DETAILED CORRESPONDENCE
Status of the Application
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 21, 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 2, 8, 13, 15, 17, 22, and 28-36 are pending in the application.
Applicant’s amendment to the claims, filed May 21, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed May 21, 2026 in response to the final rejection filed April 28, 2026 are acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Restriction/Election
In response to a requirement for restriction/election filed July 28, 2025, applicant elected without traverse Group I, pending claims 1, 2, 8, 13, 15, 17, and 28-36, the species N-methyltransferase (INMT) in claim 2, SEQ ID NO: 68 as the sequence in claim 1, and recombinant microorganism expresses INMT and produces at least one hydroxy substituted tryptamine compound in claims 30 and 31 in the reply filed September 26, 2025.
Lack of unity of invention is maintained because the species of SEQ ID NO: 1-289 in claim 1 do not share a common property or activity. Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is considered met when the alternatives are of a similar nature. When the Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as being of a similar nature where the following criteria are fulfilled:
(A) all alternatives have a common property or activity; AND
(B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR
(B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
The phrase “recognized class of chemical compounds” means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
The nucleic acids of SEQ ID NO: 1-289, which are considered to be chemical compounds, are not regarded as being of similar nature because the nucleic acids of SEQ ID NO: 1-289 are structurally distinct nucleic acids encoding structurally and functionally distinct polypeptides and all of the alternatives of SEQ ID NO: 1-289 are not considered to share a common property or activity.
The closest shared same or corresponding technical feature among the species of SEQ ID NO: 1-289 is considered to be a nucleic acid. Lack of unity of invention is also maintained because the closest shared same or corresponding technical feature among the species of SEQ ID NO: 1-289 is not a special technical feature as it does not make a contribution over the prior art. For example, Milne et al. (Metabolic Engineering 60:25-36, 2020; cited on Form PTO-892 filed October 16, 2025) discloses heterologous genes encoding enzymes for psilocybin biosynthesis (p. 29, column 2) and more specifically, GenBank Database Accession Number U00924 (July 1998, 1 page; cited on Form PTO-892) discloses a nucleic acid comprising instant SEQ ID NO: 1 (see Appendix for sequence alignment). As such, the closest shared same or corresponding technical feature among the species of SEQ ID NO: 1-289 is not a contribution over the prior art.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 28, 29, and 32-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 1, 2, 8, 13, 15, 17, 30, and 31 are being examined on the merits with claims 1 and 2 being examined only to the extent the claims read on the elected subject matter as set forth above.
In the interest of clarity, it is noted that at least one of the following claim rejections is directed to a non-elected species. However, the non-elected species has yet to be examined on the merits.
Priority
This application is filed under 35 U.S.C. 371 as a national stage of international application PCT/US2021/036031, filed June 4, 2021, which claims domestic priority under 35 U.S.C. 119(e) to U.S. provisional application no. 63/035,692, filed June 6, 2020. For reasons stated in the Office action filed October 16, 2025, the effective filing date of clams 1, 2, 8, 13, 15, 17, 30, and 31 is June 4, 2021.
Claim Objections
The objection to claim 30 for the recitation of “recombinant microorganism” is withdrawn in view of applicant’s amendment to replace “microorganism” with “yeast.”
Claim Rejections - Improper Markush Grouping
Claims 1, 2, 8, 13, 15, 17, 30, and 31 are rejected on the basis that claim 1 contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 (claims 2, 8, 13, 15, 17, 30, and 31 dependent therefrom) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Claim 1 (claims 2, 8, 13, 15, 17, 30, and 31 dependent therefrom) recites alternatives of structurally distinct nucleic acids encoding structurally and functionally distinct polypeptides. The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use. Claim 1 is a “Markush”-type claim that recites a plurality of structurally distinct nucleic acids encoding structurally and functionally distinct polypeptides. A Markush claim may be rejected under the judicially approved “improper Markush grouping” doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use.
The species of nucleic acids recited in the Markush grouping of claim 1 do not share any “single structural similarity,” i.e., a structural similarity essential to the common use of the species. When an examiner determines that the species of a Markush group do not share a single structural similarity or do not share a common use, then a rejection on the basis that the claim contains an “improper Markush grouping” is appropriate.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 17, 30, and 31 under 35 U.S.C. 112(b) for lacking antecedent basis in the recitation of “the enzyme or regulatory protein encoded thereby” is withdrawn in view of applicant’s amendment to claim 17 to replace “the” with “an” in the noted phrase.
Claim Rejections - 35 USC § 101
The rejection of claims 2, 8, 13, 15, 17, and 30 under 35 U.S.C. 101 is withdrawn in view of applicant’s amendment to claim 1 to recite “…comprising any one of SEQ ID NOs: 1-289.”
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014. This rejection has been modified from its previous version in order to address applicant’s amendment to the claims.
Claim Interpretation: As amended, claim 1 is drawn to a nucleic acid comprising any one of SEQ ID NOs: 1-289.
GenBank Database Accession Number U00924 (July 1998, 1 page; cited on Form PTO-892) teaches a naturally-occurring nucleic acid comprising instant SEQ ID NO: 1 (see attached Appendix for sequence alignment).
Given a broadest reasonable interpretation, claim 1 encompasses a naturally-occurring nucleic acid.
Patent Eligibility Analysis Step 1: The claim is drawn to a nucleic acid, which is a composition of matter and is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claimed nucleic acid is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a law of nature exception. Accordingly, the nucleic acid is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claim beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claim only recites a law of nature and does not include any additional elements that could add significantly more to the judicial exception.
