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 .
DETAILED ACTION
Response to Amendment
1. Claims 1, 6, 7,11, 14, 16 and 17 have been amended, claims 2-5, 8-10, 12 and 13 canceled and claims 18 and 19 added as requested in the amendment filed on October 14, 2025. Following the amendment, claims 1, 6, 7, 11 and 14-19 are pending in the instant application.
2. Claims 1, 6, 7, 11 and 14-19 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on October 14, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 1, 6, 7, 11 and 14-15, as amended, and new claims 18 and 19 are rejected 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.
6. Claims 1 and 11, as currently presented, are vague and indefinite for stating that no change in the levels of the diagnostic markers—amount or ratio—stands for Alzheimer’s disease or mild cognitive impairment, respectively. When one readily appreciates that a change in an amount, level or a ratio of any marker in a pathological sample as compared to a normal control could be indicative of the pathology, one would not know how no change in the measured levels of markers stands for the same. This renders the claims indefinite. Clarification is required.
7. Claim 7 recites the limitation "in ii)" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
8. Claim 18 recites the limitation "the method" in claim 16. There is insufficient antecedent basis for this limitation in the claim.
9. Claim 19 recites the limitation "the method" in claim 17. There is insufficient antecedent basis for this limitation in the claim.
10. Claims 6 and 14-15 are indefinite for being dependent from indefinite claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
11. Claims 1, 6, 7, 11, 14 and 15, and claims 16 and 17, as amended, are rejected 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. See reasons of record in section 9 of Paper mailed on June 10, 2025.
Applicant traverses the rejection at pp. 5-8 of the Response. Specifically, Applicant argues that, “with the claims as amended, the tetraspanin is defined as being specifically CD9, CD63 and CD81; the substance with an affinity to the tetraspanin is specifically defined as being an antibody; and the substance with affinity to the phosphatidylserine is specifically defined as being an antibody or Tim protein. Applicant submits that the claims, as amended, recite specific and well-defined steps that amount to significantly more than the judicial exception and that such steps are not conventional as it was neither known nor suggested in the art to diagnose Alzheimer's disease with the specific recited methods.” Applicant further submits that, “claim 11 is directed to a method for assisting the diagnosis of Alzheimer's disease or mild cognitive impairment, i.e. a method which enables the differentiation between Alzheimer’s Disease or mild cognitive impairment. […] Neither the steps recited in claim 11, with the specific materials as recited, nor the results achieved of being able to differentiate between Alzheimer's Disease and mild cognitive impairment are conventional and amount to significantly more.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
First, as fully explained earlier, claims 1, 6, 7, 11 and 14-15 do not add significantly more to the judicial exception recited within the claims because they do not recite any novel, inventive elements or particular steps that add to the observation of a natural phenomenon. The active steps of the claims represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art.
Second, contrary to Applicant’s statement, claim 11 does not allow for any differentiation, not only between Alzheimer’s disease and MCI but also between AD, MCI and normal control, see section 6 earlier. The Examiner maintains that at the time of filing claims 1, 6, 7, 11 and 14-15 read on judicial exception without significantly more, do not satisfy the requirement of 35 U.S.C. 101 and the rejection is maintained.
Amended claims 16 and 17 are also rejected under 35 U.S.C. 101. Claims 16 and 17 encompass kits for diagnosing Alzheimer's disease, the kits comprising an antibody specific for Tim protein, an antibody specific for CD9 and an antibody specific for tetraspanin. By broadest reasonable interpretation, the claims encompass antibodies directed against naturally occurring proteins and so they are products of nature. The claims do not indicate that the recited antibodies are markedly different from their naturally occurring counterparts. The instant situation is similar to the case in Oxford Immunotec Ltd. v. Qiagen, Inc., when the court determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101. The court found the kit claims to be ineligible despite the ability of the recited peptides to “perform differently” than their natural counterparts and despite the fact that the recited peptides are “synthetically created.” Claims directed to the elements together within a substrate were also deemed unpatentable. Citing Myriad, the Magistrate Judge focused on the fact that it was “undisputed that the peptides have not been changed beyond the act of isolation.” As such, “the isolated peptides are products of nature.” Such is the case here, where the specification broadly teaches antibodies by reference to their binding epitopes. These antibodies are not markedly different in form or function from naturally occurring antibodies. Since the antibodies of the kit are not markedly different from their naturally-occurring counterparts, then they are directed to the products of nature themselves and the claims are unpatentable under 35 U.S.C. 101.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
12. Claims 1, 6, 7, 11, 14 and 15 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/826,334 (reference application) for reasons of record in section 10 of Paper mailed on June 10, 2025.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claim is allowed.
14. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
December 10, 2025
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