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
Claim Status
Claims 1-20 were pending as of the previous Office Action.
Upon amendment entrance, Claims 2 and 11-42 are canceled.
Upon amendment entrance, Claims 43-51 are added.
Claims 1, 3-10 and 43-51 are pending investigation.
Priority Status
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant claims NO foreign priority; the effective filing date is 03/08/2019.
Information Disclosure Statement
References in the IDS(s) filed 09/07/2021 were acknowledged in the prior Office Action.
Drawings
The drawings submitted on 09/07/2021 were acknowledged in the prior Office Action.
Examiner Responses to Arguments/Amendments
The issues raised in the 03/19/2025 Office Action, are addressed below:
I. Response to Claim Objections –
In view of the Applicant’s amendment, which includes the cancellation of Claim 19, has been fully considered and is withdrawn.
II. Claim Amendments –
A method for treating and/or inhibiting progression of a neurological disease, condition, and/or disorder in a subject suffering from and/or at risk for developing neurological disease, condition, and/or disorder, the method comprising administering to the subject a composition comprising a reverse transcriptase inhibitor in an amount and via a route effective for treating and/or inhibiting progression of the neurological disease, condition, and/or disorder in the subject, wherein the neurological disease, condition, and/or disorder is selected from the group consisting of Alzheimer's Disease (AD), cerebral amyloid angiopathy, Alzheimer's disease-related attention deficit symptoms, and Alzheimer's disease-related neural degeneration.
III. Response to 35 U.S.C. §112 –
Claims 1-20 rejected under 35 U.S.C. §112(a) - enablement.
In view of the Applicant’s amendment and cancellation of Claims 2 and 11-20, the U.S.C. §112 enablement is withdrawn.
Claims 4 and 5 are rejected under 35 U.S.C. §112 - written description requirement.
In view of the Applicant’s amendment and cancellation of Claims 2 and 11-20, the U.S.C. §112 written description is withdrawn.
Claims 4, and 8 rejected under 35 U.S.C. §112(b) - claims are indefinite.
In view of the Applicant’s amendment and cancellation of Claims 2 and 11-20, the U.S.C. §112 for indefinite claims is withdrawn.
IV. Response to 35 U.S.C. § 102 and 103 Claim Rejections -
Claims 1-10 and 20 rejected under 35 U.S.C. §§102(a)(1) and 102(a)(2) anticipated by United States Patent 2017/0209440 of Dominguez.
Claims 1-6, 8, 11, 15, 19, and 20 rejected under 35 U.S.C. §102(a)(1) anticipated by Cummings et al., 2018 (Cummings).
Claims 1-20 rejected under 35 U.S.C. §103 obvious over Cummings and Dominguez in view of Panza et al., 2010 (Panza).
The 35 USC § 102 and 103 rejections are withdrawn because Applicant amended independent Claim 1, with the addition of a further limitation.
With respect to arguments relating to 102, the prior art was reapplied since the amended limitation are covered by the art presented in the prior Office Action. As such, the rejection is reapplied with further evidence below.
With respect to arguments relating and/or relevant to 103 below are moot due to a new prior art applied.
This necessitated a new rejection.
V. New Rejections -
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
A. First Rejection -
Claim(s) 1, 3-10, 43-45 and 47 are rejected under 35 U.S.C. 102(a)(1) & 102(a)(2) as being anticipated by C. Dominguez in US 2017/0209440 Al (pub’d 07/27/2017; hereinafter “Dominguez”) and as evidenced by G. Canet, et al, “HIV Neuroinfection and Alzheimer's Disease: Similarities and Potential Links?” (pub’d 2018 Sep 11; hereinafter “Canet” ).
With respect to Claim 1, Dominguez teaches a method for treating progression of a neurological disorder in a subject suffering from neurological disorder (para. [0002], "provided certain adjunctive therapies for HIV-related disorders comprising administering a kynurenine-3-monooxygenase inhibitor with an antiviral agent; para. [0173]: "In some embodiments, the HIV-related disorder is a neurological disorder"; para. [0011]… "Accordingly, provided is a method of treating an HIV-related disorder in a subject infected with HIV, comprising adjunctively administering to a subject in need thereof').
Dominguez further teaches a reverse transcriptase inhibitor can be administered to treat the disorder (para. [0002]: "Provided herein are certain adjunctive therapies for HIV-related disorders comprising administering a kynurenine-3-monooxygenase inhibitor with an antiviral agent"; para. [0148]: “In some embodiments, the antiviral agent is (speaking to Claim 3) selected from: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors");
wherein the neurological disease, condition, and/or disorder is selected from the group consisting of Alzheimer's Disease (AD), cerebral amyloid angiopathy, Alzheimer's disease-related attention deficit symptoms, and Alzheimer's disease-related neural degeneration (the neurological disease, condition, and/or disorder is HIV-associated neurocognitive disorder (HAND), or comprises any combination thereof (para. [0179]; "In some embodiments, the neurological disorder is HIV-associated neurocognitive disorder").
