DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 12/10/2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification para.[0017-0029].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-7, 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US 11,077,314 B1 (U.S. Patent Application No. 17/141363). Although the claims 1, 3-7, 9-14 at issue are not identical, they are not patentably distinct from each other because the patented claims drawn to species and thus, anticipate the more generic or broader claims now pending (instant Claims 1, 3-7, 9-14 ). That is, the rationale of In re Goodman applies here in that once Applicant has received a patent for a species or a more specific embodiment, Applicant is not entitled to a patent for the generic or broader invention without maintaining common ownership and ensuring that the term of the latter issued patent will expire at the end of the original term of the earlier issued patent.
Claims 1, 3-7, 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 10,744,337 B2 (U.S. Patent Application No. 16/325825) in view of view of Johnson et al. (Pub. No.: WO 2018191640 A1, hereinafter referred to as "Johnson"). More specifically, claim 1 recites essentially the same method as claim 1 of US 10,744,337 B2 (i.e. not patentably distinct from each other) except for the following feature: applying a photoceutical to treat detraining related muscle effect/symptoms features i.e. method for decreasing effects of lack of muscle use during a detraining period due to lack of physical activity; contacting photoceutical medical device to a spot on skin of a patient over at least a portion a target muscle during the detraining period, wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization; applying a photoceutical through the photoceutical medical device to the muscle to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period which is taught by reference Johnson in an analogous combinatorial photoceutical magnet therapy field of endeavor (see at least Johnson in at least fig. 1-4, 10-13, [0026-0027], [0032], [0044], [0067]. Also see claim 1 mapping of this limitation below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify claim 1 of US 10,744,337 B2 by extending photobiomodulation therapy to prevent atrophy of the muscle during the detraining period, as also disclosed by Johnson. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending therapeutics benefits to treat other muscular atrophy/detrained issues such as muscle atrophy (Johnson, [0027], [0041], [0044], [0080]). For similar reasons, examined dependent claims 2-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims 2-13 of US 10,744,337 B2 in view of Johnson as a whole.
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 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7, 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over as being unpatentable over Johnson as evidenced by Pandey et al. (Pandey SN, Kesari A, Yokota T, Pandey GS. Muscular Dystrophy: Disease Mechanisms and Therapies. Biomed Res Int. 2015;2015:456348, hereinafter referred to as “Pandey”).
As per independent Claim 1, Johnson discloses a method (Johnson in at least abstract, fig. 1-4, 10-13, [0002], [0004-0006], [0026-0032], [0037-0038], [0040-0042], [0044-0053], [0055-0056], [0067], [0080] for example discloses relevant subject-matter. More specifically, Johnson in at least fig. 3-4, fig.12, abstract, [0004-0006], [0026-0030], [0040], [0044] for example discloses a PBMT method. See Johnson [0027] “"photobiomodulation therapy (PBMT)" refers to a drug- free, non-invasive treatment procedure, in which a light signal is applied to a certain region of a subject's body to treat a certain medical condition (e.g., pain, injury, disorder, disease, or the like) via a phototherapeutic response”; [0038] “systems and methods that apply PBMT”; [0044] “system 10 can include at least a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group and a controller 12 to deliver inputs to the light source device 11 related to the delivery of the PBMT via a wired connection and/or a wireless connection”), the method comprising:
contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a target muscle (Johnson in at least fig. 12, [0005], [0032], [0044], [0067] for example discloses contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a target muscle. See at least [0005] “a method for applying PBMT to a patient diagnosed with FM to treat FM. A light source device can be contacted to a subject’s skin”; [0044] “ light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group”; [00067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal”); and
applying a photoceutical through the photoceutical medical device to the muscle from a start time to an end time to deliver therapy (Johnson in at least fig. 1-2, 10-13 [0005], [0032], [0044], [0067] discloses applying a photoceutical through the photoceutical medical device (fig. 1, 10-11, 13) to the muscle from a start time to an end time such as 300 second to deliver therapy. See at least Johnson [0005] “light signal can be applied in at least one of a pulsed operating mode, a continuous operating mode, and a super-pulsed operating mode through the light source device … light signal is applied for a time sufficient to stimulate a phototherapeutic response”; [0044] “system 10 can include at least a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group and a controller 12 to deliver inputs to the light source device 11 related to the delivery of the PBMT via a wired connection and/or a wireless connection”; [0067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal…was irradiated for 300 s”),
wherein the photoceutical comprises at least one of a pulsed light signal, a continuous light signal, and a super-pulsed light signal(Johnson in at least [0005-0006], fig. 2, [0051-0052], [0067], table 1 on pages 19-20 for example discloses the photoceutical comprises at least one of a pulsed light signal, a continuous light signal, and a super-pulsed light signal. See at least Johnson [0005] “A light signal can be applied in at least one of a pulsed operating mode, a continuous operating mode, and a super-pulsed operating mode through the light source device”).
