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 .
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/US2022/024497, filed April 12, 2022. This application also claims priority to US Provisional Application No. 63322121, filed on March 21, 2022, US Provisional Application No. 63241959, filed on September 8, 2021, and US Provisional Application No. 63175011, filed on April 14, 2021.
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.
Claim 202 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing an immune response against SARS-CoV-2, RSV, and/or Influenza respiratory infection using an mRNA vaccine in some cases, does not reasonably provide enablement for 1) preventing an influenza infection, SARS-CoV-2 infection, nor a RSV infection and 2) preventing all respiratory virus infections using an mRNA vaccine. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
• (A) The breadth of the claims;
• (B) The nature of the invention;
• (C) The state of the prior art;
• (D) The level of one of ordinary skill;
• (E) The level of predictability in the art;
• (F) The amount of direction provided by the inventor;
• (G) The existence of working examples; and
• (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The level of skill in the art is high and would include, e.g., Ph.D. level scientists.
Here, the instant claims are broadly drawn to a method for preventing a respiratory infection by administering a mRNA vaccine encoding three mRNA polynucleotides, formulated in at least one LNP, comprising the RBD and NTD domain of the SARS-CoV-2 spike protein, the HA protein of an influenza virus, and the RSV protein with the polynucleosides consisting of N1-methylpseudouridine, adenosine, guanosine, and cytidine. In regard for prevention of respiratory virus infection, it is noted that the term “preventing” was interpreted in an absolute sense to mean to always keep something from happening or arising.
As the claims are written, formulation of at least one LNP with any mRNA sequences comprising the RBD and NTD domain of the SARS-CoV-2 spike protein, the HA protein of an influenza virus, and the RSV protein with the polynucleosides consisting of N1-methylpseudouridine, adenosine, guanosine, and cytidine would satisfy claim 190. The claims are not enabled based on, but not limited to, two major lines of evidence. First, not all respiratory virus infections caused by SARS-CoV-2, RSV, or Influenza are prevented by mRNA vaccine being claimed. And second, not all respiratory virus infections are caused by SARS-CoV-2, RSV, or Influenza alone and therefore a targeted vaccine against SARS-CoV-2, RSV, and Influenza would not prevent all respiratory virus infections.
The art establishes that known SARS-CoV-2 vaccines such as BNT162b2 is not 100% effecting in preventing SARS-CoV-2 infection (Polack et al. (NEJM, 2020), Abstract). Similarly, the evidence disclosed in the specification demonstrates that mRNA vaccines satisfying claim 190 can, in some cases, prevent RSV infection in the lungs and nose of Cotton Rats but not all dosages (Fig. 37A and 37B) are effective at preventing RSV infection. Additionally, not all mRNA vaccine formulations that satisfy the limitations of claim 190, prevent RSV infection (Fig. 37A and 37B).
Furthermore, the art establishes that vaccines work by stimulating the body’s immune system to recognize specific viruses, not all viruses (Valich, Health and Medicine, University of Rochester, 2020, Section: “How do RNA vaccines work?). Imamure et al., (Reviews in Medical Virology, 2014, hereinafter, “Imamure”) teaches that EV-D68 is a known virus that infects the respiratory system, also known as a respiratory virus infection (Abstract). Therefore, there is reasonable expectation that a vaccine produced to target SARS-CoV-2, RSV, and Influenza would not prevent EV-D68 infection.
Together with the evidence discussed above, a combination SARS-CoV-2, RSV, and Influenza vaccine that satisfies the limitations of claim 190 would not predictably prevent all respiratory virus infections nor would it reliably prevent infections caused by SARS-CoV-2, RSV, and/or Influenza in every single case.
The specification only exemplifies and reduces to practice preventing RSV infection in some cases at certain doses and formulations. However, the specification offers no reasonable direction or working example for the use of an mRNA vaccine that satisfies the limitations of claim 190 prevent all respiratory virus infections.
In view of the foregoing, a vast quantity of experimentation, including expansive clinical trials, would be needed to use the invention based on the content of the disclosure.
Taken together, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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.
Claims 190 - 198, 201 - 202, and 205 - 207 are rejected under 35 U.S.C. 103 as being unpatentable over Oostvogels et al. (US20220211838A1, hereinafter, "Ootsvogels").
Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract).
Regarding claim 190, Ootsvogels teaches a combination vaccine that encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein, which consists of the receptor binding domain (RBD), the N-terminal domain (NTD), and 2 subdomains (Abstract, Claim 1, ¶0101, ¶0102), and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with at least one uracil replaces by N1-methylpseudouridine (m1ψ) nucleotide (¶0411), stating a preference for all of the uracil nucleotides replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine.
Regarding claim 191, Ootsvogels teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein (Claim 1 – 3).
Regarding claim 192, Ootsvogels teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus neuraminidase (NA) protein (Claim 3 – 6, ¶0754).
Regarding claim 193, Ootsvogels teaches the combination vaccine comprising of mRNA encoding the HA protein from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8). Please note, Daniels evidences that B/Brisbane/60/2008 as a B/Victoria lineage virus (Summary).
Regarding claim 194, 195, and 196, Ootsvogels teaches the first, second, and third mRNA can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19).
Regarding claim 197, Ootsvogels teaches a LNP comprises 20-60% cationic lipid, 5-25% neutral lipid, 25-55% cholesterol, and 0.5-15% PEG-lipid (Claim 1).
Regarding claim 198, Ootsvogels teaches a LNP comprises 40-50% cationic lipid (¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Regarding claim 201, Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21).
Regarding claim 202, Ootsvogels teaches the method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
Regarding claims 203 to 207, as discussed above, Ootsvogels teaches a combination vaccine to elicit a immune response after administration of a combination vaccine (Claim 21) that encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101), and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza (¶0024) and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with at least one uracil replaces by N1-methylpseudouridine (m1ψ) nucleotide (¶0411). Ootsvogels also teaches a LNP comprises 40-50% cationic lipid (¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299). Ootsvogels further teaches the combination vaccine comprising of mRNA encoding the HA protein from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ product and method they exemplify. As such, the claimed invention is within the scope of Ootsvogels, and thus Ootsvogels renders the invention prima facie obvious. The rationale to support this conclusion of obviousness is that Ootsvogels provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 199 - 200 and 203 - 204 are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. (PCT/US19/15412, hereinafter, “Ciaramella”) as applied to claims 190 - 198, 201 - 202, and 205 - 207 above, and further in view of Oostvogels, as evidenced by Daniels et al. (Surveillance report, 2012, hereinafter, “Daniels”).
As discussed above, claims 190 - 198, 201 - 202, and 205 – 207 were rendered prima facie obvious by the teachings of Oostogogels. The reference fails to teach the exact ionizable amino lipid, a component of LNPs, of claims 199, 200, 203, and 204.
However, Ciaramella teaches an RSV RNA vaccine that comprises of a mRNA polynucleotide encoding the RSV F protein and an LNP. The structure of the ionizable amino lipid in Ciaramella has the exact structure of the ionizable amino lipid claimed in 199, 200, 203, and 204 of the instant application (Compound 1 of Ciaramella, reproduced below).
PNG
media_image1.png
140
549
media_image1.png
Greyscale
Ootsvogels and Ciaramella are considered to be analogous to the claim invention because they both aim to treat and prevent SARS-CoV-2, influenza, and RSV infections through the use of mRNA vaccines that target two or more viruses in one composition. Ootsvogels and Ciaramella teach that the efficacy of the vaccine can change depending on the LNP used in conjunction with the mRNA (Ootsvogels ¶1287, ¶1289; Ciaramella ¶0119). Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to utilize the art-recognized method to use the combination of mRNA polynucleotides of SARS-CoV-2, Influenza, and RSV as taught by Ootsvogels with the specific LNP taught by Ciaramella because doing so would advantageously allow one to increase the effectiveness of the payload delivery and allow for a stronger vaccination against SARS-CoV-2, Influenza, and RSV. One of ordinary skill in the art would have reasonable expectation of success in using a different LNP to protect mRNA from degradation, enhance endosomal escape, and/or promote cell uptake (Guimaraes et al. J Control Release, 2019; Abstract, Introduction ¶2) given that this method is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1.
Claims 190 - 207 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 108 - 125 of copending Application No. 18555130 in view of Ootsvogels.
