DETAILED ACTION
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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/EP2019/080929 filed 11/12/2018, which claims the benefit of the priority of European Patent Application No. EP18205615.0 and EP18205611.9 filed 11/12/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-7, 9-23 are pending. Claims 9, 14-23 are withdrawn. Claim 8 is canceled. Claim 1 is amended. Claims 1-7, and 10-13 are being examined on the merits in this office action.
Claim Rejections – Withdrawn
The rejection of claims 1, 4-7, and 10-11 under 35 U.S.C. 103 as being unpatentable over Remy (WO2016059236A1 - hereinafter “Remy”) in view of French et al. (J. Mol. Evol. 1983, 19: 171-175) and Sousa et al. (Journal of Thrombosis and Haemostasis, 15: 774–784) is withdrawn in view of the claim amendments.
The rejection of claims 12-13 under 35 U.S.C. 103 as being unpatentable over Remy (WO2016059236A1 - hereinafter “Remy”) in view of French et al. (J. Mol. Evol. 1983, 19: 171-175) and Sousa et al. (Journal of Thrombosis and Haemostasis, 15: 774–784) as applied to claim 1 above, and further in view of Remy-2 (US20160194367A1 - hereinafter “Remy-2”) is withdrawn in view of the claim amendments.
The rejection of claims 1-7, 10-13 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-14,of copending Application No. 17/923,117 is withdrawn because the application is abandoned.
Claim Rejections - 35 USC § 103 - New
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 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4-7, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Remy (WO2016059236A1 - hereinafter “Remy”) in view of Mauro et al. (WO2009121845A2 – hereinafter “Mauro”).
Remy teaches immunogenic peptides comprising an MHC class II T cell epitope, and immediately adjacent or separated from said epitope [CST]-X(2)-C-X(0,2)-H, wherein X is Gly or Pro (Abstract; page 2, line 1-34; page 3, line 1-3). Examiner notes the teachings of Remy read on the instant CXX[CST](B2)m(Z3)+, wherein the sequence is C, GG(for X2, wherein X is Gly or Pro), C, G (for B2) and H (for instant Z3 which is a basic amino acid). The sequence is thus CGGCGH. Further, Remy teaches the sequence CXXCXH (SEQ ID NO: 94), wherein X represents any amino acid. This sequence reads on the instant sequence CXX[CST](B2)m(Z3), wherein X is any amino acid, (B2) is any amino acid, m is an integer from 0-3, and (Z3) is a basic amino acid K or R. Thus the sequence of Remy CXXCXH (SEQ ID NO: 94), reads on the instant sequence because it has the first amino acid as C, the fourth amino acid is C and the last amino acid is H which is a basic amino acid. Remy teaches T cell epitope and the modified redox motif sequence may be immediately adjacent to each other in the peptide or optionally separated by a one or more amino acids (so called linker sequence), (Page 11, line 1-6), and that the linker comprises 1,2,3,4 amino acids (Page13, line 30-37).
Remy does not teach that the motif is (Z2)+(B1)n[CST]XXC or (Z2)+(B1)nCXX[CST]. However, the instant motif is known in the art and is known to expand T cells as taught by Mauro et al. (WO2009121845A2).
Mauro teaches an immunogenic peptide that comprises an epitope such as CTL epitopes, that the epitopes are positioned on the N or C terminus of the peptide (claims 1-7; Page 4, line 1-30; Page 6, line 1-30). Mauro teaches the peptide of SEQ ID NO: 45, which has the sequence ACNTCYCKKCSYHCLVCF (Page 12, line 33). Examiner notes that the fragment of Mauro comprises the sequence KCSYHC, which reads on instant formula (Z2)+(B1)n[CST]XXC, wherein (Z2)+ is K, (B1)n is C, the next amino acid is S, and the two X variables are Y and H, and the last amino acid is C. Mauro teaches that the immunogenic peptide for detecting a population of T cells such as CD4 T cells, CD8 T cells, etc. (claims 11-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the immunogenic peptide of Remy and use the motif taught by Mauro since Mauro teaches that such motifs can be combined with T cell epitopes for use in detecting a population of T cells. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the motif of Mauro since Mauro teaches that the motif was successful in detecting T cells.
