DETAILED ACTION
Claims 1-20 are currently pending in the instant application. Claims 1-10 are rejected. Claims 11-20 are withdrawn.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 2 September 2026 is acknowledged.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-22, and 24-28 of U.S. Patent No. 11,939,346 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014). Conflicting claims 19-22 and 24-28 are drawn to pharmaceutical compositions comprising the crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 20 provides a capsule. Conflicting claim 21 provides a tablet. Conflicting claim 24 provides 25mg. Column 3 provides the treatment of drug resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 3 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of drug resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 20 of the ‘346 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-18, and 20-30 of U.S. Patent No. 11,851,451 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014). Conflicting claims 15-18 and 20-30 are drawn to pharmaceutical compositions comprising the crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 20 provides a capsule. Conflicting claim 21 provides a tablet. Conflicting claim 24 provides 25mg. Column 1 provides the treatment of treatment resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 1 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 19 of the ‘451 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-18, and 20-30 of U.S. Patent No. 11,629,159 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 15-18 and 20-30 are drawn to pharmaceutical compositions comprising the crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 16 provides a capsule. Conflicting claim 17 provides a tablet. Conflicting claim 20 provides 25mg. Column 1 provides the treatment of treatment resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 1 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 20 of the ‘159 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-27 of U.S. Patent No. 11,447,510 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 1-3 and 7-27 are drawn to treatment of treatment resistant depression comprising orally administering an oral dosage form of a crystalline hydate A of psilocybin. Conflicting claim 7 provides 25mg. Conflicting claim 8 provides a capsule and conflicting claim 9 provides a tablet. In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 20 of the ‘510 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-15, and 19-25 of U.S. Patent No. 11,180,517 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 1-3, 7-15, and 19-25 are drawn to treatment of treatment resistant depression comprising orally administering an oral dosage form of a crystalline polymorph A of psilocybin with peaks at 17.5 and 19.7 +/- 0.1. Conflicting claims 7 and 19 provide 25mg. Conflicting claims 8 and 21 provides a capsule and conflicting claims 9 and 22 provide a tablet. In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 20 of the ‘517 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 8 of U.S. Patent No.11,149,044 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 1-5 and 8 are drawn to pharmaceutical compositions comprising the crystalline hydrate of psilocybin of claim 1. Conflicting claim 2 provides a capsule. Conflicting claim 3 provides a tablet. Conflicting claim 8 provides 25mg. Column 1 provides the treatment of treatment resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 1 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 21 of the ‘044 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No.10,954,259 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 1-4 and 7 are drawn to pharmaceutical compositions comprising the crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 2 provides a capsule. Conflicting claim 3 provides a tablet. Conflicting claim 7 provides 25mg. Column 1 provides the treatment of treatment resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 1 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, columns 19 and 20 of the ‘259 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5-20 of U.S. Patent No. 10,947,257 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 1, 2, and 5-20 are drawn to an oral dosage form comprising the crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 15 provides a capsule. Conflicting claim 16 provides a tablet. Conflicting claim 5 provides 25mg. Column 1 provides the treatment of treatment resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with column 1 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, columns 19 and 20 of the ‘257 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5-21 of U.S. Patent No. 10,519,175 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014) and further in view of Datta et al. Nature Reviews/Drug Discovery Volume 3, January 2004, 42-57.
Conflicting claims 1, 2, and 5-21 are drawn to methods of treating drug resistant depression comprising orally administering an oral dosage form of crystalline psilocybin of claim 1 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claim 5 provides 25mg. Column 3 provides the treatment of drug resistant depression.
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims for the administration of 25mg psilocybin for the treatment of drug resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, column 19 of the ‘175 patent provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
The difference between instant claim 6 and 7 and the conflicting claims is that the conflicting claims provides oral administration, however, tablets and capsules are both versions of oral administration. Additionally, tablets and capsules are both discussed in USP General Chapter <905> for label claim and acceptance value. Therefore, it would be obvious to utilize a tablet or capsule for oral administration when the conflicting claims of the ‘175 patent provides oral administration.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-12, 14, 23-26, and 28 of copending Application No. 19/661,190 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014).
Conflicting claims 9-12, 14, 23-26, and 28 are drawn to pharmaceutical compositions comprising the crystalline psilocybin of claim 1 and 15 which has XRPD peaks at 17.5 and 19.7 +/-0.1. Conflicting claims 10 and 24 provide capsules. Conflicting claims 11 and 25 providea tablet. Conflicting claims 14 and 28 provides 25mg. Page 5 provides the treatment of drug resistant 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).
