DETAILED ACTION
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of U.S. Provisional Application No. No. 63/186,298 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitation of claim 1 directed to a polymer conjugate structure PD-(X-Poly-T)n, wherein n is an integer comprised between 1 and 6 is not included in the priority document. Accordingly, claim 1 and claims dependent on claim 1 are not entitled to the benefit of this prior application.
This application claims benefit to U.S. Provisional Application No. 63/364,364, filed May 9, 2022, and claims 1-19 are given an earliest effective filing date of May 9, 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 9, 2023, July 22, 2025, and April 7, 2026 have been considered by the examiner. NPL 9 from the 5 page IDS filed 11/9/2023 does not have a date. NPL 35 from an 8 page IDS filed 11/9/2023 does not have a date. NPL 48-50 from an 8 page IDS filed 11/9/2023 do not have a date. NPL 1-3 and 33 from an 8 page IDS filed 11/9/2023 do not have a date. NPL 19 from an 8 page IDS filed 11/9/2023 does not have a date. These references have been lined through on the IDS.
Claim Status
Claims 1-19 are under consideration in this office action.
Claim Objections
Claim 1-2, 6, and 11-12 are objected to because of the following informalities:
The phrase “depending on preference” in claim is unclear. While the scope of “T” in the claim is not indefinite, because the limitations directed to an unreactive or reactive group or a group having a targeting property are given in the alternative, the phrase “depending on preference” lacks context and does not identify the basis of the preference. This objection can be overcome by removing the phase “depending upon preference”.
In claim 1, “serotonergic receptors” and “5-HT receptors” are used interchangeably. Consistent use of terminology is preferred.
In claim 2, psilocybin is misspelled as “psylocibin”.
Claims 1 and 11-12 use acronyms without first defining what they represent in the independent claims (i.e. “CNS”, “5-HT”, “NAFLD/NASH”, “BDNF”, “ROHHAD”). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym.
In claim 6, the molecular weight range of Poly is “> 500 Da and lower than 200 Da”. Consistent use of nomenclature is preferred. Application may consider amending the claim to recite “> 500 Da and < 200 Da” or “greater than 500 Da and less than 200 Da”.
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 1-19 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 uses parentheses to enclose the limitation “enzymatically and/or hydrolytically under physiological conditions”. Claim 19 uses parentheses to enclose the limitations “e.g., methoxy, ethoxy, propoxy, or butoxy” and “e.g., fluorine, chlorine, bromine, iodine”. The use of parentheses that encompass a limitation in the claim is found indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention or are just set forth as possible examples. Appropriate correction is required.
Claim 4 recites the limitations "the moieties” in line 6 and “the Poly derivative” in line 10. There is insufficient antecedent basis for these limitations in the claim because it is unclear what the moieties and derivatives are.
Claim 4, which is dependent on claim 1, recites the limitation "the methoxy group". There is insufficient antecedent basis for this limitation in the claim because there is no “methoxy group” in claim 1.
Claim 9 is drawn to a conjugate for “use in treating diseases caused by dysfunction of immunological cells, hepatic cells, pancreatic cells, or retinal cells”, claim 10 is drawn to a conjugate “for the treatment or prevent of autoimmune disorders”, claim 11 is drawn to a conjugate “for the treatment or prevention of metabolic disorders, including NAFLD/NASH, diabetes, and retinopathies”, and claim 12 is drawn to a conjugate “for the treatment or prevention of a condition selected from the metabolic syndrome, obesity, hyperglycemia, type 2 diabetes mellitus, high blood pressure, coronary artery disease including myocardial infarction and unstable angina, NAFLD and NASH, hypogonadism, testosterone insufficiency, hypothalamic-pituitary axis disorders, and BDNF insufficiency, including WAGR syndrome, 11p deletion, and 11p inversion, and Prader-Willi, Smith-Magenis, and ROHHAD syndromes.” The use and treatment limitations introduce a method-type limitation into a composition claim without clarifying the role that limitation plays in defining the claimed composition. For example, it is unclear whether the “use” language is intended to describe (i) a structural or functional characteristic of the conjugate (e.g., functionally capable of treating the disease) or (ii) an actual step in a method of use. Both interpretations are reasonable and materially different.
Claim 9 is indefinite because the phrase “diseases caused by dysfunction of immunological cells, hepatic cells, pancreatic cells, or retinal cells” fails to provide clear boundaries for determining the diseases encompassed by the claim. The claim and specification do not reasonably apprise the ordinary artisan which diseases are included within the scope of the recited treatment population.
