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 .
Response to Amendment
The Amendment filed 05/18/2026 in which claims 1, 2, 6, 7, 15-18, 21 were amended, and claims 5, 10, 12-14, 22 were canceled, has been entered. Claims 9, 24, 25, 28, 31 were previously withdrawn. Claims 3-4, 13-14, 19-20, 26-27, 29-30, 32-37 were previously canceled.
Claims 1, 2, 6-8, 11, 15-18, 21 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 05/18/2026 after the Nonfinal Office Action mailed on 02/18/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 05/18/2026 have overcome the previous objection to the Specification.
Claim Objections
(Previous objections, withdrawn as to claims 1, 2, 7, and 21). Applicant’s amendments to the instant claims have overcome the previous objections to claims 1, 2, 7, and 21.
Claim Rejections - 35 USC § 112 (b)
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.
(Previous rejection, withdrawn as to claims 1, 2, 5-8, 10-12, 15-18, 21 and 22) Claims 1, 2, 5-8, 10-12, 15-18, 21 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ),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.
Applicant’s cancellation and amendments to the instant claims have overcome the previous objections to claims 1, 2, 5-8, 10-12, 15-18, 21 and 22.
Claim Rejections - 35 USC § 112 (d)
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.
(New rejection, necessitated by amendment as to claims 15-18) Claims 15-18 are 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 13. 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.
Claims 15-18 recite “further comprising a second circular polyribonucleotide”. It is not clear how this statement further limits the subject matter recited in claim 1 because claim 1 already recites “and a second antigen comprising an influenza antigen.” With respect to the recitation of “ORF” in claim 16, it is noted that this recitation flows from the features already present in the influenza antigen of claim 1. With respect to the recitation of “different antigens” in claim 18, it is noted that claim 1 already requires different antigens, one from a SARS-CoV-2 and the second one from an influenza virus.
Claim Rejections - 35 USC § 112 - Written Description
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.
(Previous rejection, withdrawn as to claims 5, 10, 12, and 22, maintained and modified as necessitated by amendment as to claims 1, 2, 6-8, 11, 15-18, expanded as necessitated by amendment to claim 21) Claims 2, 6-8, and 21 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 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 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.
See claims as submitted on 05/18/2026.
The previous rejections of claims 5, 10, 12, 15-18 and 22 are moot in view of Applicant’s cancelation of these claims.
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 circular polyribonucleotide comprising a sequence encoding a SARS-CoV-2 antigen, and having immunogenic properties, and a second influenza antigen. The instant claims alternatively require a circular polyribonucleotide or a variant or fragment thereof (claim 6) wherein sequence alterations such as substitutions, additions, insertions, or deletions of one or more amino acids can be made anywhere in the amino acid sequences or variants or fragments thereof of for example, SEQ ID NO: 15 (Applicant’s elected species), including within specific regions essential for transmembrane anchoring, receptor binding, membrane fusion, etc., provided that a circular polyribonucleotide bears at least 80% sequence homology to for example, SEQ ID NO: 15. It is noted that instant SEQ ID NO:15 comprises a polynucleotide 3822 base pairs long and it encodes the complete SARS-CoV-2 spike protein, including the transmembrane domain fully intact (Specification Table 3). It should also be noted that aberrant gene expression can arise from gene sequence alterations or alterations in an RNA transcript. Finally, the instant claims alternatively require a linear polyribonucleotide comprising sequences encoding two antigens, wherein one antigen is a SARS-CoV-2 sequence of for example SEQ ID NO: 15, or any sequence bearing at least 90% sequence identity to SEQ ID NO: 15 and wherein the second antigen is an influenza antigen. Functionally, both antigens having immunogenic properties (claim 21). Accordingly, it is noted that the instant claims encompass both circular and linear polyribonucleotides. 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 immunogenic properties.
As indicated above, SEQ ID NO: 15, e.g., is 3822 base pairs long. The instant claims encompass any sequence having at least 80% or 90% sequence identity to SEQ ID NO: 15. A polynucleotide sequence sharing only 80% or 90% identity relative to SEQ ID NO: 15 could have anywhere from 1 to 764 or 1 to 382 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 15, which corresponds to a massive genus (4764 = 1.26 x 10645 or 4382 = 9.7 x 10229) comprising trillions upon trillions of sequences, with respect to SEQ ID NO: 15 alone. 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: 15. This is not representative of the extremely large genus of sequences claimed, since no variants, mutants, etc. of SEQ ID NO: 15 are demonstrated to have immunogenic properties.