Claim 108 of ‘130 teaches a combination vaccine comprising of a mRNA encoding an influenza virus HA protein, a second mRNA comprising the RBD and NTD of a SARS-CoV-2 spike protein, with both mRNA containing N1-methylpseudouridine, adenosine, guanosine, and cytidine, and where first and second mRNA polynucleotides is formulated in at least one LNP.
Claim 109 of ‘130 teaches the use of three different influenza virus HA proteins, with claim 110 teaches the further encoding of three different virus NA proteins.
Claim 111 of ‘130 teaches the three different influenza virus HA proteins are from an H1N1 virus, H3N2 virus, and an influenza B/Victories lineage virus.
Claim 112 of ‘130 teaches the first and second mRNA care formulated in separate LNPs while claim 113 teaches the first and second mRNA care formulated in a single LNP.
Claim 114 of ‘130 teaches the LNP composition comprises 20-60 mol% ionizable amino lipid, 5-25 mol% non-cationic lipid, 25-55 mol% sterol, and 0.5-15 mol% PEG-modified lipid.
Claim 115 of ‘130 teaches the LNP composition comprises 40-50 mol% ionizable amino lipid, 20-40 mol% cholesterol, 5-15 mol% neutral lipid, and 0.5-3 mol% PEG-modified lipid.
Claim 116 of ‘130 teaches the ionizable lipid structure (reproduced below) where R1 is selected from the group consisting of C530 alkyl, C520 alkenyl, and -R"M'R'; R2 and R3 are independently selected from the group consisting of C1-i4 alkyl and C2-i4 alkenyl; R4 is -(CH2)nQ, wherein Q is -OR, and n is selected from 1, 2, 3, 4, and 5; each Rs is H; each R6 is H; M and M' are independently selected from -C(O)O- and -OC(O)-; R7 is H; RisH;R' is selected from the group consisting of C1-18 alkyl and C2-18 alkenyl; R" is selected from the group consisting of C3-14 alkyl and C3-14 alkenyl; and m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
PNG
media_image2.png
127
193
media_image2.png
Greyscale
Claim 117 of ‘130 teaches the exact structure of the ionizable amino lipid (reproduced below).
PNG
media_image3.png
123
345
media_image3.png
Greyscale
Claim 118 of ‘130 teaches the method of administering the combination vaccine of claim 108 to the subject.
Claim 119 of ‘130 teaches the method of preventing a respiratory virus infection in a subject by administering the combination vaccine of claim 108 to the subject.
Claim 120 of ‘130 teaches the use of a combination vaccine comprising of a mRNA encoding an influenza virus HA protein, a full-length SARS-CoV-2 spike protein, with both mRNA containing N1-methylpseudouridine, adenosine, guanosine, and cytidine, and where first and second mRNA polynucleotides is formulated in at least one LNP in a composition comprising 40-50 mol% ionizable amino lipid, 20-40 mol% cholesterol, 5-15 mol% neutral lipid, and 0.5-3 mol% PEG-modified lipid as well as an ionizable amino lipid with a structure as discussed in claim 116.
Claim 121 of ‘130 teaches the structure of the ionizable amino acid as that of claim 117.
Claim 122 of ‘130 teaches the use of three different influenza virus HA proteins, while claim 123 teaches the three different influenza virus HA proteins are from an H1N1 virus, H3N2 virus, and an influenza B/Victories lineage virus.
Claim 124 of ‘130 teaches a method of eliciting an immune response in a subject, the method comprising administering the combination vaccine of claim 120 to the subject.
Claim 125 of ‘130 teaches a method for preventing a respiratory virus infection in a subject, with the method comprising administering the combination vaccine of claim 120 to the subject.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the claims of ‘130 and the instant application significantly overlap. These claims in view of Ootsvogels make claims 190 – 207 of the instant application obvious. The general idea of using an mRNA vaccine to prevent or treat an influenza, RSV, and/or SARS-CoV-2 using the same LNP composition and method of administration in the same manner is discussed in both sets of claims. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘087 to include the mRNA encoding for all three SARS-CoV-2, RSV, and influenza antigens because doing such can lower costs while still effectively treating and/or preventing influenza and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
2.
