemia and/or hypoxia and/or anoxia.”
Claim 91 recites the limitation “the treatment of acute respiratory distress syndrome”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of acute respiratory distress syndrome” will be interpreted as “a treatment of acute respiratory distress syndrome.”
Claim 92 recites the limitation “the treatment of desynchronized metabolic activities”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of desynchronized metabolic activities” will be interpreted as “a treatment of desynchronized metabolic activities.”
Claim 93 recites the limitation “the treatment of desynchronized insulin secretion”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of desynchronized insulin secretion” will be interpreted as “a treatment of desynchronized insulin secretion.”
Claim 94 recites the limitation “the treatment of hypertension”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of hypertension” will be interpreted as “a treatment of hypertension.”
Claim 95 recites the limitation “the treatment of pulmonary hypertension”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of Examination, “the treatment of pulmonary hypertension” will be interpreted as “a treatment of pulmonary hypertension.”
Additionally, claims 55-71 and 89-95, which are dependent from claim 54, are rejected for the same reasons as set forth for claim 54 above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 54 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (hereinafter “Arai”) (U.S. Pub. No. 2010/0022998 A1) in view of Svanberg et al. (hereinafter “Svanberg”) (U.S. Pub. No. 2011/0034971 A1, IDS Reference 2 from IDS dated 03/31/2023).
Regarding claim 54, Arai teaches a device for applying Photobiomodulation (PBM) on a biological object (Abstract, where “There is provided a catheter ablation apparatus for the treatment of arrhythmia using a photodynamic therapy, comprising a catheter leading a photoradiation unit to an abnormal electrical conduction site or a hyperexcitability occurring site in the cardiac muscle of a test subject … means for generating a light ray with which the abnormal electrical conduction site or the hyperexcitability occurring site is irradiated, and means for transmitting the light ray to the abnormal electrical conduction site or the hyperexcitability occurring site”) comprising
a light source delivering light (¶[0022], where “A catheter ablation apparatus blocking abnormal electrical conduction in the cardiac muscle using a photodynamic therapy, … means for generating a light ray with which the abnormal electrical conduction site or the hyperexcitability occurring site is irradiated, and means for transmitting a light ray to the abnormal electrical conduction site”) with an adequate temporal evolution of its optical power (¶[0133], where “The intensity of the irradiation light ray refers to strength, and the unit is W/cm2 … when a PDT therapy is performed by irradiation of light rays, the total energy density (irradiation dose, J/cm2) also determines the success or failure of the PDT therapy, and the intensity or the total energy density can be suitably determined by the size of an abnormal area to be treated and the like.” Examiner interprets that a suitable intensity will cause an adequate temporal evolution and that the ranges of a combined fluence rate and a time as outlined below will provide an adequate temporal evolution of its optical power.),
characterized by the fact that said processing and/or light control unit is configured to control the light source to deliver light according to an illumination scheme protocol comprising at least a combined fluence rate and a time selected from the list comprising 3±2 mW/cm2 during 180±30 s (¶[0133], where “Examples of the intensity of irradiation light rays include 1 mW/cm2 to 100 W/ cm2 … The irradiation time is 10 to 1000 s, preferably 50 to 500 s, more preferably 50 to 200 s.”), 11±9 mW/cm2 during 80±25 s, 16±10 mW/cm2 during 40±20 s, 25±10 mW/cm2 during 15±10 s and/or 10±9,7 mW/cm2 during 40±1 s.
Although Arai teaches a method of controlling the apparatus (¶[0035], where “A method for controlling the catheter ablation apparatus according to any one of [1] to [1,3], comprising changing irradiation conditions of the irradiation light ray”), Arai does not explicitly teach said device also comprising a processing and/or a light control unit configured to determine the adequate temporal evolution of the optical power to minimize the total treatment time on the basis of the biological object optical coefficients and the light delivery geometry on/in the biological object.