Johnson does not necessarily require applying a photoceutical to treat detraining related muscle effect/symptoms features in the applied embodiment i.e. method for decreasing effects of lack of muscle use during a detraining period due to lack of physical activity; contacting photoceutical medical device to a spot on skin of a patient over at least a portion a target muscle during the detraining period, wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization; applying a photoceutical through the photoceutical medical device to the muscle to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period.
However, Johnson discloses alternate embodiments that disclose photoceutical method comprising a method for decreasing effects of lack of muscle use during a detraining period due to lack of physical activity (Here, the term “detraining” is being interpreted in light of instant application specification as-file para. [0022] as “general periods of inactivity (e.g., a period of lack of activity due to illness, injury… or the like)… For example, an individual who discontinues physical activities due to illness, injury or other factors may lose physical conditioning due to detraining”. Further, Johnson in at least [0067] discloses contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle which in the case of a patient with dystrophic muscle or muscle group as in [0044] would be for decreasing effects of lack of muscle use due to dystrophy of the muscle and during a detraining period due to lack of physical activity due to dystrophy of the muscle. As evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state of lack of muscle use due to lack of physical activity including during a detraining period as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient. ), the method comprising:
contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle during the detraining period, wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization (Here, the term “detraining” is being interpreted in light of instant application specification as-file para. [0022] as “general periods of inactivity (e.g., a period of lack of activity due to illness, injury… or the like)… For example, an individual who discontinues physical activities due to illness, injury or other factors may lose physical conditioning due to detraining”. Further, Johnson in at least [0067] discloses contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle which in the case of a patient with dystrophic muscle or muscle group as in [0044] would be during the detraining period, wherein the lack of physical activity is caused by a dystrophy disease. As evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization including during the detraining period, as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient); and
applying a photoceutical through the photoceutical medical device to the muscle from a start time to an end time to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period (Johnson in at least fig. 1-4, 10-13, [0026-0027], [0032], [0044], [0067] for example discloses applying a photoceutical through the photoceutical medical device (fig. 1-2, 10-13) to the muscle ([0044] “dystrophic muscle or muscle group”) from a start time to an end time such as 300s which in the case of a patient with dystrophic muscle or muscle group as in [0044] would encompass the recited result i.e. to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period at least in the initial stages of the dystrophic muscle or muscle group disease in patient ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photobiomodulation therapy method as taught by Johnson, by extending photobiomodulation therapy to decrease effects of lack of muscle use during a detraining period due to lack of physical activity as would occur in patients suffering from dystrophic muscle or muscle group , as also disclosed by Johnson. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending therapeutics benefits to treat other muscular atrophy/detrained issues such as muscle atrophy (Johnson, [0027], [0041], [0044], [0080]).
As per dependent Claim 3, Johnson as evidenced by Pandey as a whole further discloses method wherein the photoceutical further comprises a magnetic field (Johnson [0005] discloses photoceutical further comprises a magnetic field. See at least Johnson [0005] “light source device can be configured to contact …the subject's body and includes a cluster of light delivery sources, a permanent magnet… permanent magnet can provide a constant magnetic field from 5 mT to 1 T.”).
As per dependent Claim 4, Johnson as evidenced by Pandey as a whole further discloses method wherein the start time and end time lead to an exposure time from 30 seconds to 1 hour (Johnson in at least [0005],[0044], [0067] for example discloses the start time and end time lead to an exposure time 300 second which falls within recited range from 30 seconds to 1 hour. See at least Johnson [0005] “light signal is applied for a time sufficient to stimulate a phototherapeutic response”; [0067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal…was irradiated for 300 s”).
