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, 7, 8, 10, 11, 13-16, 32 and 33, drawn to a DNA vaccine, in the reply filed on 10/20/2025 is acknowledged.
Additionally, Applicant’s election of species:
Claim 1a, and the amino acid sequence of SEQ ID NO: 1 as a subspecies in claim 1
SEQ ID NO: 1 in claim 7
Claims 17-20, 22, 24, 27, 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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, 7, 8, 10, 11, 13-16, 32 and 33 are under examination on the merits.
Priority
Applicant’s claim for foreign priority of prior-filed European applications No. EP 20183972.7 filed on 07/03/2020 and EP 20199341.7 filed on 09/30/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/05/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 01/03/2023. The drawings are objected to because the resolution of Fig. 1 is so low as to render some of the elements unascertainable. Specifically, the triangular indicators below the X-axis are illegible. Larger graphs would overcome this objection. Further, Fig. 6B appears to be missing a key to indicate which curves represent which data conditions.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, for example in pages 1, 14 and 15. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term “Tween 20” on page 42, which is a trade name or a mark used in commerce, has been noted in this application. The term 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.
Note that “Tween 20” is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
Claims 1, 8, 11 are objected to because of the following informalities:
The recitation in claim 1 of “SPIKE protein”, should read “spike protein”. Appropriate correction is required.
The recitation in claim 8 of “said protein”, should read “said modified spike protein” for consistency of claim language. Appropriate correction is required.
The recitations in claim 11 of “promotor” and “additionally regulatory sequences”, should read “promoter” and “additional regulatory sequences”, respectively. 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 1, 7, 8, 10, 11, 13-16, 32 and 33 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 1 and 33 recite the term “preferably” which renders the claims indefinite because it is unclear whether the limitations following these phrases are part of the claimed invention or not. See MPEP § 2173.05(d). Therefore, the claims and the dependent claims are indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claim 1, recites “with the nucleic acid sequence SEQ ID NO: 1” and claim 15 recites “the Kozak translation initiation sequence is SEQ ID NO: 11”. It is not clear what these recitations means because they do not define the scope of a claim in relation to the sequences of SEQ ID NO: 1 and SEQ ID NO: 11, respectively. Specifically, it is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to SEQ ID NO: 1 and SEQ ID NO: 11. See MPEP 2111.03. Therefore, the claims are indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claims 1 and 15 were interpreted herein as reciting the open-ended language of ‘comprising’.
Claim 14 contains the trademark/trade name “RNA-OUT”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a selection marker and, accordingly, the identification/description is indefinite.
Claim 13 recites "the expression vector". There is insufficient antecedent basis for this recitation in the claim because claim 13 depends on claim 1 which has no mention of an expression vector. For purposes of compact prosecution and applying prior art, claim 13 was herein interpreted to be dependent on claim 11 which mentions an expression vector.
Claim 16 recites "the NTC8685-eRNA41H". There is insufficient antecedent basis for this recitation in the claim because claim 16 depends on claim 13 which has no mention of a NTC8685-eRNA41H. For purposes of compact prosecution and applying prior art, claim 16 was herein interpreted as reciting “a NTC8685-eRNA41H”.
Claim 33 recites "the vector". There is insufficient antecedent basis for this recitation in the claim because claim 33 depends on claim 1 which has no mention of a vector. For purposes of compact prosecution and applying prior art, claim 33 was herein interpreted to be dependent on claim 10 which mentions a vector.
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.
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 1, 7, 8, 10, 11, 13-16, 32 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
The instant claims require a DNA vaccine comprising a DNA construct having an nucleic acid sequence of a modified spike SARS-CoV-2 protein comprising a nucleic acid sequence of SEQ ID NO: 1, and having vaccine properties against SARS-CoV-2. The instant claims alternatively require a nucleic acid sequence encoding a modified spike SARS-CoV-2 protein wherein sequence alterations such as substitutions, additions, insertions, or deletions of one or more nucleotides can be made anywhere in the nucleic acid sequence of SEQ ID NO: 1, including specific regions essential for immunogenic properties, provided that the encoded modified spike SARS-CoV-2 protein bears at least 80% sequence homology to SEQ ID NO: 1. However, the Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to vaccine properties against SARS-CoV-2.
SEQ ID NO: 1, e.g., is 3819 nucleotides long. The instant claims encompass any sequence having at least 80% sequence identity to SEQ ID NO: 1. An nucleic acid sequence sharing only 80% identity relative to SEQ ID NO: 1 could have anywhere from 1 to 763 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 1, which corresponds to a massive genus (454 = 2.35 x 10459) comprising trillions upon trillions of sequences with respect to SEQ ID NO: 1.
However, while the claims are drawn to a genus that comprises innumerable sequences, the Specification has only adequately described and successfully reduced to practice the full-length of SEQ ID NO: 1. This is not representative of the extremely large genus of sequences claimed, since no variants, mutants, etc. of SEQ ID NO: 1 are demonstrated to have vaccine properties against SARS-CoV-2.
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, with respect to amino acid sequences encoded by a nucleic acid sequence, Friedberg (“Automated protein function prediction--the genomic challenge”. Brief Bioinform. 2006;7(3):225-242.) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Furthermore, Thorton (“Structural genomics takes off.” Trends Biochem Sci. 2001;26(2):88-89.) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, at lines 2-10). Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case vaccine properties against SARS-CoV-2. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to vaccine properties against SARS-CoV-2.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 7, 8, 10, 11, 32 and 33 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PG PUB 2022/0401550 A1 to Simon-Loriere et al. filed on 02/13/2020. See PTO-892: Notice of References Cited.
