DETAILED ACTION
Claims 1-14 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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 6-8, and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32-34, 36, 37, 39-46, and 49 of copending Application No. 17/518,846 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to compounds which are MDMA bound to an amino acid, which would correspond to the instant claims treating of pain by administration with, for example, an MDMA-like compound, prodrug of MDMA, prodrug of R-MDMA, prodrug of S-MDMA, analog thereof. Specifically, please see the conflicting specification paragraph [0002] which provides the treatment of disorders such as depression and anxiety. Paragraph [00016] provides the treatment of anxiety with the conflicting invention. Additionally, see paragraph [00017] of the instant specificiaton which provides that pain can be caused from an emotional state such as anxiety and depression.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘846 application to arrive at the instant products with the expectation of obtaining additional beneficial products which would treat anxiety or depression. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 4, 6-8, and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-15, 17-19 of copending Application No. 17/893,292 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims the are drawn to products which include prodrugs of MDMA and compositions comprising prodrugs of MDMA, such as MDNA bound to an amino acid, which would correspond to the instant claims treating of pain by administration with, for example, an MDMA-like compound, prodrug of MDMA, prodrug of R-MDMA, prodrug of S-MDMA, analog thereof. Specifically, please see the conflicting specification paragraph [0002] which provides the treatment of disorders such as depression and anxiety. Additionally, see paragraph [00017] of the instant specification which provides that pain can be caused from an emotional state such as anxiety and depression.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘292 application to arrive at the instant products with the expectation of obtaining additional beneficial products which would treat anxiety or depression. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-8, 10 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of copending Application No. 18/331,682 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to compositions comprising (R) MDMA, MDA and methods of treating an individual for a medical condition by administering (R) MDMA or MDA, including with prodrugs thereof. The conflicting specification paragraph [0002] provides the treatment of anxiety and depression. Conflicting paragraph [0009] additionally provides the treatment of anxiety disorders with conflicting paragraph [00039] providing other emotional pain disorders. Additionally, see paragraph [00017] of the instant specification which provides that pain can be caused from an emotional state such as anxiety and depression.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘682 application to arrive at the instant products with the expectation of obtaining additional beneficial products which would treat anxiety or depression. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating pain by administering MDMA, R-MDMA, S-MDMA, a mixture of enantiomers not in a 1:1 ration, a prodrug of MDMA, a prodrug of R-MDMA, or a prodrug of S-MDMA, and salts thereof does not reasonably provide enablement for the treatment of pain by administering an MDMA-like compound, a prodrug of an MDMA-like compound, analogs thereof or derivatives thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claims is methods of treating pain by administering an effective amount of a composition chosen from the group consisting of MDMA, R-MDMA, S-MDMA, a mixture of enantiomers not in a 1:1 ratio, an MDMA-like compound, a prodrug of MDMA, a prodrug of R-MDMA, a prodrug of S-MDMA, a prodrug of an MDMA-like compound, analogs thereof, derivatives thereof, and salts thereof to an individual; as well as presently unknown compounds embraced by the term MDMA-like compounds, prodrugs of an MDMA-like compound, analogs thereof and derivatives thereof.
(b) Nature of the invention - The nature of the invention is methods of treating pain by administering an effective amount of a composition chosen from the group consisting of MDMA, R-MDMA, S-MDMA, a mixture of enantiomers not in a 1:1 ratio, an MDMA-like compound, a prodrug of MDMA, a prodrug of R-MDMA, a prodrug of S-MDMA, a prodrug of an MDMA-like compound, analogs thereof, derivatives thereof, and salts thereof to an individual; as well as presently unknown compounds embraced by the term MDMA-like compounds, prodrugs of an MDMA-like compound, analogs thereof and derivatives thereof..
(c) State of the prior art – The state of the prior art recognizes that
The term "derivative" found in the claims can be defined as a compound, usually organic obtained from another compound by a simple chemical process or an organic compound containing a structural radical similar to that from which it is derived.
The term “analog” in regards to chemical compounds can be compounds that have a structure similar to another compound but differs in one or more atoms, functional groups, or substructures.
The term “MDMA-like compound” includes metabolites as seen on page 4 of the instant specification. The prior art recognizes metabolites as intermediates and products of biotransformations or metabolism. Fura, A. (DDT, 2006, 11, page 133, internal citations omitted) teaches the various types of small molecules that can be encompassed by this term: Biotransformation reactions can be accompanied by various events, such as the formation of chemically stable metabolites, which are devoid of pharmacological or toxicological activities, or the generation of short-lived
chemically-reactive metabolites, which can lead to toxicological activation. Biotransformation reactions can also result in the formation of chemically stable metabolites with pharmacological activity (on or off target). Accordingly, metabolites can include compounds which are rendered (in vivo) biologically inactive, toxic, biologically active with a different target than the parent compound or more/less active than the parent compound with the same target.
(d) Level of one of ordinary skill in the art - The artisans synthesizing Applicant’s compositions to use in the treatment of pain would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level (at least a B.S. degree) and/or skill in the art, as well as several years of professional experience.
(e) Level of predictability in the art – Anari et al. (DDT, 2005, 10, pages 714-715, internal citations omitted) have addressed the situations in which metabolite predictability may be available. First, Anari et al. suggest that:
An experienced scientist familiar with various in vivo biotransformation pathways should be able to predict the potential metabolites of a given substrate based on the various functional groups present in that molecule.
