DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This Office Action is responsive to the amendment filed 12 May 2026. As per the amendment: claims 68, 70-74, 79, 81-83, 86, and 86 have been amended, claims 1-67 remain as previously cancelled, and no new claims have been cancelled or added. Thus, claims 68-87 are presently pending and under examination.
Response to Arguments
Applicant’s arguments, see pg. 7-8 of Remarks, filed 05/12/2026, with respect to the rejection(s) of claim(s) 68,69, 71-79, and 82-85 and independent claims 86-87 under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gonzalez (US 2004/0158297 A1), hereinafter Gonzalez.
Applicant has amended independent claims 68, 86, and 87 to recite the limitation “selecting a nerve root based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and a nerve extending from the selected nerve root to the affected extremity…exposing selected tissue in proximity to the selected nerve root associated with the affected extremity” (emphasis added), and further argues that Porter and Pryor fail to teach or suggest the amended limitation. Examiner uses Gonzalez to teach the amendment (as shown in detail below). Examiner also further notes that although, Pryor does not explicitly state that the selected tissue, in this context the right gluteal and lateral leg, is an affected extremity in proximity to a nerve extending from the selected nerve root, in this context the lumbosacral spine, it would have been known to one skilled in the art that the nerves extending from these nerve roots innervates the right gluteal and lateral leg. Additionally, examiner would like to make note of Gonzalez’s method to test the different nerve roots for a dermatome ([0187]-[0190], Figure 5 and 6).
Therefore, claims 68-69, 71-79, and 82-85 and 86-87 are rejected under 35 U.S.C. 103, as described in detail below.
No additional specific arguments were presented with previous 35 USC 103 rejections of dependent claims 70, 80, and 81, nor specifically with respect to the previously cited Haber, Peric, Bertwell, Peric, and Snyder reference.
Therefore, claims 70, 80, and 81 remain rejected as described in detail below under 35 U.S.C. 103.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 68-69, 71-79, and 82-85 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Porter et al. (US 2007/0162093 A1, previously cited), hereinafter Porter in view of Gonzalez (US 2004/0158294 A1), hereinafter Gonzalez, and further in view of Pryor, B. "Class IV laser therapy interventional and case reports confirm positive therapeutic outcomes in multiple clinical indications." Lite Cure, LLC (2009), hereinafter Pryor (previously cited).
Regarding claim 68, Porter discloses a method of reducing sensory impairment in a subject’s extremity (Abstract: “a method for treating selected tissue by exposing the bone or tissue to a laser light for a period of time”, [0028] “the method in accordance with the present invention is adapted for the therapeutic treatment of any of a patient’s tissue, which includes muscle, nerve, bone, body fluids (including spinal fluid), epithelial, and/or connective tissues. In accordance with a preferred embodiment, the method is adapted for the relief of acute and chronic soft tissue trauma and to provide musculoskeletal pain management”, [0029]-[0034] disorder and symptoms that can be treated by the laser system 10), the method comprising: exposing selected tissue in proximity to the selected nerve root associated with the affected extremity to photonic energy from a therapeutic laser apparatus (laser system 10, [0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”); and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”).
Although, Porter does not explicitly state that the selected tissue, in this context the right foot, is an affected extremity in proximity to a nerve extending from the selected nerve root, in this context the L4-S1 segment of the lumbar spine, it would have been known to one skilled in the art that the nerves extending from these nerve roots innervates the right foot.
Additionally, Porter teaches that “after diagnosing the nature and extent of a tissue disorder, the physician preferable establishes the location, size, and number of treatment areas” ([0038]) but fails to explicitly disclose selecting a nerve root based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and a nerve extending from the selected nerve root to the affected extremity.
