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 .
Formal Matters
Claims 1-57 were originally presented on 10/18/2024. The preliminary amendments to the claims, also filed on 10/18/2024, have been received and entered. Claims 1, 4, 6, and 8-57 were cancelled.
Claims 2-3, 5, and 7 are pending and under examination.
Priority
This application is a 371 of PCT/US23/66055, filed 04/21/2023, which claims benefit of priority to U.S. Provisional Application No. 63/333,327, filed on April 21, 2022; U.S. Provisional Application No. 63/388,365, filed on July 12, 2022; U.S. Provisional Application No. 63/368,520, filed on July 15, 2022; and U.S. Provisional Application No. 63/368,522, filed on July 15, 2022.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed 10/18/2024 and 11/11/2024 have been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 2, 5, and 7 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 2 is drawn to “[c]rystalline form I” of the compound 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide, but sets forth no description of this form I, e.g., distinguishing characteristics thereof, or what is intended to be encompassed by the scope of “[c]rystalline form I”. A person of ordinary skill in the art would not be reasonably apprised whether any given “crystalline form” of the compound 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide falls within the scope of the claimed “form I”. For example, anyone can arbitrarily name any crystalline form of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide “form I”, even if it has different distinguishing characteristics, e.g., X-ray powder diffraction pattern, than the crystalline form of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide Applicant names “form I”. Applicant cannot not rely on the specification for a description of that which they are intending the claims to encompass because the disclosure does not unambiguously define “form I” as actually requiring any specific distinguishing characteristics. Rather, Applicant only discloses that “[i]n one embodiment” it is characterized by at least one of: a monoclinic, P2₁/c space group at a temperature of about 297(2) K; unit cell dimensions a = 7.5611(4) Å, b = 10.5042(5) Å, C = 23.9095(12) Å, α = 90°, ß = 98.184(2)°, and γ = 90°; an X-ray powder diffraction (XRPD) pattern substantially similar to FIG. 7; and an X-ray powder diffraction pattern characterized by at least two peaks selected from 9.2, 13.1, and 18.5 °2Θ ± 0.2 °20. See [006]. In other embodiments, however, it is entirely unclear what distinguishing characteristics “[c]rystalline form I” of the compound 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide as claimed possesses.
Here, the claim term “[c]rystalline form I” is given its plain and ordinary meaning as would be understood by those skilled in the art, i.e., any crystalline form of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide named by those skilled in the art as “form I”. However, such a claim term is considered to be ambiguous absent any recitation of particular distinguishing characteristics of the “form I”. "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) (discussing recent cases wherein the court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment). Such is the case here where Applicant describes only a single embodiment of a “crystalline form I” of the compound 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide having particular distinguishing characteristics in the disclosure. However, claim 2 cannot be construed as being limited to that embodiment.
Claims 5 and 7, which depend from indefinite claim 2, are also indefinite because they do not recite any limitations that clarify the scope of the claimed “[c]rystalline form I” recited in claim 2 from which they depend. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim 3 is 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.
Recitation of “an X-ray powder diffraction pattern substantially similar to FIG. 7” lacks objective boundaries and does not inform a person of ordinary skill in the art what specific similarities to the X-ray powder diffraction pattern of FIG. 7 a given crystalline form of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide must have or how similar those similarities must be. For example, it is unclear if an X-ray powder diffraction pattern must have all of the same peaks at the same intensities to be considered “substantially similar” to FIG. 7. The claim term “substantially similar to FIG. 7” is therefore ambiguous because it is unclear if one or more intense peaks can be completely missing from an X-ray powder diffraction pattern and such a diffraction pattern still be considered to be “substantially similar” to that of FIG. 7. Or, alternatively, if an X-ray powder diffraction pattern can contain additional intense peaks in addition to those found in FIG. 7.
Claim 7 is 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.
The term "derivative" in claim 7, appearing in the expression "a purified psilocybin derivative", is a relative term which renders the claim indefinite. In particular, "derivative" does not particularly point out the degree or type of derivation that a given compound may have in relation to the parent “psilocybin” compound and still be considered a "derivative" as intended by Applicant. Applicant has failed to provide any specific definition for this term in the present specification. Lacking such a definition, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicant seeks patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112(b) the claim is deemed properly rejected.
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.
Claim 3 is 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 3 recites the crystalline form 1 of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide “according to claim 2”, characterized by at least one of a monoclinic crystal system at a temperature of about 297 K;
A P2₁/c space group at a temperature of about 297 K;
unit cell dimensions a = 7.5611(4) Å, b = 10.5042(5) Å, C = 23.9095(12) Å, α = 90°, ß = 98.184(2)°, and γ = 90°;
an X-ray powder diffraction (XRPD) pattern substantially similar to FIG. 7; and
an X-ray powder diffraction pattern characterized by at least two peaks selected from 9.2, 13.1, and 18.5 °2Θ ± 0.2 °20.
Applicant is relying on the specification for that which would inherently be embraced by the claimed crystalline form I of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide recited in claim 2. It is noted that form I is a single species, not a genus of compounds nor a Markush group embracing different moieties - it is a single crystalline form of a specific structure. Since claim 2 has no limitations other than identifying the claim as embracing “[c]rystalline form I”, this includes all of the physical, chemical, and biological features of crystalline form I of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide as a compound and its properties are not separable. Thus, claim 3 does not appear to further limit the crystalline form I of 4-acetoxy-N,N-dimethyl-N-isopropyltrypatmmonium iodide of claim 2 since this crystalline form I of claim 2 would necessarily possess all of the physical characteristics recited in claim 3. See, for example, Table 3, Table 4, and Figure 7.
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.
Conclusion
Claims 2-3, 5, and 7 are rejected.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
500 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038