Any measure of predictability that would result from the situation above is dependent on the artisan synthesizing Applicant's metabolites being well above that of ordinary skill in the art. A person having ordinary skill in the art would not have sufficient knowledge of the metabolic pathways involved with Applicant’s instant invention such that a meaningful prediction of metabolites could be made. Second, Anari et al. suggest that software packages can be used to predict metabolite formation, in that:
[T]he metabolic pathways of a given substrate can be predicted based on knowledge of the metabolism of similar structures in the database.
Any measure of predictability that would result from the situation above is dependent on the existence of a significant pool of data on the metabolism of structurally related compounds for which Applicant has not provided. Third, Anari et al. teach the use of empirically based expert software that can be used to predict metabolites based on expert rules of metabolism. While the third method appears to be useful for the prediction of metabolites, Anari et al. concede that the expert software often fails to predict metabolites that result from extensive metabolism:
[U]nexpected metabolites are observed occasionally whose molecular masses have not been anticipated. These metabolites often are formed by extensive metabolism of the parent drug via multiple enzymatic reactions in addition to non-enzymatic rearrangements.
Furthermore, and more importantly to the statute at issue is whether any predictability of the structure of a metabolite, which would enable a person having ordinary skill in the art to make the invention, corresponds to a predictability in the biological role of the metabolite, which would enable a person having ordinary skill in the art to use the invention. There is a significant lack of predictability in the art in determining whether a given compound will possess biological activity and, if so, how the biological activity relates to given a molecular pathway or disease state.
(f) Amount of direction provided by the inventor - The application is negligent regarding direction with respect to making and using analogs, MDMA-like compounds, including metabolites, or derivatives. The specification merely mentions a few examples of specific MDMA-like compounds (paragraph [00019], and merely mentionds prodrugs of an MDMA-like compound, analogs thereof and derivatives thereof without teaching the preparation thereof. Furthermore, Applicant has not provided any guidance that would lead a person of ordinary skill in the art to be able to predict certain metabolites, analogs or derivatives or predict the activity of these metabolites, analogs, or derivatives.
Applicant has not provided how to make a derivative, any compound which upon administration to a subject is capable of providing directly or indirectly a compound of formula I or a metabolite or residue thereof.
(g) Existence of working examples - While the claims recite MDMA like compounds, analogs, and derivatives, no working examples show their formation. The specification shows no evidence of the identification and actual existence of any metabolite, analog or derivatives. Hence, Applicant must demonstrate the identification of metabolites, analogs or derivative or limit the claims accordingly.
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure – Given the state of the art and lack of predictability discussed in section (e), undue experimentation is needed to practice the full scope of Applicant’s instant invention especially in view of the lack of direction discussed in sections (f) and (g). Nedderman, A. N. R. (Biopharm. Drug Dispos. 2009, 30, pages 153-154, internal citations omitted) teaches that multiple studies and methods are needed to characterize metabolites, in that:
[M]etabolite identification studies have typically been initiated during the compound selection phase of drug discovery with in vitro investigations using microsomes, hepatocytes or alternative metabolising systems and the analysis of in vivo samples from relevant animal species. Following these studies, the synthesis and pharmacological testing of potentially active metabolites would often be considered where appropriate. In addition to these structural elucidation studies, an in vitro experiment (most commonly a glutathione conjugation assay) to assess the propensity of the compound to undergo metabolism involving reactive pathways would typically be conducted in early discovery so that elimination of the reactive pathway via chemical re-design can be attempted. During drug development, definitive metabolite identification studies are performed in humans and all safety species using radiolabelled material.
Nedderman continues by stating that these studies require such a large amount of resources that they are often postposted, in that:
[T]he majority of metabolite identification work has historically been conducted late in drug discovery and late in drug development, primarily due to the complexity of structural elucidation and the associated time and resource requirements.
Accordingly, the studies necessary to perform a full characterization of a given compound’s metabolites are complicated and require experimentation that would be considered undue on a person having ordinary skill in the art given the lack of guidance provided by Applicant.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that applicant is insufficiently enabled for making and using MDMA-like compounds, prodrugs of an MDMA-like compound, analogs thereof and derivatives thereof is clearly justified along with the conclusion that applicant is only enabled for treating pain by administering MDMA, R-MDMA, S-MDMA, a mixture of enantiomers not in a 1:1 ration, a prodrug of MDMA, a prodrug of R-MDMA, or a prodrug of S-MDMA, and salts thereof
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, claims 1, 7, 12 have forms of the work include, see “including” (claim 1), “includes” (claim 7), and “including” (claim 12). Regarding claims 1, 7, and 12, forms of the phrase "include" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 recites the limitation “wherein said anti-infammatory/anti-pain agent is in the same single dosage form with the composition” There is insufficient antecedent basis for this limitation in the claim as there is no “single dosage form” in parent claim 12 for the anti-inflammatory/anti-pain agent to be in “the same”. It is also noted that “inflammatory” is spelled incorrectly in claim 14. As “anti-infammatory.”
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) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crisp et al.
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, 10 and 11). 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 claims 2-4 are anticipated. Instant claims 5-8, 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 anticipated 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.
Claim(s) 1-14 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 1-4, WO 2022/256720 provides claims 1 and claim 83:
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Additionally, paragraph [248] provides:
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340
478
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which corresponds to the instant invention.
In addition, for instant claim 5, WO 2022/256720 provides paragraph [17]:
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460
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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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136
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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, for instant claim 11, 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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58
468
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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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56
474
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which corresponds to the instant invention.
Conclusion
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 ____________________ 6 March 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600