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 .
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.
Status of Claims
Claims 1-9 and 11 are pending. Claims 2-4, 7-9 and 11 are withdrawn. Claims 1 and 5-6 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 and 5-6) in the reply filed on 07/20/2026 is acknowledged.
Claims 2-4, 7-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to the nonelected groups, there being no allowable generic or linking claim. Election was made without traverse. Note that claims 7-9 and 11 are not directed to claim 1 (see below art and 112b rejections). Although claims 8-9 have been amended, these claims are still under Group III because the claims are directed to using the artificial dimethyltryptamine antigen not making the antigen.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus:
Claims 5-6 are drawn to an artificial dimethyltryptamine antigen.
As written, the claims encompass a large genus of dimethyltryptamine antigens having the desired functional property of dimethyltryptamine. The claims would cover all possible antigens against dimethyltryptamine.
MPEP 2163 states that “For some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, "(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 ("The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes" where the genes were novel combinations of known DNA segments.). However, the claimed invention itself must be adequately described in the written disclosure and/or the drawings. For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties)”. (Emphasis added).
In view of the Amgen decision, a disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not provide an adequate written description of an antibody (in this case, the claimed antigen) claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. Based from the disclosure, the term antigen refers to antibody.
In the present case, the specification does not disclose the structure (e.g., sequences) of the antigen, but only a limited and specific process of making said antigen (see Examples, as filed). Moreover, there is no information about any biological deposits of antigen sequences in the instant disclosure. As stated above, in view of the Amgen decision, a characterized dimethyltryptamine antigen alone is not enough to be considered adequate written description. In Amgen, the court indicates that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e. the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it.
MPEP 2163II3ii states under representative number of species that “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)).
Meanwhile, the recitation of the artificial dimethyltryptamine antigen is obtained by coupling the dimethyltryptamine hapten according to claim 1 to a carrier protein and has a molecular structural formula as shown in Formula (II), wherein the Formula (II), protein refers to the carrier protein is directed to product-by-process. MPEP 2113(I) states that product-by-process claims are not limited to the manipulations of the recited steps, only the end structure implied by the steps. In the case of the disclosed preparation, the application does not describe the structure nor disclose the sequence of antibodies from the preparation. Therefore, one cannot envision the chemical structures of the claimed antigen by referencing binding property of said antigen.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the artificial dimethyltryptamine antigen.
For all of these reasons, the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 5-6 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 1 recites the dimethyltryptamine hapten has a molecular structural formula as shown in Formula (I) is unclear to the metes and bounds of what encompasses a dimethyltryptamine hapten. In particular, Formula (I) shows a specific chemical compound with defined structures. Therefore, the recitation of “has” implies that the dimethyltryptamine hapten has other components coupled to Formula (I), which would modify Formula (I). Thus, the modification would not retain the recited Formula (I). Meanwhile, the phrase dimethyltryptamine implies a core indole structure. However, Formula (I) does not reflect a core indole structure, as it contains a trifluoro group at the amine position.
Claims 5-6 recite a product-by-process of which the method is not clear to what is being attached to the carrier protein. Is the carrier protein attached to the dimethyltryptamine hapten of claim 1 of Formula (I) or Formula (II)? These formulas have different chemical structures. Note that if the claimed antigen is produced from Formula (I) conjugating to the carrier protein, then Applicant needs to specifically point to where the passages in the instant disclosure of Formula (I) conjugating to a carrier protein (without removing the protecting group) produces the antigen. The use of dichloromethane, ammonia, ethanol and 1,4-dioxane would remove the trifluoro protecting group (as filed in Example 1) from the dimethyltryptamine structure.
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.
Claims 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaguchi et al. (“Preparation of Monoclonal Antibodies Reactive to a Hallucinogenic Drug, Psilocin”, Journal of Health Science, 50(6), pgs. 600-604, published 2004).
Yamaguchi teaches an antigen inducing an anti-psilocin mAb, N-{ 4-[3-(2-dimethylaminoethyl)indol-4-yl-oxy ]butyl} succinamic acid was synthesized by modifying the 4-hydroxyl moiety of psilocin and coupled to a carrier protein of keyhole limpet hemocyanin and hybridoma cells producing mAbs reactive to psilocin, from which four clones, BA631, CA231, KA422, and MA332 with a higher production of anti-psilcoin mAbs (see abstract and Fig 1). Also, Yamaguchi teaches the antibody cross-reacted with dimethyltryptamine by 148% (see pg. 603, left col., para. 3, Table 2), which would read on the limitation of an artificial dimethyltryptamine antigen.
Meanwhile, the recitation of the artificial dimethyltryptamine antigen is obtained by coupling the dimethyltryptamine hapten according to claim 1 to a carrier protein and has a molecular structural formula as shown in Formula (II), wherein the Formula (II), protein refers to the carrier protein is directed to product-by-process.
MPEP 2113(I) states that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (end product):
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim"). (Emphasis added).
In this particular case, the end products are only artificial dimethyltryptamine antigens, which is taught by Yamaguchi.
With respect to claim 6, Yamaguchi teaches using carrier protein of keyhole limpet hemocyanin (see abstract). However, the recitation of the carrier protein being used to produce the antigen is product-by-process. The final structure of the antigen does not include the carrier protein.
Free of Prior Art
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The closest prior art reference of record Yamaguchi. The reference teaches N-{ 4-[3-(2-dimethylaminoethyl)indol-4-yl-oxy ]butyl} succinamic acid (see Fig. 1). However, Yamaguchi fails to teach or reasonably suggest the claimed dimethyltryptamine hapten containing a trifluoro group.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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