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 .
Claims 1, 2, 5, 7, 12-16, 19, 21, 26-31, and 34-36 are pending in the instant application. Claims 13-16,19, 21, 26-31, and 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 2, 5, 7, and 12 are rejected.
Information Disclosure Statement
The information disclosure statement filed on December 13, 2024 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1, 2, 5, 7, and 12, and the species RGFP966 is acknowledged. The traversal is on the ground(s): there is no undue burden and all claims are linked by the common inventive concept of suppressing damaging reactive astrocyte states through HDAC3-regulated NFkB/RelA-p65 biology. This not found to be persuasive because the inventions are independent and distinct because there is no patentable co-action between the groups and a reference anticipating one member will not render another obvious. Each group is directed to art recognized divergent subject matter which require different searching strategies for each group. Moreover, the examiner must perform a commercial database search on the subject matter of each group in addition to a paper search, which is quite burdensome to the examiner. Therefore, the restriction requirement (between inventions) is still deemed proper and is hereby made final. Upon further search and consideration, however, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1, 2, 5, 7, and 12 has been searched and examined in its entirety).
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.
Claims 1, 2, 5, 7, and 12 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.
Regarding claim 1, the phrase “e.g.” or "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome by amending to claim to read “wherein the one or more HDAC inhibitors suppress reactive astrocytes by suppressing the formation, maintenance, and/or function of the reactive astrocytes” or something similar.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome, for example, by deleting the phrase “such as RGFP966, BRD3308, or HDAC3-IN-T247 (T247)” from the claim.
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 person shall be entitled to a patent unless –
(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 1, 5, 7, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/131788 A1.
WO 2015/131788 A1 discloses a method of treating a subject having a neurological condition, such as Alzheimer’s disease (see claim 19), wherein the neurological condition is characterized by the presence of reactive astrocytes (see claim 21), the method comprising administering a therapeutically effective amount of an inhibitor of a histone deacetylase (HDAC) (see claim 2). Therefore, a method for treating a subject with a disease or disorder associated with reactive astrocytes, such as Alzheimer’s disease, comprising administering to the subject a therapeutically effective amount of one or more histone deacetylase (HDAC) inhibitors is anticipated by the reference.
Claims 1, 2, 5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/032652 A1.
WO 2019/032652 A1 discloses a method for treating an animal for disease or nerve injury, comprising administration of a composition comprising a myelination enhancing inhibitor (see claim 1), wherein the myelination enhancing inhibitor is an HDAC3 inhibitor (see claim 3), such as RGFP966 (see claim 7), and wherein the method is for treating MS (see claim 19), for example. A method for treating an animal for MS or nerve injury, comprising administration of a composition comprising PDA106 or RGFP966 (see claim 27) is also disclosed. Therefore, a method for treating a subject with a disease or disorder associated with reactive astrocytes, such as multiple sclerosis, comprising administering to the subject a therapeutically effective amount of one or more histone deacetylase (HDAC) inhibitors, such as RGFP966, is anticipated by the reference.
With respect to the art rejection above, it is noted that the reference does not teach that the HDAC3 inhibitors can be used in the manner instantly claimed (i.e., to suppress reactive astrocytes). However, the intended use of the claimed HDAC inhibitors does not patentably distinguish the inhibitors, per se, since such disclosed use is inherent in the reference inhibitors. In order to be limiting, the intended use must create a structural difference between the claimed inhibitors and the prior art inhibitors. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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