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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/26 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/1/26 was filed after the mailing date of the previous Office Action on 1/2/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 3, 5-11 and 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Yang et al US 2018/0327373 hereafter Yang) in view of Huang et al (Accumulated Amyloid-β Peptide and Hyperphosphorylated Tau Protein: Relationship and Links in Alzheimer’s Disease, Journal of Alzheimer’s Disease 16 (2009) 15-27, hereafter Huang) and Iqbal et al (Hyperphosphorylation-induced oligomers; Frontier in Neurology, Review Article, vol 4, Article 112, August 2013 hereafter Iqbal).
Yang discloses a method for determining whether a patient suffers from a neurological disease or disorders comprising detecting the presence of amyloid proteins in a tissue of the patient wherein the contacting is in vivo where the compound is
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where in EDG is disclosed as a OR9, NR10R11 or heterocycloalkyl of no more than 10 carbons [0005]; Ar is arylene of no more than 14 carbon atoms [0207; EWG is an electron withdrawing group -F, -Cl, -Br, -CH=O, [0214]; WSG is disclosed as water soluble polyethylene glycol, [0217-0264], meeting some of the limitation of claim 1 and 11. The compound is contacted with light causes emission of detectable signal a florescent signal [0201]. The tissue in an eye [Figure 22A, B] meeting the limitation of claim 3. The detectable signal is a fluorescent signal [0201], meeting the limitation of claims 5 and 14. The neurological conditions that can be detected by the method include Alzheimer's Disease [0196], meeting the limitations of clam 6 and 18. The reference discloses that once administered to the tissue, the compound is activated by light and a signal is then detected [0201, meeting the limitations claim 1, 11, and 13. Additionally, the neurological conditions that can be detected by the method of Yang include Down's syndrome [0196], meeting the limitations of claims 7, 8, 19 and 20.
While disclosing a method where the same conditions are detectable by intravenously administration of the same compound of the instant claims, the refence does not disclose that compound activates phosphorylated tau proteins or the concentration of the proteins in the patient. However, the conditions detected by the method include Alzheimer's disease, a conditions where phosphorylated tau proteins are also present. Phosphorylated tau proteins are well known for their connection to neurological disorders as seen in the Iqbal study.
Iqbal discloses a comparison between normal brain tissue and the brain issue of an Alzheimer's disease patient (abstract). The normal brain has 2-3 phosphate per mol of the tau protein, while an Alzheimer's brain has 4-6 phosphates per mol of protein as the tissue of hyper phosphorylated (abstract). In the brain there is a combination of 3-repeat and 4-repeate tau proteins (pp 1). These are commonly found int eh brain of Alzheimer's patients as such would be present in the tissues of patients treated by the methods of Yang.
While the combination of Yang and Iqbal would disclose a method of applying a fluorescent marker to the body with an expectation f illuminating amyloid β, the combination does not disclose a combination between the amyloid plaques associated with Alzheimer’s disease and phosphorylated tau proteins. Huang established the level of skill in the art regarding this connection.
Huang discloses a connection between accumulated amyloid-β and hyperphosphorylated tau protein (abstract). Alzheimer’s Disease is associated with an accumulation of neurotic plaques where the plagues has an amyloid-β (AB) core and neurofibrillary tangles contain phosphorylated tau proteins (abstract). The AB in neurons seem to include phosphorylation of tau by alternative pathways of signal transduction on the neuronal membrane (conclusions). The amyloid targeting compound of Yang, which illuminate under light, would also bind to the associated phosphorylated tau protein as they are connected by the neuronal membrane as seen in the Huang. bind phosphorylated tau proteins.
With these aspects in mind it would have been obvious to combine the prior art to produce a method of diagnosing a patient suffering from a neurological disorder. The method is accomplished by delivering a compound of formula Ic to the eye of a patient and exposing the eye to light and capturing a fluorescent signal as found in Yang. Yang accomplishes these steps in method for treating and diagnosing Alzheimer's disease and as evidenced by Iqbal, these patients would have a concentration of hyperphosphorylated tau protein present in their tissues. The amyloid targeting compound of Yang, which illuminate under light, would also bind to the associated phosphorylated tau protein as they are connected by the neuronal membrane as seen in the Huang. bind phosphorylated tau proteins. Specifically, the tissues would have a mixture of 3 and 4 repeating taus. It would have been obvious to apply the method of Yang with an expected result of a stable means of diagnosing and treating neurological disorders.
Response to Arguments
Applicant’s arguments, see Remarks, filed 4/1/26, with respect to the rejection(s) of claim(s) 1, 3, 5-11 and 13-22 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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