DETAILED ACTION
Claims 1, 2, 6-10, and 12-14 are currently pending in the instant application and are rejected.
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 .
Response to Amendment and Arguments
Applicant's amendment and arguments filed 10 June 2026 have been fully considered and entered into the instant application. In regards to the 35 USC 112(a) rejection of claims 1-14, the amendment to claim 1 along with the cancelation of claims 3-5 and 11 has overcome this rejection. The 35 USC 112(b) rejection of claims 1-14 is overcome as claims 1, 7, and 12 have been amended and claims 3-5 and 11 canceled. The 35 USC 112(b) rejection of claim 14 have been overcome as claim 14 has been amended. In regards to the 35 USC 102 rejection of claims 1-14 as being anticipated by Crisp et al., applicant has canceled claims 3-5 and 11 and amended claim 1 to recite “wherein the administration is oral, transcutaneous, subcutaneous, intramuscular, or intranasal. The amendment to claim 1 and the cancelation of claims 3-5 and 11 has overcome the 35 USC 102(a)(1) rejection of claims 1-14 as being anticipated by Crisp et al. However, the amendment has necessitated the following 35 USC 103(a) rejection of claims 1, 2, 6-10, and 12-14 as being obvious over Crisp et al. in view of Al Shoyaib et al. In regards to the 35 USC 102(a)(1) rejection of claims 1-14 as being anticipated by WO 2022/256720, Applicant’s has canceled claim 3-5 and 11 and amended claim 1 to recite “wherein the pain is caused by a physical state in the individual’s body.” Applicant argues that WO 2022/256720 is directed to the treatment of mental health disorders and does not provide an enabling support for other conditions, such as pain caused by a physical state in an individual’s body, mentioning paragraph [0248]:
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and stating that pain is a psychiatric disorder and lists it with other disorders such as anxiety, depression, and PTSD and the interpretation of pain as other than a psychiatric disorder would be contrary to the inventive concept in WO 2022/256720 and that one of skill in the art would understand that an entactogenic compound would promote affiliative social behavior, have acute anxiolytic effects, and lead to a profound state of introspection and personal reflection, citing paragraph [064] of WO 2022/256720 discussing PTSD. Applicant also argues that one skilled in the art would not consider pain caused by a physical state in an individual’s body to be consistent with conditions that could be treated with entactogens, citing the present specification paragraph [00017]:
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and stating that the conditions associated with entactogens disclosed in WO 2022/256720 are not considered to be pain caused by a physical state in an individual’s body and that pain in WO 2022/256720 would be understood to be mere naming of subject matter that is not sufficiently enabled as the disorders in WO 2022/256720 are different from pain caused by a physical state. These arguments are not persuasive as depression, anxiety, PTSD, and chronic pain are all disorders that can be caused by a physical state in an individual’s body as evidenced by the following articles. As seen in “Chronic Pain and Mental Health Disorders: Shared Neural Mechanisms, Epidemiology and Treatment” by W. Michael Hooten, MD, “a bidirectional relationship exists between chronic pain and mental health disorders”, page 956. Page 957 provides that a bidirectional relationship exists between chronic spinal pain and depression, in which spinal pain is a risk factor for depression and depression is a risk factor for spinal pain. Here it is shown that depression pain can be pain caused by a physical state, chronic pain. Page 958 provides that a bidirectional relationship exists between chronic pain and anxiety and that individuals with migraine headache, a physical state, are more likely to be diagnosed with general anxiety disorder or PTSD, which shows that anxiety and PTSD are pains caused by a physical state. Page 965 provides that use of analgesic medications with efficacy for both pain and mental health disorders should be considered first-line agents in patients with chronic pain. “Posttraumatic stress disorder and the nature of trauma” by Bessel van der Kolk, MD provides that PTSD can be caused by a physical state, with page 9 providing that the diagnostic construct of PTSD is clinically relevant to individuals who have suffered single incident traumas such as rape, physical assaults, torture, and motor vehicle accidents, all of which would be caused by a physical state. Additionally, in an article by Thomas Rutledge Ph.D. Chronic pain is both a medical condition and a psychological condition, page 2. Chronic pain is a pain caused by a physical state, and the psychological part of chronic pain refers to the degree of negative social, emotional, and quality of life effects experienced by a patient. Page 3 of the article provides that patients with chronic pain report clinically elevated levels of depression or anxiety. Page 4 provides that chronic pain, a physical state, has the ability to disrupt all levels of Maslow’s hierarchy beside the unpleasant experience of pain itself, the chronic pain, a physical state, has anxiety as one of the most common emotional responses to chronic pain. This shows that anxiety can be a pain caused by a physical state, chronic pain. The 35 USC 102(a)(1) rejection as being anticipated by WO 2022/256720 is maintained as WO 2022/256720 provides for the treatment of depression, anxiety, PTSD, and chronic pain, all of which can be considered pain caused by a physical state. The provisional nonstatory type double patenting rejections over Application NO. 17/518,846 and 18/331,682 are withdrawn as both applications are now abandoned. In regards to the provisional nonstatutory double patenting rejection over Application No. 17/893,292, which is US Patent No. 11,896,670, the rejection is withdrawn as the claims in the ‘670 patent are processes of synthesizing a pharmacological compound.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-10, and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) and also rejected under 102(a)(1) as being anticipated by WO 2022/256720.
