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 .
The applicant's election of Group II and species, claims 8-12 and 14-16, without traverse in their reply dated 5/13/2026 is acknowledged. Claims 1-7 and 13 are withdrawn. Claims 8-12 and 14-16 are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 4/14/2023, 9/20/2023, 10/18/2023, 12/28/2023, 2/8/2024, 3/1/2024, 3/21/2024, 5/31/2024, 8/2/2024, 2/25/2025, 12/4/2025, and 1/9/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered. An initialed copy of the Form 1449 is enclosed herewith.
Specification
The disclosure is objected to because of the following informalities:
Page 6-7: formula (I) is labeled as [Formula 2], delete or change label.
Page 24 formula (I) is labeled as [Formula 3], delete or change label.
Other places that have structures including page 68, Formula 4; page 70-71, Formula 5; page 74 Formula 6; page 75-76, Formula 7; page 77-78, Formula 8; page 83, Formula 9; are not consistent with the labeling. Consider deleting the label, or changing it to read "scheme" instead of "formula".
Appropriate correction is required.
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 8-12 and 14-16 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 8, many of the compounds listed have two names (one presented in parentheses). There are differences in the specifics of these compounds rendering the claim indefinite as it is unclear which is required for the claim. For example, methyldopa and methyldopa sesquihydrate are different compounds; as the methyldopa sesquihydrate has one and a half water molecules present. For examination purposes the examiner interprets any of the listed compound, including those in parentheses, read on the claim requirements.
Dependent claims follow the same reasoning.
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 8-12 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 8 is/are directed to an abstract idea.
Step 2A, Prong 1: identify the abstract ideas. The "preventing or treating" step as claimed is an idea “of itself” and a uninstantiated plan, and thus an abstract idea.
Step 2A, Prong 2: has the abstract idea been integrated into a particular practical application? There is no application of the "preventing or treating" provided in the claim.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? The claim elements other than the abstract idea are “applying a compound to a subject”. As indicated in the references found in the office action, this is well understood routine and conventional within the testing art.
The dependent claims do not solve the above issues as they only further modify the abstract idea or are routine and conventional within the art.
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.
Claim(s) 8, 9, 11, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultz et al. (US 2014/0038949).
Regarding claim 8, Schultz describes a method for preventing or treating a lipid peroxidation reaction-induced disease or inhibiting progression of the lipid peroxidation reaction-induced disease in a subject (abstract and [0006]), which comprises
applying an effective amount of at least one compound to the subject ([0008] “In yet another aspect, the present invention provides for methods of enhancing the therapeutic effect of an immunomodulatory agent in a subject in need thereof. In some embodiments, the method comprises administering to the subject the immunomodulatory agent and a neuro transmitter receptor modulating agent; thereby enhancing the therapeutic effect of the immunomodulatory agent.”),
wherein the compound is selected from the group consisting of a group: methyldopa (methyldopa sesquihydrate), apomorphine ((R)-(-)-apomorphine hydrochloride), eseroline ((- )-eseroline fumarate), ethoxyquine (6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline), olanzapine (2-methyl-4-(4-methyl-1-piperazinyl)-1OH-thieno[2,3-b][1,5]benzodiazepine, methyl 3-amino-4-(phenylamino)benzoate, methyl 3-amino-4-((4- methoxyphenyl)amino)benzoate, methyl 3-amino-4-((3-methoxyphenyl)amino)benzoate, methyl 3-amino-4-(benzylamino)benzoate, methyl 3-amino-4-((1- phenylethyl)amino)benzoate, 1-(4-(trifluoromethoxy)phenyl)indolin-5-amine, 1-(3,5- dimethylphenyl)-1H-indol-6-amine, 1-(3,5-dimethylphenyl)indolin-6-amine, 1-(4- methoxyphenyl)-1H-indol-6-amine, 1-(4-(methylthio)phenyl)-1H-indol-6-amine, 1-(4- (trifluoromethoxy)phenyl)-1H-indol-5-amine (page 22 table 1 “methyldopa [and] METHYLDOPA SESQUIHYDRATE”).
