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 .
Status of Claims
The amendments to the claims filed January 25, 2024 are acknowledged and entered. Claims 1-16 are pending.
Priority
This application is a 371 of PCT/US2022/038042, filed July 22, 2022, which claims benefit of 63/226,382, filed July 28, 2021.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on January 25, 2024 and August 26, 2024. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
Applicant’s election without traverse of in the reply filed on May 4, 2026 is acknowledged. Applicant requested that the restriction requirement be reconsidered because the Office Action has not shown that a serious burden would be required to examine all of the claims (page 1 of response). This argument is not persuasive for the reasons set forth in the restriction requirement (see page 4). The chemical compounds corresponding to an “SK ion channel activator” are not regarded as being of similar nature because: (1) the alternatives do not all share a common structure and (2) the alternatives do not all belong to a recognized class of chemical compounds. Accordingly, the claims embrace many distinct compounds each of which requires a separate search. Additionally, there are many distinct and unrelated conditions which cause or are associated with a “cognitive impairment”. The requirement is still deemed proper and therefore made final.
Applicant’s response filed May 4, 2026 appeared to be a bona fide reply; however, the reply did not include specific species as set forth in the requirement for restriction. In the interest of compact prosecution Examiner contacted Applicant to request election of specific species of the invention. During the interview on June 1, 2026 Applicant elected 1) chlorzoxazone as the SK ion channel activator, and 2) schizophrenia as the disease associated with “cognitive impairment” (see attached interview summary).
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. The elected species of SK ion channel activator was found in the prior art; however, Schizophrenia was not found in the prior art. The search has therefore been expanded to chlorzoxazone and cognitive impairment generally. And art was found.
Claims 9 and 13 (in full) and claims 1-8 and 11-12 (all in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. The full scope of claims 10 and 14-16 are under examination as being drawn to the elected species.
Claim Rejections - 35 USC § 112a
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 1-8 and 11-12 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.
The claims require an “SK ion channel activator”. The claims do not require that the SK ion channel activator possess any particular conserved structure, or other distinguishing feature. Additionally, the specification does not describe or teach any particular conserved structure, or other distinguishing feature which defines this genus of compounds. Therefore, the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute 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.")".
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision
Applicant may overcome this rejection by amending the claims to recite a specific compound or compounds which are regarded an SK ion channel activator and for which Applicant has written support in the specification.
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.
Claims 1-5, 7-8, 10-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Aumann et al. (WO2010/015037)(hereinafter “Aumann”).
Regarding claims 1-5, 7-8, 10-12 and 14-16, Aumann teaches a method of treating a cognitive impairment in a subject comprising administration of an SK ion channel activator to the subject wherein the SK ion channel activator is chlorzoxazone (see claims 1-3, condition is….memory deficit, attention deficit; see claims 6-7, agonist specific for SK channel is…chlorzoxazone). The instant specification teaches cognitive impairments include working memory (see paragraph [00036]). Impairments in working memory would include memory deficiency.
Regarding claims 3-4, Aumann teaches subject includes a human (see page 35, lines 17-20).
Regarding claim 5, Aumann teaches wherein administration is intravenous administration (see page 9, lines 1-10, Ion-channel or receptor agonists…were infused continuously).
Regarding claims 11-12 and 14-16, Aumann teaches administration refers to delivery of the agent to the subject wherein levels would be sufficient to maintain dopamine at levels which prevent the onset of signs or symptoms of disease (page 39, lines 15-25, These levels would be sufficient…).
Aumann does not specifically recite an embodiment wherein a cognitive impairment is treated with chlorzoxazone.
The difference between the prior art and the instant claims is that the instant claims recite a method of treating a cognitive impairment comprising administration of an SK ion channel activator (chlorzoxazone) and the claims require a dose range and frequency of administration (claims 11-12 and 14-16). However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to administer chlorzoxazone to treat a cognitive impairment because Aumann had disclosed that the compound was useful for this purpose. Moreover, in view of the teaching that administration required levels that would be sufficient to maintain dopamine at levels which prevent the onset of signs or symptoms of disease, it would have been obvious to select and optimize, as is routine in the art, a dose of the drug and frequency of administration, including those claimed, that would have achieved the result of preventing the onset of disease.
One would have been motivated as a matter of practicing the method of Aumann. One would have been motivated to optimize dose and schedule of administration as a matter optimizing the amount of drug to maintain dopamine at levels which prevent the onset of signs or symptoms of disease.
One would have had a reasonable expectation of success because Aumann had already disclosed that an SK ion channel activator (chlorzoxazone) could be used to treat cognitive impairment. Furthermore, optimizing a drug dose and frequency of administration would have been routine practices in the art at the time.
Claim(s) 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Aumann et al. (WO2010/015037)(hereinafter “Aumann”) in view of Alqahtani et al. (Frontiers in Pharmacology Feb 2021, Vol. 12, Article 618411) (hereinafter “Alqahtani”).
Aumann teaches a method of treating a cognitive impairment in a subject comprising administration of an SK ion channel activator to the subject wherein the SK ion channel activator is chlorzoxazone as discussed above and which is incorporated herein by reference. Aumann further teaches the drug is administered directly to the brain (page 39, lines 15-20) but that drug delivery may be in any form (page 40, lines 4-9). Aumann is silent regarding oral administration as required by the claims; however, Alqahtani teaches oral medication is the most common form of drug administration because of advantages such as convenience of drug administration via the oral route, patient preference, cost-effectiveness, and ease of large-scale manufacturing of oral dosage forms (page 1; Oral Drug Delivery). Alqahtani teaches wherein oral administration is in the form of a tablet (see Table 3, Formulation Factors).
The difference between the prior art and the instant claims is that the instant claims require oral administration. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to administer chlorzoxazone as an oral medication because oral drug administration was known to be advantageous (e.g. convenience, patient preference and cost effective).
One would have been motivated as a matter of delivering chlorzoxazone in a convenient form that would likely be preferred by patients. As noted above, Alqahtani taught that drug administration was directly to the brain but that administration could be in any form. A person skilled in the art would have thus been motivated to search for more convenient and less invasive approaches to drug delivery such as oral administration.
One would have had a reasonable expectation of success because Aumann disclosed administration could be in any form and at the time oral administration in tablet form was a known route of drug administration.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 5, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
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