Svanberg teaches a method and system for controlling and adjusting light in interstitial photodynamic light therapy (IPDT) in a subject (Abstract), and further teaches said device also comprising a processing and/or a light control unit (¶[0090], where “A control device may be arranged as a regulator or a thresholding device in the PDT system to stop, or reduce or otherwise restrict said delivery of therapeutic light treatment at least temporary upon passing of at least one threshold value of the photodynamic treatment parameter”) configured to determine the adequate temporal evolution of the optical power to minimize the total treatment time (Examiner interprets that minimizing treatment time is a functional result of adequate temporal evolution which is taught by Arai.) on the basis of the biological object optical coefficients (¶[0114], where “a method is used where the decay of the transmitted light at increasing distances in the tissue is recorded and fitted to a model for light propagation ... more specifically, an approximation based on the assumption of diffuse light propagation--the diffusion equation. The resulting data is the effective attenuation coefficient”) and the light delivery geometry on/in the biological object (¶[0037], where “FIG. 7b is a three dimensional graph that shows the reconstructed geometry of a patient target site,” ¶[0151], where “As mentioned above, an apparatus for IPDT is provided that incorporates realtime monitoring of the light transmission signals between the treatment fibers in order to evaluate the light effective attenuation coefficient. These data together with information on the tissue geometry are used”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Svanberg, which teaches said device also comprising a processing and/or a light control unit configured to determine the adequate temporal evolution of the optical power to minimize the total treatment time on the basis of the biological object optical coefficients and the light delivery geometry on/in the biological object, with the invention of Arai in order to stop, or reduce or otherwise restrict said delivery of therapeutic light treatment (Svanberg ¶[0090]) and to predict individual fiber irradiation times since the irradiation times for each source fiber may be continuously updated throughout the treatment session (Svanberg ¶[0151]).
Regarding claim 71, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Arai teaches that the light source is adapted to be inserted in a heart compartment, the pulmonary artery or the cava vein such that light is delivered directly in the blood (¶[0110], where “A catheter-type apparatus equipped with a photoradiation unit at an end thereof, one embodiment of the apparatus of the present invention, in which a catheter is inserted to the heart via a major vein or artery, and a target, a portion of a cardiac muscle tissue to which a photosensitizer has been administered, is irradiated with a laser beam to necrotize the tissue”).
Claims 55-56, 58-60, and 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg as applied to claim 54 above, and further in view of Hammond et al. (hereinafter “Hammond”) (U.S. Pub. No. 2010/0179469 A1).
Regarding claim 55, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches a glucose sensor and wherein said processing and/or light control unit is configured to adjust the light dose according to the level of glycemia measured by said glucose sensor.
Hammond teaches phototherapy devices comprising at least one organic light emitting diode (¶[0002], where “Embodiments of the invention are directed to phototherapy devices comprising at least one organic light emitting diode”), and further teaches a glucose sensor (¶[0016], where “Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, … blood sugar content) as well as other sensors known in the art”) and wherein said processing and/or light control unit is configured to adjust the light dose according to the level of glycemia measured by said glucose sensor (¶[0016], where “The control module may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches a glucose sensor and wherein said processing and/or light control unit is configured to adjust the light dose according to the level of glycemia measured by said glucose sensor, with the modified invention of Arai in order to adjust the properties of the phototherapy device and to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient (Hammond ¶[0016]).
Regarding claim 56, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches a cardiac output sensor and wherein said processing and/or light control unit is configured to adjust the light dose according to the cardiac output measured by said cardiac output sensor.
Hammond teaches a cardiac output sensor (¶[0016], where “Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, … heart rate … as well as other sensors known in the art”) and wherein said processing and/or light control unit is configured to adjust the light dose according to the cardiac output measured by said cardiac output sensor (¶[0016], where “The control module may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches a cardiac output sensor and wherein said processing and/or light control unit is configured to adjust the light dose according to the cardiac output measured by said cardiac output sensor, with the modified invention of Arai in order to adjust the properties of the phototherapy device and to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient (Hammond ¶[0016]).
Regarding claim 58, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches a unit for administering to said biological object at least one exogenous stimulus.
Hammond teaches a unit for administering to said biological object at least one exogenous stimulus (¶[0021], where “Embodiments of the phototherapy device may comprise a heat management system to ensure proper temperature control thereby resulting in safe delivery of treatment to the patient,” ¶[0030], where “The phototherapy device may be used in conjunction with photosensitizing medicines for use in photodynamic therapy treatments”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches a unit for administering to said biological object at least one exogenous stimulus, with the modified invention of Arai in order to result in safe delivery of treatment to the patient (Hammond ¶[0021]) or to destroy nearby cells (Hammond ¶[0030]).
Regarding claim 59, Arai in combination with Svanberg and Hammond teaches all limitations of claim 58 as described in the rejection above.
