DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 4/27/26, are acknowledged.
Claim 12 has been amended.
Claim 31 has been added.
Claims 1-10, 12-13, 16, 23-31 are pending.
Claims 1-10, 23-25, 27-31 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 12-13, 16 and 26 are being acted upon.
In view of Applicant’s claim amendment’s, the previous grounds of rejection are withdrawn. The following are new grounds of rejection necessitated by Applicant’s claim amendments.
It is note that the previous office action had a typographical error and indicated that the claims were rejected for nonstationary double patenting over US patent 12249160 instead of 12249201. Regardless, Applicant’s terminal disclaimer over 11229668 and 12491201 has overcome the nonstatutory double patenting over the two patents.
Acknowledgment is made of applicant's claim for domestic priority under 35 U.S.C. 119(e). However, the provisional application USSN 62/429,990, upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for the claims this application. Specifically, insufficient support was identified for the limitation of a recombinant nucleic acid comprising the specific elements of the claims, i.e. a costimulatory ligand and its receptor, an MHC-I and MHC-II polytope, and a checkpoint inhibitor. The ‘990 application also does not disclose the MHC-I and MHC-II polytope are separated from at least one other encoded component by a linker comprising a self-cleaving peptide. Consequently, the claims have been accorded the priority of the filing date of the PCT application, i.e. 11/20/17.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 12-13, 16, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The specification and the claims as originally filed do not provide support for the invention as now claimed, specifically:
A nucleic acid wherein at least one of the MHC-I polytope and the MHC-II polytope are separated from at least one other encoded component by a linker comprising a self-cleaving peptide (Claim 12, and dependent claims).
Applicant cites paragraph 32, 57, and 66. A review of the specification fails to reveal support for the new limitations.
At paragraph 32, the specification discloses that a nucleic acid encoding a costimulatory ligand its receptor can be separated by a self-cleaving 2A peptide, or that the ligand and receptor may be in the form of a chimeric protein. This does not provide support for the present claims, since present claims are directed to the latter embodiment, i.e. a chimeric protein comprising a ligand and its receptor and not to a costimulatory receptor and its ligand separated by a self-cleaving peptide (in the present claims the self-cleaving peptide is not between the costimulatory receptor and it ligand, as disclosed in paragraph 32, but between the MHC-I and/or MHC-II polypeptide and the other components). Paragraph 57 and 66 does not mention any limitations regarding a self-cleaving peptide. It is noted that in Fig. 1-2, the specification illustrates a specific example of recombinant nucleic acid expressing in order, a MHC-I polytope, , an MHC-II polypeptide, a chimeric costimulatory ligand-receptor, and a checkpoint inhibitor expressed as a single transcript wherein each component is separated by a self-cleaving P2A or T2A peptide. However, this has a much narrower scope than what is recited in claim 12. Claim 12 recites “at least one” of the MHC-I polytope and the MHC-II polytope are separated from “at least one” other encoded component by a self-cleaving peptide. The specification does not disclose using a self-cleaving peptide as broadly claimed wherein “at least one” of the MHC-I polytope and the MHC-II polytope are separated from “at least one” other encoded component by a linker comprising a self-cleaving peptide. In the example all of the components are linked by a self-cleaving peptide in a particular arrangement. However, the present claims would encompass a single transcript wherein only the MHC-I polytope is linked to one other component via a self-cleaving peptide whereas the other elements are linked via, for example, and IRES, which is not supported by the instant specification. Furthermore, in the drawing the MHC-I polytope is linked to the MHC-II polytope, which is linked to a particular costimulatory ligand/receptor, and the present claims broadly encompass a genus of other arrangements, i.e. wherein both the MHC-I polytope and the MHC-II polytope are linked to one other component by a self-cleaving peptide.
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 12-13, 16, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0166367, in view of US 20110044953, WO00/63395, (all of record) and WO 2012115980.