See claims 1, 7, 8, 10, 11, 32 and 33 as submitted on 10/20/2025.
Regarding claim 1, Simon-Loriere et al. disclose a DNA vaccine against SARS-CoV-2 virus, wherein the vaccine comprises a DNA construct comprises a sequence for a modified spike protein of SARS-CoV-2 (Abstract, ¶¶ [0009]-[0010], [0031]). Simon-Loriere et al. further disclose a sequence for a modified spike protein of SARS-CoV-2, SEQ ID NO:1, which shares 100% sequence identity with instant SEQ ID NO: 1, see alignment below (Qy is instant SEQ ID NO: 1; Db is Simon-Loriere’s SEQ ID NO: 1). Note that the alignment below only shows the first ~600 nucleotides. However, both sequences share 100% identity for the entire length of the sequences (3819 nucleotides in length).
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615
541
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Regarding claim 7, Simon-Loriere et al. disclose wherein the sequence of SEQ ID NO:1 stems from the Wuhan strain (¶ [0004]).
Regarding claim 8, Simon-Loriere et al. further disclose wherein the modified spike protein comprises at least an epitope recognized by human T cells (MHC class I or MHC class II, as recited in claim 8) (¶ [0015]).
Regarding claim 10, Simon-Loriere et al. further disclose wherein the DNA construct is inserted into a vector (¶ [0019]).
Regarding claim 11, Simon-Loriere et al. further disclose wherein the vector is a mammalian expression vector (eukaryotic, as recited in claim 11) comprising the DNA construct operatively linked to a promoter and additional regulatory sequences (¶ [0017]).
Regarding claims 32 and 33, Simon-Loriere et al. further disclose wherein the DNA vaccine of claim 1 is in a vector and wherein the vector is in a pharmaceutical composition comprising an adjuvant (¶¶ [0019], [0021]).
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 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Simon-Loriere et al. (previously cited), as applied to claims 1, 7, 8, 10, 11, 32 and 33 above, in view of US PG Pub 2016/0263204 A1 to Langlade et al. Published on 09/15/2016. See PTO-892: Notice of References Cited.
See claims 13, 14, and 16 as submitted on 10/20/2025.
Regarding claims 13, 14, and 16, the DNA vaccine of claim 1 was anticipated by Simon-Loriere et al. as discussed above. Simon-Loriere et al. further teach wherein the expression vector comprises the following sequences: a CMV promoter (¶ [0053]), the DNA construct (Abstract, ¶¶ [0009]-[0010], [0031]), a Kozak translation initiation sequence (¶ [0044]), a polyadenylation signal (¶ [0018]) and origin of replication (¶ [0018]).
Simon-Loriere et al. do not explicitly teach the expression vector NTC8685-eRNA41H comprising a selection marker, wherein the selection marker is antibiotic free selection marker.
However, Langlade et al. teach a nucleic acid vaccine comprising an expression vector termed NTC8685-eRNA41H bearing a selection marker wherein the selection marker is antibiotic free selection marker (Fig. 1A, ¶¶ [0230][0255]). Langlade et al. further teach that there is no known virulence feature associated with this vector because the plasmid does not replicate in eukaryotic target cells. The vector backbone itself does not contain protein coding sequences and no alternative protein encoding open reading frames have been identified in the vector backbone (¶ [0255]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the expression vector of Langlade et al. into the DNA vaccine taught by Simon-Loriere et al. for the benefit of avoiding any potential virulence feature associated with the vector. 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 vector of Langlade et al. into the DNA vaccine of Simon-Loriere et al. given that the methods of cloning DNA vectors comprising DNA constructs are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claims 13, 14, and 16 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Simon-Loriere et al. (previously cited) and Langlade et al., as applied to claims 13, 14, and 16 above, in view of Ferreira et al. “Tuning gene expression with synthetic upstream open reading frames.” PNAS vol. 110,28 (2013): 11284-9. Published on 2013. See PTO-892: Notice of References Cited.
See claim 15 as submitted on 10/20/2025.
Regarding claim 15, Simon-Loriere et al. and Langlade et al. teach the expression vector of claim 13. Simon-Loriere et al. further teach a consensus Kozak sequence that functions as a translation initiation sequence comprising a sequence “ACC” in position -3 to -1 or “CACC” in positions -4 to -1 relative to the ATG initiation codon of the protein of interest (¶ [0044]).
Neither Simon-Loriere et al. nor Langlade et al. explicitly teach the sequence of instant SEQ ID NO: 11 comprises the sequence the following amino acid residues “GCCACCATG”.
However, Ferreira et al. teach multiple Kozak consensus sequences for robust, predictable, and reproducible gene expression across many cell types (Abstract, pages 1-2). One such consensus Kozak sequence taught by Ferreira et al. is identical to instant SEQ ID NO: 11, it comprises the sequence “GCCACCATG” (Figs. 1, 2, 3). Further it is noted that Ferreira et al. provide evidence that consensus Kozak sequences are widely used in the art for translation initiation control (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the consensus Kozak sequence of Ferreira et al. into the expression vector taught by Simon-Loriere et al. in view of Langlade et al. for the benefit of robust, predictable, and reproducible gene expression across many cell types. 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 consensus Kozak sequence of Ferreira et al. into the expression vector of Simon-Loriere et al. and Langlade et al. given that the methods of formulating DNA vectors comprising Kozak sequences are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claim 15 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-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672