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 31-41 are pending upon entry of amendment filed on 7/15/24.
Claims 31-41 are under consideration in the instant application.
3. Applicant’s IDS filed on 4/30/24 has been acknowledged.
4. The oath filed on 4/30/24 has been entered.
5. Claims 31, 38 and 40 are missing a conjunction. Appropriate correction is required.
6. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
7. 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.
8. Claims 35, 36, 38 and 40 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 pre-AIA the applicant regards as the invention.
Claim 35 recites the identical sequence identifiers “ SEQ ID NO:3 or SEQ ID NO:4” from different pathogenic sources. It is not clear how the same sequences are derived from tetanus, diphtheria or Epstein Barr virus, respectively.
Claim 36 recites improper Markush group; the phrase “selected from the group consisting of A, B and C” should be used.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 38 or 40 recites broader transition of comprising and narrower transition language of consisting in the same claim.
9. 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.
10. Claims 31-41 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. Specifically, there is insufficient written description to demonstrate that Applicant was in possession of the claimed genus of universal T cell epitopes other than SEQ ID NO:1-8.
The guidelines of the Examination of Patent Applications Under the 35 U.S.C. 112, §1 “Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see specially page 1106 column 3).
The instant claims are drawn to compositions comprising a huge genus of structurally distinct universal T cell epitopes. This would encompass any antigens that function in any part of enhancing T helper cells in inducing immune response. Thus, claims would encompass structurally unrelated peptides of various lengths. There is no art recognized correlation between structure and function other than SEQ ID Nos:1-8 of p. 21-22 of the instant specification. The instant specification does not disclose a correlation between structure of universal T cell epitopes with various lengths with the various functions claimed. Further, the disclosed species are not sufficiently representative of the huge genus encompassed by the present claims. Thus, one of skilled in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus in the liposomal vaccine. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398.
11. 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.
12. 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.
13. Claim(s) 31-41 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2012/055933 (IDS reference).
In lack of conjunctions for claims 31. 38 or 40, the claims read on any liposomal constructs comprising an adjuvant as well.
The ‘933 publication teaches method of inducing immune response comprising liposomal constructs comprising antigenic constructs outside of surface (p. 13-15, claims 32-43) for targeting and the drugs may be encapsulated in the liposome (p. 12-13). The ‘933 publication discloses that the liposomes can be mixed or modified with various peptides (p. 6) and modifications of peptides with fatty acids (p. 7-8). As is evidenced by specification p. 19, ACI24 is deemed multiple T cell epitopes and the ‘933 publication teaches ACI24 (p. 35), claims 35-40 are included in this rejection.
Also, the ‘933 publication teaches adjuvants include MPLA (p. 11) and kit for treatment of disease in CNS (p. 14). The ‘933 publication discloses T cell epitopes, Aβ peptides from Aβ1-15 (see p. 31-33) and other antigenic peptides from Aβ (p, 34). Conjugations can be done with or without linkers (p. 36-40). Therefore, the reference teachings anticipate the claimed invention.
14. 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.
15. Claims 31-41 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2012/055933 (IDS reference) in view of U.S. Pub. 2011/0070298 (IDS reference).
The teachings of the ‘933 publication have been discussed, supra.
The disclosure of the ‘933 publication differs from the instant claimed invention in that it does not teach the use of liposome encapsulation for T cell epitopes as in claim 31 of the instant application.
The ‘298 publication teaches the use of T helper cell epitope combine with antigenic peptides from Aβ ([0184-185]) to induce immune response and the T helper cell epitope is encapsulated.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to encapsulating liposomes with T helper cell epitope as taught by the ‘298 publication into liposomal constructs taught by the ‘933 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the T helper cell epitope and antigenic peptides from Aβ combination is frequently used in the vaccine art and the such combination improves immune response.
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.
16. 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.
17. Claims 31-41 are rejected on the ground of nonstatutory obviousness- type double patenting as being unpatentable over claims 11-13, 18, 26-29 of US Patent No: 10,828,351 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘351 patent recite methods of treating or inducing protective immune response comprising liposomal vaccine comprising beta-amyloid derived peptide antigen on the surface of liposome, peptide comprising T cell epitope within liposome and an adjuvant.
18. No claims are allowable.
19. 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 on Mon-Fri 8:30-5. 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 8, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