Hammond teaches that the at least one exogenous stimulus is an oxygen delivery (¶[0030], where “The phototherapy device may be used in conjunction with photosensitizing medicines for use in photodynamic therapy treatments. In this case, the phototherapy device activates the photosensitizing medication … When the photosensitizing medicine is irradiated with light, activated oxygen molecules are produced which can destroy nearby cells”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches the at least one exogenous stimulus is an oxygen delivery, with the modified invention of Arai in order to destroy nearby cells (Hammond ¶[0030]).
Regarding claim 60, Arai in combination with Svanberg and Hammond teaches all limitations of claim 58 as described in the rejection above.
Hammond teaches that the at least one exogenous stimulus is a temperature change (¶[0021], where “Embodiments of the phototherapy device may comprise a heat management system to ensure proper temperature control thereby resulting in safe delivery of treatment to the patient. Excess heat may also reduce the lifetime of an electronic device such as an OLED. … A thermal management system for an embodiment of the phototherapy device can include a separate heat management system for the OLED part of the device and another heat management system for the control module part of the device, such as an air cooling fan system.”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches that the at least one exogenous stimulus is a temperature change, with the modified invention of Arai in order to result in safe delivery of treatment to the patient (Hammond ¶[0021]).
Regarding claim 62, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches a metabolic monitoring unit, configured to adjust the optical power, the delivery of light, the time, the fluence rate and/or irradiance based on at least one metabolic parameter reflecting a metabolic activity of the biological object measured by the metabolic monitoring unit.
Hammond teaches a metabolic monitoring unit (¶[0016], where “specific embodiments of the invention include a phototherapy device comprising at least one organic light emitting diode. The device may be in the form of a … probe … Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, bilirubin levels in the blood, body temperature, skin temperature, heart rate, oxygen level, carbon monoxide level, carbon dioxide level, bilirubin level, skin color, blood content, bodily fluid content, blood sugar content) as well as other sensors known in the art,” where Examiner interprets that a probe with sensors to measure metabolic parameters, such as the patient parameters described, is equivalent to a metabolic monitoring unit.), configured to adjust the optical power, the delivery of light, the time, the fluence rate and/or irradiance based on at least one metabolic parameter reflecting a metabolic activity of the biological object measured by the metabolic monitoring unit (¶[0016], where “The control module may be capable of controlling any parameter of any of the components of the phototherapy device. For example, the control module may control the intensity of the light emitted from the phototherapy device, the temperature of the phototherapy device or of the illuminated object or patient, activation and deactivation of at least a portion of the OLEDs or portions of the OLEDs, the desired spectrum of the emitted light, the length of the treatment, area of illumination, or combinations thereof … The control module may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches a metabolic monitoring unit, configured to adjust the optical power, the delivery of light, the time, the fluence rate and/or irradiance based on at least one metabolic parameter reflecting a metabolic activity of the biological object measured by the metabolic monitoring unit, with the modified invention of Arai in order to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient since the use of sensors may be used by the control module to calculate and to indicate the total exposure of the patient to light from the phototherapy device and ambient light (Hammond ¶[0016]).
Regarding claim 63, Arai in combination with Svanberg and Hammond teaches all limitations of claim 62 as described in the rejection above.
Hammond teaches that the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or the irradiance (¶[0016], where “The control module may be capable of controlling any parameter of any of the components of the phototherapy device. For example, the control module may control the intensity of the light emitted from the phototherapy device, the temperature of the phototherapy device or of the illuminated object or patient, activation and deactivation of at least a portion of the OLEDs or portions of the OLEDs, the desired spectrum of the emitted light, the length of the treatment, area of illumination, or combinations thereof”) influences or modify an amplitude, a frequency of fluctuations and/or a change of the at least one metabolic parameter of the biological object (¶[0016], where “The control module may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors. Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, bilirubin levels in the blood, body temperature, skin temperature, heart rate, oxygen level, carbon monoxide level, carbon dioxide level, bilirubin level, skin color, blood content, bodily fluid content, blood sugar content) as well as other sensors known in the art.” Examiner interprets that since the control module adjusts the therapy based on an input from metabolic sensors, that the metabolic parameters are changing with the treatment.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or the irradiance influences or modify a change of the at least one metabolic parameter of the biological object, with the modified invention of Arai in order to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient since the use of sensors may be used by the control module to calculate and to indicate the total exposure of the patient to light from the phototherapy device and ambient light (Hammond ¶[0016]).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg as applied to claim 54 above, and further in view of Hammond and Rossi et al. (hereinafter “Rossi”) (U.S. Pub. No. 2020/0405858 A1).