The ‘367 publication teaches a recombinant nucleic acid encoding multiple tumor specific antigens and costimulatory molecules (see page 2 and 7, in particular). The ‘367 publication also teaches including additional nucleic acids, such as those encoding antibodies (see page 13, in particular). The ‘367 publication teaches that the tumor antigens can be tailored to the individual patient (see page 13, in particular). The ‘367 publication teaches that the tumor antigens are selected such that proteins thereof will result in a MHC-I and II reaction with the intent to stimulate both CD4 and CD8 T cell responses, and teaches including more than one tumor antigen ( see page 5-6 and paragraphs 31 and 62, in particular). The ‘367 publication teaches including more than one tumor antigen such as full length CEA and MUC-1. Any full length tumor antigen would inherently comprise multiple different MHC-I and MHC-II epitopes, i.e. each antigen would comprise a series of epitopes (see for example, Jochems or Shen, as evidence that full length tumor antigens inherently comprise a series of MHC-I or MHC-II epitopes).. For example, CEA would be an MHC-II polytope having a series of epitopes and MUC-1 would be a MHC-I polytope comprising a series of epitopes. The ‘367 publication teaches that a recombinant viral vector infects APCs, including dendritic cells and the co-expression of both the antigen and immunostimulatory molecules provides the necessary MHC restricted peptide to specific T cells and the appropriate signal to the T cell to expand antigen specific T cells (see paragraph 107 and pages 23-24, in particular). The ’367 publication teaches wild type as well as mutated version of tumor antigens (i.e. neoepitopes, see page 6, in particular).
The ‘367 publication does not explicitly teach a chimeric protein comprising a costimulatory ligand and its receptor as the costimulatory molecule, a checkpoint inhibitor as the antibody, or that the multiple antigens are linked via self-cleaving peptide.
WO00/63395 teaches CD40L and CD40 act as costimulatory molecule to induce T cell immunity and APC activation (see page 1, in particular). WO00/6339 teach a recombinant nucleic acid sequence that encodes a TNF receptor family costimulatory ligand (CD40L) and a costimulatory receptor (CD40), wherein the nucleic acid is constructed such that they form a chimeric polypeptide (see pages 2-3 and 7, in particular). WO 00/63395 teaches that doing so is advantageous since it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors (see page 4, in particular). WO00/63395 teaches that the chimeric polypeptides are constructed using CD40L, a short linker or a spacer (i.e. a linker) wherein the spacer is flexible, and the CD40 region (see page 3 and Fig. 1, in particular). WO00/63395 also teaches that the linker must be of sufficient length, preferably between 15-30 amino acids, to ensure trimerization, i.e. it must be “flexible”, see page 3, in particular). WO00/63395 teaches that said CD40/CD40L chimera can be expressed with additional genes on the same vector, under the control of the same promoter (see page 6, in particular). For example, WO00/63395 teaches that more than one gene can be coupled via an IRES sequence (i.e. configured for translation from a single transcript, see page 15-16, in particular. WO00/63395 teaches adenoviral vectors (see page 16-17, in particular). WO00/63395 teaches that the invention makes it possible to induce the presentation of tumor specific antigens on immunocompetent cells in an improved manner and to induce differentiation and proliferation of T cells and dendritic cells (i.e. APCs, see page 4, in particular).
The ‘953 publication teaches viral vectors comprising a nucleic acid encoding an anti-CTLA-4 antibody that blocks CTLA-4 signaling (i.e. a checkpoint inhibitor). The ‘953 publication teaches using said viral vectors to modifying antigen presenting cells, such as dendritic cells, in order to enhance T cell activation and treat tumors (see page 1 and 3, in particular).
WO 2012115980 teaches that nucleic acid encoding one or more proteins of interest can be configured such that the multiple proteins are translated from a single mRNA transcript, and that this can be accomplished by using an IREs or a 2A self-processing cleavable peptide between the proteins of interest (See paragraphs 70 and 99-101, 113, and 125 in particular). WO 2012115980 teaches that 2A sequences refer to small peptides that can be introduced as a linker between two proteins, allowing co-expression of multiple protein from a single vector (see paragraph 70, in particular). WO 2012115980 teaches adenovirus associated viral vectors comprising said nucleic acid, wherein the vector include adenovirus genes.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to construct the recombinant nucleic acid of the ‘367 publication, using a nucleic acid encoding a chimeric costimulatory polypeptide as taught by WO00/63395 as the costimulatory molecule and using the nucleic acid encoding the CTLA-4 antibody of the ‘953 publication as the antibody.
The ordinary artisan would be motivated use the chimeric costimulatory polypeptide of WO 00/63395 as the costimulatory molecule in the nucleic acid construct of the’367 publication, since WO 00/63395 teaches that is advantageous because it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors thus making it possible induce the presentation of tumor specific antigens on immunocompetent cells in an improved manner and to induce differentiation and proliferation of T cells and dendritic cells. One of ordinary skill in the art at the time the invention was made would be motivated to include a nucleic acid encoding the anti-CTLA-4 antibody of the ‘953 publication, as the type of additional nucleic acid encoding an antibody in the viral vector of the ‘367 publication, since the ‘953 publication teaches that viral vectors encoding anti-CTLA-4 can be used to enhance T cell activation and treat tumors.
