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. Priority This application, filed 08/03/2023 is a Continuation in Part of 16956043, filed 06/19/2020. 16956043 is a National Stage entry of PCT/US18/66286, International Filing Date: 12/18/2018. PCT/US18/66286 Claims Priority from Provisional Application 62608105, filed 12/20/2017. Status of Claims Claims 1-7 are currently pending. Claims 1-7 were examined and are rejected. 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 appl icant regards as his invention. Claims 1-7 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. Independent claim 1 recites a method for preventing, ameliorating, or alleviating neuropsychiatric symptoms and psychiatric disorders consisting of administering to a human in need thereof a matrix-type transdermal patch with a composition consisting of opipramol. This language renders the claim indefinite, since it is unclear by the “consisting of” language if excipients and carriers well-known in the art to make up transdermal patches are excluded from the claims. See MPEP 2111.03(II): The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim . In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parted Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). While para [0002] of the specification recites the exclusion of any other component such as a pharmaceutical carrier or excipient, other portions of the specification clearly describe matrix-type transdermal patches that contain polymers, adhesives, optionally solvents, tackifying agents, penetration enhancers, and drug depot reservoirs, in addition to other excipients (see para 00140-00147]). Therefore, the claim is indefinite since it’s unclear if any excipients or carriers well-known in the art to make up matrix-type transdermal patches are excluded by the “consisting of” language. Claims 2-7 are similarly rejected for depending on claim 1 and not providing further clarity. For the sake of examination, the examiner has interpreted the claim to exclude the presence of other active agents from the transdermal patch and opipramol composition, but the inclusion of pharmaceutical excipients or carriers in the matrix-type transdermal patch. Independent claim 1 recites wherein the transdermal patch results in an increased bioavailability compared to “that obtained with an equivalent oral dosage form”. It is uncertain what meets “an equivalent oral dosage form”. Does this mean an oral dosage form that is administered at the same dose as the matrix type transdermal patch? The claim is indefinite as the metes and bounds aren’t clear. Similarly, dependent claims 2-7 are rejected. Claim 7 contains multiple trademark/trade names. For example , the trade names Lunesta, Lexapro, Luvox, Marplan, Nembutal, Notec, Parlodel, Provigil, Azilect, and Restroil, among numerous others are recited in the claim . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the products and, accordingly, the identification/description is indefinite. It is suggested all trade names be deleted from claim 7. Claim Rejections-35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claim (s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yacoby-Zeevi et. al., WO 2016042413 A1, publ. 3/24/2016, in view of Blennow et. al., Lancet, vol. 368, pp. 387-403, publ. 2006 . Yacoby-Zeevi teaches an opipramol patch for controlled transdermal delivery, wherein the patch includes in addition to opipramol one or more plasticizers, one or more penetration enhancers, a pressure-sensitive adhesive, and optionally one or more hydrophilic polymers (title & abstract; para [0006]). Yacoby-Zeevi teaches administering the transdermal opipramol patch for treating a disorder selected from a CNS disorder, peripheral nervous system disorder, factitious disorder, somatoform disorder, inflammatory disorder, and pain-related disorders; treatment of cognitive disorders that cause symptoms of impaired attention, reasoning, anxiety, depression, memory, and judgment, such as Alzheimer’s disease, is taught (para [0008], [0029], [00123]). Administration of a therapeutically effective amount of opipramol is taught (para [0031]), wherein the effective dose of opipramol is exemplified as from about 5 to 60 mg/day (para [00115-00116], [00122]). A matrix transdermal patch is taught, wherein the composition is used to form the matrix and the drug (opipramol) is incorporated into the adhesive of the patch before crosslinking (para [0045], [0082]). Yacoby-Zeevi teaches “treating” to ameliorate, alleviate, reduce, or suppress symptoms of the disease, as well as slowing or stopping disease progression, in particular cognitive disorder symptoms in dementia (para [0030]). Additionally, prophylactic treatment is taught (para [0031]). Yacoby-Zeevi teaches transdermal delivery to provide improved drug