Dominguez fails to explicitly teach the group consisting of Alzheimer's Disease (AD), cerebral amyloid angiopathy, Alzheimer's disease-related attention deficit symptoms, and Alzheimer's disease-related neural degeneration.
However, evidentiary reference by Canet provides evidence that Claim 1 through teaching HIV-Associated Neurocognitive Disorders (HAND) and AD involve disruptions in amyloid and tau proteins, neuroinflammation, and blood-brain barrier (BBB) dysfunction, leading to synaptic damage and neuronal loss, is present as part of the teaching of Dominguez.
Canet connects HIV (through HAND) and AD via indications which share similar pathological markers like amyloid-beta plaques and tau tangles. These affect areas of attention, executive function, and memory, since both conditions involve chronic inflammation (microglial activation) and increased oxidative stress in the brain, and damaging neurons. They share common routes like immune activation, blood-brain barrier issues, and viral proteins affecting neural cells, leading to accelerated cognitive decline in older adults with HIV. Thus, one would reasonable expect the group consisting of Alzheimer's Disease (AD), cerebral amyloid angiopathy, Alzheimer's disease-related attention deficit symptoms, and Alzheimer's disease-related neural degeneration to be met by Dominguez.
For the following Claims 3-10, Dominguez continues teaching:
Claim 3: wherein the composition comprises, consists essentially of, or consists of a reverse transcriptase inhibitor selected from the group consisting of a nucleoside reverse transcriptase inhibitor (NRTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or any combination thereof (para. [0148]: “In some embodiments, the antiviral agent is selected from:
nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors").
Claim 4: wherein the NRTI is amdoxovir (para. [0149]: "In some embodiments, the antiviral agent is selected from", "amdoxovir'')
Claim 5: wherein the NNRTI is delavirdine (DLV) (para. [0149]: "In some embodiments, the antiviral agent is selected from…Rescriptor''; Rescriptor is a brand name of delavirdine).
Claim 6: wherein the composition is formulated for administration orally, rectally, topically, by aerosol (para. [0208]), by injection, parenterally (para. [0222]), intramuscularly, subcutaneously, intravenously.
Claim 7: wherein the composition is formulated for administration in a depot and/or for sustained release (para. [0218]).
Claims 8 and 45: wherein the composition is formulated in a targeted drug delivery system (para. [0186]; examples and embodiments – in particular to its use in part of a nanoparticle).
Claims 9 - 10: wherein further comprising administering to the subject an additional treatment (paras. [0233], [0235]: When used in combination with one or more additional pharmaceutical agent or agents, the compound, may be administered prior to, concurrently with, or following administration of the additional pharmaceutical agents).
Claims 43 - 44: wherein administering the composition comprising the reverse transcriptase inhibitor inhibits development of amyloid beta peptide (Αβ) in the subject.
wherein administering the composition comprising the reverse transcriptase inhibitor inhibits microglial cell death in the subject (para. [0011]: "Accordingly, provided is a method of treating an HIV-related disorder in a subject infected with HIV, comprising adjunctively administering to a subject in need thereof'; para. [0002]: “…provided herein are certain adjunctive therapies for HIV-related disorders comprising administering a kynurenine-3-monooxygenase inhibitor with an antiviral agent…"; para. [0148]: "In some embodiments, the antiviral agent is selected from: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors").
Claim 47: wherein the targeted drug delivery system comprises a liposome comprising a targeting molecule (para. [0229]).
This also reads on the above claims since HIV is highly tissue-specific in where it hides and replicates, forming persistent reservoirs in places like the gut, brain, and genital tract, even when viral loads are suppressed in the blood by antiretroviral therapy.
B. Second Rejection -
Claims 1, 3-6, 8, 10, 43-45, 49-51 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by J. Cummings, et. al in “Alzheimer's disease drug development pipeline: 2018” (pub’d 05/03/2018; hereinafter “Cummings”) and as evidenced by G. Canet, et al, “HIV Neuroinfection and Alzheimer's Disease: Similarities and Potential Links?” (pub’d 2018 Sep 11; hereinafter “Canet” ).
