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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2026 has been entered.
Claims 1, 2, and 5-20 are now pending. Claims 1 and 11 are amended. Claims 8-10 and 13-20 remain withdrawn.
The 35 U.S.C. 112(a) enablement rejection is hereby withdrawn in view of amendment to remove “prevent” from claim 11.
Claims 1, 2, 5-7, and 11-12 are currently being examined.
Maintained Rejection
(Arguments Addressed)
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 5-7, 11 and 12 remain rejected under 35 U.S.C. 103 as being unpatentable over Iijima et al (US20170326214 A1; Published 11/16/2017; listed in IDS), in view of Waithman et al (WO2019134018 A1; Published 12/24/2018; copy in IDS) and Lim et al. (Current state of immunotherapy for glioblastoma. Nat Rev Clin Oncol 15, 422–442; 2018, of record).
Regarding claim 1, Iijima teaches a method for treating or preventing a disease or disorder of the brain, central nervous system, or spinal cord in a subject in need thereof, comprising: (a) administering an immunogenic agent to induce an immune response, thereby inducing permeability of the blood brain barrier (BBB) in the subject; and (b) administering at least one therapeutic agent for the treatment of the disease or disorder. [see at least, 0006; 0008-0010] Iijima teaches that the immunogenic agent allows access to immunoprivileged sites and defines these sites as the blood-brain barrier. [0003-0005] Iijima teaches that the first agent (immunogenic agent) induces an activation and production of memory CD4 T cells, and that these T cells allow the second agent to access the immunoprivleged tissue. [0074, 0191-00192]
Regarding claim 2, Iijima teaches that the immunogenic agent is an antigenic protein or peptide for inducing a CD4 T-cell immune response. [see at least 0007-0008, 0009, 0073, 0084] Regarding claim 11, Iijima teaches that the method treats cancer. [see at least, 0011, 0036, 0039, 0079, 0125] Regarding claim 12, Iijima teaches that the therapeutic agent comprises an antibody or antibody fragment that specifically binds a tumor-specific or tumor associated antigen. [see at least, 0011, 0088, 0035, 0129]
However, Iijima does not teach the following: (1) that the immunogenic agent comprises an antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90 and (2) that the therapeutic agent comprises an inhibitor of an immune checkpoint protein, such as pembrolizumab (as recited in claims 5-7).
With regards to claims 5-7, Waithman teaches method for inducing immune responses and crossing blood brain barriers, for the treatment of cancer. Waithman teaches that the method includes an immunogenic agent, such as an MHC Class II peptide, which induces an immune response, as well as an agent that induces permeability of the blood brain barrier, which are “CPP peptides.” Waithman also teaches that the skilled person will also be familiar with compounds or compositions are known to bolster anti-tumor T cell immunity, including checkpoint blockade drugs, and also teaches the co-administration of an inhibitor of immune checkpoint regulators, such as PD-1 or PD-L1. [see at least pg 3, pg 29] Waithman teaches that the immunogenic agent comprises a peptide consisting of SEQ ID NO: 16, which matches 100% to the instantly claimed SEQ ID NO: 90. [see sequence alignments below, and see table 1]
RESULT 1
BGO76492
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BGO76492 standard; peptide; 13 AA.
XX
AC BGO76492;
XX
DT 05-SEP-2019 (first entry)
XX
DE Herpes simplex virus (HSV) glycoprotein D (gD), SEQ ID 16.
XX
KW Herpesvirus envelope glycoprotein D; antibacterial; antimicrobial-gen.;
KW antiparasitic; bacterial infection; cancer; cytostatic; fungal infection;
KW fungicide; gD protein; immune stimulation; infectious disease;
KW parasitic infection; prophylactic to disease; recombinant protein;
KW therapeutic; vaccine antibacterial; vaccine, anticancer;
KW vaccine, antiparasitic; vaccine, antiviral; vaccine, other antimicrobial;
KW viral infection; virucide.
XX
OS Herpesviridae.
XX
CC PN WO2019134018-A1.
XX
CC PD 11-JUL-2019.
XX
CC PF 24-DEC-2018; 2018WO-AU051408.
XX
PR 05-JAN-2018; 2018AU-00900032.
XX
CC PA (TELE-) TELETHON KIDS INST.
CC PA (PHYL-) PHYLOGICA LTD.
XX
CC PI Waithman J, Stone S, Watt P;
XX
DR WPI; 2019-60791W/59.