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 nucleic acid sequences encoding amino acid sequences required for protein expression, 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).
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 immunogenic properties and function. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to immunogenic properties and function.
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 § 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.
(Previous rejection, withdrawn as to claims 5, 10, 12, and 22, maintained and modified as necessitated by amendment as to claims 1, 2, 6-8, 11, 15-18, and 21) Claims 1, 2, 6-8, 11, 15-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnow et al., in view of Anderson et al. (Prior art of record)
See claims 1, 2, 6-8, 11, 15-18, and 21 as submitted on 05/18/2026.
Regarding claim 1, it is noted that the amened claim recites the new limitation of “a second antigen comprising an influenza antigen”. However the cited prior art already teaches such a limitation. As previously explained, Sarnow et al. teach immunogenic compositions comprising circular RNAs, wherein the circular RNAs are related to the DNA sequence from which the circular RNAs derive and the circular RNA encodes an antigen (Abstract, columns 5 and 6). Sarnow et al. further teach that such circular RNAs enable production of large amounts of desired polypeptides, particularly eukaryotic polypeptides (column 1). Sarnow et al. further teach circular polyribonucleotides encoding two or more antigens, wherein the antigens comprise open reading frames (ORFs) encoding antigens for gene expression, and wherein the antigens are from two or more different organisms (viruses, parasites or bacteria) (columns 6, 7, 14).
Sarnow et al. do not teach and circular RNA sequence comprising a sequence encoding a coronavirus antigen, wherein the coronavirus antigen is from a SARS-CoV- 2; neither do they teach a second antigen comprising an influenza antigen.
However, Anderson et al. teach immunogenic compositions for preventing and/or treating virus infections, wherein the immunogenic compositions comprise an antigen, wherein the antigen is a SARS-CoV-2 spike protein (Abstract, ¶¶ [0028-0032]). Anderson et al. further teach a 3822 bp long sequence comprising a complete RNA sequence encoding the SARS-CoV-2 spike protein (SEQ ID NO: 20). Anderson et al. further teach an influenza HA protein as an antigen suitable for an immunogenic composition comprising an antigen (¶ [0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the SARS-CoV-2 and influenza virus antigens as taught by Anderson et al. into the immunogenic composition of Sarnow et al. for the benefit of formulating an immunogenic composition comprising circular RNAs to enable production of large amounts of a SARS-CoV-2 spike protein and influenza HA protein, particularly in eukaryotic systems. 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 antigens as taught by Anderson et al. into the immunogenic composition of Sarnow et al. given that the methods of formulating circular RNAs for expression of antigens are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, it is noted that the amened claim recites the new limitation of “a second antigen comprising an influenza antigen”. However as indicated above, Anderson et al. already teaches such limitation. As previously explained, the SARS-CoV-2 RNA sequence taught by Anderson et al. referred to above shares 99.7% sequence identity with instant SEQ ID NO: 15, see alignment below (Qy is instant SEQ ID NO: 15; Db is Anderson et al.’s SEQ ID NO: 20). Note that the alignment below only shows the first ~500 base pairs, however both sequences are 3822 pb long.
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Regarding claims 6-8, it is noted that no new limitations were introduced to claims 6-8 in the amendment filed on 05/18/2026. As previously explained, Anderson et al. teach immunogenic compositions comprising an antigen, wherein the antigen is a SARS-CoV-2 spike protein (Abstract, ¶¶ [0028-0032]), wherein the spike protein lacks a cleavage site (¶ [0052]).
Regarding claims 11, 15-18, it is noted that no new limitations were introduced to claims 6-8 in the amendment filed on 05/18/2026. As previously explained, Sarnow et al. teach circular polyribonucleotides encoding two or more antigens, wherein the antigens comprise open reading frames (ORFs) encoding antigens for gene expression, and wherein the antigens are from two or more different organisms (viruses, parasites or bacteria) (columns 6, 7, 14). As explained above, Anderson et al. teach an antigen comprising an RNA sequence encoding the SARS-CoV-2 spike protein and a second antigen comprising an influenza HA protein (Abstract, ¶¶ [0028-0032], [0044]).
