DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 September 2025 has been entered.
Status of Application
The amendments and response filed 08 September 2025 are acknowledged and have been considered in their entireties. Claims 123 and 132-142 remain pending and subject to examination on the merits.
Withdrawal of Previous Objections/Rejections
The objection to claim 136 for having extraneous periods is withdrawn in view of the amendments to the claim.
The rejection claims 123, 132-134 and 136-142 under 35 U.S.C. 112(a), written description in view of the amendments to the claims to recite specific genes for modification and what kind of modifications.
New Objection(s)/Rejection(s)
Claim Objections
Claim 123 is objected to because of the following informalities: the chemical structures of Formula I, Formula II and Formula III are not present in the claim. On the structure for Formula IV appears. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 123 and 132-142 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.
Claim 123 has been amended to recite that the genetically modified psilocybe fungus has a genetic modification in at least one gene psilocybin synthesis gene selected from PsiD, PsiH, PsiM and PsiK; wherein the genetic modification is an insertion of a polynucleotide encoding said gene into the genome, a deletion of the at least one psilocybin synthesis gene(s), a substitution of at least one nucleobase, or a combination thereof; wherein the genetic modification results in an increased expression of the at least one Psilocybe synthesis gene. However, clearly deleting one of the genes cannot then result in an increased expression of said gene. This renders the claim indefinite and the dependent claims are included in the rejection as they do not remedy the noted deficiency.
Maintained Rejection(s)
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 123 and 132-142 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11905535. Although the. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims in their broadest are drawn to methods of treating a disease or condition in a subject by administering a pharmaceutical composition comprising a genetically modified Psilocybe fungus comprising a genetic modification in at least one psilocybin synthesis gene selected from PsiD, PsiH, PsiM, PsiK, or a combination thereof, wherein the genetic modification is to the genome of said Psilocybe and is an insertion of a polynucleotide encoding one of said genes, a deletion of the at least one psilocybin synthesis gene(s), a substitution of at least one nucleobase or a combination thereof, wherein the genetic modification results in increased expression of at least one of the psilocybin synthesis genes that results in an increased production of a compound selected from: dimethyltryptamine (DMT), psilocybin, psilocin, tryptamine, or derivatives or analogs thereof, compared to production of the same compound in a comparable control Psilocybe fungus without the genetic modification, wherein: the genetic modification results in an increased expression of a psilocybin biosynthesis gene compared to the expression of the psilocybin biosynthesis gene in a comparable control Psilocybe fungus without the genetic modification; and the genetically modified Psilocybe fungus comprises at least 200% more of the compound measured by dry weight of the fungus compared to the amount of the compound in a comparable control Psilocybe fungus without the genetic modification.
The claims to the ‘535 patent in their broadest are drawn to a genetically modified Basidiomycota fungus, comprising an exogenous PsiD gene or an exogenous PsiH gene, or both, and having a genetic modification that results in an increased production of a compound selected from the group consisting of: dimethyltryptamine (DMT), psilocin, tryptamine, and any combination thereof, wherein said Basidiomycota fungus with the genetic modification comprises at least 200% more psilocybin compared to a Basidiomycota fungus without the genetic modification; with dependent claims 16 and 17 comprising pharmaceutical compositions comprising the same.
Thus, the difference between the two sets of claims is the instant claims recite methods of using/treating subjects by administering the same composition recited in the ‘535 patent. In addition, the instant genus of Psilocybe is found within the Division of Basidiomycota. However, in construing the scope of the ‘535 claims ((See MPEP 804(II)(B)(1)) and ascertaining the disclosed utility (intended use) for the genetically modified Basidiomycota fungus of the ‘535 claims, it is clear the composition is intended to be utilized to treat selected from the group consisting of depression, anxiety, post-traumatic stress disorder, addiction, or secession related side-effects, psychological distress, and mental disorders and conditions. Thus, the currently claimed methods of doing just that, e.g. treating those same conditions are an obvious variation – See also, Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, (Fed. Cir. 2003), and Pfizer v. Teva, 518 F.3d 1353 (Fed Cir. 2008) and Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. July 28, 2010).
Applicant’s Remarks and Examiner’s Rebuttal:
Applicant’s traverse the rejection of record and state that because the claims to the ‘535 patent are drawn to a product and not a method of treating depression or anxiety, then the two sets of claims are distinct – See Remarks, pp. 12-13. It is asserted that not every element of the instant claims are found in the claims of the ‘535 patent, such as (1) a method of treating depression or anxiety.
The Examiner has considered this argument but does not find it convincing. Even for cases wherein patents issued from the same original application, the process of making/using and product made/used are subject to non-statutory double patenting if no restriction requirement was made, or even if the first claims presented were drawn strictly only to the product or only the methods. The later filed product or method would still be subject to non-statutory double patenting. This sort of precedence is well established in the courts, for example, in Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, (Fed. Cir. 2003), and Pfizer v. Teva, 518 F.3d 1353 (Fed Cir. 2008). In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness for inhibiting beta-lactamase. The later filed patent claimed a method of using the compound to affect beta-lactamase inhibition. Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation; the later filed patent claimed a method of using these compounds for treating inflammation. In both cases, the court ruled that the claims were not "patentably distinct," and thus the latter claims were invalid for non-statutory double patenting. In a somewhat more recent decision by the Federal Circuit, the same sort of rationale of looking to the specification to preferred embodiments was reiterated, even in CIP applications for products and methods of making or using said products; see Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010). Also see MPEP 804.01(A).
Here, upon construing the scope of the ‘535 patent claims, it is clear they are envisioned to be utilized to treat depression and anxiety (Col. 7, lines 29-36; Col 55, line 60 to Col. 56, line 6).
With regard to (2) and that anything regarding PsiM or PsiK genes are not disclosed, this is not convincing because the claims overlap in scope because PsiD and/or PsiH are explicitly claimed in the ‘535 patent and the instant claims recite a selection of one or more PsiH, PsiD, PsiK, PsiM, or a combination thereof.
With regard to (3), and that the genetic modification of at least one psilocybin gene (e.g. PsiH, PsiD, PsiK, PsiM) into a genome is selected from insertion of the one or more genes, deletion of the one or more genes, a substitution of at least one nucleobase of said one or more genes, or a combination thereof, is not disclosed in the ‘535 patent claims, this also is not convincing. This is because the PsiH and/or PsiD genes are introduced via a plasmid (See claim 2). And in construing the scope of the kinds of plasmids envisaged, it is clear that it results in either integration into the genome or is present transiently (See Col. 11, lines 28-40), wherein the examples specifically recite gene integration.
Thus, the claims patented claims and the instant claims overlap in scope with regard to the products. Further, as noted above, the courts have established non-statutory double patenting exists between products and methods of using said products. Here, the ‘535 patent clearly envisages using said products to treat depression and/or anxiety (See Col. 7, lines 29-36; Col. 55, line 60 to Col. 56, line 6).
As such, the rejection of record is maintained.
Conclusion
No claim is allowed.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 17 October 2025