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 .
Acknowledgment of Papers Received: Amendment/Response dated 9/22/25
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/22/25 was filed after the mailing date of the Non-Final Office Action on 5/21/25. 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 the combined disclosures of Yang et al (US 2018/0327373 A1 hereafter Yang) in view of Iqbal et al (Hyperphosphorylation-induced tau oligomers; Frontier In Neurology, Review Article, vol. 4, Article 112, August 2013).
Yang disclose a method for determining whether a patient suffers from a neurological disease r disorder 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, EWG and WSG are all disclosed to meet the limitations of claims 1 and 11 [0206-0434]. 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.
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. 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 with respect to claim(s) 1, 3, 5-11 and 13-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the prior art does not disclose a method for detecting phosphorylated tau protein by administration of a compound as recited in claim 1 or 11. Regarding this argument, it is the position of the Examiner that the combination of the prior art meets the limitations of the prior art since Yang discloses the detection of the same conditions, by administration of the same compound to the same tissues in the body. Yang does not disclose contact with phosphorylated tau proteins, however discloses that Alzheimer’s patients can be diagnosed by administration of the same compound. Iqbal discloses that those Alzheimer’s patients have phosphorylated tau proteins that can be activated by a proper compound, specifically about 2-3 mol of phosphate per tau protein. The method is completed by simply administering the compound to the patients, illuminating the area and detecting a signal from the area. These steps are completed by Yang. Iqbal establishes that the same Alzheimer’s patients diagnosed in Yang would have phosphorylated tau proteins that would necessarily be activated once they came int o contact with the compound of the Yang and would send back a fluorescent signal upon illumination. 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. For these reasons, the claims are still rendered obvious.
Conclusion
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 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