DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 17-32 are pending upon entry of amendment filed on 9/23/25.
Claims 25-32 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a nonelected species.
Claims 17-24 readable upon elected species of SEQ ID NO:2 as tau peptide and SEQ ID NO:39 as a T cell epitope are under consideration in the instant application.
3. Applicant’s IDS filed on 9/23/25 has been acknowledged.
4. No oath is of record.
5. The following rejections remain.
6. 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.
7. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 17-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2019/0119341 (IDS reference, of record) in view of Vos et al (Lancel Neurol. 2013, vol, 12 (10), p. 957-965, of record) for the reasons set forth in the office action mailed on 6/30/25.
The ‘341 publication teaches treatment of Alzheimer’s disease comprising administering liposomes comprising tau peptide, helper T cell epitope, CpG oligonucleotide and MPLa (note embodiments in p. 8-10). The ‘341 publication further teaches that the CpG in linked to cholesterol ([0138]), dosage of tau peptide of being 400ug-1200ug or 1800ug (note Examples) and intramuscular administrations of the liposomes ([0186]). Note embodiments 1-20 includes liposomes encapsulating tau peptide, helper Tcell epitope, CpG and MPLA.
In addition, the ‘341 publication teaches use of liposome comprising tau peptide having SEQ ID NO:2, T cell epitope set forth in SEQ ID NO:39, CpG with phosphothioated nucleotide having linker to cholesterol and MPLA as vaccine and priming and boosting at 6-12months intervals as well as 2-4 weeks to 2 years (p.13) for the ages between 50-70 years of patients. Given that the priming (e.g. week 0) and boosting (months 2 and 6 at least for 2 years) readable upon steps in claim 17 (a-c) as in [184-186] of the ‘341 publication and meets the limitations of claim 17.
Claim 17 and the dependent claims are included in this rejection as the recitation of administering liposomes 24 weeks before initiating once every 6 month and 16 weeks as in steps a-b and a-c are obvious variation of priming-boosting regimen in guidance disclosed in [184-187] of the ‘341 publication.
The disclosure of the ‘341 publication differs from the instant claimed invention in that it does not teach the use specific measurement of tau pathology, or diagnosis or characteristics of AD as in claims 18-19 and 24 of the instant application.
Vos et al teach use of Braak stage references and tauPET scan in diagnosis of AD and further use of CDR score as to determine cognitive impairment of AD in human subject (see entire reference). Further, Vos et al. teach clinical and cognitive assessment using MMSE and CDR-SB, PACC-5, Braak 3ROI SUVR >1.1 (Tables, p. 13-20) in diagnosis of AD and uses as parameter of delay of AD.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known diagnosis of AD and cognitive impairment of AD by the methods used in the Vos in the treatment of AD in the methods disclosed by the ‘341 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of AD diagnosis and determination of cognitive impairment by CDR provides accurate statistical association of AD and significant interaction within AD clinical spectrum.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 9/23/25 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references is not obvious or does not result in the claimed invention. Applicant has further asserted that the ‘341 publication relates administration of tau peptide to adult rhesus macaques in examples but no human subject with specific dosage. In addition, the currently amended limitations of having tau pathology at week 0 of the treatment has not been discussed in any of the cited references.
Unlike Applicant’s assertion, Applicant is reminded that the alternative embodiments constitute prior art. See MPEP 2123. The ‘341 publication includes a human subject ([172], p.12-13) and asymptomatic patients are included (e.g. preclinical).
In addition, Applicant has asserted that the support for “having a tau pathology at week 0 of treatment” is found in Example 4 of the instant application. The support is deemed based on the CDR global score of 0 at screening and baseline in [0199]. Having CDR of 0 at being normal is found in p. 2 of Vos reference and the limitation is taught. As such, the combination of the references result in the claimed invention and the rejection is maintained.
9. 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.
10. Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat 11,684,576 in view of Vos et al (Lancel Neurol. 2013, vol, 12 (10), p. 957-965, of record) for the reasons set forth in the office action mailed on 6/23/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘576 patent recite methods of treating AD comprising liposomes comprising tau peptide, T cell epitope, CpG and MPLA.
The claims of the ‘576 patent differs from the instant claimed invention in that it does not teach the use specific measurement of tau pathology, or diagnosis or characteristics of AD as in claims 18-19 and 24 of the instant application.
Vos et al teach use of Braak stage references and tauPET scan in diagnosis of AD and further use of CDR score as to determine cognitive impairment of AD in human subject (see entire reference). Further, Vos et al. teach clinical and cognitive assessment using MMSE and CDR-SB, PACC-5, Braak 3ROI SUVR >1.1 (Tables, p. 13-20) in diagnosis of AD and uses as parameter of delay of AD.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known diagnosis of AD and cognitive impairment of AD by the methods used in the Vos in the treatment of AD in the methods disclosed by the ‘576 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of AD diagnosis and determination of cognitive impairment by CDR provides accurate statistical association of AD and significant interaction within AD clinical spectrum.
In light of the discussion above in section 8 of the office action, the rejection is maintained.
11. The following new ground of rejection is necessitated by Applicants’ amendment filed on 10/7/25.
12. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
13. Claims 17-24 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “at week 0 of treatment” in claim 17 of the instant application. Applicants assert that the currently added limitation is found from the specification in Example 4 of the instant application. The specification supports for CDR of 0 but no support for having tau pathology at week 0 of treatment as currently amended.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
14. No claims are allowable.
15. THIS ACTION IS MADE FINAL. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
October 29, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641