Regarding claim 9, Schultz describes The method according to claim 8, wherein the disease is selected from the group consisting of Alzheimer' type dementia, chronic kidney diseases, diabetic neuropathy, liver disorder, age-related macular degeneration, postischemic brain disorder, vascular dementia, arteriosclerosis, Parkinson's disease, multiple sclerosis, cancer, asthma, hypertension, cardiovascular diseases, and age-related eye disease ([0015] “In some embodiments, the subject has a demyelinating disease. In some embodiments, the demyelinating disease is multiple sclerosis,”).
Regarding claim 11, Schultz describes The method according to claim 8, wherein the compound is methyldopa (methyldopa sesquihydrate) (page 22 table 1 “methyldopa [and] METHYLDOPA SESQUIHYDRATE”).
Regarding claim 15, Schultz describes The method according to claim 8, wherein the compound is methyldopa (methyldopa sesquihydrate) and is applied by being injected intravenously (“[0038] As used herein, the terms “administer” or “administering” refer to any type of administration, including but not limited to oral administration, administration as a suppository, topical contact, parenteral, intravenous,”).
Regarding claim 16, Schultz describes the method according to claim 8, wherein the compound is methyldopa (methyldopa sesquihydrate) and it is applied by being administered orally or parenterally (“[0038] As used herein, the terms “administer” or “administering” refer to any type of administration, including but not limited to oral administration, administration as a suppository, topical contact, parenteral, intravenous,”).
Claim(s) 8, 9, 10, 12, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KUSARI et al. (WO 2012/074788 Al, provided on the IDS on 4/14/2023).
Regarding claim 8, Kusari describes a method for preventing or treating a lipid peroxidation reaction-induced disease or inhibiting progression of the lipid peroxidation reaction-induced disease in a subject (abstract), which comprises
applying an effective amount of at least one compound to the subject (page 1 “Disclosed herein are methods of treating diseases affecting the retina by administering to a patient in need”),
wherein the compound is selected from the group consisting of a group: methyldopa (methyldopa sesquihydrate), apomorphine ((R)-(-)-apomorphine hydrochloride), eseroline ((- )-eseroline fumarate), ethoxyquine (6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline), olanzapine, (2-methyl-4-(4-methyl-1-piperazinyl)-1OH-thieno[2,3-b][1,5]benzodiazepine, methyl 3-amino-4-(phenylamino)benzoate, methyl 3-amino-4-((4- methoxyphenyl)amino)benzoate, methyl 3-amino-4-((3-methoxyphenyl)amino)benzoate, methyl 3-amino-4-(benzylamino)benzoate, methyl 3-amino-4-((1- phenylethyl)amino)benzoate, 1-(4-(trifluoromethoxy)phenyl)indolin-5-amine, 1-(3,5- dimethylphenyl)-1H-indol-6-amine, 1-(3,5-dimethylphenyl)indolin-6-amine, 1-(4- methoxyphenyl)-1H-indol-6-amine, 1-(4-(methylthio)phenyl)-1H-indol-6-amine, 1-(4- (trifluoromethoxy)phenyl)-1H-indol-5-amine (page 1 “olanzapine,”).
Regarding claim 9, Kusari describes the method according to claim 8, wherein the disease is selected from the group consisting of Alzheimer' type dementia, chronic kidney diseases, diabetic neuropathy, liver disorder, age-related macular degeneration, postischemic brain disorder, vascular dementia, arteriosclerosis, Parkinson's disease, multiple sclerosis, cancer, asthma, hypertension, cardiovascular diseases, and age-related eye disease (page 1 “the retinal disorder sought to be treated is selected from the group consisting of wet and dry age related macular degeneration,” and page 4 “Macular degeneration, also referred to as age-related macular degeneration” ).
Regarding claim 10, Kusari describes the method according to claim 8, wherein the disease is age-related macular degenerative disease (page 4 “Macular degeneration, also referred to as age-related macular degeneration”).
Regarding claim 12, Kusari describes the method according to claim 8, wherein the lipid peroxidation reaction-induced disease is a lipid peroxidation reaction-induced retinal disease in outer nuclear layer (ONL) (page 3 “Figure 5 shows that olanzapine significantly protects outer nuclear layer of blue light exposed rats.”).
Regarding claim 14, Kusari describes the method according to claim 10, wherein the age-related macular degenerative disease is an exudative age-related macular degenerative disease (page 6 “More than 20 types of macular dystrophy are known….familial exudative vitreoretinopathy,”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796
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