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 in the reply filed on 4/13/2026 is acknowledged.
Claims 4, 9-11, 14-15,22,23,35-42,50 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/2026. Claims 4 and 9-11, 14-15 are withdrawn as they fail to relate to the elected SEQ ID NO:34.
Claim Interpretation
The claims are drawn to an “armed” Seneca Valley virus comprising a Seneca Valley Viruse and a nucleic acid encoding a therapeutic protein. Given the sefinition od “armed Seneca Valley Virus” at para 78, the claims are interpreted as a SVV with the nucleic acid encoding a therapeutic protein inserted within the SVV genome.
[0078] As used herein, the phrases "armed Seneca Valley Virus" or "armed SVV" encompass a "Seneca Valley Virus" or "SVV" as defined above, that has been modified to express an agent that is useful for treating cancer. An armed SVV encodes an agent useful for treating cancer. An armed SVV has been engineered to express therapeutic genes
Claim Objections
Claim 16 objected to because of the following informalities: Claim 16 recites that the Seneca Valley Virus expresses a therapeutic agent. A virus does not carry out the action of expressing and merely encodes the therapeutic agent (protein). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8,12,20 and 21 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The specification has described the nucleotide sequences set forth by SEQ ID NO:33, encoding SEQ ID NO:34. The specification, however, has not described any variant sequences of those nucleotide sequences that are within the genus of variants that include sequences having at least 85% identity to the nucleic acid sequence of SEQ ID NO:33 or encoding a protein having an amino acid sequence set forth by SEQ ID NO:34 and have ability to bind PDL-1.
In the instant case the PD-L1 nanobody variants encompassed by the claims lack a written description. The specification fails to describe what amino acid sequences fall into this genus and it was unknown as of Applicants’ effective filing date that any of these proteins would have the same structural and functional properties as the protein whose sequence is set forth by SEQ ID NO:34. There is no evidence on the record of a relationship between the structure anti-PD-L1 nanobody variants and the amino acid sequence set forth by SEQ ID NO:34 that would provide any reliable information about the structure of proteins within the genus that have the same effect.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claims is a reference to structure in the form of a recitation of partial structural similarity, “fragment”, or vague structural resemblance. There is not even identification of any particular portion of the structure that must be conserved. The specification does not provide a complete structure of those nucleotide sequences that are fragments and variants of SEQ ID NO:33 or amino acid sequences that are fragments or variants of SEQ ID NO:34, and fails to provide a representative number of species for the encompassed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
The skilled artisan cannot envision the detailed chemical structure of all of the fragments, derivatives or variants, that are encompassed by the claims, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that it is part of the invention, and a reference to a potential method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification only provided the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description of 35 U.S.C. 112 is severable from its enablement provision [see p. 1115].
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 19-21 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 19-21 each recite “SEQ ID NO: 13-18 or 53-64”. It is unclear if the claim is directed to a single sequence from the recited sequences or if it is drawn to 2 options, a) SEQ ID NO:13-18 or b) SEQ ID NO:53-64.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 depends from claim 1. Claim recites a therapeutic protein while claim 16 refers to a therapeutic agent, which is more broad than a therapeutic protein. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3,5,13,16-18,43-45 is/are rejected under 35 U.S.C. 102a1 and a2 as being anticipated by US 2020/0197457 (Transgene).
Claim 1 is drawn to an armed Seneca Valley Virus comprising a Seneca Valley Virus and a nucleic acid encoding a therapeutic protein of interest. Applicant has elected anti-PD-L1 nanobody and SEQ ID NO:34 (claim 3,7) as a therapeutic protein, which is a immune checkpoint inhibitor (claim 2).
With regard to claims 1-3 and 5, Transgene teaches a Seneca Valley Virus (para 42,44) encoding (inserted into, claim 5) a dAb (nanobody, para 74,79) directed against PD-L1 (para 16). The teachings also meet the limitations of claim 16 which is drawn to the SVV of claim 1 wherein the SVV expresses a therapeutic agent capable of treating cancer. anti-PD-L1 is capable of treating cancer as taught by Transgene at para 3. Transgene taught cloning of oncolytic viruses into a plasmid vector (para 27,169-170; claims 17-18). Transgene teaches the vector is NTX-010, which is SVV-001 (claim 13). Transgene teaches that virus can be a pharmaceutical composition comprising a pharmaceutically acceptable vehicle (para. 1, claim 43). Transgene teaches that the oncolytic virus of the invention can be combined with additional cancer therapies including interleukins, which are cytokines (claim 44). The composition is taught to be useful in treatment of numerous cancers recited by claim 45 (para 134).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0197457 (Transgene) in view of WO2021259508 (Sapreme).
