DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Application Status
This action is written in response to applicant’s correspondence received on 06/18/2026. Claims 1-3,7,10,14,19,21,26,38,40,42,44,46,48-50,54,57 and 63 are currently pending. Claims 3, 7, 10, 19, 57 is withdrawn from prosecution as being drawn to nonelected subject matter. Accordingly, claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, and 63 are examined herein.
Election/Restrictions
Applicant’s election without traverse of Group I and the following species in the reply filed on 06/18/2026 is acknowledged:
I(a), immunostimulatory compound (claims 3, 7, 10, and 14), applicant elects “GM-CSF-receptor”, which is interpreted as granulocyte-macrophage colony-stimulating factor (GM-CSF) based on specification (Page 31, lines 12-15), the immunostimulatory compound that interacts with a surface molecule on an antigen-presenting cell which is “GM-CSF-receptor”.
I(b), targeting unit (claim 40), applicant elects human CCL3L1;
I(c), multimerization unit (claim 42), applicant elects dimerization unit;
I(d), hinge region (claim 42), applicant elects hinge exon h4;
I(e), host cell (claim 63), applicant elects higher eukaryotic cell, i.e. an animal or human cell.
Claims 3, 7, 10, 19, 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to either a nonelected Group II, there being no allowable generic or linking claim, or a nonelected species I(a). Specifically, claims 3, 7, 10 are withdrawn because they are directed to structurally distinct species that don’t include the elected species, an immunostimulatory compound that interact with GM-CSF receptor, whereas claim 19 is withdrawn because it requires unelected species beyond the election. The restriction requirement mailed on 04/20/2026 is still deemed proper. Applicant's elected Group I and species I(a)-I(e) without traverse in the reply filed on 06/18/2026.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent applications DKPA202170221, filed on 05/10/2021; DKPA202170364, filed on 07/08/2021; DKPA202270113, filed on 03/18/2022; DKPA202270186, filed on 04/07/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a 371 of PCT/EP2022/062665 filed on 05/10/2022.
Drawings
The drawing is objected to because 37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG.” and 37 CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.”
In the current case, the view number for Figure 1 is preceded by the word "Fig." instead of the abbreviation "FIG.". And the view numbers for the partial views for Figures 3 that appear on several sheets as “Fig. 3a, Fig. 3b, Fig. 4a, Fig. 4b, Fig. 38a, Fig. 38b” instead of a capital letter such as “FIG. 3A, FIG.3B, FIG.4A, FIG.4B …”, etc. Some view numbers for the partial views for Figures 18, 26, 27, 38b, 38c, 41 that appear on several sheets are followed by "(Cont.)" instead of a capital letter such as FIG. 18A, FIG. 38B, etc.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Genscript, Invitrogen, Thermo Fisher Scientific/Sci, R&D Systems, Janvier Labs, Mabtech, eFluor, ATCC, Bio-Rad, NEB, Trans-Blot Turbo, EveryBlot, BTX AgilePulse, Southern Biotech, Merck, Sino Biological, NucleoCounter, ChemoMetec, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 14 is objected to because of the following informalities:
The recitation “or wherein the one or more immunostimulatory compounds … selected from hGM-CSF-receptor, … and hIL-4R” is duplicated verbatim. A single recitation in the claim is sufficient.
Claim 48 is objected to because of the following informalities:
The recitation “liker” should be “linker”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, and 63 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 2, 14, 26, 40, 42, 46, 50, 63, it is noted that the claims recite “such as”. Regarding claims 2, 14, 40, 44, 46, 49, it is noted that the claims recite “preferably”. These languages are considered to be indefinite because these phrases lead to confusion regarding the scope of the claims, it appears ambiguous whether the limitations following “such as” or “preferably” are required or merely preferred embodiments. See MPEP 2173.05(c), 2173.05(d). Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Brekke (WO2013092875A1, published on 06/17/2013), in view of Lee (US8445268B2, issued on 05/21/2013), as evidenced by Fan (2014, Addgene blog, see PTO-892 listing). The rejection of claim 40 is evidenced by Carpenter (Genes Immun. 2012;13(5):374-9). The rejection of claim 63 is evidenced by Smahel (Vaccine. 2003 Mar 7;21(11-12):1125-36).