It would also be obvious to construct the nucleic acids encoding each element from a single promoter separated by a self-cleaving peptides, as taught by WO 2012115980. The ordinary artisan would be motivated to do so with a reasonable expectation of success, since WO 2012115980 teaches that self-cleaving peptides can be introduced as a linker between multiple proteins of interest, allowing co-expression of multiple protein from a single vector. Doing so would result in at least one of the tumor antigens (i.e. MHC polytopes) being separated from at least one other encoded component by a linker comprising a self-cleaving peptide.
Applicant’s arguments filed 4/27/26 have been fully considered, but they are not persuasive.
Applicant argues that the cited references to not address how to construct the elements from a single transcript aby incorporating self-cleaving linkers, and do not address the technical challenges when doing so.
As taught by WO 2012115980, it is well within the purview to encode multiple proteins of interest from a single vector as a single transcript using either IRES or self-cleaving peptides to separate the multiple components. It is noted that the teachings of the instant specification regarding expressing transcripts for a single vector are no more detailed than those of the prior art. Expressing multiple proteins form a single vector, such as by using IRES or P2A self-cleaving peptides wis well known in the art.
Claim 12-13, 16, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/026370, in view of US 20110044953, WO00/63395 (all of record), and WO 2012115980.
WO 2005/026370 teaches a method of treating cancer comprising administering to a patient a vector comprising a recombinant nucleic acid encoding multiple tumor specific antigens and a costimulatory molecule (see page 2 and 15, in particular). WO 2005/026370 teaches CD40L as a type of costimulatory molecule (see page 15-16, in particular). WO 2005/026370 teaches expression of the tumor antigen following administration leads to an anti-cancer T cell immune response (see pages 2-3, in particular). WO 2005/026370 teaches wild type as well as mutated version of tumor antigens (i.e. neoepitopes, see page 4, in particular). WO20150258186 also teaches further administration of anti-CTLA-4 (i.e. a checkpoint inhibitor antibody) to suppress negative regulatory mechanism (see page 17, in particular). WO 2005/026370 teaches using viral vectors, such as adenovirus (i.e. vectors are expressed in APC, see page 19, in particular). WO 2005/026370 teaches induction of T cell and CTL response and examples of using a nucleic acid encoding multiple tumor antigens (see pages 27-29). WO 2005/026370 teaches that the co-stimulatory component may be included as a nucleic acid, and teaches nucleic acids may be delivered in viral vectors (see pages 15 and 19-20, in particular). WO 2005/026370 exemplifies a viral vector encoding said multiple tumor antigens and costimulatory molecules in a single nucleic acid vector sequence (see pages 27-28 and Fig. 1, in particular). WO 2005/026370 teaches an example using a nucleic acid encoding three tumor antigens PG1, MART-1 and MAGE, or a combination NYESO and TRp-2 and using full length tumor antigens. . A full length tumor antigen would comprise multiple different MHC-I and MHC-II epitopes, i.e. each antigen would comprise a series of epitopes.
WO 2005/026370 does not explicitly teach a chimeric protein comprising a costimulatory ligand and its receptor as the costimulatory molecule, a checkpoint inhibitor, or linking via self-cleaving peptide.
The ‘953 publication teaches viral vectors comprising a nucleic acid encoding an anti-CTLA-4 antibody that blocks CTLA-4 signaling (i.e. a checkpoint inhibitor). The ‘953 publication teaches using said viral vectors to modifying antigen presenting cells, such as dendritic cells, in order to enhance T cell activation and treat tumors (see page 1 and 3, in particular). The ‘953 publication teaches that it is advantageous since it provides localized delivery of the antibody and increases the intensity and duration of T cell responses (see pages 1and 3, in particular). The ‘953 publication teaches anti-CTLA-4 according to US 5,855,887 (i.e. ipilimumab).
