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
The Amendment filed 10/21/2025 in response to Office Action of 4/21/2025, is acknowledged and has been entered. Claims 1, 2, 4-20 are now pending. Claims 1, 2 and 4 are amended. Claims 8-10 and 13-20 remain withdrawn.
The 35 U.S.C. 102 rejection, 35 U.S.C. 112(a) written rejection, and the 35 U.S.C. 112(a) enablement rejection, directed towards claims 1, 2, 4-7 and 1-12, are hereby withdrawn in view of amendments.
Claims 1, 2, 4-7, 11-12 are currently being examined.
Maintained Rejection
(Arguments Addressed)
Claim Rejections - 35 USC § 112
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.
Claim 11 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating cancer, does not reasonably provide enablement for preventing cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claims recite 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. The claims recite that the disease or disorder is cancer.
Regarding prevention of cancer:
(1) State of the art
A search of relevant art, does not reveal any demonstration that administering an immunogenic agent, and at least one therapeutic agent prevents cancer. Szabo et al (Selecting targets for cancer prevention: where do we go from here?. Nat Rev Cancer 6, 867–874; 2006) teaches the intricacies and complications of cancer prevention. Szabo teaches that rapidly expanding understanding of the biology of carcinogenesis in many different organs provides many potential targets for intervention, however, the translation of these concepts into healthcare strategies requires an intensive efficacy and safety assessment process that spans from preclinical to phase I–III clinical testing. Szabo teaches that in addition to efficacy and toxicity concerns of cancer drugs targeting functions, there are a number of practical issues that should be considered, including drug formulation and dosing schedule to ensure adherence, as well as the cost. Szabo also teaches that in some cases the targets selected for drug therapy may even cause harm. [Whole document]
(2) Presence or Absence of examples
The specification does not provide any examples of an immunogenic agent and a therapeutic agent preventing cancer. There are no examples in the specification that disclose the prevention of cancer comprising the instantly claimed method. The specification lacks the critical steps necessary in presenting some type of predictable response in a population of hosts deemed necessary to prevent cancer with an immunogenic agent and a therapeutic agent.
Predictability
As noted above, the prior art, Szabo, teaches that in addition to efficacy and toxicity concerns of cancer drugs targeting functions, there are a number of practical issues that should be considered, including drug formulation and dosing schedule to ensure adherence, as well as the cost. Szabo also teaches that in some cases the targets selected for drug therapy may even cause harm. [Whole document] The specification does not provide any steps necessary to prevent cancer.
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that administration of an immunogenic agent and any therapeutic agent that prevents the onset of cancer in subjects as claimed.
Quantity of Experimentation
Undue experimentation would be required to determine what agents is administered to which population of subjects could predictably prevent cancer as claimed. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed combination prevents cancer. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Response to Arguments
Applicant argues that the method of preventing cancer is fully enabled by the specification (page 46, lines 17-20, page 51 lines 11-25, page 87, lines 18-27 and Example 2 and Figure 18). Applicant argues that the specification demonstrates that anti-PD-1 therapy in combination with HSV-2 immunization and HSV-2 in peptide stimulation prevented tumor growth and significantly improved survival in mice.
Applicant’s arguments have been considered but are not persuasive.
Page 46, lines 17-20: “In one embodiment, the therapeutic agent comprises a therapeutic antibody or antibody fragment. The therapeutic antibody or antibody fragment includes any antibody known in the art which binds a pathogen, induces the killing of a pathogen, reduces pathogenic infection, or prevents spread of a pathogenic infection”
Page 51, lines 11-25: “The invention provides a method for treating, or preventing infection or a disease or disorder of the brain, central nervous system or spinal cord. The therapeutic compounds or compositions of the invention may be administered prophylactically or therapeutically to subjects suffering from or at risk of (or susceptible to) developing the disease or disorder. Such subjects may be identified using standard clinical methods. In the context of the present invention, prophylactic administration occurs prior to the manifestation of overt clinical symptoms, such that an infection is prevented or alternatively delayed in its progression. In the context of the field of medicine, the term "prevent" encompasses any activity which reduces the burden of mortality or morbidity from the disease or disorder. Prevention can occur at primary, secondary and tertiary 20 prevention levels. While primary prevention avoids the development of a disease, secondary and tertiary levels of prevention encompass activities aimed at preventing the progression of an infection and the emergence of symptoms as well as reducing the negative impact of an already established disease by restoring function and reducing disease or disorder-related complications.”
Example 2; Figure 18; Page 87, lines 18-27: “anti-PD-1 therapy prevented tumor growth and significantly improved survival in mice with HSV-2 immunization and HSV-2 i.n. peptide stimulation”
As noted above, there is no support of enablement for the prevention of cancer utilizing the instantly claimed method. The first two paragraphs that the Applicant pointed out to just explain the prevention. Example 2; Figure 18 and page 87 do not fall within the scope of the claims, as the immunogenic agent is HSV. Regardless, undue experimentation would be required to determine what agents is administered to which population of subjects could predictably prevent cancer as claimed. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed combination prevents cancer. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
New Rejection
(Necessitated by Amendments)
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, 4-7, 11 and 12 are 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).
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 (as recited in claim 4), 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 4-7, 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 Relevant Arguments
Applicant amended the claims to include MHC class II peptide as the antigenic agent. Applicant argues that the references cited in the Office Action, alone or in combination, do not teach or suggest each and every element of claim 1. Applicant argues that Waithman and Lim do not teach or suggest a method for treating or preventing disease or disorder of the brain, CNS, or spinal cord. Applicant argues that the present invention addresses the challenges of modulating the blood brain barrier to delivery of therapeutics.
Applicant’s arguments have been considered but are not persuasive. 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 Lim is to demonstrate a reasonable expectation of success to combine the immunogenic agent and an immune checkpoint inhibitor. 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. Applicant's claimed invention fails to patentably distinguish over the state of the art represented by the cited references taken in combination. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 and 2 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. Although the claims at issue are not identical, they are not patentably distinct from each other because 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.
Claims 4-7, 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, as applied to claims 1 and 2 above, and further 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, 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). Although the claims at issue are not identical, they are not patentably distinct from each other because 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4-7 remain 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), as applied to claims 1, 2, 11 and 12 above, and further 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).
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 double patent rejections be held in abeyance until claims in the present application are found to be allowable.
Conclusion
Conclusion: No claim is 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678