However, Gonzalez teaches a method of reducing sensory impairment in a subject’s extremity (Abstract: “A process for identifying and treating an area of dysfunction.”, [0002] “the present invention relates to a process for testing and treating neurological inhibition by resetting sensory afferent and motor efferent nerve supply to the area in which neurological inhibition is detected.”), the method comprising: selecting a nerve root based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and a nerve extending from the selected nerve root to the affected extremity (Figure 2A: Steps 24-30, [0128]-[0129] “The first step consists of performing a singular traditional sensory or motor function test (24). Testing a sensory and motor function has been described above and includes neurologic, orthopedic, physiologic, visceral, and biochemical tests. Other sensory or motor function tests may also be used. If the singular test is aberrant or positive for the dysfunction (26), the area of dysfunction is identified (28)…A myotome test is a neurological evaluation of one nerve that exits the spine and innervates a specific area of the body.”, [0138] “The treatment of the dysfunction according to the invention comprises identifying nerve root and pathway to the area of dysfunction”); exposing selected tissue in proximity to the selected nerve root associated with the affected extremity to photonic energy from a therapeutic laser apparatus; and exposing selected tissue of the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus to reduce at least one symptom of the sensory impairment ([0144] “Corrections are performed for the dysfunction by stimulating the nerve associated with the dysfunction….A coherent laser light is the most convenient and comprehensive form of stimulation for treating the nervous system.”, Figure 2A: Step 32, [0164] “When there is an aberrant neurological inhibition or neurological overload in the body, the sensory afferent and motor efferent nerve supply to the areas or functions being tested must be reset. The goal is to re-establish the proper rhythmic patterns associated to the areas or functions being tested. This is achieved by performing corrections for the neurological inhibition using a therapeutic device to stimulate the area of dysfunction, spine and head (42)”, [0165] “Any therapeutic device can perform the stimulation. The most effective being pulsed or non-pulsed laser light. To perform the correction one or more of the following area needs to be stimulated: the area being tested, nerve and nerve root associated to the tested area”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porter to incorporate the teachings of Gonzalez for selecting a nerve root based on a location of the sensor impairment in an affected extremity and an anatomical relationship between the affected extremity and a nerve extending from the selected nerve root to the affected extremity, as these prior art references are directed to treating sensory impairments. One would be motivated to do this as to find areas of dysfunction and to be able to treat these dysfunction in a quick and non-invasive manner, as recognized by Gonzalez ([0218]).
Porter and Gonzalez, alone or in combination, fail to explicitly teach exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts.
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”) and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Although, Pryor does not explicitly state that the selected tissue, in this context the right gluteal and lateral leg, is an affected extremity in proximity to a nerve extending from the selected nerve root, in this context the lumbosacral spine, it would have been known to one skilled in the art that the nerves extending from these nerve roots innervates the right gluteal and lateral leg. Additionally, examiner would like to make note of Gonzalez’s method to test the different nerve roots for a dermatome ([0187]-[0190], Figure 5 and 6).
Regarding claim 69, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter and Gonzalez, alone or in combination, fail to teach wherein the therapeutic laser apparatus is a Class IV therapeutic laser apparatus.
However, Pryor teaches wherein the therapeutic laser apparatus is a Class IV therapeutic laser apparatus (pg. 2, Materials and Methods: “All patients in the interventional and case studies were treated with the LiteCure LCT-1000® according to therapeutic protocols developed through the scientific literature…The LCT-1000 delivers up to 10 Watts of deep, penetrating laser therapy through an optically correct quartz ball, providing massage benefits in addition to the demonstrated therapeutic results of the Class IV laser”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the laser light therapy of Porter with the Class IV therapeutic laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Regarding claim 71, Porter in view of Gonzalez in view of Pryor discloses the method of claim 68 (as shown above). Porter further teaches wherein exposing selected tissue in proximity to the selected nerve root to photonic energy occurs for at least 1 minute ([0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”).
Regarding claim 72, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing selected tissue in proximity to the selected nerve root to photonic energy occurs for no greater than 10 minutes ([0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”).
Regarding claim 73, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing selected tissue of the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy occurs for at least 5 minutes ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”).
Regarding claim 74, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing selected tissue on the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy occurs for no greater than 20 minutes ([0048] “a total of approximately ten minutes of treatment with a laser over the soles of his feet”, [0049] “The treatment with a laser included the patient receiving 2 treatments bilaterally along the subscapular region, with total treatment time being approximately 20 minutes in length”).
Regarding claim 75, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposure of the selected tissue occurs for a period of time sufficient to deliver a total dosage of at least 7000 Joules to the selected tissue ([0013] “In certain applications, for example, when treating fever blisters, fibromyalgia, etc., treatments within a 24 hour period may exceed 32,000 Joules, and such treatments may be repeated daily.”)