WO00/63395 teaches CD40L and CD40 act as costimulatory molecule to induce T cell immunity and APC activation (see page 1, in particular). WO00/6339 teach a recombinant nucleic acid sequence that encodes a TNF receptor family costimulatory ligand (CD40L) and a costimulatory receptor (CD40), wherein the nucleic acid is constructed such that they form a chimeric polypeptide (see pages 2-3 and 7, in particular). WO 00/63395 teaches that doing so is advantageous since it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors (see page 4, in particular). WO00/63395 teaches that the chimeric polypeptides are constructed using CD40L, a short linker of 1 to 30 amino acids, and the CD40 region, thus rendering obvious linkers of the size recited in claim 22 (see page 3 and Fig. 1, in particular). WO00/63395 teaches that said CD40/CD40L chimera can be expressed with additional genes on the same vector, under the control of the same promoter (see page 6, in particular). For example, WO00/63395 teaches that more than one gene can be coupled via an IRES sequence (i.e. configured for translation from a single transcript, see page 15-16, in particular. WO00/63395 teaches adenoviral vectors (see page 16-17, in particular). WO00/63395 teaches that the invention makes it possible to induce the presentation of tumor specific antigens on immunocompetent cells in an improved manner and to induce differentiation and proliferation of T cells and dendritic cells (i.e. APCs, see page 4, in particular).
WO 2012115980 teaches that nucleic acid encoding one or more proteins of interest can be configured such that the multiple proteins are translated from a single mRNA transcript, and that this can be accomplished by using an IREs or a 2A self-processing cleavable peptide between the proteins of interest (See paragraphs 70 and 99-101, 113, and 125 in particular). WO 2012115980 teaches that 2A sequences refer to small peptides that can be introduced as a linker between two proteins, allowing co-expression of multiple protein from a single vector (see paragraph 70, in particular) WO 2012115980 teaches adenovirus associated viral vectors comprising said nucleic acid, wherein the vector include adenovirus genes.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the chimeric costimulatory polypeptide as of WO00/63395, as the costimulatory molecule in the recombinant nucleic acid of WO 2005/026370, and to include a nucleic acid encoding the CTLA-4 antibody as taught by the ‘953 publication.
The ordinary artisan would be motivated to include a nucleic acid encoding anti-CTLA-4 antibody as taught by the ‘953 publication, in the multi-expression vector of WO 2005/026370, to provide for anti-CTLA-4 blocking of inhibitor immune mechanism as taught in WO2005/026370. The ordinary artisan at the time the invention was made would have been motivated to do so since the ‘953 publication teaches that it is advantageous since it provides localized delivery of the antibody and increases the intensity and duration of T cell responses
Furthermore, the ordinary artisan would be motivated to construct the recombinant nucleic acid encoding CD40L in WO2005/026370, using the chimeric CD40L/CD40, as taught by WO00/63395, since WO 00/63395 teaches that it is advantageous because it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors.
It would also be obvious to construct the nucleic acids encoding each element from a single promoter separated by a self-cleaving peptides, as taught by WO 2012115980. The ordinary artisan would be motivated to do so with a reasonable expectation of success, since WO 2012115980 teaches that self-cleaving peptides can be introduced as a linker between multiple proteins of interest, allowing co-expression of multiple proteins from a single vector. Doing so would result in at least one of the tumor antigens (i.e. MHC polytopes) being separated from at least one other encoded component by a linker comprising a self-cleaving peptide.
Applicant argues that the claims are not obvious for the reasons set forth above.
The claims stand rejected for the same reasons set forth above.
Claim 12-13, 16, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0028044 or US 2017/0312351, in view of US 20110044953 (of record) WO00/63395 (of record), and WO 2012115980.
The ‘044 publication teaches a recombinant nucleic acid adenovirus vector comprising a nucleic acid encoding multiple tumor neoepitope antigens, a costimulatory molecule and a checkpoint inhibitor (See paragraphs 12-15 and 29 in particular). The ‘044 publication teaches that the neoepitopes can have comprising a series of multiple MHC-I and MHC-II epitopes representing polytopes,(see paragraph 66, 68, and 70, and the drawings in particular). For example, the ‘044 publication teaches 20 epitopes linked together in a series, wherein the epitopes may be presented via MHC-I and MHC-II, i.e. a MHC-I polytope and an MHC-II polytope comprising a series of epitopes. The ‘044 publication teaches CD40 and CD40L as costimulatory molecules, and that the elements are produced from a single transcript using an IRES or 2A sequence (See paragraph 73-74, in particular). See also the teachings of WO 2012115980 described above regarding encoding multiple proteins as a single transcript using a self cleaving peptide between each. The teachings of the ‘351 publication are nearly identical to that of the ‘044 publication, and the ‘351 publication also teaches a recombinant nucleic acid adenovirus vector comprising a nucleic acid encoding multiple tumor neoepitope antigens, a costimulatory molecule and a checkpoint inhibitor, wherein the neoepitopes can have a series of multiple MHC-I and MHC-II epitopes representing polytopes, and wherein the costimulatory molecules are CD40 and CD40L.
