DETAILED ACTION
This office action is in response to the claims filed 6/6/2025. As directed by the amendment, claims 2 and 4-6 have been amended, claims 1 and 3 have been canceled, and no claims have been newly added. Thus, claims 2 and 4-10 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2 and 4-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (e.g. an abstract idea) without significantly more.
Independent claim 2 recite a method for providing therapeutic treatment to a patient comprising a combination of a first step and a treatment, comprising:
performing a first treatment on the patient, wherein the first treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation;
performing a second treatment on the patient, wherein the second treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation;
wherein the combination of preceding steps provides for a beneficial difference over performing the first treatment alone, and wherein the beneficial difference is directed to an outcome, and wherein the outcome is selected from a group of outcomes consisting of pain reduction, reduction of arthritis symptoms, corrected posture, reduction in number of headaches, alleviation of compressed nerves, enhanced breathing, corrected posture, reduction in number of headaches, alleviation of compressed nerves, enhanced breathing, enhanced mobility and scoliosis reduction.
These steps describe a process that a human would mentally follow and manually administer when providing treatment to a patient, which is analogous to the method of cutting hair held in in re Brown and held to be a patent-ineligible abstract idea (see In re Brown, 645 Fed. Appx. 1014 (Fed. Cir. 2016)). The recitation of claim 2’s different treatment is presented with a high degree of generality. For example, if one were to perform “chiropractic treatment”, it would require the expertise of a medical practitioner to determine a body part to be treated, which chiropractic treatment to perform, how many manipulations to perform, etc. If one were to perform “trigger point injections”, it would require a medical practitioner to make decisions on which body part is to be treated, which areas are to be injected, how often the needle is inserted and retracted, whether an anesthetic is applied, etc. Therefore, the method of claim 2 and the method of cutting hair recited in In re Brown, describe a mental processes of performing a treatment to the person using the practitioner’s knowledge to perform the treatment. As such, the recitation in claim 2 of performing a first treatment to the patient (performing a first treatment on the patient, wherein the first treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation) and then performing a second treatment (performing a second treatment on the patient, wherein the first treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation) to provide a beneficial difference over the first treatment alone is considered to comprise an abstract idea comprising a mental process, as the broadest reasonable interpretation of the method would include a medical practitioner performing a course of treatment comprising a first treatment and a second treatment on a patient while performing mental steps to determine the specific steps involved in the modality of treatment in the first and second steps to provide a benefit to a patient, and assessing whether the combination of steps provides for a beneficial difference over performing the first treatment alone. Furthermore, the broadest reasonable interpretation of claim 2 is considered to read on a manual medicine practitioner performing different treatment modalities on a patient to provide a benefit of a manual medicine procedure. Therefore, claim 2 is considered to read on an abstract idea because it is reads to on a manual medicine practitioner performing treatment on a patient, and therefore would be directed to organizing human activity between a medical practitioner and a patient.
The remaining limitations in claim 2 “wherein the first treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation” are not considered to add something more to the judicial exception, as modalities used in a treatment strep are considered to be modalities that routine in the art. Just as the specific manual application of the treatment steps in In re Brown were not considered to be something more than the judicial exception, the performing of a first treatment step of claim 2 is not considered to be more than the judicial exception. Furthermore, the limitation “performing a second treatment on the patient, wherein the second treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation” are not considered to be more than the judicial exception because it repeats the steps of treating a patient using a treatment modality, and as discussed above would considered to be an abstract idea involving mental steps and also methods of organizing human activity. The limitation “wherein the combination of preceding steps provides for a beneficial difference over performing the first treatment alone, and wherein the beneficial difference is directed to an outcome, and wherein the outcome is selected from a group of outcomes consisting of pain reduction, reduction of arthritis symptoms, corrected posture, reduction in number of headaches, alleviation of compressed nerves, enhanced breathing, corrected posture, reduction in number of headaches, alleviation of compressed nerves, enhanced breathing, enhanced mobility and scoliosis reduction” also does not add something more to the judicial exception because the outcome of the combination of the preceding steps providing for a beneficial difference over performing the first treatment alone would require the mental steps of a practitioner making subjective evaluations of the results of the first treatment and using the results of the proceeding steps to provide a second treatment step to provide the claimed beneficial outcome for the patient.
