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
1. Applicant’s amendment and response filed 3/17/26 is acknowledged and has been entered in part.
Applicant’s proposed amendment to paragraph [0037] in the specification discloses “[0001]” rather than ‘[0037]’ at the paragraph number. Accordingly the amendment to the specification has not been entered. Accordingly, the objection to the disclosure set forth below is maintained.
2. The terminal disclaimer filed on 3/17/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12,011,480 or US 10,458,882 has been reviewed and is accepted. The terminal disclaimer has been recorded.
3. Applicant is reminded of Applicant's election of Group I in Applicant’s amendment and response filed 6/12/25.
Claims 1, 2, 5, 7, 8, 10-13 and 36 are presently being examined. Claim 1 is an independent claim.
4. Applicant is reminded that the disclosure is objected to because of the following informalities: the description of the drawings for Figure 13C is missing at [0037].
Appropriate correction is required.
Applicant’s proposed amendment to paragraph [0037] in the specification discloses “[0001]” rather than ‘[0037]’ at the paragraph number. Accordingly the amendment to the specification has not been entered. However, when Applicant corrects the paragraph number, the objection will be obviated.
5. Claim interpretation: The specification discloses at [0049] that the term “about is used to indicate that a value includes the standard deviation of error for the device or method being employed to determine the value….the term “about when used before a numerical designation…indicates approximations which may vary by (+) or (-) 10%, 5%, or 1%. The specification discloses at [0064] that the term “disease-relevant” antigen intends an antigen or fragment thereof selected to treat a selected disease. The open transitional phrases “comprises” and “comprising” opens the claims to include other non-recited portions or ingredients. An amino group is a functional group that consists of a single nitrogen atom bonded to two hydrogen atoms. If it is attached to an organic compound (contains carbon), it is classified as an amine. The instant specification discloses that it should be noted that a strict distinction between “functional groups” generated at the surface and linking molecules bearing “functional groups” is not possible, since sometimes the modification of the surface requires the reaction of smaller linking molecules with the nanosphere surface ([0145]). Due to this disclosed inability to make a distinction between functional groups generated at the surface of the NS and the linker, a linker imparting an amino group to the NSNP (nanosphere/nanoparticle) surface is being interpreted as a surface modification via amino groups.
6. 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.
7. Claims 1, 2, 5, 7, 8, 10-13 and 36 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Applicant has presently amended the claims and has canceled claim 35.
The issue set forth below in this office action was of record in the prior office action of record and claim 35 was included in the rejection. This is a new ground of rejection necessitated by Applicant’s amendment filed 3/17/26 as Applicant has amended the claims to incorporate the limitation recited in previous dependent claim 35 into base claim 1.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP 2163 I.A.
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that "if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function".). "Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function." See MPEP 2163 II.3.
Applicant has broadly claimed a complex and composition thereof comprising a nanoparticle (NP) and disease-relevant antigen-MHCII complexes and further comprising a linker as is recited in instant base claim 1, and including the limitations of the dependent claims.
The specification does not disclose a representative number of species of a complex comprising any disease-relevant antigen-MHCII complex, nor sufficient relevant identifying characteristics in the form of structure or functional characteristics coupled with a known or disclosed correlation between structure and function.
As is enunciated above in the claim interpretation in this office action, the specification discloses at [0064] that the term “disease-relevant” antigen intends an antigen or fragment thereof selected to treat a selected disease. As such, the claimed complexes must comprise an antigen peptide that has the functional property of binding to any in the genus of MHCII molecules, human or non-human, and the antigen peptide can derive from the broad and structurally diverse genus of any subsequence of an antigen that is considered disease relevant that can treat any disease in the genus of diseases.
It is therefore clear that the limitation “disease-relevant antigen-MHC II complex” is much broader than is disclosed in the instant specification or present in the art before the filing date of the claimed invention. In addition, evidentiary reference HLA Nomenclature 2023 (2023, 2 pages, of record) teaches that there are over 10,700 different HLA class II molecules alone (i.e., human MHCII molecules) (see entire reference, especially the Numbers of HLA Alleles section). Although the identities of the individual human MHC class II molecules are known, it is clear that the genus of disease-relevant antigens (peptides) that are cognate for particular diseases and treatment thereof and also cognate for the functional property of binding to their respective MHC class II molecules is broader than is disclosed in the specification or disclosed in the art.
Therefore, it appears that the instant specification does not adequately disclose the breadth of the complex/ composition thereof recited in the instant claims. In light of this, a skilled artisan would reasonably conclude that Applicant was not in possession of the genus of all such complexes at the time the instant application was filed.
Applicant’s arguments in the amendment and response filed 3/17/26 on pages 7-8 have been fully considered but are not persuasive.
Although the structure and sequence of different MHC class II molecules are known in the art (10,700 of them), it is clear that the genus of disease-relevant antigens (peptides) that are cognate for particular diseases and also cognate for the functional property of binding to their respective MHC class II molecules is broader than is disclosed in the specification or disclosed in the art.
8. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claim 5 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.
9. 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.
10. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 under 35 U.S.C. 103 as being unpatentable over WO2012/041968 A1 (IDS reference) in view of Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Applicant has presently amended instant base claim 1 to recite the structure of a linker that the art references do not teach.
11. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-3 and 36 under 35 U.S.C. 103 as being unpatentable over US 2025/0121043 A1 (PgPub of application serial no. 18/638,077) in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Applicant has presently amended instant base claim 1 to recite the structure of a linker that the art references do not teach.
12. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 under 35 U.S.C. 103 as being unpatentable over US 8,354,110 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Applicant has presently amended instant base claim 1 to recite the structure of a linker that the art references do not teach.
13. Applicant’s terminal disclaimer filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13, 35 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No.12,011,480 in view of WO2012/041968 A1 (IDS reference).
14. Applicant’s terminal disclaimer filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13, 35 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No.10,458,882 in view of WO2012/041968 A1 (IDS reference).
15. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,603,948 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of US 9,603,948 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
16. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,080,808 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of US 10,080,808 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
17. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23, 30 and 32-36 of copending Application No. 18/048,339 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of 18/048,339 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
18. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-63 of copending Application No. 18/638,077 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of 18/638,077 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
19. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-21 of U.S. Patent No. 8,354,110 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contr. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of US 8,354,110 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
20. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-49 of copending Application No. 17/153,212 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of 17/153,212 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
21. Applicant’s amendment filed 3/17/26 has overcome the prior rejection of record of claims 1, 2, 5, 7, 8, 10-13 and 36 as rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,397,038 in view of WO2012/041968 A1 (IDS reference), Pfister and Morbidelli (J. Contro. Release, 2014, 180: 134-149, IDS reference), and Cochran et al (Immunity, 2000, 12: 241-250, IDS reference).
Neither the do the claims of US 12,397,038 recite, nor the cited art references teach or disclose the linker that is presently recited in instant base claim 1.
22. No claim is allowed.
23. 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.
24. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights