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 .
DETAILED ACTION
Claims 1-113 are pending in the application. Claims 1-7, 9-18, 23-25 and 28-91 are rejected. Claims 8, 19-22, 26, 27 and 92-113 are objected to.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/EP2023/057827, filed March 27th, 2023, which claims priority under 35 U.S.C. 119(a-d) to EP22000083.0, EP22000086.3, EP23153995.8 and EP23153939.6, filed March 27th, 2022, March 27th, 2022, January 30th, 2023 and January 30th, 2023.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on January 15th, 2025, February 27th, 2025, March 28th, 2025, April 30th, 2025, May 30th, 2025, July 31st, 2025, August 29th, 2025, September 26th, 2025, October 31st, 2025, December 15th, 2025, January 21st, 2026 and February 23rd, 2026.
Claim Objections
Claims 19-22, 27 and 92-113 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claims 8, 26, 27 and 92-113 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim 18 recites exemplary language that would normally be rejected under 35 USC 112(b); however, since the preamble does not limit the scope of the claim, the exemplary language is moot. Regardless, the exemplary language should be deleted.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 9-18, 23-25 and 28-91 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a naturally occurring compound. This judicial exception is not integrated into a practical application because the claims do not require more than the natural product itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only recite an intended use that does not materially limit the compound.
Applicant is directed to MPEP 2106 regarding criteria for subject matter eligibility.
Step 1
Step 1 in the analysis is “Is the claim to a process, machine, manufacture or composition of matter?” In this situation, the claims are directed to compositions of matter (Step 1: YES).
Step 2A: Prong One
The next step (2A) is a two-prong inquiry where prong one is “Does the claim recite an abstract idea, law of nature, or natural phenomenon?” In this situation, the claims embrace a naturally occurring compound, i.e. nature-based product. Reckweg et al. (Journal of Neurochemistry 2022, 162, 128-146) teach in the abstract: “5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a naturally occurring tryptamine…”. There is no indication or requirement of the instant claims that the material(s) claimed is different structurally from the compound as found in its natural environment.
For the reasons above, the instant claims are directed to a nature-based product or mixture of nature-based products. As noted in MPEP 2106.04(b)(II):
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. […]
Furthermore, MPEP 2106.04(c)(I)(A) states:
Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.
MPEP 2106.04(c)(II) sets forth the process for performing the markedly different characteristic analysis including the steps of “selecting the appropriate counterpart(s),” “identifying appropriate characteristics for analysis,” and “evaluating characteristics to determine whether they are ‘markedly different’”.
The appropriate counterpart would 5-MeO-DMT as it occurs in nature. MPEP 2106.04(c)(II)(A) notes:
Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013)
Accordingly, even though 5-MeO-DMT occurs in, for instance, humans, the counterpart is not the entire human.
MPEP 2106.04(c)(II)(B) outlines identifying appropriate characteristics that can include “Biological or pharmacological functions or activities;” “Chemical and physical properties;” and “Structure and form, whether chemical, genetic or physical.” In the instant situation, Applicant discloses that 5-MeO-DMT can allegedly be used in treating sleep disturbances.
MPEP 2106.04(c)(II)(C) outlines evaluating characteristics and notes:
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.
In this situation, 5-MeO-DMT only appears to be functionating based on its inherent properties.
For the reasons above, the instantly claimed compositions do not possess markedly different characteristics relative to the naturally occurring counterparts since they have the same structure and property of the materials that occur in nature. (STEP 2A, Prong One: YES).
Step 2A: Prong Two
The second prong of step 2A is (MPEP 2106.04(d)) to determine whether the claim as a whole integrates (or does not integrate) the judicial exception into a practical application. In the instant situation, the claims are generally only a compound that do not require application to any particular condition or any specific type of formulation. Regarding the recitation of “for use” in claim 1, statements of intended use are not given patentable weight. See MPEP 2111.02(II). Similarly, the dependent claims cover the identical 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof embraced by claim 1 since they are address the intended use of claim 1.
Step 2B
The final step (MPEP 2106.05(II)) is “Does the claim recite additional elements that amount to significantly more than the judicial exception?” The same section instructs:
Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
The instant claims are drawn to 5-MeO-DMT. None of the claims require anything beyond the naturally occurring compound.
