DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 December 2025 has been entered.
Response
No claims have been amended in the response filed on 15 May 2025. Claims 1-55 were previously cancelled and claims 56-63 are pending in the instant application and are under examination in the instant office action.
Information Disclosure Statement (Maintained)
Listing of references in the specification does not constitute a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Specifically, no IDS has been filed to remedy the deficiencies between those references cited in the specification (ex. “Masliah et al., 1991” on page 3 and “Noguchi et al., (2009)” on pages 19 and 57; etc.) and those that appear on the proper information disclosure statement filed on 15 February 2023.
Priority
As indicated previously, Claim 56 has an effective filing date of 22 February 2010, and claims 57-63 have an effective filing date of 22 February 2011.
Claim Rejections - 35 USC § 102 (Maintained)
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim 56 stands as rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Knauer et al., PNAS, 89:7437-7441, 1992 for reasons of record in the previous action.
On page 2 of Remarks filed 2 December 2025, Applicant traverses this rejection on the ground that Knauer does not teach the claimed composition, which “permits performing certain PKC epsilon protein-based methods described in the application for diagnosing Alzheimer’s disease in a human patient” (pg. 2, bullet III, second paragraph). “Applicants again respectfully maintain that the Examiner has not shown how Knauer teaches every element of the claimed composition.” It should be noted that Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art as disclosed by the references cited.
As previously stated in Response to Applicant's assertion that the composition of the claims “permits performing” a diagnostic method: First, this is an unclaimed feature and is only stated in Applicant’s Remarks; Second, a recitation of intended use of a claimed invention must result in a structural difference between the claimed invention and the composition disclosed in the prior art. See MPEP 2111.02(I) and (II). No such structural difference between the composition of the claims and that of the prior art reference has been argued by Applicant. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP 2112.01(II) states: “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
The burden of proof is upon the Applicant to show a novel or unobvious distinction between the structural characteristics of prior art composition and those of the claimed composition. Patent owner’s burden under the circumstances presented herein was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . .
The Knauer et al. prior art reference teaches synthesis of labelled peptides of amyloid-β 1-28, 1-39, and 1-42 (pg. 7437, Materials, first sentence) in contact with confluent human skin fibroblasts (Abstract and pg. 7438, Cell culture, first sentence and pg. 7438, Uptake/Degradation, first sentence). Since there is no specific argument presented pertaining to how the composition of the claims structurally differs from that of the prior art, then the rejection is maintained.
Claims 57-58 and 61-62 stand as rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Cecchi et al., Neurobiology of Aging, 28:863-876 (2007) for reasons of record in the previous action.
On pages 2-3 of Remarks filed 2 December 2025, Applicant traverses this rejection on the ground that composition comprising cultured human skin fibroblasts in contact with amylospheroids “permits performing certain PKC epsilon protein-based methods”.
This is not persuasive. Again, this argument does not comply with 37 CFR 1.111(c) because it does not clearly point out the errors in the rejection nor point out the patentable novelty which Applicant thinks the claims present in view of the prior art.
The Cecchi prior art teaches cultured human skin fibroblast cells from controls and patients belonging to Familial Alzheimer’s Disease cohorts (pg. 865, at section 2.4) in contact with amylospheroids (ASPDs) (pg. 868 at 3.2 and Fig. 5).
Applicant has failed to provide any evidence that the structure disclosed in Cecchi materially differs from the claimed composition.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 103 (Maintained)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 59-60 and 63 stand as rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cecchi, applied to claims 57-58 and 61-62 above, and further in view of Hoshi et al., 2003 for reasons of record in the previous action.
On pg. 3 of Remarks (Id), Applicant traverses this rejection on the grounds: “the ASPDs have a molecular weight of greater than 100 kDa (claim 59), the ASPD concentration is 500 nM (claim 60), or (i) the ASPDs comprise Aβ1-42, have a molecular weight of greater than 100 kDa, and have a concentration of 500 nM; (ii) the cultured human skin fibroblast cells are confluent; and (iii) the temperature of the composition is 37° C (claim 63). These compositions permit performing certain PKC epsilon protein-based methods described in the application for diagnosing Alzheimer's disease in a human patient. Applicants respectfully maintain that the Examiner has not shown how Cecchi and Hoshi combined would have suggested to the skilled person the claimed compositions, which compositions permit performing the subject diagnostic methods” (pg. 3, paragraphs 5 and 6). These arguments are verbatim the same as previously presented in Remarks filed 15 August 2024.
These arguments are unpersuasive because, first, permitting performing a method for diagnosis is an unclaimed feature; and, second, a recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. No structural difference has been pointed out by Applicant even though the burden of proof is upon the Applicants to show a novel or unobvious distinction between the structural characteristics of prior art composition and those of the claimed composition. MPEP 2112.01(II) states: “if the composition is physically the same, it must have the same properties.” The instant application cites the ASPD of Hoshi are “>100kDa” (see citation of Hoshi et al. 2003 at paragraph [00103] of the instant specification). For all these reasons, the rejection is maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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, Jeffrey Stucker can be reached at 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.
/STACEY N MACFARLANE/Examiner, Art Unit 1675
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675