As per dependent Claim 5, Johnson as evidenced by Pandey as a whole further discloses method further comprising: moving the photoceutical medical device to another spot on the skin of the patient over at least another portion of the muscle or at least a portion of another muscle (Johnson in fig. 3, [0032], [0044], [0053-0056], [0067] for example discloses moving the photoceutical medical device to another spot on the skin of the patient over at least another portion of the muscle or at least a portion of another muscle. See at least Johnson [0055-0056] “a light source device (e.g. light source device 11) can be contacted to a subject's skin… light signal is applied for a time sufficient to stimulate a phototherapeutic response”; [0044] “delivers the PBMT to the dystrophic muscle or muscle group”); and
applying the photoceutical through the photoceutical medical device to the other portion of the muscle or the portion of the other muscle from another start time to another end time (Johnson fig. 4, [0032], [0044], [0053], [0057], [0067] for example discloses applying the photoceutical through the photoceutical medical device to the other portion of the muscle or the portion of the other muscle from another start time to another end time. See at least Johnson [0057] “method 30 continues in FIG. 4, which shows a method 40 that occurs after moving the light source device. At step 42, the light source (e.g. light source device 11) can be moved to another area of the subject's skin proximal to another tender area. At step 44, a light signal can be applied to the other tender area. At step 46, a phototherapeutic response can be stimulated in the other tender area.”; [0044] “delivers the PBMT to the dystrophic muscle or muscle group”).
As per dependent Claim 6, Johnson as evidenced by Pandey as a whole further discloses method wherein the photoceutical further comprises a static magnetic field from 5 milli Tesla (mT) to 1 Tesla (T) (Johnson in [0006] “permanent magnet can provide a constant magnetic field from 5 mT to 1 T.”).
As per dependent Claim 7, Johnson as evidenced by Pandey as a whole further discloses method of claim 1, wherein the photoceutical medical device comprises: at least one super pulsed laser to provide the super-pulsed light signal at a first wavelength (Johnson in at least table 1 on pages 19-20, [0030], [0042], [0051-0052] for example discloses at least one super pulsed laser to provide the super-pulsed light signal LS1 15. See at least Johnson [0042] “one or more super pulsed lasers”; [0051] “ LSI 15 can be configured to generate a first portion of the light signal with a wavelength from 890-910 nm (infrared); …LSI 15, which is in the middle of each light delivery source cluster 13, can operate in the super- pulsed operating mode”); and
at least two non-coherent light sources to provide the pulsed light signal at a second wavelength or a third wavelength, and/or the continuous light signal at the second wavelength or the third wavelength (Johnson in at least [0005-0006], table 1 on pages 19-20, [0028], [0030], [0042], [0051-0052] for example discloses at least two non-coherent light sources LS2, LS3 to provide the pulsed light signal and/or the continuous light signal. see at least Johnson [0042] “one or more infrared emitting diodes, and one or more light emitting diodes”; [0051] LSI 15 can be configured to generate … LS2 16 can be configured to generate a second portion of the light signal with a wavelength from 600-700 nm (red); and LS3 17 can be configured to generate a third portion of the light signal with a wavelength from 810-880 nm… LS2 16 and LS3 17, which surround LSI, can each operate in the continuous operating mode or the pulsed operating mode” ).
As per dependent Claim 9, Johnson as evidenced by Pandey as a whole further discloses method wherein the photoceutical comprises super-pulsed light of a first wavelength from at least one super-pulsed light source, pulsed and/or continuous light of a second wavelength from at least two non-coherent light sources, and pulsed and/or continuous light of a third wavelength from at least two other non-coherent light sources (Johnson in [0005-0006], table 1 on pages 19-20, [0030], [0042], [0051-0052] for example discloses photoceutical comprises super-pulsed light of a first wavelength from at least one super-pulsed light source, pulsed and/or continuous light of a second wavelength from at least two non-coherent light sources, and pulsed and/or continuous light of the third wavelength from at least two other non-coherent light sources. See at least Johnson [0042] “the light signal can be configured so that individual light waves (from chosen light sources, with a selected wavelength, with a given power, and the like) within the light signal work constructively to create a synergistic effect. The light signal can be delivered by a light source device that includes a combination of one or more super pulsed lasers … one or more infrared emitting diodes, and one or more light emitting diodes”; [0051] LSI 15 can be configured to generate … LS2 16 can be configured to generate a second portion of the light signal with a wavelength from 600-700 nm (red); and LS3 17 can be configured to generate a third portion of the light signal with a wavelength from 810-880 nm… LS2 16 and LS3 17, which surround LSI, can each operate in the continuous operating mode or the pulsed operating mode”).