Claim 14 is a composition for “oral, sublingual, transmucosal, intranasal, transdermal, parenteral, rectal, topical, vaginal, ophthalmic, intravitreal, corneal, or inhalation use.” The use limitation introduces a method-type limitation into a composition claim without clarifying the role that limitation plays in defining the claimed composition. For example, it is unclear whether the “use” language is intended to describe (i) a structural or functional characteristic of the composition (e.g., formulated for a specific route of administration) or (ii) an actual step of use. Both interpretations are reasonable and materially different.
Claim 15, which is dependent on claim 14, is drawn to a composition administered at doses ranging from 0.001 mg to 1 gram. Claim 15 fails to remedy the deficiency of claim 14. Further, the “administered” limitation of claim 15 also introduces a method-type limitation into a composition claim, and it is unclear whether the “administered” language limits the structure of the composition or is an actual method step. Both interpretations are possible and materially different.
Claim 16 is drawn to a composition wherein the Poly backbone “is chosen from” a group that includes a list of poly backbones and “other polysaccharides”. The phrase “is chosen from” renders the claims indefinite because it is not clear if the recited transitional phrase should be interpreted as open or closed language. The claim should be amended to use the more precise phrase “selected from the group consisting of”, as the phrase “selected from the group comprising” is also indefinite. Further, the inclusion of “other polysaccharides” is so broadly presented that the metes and bounds of the claim cannot be clearly interpreted. Appropriate correction is required.
The preamble of claims 16-19 recite “The composition”; however, there is no mention of a composition in claim 1. Rather, claim 1 is drawn to a conjugate”. Thus, there is insufficient antecedent basis for the composition limitation in the claims.
Regarding claim 19, the term “e.g.” renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
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 1-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Claims 1 and 3-19 are directed to a psychedelic drug (PD) polymer conjugate of general structure PD-(X-Poly-T)n, where X is a linker, PD is a CNS active PD targeting 5HT receptors, Poly is a covalently bonded chain of repeating monomer units, and T is an unreactive or reactive chemical group. As such, the claim is directed to broad genera of PD and chemical structures of X, Poly, and T. The PD is defined entirely by function, e.g., psychedelic properties and binding to 5HT receptors.
In claim 2, the PD is limited to psilocin or psilocybin. Even though the PD is sufficiently described, this claim remains rejected under 35 U.S.C. 112(a) because the chemical structures of X, Poly, and T are not sufficiently described.
With respect to the Poly, the specification describes at least 10 examples of different polymers [0017]. For T, the specification includes at least 25 examples [0018]. The claims, under broadest reasonable interpretation, are drawn to broad genera of Poly and T structures that are not limited to these examples in the specification.
Regarding the PD, the specification describes at least 15 different PD (pg 13). The specification, however, does not provide a common structure for PD and offers no guidance as to what is possessed under the broad claims. As such, PD encompasses a broad genus of PDs that target 5HT receptors. These drugs are not limited to those that bind 5HT2A or 5HT2C receptors, but to all 5HT receptors. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of PD that target 5HT receptors.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole may not be adequately described by its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function.
The written description requirement for a claimed genus 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. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing a few species within the genus.
Methods of use of agents described by function alone are not special and are not excluded from the written description requirement. As was held in University, Rochester v G.D. Searle Co., 358 F.3d 916 (Fed. Cir. 2004), a functional genus cannot be described by a method of obtaining or screening for the agent that meets the functional limitations of the claim. The written description requirement applies to whatever is claimed and methods of use are not excluded therefrom. The skilled artisan would not have understood that Applicant was in possession of, for example, the genus of biomaterials as the specification merely exemplifies one or two species of a potential vast genus of structurally and functionally different biomaterials.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genera of Poly, X, T and PD, and because the genera are highly variant, PD targeting serotonergic receptors, for example, alone is insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, applicant was not in possession of the claimed genera of claims 1-19 at the time the invention was filed. In the instant application, neither the art nor the specification provide a sufficient representative number of PD, Poly, or T or a sufficient structure-function correlation to meet the written description requirements.
Therefore, only those active agents specifically named in the specification, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. 112(a). Applicant is reminded that Vas-Cath makes it clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see Vas-Cath at page 1115).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 7-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 20180221396, published August 9, 2018 (“Chadeayne”; IDS from 11/9/2023).