Regarding claim 76, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposure of the selected tissue occurs for a period of time sufficient to deliver a total dosage of at least 9000 Joules to the selected tissue ([0013] “In certain applications, for example, when treating fever blisters, fibromyalgia, etc., treatments within a 24 hour period may exceed 32,000 Joules, and such treatments may be repeated daily.”).
Regarding claim 77, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing steps occur in a first treatment in a series of treatments occurring over a period of days or weeks ([0053] “The treatment protocol consisted of daily exposure to the laser over the entire length of his spinal cord, as well as over the lumbar plexus. Each session lasted approximately 30 minutes. The length of the total sessions was five days, followed by 10 days of rest, and the process was then repeated.”).
Regarding claim 78, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above), Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus ([0053] “The treatment protocol consisted of daily exposure to the laser over the entire length of his spinal cord, as well as over the lumbar plexus”, [0052] “The treatment included the patient receiving a total of ten treatments consisting of five minutes to the L4-S1 segment of the lumbar spine”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”).
Porter and Gonzalez, alone or in combination, fail to teach exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts.
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,550 joules to the lumbosacral spine and right gluteal., Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Regarding claim 79, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above). Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue of the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “The treatment included the patient receiving a total of ten treatments consisting of…five minutes to the areas of hyperesthesia on the right foot”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”).
Porter and Gonzalez, alone or in combination, fail to teach exposing the selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts.
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing the selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,550 joules to the lumbosacral spine and right gluteal., Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter and Gonzalez with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Regarding claim 82, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above). Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus ([0053] “The treatment protocol consisted of daily exposure to the laser over the entire length of his spinal cord, as well as over the lumbar plexus”, [0052] “The treatment included the patient receiving a total of ten treatments consisting of five minutes to the L4-S1 segment of the lumbar spine”)
Regarding claim 83, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above). Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue of the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “The treatment included the patient receiving a total of ten treatments consisting of…five minutes to the areas of hyperesthesia on the right foot”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”).
Regarding claim 84, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing selected tissue occurs bilaterally ([0049] “The treatment with a laser included the patient receiving 2 treatments bilaterally along the subscapular region”).
Regarding claim 85, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein the sensory impairment is associated with peripheral neuropathy ([0053] “A 60 year old male physician presented with an undiagnosed peripheral neuropathy which manifested with symptoms including loss of sensation and prior perception of his lower extremities… No specific diagnosis was ever established except "peripheral neuropathy". This problem had been present for over 15 years, and the doctor felt that his symptoms were progressing. The treatment protocol consisted of daily exposure to the laser over the entire length of his spinal cord, as well as over the lumbar plexus”, [0028] The method in accordance with the present invention is adapted for the therapeutic treatment of any of a patient's tissue, which includes muscle, nerve, bone, body fluids (including spinal fluid), epithelial, and/or connective tissues… A wide range of disorders of biological tissue or their symptoms may be treated by laser system 10, including the following:…”[0030]…”peripheral neuropathy”)
Claim 70 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Porter in in view of Gonzalez view of Pryor as applied to claim 68 above, and further in view of Haber et al. (US Patent 6,366,802 B1, previously cited), hereinafter Haber.
Regarding claim 70, Porter in view of Gonzalez in view of Pryor teaches the method of claim 68 (as shown above). Porter further discloses wherein exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus (laser system 10, [0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”); and exposing selected tissue of the affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”).
Porter and Gonzalez, alone or in combination, fail to teach the exposing of the selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts occurs before exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts. (emphasis added).
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”) and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Porter, Gonzalez, and Pryor, alone or in combination, fail to teach the exposing of the selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts occurs before exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts. (emphasis added)
Haber teaches photo illumination of sites along a nerve supplying a painful region wherein “Begin with treatment applied to the spinal nerves innervating the extremity(ies) involved using 30 seconds at each spinal level on the side of involvement. The next site selected is the center of the palm of the hand or plantar aspect of the foot.” (Column 11, lines 51-60).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porter, Gonzalez, and Pryor to incorporate the teachings of Haber for exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts occurs before exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts, as these prior art references are directed to laser therapy applied to treatments for neuropathy. One would be motivated to do this allows for bilateral symmetry of thermal emissivity which is effective in reducing pain and empowering function, as recognized by Haber (Column 12, lines 1-4).