As per dependent Claim 10, Johnson as evidenced by Pandey as a whole further discloses method wherein the first wavelength is between 850 nm and 950 nm, the second wavelength is between 800 nm and 900 nanometers (nm), and the third wavelength is between 580 nm and 800 nm (Johnson in table 1 on pages 19-20, [0006] for example discloses the first wavelength is between 850 nm and 950 nm, the second wavelength is between 800 nm and 900 nm, and the third wavelength is between 580 nm and 800 nm. See at least [0006] “cluster of light delivery sources can include: a first light source configured to generate a first portion of a light signal with a wavelength from 890-910 nm in a super-pulsed operating mode; a second light source configured to generate a second portion of the light signal with a wavelength from 600-700 nm in a pulsed operating mode or a continuous operating mode; and a third light source configured to generate a third portion of the light signal with a wavelength from 810-880 in the pulsed operating mode or the continuous operating mode”).
As per dependent Claim 11, Johnson as evidenced by Pandey as a whole further discloses method wherein the photoceutical medical device comprises: at least four super-pulsed lasers, each configured to provide the super-pulsed light of the first wavelength; at least eight pulsed and/or continuous light sources, each configured to provide the light of the second wavelength; at least eight other pulsed and/or continuous light sources, each configured to provide the light of the third wavelength (Johnson in at least [0030], [0042], [0052] for example discloses at least one super-pulsed lasers, each configured to provide the super-pulsed light of the first wavelength; at least eight pulsed and/or continuous light sources, each configured to provide the light of the second wavelength; at least one other pulsed and/or continuous light sources, each configured to provide the light of the third wavelength which reads on subject-matter as now explicitly, positively and specifically recited as prior art “one or more” would encompass “at least four” and “at least eight” of respective light source types as recited. See at least Johnson [0042] “light signal can be delivered by a light source device that includes a combination of one or more super pulsed lasers (which deliver a desired peak power from an ultrashort pulse with a minimized level of heat accumulated in the patient's tissue), one or more infrared emitting diodes, and one or more light emitting diodes.”; [0052] “Many configurations of each light delivery source cluster 13 are possible. Two examples of possible configurations are set forth, but countless other possibilities exist (including with other light sources), as long as there are one or more LI, one or more L2, one or more L3”); and
at least eight magnetic sources to provide a magnetic signal (Johnson’s disclosure in at least table 1 on pages 19-20, [0006], [0042], [0047], [0080] for example of a magnetic source to provide a magnetic signal makes subject-matter as now explicitly, positively and specifically recited by the Applicants obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to derive as a matter of making separable what is disclosed as integral in prior art (MPEP 2144.04) and/or as a matter of mere duplication of prior art disclosed integral element (see MPEP 2144.04) in order to obtain a substantially functionally equivalent and predictable result of delivering therapeutically effective PBMT to the patient’s targeted body part such as dystrophic muscle or muscle group (Johnson, [0027], [0044], [0080]) . See at least Johnson [0042] “light source device can include a permanent magnet to provide a static (or constant) magnetic field”).
As per dependent Claim 12, Johnson as evidenced by Pandey as a whole further discloses method wherein the muscle is any soft tissue within the patient's body that contracts to change a length and/or a shape of the soft tissue (Johnson in at least [0006], [0032], [0044], [0067] for example discloses the muscle is any soft tissue within the patient's body that contracts to change a length and/or a shape of the soft tissue. See at least Johnson [0006] “light source device can be configured to contact a subject's skin proximal to a tender area on the subject's body ”; [0044] “system 10 can include at least a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group”; [0067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal”).
As per dependent Claim 13, Johnson as evidenced by Pandey as a whole further discloses method wherein the muscle is skeletal muscle (Johnson in at least [0032], [0044], [0067] for example discloses muscle is skeletal muscle. See at least Johnson [0044] “system 10 can include at least a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group”; [0067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal”).