Brekke (2013) teaches a “nucleic acid molecule … comprised by a vector” (Page 39, claims 42-45), wherein (a) the nucleic acid encodes “an amino acid chain” (Page 39, claims 41-42), i.e. a first nucleic acid encoding a first polypeptide comprising
“… a targeting unit” wherein “the chemotactic targeting modules attract CCR1 and CCR5 expressing antigen presenting cells” (APCs; Page 5, lines 15-16), i.e. a targeting unit that targets APCs,
“… a dimerization unit”, i.e. a multimerization unit, and
“… an antigenic unit comprising an amino acid sequence of human papillomavirus (HPV)” (Page 39, claim 41), i.e. one or more antigens or parts thereof.
Brekke does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6).
Lee does not teach that the “bicistronic” plasmid construct expresses two Her-2/neu and GM-CSF as “separate molecules”. However, as evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Therefore, it is inherent to the bicistronic vector of Lee that comprises one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to persons having ordinary skills in the art (PHOSITAs) before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by Brekke (2013) to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple combination of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Regarding claim 2 and 14, Lee teaches “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6), because GM-CSF receptors (CD116) are expressed on the surface of APCs, e.g. dendritic cells (DCs), as evidenced by Breton (Page 402, left column, last 3 lines), and GM-CSF inherently interacts with GM-CSF receptors. Breton (2015) further teaches that “conventional DCs (cDCs) induce immunity or tolerance by capturing, processing, and presenting antigen to T lymphocytes” (Page 401, first 3 lines).
Regarding claim 21, Lee (2013) further teaches a vector comprising one or more co-expression elements which cause the transcription of the first polypeptide, i.e. a truncated Her-2/neu, and the one or more immunostimulatory compounds, i.e. GM-CSF, on a single transcript and the independent translation into a separate first polypeptide and separate one or more immunostimulatory compounds (Example 11; Claim 1) involving an internal ribosomal entry site (IRES) having the nucleotide, as evidenced by Fan (2014; Page 2, Figure on IRES).
Regarding claim 26, Brekke (2013) further teaches a vector wherein the antigenic unit comprises one antigen derived from a pathogen or parts thereof, HPV16 or HPV18 E6/E7 (Page 6, line 15). Brekke further supports that these antigens derive from pathogens with the recitation “The early gene products E6 and E7 from "high-risk" HPV types such as HPV16 and 18 may be responsible for transformation of the basal-epithelium cells and induction of precancerous lesions” (Page 6, lines 21-23).
Regarding claims 38 and 40, Brekke (2013) further teaches that “The term "targeting unit" as used herein refers to a unit that delivers the protein with its antigen to … APC ... The targeting unit … is derived from or identical to mature LD78-beta”, and human LD78-beta or LD78b is comprised in the targeting unit in Example 1 (Page 24, line 15). Brekke further teaches the surface molecule CCR5 on APCs (Page 5, line 15). As evidenced by Carpenter (Genes Immun. 2012; 13(5): 374-9), LD78-beta is also called CCL3L1 (Page 374, left column, 4th ¶, lines 1-2). Carpenter further teaches that LD78-beta/CCL3L1 competes with HIV to bind the cell surface receptor CCR5 (Page 377, right column, 4th ¶, lines 3-5). Hence, Brekke teaches a co-expression vector comprising a targeting unit that comprises a moiety that interacts with surface molecules on APCs, and that the targeting unit comprises or consists of human CCL3L1, which interacts with the cell surface molecule CCR5 on APCs.
Regarding claims 42, Brekke (2013) further teaches a dimerization unit (Claim 6).
Regarding claims 44, Brekke (2013) further teaches a dimerization unit that comprises a hinge region (Claim 7), and further comprises another domain that facilitates dimerization, i.e. an immunoglobin domain (Claim 10).
