DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 3, 12-13, 16-18, 20, and 27-33 have been canceled.
Claim 34 has been added.
Claims 1-2, 4-11, 14-15, 19, 21-26, and 34 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1, 5-11, 14-15, 21-26, and 34, and without traverse of species intestinal alkaline phosphatase (IAP) (Species 1), a subject having an elevated level of N6-carboxymethyllysine (CML), a CML precursor, a CML metabolite, or a CML analog in a biological sample of the subject as compared to a reference level (Species 2), a reduced concentration of CML, a CML precursor, a CML metabolite, or a CML analog in a blood sample of the subject (Species 3), and Alzheimer’s disease (Species 4), in the reply filed on 6/1/2026 is acknowledged.
Claims 2, 4, 6, 8-11, 15, 19, and 23-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1, 5, 7, 14, 21-22, 25-26, and 34 are being examined in this application, insofar as they read on the elected species of intestinal alkaline phosphatase (IAP) (Species 1), a subject having an elevated level of N6-carboxymethyllysine (CML), a CML precursor, a CML metabolite, or a CML analog in a biological sample of the subject as compared to a reference level (Species 2), a reduced concentration of CML, a CML precursor, a CML metabolite, or a CML analog in a blood sample of the subject (Species 3), and Alzheimer’s disease (Species 4).
Claim Objections
Claims 21-22 and 25-26 are objected to because of the following informalities:
Claim 21, the recitation of “an agent” on line 2 is suggested to read “the agent”.
Claim 22, the recitation of “an agent” on line 2 is suggested to read “the agent”.
Claim 25, the recitation of “an agent” on line 2 is suggested to read “the agent”.
Claim 26, the recitation of “an agent” on line 2 is suggested to read “the agent”.
Appropriate correction is required.
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 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 of this title, 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.
Claims 1, 5, 7, 14, 21-22, 25-26, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bristol et al (WO 2019/183208 A1; 9/26/2019.) in view of Bar et al (Neurobiology of Aging. 2003;24:333-338.) and Girones et al (Free Radical Biology & Medicine. 2004;36(10):1241-1247. Cited on IDS).
The instant claims recite a method of decreasing the rate of development of oxidative stress or mitochondrial dysfunction in microglia, or microglial dysfunction in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a gut barrier function enhancer and/or an agent for reducing or eliminating gut microbiota dysbiosis.
Bristol teaches the use of alkaline phosphatase-based agents (AP-based agents) including intestinal alkaline phosphatases (IAP) (para 025) in therapeutic applications for modulating immune functions, metabolic functions, and neurological functions (para 0195), wherein the AP-based agents and/or pharmaceutical compositions are formulated as compositions adapted for oral administration (para 086). Bristol teaches a method of treating a neurological disease in a subject in need thereof comprising administering to a subject in need thereof a formulation comprises IAP (a therapeutically effective amount of a gut barrier function enhancer and/or an agent for reducing or eliminating gut microbiota dysbiosis) (Claims 51 & 63), wherein said neurological disease includes Alzheimer’s disease (para 0241).
Bristol does not teach the method decreases the rate of development of oxidative stress or mitochondrial dysfunction in microglia, or microglial dysfunction (claim 1), and the subject has previously been identified as having an elevated level of CML in a biological sample of the subject as compared to a reference level (claims 5, 7, 14 and 34).
However, Bristol does teach using IAP for treating a neurological disease in a subject in need thereof, wherein the neurological disease includes Alzheimer’s disease. Bar teaches oxidative stress has been implicated as an important mechanism in neurological disorders including Alzheimer’s disease (p.333 col left – para 1). Bar teaches assessing levels of CML in paired samples of cerebrospinal fluid (CSF) from patients with Alzheimer’s and controls (p.333 col right – para 2, p.334 col left – para 1), wherein CML levels in CSF are measured and determined (p.334 col right – para 2 & 5), and levels of CML are significantly increased in CSF of Alzheimer’s patients (Fig. 1). In addition, Girones teaches oxidative stress mechanisms have been implicated in the pathogenesis of Alzheimer’s disease (p.1241 col right – para 1), and high levels of oxidative stress have been observed in Alzheimer’s disease (p.1245 col right – para 1).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer IAP to a subject been identified as having an elevated level of CML in the subject’s biological sample to decrease the rate of development of oxidative stress or mitochondrial dysfunction in microglia, or microglial dysfunction, since Bar and Girones both disclose that oxidative stress has been implicated as an important mechanism in Alzheimer’s disease, Girones discloses that high levels of oxidative stress have been observed in Alzheimer’s disease, and Bristol discloses that IAP is used for treating a neurological disease including Alzheimer’s disease. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to administer IAP to a subject been identified as having an elevated level of CML in the subject’s biological sample to decrease the rate of development of oxidative stress or mitochondrial dysfunction in microglia, or microglial dysfunction, with a reasonable expectation of success.
In regard to claim 26, it is noted that the “wherein following administration of the gut barrier function enhancer and/or an agent for reducing or eliminating gut microbiota dysbiosis, the subject exhibits a reduced concentration of CML, a CML precursor, a CML metabolite, or a CML analog in a blood sample” clause does not recite any additional active method steps, but simply states a characterization or conclusion of the results of process step positively recited (e.g. analyzing). Therefore, the “wherein” clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). In addition, Bristol does teach administration of the claimed gut barrier function enhancer and/or an agent for reducing or eliminating gut microbiota dysbiosis.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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