DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application on September 17, 2026, after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 17, 2026, has therefore been entered.
Claim Status
3. Claims 8 and 11 have been canceled; and the remaining claims (claims 1, 4-7, 9-10, and 12-16) have been amended to recite methods for treating movement disorders “caused by dying or dead neurons in the motor cortex” and/or the administration of CCK4 and no analogues thereof. Claims 1, 4-7, 9-10, and 12-16 are therefore pending examination and currently under consideration for patentability.
Information Disclosure Statement
4. The listing of references in the specification (e.g., pg. 29-33) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The references should be placed on an information disclosure statement if Applicant would like them considered.
Objection to the Specification
5. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “Hamilton” at page 10, ln. 19), which is a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology whenever possible; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Please, review the specification for other improper trademarks and correction is required.
b. The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable code (see e.g., page 10, ln. 20). Applicant is required to delete embedded hyperlinks and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Please, review the specification for other improper hyperlinks and correction is required.
Interview Summary
6. The 35 U.S.C. 112(a) (written description) and 35 U.S.C. 103 rejections of record were discussed with Applicant’s representative on August 18, 2026. See the PTO-413 Interview Summary form attached to this Office action for more information.
Withdrawn Rejection
7. The rejection of claims 1, 4-7, 9-10, and 12-16 under 35 U.S.C. § 102(a)(1) as anticipated by Zhang et al. (2022) is withdrawn in light of Applicant’s amendments. See section 5 of the Final Office action of June 17, 2026. The rejection of claims 8 and 11 are moot in view of Applicant’s cancelation of the claims.
Maintained Rejection
8. The rejection of claims 1, 4-7, 9-10, and 12-16 under 35 U.S.C. § 112(a) (written description) as set forth in section 4 of the Final Office action of June 17, 2026, is maintained. The rejection of claims 8 and 11 are moot in view of Applicant’s cancelation of the claims.
Claim Rejections - 35 USC § 112
9. 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.
Written Description
Claims 1, 4-7, 9-10, and 12-16 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 claims contain 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 written description rejection of record has been modified below to address movement disorders “caused by dying or dead neurons in the motor cortex” and repeated below for Applicant’s convenience:
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
The instant claims are directed to methods for treating movement disorders comprising administering CCK4; wherein the movement disorders are caused by dying or dead neurons in the motor cortex; and methods for regaining motor learning ability comprising administering CCK4 (e.g., claim 10). The methods further recite various dosing regimens and timelines.
The specification provides examples of (i) characterizing CCK knockout or antagonism in the motor cortex (see FIGs. 1-5); (ii) treating movement disorders or motor learning defects caused by CCK knockout by administering a CCK-B receptor agonist (see FIGs. 6C-6E); and (iii) restoring neuronal plasticity defects caused by CCK knockout by administering a CCK-B receptor agonist (see FIGs. 6A-6B). No other experimental models suitable as a proxy for movement disorders were tested. However, the claims are directed to a genus of movement disorders not representative of the single species of movement disorder (e.g., caused by CCK knockout or antagonism) provided in the examples.
The claims recite methods for treating movement disorders caused by dying or dead neurons in the motor cortex and motor learning deficits. The specification only teaches a single example of treating a movement disorder, e.g., treating a movement disorder specifically caused by CCK knockout. However, the claims are not limited to a movement disorder or motor learning deficit caused by CCK knockout. The specification also provides no guidance as to what movement disorders may be related to a CCK deficiency, and neither would a skilled person appreciate the claim-recited movement disorders caused by dying or dead neurons in the motor cortex to be related to a CCK deficiency. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that:
"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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
A skilled person would recognize CCK-B receptor agonism as effective for the treatment of Parkinson’s disease (see e.g., Zhang et al. ("Neuroprotective effects of a cholecystokinin analogue in the 1-methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine Parkinson’s disease mouse model." Frontiers in neuroscience 16 (2022): 814430) at abstract; cited previously on the 1/20/26 PTO-892); and for enhancing some forms of memory (e.g., “encoding sound-sound, visuoauditory, fear, and spatial memory” see instant specification at paragraph [0113]). However, it would not have been apparent that successfully treating a movement disorder caused by the artificial reduction of CCK in the motor cortex and having no know relevance to a disease state with a CCK-B receptor agonist (i.e., as demonstrated in the specification) may also predict the treatment of movement disorders caused by dying or dead neurons in the motor cortex. There is no nexus between the instantly demonstrated rescue of CCK deficiencies in the motor cortex and treating movement disorders caused by dying or dead neurons in the motor cortex, as encompassed by the instant claims. Applicant also has not established any nexus that CCK abnormalities specifically exist in the relevant subject populations, e.g., subjects suffering from “dying or dead neurons in the motor cortex” or “stroke” (e.g., claim 9) to establish possession of the claimed invention. In other words, a skilled person would have no reason to believe the claim-recited CCK-B receptor agonist treatments may beneficially treat the movement disorders instantly claimed since the specification only demonstrates movement disorders specifically caused by CCK knockout.