As per dependent Claim 14, Johnson as evidenced by Pandey as a whole further discloses method further comprising: selecting the spot on skin of a patient over at least a portion a muscle (Johnson in fig. 3, [0032], [0044], [0053-0056], [0067] for example discloses selecting the spot on skin of a patient (fig. 3) which could be a muscle as disclosed in [0032], [0044] and [0067]. See at least Johnson [0055-0056] “a light source device (e.g. light source device 11) can be contacted to a subject's skin… light signal is applied for a time sufficient to stimulate a phototherapeutic response”; [0044] “delivers the PBMT to the dystrophic muscle or muscle group”; [0067] “multiple light sources (LLLT and LED) Pain Away/PainCure™ nine-diode cluster device (Multi Radiance Medical®, Solon, OH, USA) was applied to…trapezius, supraspinatus…gluteal…was irradiated for 300 s”); and selecting another spot on the skin of the patient over at least a portion of another muscle or at least another portion of the muscle(Johnson fig. 4, [0032], [0044], [0053], [0057], [0067] for example discloses selecting another spot on the skin of the patient (fig. 4) which could be over at least a portion of another muscle or at least another portion of the muscle as disclosed in [0032], [0044] and [0067]).
Response to Amendment
According to the Amendment, filed 12/10/2025, the status of the claims is as follows:
Claims 1, 4, 5, 7, 9, 10 are currently amended;
Claims 3, 5, 11-14 are as originally filed; and
Claims 2, 8,15-20 are cancelled.
The Specification/Drawings has been amended in view of the Amendment, filed 12/10/2025. No new matter was introduced.
By the current amendment, as a result, claims 1, 3-7, 9-14 are now pending in this application and are being examined on the merits.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Pages 7-8 of Applicant’s Amendment dated 12/10/2025
The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 09/10/2025: [1] The objection to Specification/Drawings is withdrawn in view of the amendment and arguments, filed 12/10/2025; [2] The objection to claims is withdrawn in view of the amendment and arguments, filed 12/10/2025; [3] The 35 U.S.C. 112(b), rejections to claims as raised in Office Action dated 09/10/2025 are withdrawn in view of the amendment, filed 12/10/2025.
Non-statutory Double Patenting Issues Raised and Arguments/Remarks to Rejections Based on Non-statutory Double Patenting presented on Pages 8 of Applicant’s Amendment dated 12/10/2025 where Applicant’s’ remarks inter alia that:
Non-statutory Double Patenting[i] Claims 1-20 stand rejected for non-statutory double patenting as follows.
[ii] Claims 1-14 over claims 1-14 of US 11,977,314.
[iii] Claims 1-20 over claims 1-19 of US 10,744,337 in view of Johnson (WO 2018191640).
[iv] Claims 15-20 over claims 1-7 of US 11,590,355 in view of Johnson.
[v] Claims 1-20 preliminarily over claims of co-pending 17/977,413
[vi]Applicant, through its undersigned representative, respectfully requests that the non-statutory double patenting rejections be held in abeyance until an indication of allowable subject matter has been made.
Applicant’s request [i-vi] above for abeyance of non-statutory obviousness-type double patenting is acknowledged. However, in the interest of clarity and thoroughness of the prosecution record, examined claims rejection on the ground of non-statutory double patenting as being unpatentable over claims of above patents and co-pending applications is being reiterated.
Additionally, with respect to Applicant’s arguments [ii] above, Examiner notes the non-statutory double patenting rejection of claims 1-20 is with respect to claims of US 11,077,314 and not US 11,977,314 as asserted above.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 8-10 of Applicant’s Amendment dated 12/10/2025 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of the Amended Independent Claim 1[A] Claims 1-20 stand rejected under 35 U.S.C. § 103 over Johnson. Claims 2, 8, and 15-20 have been cancelled herein, rendering this rejection moot as to claims 2, 8, and 15-20. Claim 1 has been amended as follows:
1. (Currently Amended) A method for decreasing effects of lack of muscle use during a detraining period due to lack of physical activity, the method comprising:
contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle during the detraining period, wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization; and
applying a photoceutical through the photoceutical medical device to the muscle from a start time to an end time to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period,
wherein the photoceutical comprises at least one of a pulsed light signal, a continuous light signal, and a super-pulsed light signal. (emphasis added)
[B] Johnson does not teach or suggest decreasing negative effects due to the lack of muscle use during the detraining period. Instead, Johnson is related to applying PBMT to a tender area on a patient's body to treat fibromyalgia by reducing symptoms of fibromyalgia (see [0003]). Treating fibromyalgia is completely different from treating a person experiencing detraining as recited in claim 1.