Regarding claim 57, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches a Krebs cycle enzymes kinetics measurement means and wherein said processing and/or light control unit is configured to adjust the light dose according to said enzyme activity measured by said Krebs cycle enzymes kinetics measurement means.
Hammond teaches integrated sensors that measure patient parameters (¶[0016], where “Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, bilirubin levels in the blood, body temperature, skin temperature, heart rate, oxygen level, carbon monoxide level, carbon dioxide level, bilirubin level, skin color, blood content, bodily fluid content, blood sugar content) as well as other sensors known in the art”), with a light control unit configured to adjust the light dose based on the measurements (¶[0016], where “The control module may be capable of controlling any parameter of any of the components of the phototherapy device. For example, the control module may control the intensity of the light emitted from the phototherapy device, the temperature of the phototherapy device or of the illuminated object or patient, activation and deactivation of at least a portion of the OLEDs or portions of the OLEDs, the desired spectrum of the emitted light, the length of the treatment, area of illumination, or combinations thereof … The control module may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches integrated sensors that measure patient parameters with a light control unit configured to adjust the light dose based on the measurements, with the modified invention of Arai in order to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient since the use of sensors may be used by the control module to calculate and to indicate the total exposure of the patient to light from the phototherapy device and ambient light (Hammond ¶[0016]).
Although Hammond teaches sensors that measure patient parameters with a light control unit configured to adjust the light dose based on the measurements, none of Arai, Svanberg, nor Hammond teaches a Krebs cycle enzymes kinetics measurement means and wherein said processing and/or light control unit is configured to adjust the light dose according to said enzyme activity measured by said Krebs cycle enzymes kinetics measurement means.
Rossi teaches biophotonic regimens that include application of a biophotonic composition onto the areas to be treated by phototherapy (¶[0061]), and further teaches a Krebs cycle enzymes kinetics measurement means (¶[0014], where “the present disclosure provides for a method for modulating the efficiency of a biophotonic regimen at healing a wounded tissue; the method comprising: … measuring the level of at least one cellular marker associated with energy production in the wounded tissue after commencement of the biophotonic regimen … wherein the at least one cellular marker associated with energy production is selected from ATP, ADP, GTP, GDP, Hsp70, Hsp60, MMPs, leptins, UCPs, ATP synthase, NADH, NAD, FAD, FADH, pyruvate, succinate, fumarate, co-enzyme A, pyruvate dehydrogenase, acetyl-CoA, citrate synthase, citrate, aconitase, isocitrate dehydrogenase, alpha-ketogluterate dehydrogenase, succinyl-CoA, succinyl CoC dehydrogenase, succinate dehydrogenase, fumarase, malate, malate dehydrogenase, oxalo acetate, citric acid, NADH-coenzyme Q oxidoreductase, succinate-Q oxidoreductase, flavoprotein-Q oxidoreductase, Q-cytochrome c oxidoreductase, cytochrome c and cytochrome c oxidase”) and wherein said processing and/or light control unit is configured to adjust the light dose according to said enzyme activity measured by said Krebs cycle enzymes kinetics measurement means (¶[0014], where “wherein when the level of the at least one cellular marker associated with energy production in b) is lower than the level of the at least one cellular marker associated with energy production in a), parameters of the biophotonic regimen are modulated.” Examiner takes the position that since Hammond teaches integrated sensors that determine patient parameters, and since Krebs cycle enzymes are a patient parameter, that the sensors of Hammond can be combined with the measurements in Rossi to determine the amount of Krebs cycle enzymes and modulate therapy based on said measurements.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Rossi, which teaches a Krebs cycle enzymes kinetics measurement means and wherein said processing and/or light control unit is configured to adjust the light dose according to said enzyme activity measured by said Krebs cycle enzymes kinetics measurement means, with the modified invention of Arai in order to modulate the efficiency of a biophotonic regimen at healing a wounded tissue (Rossi ¶[0014]).
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg and Hammond as applied to claim 58 above, and further in view of Dunning et al. (hereinafter “Dunning”) (U.S. Pub. No. 2012/0065709 A1, IDS Reference 2 from IDS dated 07/23/2025).
Regarding claim 61, Arai in combination with Svanberg and Hammond teaches all limitations of claim 58 as described in the rejection above.
None of Arai, Svanberg, nor Hammond teaches that the at least one exogenous stimulus is a gasotransmitter donor.
