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. 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. DETAILED ACTION This action is in response to claims filed 9/27/23. Claims 1-18 are pending and under examination. Notice Applicant is advised that should claim 1 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In this case, the sole difference between claims 1 and 13 is that claim 13 specifies the antibody and immune complex are “detectable”. There is no special definition of this term in the specification. Under an ordinary definition, any composition is “detectable” by some means. While antibodies are often labeled for detection, this is not required by the claim and the antibodies themselves are inherently “detectable” because they are, e.g., matter, atoms, amino acids, etc., which the art possesses means for detecting. This is best illustrated by claim 2, which does not add any additional limitations to the antibody or the complex but nevertheless quantifies (detects) the complex. As such, claims 1 and 13 are coextensive in scope despite a slight difference in wording and are considered substantial duplicates. Further: Claims 4 and 14 Claims 5 and 15 Claims 3 and 16 Claims 6 and 17 Claims 7 and 18 are substantial duplicates. These claims are verbatim identical and therefore are duplicates for the same reasons as claims 1 and 13. Claim 3 differs from 16 by claim 3 specifying the isolation “of step b”, but the isolation in claim 13 is also step b and so the isolation of claim 16 (“said immune complex is isolated”) also occurs in step b despite not explicitly specifying this. Note that claims 2 and 8 are not substantial duplicates. Claims 2 and 8 differ in that claim 2, by depending from claim 1, requires an isolation step, whereas claim 8 does not. Claim Objections Claim 1, 3, 8, and 13 are objected to because of the following informalities: only one period is allowed in a claim except for when used with abbreviations (MPEP §608.01(m)). Headings such as “a.” or “b.” do not appear to be abbreviations for anything and so should not be accompanied by a period. Further, if these are in fact abbreviations, it is not a common abbreviation and must be accompanied by the full name of what is being abbreviated at its first recitation . Appropriate correction is required. While Applicant may choose any acceptable form, the Examiner notes that forms such as “a)” and “(a)” are acceptable , similar to the formatting in parent patents US 10183990, US10875908, US11208473, and US11802148. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp . Claims 1-1 8 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-2 of U.S. Patent No. 10183990 in view of Roux (US20120115151; form 892) . Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a method of making a p53 antibody. T hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel , 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘ that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim, ’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘ determine how much of the patent disclosure pertains to the invention claimed in the patent ’ because only ‘ [t]his portion of the specification supports the patent claims and may be considered. ’ The court pointed out that ‘ this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 , since only the disclosure of the invention claimed in the patent may be examined. ’’’ MPEP §804(II)(B)(1) In this case, in support for the “anti-human p53 antibody” of the reference claims, the reference document discloses antibody 2D3A8. This antibody inherently possesses the instantly claimed CDRs, heavy and light constant regions, and is monoclonal; see declaration filed 8/6/20 in parent application 16/214455, now US 10875908. The reference claims do not claim a use for the antibody produced by the method of the reference document. Roux teaches detecting the presence of a p53 isoform (claim 1). The isoform is conformationally altered as the p53 isoform is a “delta” version, which is due to a missplice (paragraph 34) and differs from the wild-type (paragraph 148). The detection is via an antibody binding contacting the biological sample (claim 10), thereby creating (“providing”) an immunocomplex. Roux teaches isolating the antibody (paragraph 79; 83;85) and the peptide (paragraph 107; claim 13). Regarding claim 1, this would have made it obvious to one of ordinary skill in the art at the time of filing that the detected p53/antibody complex could be isolated in a similar manner. Roux also teaches immunoprecipitation (paragraph 49), which would isolate the complex within the scope of the instant claim. Finally, since Roux teaches this applies to any p53 antibody, it would have been an obvious use of the reference antibody which also binds p53. Regarding claim 2, Roux also teaches quantification (paragraph 111), rendering such quantification an obvious variation. Regarding claim 3, immunoprecipitation would have been obvious as above. Regarding claims 4-5, these are structures of the antibody produced by the method of the reference claims. Regarding claim 6, Roux also teaches, e.g., Western blots for detection (paragraph 49). Regarding claim 7 , Roux also teaches the biological sample is blood (paragraph 47). Regarding claims 13-18, these are duplicates of the above claims as set forth above and so are not patentably distinct for the same reasons. Regarding claims 8-12, these claims share the same limitations as above but for lacking an isolation step and including a quantification step. The quantification step is addressed above and so these claims are not patentably distinct for the same reasons. Claims 1-1 8 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-7 of U.S. Patent No. 10875908 . Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to an antibody comprising SEQ ID NOs: 4 and 5, which inherently possesses the instantly claimed CDRs and variable regions of the antibody of the instant methods. Further, the instant detection methods are claimed; while limited to in vitro testing, those claims nevertheless anticipate the instant detection methods. In support of such detection methods, the reference specification discloses the instant limitations as well as the use of such a detection method for diagnosing, e.g., AD. The reference claims include immunoprecipitation (claim 6) which meets the isolation limitations. Further, the combination of reference claims 6 (western blot) and 7 (levels of the immunocomplex) would have made obvious quantification as quantification is necessary to determine a comparative “level”. The samples of the reference claim include, e.g., blood (claim 5). Claims 1-1 8 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-8 of U.S. Patent No. 11203635 . Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to the same antibody of the instant methods: one which comprises CDRs of SEQ ID NOs: 8-13, possessing the same variable regions, constant regions, and is monoclonal. In support of the reference composition claims, the reference specification discloses its utility in detecting p53 /antibody immunocomplexes ( C3 ) , isolation by immunoprecipitation (C3) and quantifying levels (C6) in serum (C6) . Claims 1-1 8 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-10 of U.S. Patent No. 11208473 in view of Roux (US20120115151) . Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are also directed to detecting p53 using the same antibody (claim 1) in blood (claim 3) using immunoprecipitation (claim 4) . While the reference claims do not explicitly claim quantification, doing so would have been obvious in view of Roux, which teaches p53/Ab complexes can be quantified by techniques such as Western blot (see above), which is also a technique of reference claim 4). Claims 1-18 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-5 of U.S. Patent No. 11802148. Alt hough the claims at issue are not identical, they are not patentably distinct from each other because the reference claims contact a blood sample (blood; biological sample) with the same antibody as instantly claimed (claim 1;3;5). The reference claims include isolation (immunoprecipitation; claim 4) and quantification (claim 1) using the same assays (claim 4) . Allowable Subject Matter The claims are allowable over the prior art; see Office Action mailed 8/24/20 in parent application 16/214455, now US 10875908. Briefly, one cannot a priori predict a combination of CDRs which will bind a given target. No prior art disclosing the instantly claimed six CDRs in a single antibody was discovered and so the claims are directed to a non-obvious combination. Regarding the enablement rejection over diagnosing AD specifically, the Examiner proposes that limiting claim 1 such that the biological sample is B lymphocytes would be acceptable. The specification contains an example where AD is definitely diagnosed using the claimed method using B lymphocytes and there is no concrete evidence that other conditions, such as MCI, would present the same way when using the “ratio” method. However, there is enough evidence to conclude that altered p53 levels across other biological samples are unpredictable and so would require undue experimentation to determine if the method could successfully diagnose AD in these other samples, particularly as the B lymphocytes are wholly absent from, e.g., plasma and serum. It is noted that in some cases, the instant claims are nearly identical to previous patented claims. However, any difference in scope is sufficient to avoid a statutory double patenting rejection. The instant claims are not deemed to be statutory double patenting over US 11802148. Claim 1 of the reference patent is limited to a blood sample, while none of the instant claims are limited to such. However, it is noted that the preamble (“identifying in a subject the presence of Alzheimer’s disease of mild cognitive impairment”) does not impart any patentable distinction because the body of the claim is complete ; s ee Pitney Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999) and s ee MPEP § 2111.02. Further, the “is indicated” portion of the reference claim is an inherent property of the complex itself. The instant complexes “indicate” the same information whether claimed or not. The instant claims are not deemed to be statutory double patenting over US 11208473. Despite a slight difference in wording, the complex is necessarily “provided” in the reference claims as the complex is detected. However, instant claim 8, which is the closest in scope to the reference claims, requires “quantifying” whereas the reference claims require “detecting”. Detection is broader and includes the binary “yes/no” detection of the presence of the complex. Instant independent claim 8 requires “quantifying”, which requires arriving at a particular amount (quantity) of the complex. Instant independent claims 1 and 13 require “isolating” the complex, which is included, but not required , by any of the reference claims. Similarly, reference patent US10875908 is drawn to a method of detecting (claim 4) and does not require quantifying or isolating. Reference claim 7 requires quantifying. While not explicit, the claim requires the complex at a “higher level”, thus requiring quantification. However, this detection/quantification claim requires the immunocomplex to be at a higher level than compared to a control, which is not a limitation of the instant detection/quantification methods. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ADAM M WEIDNER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3045 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-T 9-18; W-R 9-15 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jeffrey Stucker can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0911 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Adam Weidner/ Primary Examiner, Art Unit 1675