Transgene meets the limitations of claim 1 as set forth above. While Transgene teaches a Seneca Valley Virus encoding a PD-L1 nanobody, it does not teach the nucleic acid sequence encoding the nanobody or the amino acid sequence of the nanobody.
Claim 6 limits the nucleic acid sequence encoding the PDL-1 nanobody to SEQ ID NO:34 and claim 7 limits the nucleic acid sequence to one that encodes the amino acid sequence set forth by SEQ ID NO:34. Claim 8 limits the nucleic to encoding a protein at least 85% identical to SEQ ID NO:34.
Sapreme teaches the sequence set forth in SEQ ID NO:32 that is identical to SEQ ID NO:34, which is taught to be the PD-L1 sdAb B1. Sapreme teaches PD-L1 as a protein present on tumor cells and is a target for nanobody (sdAb) therapy. Sapreme provides SEQ ID NO:31 as the nucleic acid encoding SEQ ID NO:32 (which SEQ ID NO:34 of the instant invention). The alignment of SEQ ID NO:31 of Sapreme and the amino acid sequence of the PD-L1 nanobody (SEQ ID NO:34) is set forth below:
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It would have been obvious at the time of filing, when carrying out the invention of Transgene, to turn to Sapreme for the provision of the PD-L1 nanobody amino acid sequence to generate a nucleic acid sequence that encodes PD-L1 for delivery to tumor cells. One would have been motivated to use the sequence of Sapreme as Sapreme discusses the use of the PD-L1 sdAb B1 in treating tumor cells. One would have had a reasonable expectation of success in combining the teachings as it was routine in the art to back translate protein sequences into nucleic acids to place them into a nucleic acid vector.
With regard to claim 6, while Sapreme teaches SEQ ID NO:31 as encoding SEQ ID NO:32, which is identical to SEQ ID NO:34 of the instant invention (claims 7), Sapreme SEQ ID NO:31 is not identical to the sequence set forth by SEQ ID NO:33 of the instant invention (claim 6; 279/378 nucleotides match, 73.8%). However, SEQ ID NO:31 of Sapreme and SEQ ID NO:33 of the instant invention, encode the same protein and it would be a matter of design choice to use the degeneracy of the genetic code to obtain SEQ ID NO:33 given SEQ ID NO:31 of Sapreme.
Claim(s) 12,18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0197457 (Transgene; IDS) in view of WO2021259506 (Sapreme) as applied to claims 1 and 5 above, and further in view of Poirer (2012, Journal of General Virology, Volume 93 Issue 12 e00576-19, 13 pages; IDS).
Claim 12 limits the virus of claim 5 to comprising a nucleic acid encoding SEQ ID NO:34, which is taught by Sapreme (see above), wherein the nucleic acid encoding the therapeutic protein (SEQ ID NO:34) is inserted between the 2A and 2B gene. In teaching a SVV encoding a PD-L1 nanobody, Transgene does not discuss where to insert the coding sequence within the SVV genome.
However, Poirer taught insertion of a GFP gene in the SVV-001 genome between the 2A and 2B genes in plasmid pNTX-09 to generate pNTX-11, which is the plasmid used in the instant invention (see para 216). Poirer taught how to insert an exogenous coding sequence while retaining native coding sequences of all SVV-001 proteins.
It would have been obvious at the time of filing to insert the nucleic acid encoding the nanobody in to the SVV genome as taught by Transgene between the 2A and 2B genes as taught by Poirer to arrive at the invention as claimed. One would have been motivated to use the insertion site taught by Poirer because the cloning site was provided and known to result in a replication competent virus that did not lose the insertion with passage. One would have had a reasonable expectation of success in making the combination as replacing a nucleic acid insertion in a vector was well with the skill of the ordinary artisan.
With regard to claims 19-21, SEQ ID NO:55 is a plasmid NTX-11 comprising SEQ ID NO:34 at site between the 2A and 2B genes. By inserting the cDNA encoding the nanobody of Transgene and Sapreme in this site of NTX-11 as taught by Poirer, SEQ ID NO:55 is inherently derived.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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