DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is a non-final rejection
Claims 1-20 are pending
Claims 1-20 are rejected under 35 USC § 101-Statutory double patenting
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 3-5-2024
Claim Rejections – Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of co-pending Application No. 19071714 (US 20250285735 A1) (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Dependent claims 2-20 of the instant application are also rejected on the ground of statutory double patenting as being unpatentable over claims 2-20 of co-pending U.S. Application No. 19071714 (US 20250285735 A1).
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of co-pending Application No. 19071720 (US 20250285725 A1) (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Dependent claims 2-20 of the instant application are also rejected on the ground of statutory double patenting as being unpatentable over claims 2-20 of co-pending U.S. Application No. 19071720 (US 20250285725 A1).
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of co-pending Application No. 19071726 (US 20250285726 A1) (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Dependent claims 2-20 of the instant application are also rejected on the ground of statutory double patenting as being unpatentable over claims 2-20 of co-pending U.S. Application No. 19071726 (US 20250285726 A1).
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of co-pending Application No. 19071712 (US 20250281429 A1) (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Dependent claims 2-20 of the instant application are also rejected on the ground of statutory double patenting as being unpatentable over claims 2-20 of co-pending U.S. Application No. (US 20250281429 A1).
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of co-pending Application No. 19071716 (US 20250285724 A1) (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Dependent claims 2-20 of the instant application are also rejected on the ground of statutory double patenting as being unpatentable over claims 2-20 of co-pending U.S. Application No. 19071716 (US 20250285724 A1).
Subject Matter Free of Prior Art
Closest prior art:
The reference Sharma, Paull , Elman, Ross, Rao, and Colby disclose as shown below:
Sharma et al (US 20180140835 A1)- DEVICES, SYSTEMS AND METHODS FOR PAIN MANAGEMENT AND BONE HEALING- teaches: efficacious therapies based on delivery of combinations of thermoceuticals, electroceuticals, ultrasound via computer-implemented systems. Sensors coupled to the device are configured to measure changes in tissue and bone conditions, physiological data resulting from the delivered therapy. The personalized therapy can be adjusted based on the changes in the physiological or sensor data and/or patient feedback. The patient information, information about the applied therapy, and therapy outcome information can be added to the analytics database.
Paull et al (WO 2022086783 A1)- METHODS AND SYSTEMS FOR TREATING GASTROINTESTINAL AND INFLAMMATORY HEALTH CONDITIONS USING PRESCRIPTION DIGITAL THERAPEUTICS- teaches: A prescription digital therapeutic (PDT) system is provided to patients/users suffering from gastrointestinal (GI) and/or inflammatory health conditions, wherein the PDT system allows guided behavioral therapy and skills training to be administered in a convenient and flexible, yet structured fashion, via a system associated with an application such as a mobile application. Guided behavioral therapy technologies may be based at least in part on cognitive behavioral therapy (CBT) techniques to allow for development of a skillset for treating gastrointestinal (GI) and/or inflammatory diseases, disorders and/or conditions, and for managing stress and/or other psychological symptoms associated with such diseases, disorders and/or conditions. Patient interactions with the PDT system are monitored to control progression through the system content and to continually refine one or more personalized intervention regimens associated with the guided behavioral therapy..
Elman et al (WO 2025175318 A2) - PHARMACOTHERAPIES FOR IMPROVING TREATMENT ADHERENCE AFTER DISCONTINUATION OF INCRETIN-BASED THERAPIES - teaches: methods of improving treatment adherence and compliance after discontinuation of incretin-based therapies, such as GLP-1 and/or GIP agonists, using pharmacotherapies comprising the disclosed therapeutic compounds and combinations. In some aspects, methods include treatment of psychological factors affecting other medical conditions (PFAOMC) following the administration of incretin-based therapies to treat obesity or hyperglycemia, and related disorders. In some aspects, disclosed pharmacotherapies for use in the methods include agents that modulate monoaminergic neurotransmission, administered alone or together, such as in disclosed combinations having advantageous synergistic effects..
Ross et al (US 20220240844 A1) - Evaluating Rehabilitation Potential In Pain Patients - teaches: evaluating rehabilitation potential in patients experiencing painful musculoskeletal or neuropathic conditions or both, by maximizing multidimensional rehabilitation outcomes by better identifying the specific needs of each patient; understanding the many obstacles to rehabilitation success falling into motivational, physical, and emotional categories; physical obstacles to rehabilitation including but not limited to incorrect diagnoses and deconditioning; emotional obstacles including fear avoidance, catastrophizing, generalized anxiety, depression, childhood adverse events, emotional awareness deficits; and motivational obstacles including factitious disorder, personality disorders, malingering and apathy. The resulting comprehensive pain rehabilitation program combines multiple treatment options. Medicinal treatments include anti-inflammatory medications; muscle relaxants; opioids and cannabinoids; injection therapies; neuropathic medications; and pain adjuvant medications. Mental health services include mindfulness, biofeedback, progressive relaxation, cognitive behavioral therapies, logotherapy, and trauma therapies. Physical rehabilitation services include physical or occupational therapy; chiropractic; massage therapy; acupuncture; osteopathy and personalized exercises.