Regarding claims 46, the recitation “liker” is interpreted as “linker”. Brekke (2013) further teaches a glycine-serine rich unit linker that connects the antigenic unit to the multimerization unit (Claim 18), wherein a preferred embodiment is a G3S2G3SG linker, which is the identical linker with the amino acid sequence GGGSSGGGSG set forth in SEQ ID NO: 134, the recitation of which follows “such as”, hence is interpreted as a preferred embodiment of the claim. See alignment below:
Query: Brekke linker in claim 18: GGGSSGGGSG
||||||||||
Sbjct: Instant SEQ ID NO: 134: GGGSSGGGSG
Regarding claim 48, Brekke (2013) further teaches that “… between the antigenic unit and the targeting unit comprising the hinge region and the … second domain that may contribute to the dimerization. …, and … the hinge region and the second domain are connected through a linker …” (Page 16, last 7 lines) and that “The hinge region … functions as a flexible spacer between the domains” (Page 8, lines 35-37). Hence, Brekke teaches the claimed co-expression vector encoding a first polypeptide, wherein a unit linker connects the antigenic unit to the multimerization unit, and wherein the unit linker is a flexible linker.
Regarding claim 49, Brekke (2013) further teaches that the vector comprises the first nucleic acid sequence encoding a first polypeptide which further comprises a “signal peptide” (Claim 1).
Regarding claim 50, Brekke (2013) further teaches “In some embodiments the vector … is a virus, e.g. an adenovirus, vaccinia virus or an adeno-associated virus. In some embodiments a retroviruses is used as vector” (Page 10, lines 8-13).
Regarding claim 54, Brekke (2013) further teaches a pharmaceutical composition comprising the vector as defined in claim 1 and a pharmaceutically acceptable carrier or diluent (Claim 51).
Regarding claim 63, Brekke (2013) further teaches “a host cell comprising the nucleic acid molecule” (Claim 49), and teaches using TC-1 cell lines as host cells in Examples 3 (Page 25; FIGs. 4-6). As evidenced by Smahel (2003; See full citation above in the rejection statement), TC-1 cells are mouse cells (Page 1125, Abstract, first line). Hence, Brekke teaches a co-expression vector according to claim 1, wherein the vector is comprised in a higher eukaryotic cell.
Non-Statutory 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, 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.
US Patent US12059459B2
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over US12059459B2, in view of Lee (2013), as evidenced by Fan (2014). The rejection of claim 40 is evidenced by Carpenter (2012). See full citations above in §103. Although the claims at issue are not identical, they are not patentably distinct from each other.
US12059459B2 teaches the basic architecture of a vaccibody construct comprising a “DNA polynucleotide comprising a nucleotide sequence encoding
a targeting unit…
a dimerization unit …
an antigenic unit, …” wherein
(a) said antigenic unit comprises a cancer neoepitope sequences…
US12059459B2 does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6). As evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Hence, Lee teaches a vector comprising one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to PHOSITAs before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by US12059459B2 to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple combination of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, correspond to claims 1-2, 7, 9-10, 15, 19-21 of US12059459B2.
US Patent application 19/128,436 (Hereinafter, ’436)
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the co-pending ’436, in view of Lee (2013), as evidenced by Fan (2014). The rejection of claim 40 is evidenced by Carpenter (2012). See full citations above in §103. Although the claims at issue are not identical, they are not patentably distinct from each other.
’436 teaches in claim 1 the basic architecture of a vaccibody vector comprising a
(a) “a first nucleic acid sequence encoding a first polypeptide, wherein the first polypeptide comprises
a targeting unit that targets antigen-presenting cells,
a dimerization unit …and
an antigenic unit comprising one or more epitopes from an antigen derived from one or more pathogens; and”
(b) “one or more further nucleic acid sequences encoding one or more further polypeptides,…”
’436 does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6). As evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Hence, Lee teaches a vector comprising one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to PHOSITAs before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by ’436 to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple combination of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, correspond to claims 1, 3, 14, 29-31, 33, 36, 37, 40-42, 46, 49 of ’436.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Patent application 18/558,492 (Hereinafter, ’492)
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the co-pending ’492, in view of Lee (2013), as evidenced by Fan (2014). The rejection of claim 40 is evidenced by Carpenter (2012). See full citations above in §103. Although the claims at issue are not identical, they are not patentably distinct from each other.
