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 .
Election Restrictions
Applicant’s election without traverse of Group I, claims 1-18 drawn to an oncolytic adenovirus, in the reply filed on 04/27/2026 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-18 are under examination on the merits.
Priority
This application discloses and claims only subject matter disclosed in prior application No. PCT/CN2021/095796 filed on 05/25/2021, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a continuation or division. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/27/2023, 07/04/2024 and 06/13/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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/patents-application- process/filing-online/legal-framework-efs-web), 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 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is defective because the size of the ASCII text file is not listed in bytes.
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.
Claim Objections
Claims 3, 5, 7-10 are objected to because of the following informalities:
On claims 3, 5, the recitation of “a IRES” should read “an IRES”. Appropriate correction is required.
On claim 7, the recitation of “is linked to 3’ terminus of E1a gene” should read “is linked at the 3’ end of the E1a gene”. Appropriate correction is required.
On claims 8, the recitation of “the backbone of the oncolytic adenovirus is Ad5” should read “wherein the backbone of the oncolytic adenovirus is an Ad5.” Appropriate correction is required.
On claims 9, the recitation of “a chimera capsid protein Hexon” should read “a chimeric capsid Hexon protein”. Further the recitation of “chimera Hexon” in claim 9 and claim 10 should also read “chimeric capsid Hexon protein” for consistency of claim language. Appropriate correction is 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 3-6, 15-17 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.
Claims 3, 5 recite “a fragment encoding a protease recognition site or a IRES (Internal Ribosome Entry Site) sequence is provided between two sequences next to each other, and IL-12, IFN-γ and CCL5 are released respectively”. This recitation is unclear because the term “between two sequences next to each other” is vague and lacks clarity. For instance, it is not clear if the indicated term encompasses any sequence or claim requires a protease recognition site or an IRES specifically between the sequences encoding the genes IL-12, IFN-γ and CCL5. Further, it is also not clear if the sequences of these three genes are required to be next to each other because the preamble of the claims only recites “are in one expression cassette” in claim 3, and “are in two expression cassettes” in claim 5. Further, it is not clear what the term “released respectively” means or how it is mean to be understood. The Specification lacks clear explanation of this term thus the meets and bounds of the term are unclear. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claims 3 and 5 were interpreted herein as referring to a protease recognition site or an IRES sequence which is lies between two coding sequences, and wherein the genes are expressed individually.
Claim 7, recites “a fragment encoding an oxygen-dependent degradation domain (ODD) is linked to 3’ terminus of E1a gene and a fusion protein of E1a with ODD in the C-terminus is expressed by the oncolytic adenovirus.” It is not clear if the ODD linked to a 3’ end of an E1a gene is the same fusion protein referred to as “a fusion protein” on line 2, it is also not clear what C-terminus is being referred to in line 3. For purposes of compact prosecution and applying prior art, claim 7 was interpreted herein as referring to a fusion protein comprising an ODD and an E1a gene expressed by the oncolytic adenovirus of claim 1.
Claim 13 recites "the promoter”. There is insufficient antecedent basis for this recitation in the claim because claim 1, which claim 13 depends on, does not recite a promoter. Therefore the claim is indefinite.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
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.
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, 7, 8, 11, 13, 14, are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. “The combination of an oxygen-dependent degradation domain-regulated adenovirus expressing the chemokine RANTES/CCL5 and NK-92 cells exerts enhanced antitumor activity in hepatocellular carcinoma.” Oncology reports vol. 29,3 (2013): 895-902 (cited in Applicant’s IDS submitted on 06/13/2025), in view of de Graaf, J F et al. “Armed oncolytic viruses: A kick-start for anti-tumor immunity.” Cytokine & growth factor reviews vol. 41 (2018): 28-39 (cited in Applicant’s IDS submitted on 06/13/2025).
See claims 1, 2, 7, 8, 11, 13, 14, as submitted on 02/13/2024.