Claims 190, 197 - 201, 203 - 204, and 207 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 - 10, and 12 of U.S. Patent No. US11911453B2 in view of Ootsvogels.
Claim 1 of the conflicting patent teaches a vaccine comprising of a mRNA encoding an RSV F protein and an LNP comprising 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % sterol, and 0.5-15 mol % PEG-modified lipid.
Claim 4 and 5 of conflicting patent teaches the mRNA of claim 1 of conflicting literature comprised of at least 80% 1-methyl-pseudouridine.
Claim 6 of conflicting patent teaches the LNP comprising 40-50 mol % ionizable cationic lipid, 10-20 mol % neutral lipid, 35-45 mol % cholesterol, and 1-5 mol % PEG-modified lipid.
Claim 7 of ‘conflicting patent teaches the ionizable lipid structure (reproduced below) where:
R1 is selected from the group consisting of C5-30 alkyl, C5-20 alkenyl, —R*YR″, —YR″, and —R″M′R′;
R2 and R3 are independently selected from the group consisting of H, C1-14 alkyl, C2-14 alkenyl, —R*YR″, —YR″, and —R*OR″, or R2 and R3, together with the atom to which they are attached, form a heterocycle or carbocycle;
R4 is selected from the group consisting of a C3-6 carbocycle, —(CH2)nQ, —(CH2)nCHQR, —CHQR, —CO(R)2, and unsubstituted C1-6 alkyl, where Q is selected from a carbocycle, heterocycle, —OR, —O(CH2)nN(R)2, —C(O)OR, —OC(O)R, —CX3, —CX2H, —CXH2, —CN, —N(R)2, —C(O)N(R)2, —N(R)C(O)R, —N(R)S(O)2R, —N(R)C(O)N(R)2, —N(R)C(S)N(R)2, —N(R)R8, —O(CH2)nOR, —N(R)C(═NR9)N(R)2, —N(R)C(═CHR9)N(R)2, —OC(O)N(R)2, —N(R)C(O)OR, —N(OR)C(O)R, —N(OR)S(O)2R, —N(OR)C(O)OR, —N(OR)C(O)N(R)2, —N(OR)C(S)N(R)2, —N(OR)C(═NR9)N(R)2, —N(OR)C(═CHR9)N(R)2, —C(═NR9)N(R)2, —C(═NR9)R, —C(O)N(R)OR, and —C(R)N(R)2C(O)OR, and each n is independently selected from 1, 2, 3, 4, and 5;
each R5 is independently selected from the group consisting of C1-3 alkyl, C2-3 alkenyl, and H;
each R6 is independently selected from the group consisting of C1-3 alkyl, C2-3 alkenyl, and H;
M and M′ are independently selected from —C(O)O—, —OC(O)—, —C(O)N(R′)—, —N(R′)C(O)—, —C(O)—, —C(S)—, —C(S)S—, —SC(S)—, —CH(OH)—, —P(O)(OR′)O—, —S(O)2—, —S—S—, an aryl group, and a heteroaryl group;
R7 is selected from the group consisting of C1-3 alkyl, C2-3 alkenyl, and H;
R8 is selected from the group consisting of C3-6 carbocycle and heterocycle;
R9 is selected from the group consisting of H, CN, NO2, C1-6 alkyl, —OR, —S(O)2R, —S(O)2N(R)2, C2-6 alkenyl, C3-6 carbocycle and heterocycle;
each R is independently selected from the group consisting of C1-3 alkyl, C2-3 alkenyl, and H;
each R′ is independently selected from the group consisting of C1-18 alkyl, C2-18 alkenyl, —R*YR″, —YR″, and H;
each R″ is independently selected from the group consisting of C3-14 alkyl and C3-14 alkenyl;
each R* is independently selected from the group consisting of C1-12 alkyl and C2-12 alkenyl;
each Y is independently a C3-6 carbocycle;
each X is independently selected from the group consisting of F, Cl, Br, and I; and
m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
PNG
media_image2.png
127
193
media_image2.png
Greyscale
Claim 10 of conflicting patent teaches the exact structure of the ionizable amino lipid (reproduced below).