Although not precedential and therefore not relied on in this rejection, Ex parte Jou, PTAB 2019-003305 held that a method of treating pain using manual manipulation techniques for treating pain due to soft tissue injury using steps of assessing a patient (identifying and locating soft tissue structural changes of an injured site by:) and performing a treatment on a patient based on the assessment (after precisely identifying the precise locus of injury, treating the injured site by:) was found to be patent ineligible as being directed to an abstract idea, as it involves mental steps and is directed to a method of organizing human activity between a practitioner and a patient. It was further held that the specific assessment steps and the specific treatment steps were drawn to steps that are routine in the art, and therefore do not add more to the judicial exception.
Clams 4-10 recite specific modalities used for the specific treatment performed (e.g. chiropractic adjustment), and/or specific beneficial outcomes (e.g. pain reduction, enhanced mobility, alleviation of compressed nerves, reduction of arthritis symptoms). These limitations are not considered to add something more to the judicial exception, as modalities used in the treatment strep are considered to be routine modalities that are used in the art, and the recited beneficial outcomes would require a practitioner to use mental steps to determine an appropriate course of treatment to provide for the recited beneficial outcomes. Just as the specific assessment steps and manual application of the treatment steps in In re Brown were not considered to be something more than the judicial exception, the performing of a first assessment step and a second treatment step to achieve a beneficial outcome of claim 2 is not considered to be significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
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.
Claim(s) 2 and 4-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dvorak et al (Dvorak et al, “Musculoskeletal Manual Medicine”. Stuttgart: Thieme (2007)) in view of Leahy et al (6,090,045).
Regarding claim 2, Dvorak discloses in fig 7.1 on page 136 a method for providing therapeutic treatment to a patient (a structural-functional musculoskeletal examination sequence), wherein the method comprises a combination of a first step (Structural-Functional MSK evaluation) and a treatment (Treatment-Management Planning): comprising performing an assessment step (Structural-Functional MSK evaluation), and performing a first treatment on the patient, wherein the first treatment is selected from a group of treatments consisting of chiropractic adjustment (chiropractic adjustment is described in table 2.1 as a generic term with over 100 sub techniques including high-velocity, low amplitude (HVLA) thrust and low-force techniques (page 4), which are also known as “manipulation”, “thrust”, or “mobilization with impulse techniques” (page 167), and disclose mobilization with impulse techniques for T3 to T10 spine on pages 408-414), trigger point injection (“Muscle Trigger Point Therapy” teaches injection techniques in which a saline solution or local anesthetic agent is injected in a myofascial trigger point (“Muscle Trigger Point Therapy”, pages 28-29), dry needling (“Muscle Trigger Point Therapy” teaches utilizing a “dry needle” technique (“Muscle Trigger Point Therapy”, pages 28-29), transcutaneous electrical nerve stimulation, and functional electrical stimulation (electrotherapy such as TENS for transcutaneous electrical nerve stimulation or functional electrical stimulation using low-frequency current can be used (“Electrotherapy”, page 39), and Dvorak discloses the importance of providing a first step of the structural and function MSK examination to arrive at a structurally and functionally sound diagnosis and to determine the most appropriate treatment intervention according to the specific objectively verifiable findings (“7 The Structural and Functional Neuro-Musculoskeletal Examination: Introduction”, page 135), and wherein the beneficial difference is directed to an outcome, and wherein the outcome is selected from a group of outcomes consisting of pain reduction (manual medicine has been shown to improve short-term pain) (“Effectiveness of Cost Considerations: Evidence and Recommendations”, pages 167-170), reduction of arthritis symptoms (manual medicine techniques can be used to treat common shoulder disorders such as glenohumeral arthritis) (“Glenohumeral Arthritis“, page 263), corrected posture (NMT Type 2 treatment is performed to improve overall posture (“Diagnosis, Lumbar Spinal Stenosis, page 161), reduction in number of headaches (manual medicine treatment can be used in cases where cervical vertigo is the result of structural disturbances) (“Cervicogenic Vertigo and Headache”, pages 226-231), enhanced breathing, corrected posture, and scoliosis reduction (primary goals of scoliosis treatment include enhanced breathing (maintenance of respiratory function), corrected posture, and scoliosis reduction (prevention of curve progression) (“Treatment of Scoliosis”, page 249), and scoliosis can be treated with manual medicine to maintain flexibility in scoliosis patients (“Treatment”, pages 250-251”), and enhanced mobility (increase physical function measured by LIFEware System Measure) (“LIFEware System Measures”, pages 175-185), and alleviation of compressed nerves (selected clinical syndromes that can be treated include carpal tunnel syndrome (CTS), which includes nerve compression) (“Carpal Tunnel Syndrome: Synonyms and Related Terms”, pages 276-278).
The now-modified Dvorak’s method does not disclose performing a second treatment on the patient, wherein the second treatment is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation.