For these reasons, the claims do not require significantly more than the exception itself. (STEP 2B: NO).
Based on the analysis above, the instant claims are deemed to be drawn to subject matter that is ineligible under 35 USC 101.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-7, 9-18, 23-25 and 28-91 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 is directed to 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof for use in an application. Statements of intended use, however, are not given patentable weight. See MPEP 2111.02(II). Accordingly, the dependent claims cover the identical 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof embraced by claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7, 9-18, 23-25 and 28-91 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reckweg et al. Journal of Neurochemistry 2022, 162, 128-146, published February 11th, 2022.
Reckweg et al. teach in the abstract: “5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a naturally occurring tryptamine…”. Regarding the recitation of “for use” in claim 1, statements of intended use are not given patentable weight. See MPEP 2111.02(II). Similarly, the dependent claims cover the identical 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof embraced by claim 1 since they are address the intended use of claim 1.
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 1-7, 9-18, 23-25 and 28-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
(1 of 30) claims 1-12 of U.S. Patent No. 12,685,721;
(2 of 30) claims 1-15 of U.S. Patent No. 12,612,363;
(3 of 30) claims 1-22 of U.S. Patent No. 12,685,722;
(4 of 30) claims 1-29 of U.S. Patent No. 12,642,787; and
(5 of 30) claims 1-22 of U.S. Patent No. 12,172,960.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite compositions comprising 5-MeO-DMT, methods of making 5-MeO-DMT, methods of using 5-MeO-DMT or pharmaceutically acceptable salts of 5-MeO-DMT. Regarding the recitation of “for use” in claim 1, statements of intended use are not given patentable weight. See MPEP 2111.02(II). Similarly, the dependent claims cover the identical 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof embraced by claim 1 since they are address the intended use of claim 1.
Claims 1-7, 9-18, 23-25 and 28-91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
(6 of 30) claims 1-4, 6, 15-17, 19-24 and 28-31 of copending Application No. 18/675,614;
(7 of 30) claims 1-18 of copending Application No. 19/564,993;
(8 of 30) claims 1-7, 9-14 and 31-37 of copending Application No. 19/573,936;
(9 of 30) claims 86-92 of copending Application No. 18/373,906;
(10 of 30) claims 33-68 of copending Application No. 18/850,394;
(11 of 30) claims 1-18, 28, 32, 35-38 of copending Application No. 18/373,903;
(12 of 30) claims 284-314 of copending Application No. 18/851,343;
(13 of 30) claims 98-132 of copending Application No. 18/850,370;
(14 of 30) claims 70-100 of copending Application No. 18/850,362;
(15 of 30) claims 120-150 of copending Application No. 18/850,376;
(16 of 30) claims 115-144 of copending Application No. 18/850,348;
(17 of 30) claims 78-84, 86-88, 90-92, 97-112 of copending Application No. 18/851,356;
(18 of 30) claims 1-87 of copending Application No. 18/373,914;
(19 of 30) claims 119-143 of copending Application No. 18/851,362;
(20 of 30) claims 283-305 of copending Application No. 18/851,336;
(21 of 30) claims 1-112 of copending Application No. 18/851,349;
(22 of 30) claims 97-124 of copending Application No. 18/851,301;
(23 of 30) claims 114-137 of copending Application No. 18/851,294;
(24 of 30) claims 1-68 of copending Application No. 18/851,311;
(25 of 30) claims 1-38 of copending Application No. 18/373,904;
(26 of 30) claims 1-24 of copending Application No. 18/920,063;
(27 of 30) claims 1-11 of copending Application No. 18/290,976;
(28 of 30) claims 1-18 of copending Application No. 19/712,663;
(29 of 30) claims 1-38 of copending Application No. 19/732,033; and
(30 of 30) claims 34-43 of copending Application No. 19/739,909.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending cases recite compositions comprising 5-MeO-DMT, methods of making 5-MeO-DMT, methods of using 5-MeO-DMT, a pharmaceutically acceptable salt of 5-MeO-DMT or 5-MeO-DMT in a different intended use. Regarding the recitation of “for use” in claim 1, statements of intended use are not given patentable weight. See MPEP 2111.02(II). Similarly, the dependent claims cover the identical 5-methoxy-N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof embraced by claim 1 since they are address the intended use of claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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