PNG
media_image3.png
123
345
media_image3.png
Greyscale
Claims 12 of conflicting patent teaches the method of administering the vaccine of claim 1 induce an immune response to the subject.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting patent and the instant application significantly overlaps. These claims make claims 190, 197 - 201, 203 - 204, and 207 of the instant application obvious. While ‘453 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding an RSV antigen can be included with mRNAs encoding antigens from influenza and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the RSV F protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘453 to include the mRNA encoding for RSV with the influenza and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or reducing the severity of RSV, influenza, and SARS-CoV-2 infection.
.
3.
Claims 190, 197 - 201, 203 - 204, and 207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 20, and 35 of copending Application No. 18314980 in view of Ootsvogels and Ciaramella as discussed above.
Claims 1 of the conflicting application teaches a vaccine comprising of a mRNA encoding a RSV protein and an LNP.
Claim 7of the conflicting application teaches a vaccine of claim 1 where one mRNA encodes for an RSV protein including an RSV F protein.
Claim 20 of the conflicting application teaches a vaccine of claim 1 where the non-cationic lipid is a neutral lipid, and the sterol is a cholesterol.
Claim 35 of the conflicting application teaches the use vaccine of claim 1 to elicit an immune response, the mRNA is comprised of m1ψ, adenosine, cytosine, and guanosine, and the LNP comprises a cationic lipid, a PEG-modified lipid, a sterol and a non-cationic lipid and that the cationic lipid is an ionizable cationic lipid.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
Ciaramella teaches an RSV RNA vaccine that comprises of a mRNA polynucleotide encoding the RSV F protein and an LNP. The structure of the ionizable amino lipid in Ciaramella has the exact structure of the ionizable amino lipid claimed in 199, 200, 203, and 204 of the instant application (Compound 1 of Ciaramella, reproduced below).
PNG
media_image1.png
140
549
media_image1.png
Greyscale
The scope of the conflicting application and the instant application significantly overlaps. These claims make claims 190, 197 - 201, 203 - 204, and 207 of the instant application obvious. While ‘980 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding an RSV antigen can be included with mRNAs encoding antigens from influenza and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the RSV F protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Ciaramella teaches an exact ionizable amino lipid as described in the instant application. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘980 to include the mRNA encoding for RSV with the influenza and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
4.
Claims 190 - 193, 197 - 201, 203, and 205 – 207 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of U.S. Patent No. US12318443B2 in view of Ootsvogels.
Claim 1 of the conflicting patent teaches a mRNA vaccine comprised of a polynucleotide encoding an influenza virus HA antigen and is formulated in a LNP with 100% of uracil nucleosides in the open reading frame are N1-methylpseudouridine. The LNP has a formula of:
R1 is selected from the group consisting of C5-30 alkyl, C5-20 alkenyl, and —R″M′R′;
R2 and R3 are independently selected from the group consisting of C1-14 alkyl and C2-14 alkenyl;
R4 is —(CH2)nQ, where Q is —OR, and each n is independently selected from 1, 2, 3, 4, and 5;
each R5 is H;
each R6 is H;
M and M′ are independently selected from —C(O)O—
and —OC(O)—;
R7 is H;
R is H;
R′ is H;
R″ is selected from the group consisting of C3-14 alkyl and C3-14 alkenyl; and
m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
Claim 2 of the conflicting patent teaches an ionizable lipid (reproduced below).
PNG
media_image4.png
355
1417
media_image4.png
Greyscale
Claim 3 of the conflicting patent teaches a mRNA vaccine of claim 1 where the LNP comprises 20-60 mol % cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % sterol, and 0.5-15 mol % PEG-modified lipid, wherein the LNP comprises 0.5 mol % to 5 mol % PEG-modified lipid.
Claims 4 - 6 of the conflicting patent teaches a mRNA vaccine of claim 1 the HA antigen is an H10 HA antigen, including from the Influenza A H10N8.
Claims 7 – 8 of the conflicting patent teaches the use of the mRNA vaccine of claim 1 to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting patent and the instant application significantly overlaps. These claims make claims 190 - 193, 197 - 201, 203, and 205 – 207 of the instant application obvious. While ‘443 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding at least one influenza virus antigen can be included with mRNAs encoding antigens from RSV and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the influenza antigen in conjunction with the LNP is discussed in both the application and prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘443 to include the mRNA encoding for the HA antigen of influenza A with other HA influenza antigens, RSV antigens, and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
5.