Claims 80-81 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Porter in view of Gonzalez in view of Pryor as applied to claim 77 above, and further in view of Peric, Z., and B. Cvetkovic. "Electrophysiological evaluation of low-intensity laser therapy in patients with diabetic polyneuropathy." Facta Universitatis, Series: Medicine and Biology 13.1 (2006): 11-14., hereinafter Peric (previously cited).
Regarding claim 80, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above). Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue in proximity to the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”).
Porter, Gonzalez, and Pryor, alone or in combination, fail to teach a power of less than 6.5 Watts.
However, Peric teaches a low-level laser therapy or low-intensity laser therapy for the treatment of diabetic neuropathy wherein the “LILT device had…a total power of 60 mW…treatments lasted for one minute per site (four paravertebral points in the lumbosacral region, three points along n.ischiadicus and two points on the dorsum of the feet)” (pg. 12, Subjects and Methods, paragraph 1, lines 16-21”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porter, Gonzalez, and Pryor to incorporate the teachings of Peric to expose the selected tissue to photonic energy at a power of less than 6.5 Watts, as these prior art references are directed to neuropathy and delivering energy to the lumbar region and the feet. One would be motivated to do this as low-intensity laser therapy (LILT) may be an effective adjunctive or alternative treatments for painful diabetic neuropathy (DPN) without significant heating, as recognized by Peric (Introduction).
Regarding claim 81, Porter in view of Gonzalez in view of Pryor teaches the method of claim 77 (as shown above). Porter further discloses wherein the treatments of the series of treatments following the first treatment comprise exposing the selected tissue of the affected extremity in proximity to the nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”).
Porter, Gonzalez, and Pryor, alone or in combination, fail to teach a power of less than 5.5 Watts.
However, Peric teaches a low-level laser therapy or low-intensity laser therapy for the treatment of diabetic neuropathy wherein the “LILT device had…a total power of 60 mW…treatments lasted for one minute per site (four paravertebral points in the lumbosacral region, three points along n.ischiadicus and two points on the dorsum of the feet)” (pg. 12, Subjects and Methods, paragraph 1, lines 16-21”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porter, Gonzalez and Pryor to incorporate the teachings of Peric to expose the selected tissue to photonic energy at a power of less than 5.5 Watts, as these prior art references are directed to neuropathy and delivering energy to the lumbar region and the feet. One would be motivated to do this as low-intensity laser therapy (LILT) may be an effective adjunctive or alternative treatments for painful diabetic neuropathy (DPN) without significant heating, as recognized by Peric (Introduction).
Claims 86-87 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bertwell (US Patent 6,607,550 B1, previously cited), hereinafter Bertwell in view of Gonzalez (US 2004/0158294 A1) in view of Porter in view of Pryor and further in view of Snyder, Michael J. “Class IV Laser Therapy - Snyder Chiropractic & Wellness Center.” High Power Laser Therapy Center, 10 May 2010, highpowerlasertherapy.com/class-iv-laser-therapy/ (citations below from Wayback Machine in 10 May 2010, previously cited).
Regarding claim 86, Bertwell discloses a method of reducing sensory impairment in a subject’s extremity (Abstract: “a method for the reduction of sensory impairment”, Column 5, lines 66: “the patient’s feet and/or lower leg”), the method comprising:
Evaluating the sensory impairment (Column 4, lines 4-12: explains different methods of determining sensory impairment including a Semmes Weinstein test, Column 5, lines 46-50: “All had neuropathy based on the Semmes Weinstein (SW) monofilament test which measures the ability of the patient to feel a monofilament applied to their skin. In addition, the ability to detect hot-versus-cold (H/C) was also absent or impaired in each patient.”)
Exposing selected tissue to photonic energy (Abstract: “provides photo-energy to skin and subcutaneous structures suffering from sensory impairment”)
Bertwell fails to disclose identifying one or more nerves and nerve roots that are associated with, or suspected of associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the affected extremity, exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts at least 1 minute and no longer than 20 minutes, exposing selected tissue of an affected extremity in proximity to a nerve extending from the identified nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts at least 1 minute and no longer than 20 minutes, wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject ; and repeating the exposing steps in one or more subsequent treatments until at least one symptom of the sensory impairment is reduced.