In regards to instant claims 1 and 2, WO 2022/256720 provides claims 1 and claim 83:
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Additionally, paragraph [248] provides:
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and paragraph [013] provides:
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along with paragraphs [102]-[110] which corresponds to the instant invention.
In addition, for instant claim 6, WO 2022/256720 provides claim 14:
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which corresponds to the instant invention.
In addition, for instant claims 7 and 8, WO 2022/256720 provides paragraph [85]:
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which corresponds to the instant invention.
In regards to instant claim 9, WO 2022/256720 provides claims 108 and 109:
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which corresponds to the instant invention.
In addition, for instant claim 10, WO 2022/256720 provides paragraph [207] and [234]:
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which corresponds to the instant invention.
In addition, WO 2022/256720 provides paragraph [22]:
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which corresponds to the instant invention.
In addition, for instant claims 12 and 13, WO 2022/256720 provides paragraph [111]:
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which corresponds to the instant invention.
Lastly, for instant claim 14, WO 2022/256720 provides paragraph [148]:
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which corresponds to the instant invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 6-10, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crisp et al. in view of Al Shoyaib et al. and US Pre-Grant Publication 2021/0183519.
Crisp et al. provides MDMA has antinociceptive effects, which is the blocking the detection of a painful or harmful stimulus, see page 497. MDMA is shown to provide mood-elevation, page 497. Additionally, MDMA is shown to induce analgesia, page 497. Nociceptive tests are provided including the tail flick test and the hot plate test. Figures 1A and B. provide the tail flick latency for MDMA. Page 500 provides the combination of naltrexone and MDMA in Figure 3A. which is 3mg/kg of MDMA. Therefore, as Crisp et al. provides MDMA has antinociceptive effects and mood elevation, and provides the administration of MDMA to rats for the tail flick text and the hot plate test, Crisp et al. provides for the treatment of pain with MDMA (including R-MDMA and S-MDMA (instant claims 1, and 10). As Crisp et al. provides the tail-flick test and the hot plate test, and provides that MDMA has antinociceptive effects, induces analgesia and provides mood-elevation, instant claim 2 is obvious. Instant claims 6-8, while limiting the MDMA like compound, the prodrug, and the salt, claims 5-8 do not require that the composition is limited to only an MDMA like compound, a prodrug, or a salt, and therefore can still be administered as MDMA, R-MDMA or S-MDMA. As Crist et al provides Figure 3A which administers 3mg/kg, claim 9 is obvoius as an individual human can weigh, for example 60-80 kilograms, corresponding to a dose of 180-240mg per individual. For instant claims 12-14, as evidenced by Younger et al., naltrexone is considered an analgesic as page 451 provides that naltrexone exerts an analgesic effect. Additionally, page 451 provides that naltrexone is an anti-inflammatory agent. Page 452 also provides that naltrexone exhibits properties such as analgesia and anti-inflammatory actions.
The difference between Crisp et al. and the instant claims is that Crisp et al. administers intraperitoneal. However, as seen in Al Shoyaib et al. Intraperitoneal (IP) route of drug administration in laboratory animals is a common practice in many in vivo studies of disease models, page 1, due to its ease of mastery, quick, and low impact of stress on laboratory rodents. Page 2 provides that the main disadvantage of this route is that it is minimally used in clinic. While IP administration is justifiable as a routine in experimental animals for pharmacological and proof-of-concept studies, it is not to evaluate the pharmacokinetics for clinical translation.
However, one skilled in the pharmacological arts would have the knowledge to administer MDMA via methods such as oral, intramuscular as it is known that IP route of administration is common practice in rat models, but does not translate to clinical use, but MDMA can be administered as seen in US 2021/0183519, paragraph [0064] via routes such as oral and intramuscular. Paragraph [0051] provides MDMA as the psychedelic agent which is an empathogenic agent. Paragraphs [0045] provides the treatment of depression, anxiety, with paragraph [0059] providing treatment of chronic pain. Paragraph [0159] provides pain management in relation to an existing physical condition. Paragraphs [0173]-[0180] provide multiple administration routs such as oral, and by intramuscular, subcutaneous, etc.
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 REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 1 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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