Claims 190, 197 - 200, 201, 203 - 204, and 207 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 10 and 12 -13 of U.S. Patent No. US12453766B2 in view of Ootsvogels.
Claims 1 – 4 of the conflicting patent teaches a mRNA vaccine comprising a polynucleotide encoding a RSV F protein, that is chemically modified to include N1-methylpseudouridine and is formulated in an LNP.
Claim 5 - 10 of the conflicting patent teaches the mRNA vaccine of claim 1 where the LNP comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % sterol, and 0.5-15 mol % polyethylene glycol (PEG)-modified lipid and has a formula of:
R1 is selected from the group consisting of C5-30 alkyl, C5-20 alkenyl, and —R″M′R′;
R2 and R3 are independently selected from the group consisting of C1-14 alkyl and C2-14 alkenyl;
R4 is-(CH2)nQ, wherein Q is —OR, and n is selected from 1, 2, 3, 4, and 5;
each R5 is H;
each R6 is H;
M and M′ are independently selected from —C(O)O— and —OC(O)—;
R7 is H;
R is H;
R′ is selected from the group consisting of C1-18 alkyl and C2-18 alkenyl;
R″ is selected from the group consisting of C3-14 alkyl and C3-14 alkenyl; and
m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
And the ionizable lipid is:
PNG
media_image5.png
131
452
media_image5.png
Greyscale
Claim 12 and 13 of the conflicting patent teaches the use of a mRNA vaccine to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting patent and the instant application significantly overlaps. These claims make claims 190, 197 - 200, 201, 203 - 204, and 207 of the instant application obvious. While ‘766 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding an RSV antigen can be included with mRNAs encoding antigens from influenza and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the RSV F protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘766 to include the mRNA encoding for RSV with the influenza and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
6.
Claims 190, 197 - 200, and 203 - 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 102 - 114 of U.S. Application No. 17796401in view of Ootsvogels.
Claims 1 and 102 - 106 of the conflicting application teaches a mRNA vaccine comprising a polynucleotide encoding at least a portion of RSV F protein,
Claims 107 – 112 of the conflicting application teaches a mRNA vaccine with the LNP comprised of any combination of a mixture of lipids that comprises a PEG-modified lipid, a non-cationic lipid, a sterol, an ionizable cationic lipid. The molar ratio for the LNP can be 0.5-15 mol% PEG-modified lipid; 5-25 mol% non-cationic lipid; 25-55 mol% sterol; and 20-60 mol% ionizable cationic lipid with claim 25 further limiting the molar ratio to 1-5 mol% PEG-modified lipid; 10-20 mol% non-cationic lipid; 35-45 mol% sterol; and 40-50 mol% ionizable cationic lipid, where the sterol to be cholesterol; and the ionizable cationic lipid has the structure of Compound 1 (reproduced below):
PNG
media_image6.png
258
1188
media_image6.png
Greyscale
Claims 113 and 114that is chemically modified to include N1-methylpseudouridine.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting application and the instant application significantly overlaps. These claims make claims 190, 197 - 200, and 203 - 204 of the instant application obvious. While ‘401 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding an RSV antigen can be included with mRNAs encoding antigens from influenza and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the RSV F protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘401 to include the mRNA encoding for RSV with the influenza and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
7.
Claims 190, 197 – 200, and 203 - 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 166, 167, 175, and 176 of U.S. Application No. 17797784 in view of Ootsvogels and Ciaramella as discussed above.
Claim 166 of the conflicting application teaches a mRNA vaccine comprising a polynucleotide encoding the RBD and NTD of SARS-CoV-2 spike protein.
Claim 167 of the conflicting application teachesa mRNA vaccine of claim 166 that is chemically modified to include N1-methylpseudouridine
Claim 175 of the conflicting application teachesa mRNA vaccine where the mRNA is formulated with an LNP that comprises a molar ratio of about 20-60 mol% ionizable cationic lipid, 5-25 mol% neutral lipid, 25-55 mol% sterol, and 0.5- 15 mol% PEG-modified lipid.