[C] The intent of claim 1 is to address detraining-related degradation of muscle structure and function (recited in claim 1 as, applying a photoceutical through the photoceutical medical device to the muscle ... to decrease negative effects due to lack of muscle use during a detraining period. Notably, the detraining period results in a lack of physical activity. The detraining period of claim 1 is fundamentally distinct from the clinical condition of fibromyalgia. Additionally, the PBMT of claim 1 specifically targets mechanisms unique to detraining, including changes in muscle morphology, performance, fatigue resistance, and metabolic function, which are not shared with the pathophysiology of fibromyalgia.
[D] Detraining refers to the measurable decline in muscular performance, morphology, and metabolic capacity that occurs following inactivity, immobilization, injury, disease states, or age-related deconditioning (recited in claim 1 as lack of physical activity of detraining that is caused by an injury, a disease, or a period of hospitalization). These mechanisms include reductions in muscle fiber cross-sectional area. mitochondrial density, neuromuscular efficiency, and oxidative capacity.
[E] The pathological drivers of detraining are peripheral and structural, reflecting disuse or impaired loading. Fibromyalgia, by contrast, is not a consequence of insufficient loading, inactivity, or muscle disuse, nor is it associated with measurable muscular atrophy, impaired oxidative capacity, or other hallmark features of detraining physiology. The primary pathology of fibromyalgia is central sensitization, not muscle degradation like that of detraining. Although tender points may be located near or within areas of soft tissue, the presence of tender points does not indicate muscle deterioration or a detraining state. Thus, the treatment of fibromyalgia pain cannot be considered equivalent to the preservation, restoration, or mitigation of muscular detraining as recited in claim 1.
[F] Moreover, the PBMT described by Johnson can be used with alternative therapies like exercise (see [0004] and FIGS. 5-9) to achieve a more favorable treatment outcome (see [0027]), while the patient of claim 1 is entirely unable to exercise
[G] Johnson cannot be used to render claim 1 obvious to one having ordinary skill in the art. Accordingly, it is respectfully requested that this rejection be withdrawn.
Applicant’s arguments [A-G] above with respect to the above claim limitation in Claim 1 have been considered but are not persuasive for the following reasons:
With respect Applicant’s arguments [A] above, Johnson does not necessarily require applying a photoceutical to treat detraining related muscle effect/symptoms features in the applied embodiment. However, Johnson discloses alternate embodiments that disclose photoceutical method comprising a method for decreasing effects of lack of muscle use during a detraining period due to lack of physical activity (Here, the term “detraining” is being interpreted in light of instant application specification as-file para. [0022] as “general periods of inactivity (e.g., a period of lack of activity due to illness, injury… or the like)… For example, an individual who discontinues physical activities due to illness, injury or other factors may lose physical conditioning due to detraining”. Further, Johnson in at least [0067] discloses contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle which in the case of a patient with dystrophic muscle or muscle group as in [0044] would be for decreasing effects of lack of muscle use due to dystrophy of the muscle and during a detraining period due to lack of physical activity due to dystrophy of the muscle. As evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state of lack of muscle use due to lack of physical activity including during a detraining period as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient. ), the method comprising: contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle during the detraining period, wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization (Here, the term “detraining” is being interpreted in light of instant application specification as-file para. [0022] as “general periods of inactivity (e.g., a period of lack of activity due to illness, injury… or the like)… For example, an individual who discontinues physical activities due to illness, injury or other factors may lose physical conditioning due to detraining”. Further, Johnson in at least [0067] discloses contacting a photoceutical medical device to a spot on skin of a patient over at least a portion a muscle which in the case of a patient with dystrophic muscle or muscle group as in [0044] would be during the detraining period, wherein the lack of physical activity is caused by a dystrophy disease. As evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization including during the detraining period, as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient); and
applying a photoceutical through the photoceutical medical device to the muscle from a start time to an end time to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period (Johnson in at least fig. 1-4, 10-13, [0026-0027], [0032], [0044], [0067] for example discloses applying a photoceutical through the photoceutical medical device (fig. 1-2, 10-13) to the muscle ([0044] “dystrophic muscle or muscle group”) from a start time to an end time such as 300s which in the case of a patient with dystrophic muscle or muscle group as in [0044] would encompass the recited result i.e. to decrease negative effects due to the lack of muscle use during the detraining period, wherein the effects due to the lack of muscle use comprise loss of strength of the muscle gained from the previous physical activity and/or prevent atrophy of the muscle during the detraining period at least in the initial stages of the dystrophic muscle or muscle group disease in patient ). Thus, applied art as a whole discloses all claim 1 limitations as now explicitly, positively and specifically recited by the Applicant when broadly yet reasonably interpreted in light of instant application specification as-filed including disclosure in the provisional application of the instant application.