Regarding claim 2-3, Mauro teaches an immunogenic peptide that comprises an epitope such as CTL epitopes, that the epitopes are positioned on the N or C terminus of the peptide (claims 1-7; Page 4, line 1-30; Page 6, line 1-30). Mauro teaches the peptide of SEQ ID NO: 45, which has the sequence ACNTCYCKKCSYHCLVCF (Page 12, line 33). Examiner notes that the fragment of Mauro comprises the sequence KCSYHC, which reads on instant formula (Z2)+(B1)n[CST]XXC, wherein (Z2)+ is K, (B1)n is C, the next amino acid is S, and the two X variables are Y and H, and the last amino acid is C. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the immunogenic peptide of Remy and use the motif taught by Mauro since Mauro teaches that such motifs can be combined with T cell epitopes for use in detecting a population of T cells.
Regarding claim 4, Remy teaches immunogenic peptides comprising an MHC class II T cell epitope, and immediately adjacent or separated from said epitope [CST]-X(2)-C-X(0,2)-H, wherein X is Gly or Pro (Abstract; page 2, line 1-34; page 3, line 1-3).
Regarding claim 5, Remy teaches that the epitope comprises 8-25 amino acids (Page 15, line 10-14; page 16, line 35-36).
Regarding claim 6, Remy teaches that the length of the peptide vary from 13 or 14 amino acids (page 16, line 35-36).
Regarding claim 7, Remy teaches where the antigen is an auto- antigen (claims 16-17).
Regarding claim 10, Remy teaches immunogenic peptides comprising an MHC class II T cell epitope, and immediately adjacent or separated from said epitope [CST]-X(2)-C-X(0,2)-H, wherein X is Gly or Pro (Abstract; page 2, line 1-34; page 3, line 1-3).
Regarding claim 11, Remy teaches T cell epitope and the modified redox motif sequence may be immediately adjacent to each other in the peptide or optionally separated by a one or more amino acids (so called linker sequence), (Page 11, line 1-6), and that the linker comprises 1,2,3,4 amino acids (Page13, line 30-37).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Remy (WO2016059236A1 - hereinafter “Remy”) in view of Mauro et al. (WO2009121845A2 – hereinafter “Mauro”) as applied to claim 1 above, and further in view of Remy-2 (US20160194367A1 - hereinafter “Remy-2”).
The teachings of Remy are disclosed above and incorporated herein by reference.
Remy does not teach wherein said oxidoreductase motif does not naturally occur within a region of 11 amino acids N-terminally or C-terminally of the T-cell epitope in said antigenic protein as recited in claim 12.
Remy-2 teaches an isolated immunogenic peptide of between 12 and 75 amino acids comprising: an MHC class II T cell epitope of an allergen or auto-antigen; and a C-X(2)-[CST] or [CST]-X(2)-C redox motif, and wherein X is an amino acid, wherein said redox motif is either immediately adjacent to said epitope, or is separated from said epitope by at most 7 amino acids, and wherein the sequence of said allergen or autoantigen does not comprise said redox motif within a sequence of 11 amino acids N or C terminal of said epitope (claim 37), that the amino acid X in the [CST]-X(2)-[CST] motif of particular embodiments of the reducing compounds of the invention can be any natural amino acid, including S, C, or T or can be a non-natural amino acid [0107]. Remy-2 teaches that the peptides of the invention have been shown to be useful a medicine, more in particular for the prevention or treatment of immune disorders, more specifically of allergic disorders or autoimmune diseases (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Remy and use the oxidoreductase motif that does not naturally occur within a region of 11 amino acids N-terminally or C-terminally of the T-cell epitope as taught by Remy-2 so as to further increase the immunogenic properties described herein [0136]. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since Remy-2 teaches that the peptides of the invention have been shown to be useful a medicine, more in particular for the prevention or treatment of immune disorders, more specifically of allergic disorders or autoimmune diseases (Abstract).
Regarding claim 12, Remy-2 teaches wherein the sequence of said allergen or autoantigen does not comprise said redox motif within a sequence of 11 amino acids N or C terminal of said epitope (claim 37, 46; [0011, 0022, 0024]). It would have been obvious to one of ordinary skill in the art to modify the teachings of Remy and use the oxidoreductase motif that does not naturally occur within a region of 11 amino acids N-terminally or C-terminally of the T-cell epitope as taught by Remy-2 so as to further increase the immunogenic properties described herein [0136].
Regarding claim 13, Remy teaches that the T-cell epitope is an epitope of an antigenic protein which does not naturally comprise the motif [0022]. It would have been obvious to one of ordinary skill in the art to modify the teachings of Remy and use the oxidoreductase motif that does not naturally occur so as to further increase the immunogenic properties described herein [0136].
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 04/09/2026, with respect to the rejection(s) of claim(s) 1, 4-7, and 10-13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mauro et al.
Conclusion
No claims are allowed.
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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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