Claim 176 of the conflicting application teachesa mRNA vaccine the ionizable catonic lipid to comprises:
R1 is selected from the group consisting of C5-30 alkyl, C5-20 alkenyl, and —R″M′R′;
R2 and R3 are independently selected from the group consisting of C1-14 alkyl and C2-14 alkenyl;
R4 is-(CH2)nQ, wherein Q is —OR, and n is selected from 1, 2, 3, 4, and 5;
each R5 is H;
each R6 is H;
M and M′ are independently selected from —C(O)O— and —OC(O)—;
R7 is H;
R is H;
R′ is selected from the group consisting of C1-18 alkyl and C2-18 alkenyl;
R″ is selected from the group consisting of C3-14 alkyl and C3-14 alkenyl; and
m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
Ciaramella teaches an RSV RNA vaccine that comprises of a mRNA polynucleotide encoding the RSV F protein and an LNP. The structure of the ionizable amino lipid in Ciaramella has the exact structure of the ionizable amino lipid claimed in 199, 200, 203, and 204 of the instant application (Compound 1 of Ciaramella, reproduced below).
PNG
media_image1.png
140
549
media_image1.png
Greyscale
The scope of the conflicting application and the instant application significantly overlap. These claims make claims 190, 197 – 200, and 203 - 204 of the instant application obvious. While ‘784 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding a SARS-CoV-2 antigen, including a full length or S1 subunit of the spike protein, can be included with mRNAs encoding antigens from influenza and RSV which are formulated with an LNP. Furthermore, the use a mRNA encoding at least a portion of the SARS-CoV-2 spike protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Ciaramella teaches the exact ionizable amino lipid of the instant application. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘784 to include an mRNA encoding for a full length or a portion of the SARS-CoV-2 spike protein with the influenza and RSV antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
8.
Claims 190 - 193, 197 - 200, 203, and 205 – 206 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5, and 10 of U.S. Patent No. US12329811B2 in view of Ootsvogels.
Claim 1 of the conflicting patent teachesa mRNA vaccine comprising of mRNA encoding three HA proteins from two influenza A virus and one Influenza B virus, three NA proteins from three different influenza viruses (corresponding to the origin virus of the HA proteins) with the polynucleosides comprised of N1-methylpseudouridine, adenosine, guanosine, and cytidine. The mRNA are formulated with an LNP comprised of an ionizable amino lipid, a sterol, a neutral lipid, and a polyethylene glycol (PEG)-modified lipid. The ionizable amino lipid has the formula:
R1 is selected from the group consisting of C5-30 alkyl, C5-20 alkenyl, and —R″M′R′;
R2 and R3 are independently selected from the group consisting of C1-14 alkyl and C2-14 alkenyl;
R4 is —(CH2)nQ, wherein Q is —OR, and n is selected from 1, 2, 3, 4, and 5;
each R5 is H;
each R6 is H;
M and M′ are independently selected from —C(O)O— and —OC(O)—;
R7 is H;
R is H;
R′ is selected from the group consisting of C1-18 alkyl and C2-18 alkenyl;
R″ is selected from the group consisting of C3-14 alkyl and C3-14 alkenyl;
m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.
Claims 2 – 4 of the conflicting application teaches the HA and NA proteins being of H1N1, H3N2, and influenza B origin.
Claim 5 of the conflicting application teaches the LNP of the mRNA composition comprising of 40-55 mol % ionizable amino lipid, 30-45 mol % sterol, 5-15 mol % neutral lipid, and 1-5 mol % PEG-modified lipid.
Claim 10 of the conflicting application teaches the ionizable amino lipid of the mRNA composition as:
PNG
media_image7.png
355
1402
media_image7.png
Greyscale
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting patent and the instant application significantly overlap. These claims make claims 190 - 193, 197 - 200, 203, and 205 – 206 of the instant application obvious. While ‘811 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding at least one influenza virus antigen can be included with mRNAs encoding antigens from RSV and coronaviruses which are formulated with an LNP. Furthermore, the use of a mRNA encoding the influenza antigen in conjunction with the LNP is discussed in both the application and prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘811 to include the mRNA encoding for the HA antigen of influenza A with other HA influenza antigens, RSV antigens, and SARS-CoV-2 antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
9.