Therefore, neither the art nor the specification provides a sufficient representative number of movement disorders to meet the written description requirements.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the 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. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Applicant’s Arguments
A. Applicant argues that: a person of ordinary skill in the art understands that the CCK knockout mouse used in the specification is not a disease model, but rather an experimental tool used to investigate the physiological function of CCK in the brain. Applicant cites the instant application’s companion journal article which states: the CCK knockout mouse showed defective motor learning ability, which suggests CCK may support motor skill learning by modulating neuroplasticity in the motor cortex. Applicant states that the CCK knockout mouse is not, and was never intended to be, a disease model that recapitulates the pathology of movement disorders. Applicant submits the Office has improperly construed the CCK knockout mouse as a disease model, and that the CCK knockout mouse serves only to establish the core mechanistic principle that: activation of CCK-B receptors enhances neural plasticity of the motor cortex to support motor-skill learning. Applicant characterizes the instant application as directed to methods of employing BBB-permeable agents that activate CCK-B receptors in the motor cortex, thereby enhancing motor-cortical neural plasticity; and that the examples establish such.
B. Applicant further argues that: claim 1 is instantly limited to movement disorders caused by dying or dead neurons in the motor cortex; and that said pathological conditions are characterized by impairment of motor-cortical neural plasticity, which underlies deficits in motor-skill learning. Applicant concludes: the instant claims are directed to a specific pathological category—movement disorders caused by dying or dead neurons in the motor cortex; and that the specification’s disclosure that CCK4 restores motor cortex neuroplasticity—a common characteristic of movement disorders caused by dying or dead neurons in the motor cortex—shows Applicant is in possession of the instantly claimed subject matter.
Response to Arguments
A. Applicant’s arguments have been fully considered but they are not deemed persuasive.
The Office disagrees that the CCK knockout mouse model—whether characterized as an experimental tool or a disease model—sufficiently demonstrates that activation of CCK-B receptors can enhance neuroplasticity in the motor cortex to support motor-skill learning, let alone in the context of neuronal death in the motor cortex and/or in the context of subjects having normal CCK expression levels as encompassed by the instant claims.
The Office agrees that the CCK knockout mouse shows defective motor learning, which is rescued by administering CCK4. Therefore, the Office agrees that activation of CCK-B receptors signaling may support motor skill learning by modulating neuroplasticity in the motor cortex. In other words, activation of CCK-B receptors appears to be necessary for normal neuroplasticity in the motor cortex, and thus motor-skill learning.
However, a showing that CCK signaling is necessary for normal neuroplasticity in the motor cortex is not commensurate with Applicant’s assertion that CCK-B receptor agonism can enhance neuroplasticity in the motor cortex. To enhance neuroplasticity means e.g., CCK-B receptor agonism will increase the neuroplasticity of living neurons in the motor cortex to an above-normal level and thereby compensate for dying or dead neurons in the motor cortex.
As stated in the companion journal article cited by Applicant, the results obtained with the CCK knockout mouse suggest that CCK “may support motor skill learning by modulating neuroplasticity in the motor cortex.” This suggests CCK signaling is required for normal neuroplasticity in the motor cortex. Applicant believes this finding should be extended to CCK-B receptor agonism will enhance neuroplasticity in the motor cortex. This extension is not warranted because: a showing that a substance is necessary for a process does not suggest that providing additional quantities of the substance will further “enhance” the process.
