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 .
Claim Status
The amendments and arguments filed 6/25/26 are acknowledged. Claims 1-2, 8 and 10 are cancelled. Claims 3-7 and 9 are amended. Claims 3-7 and 9 are pending. Claims 3-7 and 9 are currently under consideration for patentability under 37 CFR 1.104.
Withdrawn Claim Rejections
The rejection of claims 3-7 and 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 8 is rendered moot by cancellation of the claim.
The rejection of claims 3-7 and 9 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claim 8 is rendered moot by cancellation of the claim.
The rejection of claims 3-7 and 9 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 8 is rendered moot by cancellation of the claim.
Maintained Claim 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.
The rejection of claim(s) 3-7 and 9 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Spetzler et al (US 2014/0141986 A1; filed 2/17/12; published 5/22/14) is maintained. The rejection of claim 8 is rendered moot by cancellation of the claim.
The instant claims are directed to a method for analyzing a body fluid sample from a subject suspected of having mild cognitive impairment comprising detecting presence or absence of Claudin-5. The method can comprise distinguishing mild cognitive impairment from a group of diseases consisting of Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, obsessive-compulsive disorder, and bipolar disorder. The method can comprise measuring the amount of Claudin-5 in the body fluid collected from the subject and the fluid can be measured using an anti-Claudin-5 antibody. The method can be performed with a subject suspected of having cognitive impairment, and the method can comprise one or more of a variety of medical procedures.
Regarding the limitations of instant claim 3-4, Spetzler describes use of biomarkers in diagnostic, therapy-related or prognostic methods to identify phenotypes, such as a condition or disease, or the stage or progression of a disease (see e.g. abstract). This method can involve identifying a novel biosignature for the diagnosis, prognosis, or theranosis of a phenotype, using vesicles isolated from a subject (see e.g. paragraph [01203]). Diagnosis inherently indicates that a distinction has been made between disease types. Differences between biosignatures in a test subject and a control subject can be used to identify subjects that have the phenotype or disorder (see e.g. paragraph [01203]). The phenotype can be a neurological disorder (see e.g. paragraph [01207]). The neurological disorder can be mild cognitive impairment (see e.g. paragraph [1189]). The biomarkers used in the biosignature can be those in Table 5 (see e.g. paragraph [01208]), and Table 5 specifically lists Claudin-5 (see e.g. page 65).
Regarding the limitations of claims 5-6, Spetzler teaches that detection can occur through a binding agent such an antibody (see e.g. paragraph [0247]-[0248], [1306]), such as a monoclonal antibody (see e.g. paragraph [0252]). Spetzler teaches that the method comprises determining the presence, amount, or concentration of one or more biomarkers in the sample (see e.g. paragraph [0329]).
Regarding the limitations of instant claim 7, Spetzler anticipates comparing the level of the biomarker with healthy controls (see e.g. paragraph [0166], [0340]).
Regarding the limitations of instant claim 9, the method of Spetzler can include measurement of Amyloid beta to test for Alzheimer’s disease (see e.g. paragraph [0652], [1180], [1195]).
Applicant’s Arguments
Applicant argues:
1. Spetzler describes a broad framework involving biomarker panels, listing large numbers of potential biomarkers, including Claudin-5, and numerous possible diseases or phenotypes, and Applicant concedes that one of these diseases or phenotypes is mild cognitive impairment. However, Spetzler does not specifically teach the claimed method, which comprises detecting the presence or absence of Claudin-5 in a body sample of a subject suspected of having MCT.
2. The Office relies on disparate portions of Spetzler in an effort to reconstruct the claimed method. The elements are separated by many pages, and therefore the elements are assembled from unrelated disclosures within the reference.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
The method of Spetzler method can involve identifying a novel biosignature for the diagnosis, prognosis, or theranosis of a phenotype, using vesicles isolated from a subject (see e.g. paragraph [01203]). This indicates that a subject is suspected of having the disease, if the test is prognosing a known disease, such as a neurological disorder. Spetzler specifically teaches that the neurological disorder can be mild cognitive impairment (see e.g. paragraph [1189]). The biomarkers used in the biosignature can be those in Table 5 (see e.g. paragraph [01208]), and Table 5 specifically lists Claudin-5 (see e.g. page 65). Claudin-5 can be used in a biomarker signature to prognose mild cognitive impairment, and therefore the claims are anticipated.
In the instant case, the claims require measurement of Claudin-5 in a subject suspected of having a mild cognitive impairment. These limitations are specifically named in Spetzler. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). Applicant has acknowledged in the reply filed 6/25/26 that the elements of the instant method, including measuring claudin-5 and testing mild cognitive impairment are described in Spetzler. Spetzler teaches all parts of the method, including a method for measuring biomarkers, the specific biomarker of the instant claims, and the specific disorder of the claims. While the elements appear in different paragraphs of the reference, they are still described as elements of the same method. The appearance in different paragraphs does not change the fact that the method measures biomarkers, the exact biomarker of the instant claims is named as one species of applicable biomarkers, and the method can provide diagnosis, prognosis, or theranosis of the exact disorder of the instant claims. Therefore the method is anticipated by the cited reference.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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