However, Gonzalez teaches a method of reducing sensory impairment in a subject’s extremity (Abstract: “A process for identifying and treating an area of dysfunction.”, [0002] “the present invention relates to a process for testing and treating neurological inhibition by resetting sensory afferent and motor efferent nerve supply to the area in which neurological inhibition is detected.”), the method comprising: identifying one or more nerves and nerve roots that are associated with, or suspected of being associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the selected nerve root to the affected extremity (Figure 2A: Steps 24-30, [0128]-[0129] “The first step consists of performing a singular traditional sensory or motor function test (24). Testing a sensory and motor function has been described above and includes neurologic, orthopedic, physiologic, visceral, and biochemical tests. Other sensory or motor function tests may also be used. If the singular test is aberrant or positive for the dysfunction (26), the area of dysfunction is identified (28)…A myotome test is a neurological evaluation of one nerve that exits the spine and innervates a specific area of the body.”, [0138] “The treatment of the dysfunction according to the invention comprises identifying nerve root and pathway to the area of dysfunction”); exposing selected tissue in proximity to the one or more nerve roots to photonic energy from a therapeutic laser apparatus; and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve roots to photonic energy from a therapeutic laser apparatus ([0144] “Corrections are performed for the dysfunction by stimulating the nerve associated with the dysfunction….A coherent laser light is the most convenient and comprehensive form of stimulation for treating the nervous system.”, Figure 2A: Step 32, [0164] “When there is an aberrant neurological inhibition or neurological overload in the body, the sensory afferent and motor efferent nerve supply to the areas or functions being tested must be reset. The goal is to re-establish the proper rhythmic patterns associated to the areas or functions being tested. This is achieved by performing corrections for the neurological inhibition using a therapeutic device to stimulate the area of dysfunction, spine and head (42)”, [0165] “Any therapeutic device can perform the stimulation. The most effective being pulsed or non-pulsed laser light. To perform the correction one or more of the following area needs to be stimulated: the area being tested, nerve and nerve root associated to the tested area”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell to incorporate the teachings of Gonzalez for identifying one or more nerves and nerve roots that are associated with, or suspected of being associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the selected nerve root to the affected extremity; exposing selected tissue in proximity to the one or more nerve roots to photonic energy from a therapeutic laser apparatus; and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve roots to photonic energy from a therapeutic laser apparatus, as these prior art references are directed to treating sensory impairments. One would be motivated to do this as to find areas of dysfunction and to be able to treat these dysfunction in a quick and non-invasive manner, as recognized by Gonzalez ([0218]).
Bertwell and Gonzalez, alone or in combination, fail to teach exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts at least 1 minute and no longer than 20 minutes, and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve roots to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts at least 1 minute and no longer than 20 minutes, wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject.
However, Porter teaches a method for treating selected tissue by exposing the selected tissue to laser to treat disorders of neurological conditions such as peripheral neuropathy ([0030]) which involves exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus (laser system 10) at least 1 minute and no longer than 20 minutes ([0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”); exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at least 1 minute and no longer than 20 minutes ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell and Gonzalez to incorporate the teachings of Porter to exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at least 1 minute and no longer than 20 minutes, exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at least 1 minute and no longer than 20 minutes, as these prior art references are directed to neuropathy treatments. One would be motivated to do this as these treatment parameters have shown to be effective in patients with neuropathy, as recognized by Porter ([0048]-[0054]).
Bertwell, Gonzalez, and Porter, alone or in combination, fail to teach exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts, and wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject. (emphasis added).
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”) and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Bertwell, Gonzalez, Porter, and Pryor, alone or in combination, fail to teach the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject. (emphasis added).
However, Snyder teaches the use of a class IV high power laser therapy for the treatment of neuromusculoskeletal conditions where “the average treatment times are only 5-20 minutes” or “5-15 minutes per site” and the Class IV laser provides “7.5 Watts of power”, and thus the joules of total energy provided can be Energy (J) = Power (W) x Time (s) = 7.5 Watts x (20 minutes*60 seconds/min) = 9000 J.
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell, Gonzalez, Porter, and Pryor to incorporate the teachings of Snyder to have the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject as these prior art references are directed to treating neuropathy and both Pryor and Snyder use Class IV lasers. One would be motivated to do this as this energy can result in decrease pain, as recognized by Snyder.