’492 teaches in claim 1 the basic architecture of a vaccibody vector comprising a
(1) “a polypeptide comprising a nucleotide sequence encoding a polypeptide comprising:
a) a targeting unit targeting or capable of targeting antigen-presenting cells,
b) a multimerization unit, such as a dimerization unit, and
c) an antigenic unit comprising one or more T cell epitopes and one or more antigens or parts of fragments thereof; …”
’492 does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6). As evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Hence, Lee teaches a vector comprising one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to PHOSITAs before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by ’492 to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple combination of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, 54, correspond to claims 1-22 of ’492.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Patent application 18/552,383 (Hereinafter, ’383)
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the co-pending ’383, in view of Lee (2013), as evidenced by Fan (2014). The rejection of claim 40 is evidenced by Carpenter (2012). See full citations above in §103. Although the claims at issue are not identical, they are not patentably distinct from each other.
’383 teaches in claim 1 the basic architecture of a vaccibody vector structure by claiming a method of treating a subject having cancer, the method comprising administering to a subject
“(a) an anticancer vaccine comprising
(i) a polypeptide comprising a nucleotide sequence encoding
a targeting unit that targets antigen-presenting cells,
a multimerization unit, and
an antigenic unit comprising one or more cancer antigens or parts thereof; …”
’383 does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules. But ’383 does teach “(b) one or more checkpoint inhibitors”.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6). As evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Hence, Lee teaches a vector comprising one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to PHOSITAs before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by ’383 to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple substitution of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 correspond to claims 1-24 of ’383.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Patent application 17/997,407 (Hereinafter, ’407)
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the co-pending ’407, in view of Lee (2013), as evidenced by Fan (2014). The rejection of claim 40 is evidenced by Carpenter (2012). See full citations above in §103. Although the claims at issue are not identical, they are not patentably distinct from each other.
’407 teaches in claim 1 the basic architecture of a vaccibody vector structure by claiming “a vaccine a pharmaceutically acceptable carrier and an immunologically effective amount of
a polynucletodie comprising a nucleotide sequence encoding a polypeptide comprising
a targeting unit,
a dimerization unit, and
an antigenic unit,
wherein the targeting unit interacts with surface molecules on antigent-presentation cells, … wherein the antigenic unit comprises at least one … epitope …”
’407 does not teach (b) one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
However, Lee (2013) teaches “A bicistronic plasmid construct comprising a polynucleotide encoding …, a Her-2/neu, … and granulocyte-macrophage colony-stimulating factor (GM-CSF)…”, and that “GM-CSF … induce the proliferation and activation of antigen presenting cells (APC) … and promote immune response …” (Column 6, lines 2-6). As evidenced by Fan (2014)’s teaching that “multicistronic vectors simultaneously express two or more separate proteins …” (Page 1, lines 7-8). Hence, Lee teaches a vector comprising one or more further nucleic acid sequences encoding one or more immunostimulatory compounds, wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules.
Regarding claim 1, it would have been obvious to PHOSITAs before the effective filing date of the claimed invention to have further modified the vaccibody vector taught by ’407 to have comprised at least one further nucleic acid sequence encoding at least one immunostimulatory compound in the vector wherein the vector allows for the co-expression of the first polypeptide and the one or more immunostimulatory compounds as separate molecules, taught by Lee (2013). It would have merely amounted to a simple substitution of prior art elements according to known methods to yield predictable results. One would have been motivated to do so because Lee (2013) teaches that using a cytokine as an adjuvant using a bicistronic vector is helpful for overcoming immune tolerance against the cancer vaccine (Column 5, lines 60-65). One would have reasonable expectation of success because Lee describes reduced tumor growth (FIG. 15c) and increased survival in animal cancer models (FIG. 15a, 15d, 16) treated with host cells comprising vectors encoding GM-CSF along with vaccibody vaccine.
Claims 1-2, 14, 21, 26, 38, 40, 42, 44, 46, 48-50, and 54 correspond to claims 1, 42, 46, 48, 56, 71 of ’407.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Delphinus D. Yu whose telephone number (571) 272-1576. The examiner can normally be reached Mon-Thr 7:30am to 4:30pm Fri 10am to 2pm ET.
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/DELPHINUS DOU YI YU/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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