XX
CC PT New conjugate useful in pharmaceutical composition for inducing immune
CC PT response, or treating or preventing cancer or infectious disease in
CC PT human, comprises antigen presenting cell targeting moiety, moiety, and
CC PT antigen.
XX
CC PS Disclosure; SEQ ID NO 16; 91pp; English.
XX
CC The present invention relates to a novel conjugate comprising an antigen
CC presenting cell targeting moiety, a moiety capable of endosomal and
CC lysosomal escape and an antigen. The antigen presenting cell targeting
CC moiety is releasable from the moiety capable of endosomal escape and the
CC antigen. The invention further claims: (1) a chimeric or a fusion
CC polypeptide comprising an antigen presenting cell targeting moiety, a
CC moiety capable of endosomal and lysosomal escape and an antigen; (2) a
CC composition such as an antigenic composition (preferably a vaccine
CC composition) comprising the conjugate, the chimeric polypeptide or the
CC fusion polypeptide and optionally an adjuvant; (3) a pharmaceutical
CC composition comprising the conjugate, the chimeric polypeptide or the
CC fusion polypeptide and a pharmaceutically acceptable diluent, excipient
CC or carrier; (4) a nucleic acid molecule encoding the conjugate, the
CC chimeric polypeptide or the fusion polypeptide; (5) a vector comprising
CC the nucleic acid molecule; (6) a cell comprising the vector or the
CC nucleic acid; (7) a method for eliciting a cell-mediated immune response
CC to an antigen; (8) a method for preventing and treating cancer or
CC infectious disease; and (9) a kit or an article of manufacture comprising
CC the conjugate, the chimeric polypeptide, the fusion polypeptide, the
CC composition, the nucleic acid, the vector or the cell. The vaccine
CC composition of the present invention is useful for preventing and
CC treating cancer and infectious disease caused by an infectious agent
CC selected from virus, bacterium, parasite or fungi.
XX
SQ Sequence 13 AA;
Query Match 100.0%; Score 77; Length 13;
Best Local Similarity 100.0%;
Matches 13; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 IPPNWHIPSIQDA 13
|||||||||||||
Db 1 IPPNWHIPSIQDA 13
Lim teaches the treatment of Glioma, which is a primary cancer of the central nervous system. Lim teaches that PD-L1 is expressed in a subset of glioblastomas, and that higher PD-L1 expression in glioblastoma is correlated with poorer patient prognoses. Lim demonstrates findings and responses of patients who respond to pembrolizumab.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90, as recited in claim 4, as the immunogenic agent in the method of Iijima. One would have been motivated to, and have a reasonable expectation of success, because: (1) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, and (2) Waithman teaches methods of inducing immune responses, including administering an immunogenic agent, an MHC Class II peptide, or a peptide that consists of SEQ ID NO: 90. One of skill in the art could have substituted one immunogenic agent for another, and the results of inducing an immune response to induce permeability of the blood brain barrier in a subject, would have been predictable
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use an immune checkpoint inhibitor as recited in claims 5-7, such as pembrolizumab, as the therapeutic agent in the method of Iijima. One would have been motivated to, and have a reasonable expectation of success, because: (1) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, (2) Iijima teaches that the therapeutic agent comprises an antibody or antibody fragment that specifically binds a tumor-specific or tumor associated antigen, (3) Waithman teaches methods of inducing an immune system and teaches the co-administration of immune checkpoint inhibitors, and (4) Lim teaches the use of pembrolizumab in glioblastoma. Given the known need to treat cancer and the known methods of combining of an immunogenic agent and an anti-cancer immunotherapeutic agent, and given the known methods of utilizing immune checkpoint inhibitors in cancers, including brain tumors, one of skill in the art could have used an immune checkpoint inhibitor, such as pembrolizumab, in the method of Iijima, with a reasonable expectation of success.
Response to Arguments
Applicant amended claim 1 to include the limitations of previous claim 4. Applicant argues that the combination of the references does not teach or suggest a the method of claim 1. Applicant argues that the present invention addresses the challenges of modulating the blood brain barrier to delivery of therapeutics. Applicant argues that the primary reference does not teach or suggest an immunogenic agent comprising an antigenic MHC Class II peptide let alone that the immunogenic agent induces permeability. Applicant argues that Waithman does not cure the deficiencies of primary reference. Applicant argues that Waithman discloses a cell-penetrating peptide for cell delivery and internalization of an antigen at the plasma membrane of an antigen presenting cell and subsequent MHC loading.