Regarding claim 21, the amened claim recites “a SARS-CoV-2 antigen having at least 90% sequence identity to [SEQ ID NO: 15], and a second antigen, wherein the second antigen is an influenza antigen. As explained before the cited prior art already teach those limitations as follows. Sarnow et al. further teach immunogenic compositions comprising multiple (two or more) linear polyribonucleotide sequences (columns 6, 7, 14). As explained above, Anderson et al. teach a polynucleotide sequence encoding a SARS-CoV-2 spike protein antigen and an influenza HA protein antigen (Abstract, ¶¶ [0028-0032], [0044], [0055]). The sequence taught by Anderson et al. is linear (SEQ ID NO: 20) and shares 99.7% sequence identity with instant SEQ ID NO:15 (see alignment above). The teachings of Sarnow et al. and Anderson et al. in combination teach the limitations of claims 21.
Accordingly, the invention as a whole 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.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
Applicant contends on pages 8-9 of the Remarks submitted on 05/18/2026:
“The independent claims have been amended to recite that the polyribonucleotide encodes both a SARS-CoV-2 antigen and an influenza antigen. The claimed constructs engender the underlying technical effect of inducing a distinct immune response to each encoded antigen. It is not necessary that Applicant exemplify the technical effect of the claimed invention is achieved with each and every SARS-CoV-2 antigen. Applicant clearly described such a construct in the specification as filed, for example, by generating a circular polyribonucleotide encoding a SARS-CoV-2 antigen and an influenza antigen as used in Example 33 and Figure 17 to induce an immune response…”
In response:
The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the instant claims merely recite an “immunogenic composition comprising a circular polynucleotide…” Further, the instant claims recite “comprising” and are interpreted in an open-ended fashion and do not even exclude additional components (See MPEP 2111). As indicated above, the instant claim encompass a massive genus comprising trillions upon trillions of sequences, with respect to SEQ ID NO: 15 alone. The Specification has only adequately described and successfully reduced to practice the full-length of SEQ ID NO: 15. This is not representative of the extremely large genus of sequences claimed, since no variants, mutants, etc. of SEQ ID NO: 15 are demonstrated to have immunogenic properties. Therefore, it is maintained that in view of the language, 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.
Applicant contends on pages 10-11 of the Remarks submitted on 05/18/2026:
“Neither Sarnow nor Anderson provides the necessary motivation to pursue the claimed subject matter. As an initial matter, neither of the cited references teaches or suggests administration of a polyribonucleotide encoding a coronavirus antigen and an influenza antigen. Importantly, both Sarnow and Anderson are entirely silent with respect to the polyribonucleotide encoding an influenza antigen. Accordingly, the cited references fail to disclose each of the elements of the claimed invention, and thus, the claimed invention is non-obvious over the cited references. Furthermore, the claimed subject matter engenders surprising and advantageous results that could not have been predicted in light of the cited art. The amended claims are based at least in part on Applicant's surprising discovery that a circular polyribonucleotide encoding a SARS-CoV-2 antigen and influenza antigen could successfully induce an immune response to each antigen. None of the cited references demonstrate delivery of a SARS-CoV-2 antigen and an influenza antigen to a subject and subsequently elicit an immune response SARS-CoV-2 antigen and an influenza antigen as demonstrated by Applicant.”
In response:
To reiterate, the instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the claimed invention does not recite nor require administration of a polyribonucleotide. With respect to motivation, as indicated above Sarnow et al. teach that circular RNAs enable production of large amounts of desired polypeptides, particularly eukaryotic polypeptides and Anderson et al. teach immunogenic compositions specifically eliciting immune responses thereby preventing and/or treating virus infections. Therefore, it is maintained that in view of the language of the instant claims, one of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the instant claims in view of Sarnow et al. and Anderson et al. Further, as to the alleged surprising and advantageous results, it is noted that both Sarnow et al. and Anderson et al. teach successful compositions specifically for eliciting immune responses. Therefore, such a result of successfully inducing an immune response to the antigens would be considered entirely expected and consistent with the prior art. It is not clear why Applicant refers to such a result as surprising (Remarks, page 10).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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