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 .
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.
Claim Status
Claims 239-244 are currently pending and examined on the merits.
Information Disclosure Statement
Two IDS were received on 4/19/24 and 12/30/24. All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
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 241-242 is 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.
Claim 241 recites the limitation "the ORF". There is insufficient antecedent basis for this limitation in the claim.
Claim 242 contains the limitation “(i)… and/or (x)” It is unclear if this claim is indicating that each of limitation (i)-(x) are intended to be recited in the alternative, or if this limitation is indicating that each of (i)-(ix) are an alternative to (x).
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claim 242 is 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 written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163. Possession of a genus may be shown through sufficient description of a representative number of species which are representative of the entire genus, and is an inverse function of the skill and knowledge in the art. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim 242 is drawn to a recombinant herpesvirus comprising at least one transgene encoding for a payload protein selected from HPGD, ADA2, HYAL1, CHP, CCL21, IL-12, CD47 antagonist, TGFβ antagonist, PD1 antagonist, CTX, and combinations thereof. Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 90% identical to an amino acid sequence disclosed by the present application, would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses peptide sequences for HPGD (SEQ ID NO 875-876, [0340]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of an HPGD. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 875-876 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for ADA2 (SEQ ID NO 877, [0341]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of an ADA2. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 877 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for HYAL1 (SEQ ID NO 878-879, [0342]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of HYAL1. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 878-879 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for CHP (SEQ ID NO 880, [0343]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of CHP. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 880 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for CCL2 (SEQ ID NO 881-882, [0344]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of CCL2. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 881-882 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for subunits of IL-12 (SEQ ID NO 883-886, [0340]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of an IL-12 subunit. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 883-886 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for an anti-CD47 VHH CDR (SEQ ID NO 895-897, [0346]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of an anti-CD47. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 895-897 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for an anti-TGFβ and anti-TGFβ VH CDR (SEQ ID NO 898-903, [0347]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of an anti-TGFβ. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 898-903 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for a PD1 antagonist and PD1 VHH CDR (SEQ ID NO 891-892, 904-906, [0348]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of a PD1 antagonist. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 891-892, 904-906 that are capable of providing for said function as claimed.
The instant specification discloses peptide sequences for CTX (SEQ ID NO 915-916, [0350]), and indicates that exemplary sequences are known in the art. However, the specification does not disclose what changes mutations, etc., could be made to the sequences set forth and would predictably result in the claimed function of CTX. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 915-916 that are capable of providing for said function as claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 239-240, 243-244 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Finer et al., US Patent No. 11,612,625 (cited on IDS dated 4/19/24, hereinafter Finer)
Regarding claim 239, Finer discloses oncolytic viral vectors which restrict viral replication through insertion of microRNA (miRNA) useful for the treatment of cancer (Abstract, col 2 ln 20-38). Preferably the oncolytic virus is a recombinant herpes simplex virus comprising at least two miRNA targets inserted into a locus of one or more essential viral genes (col 2 ln 39-57, col 16 ln 62-col 17 ln 6). Finer discloses that 20 or more miRNA target sequences may be included in the miRNA target sequence cassette (col 22 ln 30-63, col 23 ln 27-37). In particular, target sequences which may be present include miR-122-5p, miR-145-5p, miR-124-3p, miR-137-3p, miR-34c-5p, miR-129-2-3p (col 24 ln 47-67, col 26 ln 6-48, col 30 ln 63-col 32 ln 3, col 38 ln 10-col 39 ln 11col 42 ln 9-39, col 45 ln 54-col 7, col 53 ln 21-col 56 ln 45, Table 2, Table 10, Table 16).
Regarding claim 240, Finer discloses that in some embodiments the oncolytic viruses may comprise a nucleic acid sequence encoding a payload molecule, such as IL-12 or an anti-PD1 antibody (col 8 ln 7-ln 13, col 46 ln 41-63, col 50 ln 22-31, col 53 ln 19-col 56 ln 45).
Regarding claim 243, Finer discloses that the oncolytic virus may be combined with a pharmaceutically acceptable carrier (col 7 ln 28-34, col 16 ln 14-29, col 57 ln 1-col 61 ln 49, claim 15).
Regarding claim 244, Finer discloses that the composition may further be administered to a subject such that the oncolytic virus infects and replicates within a cancerous cell resulting in cell death (col 7 ln 35-col 8 ln 6, col 61 ln 50-col 64 ln 11, claim 16).
Therefore, every limitation of claims 239-240, 243-244 is present in Finer, and the subject matter is anticipated.
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.
Claim(s) 239-240, 243-244 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finer.
Regarding claim 239, Finer does not explicitly disclose that the oncolytic virus contains each of miR-122-5p, miR-145-5p, miR-124-3p, miR-137-3p, miR-34c-5p, miR-129-2-3p. However, Finer discloses that any suitable miRNA target sequences which disrupt the function of cancer cells may be utilized in combination (col 2 ln 39-57, col 16 ln 62-col 17 ln 6, col 22 ln 30-63, col 13 ln 62-col 14 ln 32, col 23 ln 27-37). Finer further discloses that each of miR-122-5p, miR-145-5p, miR-124-3p, miR-137-3p, miR-34c-5p, miR-129-2-3p may be used in the oncolytic virus (col 24 ln 47-67, col 26 ln 6-48, col 30 ln 63-col 32 ln 3, col 38 ln 10-col 39 ln 11col 42 ln 9-39, col 45 ln 54-col 7, col 53 ln 21-col 56 ln 45, Table 2, Table 10, Table 16). Therefore, discloses every element of the claimed recombinant herpes virus.
Claim(s) 241 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finer as applied to claim 239-240, 243-244 above, and further in view of Baumhauf et al., US Publication No. 2020/0399322 (hereinafter Baumhauf).
Regarding claim 241, Finer does not explicitly disclose that the ORF has a G/C content of at least 60%.
Bamhauf discloses methods of optimizing nucleic acid molecules for therapeutic applications (Abstract). Bamhauf discloses that the G/C content of nucleic acid molecules influences their stability, with higher G/C content correlating to higher stability ([0007]). Baumhauf discloses that in preferred embodiments, the ORF of an optimized nucleic acid molecule comprises an increased G/C content as compared to a wild type ([0390]-[0391]). The ORF may comprise the maximum amount of substitutable codons possible ([0415]-[0416]). In some embodiments, the nucleic acid molecules may comprise a cell penetrating peptide such as herpes simplex virus ([0511]-[0512]).
As both Finer and Baumhauf are directed recombinant therapies, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the modifications disclosed by Baumhauf in the methods of Finer as Baumhauf explains that G/C modifications result in increased stability of a nucleic acid molecule.
Claim(s) 242 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finer as applied to claim 239-240, 243-244 above, and further in view of Wang et al., US Patent No. 11,345,732 (hereinafter Wang).
Regarding claim 242, Finer does not disclose that the payload proteins encode for certain sequences.
Wang discloses modified IL-12 for use in oncolytic viruses (Abstract). Wang explains that the disclosed IL-12 demonstrate improved oncolytic effects as compared to other viruses encoding other IL-12 modifications (Abstract). Wang discloses that, preferably, the p35 subunit comprises SEQ ID No. 5 (corresponds to SEQ ID NO. 883 of the present application) and the p40 subunit comprises SEQ ID N. 6 (corresponds to SEQ ID NO. 884 of the present application) (claim 1).
As both Finer and Wang are both in the field of recombinant treatment methods for cancer, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the modified IL-12 of Wang in the methods of Finer, as Wang explains that the disclosed IL-12 demonstrates improved oncolytic effects.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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