Rao et al (WO 2025207633 A1) - INTRAVENOUS ADMINISTRATION OF IBOGAINE FOR TREATING OPIOID USE DISORDER - teaches: methods of treating opioid use disorder in a patient in need thereof by intravenously administering to the patient a therapeutically effective amount of ibogaine or pharmaceutically acceptable salt thereof.
Colby et al (US 20090307181 A1) - Genetic Analysis - teaches: methods for generating genetic profiles or analyses. Included are methods for conducting comprehensive, dynamic genetic analysis. Also provided are methods for determining genetic health scores for specific phenotypes, such as diseases, disorders, traits, and conditions, as well as for organ systems, for certain medical specialties, and for overall health.
The closest prior art of record noted above fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims (Claim 1 recited here as representative). In particular, the closest prior art of record fails to expressly teach or suggest the combination of:
A method of treating a musculoskeletal condition, comprising:
conducting an initial consultation with a patient, wherein the initial consultation is performed by a physician, a physical therapist (PT), and a licensed clinical social worker (LCSW);
determining, during the initial consultation, the musculoskeletal condition of the patient;
determining, during the initial consultation, a pain medication protocol for the patient comprising one or more of methylprednisolone, lidocaine, amitriptyline, meloxicam, acetaminophen, cyclobenzaprine, and a nonsteroidal anti- inflammatory drug (NSAID), wherein the pain medication protocol does not comprise an opiate, quetiapine, benzodiazepine, or a stimulant, and wherein the pain medication protocol is based on the patient indicating a desire for a pain medication;
administering the pain medication protocol to the patient;
determining, during the initial consultation, a physical therapy protocol for the patient, wherein the physical therapy protocol comprises performance of one or more exercises two times a week for six weeks and re-evaluation of the patient at a conclusion of the physical therapy protocol;
administering the physical therapy protocol to the patient;
obtaining, in connection with the initial consultation, height and weight information from the patient;
determining, based on the height and weight information, a body mass index (BMI) of the patient;
in response to the BMI of the patient exceeding a threshold BMI, determining a diet and fitness protocol for the patient;
administering the diet and fitness protocol to the patient;
obtaining, in connection with the initial consultation, blood and urine from the patient;
performing testing on the blood, wherein the testing comprises one or more of a metabolic panel, a lipid panel, a thyroid panel, a diabetes panel, a nutrition panel, and a vitamin panel;
performing a toxicology test on the urine to determine whether the patient has engaged in substance abuse;
based on one or more results of the blood testing and the toxicology test, determining a weight loss medication protocol for the patient comprising one or more of phentermine, orlistat, and semaglutide;
administering the weight loss medication protocol to the patient;
determining, during the initial consultation, a behavioral health condition of the patient;
determining, based on the behavioral health condition of the patient, a behavioral health treatment protocol for the patient, wherein the behavioral health treatment protocol comprises one or more of non-facilitated self-help, guided self-help, counseling, cognitive behavioral therapy (CBT), behavioral activation (BA),physical exercise, mindfulness, meditation, interpersonal psychotherapy (IPT),and short-term psychodynamic psychotherapy (STPP);
administering the behavioral health treatment protocol to the patient;
determining, based on the behavioral health condition of the patient, a behavioral medication protocol for the patient comprising one or more of a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), an anticonvulsant, an anxiolytic, a tricyclic antidepressant (TCA), a tetracyclic antidepressant(TeCA), a monoamine oxidase inhibitor (MAOI), a betablocker, an antihistamine, an antipsychotic, and an herbal compound, and wherein the behavioral health treatment protocol does not comprise benzodiazepine or an antipsychotic;
administering the behavioral medication protocol to the patient;
determining, during and in connection with the initial consultation, whether the patient has opiate use disorder (OUD);
response to the patient indicating OUD, determining an OUD treatment protocol for the patient comprising buprenorphine and naloxone for two weeks, a follow-up appointment, and a follow-up toxicology test;
determining, during the initial consultation, a case management protocol for the patient comprising monthly monitoring by a case manager of the patient's social 2determinants of health and reports from a prescription drug monitoring program for the patient;
administering the case management protocol to the case manager;
determining, during the initial consultation, whether the patient smokes;
in response to determining the patient smokes, determining a smoking cessation protocol for the patient comprising one or more of a nicotine patch, varenicline, andbupropion;
administering the smoking cessation protocol to the patient;
determining, during the initial consultation, in connection with the testing of the blood, or in connection with imaging performed on the patient, whether to refer the patient to a specialist based on one or more of vitals of the patient, abnormal lab results, the imaging, and the patient reporting one or more of unintentional weight loss, unexplained night sweats, active vomiting, active diarrhea, current fever, complaint by the patient of objective muscle weakness, acute problems with bowel or bladder function, dizziness, chest pain, and dyspnea; and
in response to determining to refer the patient to a specialist or other physician, providing referral information to the patient.
Therefore, the claims of the instant application are novel and unobvious.
Foreign prior art and NPL search was conducted however no relevant prior art was found.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684