Chadeayne teaches a conjugate comprising psilocybin bound to excipients, including polyethylene glycol and polyvinylpyrrolidone [0085]-[0089], [0277], [0278], which reads on the PD polymer conjugate comprised of CNS active PD that targets serotonergic receptors of instant claim 1 and the PD of psilocybin on instant claim 2. Psilocybin comprises amino and phosphate groups [0086], which reads on the chemically reactive functional group of claim 1. Chadeayne teaches structures of psilocybin and psilocin with a hydrogen at the nitrogen on the indole group ([0085]-[0087], see structures of psilocybin and psilocin, respectively from pg 12 of Chadeayne disclosure),
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which reads on the limitation wherein the (X-Poly-T) group is, independently, hydrogen. Chadeayne teaches compositions comprising the psilocybin derivatives [0019]-[0020], which reads on the composition of instant claims 13-15. This composition can be administered orally [0334], which reads on instant claim 14.
Chadeayne teaches that the compositions cross the blood-brain barrier [0333], which reads on instant claim 7.
Claims 8-12 recite an intended use that does not impart structural limitations to the conjugate.
Because Chadeayne teaches the PD conjugate of claim 1, it would be expected, absent any evidence to the contrary, that this conjugate could be used in treating diseases affecting peripheral cells (as in claim 8), diseases caused dysfunction of immunological cells (as in claim 9), treating or preventing autoimmune disorders (claim 10), treating or preventing metabolic disorders (claim 11), and treating or preventing metabolic syndrome, obesity, hyperglycemia, type 2 diabetes mellitus, high blood pressure, coronary artery disease including myocardial infarction and unstable angina, NAFLD and NASH, hypogonadism, testosterone insufficiency, hypothalamic-pituitary axis disorders, and BDNF insufficiency, including WAGR syndrome, 11 p deletion, and 11 p inversion, and Prader- Willi, Smith-Magenis, and ROHHAD syndromes (claim 12). Because the PD conjugate satisfies all the structural limitations set forth in the claims, it necessarily follows that the conjugate inherently possesses the functionality and the ability to serve the intended use recited in the claims, absent objective evidence to the contrary.
Claim Rejections - 35 USC § 103
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180221396, published August 9, 2018 (“Chadeayne”) in view of US 2009/0185998, published July 23, 2009 (“Veronese”; IDS from 11/9/2023).
Chadeayne teaches a PD conjugate of general structure PD-(X-Poly-T)n, where (X-Poly-T) is hydrogen. Chadeayne does not teach the limitations of claims 3-7 and 15-19.
Veronese teaches chemically active poly(ethylene glycols) and other hydrophilic polymers that are suitable for coupling to pharmaceutically or diagnostically active agents such as peptides, oligonucleotides, proteins or non-peptide molecules; the compounds are represented by the formula Poly-(X-NH-CO-A)n, wherein Poly is a hydrophilic polymer; A together with -NH-CO-- forms a reactive group; X is a spacer or a bond; n is an integer comprised between 1 and 50 (abstract), as in instant claim 1.
Veronese teaches the coupling of small molecule of drugs to polyethylene glycol [0015], as in instant claims 3 and 16. Veronese teaches that the poly preferably comprised methoxy-polyethylene glycol [0032], as in instant claim 4. The linker X can be an alkyl group comprising 2-10 carbons substituted by an oxy group [0046], as in the limitation of claim 5 wherein the linker is an ether group.
The Poly of Veronese has a molecular weight from about 300 to 100000 Daltons [0018], which overlaps with the poly molecular weights of claims 6 and 17-18. Veronese teaches that Poly may be a linear or branches structure of polyethylene glycol [0032], as in instant claim 18.
In Example 1 of Veronese, PEG is bound to CH3O, a methoxy group [0048], as in the lower alkoxy limitation of claim 19.
Given that Chadeayne teaches a PD conjugate and further given that Veronese teaches drug conjugate structures of general structure drug-(X-Poly-T), it would have been obvious to one of ordinary skill in the art to substitute the small molecule PD psilocybin in the structure of Veronese and have a reasonable expectation of successfully generating the claimed conjugate. The motivation to do so comes from Veronese, who teaches that conjugation of these activated PEGs and related polymer derivatives to a drug makes it possible to impart water solubility, increased size, reduced kidney clearance, stability and reduced immunogenicity to the conjugate [0017]. Because of these advantages of the Veronese conjugate, one of ordinary skill in the art would have applied this known conjugate structure to a known PD-conjugate that was ready for improvement with a reasonable expectation of success. Such would amount to the combination of a known element in a known technique to improve a similar product in the same way. Applying a known technique to a known product ready for improvement to yield predictable results is obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
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