bioavailability compared to oral administration; additionally, transdermal delivery is associated with greater treatment compliance and allows for an easily adjustable dosing rate (para [0003]). Administration to animals and humans is taught (para [0032], [0036]). As Yacoby-Zeevi doesn’t teach an additional active agent is required, the transdermal matrix opipramol patch meets the limitations of the instant claims, for alleviating, ameliorating, neuropsychiatric symptoms and psychiatric disorders associated with TBI and related disorders, consisting of administering to a human in need a matrix-type transdermal patch with a composition consisting of opipramol. Alzheimer’s disease and dementia as taught by Yacoby-Zeevi are included in the claims as a TBI related disorder, and the effective amount of opipramol from about 5 to 60 mg/day meets the dose recited in the instant claims. Regarding the recitation “wherein the transdermal patch results in a 20-50% bioavailability increase… in bioavailability compared to that obtained with an equivalent oral dosage form” as recited by instant claim 1 , Yacoby-Zeevi teaches treatment of the same patient population as claimed with a matrix type opipramol transdermal patch as claimed, in the same effective daily dose as claimed. Therefore, it would have been reasonably expected the bioavailability increase of the matrix type transdermal patch compared to an equivalent oral dosage form would have been the same as claimed. See MPEP 2112.02(II): The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) . As Yacoby-Zeevi teaches treatment of a patient having disease symptoms, it would have been prima facie obvious to have administered opipramol in the transdermal matrix patch after the onset of the disease and after the development of symptoms, as recited by instant claims 4-5. Since Yacoby-Zeevi further teaches prophylactic treatment, it would have been prima facie obvious to have administered opipramol in the transdermal matrix patch prior to the onset of the disease, as recited by instant claim 3. Yacoby-Zeevi doesn’t explicitly teach separately administering an additional therapeutic agent. Blennow teaches Alzheimer’s disease as the most common cause of dementia, characterized by progressive impairment of episodic memory, aphasia, apraxia, and impairment in judgment, decision-making, and orientation (title & abstract; p. 392, left col., see 1 st 2 para under Clinical features). Blennow teaches symptomatic therapy for Alzheimer’s disease involves acetylcholinesterase inhibitors such as donepezil, based on the hypothesis that increased availability of acetylcholine would ameliorate cholinergic neuron degeneration associated with the disease (p. 394, right col., last para-p. 395, left col., top 3 para). Blennow teaches donepezil has been shown to provide positive effects in severe Alzheimer’s disease and to be efficacious in mild to moderate Alzheimer’s disease (p. 395, right col., 1 st -2 nd full para). Other treatments include the selective serotonin reuptake inhibitor (SSRI) , paroxetine , for reducing plaque load associated with Alzheimer’s (p. 398, Table 2). It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the method of the instant claims, and have alleviated or ameliorated neuropsychiatric symptoms and psychiatric disorders associated with TBI related disorders such as Alzheimer’s or dementia by administering to a human in need of treatment a matrix-type opipramol transdermal patch as described by Yacoby-Zeevi, and to have further administered the therapeutic agent, donepezil, or the SSRI, paroxetine, in consideration of Blennow . As discussed previously, Yacoby-Zeevi teaches a transdermal opipramol patch, such as a matrix transdermal patch for treatment of a variety of CNS conditions, including Alzheimer’s disease and dementia as well as symptoms thereof, while Blennow teaches donepezil as an acetylcholinesterase inhibitor shown to have efficacy for treating symptoms of Alzheimer’s disease. Blennow further includes the SSRI, paroxetine, as an Alzheimer’s therapeutic to reduce plaque load in the disease. One of ordinary skill in the art would have been motivated to have treated Alzheimer’s disease or dementia by transdermally administering to a patient in need thereof the transdermal matrix opipramol patch taught by Yacoby-Zeevi, and have further administer ed donepezil as recited by instant claim 7, or an SSRI as recited by instant claim 6 , in view of these therapeutics being taught to have efficacy for Alzheimer’s disease, and have had a reasonable expectation of success. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH PIHONAK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7710 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 9:00-5:30 EST . 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