The ‘044 and ‘351 publications do not explicitly teach a chimeric protein comprising a costimulatory ligand and its receptor as the costimulatory molecule.
WO00/63395 teaches CD40L and CD40 act as costimulatory molecule to induce T cell immunity and APC activation (see page 1, in particular). WO00/6339 teach a recombinant nucleic acid sequence that encodes a TNF receptor family costimulatory ligand (CD40L) and a costimulatory receptor (CD40), wherein the nucleic acid is constructed such that they form a chimeric polypeptide (see pages 2-3 and 7, in particular). WO 00/63395 teaches that doing so is advantageous since it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors (see page 4, in particular). WO00/63395 teaches that the chimeric polypeptides are constructed using CD40L, a short linker or a spacer (i.e. a linker) wherein the spacer is flexible, and the CD40 region (see page 3 and Fig. 1, in particular). WO00/63395 also teaches that the linker must be of sufficient length, preferably between 15-30 amino acids, to ensure trimerization, i.e. it must be “flexible”, see page 3, in particular). WO00/63395 teaches that said CD40/CD40L chimera can be expressed with additional genes on the same vector, under the control of the same promoter (see page 6, in particular). For example, WO00/63395 teaches that more than one gene can be coupled via an IRES sequence (i.e. configured for translation from a single transcript, see page 15-16, in particular. WO00/63395 teaches adenoviral vectors (see page 16-17, in particular). WO00/63395 teaches that the invention makes it possible to induce the presentation of tumor specific antigens on immunocompetent cells in an improved manner and to induce differentiation and proliferation of T cells and dendritic cells (i.e. APCs, see page 4, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to construct the recombinant nucleic acid of the ‘044 publication or ‘351 publication, using a nucleic acid encoding a chimeric costimulatory polypeptide as taught by WO00/63395 as the costimulatory molecule.
The ordinary artisan would be motivated use the chimeric costimulatory polypeptide of WO 00/63395 as the costimulatory molecule, since WO 00/63395 teaches that is advantageous because it allows not only activation of the cell expressing the chimeric polypeptide, but an activating effect in trans in other cells that naturally express the receptors thus making it possible induce the presentation of tumor specific antigens on immunocompetent cells in an improved manner and to induce differentiation and proliferation of T cells and dendritic cells.
It would also be obvious to construct the nucleic acids encoding each element from a single promoter separated by a self-cleaving peptides, as taught by WO 2012115980. The ordinary artisan would be motivated to do so with a reasonable expectation of success, since WO 2012115980 teaches that self-cleaving peptides can be introduced as a linker between multiple proteins of interest, allowing co-expression of multiple protein from a single vector. Doing so would result in at least one of the tumor antigens (i.e. MHC polytopes) being separated from at least one other encoded component by a linker comprising a self-cleaving peptide.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-13, 16, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,623,001. in view of WO 2012115980, WO00/63395, and US 2015/0258186.
The ‘001 patent claims a recombinant nucleic acid sequence consisting of a promoter operably coupled to a nucleic acid sequence encoding a plurality of neoepitopes that are directed to presentation by at least one class I molecule or at least one class II molecule for treating a tumor, wherein the recombinant nucleic acid is a viral expression vector, and wherein the recombinant nucleic acid further comprises at least one sequence encoding a co-stimulatory molecule and a sequence encoding a checkpoint inhibitor. It would be obvious to use the chimeric costimulatory molecule of WO 00/633395 as the type of costimulatory molecule, and to use the multi-antigen construct of the ‘186 publication as the plurality of neoepitopes.. It would also be obvious to construct the nucleic acids encoding each element from a single promoter separated by a self-cleaving peptides, as taught by WO 2012115980. The ordinary artisan would be motivated to do so with a reasonable expectation of success, since WO 2012115980 teaches that self-cleaving peptides can be introduced as a linker between multiple proteins of interest, allowing co-expression of multiple protein from a single vector. Doing so would result in at least one of the polytopes being separated from at least one other encoded component by a linker comprising a self-cleaving peptide.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
Prosecution Insights