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims along with page 5 of the conflicting specification provide for the administration of 25mg psilocybin in a capsule or tablet for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Additionally, page 23 of the ‘190 application provides a good blend will have an Acceptance value, AV of less than 15, and more preferably less than 10 and it will also have a % label claim of greater than 90%, more preferably greater than 94%.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22, 25-27, 29, 34-37, 46 and 47 of copending Application No.18,/718,103 in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014) and further in view of Datta et al. Nature Reviews/Drug Discovery Volume 3, January 2004, 42-57.
Conflicting claims 1-22, 25-27, 29, 34-37, 46 and 47 are drawn to methods of treating treatment resistant depression comprising administering psilocybin. Conflicting claim 34 provides 25mg. Conflicting claim 36 provides oral administration. Conflicting claim 37 provides crystalline psilocybin. Conflicting claims 46 and 47 provide XRPD peaks at 17.5 and 19.7 +/- 0.1.
In regards to the Acceptance value and % label claim limitations in the instant claims, as seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the conflicting claims for the administration of 25mg psilocybin for the treatment of drug resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
The difference between instant claim 6 and 7 and the conflicting claims is that the conflicting claims provides oral administration, however, tablets and capsules are both versions of oral administration. Additionally, tablets and capsules are both discussed in USP General Chapter <905> for label claim and acceptance value. Therefore, it would be obvious to utilize a tablet or capsule for oral administration when the conflicting claims of the ‘103 application provides oral administration.
This is a provisional nonstatutory double patenting rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris et al. (IDS filed 5/20/26, Cite No. 733: CARHART-HARRIS et al. "Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study." The Lancet Psychiatry. 2016 Jul;3(7):619-627. doi: 10.1016/S2215-0366(16)30065-7) in view of USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014) and further in view of Datta et al. Nature Reviews/Drug Discovery Volume 3, January 2004, 42-57.
Carhart-Harris et al. provides for the treatment of treatment resistant major depression by administering 25mg of an oral dose of psilocybin, see methods, page 619. Psiliocybin was well tolerated and led to enduring reductions in symptom severity after two sessions (page 620). Page 621 provides that the psilocybin was formulated into 5mg capsules with patients receiving five 5mg capsules for the 25mg does.
The difference between instant claims 1-8 and the prior art is that the instant claims specify the acceptance Value (AV) of less than 15 and a percentage of a label claim of greater than 90%. However, as seen in the instant specification, paragraphs [0099]-[00101]:
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. As seen in USP General Chapter <905> “Uniformity of Dosage Units” (US Pharmacopeial Convention, Rockville, MD, 2014), to ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim (page 1). Additionally, Acceptance Value and the calculation thereof is provided on pages 2 and 3. The information provided was harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia, page 1. The limitations of Acceptance Value and percentage of label are conventional attributes that a person having ordinary skill in the art would routinely optimize to produce a good blend. The limitations of Acceptance Value and percentage of label do not identify additional ingredients or change the therapeutic method, rather they characterize the uniformity of the drug content. A person having ordinary skill in the art would ordinarily seek to ensure both that the individual dosage unit contains sufficient uniform amounts of the active ingredient and that the measured drug content would remain close to the intended 25mg. As the prior art teaches administration of 25mg psilocybin in a capsule for the treatment of treatment resistant depression, the claim limitations of AV and percent of a label would be ordinary pharmaceutical manufacturing and quality control objectives well within the skill of a person of ordinary skill in the art, who would, without undue experimentation, adjust formulation variables to obtain acceptable content uniformity and potency via routine formulation and manufacturing optimization. Please see MPEP 2144.05 and 2144.05(II) and In re Aller, 220 F.2d 454,456,105 USPQ 233, 235 (C.C.P.A. 1955): [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
The difference between instant claim 6 and the prior art is that the prior art administers a capsule instead of a tablet. However, Carhart-Harris et al. provides oral administration of psilocybin, including capsules. Tablets and capsules are both versions of oral administration. Additionally, Tablets and capsules are both discussed in USP General Chapter <905> for label claim and acceptance value. Therefore, it would be obvious to utilize a tablet for oral administration when Carhart-Harris et al. provides oral administration including capsules.
The difference between instant claim 8 and the prior art is that the prior art does not state that the psilocybin is crystalline. However, as seen by Datta et al. Nature Reviews/Drug Discovery Volume 3, January 2004, 42-57, Most marketed pharmaceuticals consist of molecular crystals, page 42 as pharmaceutical solids can be classified as either crystalline solids, or amorphous solids. Amorphous solids are not marketed as widely as the crystalline forms because of their lower chemical stability and their innate tendency to crystallize, page 42. Therefore, it would be obvious to utilize crystalline psilocybin as most marketed pharmaceuticals consist of molecular crystals.
Conclusion
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 22 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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