Dunning teaches methods of using electromagnetic radiation in the visible portion of the spectrum to modulate mitochondrial function in the treatment of various conditions, including Alzheimer's disease, other demential, hypoxia and diabetic peripheral neuropathy, and sensory disorders of the extremities (Abstract), and further teaches that the at least one exogenous stimulus is a gasotransmitter donor (¶[0027], where “the present invention includes a method for increasing mitochondrial nitrite reductase activity, increasing Cytochrome c oxidase activity, increasing nitric oxide production, or increasing tissue blood flow in a tissue of a mammalian subject, comprising: exposing said tissue to electromagnetic radiation in a visible portion of the electromagnetic spectrum from about 375 nm to about 650 nm, or from about 375 nm to about 625 nm,” where nitric oxide is a gasotransmitter donor).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches that the at least one exogenous stimulus is a gasotransmitter donor, with the modified invention of Arai in order to increase nitric oxide production and treat a tissue that is a hypoxic or ischemic tissue, a tissue affected by diabetic peripheral neuropathy, a tissue of the central nervous system, including brain tissue or spinal cord tissue, a tissue affected by hypoxia, ischemia, oxidative stress or neurodegeneration, or a tissue located some distance from the tissue affected by hypoxia, ischemia, oxidative stress or neurodegeneration (Dunning ¶[0027]).
Claims 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg and Hammond as applied to claim 63 above, and further in view of Gardiner et al. (hereinafter “Gardiner”) (U.S. Pub. No. 2003/0035301 A1).
Regarding claim 64, Arai in combination with Svanberg and Hammond teaches all limitations of claim 63 as described in the rejection above.
None of Arai, Svanberg, nor Hammond teaches that the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or irradiance is based on the frequency analysis of the at least one metabolic parameter using frequencies comprised between 0.04 mHz and 1000 mHz or 5 mHz and 500 mHz or 10 mHz and 200 mHz or 50 mHz - 3 Hz or 70 mHz - 2 Hz or 0.1 Hz - 1Hz.
Gardiner teaches illuminators and systems are provided that permit the production of a beam of electromagnetic radiation having selected peak wavelength, bandwidth, intensity, pulse frequency and pulse duration for a variety of analytical and therapeutic applications (Abstract), and further teaches that the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or irradiance (¶[0097], where “During treatment of physiological of pathophysiological conditions, the oscillating interrupter can provide variable pulse width, variable frequency, and can be used to vary the wavelength. The configuration of transparent areas in an interrupter and the rotational speed of the interrupter can be adjusted to provide a wide variety of waveforms”) is based on the frequency analysis of the at least one metabolic parameter (¶[0111], where “A data filter in a commercial application including joint time frequency analysis using Fast Fourier Transform "FFT" as well as other deconvolution methods can permit correlation of spectral and time related data (pulse or chop) and physiological effects of electromagnetic radiation … measurements involve monitoring a radiation signal using the interrupter or electro-optical shutter to expose a part of a subject's body to radiation of a known wavelength, wavelength variation, bandwidth, pulse width, intensity, and pulse frequency,” ¶[0164], where “One purpose of the amplifier assembly is to allow a human subject to have sensors placed on them without the risk of electrical signals from the computer interface from causing harm to the subject.” Examiner interprets that measuring physiological effects equates to metabolic parameters. Additionally, Arai in combination with Svanberg and Hammond teaches the requisite metabolic parameter measurement as well as adjustment of the optical power, the delivery of light, the time, the fluence rate and/or irradiance.) using frequencies comprised between 0.04 mHz and 1000 mHz (¶[0111], where “The system consists of an interrupter, which can be run at a frequency of about 1 Hertz (Hz) to about 1000 Hz. In alternative embodiments, the interrupter can operate at a frequency of between about 1 Hz and about 500 Hz”) or 5 mHz and 500 mHz or 10 mHz and 200 mHz or 50 mHz - 3 Hz or 70 mHz - 2 Hz or 0.1 Hz - 1Hz.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Gardiner, which teaches that the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or irradiance is based on the frequency analysis of the at least one metabolic parameter using frequencies comprised between 0.04 mHz and 1000 mHz, with the modified invention of Arai in order to allow a human subject to have sensors placed on them without the risk of electrical signals from the computer interface from causing harm to the subject (Gardiner ¶[0164]).
Regarding claim 65, Arai in combination with Svanberg, Hammond, and Gardiner teaches all limitations of claim 64 as described in the rejection above.