Regarding claim 1, Li et al. teach a modified oncolytic adenovirus expressing CCL5, wherein other genes can be inserted into the viral genome, for the purpose of recruiting natural killer cells (NK92) and thereby improving the anticancer immune response (Abstract, pages 1-2).
Li et al. do not teach wherein IL-12 and IFN-γ are expressed by the oncolytic adenovirus.
However, de Graaf et al. teach a that oncolytic viruses, including modified oncolytic adenoviruses, can function to “kick start” an antitumor immune response by releasing tumor associated antigens and release of inflammatory signals (Abstract, pages 1-3). de Graaf et al. further teach that oncolytic viruses can be engineered to express different cytokines or chemokines, which are small genes and are in general easy to build in a viral genome (page 3). Examples of such cytokines or chemokines include IL-12 which provides the additive immunologic effect of infiltration of macrophages, T helper, cytotoxic T lymphocytes (CTL), and NK cells and IFN-γ which provides the additive immunologic effect of increased cytokine expression and improved dendritic cell maturation (table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated IL-12 and IFN-γ into the oncolytic adenovirus of Li et al. for the benefit of adding the immunologic effects of infiltration of macrophages, T helper, cytotoxic T lymphocytes (CTL), and NK cells, increasing cytokine expression and improving dendritic cell maturation as taught by de Graaf et al. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating such transgenes into the oncolytic adenovirus of Li et al. given that the methods of formulating oncolytic adenoviruses expressing multiple transgenes are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, Li et al. teach expressing the transgenes CCL5 and oxygen-dependent degradation domain (ODD) from a single cassette driven by a promoter (page 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated, with a reasonable expectation of success, the transgenes IL-12 and IFN-γ into the single cassette driven by a promoter into the oncolytic adenovirus of Li et al.
Regarding claim 7, Li et al. teach wherein the oncolytic adenovirus of claim 1 comprises a fusion protein comprising an ODD and an E1a gene (SG5/11-CCL5-ODD) expressed by the oncolytic adenovirus of claim 1 (page 3). See also rejections under 35 USC § 112(b) above. With respect to the recitation of “wherein a fragment encoding an oxygen-dependent degradation domain (ODD) is linked to the 3’ terminus of E1a”, it is noted that Li et al. teach an ODD at the 3’ end of the E1a gene. Further, it is noted that it is well within the purview of one of ordinary skill in the art to determine the order of the genes and the configuration of genes are considered to be those determined by routine optimization according to one of ordinary skill in the art in view of the teachings of Li et al. and de Graaf et al. Further, it is noted that there is no indication that any particular gene configuration, i.e. an ODD linked to 5’ end or a 3’end of another gene, presents advantageous features over any other configuration.
Regarding claims 8, 11, 13, Li et al. teach wherein the backbone of the oncolytic adenovirus is an Ad5 (Abstract) comprising a chimera of the fiber protein of serotypes Ad5 and Ad11 (page 3), wherein the oncolytic adenovirus comprises a CMV promoter (page 3).
Regarding claim 14, Li et al. and de Graaf et al. in combination teach the oncolytic adenovirus of claim 1. With respect to the gene configurations recited in claim 14, it is noted that it is well within the purview of one of ordinary skill in the art to determine the order of the genes and such gene configurations are considered to be those determined by routine optimization according to one of ordinary skill in the art in view of the teachings of Li et al. and de Graaf et al. Further, it is noted that there is no indication that any particular gene configuration of those recited in claim 14 presents advantageous features over any other configuration.
Accordingly, claims 1, 2, 7, 8, 11, 13, 14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 3-6, 9, 10, 12, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. and de Graaf et al. as applied to claims 1, 2, 7, 8, 11, 13, 14 above, further in view of US PGPub US 2022/0235332 A1 to Su, as evidenced by Small et al. “Construction and characterization of E1- and E3-deleted adenovirus vectors expressing two antigens from two separate expression cassettes.” Human gene therapy vol. 25,4 (2014): 328-38. See PTO-892: Notice of References Cited.
See claims 3-6, 9, 10, 12, 18 as submitted on 02/13/2024.