Applicants’ arguments have been considered but are not persuasive. As recited in previous office action, the Examiner relied on the combination of references to render the invention obvious. Iijima teaches a method of treating a disease or disorder of the brain, CNS or spinal cord comprising administering an immunogenic agent that induces permeability of the blood brain barrier. Iijima explicitly states the challenges of modulating the blood brain barrier by utilizing this method to induce permeability by utilizing an immunogenic agent. Although Iijima does not teach that the immunogenic agent is an MHC class II peptide, the Examiner relied on the secondary references to render the invention obvious. Waithman teaches methods of inducing immune responses and crossing blood brain barriers, which includes MHC class II peptides. The purpose of Waithman was to demonstrate that MHC Class II peptide, which induces an immune response, as well as an agent that induces permeability of the blood brain barrier, which are “CPP peptides.” Waithman also teaches that the skilled person will also be familiar with compounds or compositions are known to bolster anti-tumor T cell immunity, including checkpoint blockade drugs, and also teaches the co-administration of an inhibitor of immune checkpoint regulators, such as PD-1 or PD-L1. [see at least pg 3, pg 29] Waithman also that the immunogenic agent comprises a peptide consisting of SEQ ID NO: 16, which matches 100% to the instantly claimed SEQ ID NO: 90.
Thus, it is the combination of all of the cited and relied upon references which made up the state of the art with regard to the claimed invention.
Maintained Rejection
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, subsecPATtion 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.
Claims 1, 2, 5-7, 11 and 12 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 10 of U.S. Patent No. 11,147,862, in view of Iijima et al (US20170326214 A1; Published 11/16/2017; listed in IDS), Waithman et al (WO2019134018 A1; Published 12/24/2018; copy in IDS) and Lim et al. (Current state of immunotherapy for glioblastoma. Nat Rev Clin Oncol 15, 422–442; 2018).
The U.S. Patent recites a method for aiding access of an antibody to immunoprivileged tissue, wherein the immunoprivileged tissue selected from the brain of spinal cord. The U.S. Patent recites that the method comprises: (a) administering an immunogenic agent to induce an immune response, and (b) administering an antibody, or antibody fragment, whereby the immune response allows access of the antibody or antibody fragment to the immunoprivileged tissue.
However, the U.S. Patent does not recite that the antigenic: (1) that the immunogenic agent comprises an antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90, (2) that the therapeutic agent comprises an inhibitor of an immune checkpoint protein, such as pembrolizumab, or (3) that the method treats cancer.
Iijima teaches a method for treating a disease or disorder of the brain, central nervous system, or spinal cord in a subject in need thereof, comprising: (a) administering an immunogenic agent to induce an immune response, thereby inducing permeability of the blood brain barrier (BBB) in the subject; and (b) administering at least one therapeutic agent for the treatment of the disease or disorder. [see at least, 0006; 0008-0010] Iijima teaches that the immunogenic agent is an antigenic protein or peptide for inducing a CD4 T-cell immune response. [see at least 0007-0008, 0084]
Iijima teaches that the method treats cancer. [see at least, 0011, 0036, 0039, 0079, 0125] Iijima teaches that the therapeutic agent comprises an antibody or antibody fragment that specifically binds a tumor-specific or tumor associated antigen. [see at least, 0011, 0088, 0035, 0129]
Waithman teaches method for inducing immune responses and crossing blood brain barriers, for the treatment of cancer. Waithman teaches that the method includes an immunogenic agent, such as an MHC Class II peptide, which induces an immune response, as well as an agent that induces permeability of the blood brain barrier, which are “CPP peptides.” Waithman also teaches that the skilled person will also be familiar with compounds or compositions are known to bolster anti-tumor T cell immunity, including checkpoint blockade drugs, and also teaches the co-administration of an inhibitor of immune checkpoint regulators, such as PD-1 or PD-L1. [see at least pg 3, pg 29] Waithman teaches that the immunogenic agent comprises a peptide consisting of SEQ ID NO: 16, which matches 100% to the instantly claimed SEQ ID NO: 90. [see sequence alignments above, and see table 1]
Lim teaches the treatment of Glioma, which is a primary cancer of the central nervous system. Lim teaches that PD-L1 is expressed in a subset of glioblastomas, and that higher PD-L1 expression in glioblastoma is correlated with poorer patient prognoses. Lim demonstrates findings and responses of patients who respond to pembrolizumab.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90, as the immunogenic agent in the method of the U.S. Patent. One would have been motivated to, and have a reasonable expectation of success, because: (1) the U.S Patent application recites a method for inducing an immune response comprising admisntering an immunogenic agent, (2) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, and (3) Waithman teaches methods of inducing immune responses, including administering an immunogenic agent, an MHC Class II peptide, or a peptide that consists of SEQ ID NO: 90. One of skill in the art could have substituted one immunogenic agent for another, and the results of inducing an immune response to induce permeability of the blood brain barrier in a subject, would have been predictable