However, Leahy in fig 6 teaches a method for performing a manual medicine, wherein a first treatment is administered to a patient (P608) (manipulating soft tissues to of the patient to implement treatment) (col 11, ln 24-28), and performing a second additional related protocol at step (P614) which can be optionally implemented by a repetition of steps (P608-612) (col 11, ln 48-65), and as shown in fig 6, the repeating treatment of the patient comprises performing a re-exam step if sufficient improvement has not occurred, and based on new findings, implementing another treatment protocol at (P608) (col 11, ln 48-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Dvorak by, following the step of performing a first treatment step on the patient, and performing a second additional related treatment step on the patient as taught by Leahy in order to in order to repeat treatments of the patient at successive time intervals until, in the judgement of the practitioner, the patient’s symptoms have improved sufficiently to justify cessation of treatment (Leahy, col 11, ln 66-col 12, ln 9). The-modified Dvorak’s method is considered that the second treatment on the patient is selected from a group of treatments consisting of chiropractic adjustment, trigger point injection, dry needling, replacing stem cells, transcutaneous electrical nerve stimulation, functional electrical stimulation, and transcranial magnetic stimulation, because, as shown in fig 6 of Leahy, the treatment protocol is repeated at (P608), and as discussed above, because the treatment step in Dvorak discloses the claimed treatment modalities, because the second treatment step is repeated in fig 6 of Leahy, the second treatment step would include the recited treatment modalities as taught in Dvorak and would be different from the first treatment because it would be an additional related treatment as recited in step (P608) of Leahy.
The now-modified Dvorak’s method dies not disclose wherein the combination of the first treatment and the second treatment provides for a beneficial difference over performing the first treatment alone.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Dvorak so that the combination of the first step and the treatment provides for a beneficial difference over performing the first treatment alone, as Dvorak discloses the purpose of assessing the patient is to arrive at a structurally and functionally sound diagnosis and to determine the most appropriate treatment intervention according to the specific objectively verifiable findings and particular needs of the individual patient, for both short- and long-term management (Dvorak, “7 The Structural and Functional Neuro-Musculoskeletal Examination: Introduction”, page 135) and Leahy discloses repeating treatments until patients symptoms have improved sufficiently to justify cessation of treatment (Leahy, col 11, ln 65-col 12, ln 9), and therefore, selecting the most appropriate treatment intervention in the second treatment after performing a re-exam on the patient by routine experimentation to maximize the benefit of the treatment would be an obvious modification to address the needs of the individual patient, for both short- and long-term management.
Regarding claim 4, Dvorak discloses in claim 2 above that the second treatment can be chiropractic adjustment (manual medicine includes manipulation techniques which encompasses chiropractic adjustment) (Dvorak, table 2.1, page 4), and discloses that manual medicine techniques can be performed to treat clinical disorders and syndromes of the spine (“14 Selected Clinical Syndromes: Clinical Disorders and Syndromes of the Spine, Dvorak, pages 214-251), including treating headaches (“Cervicogenic Headache”, page 228) and spine disorders (“Degenerative Disorders of the Spine”, pages 231-232).
Regarding claim 7, Dvorak discloses the outcome is pain reduction (manual medicine techniques are used to treat pain from headache (“Cervicogenic Headache”, Dvorak, page 228) and spine disorders (“Degenerative Disorders of the Spine”, Dvorak, pages 231-232).
Regarding claim 10, Dvorak disclose there is a second outcome, and the second outcome is reduction of arthritis symptoms (manual medicine techniques can also be used to treat rheumatoid arthritis) (“Rheumatoid Arthritis”, pages 236-237).
Regarding claim 5, Dvorak discloses the diagnosis and treatment of common shoulder disorders (“Clinical Disorders and Syndromes of the Upper Limb: The Shoulder”, pages 252-267) wherein electromyography is performed on the patient (EMG studies can confirm motor activity in the deltoid and supraspinatus muscles when examining the rotator cuff (Evaluation: Global Shoulder Strength Test for Rotator Cuff: Examination Procedure”, page 489), and discloses in claim 2 above that the second treatment can be chiropractic adjustment (manual medicine techniques can provide significant benefit in the course of treatment for a rotator cuff tear (“Rotator Cuff Tear: Treatment Options”, pages 256-257).
Regarding claim 8, Dvorak discloses the diagnosis and treatment of common shoulder disorders (“Clinical Disorders and Syndromes of the Upper Limb: The Shoulder”, pages 252-267), wherein the outcome is enhanced mobility (improved range of motion assessments and increase in patient’s functional ability) (“Pain and Function”, page 258-259).