Regarding claims 3 and 4, Li et al. and de Graaf et al. in combination teach the oncolytic adenovirus of claim 1. Li et al. further teach expression of transgenes from a single expression cassette driven by a promoter (page 3).
Neither Li et al. nor de Graaf et al. teach wherein a protease recognition site or an IRES sequence lies between two gene sequences, and the genes are expressed individually. See also rejections under 35 USC § 112(b) above.
However, Su teaches an oncolytic adenovirus packaging system comprising an adenoviral genome comprising a protease recognition site comprising an E2A peptide between two gene sequences thereby allowing the genes to be expressed individually (Figs. 1-3, 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated an E2A peptide sequence into the oncolytic adenovirus of Li et al. for the benefit of allowing individual expression of genes as taught by Su. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating an E2A peptide sequence into the oncolytic adenovirus of Li et al. given that the methods of formulating oncolytic adenoviruses expressing multiple transgenes wherein the transgenes are expressed individually are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 5 and 6, Li et al. and de Graaf et al. in combination teach the oncolytic adenovirus of claim 1. Li et al. further teach two expression cassettes within the oncolytic adenovirus of claim 1, wherein an E1a protein and the transgenes CCL5 and ODD are expressed form one cassette controlled by the hTERT promoter and an E1b protein is expressed form a second cassette controlled by the hypoxia response promoter (HRE) (page 3). As evidenced by Small et al., expression of transgenes from two separate expression cassettes in one adenoviral genome is a well-known practice in the art and it provides the benefit of sustained protein expression of transgenes (Abstract, pages 1-2). It would have been prima facie obvious to a person skilled in the art to have included with reasonable expectation of success a second expression cassette an oncolytic adenovirus comprising the transgenes IL-12 and IFN-γ for the benefit of sustained protein expression of transgenes as taught by Li et al. and evidenced by Small et al. As indicated above, Su teaches an oncolytic adenovirus packaging system comprising an adenoviral genome comprising a protease recognition site comprising an E2A peptide between two gene sequences thereby allowing the genes to be expressed individually (Figs. 1-3, 5). Similarly, it would have been prima facie obvious to a person skilled in the art to have included with reasonable expectation of success a E2A protein between the transgenes as taught by Su such that all transgenes are expressed individually.
Regarding claims 9 and 10, Li et al. and de Graaf et al. in combination teach the oncolytic adenovirus of claim 1. Su further teaches an oncolytic adenovirus comprising a chimeric capsid Hexon protein which comprises a chimeric sequence formed by Ad5 Hexon and Ad48 Hexon (¶¶ [0024], [0063], SEQ ID NO: 5). Su further teaches a nucleotide sequence for a chimeric capsid Hexon protein termed Ad5H48 which shares 100% identity with positions 18327-21170 of instant SEQ ID NO: 3. See alignment below (Qy is instant SEQ ID NO: 3 positions 18327-21170; Db is Su’s SEQ ID NO: 5). Note that the alignment below shows only the first ~ 300 nucleotides, however the sequences share 100% identity along all 2844 nucleotides. Su further teaches that combining sequences of Ad5 Hexon and Ad48 Hexon to form a chimeric Hexon protein is an effective way to avoid or reduce pre-existing immunity to Ad5, which is widely present in nature (¶ [0014]). The benefit of including a chimeric Hexon protein provides additional motivation to include such chimeric embodiment in the oncolytic adenovirus of claim 1.
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Regarding claim 12, Li et al. and de Graaf et al. in combination teach the oncolytic adenovirus of claim 1. As explained above, Li et al. teach the backbone of the oncolytic adenovirus is an Ad5 (Abstract) comprising a chimera of the fiber protein of serotypes Ad5 and Ad11 (page 3). Su further teaches a nucleotide sequence for a chimeric Fiber protein termed Ad5F11b which shares 99.8% identity with positions 33373-34356 of instant SEQ ID NO: 3. These two sequences only differ by one base pair at the end codon. However, both end codons: “TGA” in instant SEQ ID NO: 3 positions 33373-34356, and “TAA” in Su’s SEQ ID NO: 5 are stop codons. Therefore, both sequences encode the same exact amino acid sequence for a chimeric Fiber protein. See alignment below (Qy is instant SEQ ID NO: 3 positions 33373-34356; Db is Su’s SEQ ID NO: 6). Note that the alignment below shows only the first ~ 300 nucleotides, however the sequences share 99.8% identity along all 984 nucleotides.