Regarding claim 87, Bertwell discloses a method of reducing sensory impairment in a subject’s extremity (Abstract: “a method for the reduction of sensory impairment”, Column 5, lines 66: “the patient’s feet and/or lower leg”), the method comprising:
Evaluating the sensory impairment (Column 4, lines 4-12: explains different methods of determining sensory impairment including a Semmes Weinstein test, Column 5, lines 46-50: “All had neuropathy based on the Semmes Weinstein (SW) monofilament test which measures the ability of the patient to feel a monofilament applied to their skin. In addition, the ability to detect hot-versus-cold (H/C) was also absent or impaired in each patient.”)
Exposing selected tissue to photonic energy (Abstract: “provides photo-energy to skin and subcutaneous structures suffering from sensory impairment”)
Bertwell fails to disclose identifying one or more nerves and nerve roots that are associated with, or suspected of associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the affected extremity, exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts at least 1 minute and no longer than 20 minutes, exposing selected tissue of an affected extremity in proximity to a nerve extending from the identified nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts at least 1 minute and no longer than 20 minutes, wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject ; and repeating the exposing steps in one or more subsequent treatments until at least one symptom of the sensory impairment is reduced.
However, Gonzalez teaches a method of reducing sensory impairment in a subject’s extremity (Abstract: “A process for identifying and treating an area of dysfunction.”, [0002] “the present invention relates to a process for testing and treating neurological inhibition by resetting sensory afferent and motor efferent nerve supply to the area in which neurological inhibition is detected.”), the method comprising: identifying one or more nerves and nerve roots that are associated with, or suspected of being associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the selected nerve root to the affected extremity (Figure 2A: Steps 24-30, [0128]-[0129] “The first step consists of performing a singular traditional sensory or motor function test (24). Testing a sensory and motor function has been described above and includes neurologic, orthopedic, physiologic, visceral, and biochemical tests. Other sensory or motor function tests may also be used. If the singular test is aberrant or positive for the dysfunction (26), the area of dysfunction is identified (28)…A myotome test is a neurological evaluation of one nerve that exits the spine and innervates a specific area of the body.”, [0138] “The treatment of the dysfunction according to the invention comprises identifying nerve root and pathway to the area of dysfunction”); exposing selected tissue in proximity to the one or more nerve roots to photonic energy from a therapeutic laser apparatus; and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve roots to photonic energy from a therapeutic laser apparatus ([0144] “Corrections are performed for the dysfunction by stimulating the nerve associated with the dysfunction….A coherent laser light is the most convenient and comprehensive form of stimulation for treating the nervous system.”, Figure 2A: Step 32, [0164] “When there is an aberrant neurological inhibition or neurological overload in the body, the sensory afferent and motor efferent nerve supply to the areas or functions being tested must be reset. The goal is to re-establish the proper rhythmic patterns associated to the areas or functions being tested. This is achieved by performing corrections for the neurological inhibition using a therapeutic device to stimulate the area of dysfunction, spine and head (42)”, [0165] “Any therapeutic device can perform the stimulation. The most effective being pulsed or non-pulsed laser light. To perform the correction one or more of the following area needs to be stimulated: the area being tested, nerve and nerve root associated to the tested area”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell to incorporate the teachings of Gonzalez for identifying one or more nerves and nerve roots that are associated with, or suspected of being associated with, the sensory impairment based on a location of the sensory impairment in an affected extremity and an anatomical relationship between the affected extremity and the one or more nerves extending from the selected nerve root to the affected extremity; exposing selected tissue in proximity to the one or more nerve roots to photonic energy from a therapeutic laser apparatus; and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve roots to photonic energy from a therapeutic laser apparatus, as these prior art references are directed to treating sensory impairments. One would be motivated to do this as to find areas of dysfunction and to be able to treat these dysfunction in a quick and non-invasive manner, as recognized by Gonzalez ([0218]).
Bertwell and Gonzalez, alone or in combination, fail to teach exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts at least 1 minute and no longer than 20 minutes, exposing selected tissue of an affected extremity in proximity to a nerve extending from the identified nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts at least 1 minute and no longer than 20 minutes, wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject ; and repeating the exposing steps in one or more subsequent treatments until at least one symptom of the sensory impairment is reduced.