Regarding claim 6, Dvorak discloses diagnosis and treatment of wrist disorders including carpal tunnel syndrome (“The Wrist: Wrist Disorders”, pages 276-285), including carpal tunnel syndrome (“Carpal Tunnel Syndrome (CTS)”, pages 276-279), wherein electrodiagnostic studies are performed on the patient (“Carpal Tunnel Syndrome (CTS): Clinical Presentation”, page 277), and discloses in claim 2 above that the second treatment can be chiropractic adjustment (manual medicine technique approaches) (“Carpal Tunnel Syndrome (CTS): Treatment Options”, page 277).
Regarding claim 9, Dvorak discloses the outcome is alleviation of compressed nerves (carpal tunnel syndrome is caused by median nerve compression at the wrist (“Carpal Tunnel Syndrome (CTS): Synonyms and Related Terms”, page 277), and therefore treatments to treat carpal tunnel syndrome will alleviate the compressed nerves that is the cause of carpal tunnel syndrome).
Response to Arguments
Applicant's arguments filed 6/6/2025 have been fully considered but they are not persuasive.
Applicant argues on page 6, first full paragraph-third full paragraph of applicant’s remarks, that performing the multi-step process of claim 2 would not require a mental step because the performance of the second step would depend on the performance of the first step, and therefore would not require a mental step to determine the effectiveness of the first step. However, applicant’s recitation of the treatments is very broad. For example, if one were to perform “chiropractic treatment”, it would require the expertise of a medical practitioner to determine a body part to be treated, which chiropractic treatment to perform, how many manipulations to perform, etc. If one were to perform “trigger point injections”, it would require a medical practitioner to make decisions on which body part is to be treated, which areas are to be injected, how often the needle is inserted and retracted, whether an anesthetic is applied, etc. Because each treatment modality is in claim 2 is presented with a high degree of generality, it is considered to read on a medical practitioner performing mental steps determine a beneficial treatment for a patient using the recited claim modalities. Furthermore, the broadest reasonable interpretation of claim 2 is considered to read on a manual medicine practitioner performing different treatment modalities on a patient to provide a benefit of a manual medicine procedure. Therefore, claim 2 is considered to read on an abstract idea because it is reads to on a manual medicine practitioner performing treatment on a patient, and therefore would be directed to organizing human activity between a medical practitioner and a patient.
Applicant argues on page 7, first and second full paragraphs of applicant’s remarks, that Leahy only discusses the manipulation of soft tissues and does not contemplate the treatment of treatment modalities recited in claim 2, and “another treatment protocol” in Leahy refers to a different soft tissue manipulation and not to a completely different treatment. However, Leahy is relied upon to teach a method for treating the human body by performing a first treatment is administered to a patient and performing a second additional related protocol which can be optionally implemented by a repetition of steps if sufficient improvement has not occurred, and based on new findings, implementing another treatment protocol. Although Leahy does not disclose the specific treatment modalities recited in claim 2, Dvorak discloses the claimed treatment modalities, and Leahy’s method of performing a second additional related protocol is considered to be relevant to Dvorak to allow a practitioner to perform an additional related protocol if sufficient improvement has not occurred, therefore, the additional related protocol is considered to correspond to the treatment modalities discloses in Dvorak. Therefore, the rejection is maintained.
Applicant argues on page 7, third and fourth paragraphs full paragraphs of applicant’s remarks, that Leahy’s method is not compatible with Dvorak or Kawamura, as Dvorak and Kawamura are directed to image processing and Leahy rejects this approach. However, the claims do not recite an image processing step, and therefore the argument is moot. Furthermore, Dvorak discloses additional steps for assessing a patient, including a functional muscle and myofascial assessment and range of motion testing (Dvorak, page 136, “Fig 7.1, The structural-functional musculoskeleton examination sequence for the integrated manual medicine approach”), and therefore, Dvorak does not rely solely on performing an imaging step in the evaluation of a patient, but includes other steps such as a functional muscle and myofascial assessment and range of motion testing. Also, Leahy is relied upon to teach the feature of assessing a patient after performing a first treatment, and performing second treatment different from the first treatment comprising an additional related protocol, and therefore, Leahy’s teaching would be relevant to Dvorak’s disclosure in order to provide a beneficial second treatment that that is performed on a patient until, in the judgement of the practitioner, the patient’s symptoms have improved sufficiently to justify cessation of treatment (Leahy, col 11, ln 66-col 12, ln 9). Therefore, the rejection is maintained.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785 /COLIN W STUART/Primary Examiner, Art Unit 3785