Hammond teaches that the at least one metabolic parameter is selected from the list comprising: temperature of the biological object (¶[0016], where “Such sensors include, but are not limited to, temperature sensors”), autofluorescence of the biological object, redox ratio, hemoglobin saturation, hemoglobin derivative contents, pH and/or bicarbonate levels (¶[0016], where “Such sensors include, but are not limited to … medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, … blood content … as well as other sensors known in the art”), reactive oxygen species concentration, hydrogen sulfide level, hydrogen selenide level, ion concentration, cytochrome level, vascular tone of the biological object, vasomotion, electrical bioimpedance measurements, marker level, glucose level (¶[0016], where “Such sensors include, but are not limited to, … medical sensors (that measure patient parameters such as … blood sugar content) as well as other sensors known in the art”), succinate level, lactate and lactate dehydrogenase level, thioredoxin level, oxidative stress and/or chloride ions level.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Hammond, which teaches that the at least one metabolic parameter is selected from the list comprising: temperature of the biological object, hemoglobin saturation, hemoglobin derivative contents, pH and/or bicarbonate levels, or glucose level, with the modified invention of Arai in order to limit exposure to light of certain wavelengths such as ultraviolet light to prevent detrimental effects to the patient since the use of sensors may be used by the control module to calculate and to indicate the total exposure of the patient to light from the phototherapy device and ambient light (Hammond ¶[0016]).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg and Hammond as applied to claim 62 above, and further in view of Chariff (U.S. Pub. No. 2016/0136450 A1).
None of Arai, Svenberg, nor Hammond teaches that the processing and/or light control unit is configured to predict the optimal time to start the application of PBM based on the at least one metabolic parameter measured by the metabolic monitoring unit.
Chariff teaches a method of treating diabetes including activating a laser system, wherein the laser system emits a composite laser beam with more than one wavelength (Abstract), which is a form of light therapy, and further teaches that the processing and/or light control unit is configured to predict the optimal time to start the application of PBM based on the at least one metabolic parameter measured by the metabolic monitoring unit (¶[0019], where “the controller 38 may include stored laser treatment regimens. These regimens may be based on specific glucose levels … For example, the detection of high glucose levels may trigger an extensive laser treatment (e.g., longer duration, more intense laser beam, or a combination thereof) by the laser system 8. Similarly, moderate levels of glucose may trigger a less extensive laser treatment (e.g., shorter duration, less intense laser beam, etc.) by the laser system 8. In some embodiments, the regimen may include waiting a predetermined time period before starting the laser treatment again and/or the laser system 8 may wait for another glucose measurement before restarting the laser treatment.” Examiner interprets that by determining a time period to start treatment based on measured glucose levels, that this is an optimal treatment time as the regimens are based on the most effective treatment.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Chariff, which teaches that the processing and/or light control unit is configured to predict the optimal time to start the application of PBM based on the at least one metabolic parameter measured by the metabolic monitoring unit, with the modified invention of Arai in order to establish regimens based on a specific glucose level (Chariff ¶[0019]) and to establish a treatment regimen that will bring the glucose levels to a normal and/or acceptable level (Chariff ¶[0022]).
Claims 67 and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg as applied to claim 54 above, and further in view of Yaroslavsky et al. (hereinafter “Yaroslavsky”) (U.S. Pub. No. 2007/0219604 A1, IDS Reference 1 from IDS Dated 07/23/2025).
Regarding claim 67, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches that the fact that the processing and/or light control unit is configured to generate a combined or sequential light comprising at least one potent wavelength and at least one ineffective wavelength when used alone.
