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 .
DETAILED ACTION
This Office Action is a response to Applicant’s Preliminary Amendment filed June 24, 2026 and Applicant’s Election filed May 18, 2026.
Claim 14 has been amended.
Claims 1-16 are pending in the present application.
Election/Restrictions
Applicant’s election (without traverse) of Group III in the reply filed on May 18, 2026 is acknowledged. Applicant’s further species election of a gene carrier containing Nurr1 and Foxa2 genes in the reply filed on May 18, 2026 is also acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 18, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1-14 have been examined on the merits as detailed below:
Petition to Make Special
Applicant’s petition filed June 24, 2026 to make the present application special under Patent Prosecution Highway Pilot Program is acknowledged.
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed June 24, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant’s IDS filed November 9, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies can be found in the application as filed.
Drawings
The Drawings filed November 9, 2023 are acknowledged and have been accepted by the Examiner.
Claim Interpretation
Claim 14 recites in the preamble, “A method for treating a disease caused by a-synuclein protein phosphorylation”. The present Specification does not define, “a disease caused by a-synuclein protein phosphorylation”. However the present Specification discloses:
The present invention relates to a composition for inhibiting alpha-synuclein aggregation and a method for inhibiting alpha-synuclein aggregation and, more specifically, to techniques for inhibiting alpha-synuclein aggregation and phosphorylation by introducing Nurr1 and Foxa2 genes to induce the expressions thereof, and the composition according to the present disclosure has an excellent effect of inhibiting α-synuclein aggregation and phosphorylation and thus can be used in the treatment and prevention of Parkinson's disease.
It is known in the art that a protein called phosphorylated α-synuclein, is associated with several neurodegenerative diseases such as Parkinson’s disease. See National Institutes of Health (NIH), A common marker of neurological diseases may play role in healthy brains | National Institutes of Health (NIH) (https://www.nih.gov/news-events/news-releases/common-marker-neurological-diseases-may-play-role-healthy-brains) downloaded on June 25, 2026. Also, see Meade et al. (Molecular Neurodegeneration, July 22, 2019 Vol. 14:14-29) (submitted and made of record on the IDS filed June 24, 2026) at Post-translational modifications on page 9.
The claims in this application are given their broadest reasonable interpretation (BRI) using the plain meaning of the claim language in light of the Specification as it would be understood by one of ordinary skill in the art. See MPEP 2111. Given Applicant’s Disclosure and what is disclosed in the art, the Examiner will interpret the phrase, “a disease caused by a-synuclein protein phosphorylation” to include Parkinson’s disease.
Additionally, claim 14 recites the term, “Nurr1”. The present Specification does not define this term, however the art indicates that Nurr1 is short for Nuclear receptor related 1 protein. See The Science of Parkinson’s - Are we getting NURR to the end of Parkinson’s disease? – The Science of Parkinson's (https://scienceofparkinsons.com/2017/10/21/are-we-getting-nurr-to-the-end-of-parkinsons-disease) downloaded on June 25, 2026. The Examiner will interpret “Nurr1” as recited in claim 14 to mean nuclear receptor related 1 protein.
Claim Rejections - 35 USC § 112
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.
Claim 15 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 pre-AIA the applicant regards as the invention.
Claim 15 is rejected because the claim recites the term, “gene carrier”. The claim is rejected for a lack of antecedent basis because claim 14 from which claim 15 depends references “gene carriers” (plural), not “gene carrier” (singular). Appropriate correction is required.
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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 14-16 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 14 has been amended and is now drawn to a method for treating a disease caused by a-synuclein protein aggregation or phosphorylation, the method including: administering to a subject in need thereof a composition comprising gene carriers containing Nurr1 and Foxa2 genes.
A review of the application finds support for the phrase, “a composition comprising a gene carrier containing Nurr1 and Foxa2 genes”. A gene carrier (singular) is supported by Applicant’s Disclosure, however, “gene carriers” (plural) does not appear to be supported.
If Applicants believe the Specification supports, “a composition comprising gene carriers containing Nurr1 and Foxa2 genes”, the Examiner urges Applicant to point to, with particularity, where support can be found for the claims as now filed. Otherwise, Applicant is required to cancel the new matter in reply to this Office Action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
Claims 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh et al. (EMBO Molecular Medicine, 2015 Vol. 7:510-525) (submitted and made of record on the IDS filed June 24, 2026 and November 9, 2023).
The claims are drawn to a method for treating a disease caused by a-synuclein protein aggregation or phosphorylation, the method including: administering to a subject in need thereof a composition comprising gene carriers containing Nurr1 and Foxa2 genes. Applicant is reminded that the Examiner is interpreting the phrase, “a disease caused by a-synuclein protein phosphorylation” to include Parkinson’s disease. For further explanation, see the section titled, “Claim Interpretation” above.
Oh et al. demonstrate how adeno-associated virus (AAV)-mediated gene delivery of Nurr1 and Foxa2 protects neurons and reverses motor deficits in living mouse models of Parkinson's disease. See Figure 5, for example. Oh et al. disclose that viral vector expression of Nurr1 and Foxa2 genes is a promising approach in Parkinson's disease. See Abstract and Discussion.
Oh et al. disclose exploiting transduction by viral vectors, wherein lentiviral vectors expressing Nurr1 or Foxa2 under the control of the CMV promoter were generated by inserting the respective cDNA into the multi‐cloning site of pCDH. Oh et al. also disclose AAVs expressing Nurr1 or Foxa2 (tagged with hemagglutinin (HA) under the control of the CMV promoter were generated by subcloning the respective cDNAs into pAAV‐MCS vector.
Therefore, claims 14-16 are anticipated by Oh et al.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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