The specification does not indicate that there are any defects in CCK expression level or signaling associated with death of motor cortex neurons; or that defects in neuroplasticity or motor learning associated with death of motor neurons can be treatable by CCK agonists. The specification demonstrates that CCK knockout causes motor cortex neuroplasticity and motor learning defects, which is remedied by replacing the knocked out CCK with CCK4. Such is not commensurate with the “enhancement” of neuroplasticity in the motor cortex that would be required to treat movement disorders caused by dying or dead neurons in the motor cortex, i.e., by enhancing the neuroplasticity of the living neurons in the motor cortex.
Therefore, both the art and the specification provide insufficient written description for the instantly claimed subject matter because: it is unknown if CCK-B receptor agonism will enhance neuroplasticity in the motor cortex in subjects having normal expression levels of CCK (e.g., a subject with WT CCK genotype and having dying or dead neurons in the motor cortex).
B. With regards to Applicant’s argument that claim 1 is limited to movement disorders caused by dying or dead neurons in the motor cortex, which is characterized by impairment of neuroplasticity in the motor cortex—the Office agrees that the impairment of neuroplasticity is a characteristic of said movement disorders. However, the primary characteristic of movement disorders caused by dead or dying neurons in the motor cortex is: dead or dying neurons in the motor cortex. Therefore, the specifications disclosure that CCK4 restores motor cortex neuroplasticity in CCK knockout mice—said mice lacking dead or dying neurons in the motor cortex—does not read on the primary characteristic of said movement disorders. Additionally, and for the reasons discussed above, it is unknown how CCK4 would treat movement disorders caused by dying or dead neurons in the motor cortex because: it is unpredictable if CCK is even dysregulated in movement disorders caused by dying or dead neurons in the motor cortex, and furthermore, if CCK-B receptor agonism may enhance the neuroplasticity of the living neurons in the motor cortex. The instant specification has not demonstrated enhancement of neuroplasticity in neurons in the motor cortex, let alone in the context of neuronal death in the motor cortex and/or in the context of subjects having normal CCK expression levels (i.e., WT genotype) as encompassed by the instant claims.
Accordingly, both the art and the specification provide insufficient written description for the methods of treating movement disorders or regaining motor learning ability encompassed by the claims.
New Claim Objections
10. Claims 1, 4-7, 9-10, and 12-16 are objected to because of the following informalities:
A. Claims 1, 4-6, 10, and 12-16 recite the terms “administrating” or “administrated” instead of the more common terms “administering” and “administered,” which are considered to be more grammatically correct. Appropriate correction is required.
B. Claim 9 recites “wherein the dying or dead neurons in the motor cortex is induced by brain injury or stroke.” Since the dying or dead neurons are in plural form, the word “are” should be used in place of the word “is” to be grammatically correct. Appropriate correction is required.
Claims 7 and 9 are objected to for depending from an objected to claim.
New Claim Rejections - 35 USC § 112(a)
New Matter
11. Claims 1, 4-7, and 9 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 because the claims contain new matter. 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.
Per MPEP 2163, "New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)".
Claims 1, 4-7, and 9 have been amended to recite methods of treating movement disorders caused by “dying” neurons in the motor cortex. The limitation “dying” recited in these claims finds no support in the original specification as filed, nor does Applicant point to any support for the limitation. As such, amending the claims to include “dying” neuron subject matter represents the introduction of limitations that are not supported by the as-filed disclosure, and thus represents new matter in violation of the written description requirement.
Claims 4-7 are rejected because they depend from claim 1 and encompass the same new matter.
New Claim Rejections - 35 USC § 112(b)
12. 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, 4-7, and 9 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.
Claims 1, 4-7, and 9 recite methods for treating movement “disorders” (i.e., plural) by administering CCK4 to a subject in need thereof (i.e., the subject is singular). It is unclear if the claim requires the subject to have multiple movement disorders simultaneously. The claims would be clearer if they recited e.g., methods for treating “a movement disorder.”
Claims 4-7 and 9 are rejected for depending from an indefinite claim.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached on M-Th from 7 to 4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number 20857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