However, Porter teaches a method for treating selected tissue by exposing the selected tissue to laser to treat disorders of neurological conditions such as peripheral neuropathy ([0030]) which involves exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus (laser system 10) at least 1 minute and no longer than 20 minutes ([0052] “the patient receiving a total of ten treatment consisting of 5 minutes to the L4-S1 segment of the lumbar spine”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”); exposing selected tissue of an affected extremity in proximity to a nerve extending from the identified nerve root to photonic energy from a therapeutic laser at least 1 minute and no longer than 20 minutes ([0052] “the patient receiving a total of ten treatment consisting of…five minutes to the areas of hyperesthesia on the right foot”, [0027] “a laser generating 10 Watts of output power may be used to deliver optical energy to a…treatment area”); and repeating the exposing steps in one or more subsequent treatments until at least one symptom of the sensory impairment is reduced ([0048] “He presented for treatment by referral and was given a total of approximately ten minutes of treatment with a laser over the soles of his feet. After a second treatment of approximately five minutes, the patient was pain-free. He has remained in that state to date without further treatments”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell and Gonzalez to incorporate the teachings of Porter to exposing selected tissue in proximity to a selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 6.5 Watts at least 1 minute and no longer than 20 minutes, exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy from a therapeutic laser apparatus at a power of at least 5.5 Watts at least 1 minute and no longer than 20 minutes; and repeating the exposing steps in one or more subsequent treatments until at least one symptom of the sensory impairment is reduced, as these prior art references are directed to neuropathy treatments. One would be motivated to do this as these treatment parameters have shown to be effective in patients with neuropathy and by repeating the exposing steps until a reduction of a symptom is noted allows for the patient to be treated successfully without extra energy being applied, as recognized by Porter ([0048]-[0054]).
Bertwell, Gonzalez, and Porter, alone or in combination, fail to teach exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts and exposing selected tissue of an affected extremity in proximity to a nerve extending from the selected nerve root to photonic energy at a power of at least 5.5 Watts, and wherein the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject. (emphasis added).
However, Pryor teaches therapeutic performance of Class IV laser systems using case studies involving exposing selected tissue in proximity to a selected nerve root to photonic energy at a power of at least 6.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”) and exposing selected tissue of an affected extremity in proximity to the one or more nerves extending from the identified nerve root to photonic energy at a power of at least 5.5 Watts (pg. 4, Case 2- Right hip and leg pain: “Ten watts at 5,950 Joules to the lumbosacral spine, right gluteal, and lateral leg”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic laser apparatus of Porter with the Class IV laser of Pryor (i.e. LiteCure LCT-1000, pg.2 Materials and Methods), as these prior art references are directed to delivering photonic energy for healing and improved pain relief. One would be motivated to do this as Class I-III lasers do not provide the optimal clinical outcomes in most disease conditions because they cannot deliver the necessary dosage to deep structures without using excessively long treatment times, however, Class IV lasers can provide both the wavelength and output power levels necessary to trigger therapeutic cellular metabolic changes, as recognized by Pryor (pg. 5, Conclusion).
Bertwell, Gonzalez, Porter, and Pryor, alone or in combination, fail to teach the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject. (emphasis added).
However, Snyder teaches the use of a class IV high power laser therapy for the treatment of neuromusculoskeletal conditions where “the average treatment times are only 5-20 minutes” or “5-15 minutes per site” and the Class IV laser provides “7.5 Watts of power”, and thus the joules of total energy provided can be Energy (J) = Power (W) x Time (s) = 7.5 Watts x (20 minutes*60 seconds/min) = 9000 J.
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertwell, Gonzalez, Porter, and Pryor to incorporate the teachings of Synder to have the exposing steps in a first treatment provide at least 7000 Joules of total energy to the subject as these prior art references are directed to treating neuropathy. One would be motivated to do this as this energy can result in decrease pain, as recognized by Snyder.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee at al. (US 2010/0292758 A1) teaches a method laser stimulation of animal tissues and particularly to lasers and methods to treat sensory deficiencies ([0003]) with power of less than 5 Watts
McCarthy et al. (US 2013/0131103 A1) teaches methods for the effective treatment of impaired nerve signal conduction (Abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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