With respect to Applicant’s arguments [B] above, referencing para. [0003], the reference here is unclear as [0003] is in background section of Johnson and more relevantly, the Office Action dated 09/10/2025 does not cite Johnson [0003] in rejection of claim 1 in Office Action dated 09/10/2025. Examiner also directs Applicant’s attention to Johnson [0027], [0038] and [0044] which were actually cited which are relevant to claimed limitations. Specifically [0027] "photobiomodulation therapy (PBMT)" refers to a drug- free, non-invasive treatment procedure, in which a light signal is applied to a certain region of a subject's body to treat a certain medical condition (e.g., pain, injury, disorder, disease, or the like) via a phototherapeutic response” (emphasis added); [0038] “systems and methods that apply PBMT”; [0044] “system 10 can include at least a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group and a controller 12 to deliver inputs to the light source device 11 related to the delivery of the PBMT via a wired connection and/or a wireless connection” (emphasis added). So, contrary to Applicant’s assertions Johnson discloses embodiments that extend photoceutical application to treat dystrophic muscle or muscle group and additionally to pain, injury, disorder, disease, or the like and not just fibromyalgia referenced in [0003] of Johnson by Applicants. As evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state of lack of muscle use due to lack of physical activity including during a detraining period as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient.
In response to applicant's argument [C-D] above asserting that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “detraining-related degradation of muscle structure and function”, “mechanisms unique to detraining, including changes in muscle morphology, performance, fatigue resistance, and metabolic function”, “measurable decline in muscular performance, morphology, and metabolic capacity that occurs following inactivity, immobilization, injury, disease states, or age-related deconditioning”, “mechanisms include reductions in muscle fiber cross-sectional area. mitochondrial density, neuromuscular efficiency, and oxidative capacity”) are not recited in the rejected claim(s). Examiner notes the Applicant recites very broad claim limitations while arguing narrower or even non-existent subject-matter in the specification as-filed. Please note that, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner suggest amending claim 1 to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
With respect to Applicant’s arguments [D] above, Examiner notes that Applicants explicitly and specifically define “detraining” in [0022] of specification as-files as “the partial or complete loss of training-induced adaptations (e.g., physical conditioning) due to a training stimulus that is insufficient or removed entirely. While typically used to refer to a period when exercise is stopped (e.g., a period of lack of training for a marathon because of a minor injury), detraining can also refer to general periods of inactivity (e.g., a period of lack of activity due to illness, injury, hospitalization, ventilation, or the like). For example, an individual who discontinues physical activities due to illness, injury or other factors may lose physical conditioning due to detraining.” (emphasis added) while offering an extrinsic definition of “detraining” in [D] as “the measurable decline in muscular performance, morphology, and metabolic capacity that occurs following inactivity, immobilization, injury, disease states, or age-related deconditioning… These mechanisms include reductions in muscle fiber cross-sectional area. mitochondrial density, neuromuscular efficiency, and oxidative capacity” with no measurable metrics or any of the above assertions and subject-matter in [D] being recited in claims. Examiner notes that “detraining” as explicitly and specifically defined in instant application specification as-filed [0022], encompasses prior art, Johnson’s embodiments disclosed in at least [0044] of “a light source device 11 that delivers the PBMT to the dystrophic muscle or muscle group …PBMT can be applied to the tender area by a light signal that is generated by a light source device 11. To facilitate the delivery of the light signal to the tender area, the light source device 11 can be shaped so that at least a portion makes contact with the subject's skin proximal to the tender area”. Additionally, as evidenced in Pandey page 1 col. 1, patient with dystrophic muscle or muscle group would suffer from progressive weakness, degeneration of skeletal muscles, skeletal muscle inactivity, muscle wasting due to which it is reasonable to expect a patient suffering from patient with dystrophic muscle or muscle group to be in a state wherein the lack of physical activity is caused by an injury, a disease, or a period of hospitalization including during the detraining period, as recited at least in the initial stages of the dystrophic muscle or muscle group disease in patient.
