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
Restriction and Status of the Claims
Applicant’s election with traverse of “a method of promoting spinogenesis in a neuron comprising contacting the neuron with imipramine” in the response filed on March 16th 2026 is acknowledged. Applicant argues that “examination of these limited compounds would not pose an undue search or examination burden,” and subsequently has amended claim 1 to recite the three compounds in a single Markush group. However, applicant has not argued the relevance of the art used in the restriction requirement filed on December 15th 2025. Therefore, the restriction requirement is deemed valid. Furthermore, the incorporation of ‘semapimod’ and ‘brilacidin’ into claim 1 constitutes an improper Markush group (see the below improper Markush rejection).
Claims 1-7, 10 and 13-14 are pending. Claims 5-10 have been withdrawn from further consideration as being directed towards nonelected inventions. Claims 2-4 and 13-14 have been rejoined in that the addition of a neuronal disease does not constitute a further examination burden. Claims 1-4 and 13-14 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on March 16th 2026, April 19th 2024, and September 22nd 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 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 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “a compound selected from imipramine, semapimod, or brilacidin” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The chemical structures of imipramine, semapimod, and brilacidin are distinct in that there is no common chemical moieties uniting the compounds.
The compounds of imipramine, semapimod, and brilacidin are distinct in that they do not share a common mechanism of action (imipramine is a broadly acting tricyclic antidepressant; semapimod is an anti-inflammatory/antimicrobial that inhibits nitric oxide synthesis; brilacidin is a host defense protein mimetic that mimics antimicrobial peptides)
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a method of promoting spinogenesis in a neuron comprising contacting the neuron with a compound. This judicial exception is not integrated into a practical application because the claims recite merely the contact of a particular type of cell with a compound (i.e. a natural phenomenon) and the results of said contact (the promotion of spinogenesis in the cell). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the natural phenomenon and the result of said natural phenomenon are recited.
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 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (Chen et al., (2008), Changes in rat hippocampal CA1 synapses following imipramine treatment. Hippocampus, 18: 631-639).
Claims 1 and 13 are directed towards a method of promoting spinogenesis (i.e. the growth of new dendritic spines) in a neuron comprising contacting the neuron with imipramine. Chen teaches the growth of new dendritic spines via administration of imipramine (Chen, pg. 636, Discussion), anticipating claim 1.
Claim 13 limits the compound administered in claim 1 to imipramine and is anticipated by Chen for the same reasons as claim 1.
Claims 2-4 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chavant (Chavant et al., Imipramine, in Part through Tumor Necrosis Factor α Inhibition, Prevents Cognitive Decline and β-Amyloid Accumulation in a Mouse Model of Alzheimer's Disease, The Journal of Pharmacology and Experimental Therapeutics, Volume 332, Issue 2, 2010, Pages 505-514).
Claims 2-4 and 14 are directed towards the treatment of Alzheimer’s disease via administration of imipramine. Chavant teaches the treatment of Alzheimer’s disease with imipramine (Chavant, Abstract), anticipating claims 2-4 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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