With respect to Claims 1, 3-6, 8, 10, 43-45, and 49-51, Cummings teaches:
a review of various methods for inhibiting development of amyloid beta peptide in a subject suffering from Alzheimer's Disease (neurological disease, condition, and/or disorder; speaking to Claim 1, 3, 43-44; pg. 211, col. 2, full para. 3);
The method is disclosed in the administering to the subject -- clinical trials for Phases I, II and III of AD agents -- within in a composition comprising a reverse transcriptase inhibitor (speaking to Claim 4-6);
tissue-specific antibody (anti-αβ peptide antibody; speaking to Claim 45);
inhibiting development of amyloid beta peptide (pg. 197, col. 1, full para. 1; speaking to Claim 43);
composition is formulated for administration (pg. 204, Table 3; speaking to Claims 6-10);
additional AD treatment (pg. 204, Table 3; speaking to Claims 6-10);
inhibiting microglial cell death (speaking to Claims 1, 10, 44);
with multiple examples of therapeutic agents for (solo and additional) treatment for AD (Claims 49-51; pgs. 198-200; Table 1);
wherein the acetylcholinesterase (AChE) inhibitor is selected from the group consisting of donepezil, rivastigmine, and galantamine (Claims 49; pg. 203; Table 3, DPC-201);.
wherein the N-methyl-d-aspartate receptor (NMDAR) antagonist is memantine (Claim 50; pg. 211, col. 1, full para 2).
These methods also disclose an amount and via a route effective for treating and/or inhibiting progression (interpreted as disclosed through the clinical trials & results discussed) of the AD in the subject (pg. 212, Fig. 4: Normal tau protein goes through multiple biological transformations in AD, and strategies to target tau are diverse. Fig. 4 depicts tau’s role in AD pathogenesis and shows the purported MOA of candidate therapies directed at tau biology).
Canet connects HIV (through HAND) and AD via indications which share similar pathological markers like amyloid-beta plaques and tau tangles. These affect areas of attention, executive function, and memory, since both conditions involve chronic inflammation (microglial activation) and increased oxidative stress in the brain, and damaging neurons. They share common routes like immune activation, blood-brain barrier issues, and viral proteins affecting neural cells, leading to accelerated cognitive decline. Thus, one would reasonable expect a route effective for treating to be met by Cummings.
C. Third Rejection –
Claim Rejections - 35 USC § 103
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 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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-10 and 43-51 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings (Claims 1, 3-6, 8, 10, 43-45, 49-51) and in view of Dominguez (Claims 1, 3-10, 43-45 and 47) and in view of J. Shen in “MicroRNAs as Potential Biomarkers in Human Solid Tumors” (pub’d 02/28/2013; hereinafter “Shen”).
The teachings of Cummings and Dominguez in combination, are disclosed above and those teachings are incorporated by reference herein.
With respect to Cummings (Claims 1, 3-6, 8, 10, 43-45, 49-51) and Dominguez (Claims 1, 3-10, 43-45 and 47) teaches a review of various methods for inhibiting development of amyloid beta peptide in a subject suffering from Alzheimer's Disease;
These methods also disclose an amount and via a route effective for treating and/or inhibiting progression (interpreted as disclosed through the clinical trials & results discussed) of the AD in the subject (pg. 212, Fig. 4: Normal tau protein goes through multiple biological transformations in AD, and strategies to target tau are diverse. Fig. 4 depicts tau’s role in AD pathogenesis and shows the purported MOA of candidate therapies directed at tau biology).
Cummings & Dominguez, in combination, fail to teach the limitation of Claim 51; wherein the inhibitory nucleic acid is an miRNA selected from the group consisting of miR-126, miR-145, miR-195, miR-21, and miR-29b; and combinations thereof
Shen teaches in Claim 51, wherein the inhibitory nucleic acid is an miRNA selected from the group consisting of miR-126, miR-145, miR-195, miR-21, and miR-29b (Table 1; contains Examples of miRNA as diagnostic biomarkers in human cancers: miR-126, miR-145, miR-195, miR-21, and miR-29b).
Thus, it would have been obvious to combine Cummings, Dominguez and Shen in combination, in view of its utility in using a reverse transcriptase inhibitor to the method by routine experimentation, in order to find the most effective composition for the method. In addition, miR-126, miR-145, miR-195, miR-21, and miR-29b are important microRNAs (miRNAs) involved in regulating cell growth, inflammation, and blood vessel formation (angiogenesis), often acting as tumor suppressors (miR-145, miR-195, miR-29b) or oncogenes (miR-21), with miR-126 being key in vascular health, all showing dysregulation in diseases like cancer, diabetes, and cardiovascular issues, making them potential biomarkers or therapeutic targets.
This would be obvious thus to illuminate the mechanism of the treatment. The rationale for this is known that they are being explored as targets for new therapies, with anti-miRs (to block them) or miRNA mimics (to restore them) being developed for conditions like atherosclerosis and cancer. Both of which accordingly, have utility in treating Alzheimer's disease.
Conclusions
Claims 1, 3-10 and 43-51 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:00-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621