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 .
Current Status of 18/144,990
This Office action is responsive to the amended claims of 01/12/2026. Claims 1-18 are pending, and claims 1-13 have been examined on the merits.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-13) in the reply filed on 01/12/2026 is acknowledged. The traversal is on the ground(s) that subject matter of all claims and inventions is sufficiently related and does not constitute a search burden. This is not found persuasive because the claimed therapeutic targets, methods of treatment, and pharmaceutical compositions are directed to distinct inventions that require separate and non-overlapping searches. The mere fact that the claims generally relate to glioma does not render them sufficiently related for examination purposes. Therefore, the restriction requirement is maintained..
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application has not identified any priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/09/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because figures 10-13 of the DRW.SUPP of 05/09/2023 are small and grainy rendering them difficult to read. This objection can be overcome by separating the figures as was done for Figures 8, 9, and 14 in the drawings submitted on 09/05/2023. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-13 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. This is a written description rejection.
Claims 1-13 lack written description as base claim 1 recites the limitation "a method for treating or alleviating gliomas in a subject by blocking neuron-derived IGF-1 from neurons in the subject, or a receptor thereof." As written, the claim encompasses all neurons, all gliomas, and any method of blocking IGF-1 signaling. However, the specification does not reasonably convey that the inventors were in possession of such a broad method at the time of filing. Rather, the disclosure supports a specific method of treatment rather than the broad concepts suggested by the claim.
The specification describes three experimentally supported approaches for suppressing gliomagenesis, each is tied to disruption of olfactory circuit-dependent IGF-1 signaling rather than generalized inhibition of neuron-derived IGF-1. First, the Applicants demonstrate that manipulation of olfactory sensory activity alters tumor development in a genetically engineered mouse model. Chemogenetic suppression of olfactory receptor neurons using Omp-hM4Di transgenes decreases tumor volume and reduces proliferation of pre-transforming mutant oligodendrocyte precursor cells (OPCs), while enhanced olfactory activity using Omp-hM3Dq increases tumor growth (see [0047-0049]). Similarly, physical deprivation of the olfactory input through naris occlusion suppresses tumor formation and decreases proliferation of mutant OPCs in the olfactory bulb (see [0052-0053]).
Second, the specification demonstrates that genetic elimination of IGF-1 production in specific neuronal populations, specifically mitral/tufted neurons, which are identified as the primary source of IGF-1 within the olfactory bulb. Conditional knockout of IGF-1 in these neurons significantly suppresses gliomagenesis and reduces OPC proliferation (see [0057-0061]). The specification further reports that specific knockout of IGF-1 in Gad2-positive interneurons reduces proliferation of mutant OPCs and prolongs survival in the glioma mouse model (see [0064-0065]).
Third, Applicants show that disrupting IGF-1 receptor signaling in tumor precursor cells eliminates the proliferative effect of increased olfactory activity, demonstrating that IGF-1 signaling is required for the tumor-promoting effect (see [0062]). These experiments collectively support a treatment concept directed to disrupting olfactory circuit-dependent IGF-1 signaling within the olfactory bulb microenvironment of the described mouse model, rather than broadly blocking neuron-derived IGF-1 from neurons generally as recited in the base claim.
Accordingly, the specification does not reasonably convey to a person of ordinary skill in the art that the inventors had possession of the full scope of the claimed method. The disclosure is limited to the experiments discussed above. The specification does not describe or demonstrate methods for broadly blocking neuron-derived IGF-1 from neurons generally, treating gliomas arising outside the olfactory circuitry, or inhibiting IGF-1 signaling using the wide range of pharmacological or genetic mechanisms encompassed by the claims. The specification only describes disruption of IGF-1 signaling within a specific olfactory neuronal microenvironment within the model system. It does not reasonably convey possession of the much broader genus of treatment recited in the instant claims.
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 13 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 limitation “a method for treating or alleviating gliomas in a subject by blocking neuron-derived IGF-1 from neurons in the subject, or a receptor thereof.” The phrase “or a receptor thereof” renders the claim indefinite because it is unclear what receptor is being referenced. As written, the term “thereof” could reasonably be interpreted as blocking the IGF-1 receptor, or blocking a receptor of the neurons. Accordingly, the scope of the claim cannot be determined with reasonable certainty.
The examiner suggests amending the claim to explicitly identify the receptor being referenced. For example: “…blocking neuron-derived IGF-1 from neurons in the subject or blocking the IGF-1 receptor” or “…blocking neuron-derived IGF-1 signaling…” Such clarification would remove the uncertainty present in the claim as written.
Claim 13 recites the limitation "wherein genetically inhibiting comprises one selected from a group consisting of knocking out genes by CRISPR/Cas9, inhibiting RNAs by shRNA, miRNA, siRNA and ASO and inhibiting proteins by neutralization antibody" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625