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Regarding claim 18, Su teaches the deletion of coding sequences for an E1A-CR2, E1B-19Kd, E1B-55KD, and the entire E3 region which comprises an E3B-14.6K and an E3B-14.7K (¶¶ [0010]-[0012]) (see also Specification ¶ [0047]). Su further teaches that these deletions not only expand the vector capacity but also promote the apoptosis of infected cancer cells (¶ [0012]). The teachings of Su regarding the benefits of these deletions provide additional motivation to include them in the oncolytic adenovirus of claim 1.
Accordingly, claims 3-6, 9, 10, 12, 18 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., de Graaf et al. and Su as applied to claims 1, 2, 7, 8, 11, 13, 14, 3-6, 9, 10, 12, and 18 above, further in view of Small et al. (previously cited).
See claims 15-17 as submitted on 02/13/2024.
Regarding claims 15 and 16, Li et al., de Graaf et al. and Su in combination teach the oncolytic adenovirus of claim 5. As explained above Small et al. teach two expression cassettes for expression of transgenes in an adenoviral genome (Abstract, pages 1-3). With respect to the recitation of “wherein the sequence encoding IL-12 is in the first expression cassette, the sequence encoding IFN-γ and the sequence encoding CCL5 are in the second expression cassette”, it is noted that it is well within the purview of one of ordinary skill in the art to determine the distribution of the transgenes in the two expression cassettes and such transgene distribution is considered to be one determined by routine optimization according to one of ordinary skill in the art in view of the teachings of Li et al., de Graaf et al., Su and Small et al. Further, it is noted that there is no indication that any particular transgene distribution in the two expression cassettes as those recited in claim 15 presents advantageous features over any other transgene distribution.
Neither Li et al., nor de Graaf et al. nor Su explicitly teach the orientation of the expression cassettes relative to the direction of the viral genome.
However, Small et al. teach two expression cassettes in an adenoviral genome, wherein one cassette is in the forward orientation (5′–3′) in relation to the viral genome and the second cassette is in the reverse orientation (3′–5′) and transgene expression levels reached acceptable yields for all transgenes (Abstract, pages 1-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the two expression cassettes in opposite orientations, one in the 5′–3′ orientation and the second in the 3′–5 orientation relative to the viral genome into the oncolytic adenovirus of Li et al. de Graaf et al. and Su for the benefit of achieving acceptable yields for all transgenes as taught by Small et al. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the two expression cassettes in opposite orientations in the oncolytic adenovirus of Li et al. de Graaf et al. and Su given that the methods of formulating oncolytic adenoviruses expressing multiple expression cassettes are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 17, Small et al. further teach two different promoters for each one of the expression cassettes, wherein each promoter comprises a sequence from a different species. For example, a human CMV promoter and a chicken β-actin promoter (Abstract, page 1-3). Small et al. further teach that shared sequences among the two expression cassettes, for example, the CMV promoter, negatively affects levels of transcription of the transgenes and thereby protein expression (pages 2, 10). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the two different promoters for the two expression cassettes as taught by Small et al. Therefore, the claimed embodiment comprising a murine CMV promoter and a human CMV promoter as recited in claim 17 merely represents an obvious variant and/or routine optimization of the teachings of the cited prior art. Further, it is noted that is the use of known promoters, such as an mCMV and an hCMV promoter, which results in predictable results, namely optimal expression of the desired protein, represents an obvious practice in the art. Further, it is noted that Applicant has not demonstrated any unexpected/surprising results with the two claimed promoters.
Accordingly, claims 15-17 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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