With respect to Applicant’s arguments [E] above, Examiner notes that prior art Johnson makes obvious all the limitations as now explicitly, positively and specifically recited by the Applicants when broadly yet reasonably interpreted in light of the instant application specification as-filed.
Examiner suggest amending claim 1 to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
Additionally, Applicant’s admit and disclose as well-known prior art, subject-matter of claim 1 in provisional application of the instant application by stating the following:
“However, it is common practitioners interrupt their physical training programs due to illness, injury, or other factors that may interfere in the capacity for physical activity, causing a loss of gains obtained during the training period (Lovell et al.2012; Stebbings et al. 2013)”
“Studies have also shown that PBMT can boost the gain in different training protocols, such as strength training (Baroni et al. 2015). This effect is attributed to PBMT modulating mitochondrial activity through interaction with cytochrome c oxidase (CCO), increasing the adenosine triphosphate (ATP) production, which in turn, accelerates cell metabolism (Hayworth et al. 2010; Albuquerque-Pontes et al. 2015).”
“some biological processes can also be modulated by the use of static magnetic fields (sMF) (World Health Organization, 2006; Okano et al. 2008). This interaction between sMF and different biological tissues can lead to increased ATP intracellular levels
(Okano et al. 2008; Coballase-Urrutia et al. 2018; Wang et al. 2018)… In fact, it has been demonstrated that the use of PBMT associated with sMF, generates greater transfer of electrons, activating the mitochondrial respiratory chains and increasing ATP production (Friedmann et al. 2009).”
“In clinical scenario, studies already demonstrated that association of PBMT and sMF promotes ergogenic effects (Miranda et al. 2018; Pinto et al. 2016; De Marchi et al. 2019). Moreover, Vanin et al. (2016) verified that PBMT/sMF enhances performance of individuals during a period of 12 weeks of strength training, increasing the maximum voluntary contraction (MVC), as well as in the one-repetition maximum (1RM) test with the leg press and leg extension exercises”
“A study conducted by Nakano et al. (2009) showed that PBMT minimized disuse atrophy in rats, and they attributed these beneficial effects to satellite cell proliferation and angiogenesis.
Authors also observed satellite cell activation in irradiated animals, which may be related to increase of myoblast proliferation presented (Nakano et al. 2009)… PBMT may delay the muscle strength loss during the detraining period after a strength-training program. Since a positive interaction between PBMT and sMF was previously demonstrated in pre-clinical (Friedmann et al. 2009) and clinical settings (Vanin et al. 2016; Pinto et al. 2016;
Miranda et al. 2018; De Marchi et al. 2019),”
In response to applicant's argument that [E-F] above, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
With respect to Applicant’s arguments [F] above, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “patient of claim 1 is entirely unable to exercise”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner notes that a broad yet reasonable interpretation of claim 1 as now explicitly, positively and specifically, recited the Applicants in light of instant application specification as-filed does not encompass and necessitate the extremely narrow interpretation being argued by the Applicants i.e. “patient of claim 1 is entirely unable to exercise”. Examiner suggest amending claim 1 to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
With respect to Applicant’s arguments [G] above, for the above reasons, since the 35 U.S.C. § 103 rejection of claim 1 still applies, the 35 U.S.C. § 103 rejection of claim 1 is still being maintained at this time. Please also cross-reference detailed claim 1 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above. Examiner suggest amending claim 1 to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 8-10 of Applicant’s Amendment dated 12/10/2025 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of Dependent Claims 3-7, 9-14.
[a] Claims 1-20 stand rejected under 35 U.S.C. § 103 over Johnson. Claims 2, 8, and 15-20 have been cancelled herein, rendering this rejection moot as to claims 2, 8, and 15-20. Claim 1 has been amended.
[b] Johnson cannot be used to render claim 1, as well as the associated dependent claims, obvious to one having ordinary skill in the art. Accordingly, it is respectfully requested that this rejection be withdrawn.
Applicant’s arguments with respect to dependent claims 3-7, 9-14 been considered but are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 3-7, 9-14 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
For the above reasons detailed, since 35 U.S.C. § 103 rejection of claim 3-7, 9-14 still applies and the 35 U.S.C. § 103 rejection of claim 3-7, 9-14 is being maintained at this time. Please also cross-reference detailed claim 1 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Conclusion
Applicant’s’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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