Yaroslavsky teaches devices and methods for utilizing electromagnetic radiation and other forms of energy to treat a volume of tissue at depth (Abstract), and further teaches the processing and/or light control unit is configured to generate a combined or sequential light (¶[0106], where “Using these principles, specific tissue volumes at depth can be targeted and treated ... An entire volume 278 is treated by sequentially treating a series of sub-volumes 280-288 within the tissue”) comprising at least one potent wavelength (¶[0181], where “More preferably, the following wavelengths of LILT can be used: 400 to 430 nm, 480 to 520 nm, 570 to 690 nm, 750 to 780 nm, 800 to 840 nm, 880 to 920 nm, 950 to 1100 nm,” where Examiner interprets that these wavelengths are potent wavelengths since they are specifically selected to treat the tissue.) at least one ineffective wavelength when used alone (¶[0176], where “Different wavelengths can be generated either simultaneously or sequentially.” Examiner interprets that the wavelengths are either combined or sequential in order to effectively treat tissue at depth and that utilizing a single wavelength would be ineffective since the device requires combined or sequential application. ¶[0181], where “More preferably, the following wavelengths of LILT can be used: 400 to 430 nm, 480 to 520 nm, 570 to 690 nm, 750 to 780 nm, 800 to 840 nm, 880 to 920 nm, 950 to 1100 nm,” where Examiner interprets that wavelengths excluded from the preferred ranges are ineffective.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Yaroslavsky, which teaches that the processing and/or light control unit is configured to generate a combined or sequential light comprising at least one potent wavelength and at least one ineffective wavelength when used alone, with the modified invention of Arai in order to treat tissue at depth (Yaroslavsky ¶[0181]).
Regarding claim 69, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches that the light is delivered sequentially to treat simultaneously different depths of the biological object and at different distances from a surface of the biological object.
Yaroslavsky teaches that the light is delivered sequentially to treat simultaneously different depths of the biological object and at different distances from a surface of the biological object (¶[0106], where “Using these principles, specific tissue volumes at depth can be targeted and treated … by first irradiating the tissue at a level that effectively treats the tissue, and varying the flux of that irradiation at a magnitude that corresponds to the depths at which the should joint is found. As another example, referring to FIG. 6, by varying the flux to ensure that the proper dose of EMR is delivered at predetermined depths within the tissue, an entire volume can be treated. An entire volume 278 is treated by sequentially treating a series of sub-volumes 280-288 within the tissue”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Yaroslavsky, which teaches that the light is delivered sequentially to treat simultaneously different depths of the biological object and at different distances from a surface of the biological object, with the modified invention of Arai in order to treat tissue at depth (Yaroslavsky ¶[0181]) and to optimize the depth of treatment (Yaroslavsky ¶[0147]).
Regarding claim 70, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches that the light is modulated in intensity ranging between 0.04 mHz and 1000 mHz or between 5 mHz and 500 mHz or between 10 mHz and 200 mHz.
Yaroslavsky teaches that the light is modulated in intensity ranging between 0.04 mHz and 1000 mHz (¶[0109], where “Preferably, the modulation function is a harmonic function with a frequency between 0.01 and 1 Hz. The modulation function is characterized by the mean incident irradiance I0 and by the modulation depth” where Examiner interprets that the light is modulated in intensity at frequencies within these ranges. Furthermore, mean incident irradiance is light intensity since it is a power per unit area and modulation depth describes the degree of the intensity.) or between 5 mHz and 500 mHz or between 10 mHz and 200 mHz.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Yaroslavsky, which teaches that the light is modulated in intensity ranging between 0.04 mHz and 1000 mHz, with the modified invention of Arai in order to extend the volume of effectively treated tissue (Yaroslavsky ¶[0108]).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg and Yaroslavsky as applied to claim 67 above, and further in view of Streeter (U.S. Pub. No. 2003/0181962 A1).
Regarding claim 68, Arai in combination with Svanberg and Yaroslavsky teaches all limitations of claim 67 as described in the rejection above.
Yaroslavsky teaches that the potent wavelength is 689nm or 808nm (¶[0181], where “More preferably, the following wavelengths of LILT can be used: … 570 to 690 nm, … 800 to 840 nm,” where the wavelengths are within the disclosed ranges.)
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Yaroslavsky, which teaches that the potent wavelength is 689nm or 808nm, with the modified invention of Arai in order to treat tissue at depth (Yaroslavsky ¶[0181]).
Although Yaroslavsky teaches at least one ineffective wavelength, none of Arai, Svanberg, nor Yaroslavsky teaches that the ineffective wavelength is 730nm.
Streeter teaches energy therapy methods for inhibiting cell growth, differentiation, migration and proliferation (Abstract), and further teaches that the ineffective wavelength is 730nm (¶[0022], where “The methods described herein preferably use electromagnetic energy having a wavelength in the visible to near-infrared wavelength range below about 820 nm … the wavelength is about 730 nm”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Streeter, which teaches that the ineffective wavelength is 730nm, with the modified invention of Arai in order to obtain the desired bio-inhibitory effects on cellular growth, differentiation, proliferation or migration (Streeter ¶[0022]).
Claims 89-90 and 92-94 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg as applied to claim 54 above, and further in view of Dunning.