As such, the claim does not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
RESPONSE TO REMARKS: Applicant argues the sequences of claim 1 are codon optimized and do not occur in nature. Thus, according to applicant, the claimed nucleic acid is markedly different from a naturally-occurring nucleic acid.
Applicant’s arguments are not found persuasive. For the reasons set forth above, the claims encompass a nucleic acid that is not markedly different from a naturally-occurring nucleic acid and claim 1 is rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112(a)
The rejections of claims 1, 8, 13, 15, 17, 30, and 31 under 35 U.S.C. 112(a) as failing to comply with the written description and enablement requirements are withdrawn in view of applicant’s amendment to claim 1 to recite “…comprising any one of SEQ ID NOs: 1-289.”
Claim Rejections - 35 USC § 102
The rejection of claims 1, 2, 13, 15, 17, and 30 under 35 U.S.C. 102(a)(1) as being anticipated by Milne et al. (Metabolic Engineering 60:25-36, 2020; cited on Form PTO-892 filed October 16, 2025; hereafter “Milne-1”), and
the rejection of claims 1, 2, 13, 15, 17, 30, and 31 under 35 U.S.C. 102(a)(2) as being anticipated by Milne et al. (WO 2022/248635 A2 with priority to EP 21176391.7 filed May 27, 2021; cited on Form PTO-892 filed October 16, 2025; hereafter “Milne-2”)
are withdrawn in view of applicant’s amendment to claim 1 to recite “…comprising any one of SEQ ID NOs: 1-289.” Neither Milne-1 nor Milne-2 teaches or suggests a nucleic acid comprising the nucleotide sequence of SEQ ID NO: 68.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank Database Accession Number U00924 (July 1998, 1 page; cited on Form PTO-892; hereafter “GenBank”).
As amended, claim 1 is drawn to a nucleic acid comprising any one of SEQ ID NOs: 1-289.
GenBank teaches a nucleic acid comprising instant SEQ ID NO: 1 (see attached Appendix for sequence alignment).
Therefore, GenBank anticipates claim 1 as written.
Claim Rejections - 35 USC § 103
The rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Milne-1 in view of Riggs et al. (WO 2007/120809 A1; cited on Form PTO-892 filed October 16, 2025; hereafter “Riggs”) and Dälken et al. (PLoS ONE 5:e14404, 2010, 10 pages; cited on Form PTO-892 filed October 16, 2025; hereafter “Dälken”), and
the rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Milne-2 in view of Riggs and Dälken
are withdrawn in view of applicant’s amendment to claim 1 to recite “…comprising any one of SEQ ID NOs: 1-289.” The cited prior art does not teach or suggest a nucleic acid comprising the nucleotide sequence of SEQ ID NO: 68.
Claim Rejections - Double Patenting
The rejection of claims 1, 2, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,441,164 B2 (cited on Form PTO-892 filed October 16, 2025),
the rejection of claim 8 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,441,164 B2 in view of Riggs and Dälken, and
the rejection of claims 13, 15, and 17 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,441,164 B2 in view of Milne-1,
are withdrawn in view of applicant’s amendment to claim 1 to recite “…comprising any one of SEQ ID NOs: 1-289.” The claims of the patent do not recite and the cited prior art does not teach or suggest a nucleic acid comprising the nucleotide sequence of SEQ ID NO: 68.
Conclusion
Status of the claims:
Claims 1, 2, 8, 13, 15, 17, 22, and 28-36 are pending.
Claims 22, 28, 29, and 32-36 are withdrawn from consideration.
Claims 1, 2, 8, 13, 15, 17, 30, and 31 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX
LOCUS U00924 120 bp mRNA linear PRI 23-JUL-1998
DEFINITION Human clone CE29 3.2 (CAC)n/(GTG)n repeat-containing mRNA.
ACCESSION U00924
VERSION U00924.1
KEYWORDS .
SOURCE Homo sapiens (human)
ORGANISM Homo sapiens
Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi;
Mammalia; Eutheria; Euarchontoglires; Primates; Haplorrhini;
Catarrhini; Hominidae; Homo.
REFERENCE 1 (bases 1 to 120)
AUTHORS Epplen,C. and Epplen,J.T.
TITLE Expression of (cac)n/(gtg)n simple repetitive sequences in mRNA of
human lymphocytes
JOURNAL Hum. Genet. 93 (1), 35-41 (1994)
PUBMED 7505766
REFERENCE 2 (bases 1 to 120)
AUTHORS Epplen,J.T.
TITLE Direct Submission
JOURNAL Submitted (20-AUG-1993) Jorge T. Epplen, Ruhr-Universitaet Bochum,
Molecular Human Genetics, Universitaetsstr. 150, Bochum W-4630,
Germany
FEATURES Location/Qualifiers
source 1..120
/organism="Homo sapiens"
/mol_type="mRNA"
/isolate="CE"
/db_xref="taxon:9606"
/clone="CE29 3.2"
/sex="female"
/cell_line="T cell clone"
/cell_type="T lymphocytes"
/tissue_type="peripheral blood"
/clone_lib="CE29"
/dev_stage="adult"
ORIGIN
Query Match 100.0%; Score 18; Length 120;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CACCACCACCACCATCAC 18
||||||||||||||||||
Db 5 CACCACCACCACCATCAC 22
Prosecution Insights