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to treat cancer and use an immune checkpoint inhibitor, such as pembrolizumab, as the therapeutic agent in the method of U.S. Patent. One would have been motivated to, and have a reasonable expectation of success, because: (1) the U.S. Patent recites a method for treating cancer comprising administering an immunogenic agent, and a therapeutic agent, (2) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, (3) Iijima teaches that the therapeutic agent comprises an antibody or antibody fragment that specifically binds a tumor-specific or tumor associated antigen, and that the method treats cancer(4) Waithman teaches methods of inducing an immune system and teaches the co-administration of immune checkpoint inhibitors, and (5) Lim teaches the use of pembrolizumab in glioblastoma. Given the known need to treat cancer and the known methods of combining of an immunogenic agent and an anti-cancer immunotherapeutic agent, and given the known methods of utilizing immune checkpoint inhibitors in cancers, including brain tumors, one of skill in the art could have used an immune checkpoint inhibitor, such as pembrolizumab, as the therapeutic agent of the co-pending application, with a reasonable expectation of success.
Claims 1-2, 5-7, 11 and 12 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-10 of copending Application No. 17/467,574 (reference application), in view of Iijima et al (US20170326214 A1; Published 11/16/2017; listed in IDS), Waithman et al (WO2019134018 A1; Published 12/24/2018; copy in IDS) and Lim et al. (Current state of immunotherapy for glioblastoma. Nat Rev Clin Oncol 15, 422–442; 2018).
The co-pending application recites a method for treating a disease or disorder of an immunoprivileged tissue, comprising: (a) administering an immunogenic agent to induce an immune response, and (b) administering a therapeutic agent, whereby the immune response allows access of the therapeutic agent to the immunoprivileged tissue. The co-pending application recites that that the method treats cancer, and that the therapeutic agent binds to an antigen associated with the disorder.
However, the co-pending application does not recite that the antigenic: (1) that the immunogenic agent comprises an antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90, (2) that the therapeutic agent comprises an inhibitor of an immune checkpoint protein, such as pembrolizumab.
The teachings of Iijima, Waithman and Lim is recited above.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use antigenic MHC Class II peptide, or a peptide comprising the instantly claimed SEQ ID NO: 90, as the immunogenic agent in the method of the copending application. One would have been motivated to, and have a reasonable expectation of success, because: (1) the co-pending application recites a method for treating cancer comprising administering an immunogenic agent, and a therapeutic agent, (2) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, and (3) Waithman teaches methods of inducing immune responses, including administering an immunogenic agent, an MHC Class II peptide, or a peptide that consists of SEQ ID NO: 90. One of skill in the art could have substituted one immunogenic agent for another, and the results of inducing an immune response to induce permeability of the blood brain barrier in a subject, would have been predictable
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use an immune checkpoint inhibitor, such as pembrolizumab, as the therapeutic agent in the method of the co-pending application. One would have been motivated to, and have a reasonable expectation of success, because: (1) the co-pending application recites a method for treating cancer comprising administering an immunogenic agent, and a therapeutic agent, (2) Iijima teaches the instantly claimed method comprising administering an immunogenic agent to induce an immune response, and administering at least one therapeutic agent, (3) Iijima teaches that the therapeutic agent comprises an antibody or antibody fragment that specifically binds a tumor-specific or tumor associated antigen, (4) Waithman teaches methods of inducing an immune system and teaches the co-administration of immune checkpoint inhibitors, and (5) Lim teaches the use of pembrolizumab in glioblastoma. Given the known need to treat cancer and the known methods of combining of an immunogenic agent and a an anti-cancer immunotherapeutic agent, and given the known methods of utilizing immune checkpoint inhibitors in cancers, including brain tumors, one of skill in the art could have used an immune checkpoint inhibitor, such as pembrolizumab, as the therapeutic agent of the co-pending application, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to ODP arguments
Applicant request that the above double patent rejections be held in abeyance until claims in the present application are found to be allowable.
Conclusion
Conclusion: No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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/SARAH A ALSOMAIRY/ Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
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