Regarding claim 89, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of myocardial infarction (MI), including acute MI.
Dunning teaches the treatment of myocardial infarction (MI), including acute MI (¶[0112], where “Exemplary conditions or disorders of other parts of the body include cardiovascular disorders (e.g., atherosclerotic and cardiovascular diseases including myocardial infarctions”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches the treatment of myocardial infarction (MI), including acute MI, with the modified invention of Arai in order to treat a subject having a disorder involving impaired mitochondrial function (Dunning ¶[0112]).
Regarding claim 90, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches for the treatment of biological objects subjected to ischemia and/or hypoxia and/or anoxia.
Dunning teaches the treatment of biological objects subjected to ischemia and/or hypoxia and/or anoxia (¶[0019], where “the invention provides methods for treating diseases or conditions which may be exacerbated or caused by hypoxia or oxidative stress”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches the treatment of biological objects subjected to hypoxia, with the modified invention of Arai in order to treat exacerbated conditions (Dunning ¶[0019]).
Regarding claim 92, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of desynchronized metabolic activities.
Dunning teaches the treatment of desynchronized metabolic activities (¶[0112], where “This method of the present invention is particularly useful for the treatment or prophylaxis of disorders associated with impaired mitochondrial function ... Such conditions or diseases of the nervous system include not only Alzheimer's Disease, Parkinson's Disease, Huntington's Disease, but also spinocerebellar ataxias, and psychoses (including depression or schizophrenia) associated with oxidative metabolic abnormalities”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches the treatment of desynchronized metabolic activities, with the modified invention of Arai in order to treat a subject having a disorder involving impaired mitochondrial function (Dunning ¶[0112]).
Regarding claim 93, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of desynchronized insulin secretion.
Dunning teaches the treatment of desynchronized insulin secretion (¶[0018], where “In some aspects, the invention provides methods of improved control of hyperglycemia or blood glucose levels in diabetes patients by exposing the subject to electromagnetic radiation”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches the treatment of desynchronized insulin secretion, with the modified invention of Arai in order to improve control of hyperglycemia or blood glucose levels in diabetes patients (Dunning ¶[0018]).
Regarding claim 94, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of hypertension.
Dunning teaches the treatment of hypertension (¶[0028], where “the present invention includes a method for treating or preventing reduced blood flow, hypoxia, ischemia, oxidative stress, or neurodegeneration, or for increasing cerebral blood flow, in a mammalian subject … the mammalian subject has a disease or disorder selected from the group consisting of: … cardiovascular diseases, including atherosclerosis and hypertension”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dunning, which teaches the treatment of hypertension, with the modified invention of Arai in order to treat or prevent reduced blood flow (Dunning ¶[0028]).
Claims 91 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Svanberg as applied to claim 54 above, and further in view of Ingber at al. (hereinafter “Ingber”) (U.S. Pub. No. 2016/0008421 A1).
Regarding claim 91, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of acute respiratory distress syndrome (ARDS).
Ingber teaches methods of modulating vascular permeability by changing the mechanical properties of extracellular matrices (ECM) and methods of treatment of diseases, conditions and symptoms related to vascular permeability such as pulmonary edema and acute respiratory distress syndrome (ARDS) (Abstract), where light therapy is used (¶[0085], where “In various embodiments of the methods described herein, administering the light energy is via an endoscope or a catheter. In various embodiments, administering the light energy is via transdermal delivery”), and further teaches the treatment of acute respiratory distress syndrome (ARDS) (¶[0071], where “altering vascular permeability can treat a pulmonary disease or condition selected from the group consisting of … acute respiratory distress syndrome (ARDS)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Ingber, which teaches the treatment of acute respiratory distress syndrome (ARDS), with the modified invention of Arai in order to alter vascular permeability to treat a pulmonary disease or condition (Ingber ¶[0071]).
Regarding claim 95, Arai in combination with Svanberg teaches all limitations of claim 54 as described in the rejection above.
Neither Arai nor Svanberg teaches the treatment of pulmonary hypertension.
Ingber teaches the treatment of pulmonary hypertension (¶[0071], where “In various embodiments of the methods described herein, altering vascular permeability can treat a pulmonary disease or condition selected from the group consisting of … pulmonary vascular hypertension”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Ingber, which teaches the treatment of pulmonary hypertension, with the modified invention of Arai in order to alter vascular permeability to treat a pulmonary disease or condition (Ingber ¶[0071]).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792