Claims 190, 197 – 201, 203 – 204, and 207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8, 11 -12, 15, 24, and 25 -29 of U.S. Application No. 18569776 in view of Ootsvogels.
Claims 1 – 8, 11 - 12, and 15 of the conflicting application teaches the mRNA of a full length coronavirus spike protein. These claims contain different variations of the spike protein but nonetheless encode for the spike protein.
Claim24 of the conflicting application teaches the mRNA comprising of a chemical modification that may be 1-methylpseudouridine.
Claims 25 - 28 of the conflicting application teaches the mRNA formulated with a LNP that comprises of a combination of a PEG-modified lipid, a non-cationic lipid, a sterol, an ionizable amino lipid. The molar ratio of the LNP can be 0.5-15 mol % PEG-modified lipid; 5-25 mol % non-cationic lipid; 25-55 mol % sterol; and 20-60 mol % ionizable amino lipid, with claim 27 further specifying, the PEG-modified lipid is 1,2 dimyristoyl-sn-glycerol, methoxypolyethyleneglycol (PEG2000 DMG), the non-cationic lipid is 1,2 distearoyl-sn-glycero-3-phosphocholine (DSPC), the sterol is cholesterol, and the ionizable amino lipid has the structure of Compound 1:
PNG
media_image8.png
308
896
media_image8.png
Greyscale
Claim 29 of the conflicting application teaches the use of mRNA vaccine to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting application and the instant application significantly overlaps. These claims make claims 190, 197 – 201, 203 – 204, and 207 of the instant application obvious. While ‘776 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding a SARS-CoV-2 antigen, including a full length or S1 subunit of the spike protein, can be included with mRNAs encoding antigens from influenza and RSV which are formulated with an LNP. Furthermore, the use a mRNA encoding at least a portion of the SARS-CoV-2 spike protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘776 to include an mRNA encoding for a full length or a portion of the SARS-CoV-2 spike protein with the influenza and RSV antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
10.
Claims 190, 197 – 201, 203 – 204, and 207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 4 -7, 13, 19, 25, 31, and 33 - 38 of U.S. Application No. 18028126in view of Ootsvogels
Claims 1 – 3, 4 -7, 13, 19, 25, and 31 of the conflicting application teaches the mRNA of a full-length coronavirus spike protein formulated with an LNP. These claims contain different variations of the spike protein but nonetheless encode for the spike protein.
Claims 33 and 34 of the conflicting application teaches the mRNA comprising of a chemical modification that may be 1-methylpseudouridine.
Claims 35 - 37 of the conflicting application teaches the mRNA formulated with a LNP that comprises of a combination of a PEG-modified lipid, a non-cationic lipid, a sterol, an ionizable amino lipid. The molar ratio of the LNP can be 0.5-15 mol % PEG-modified lipid; 5-25 mol % non-cationic lipid; 25-55 mol % sterol; and 20-60 mol % ionizable amino lipid, with claim 27 further specifying, the PEG-modified lipid is 1,2 dimyristoyl-sn-glycerol, methoxypolyethyleneglycol (PEG2000 DMG), the non-cationic lipid is 1,2 distearoyl-sn-glycero-3-phosphocholine (DSPC), the sterol is cholesterol, and the ionizable amino lipid has the structure of Compound 1:
PNG
media_image8.png
308
896
media_image8.png
Greyscale
Claim 38 of the conflicting application teaches the use of mRNA vaccine to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting application and the instant application significantly overlap. These claims make claims 190, 197 – 201, 203 – 204, and 207 of the instant application obvious. While ‘126 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding a SARS-CoV-2 antigen, including a full length or S1 subunit of the spike protein, can be included with mRNAs encoding antigens from influenza and RSV which are formulated with an LNP. Furthermore, the use a mRNA encoding at least a portion of the SARS-CoV-2 spike protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘126 to include an mRNA encoding for a full length or a portion of the SARS-CoV-2 spike protein with the influenza and RSV antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
11.
Claims 190, 197 – 200, and 203 - 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10 – 11, 60 – 62, and 64 -73 of U.S. Application No. 18272512 in view of Ootsvogels.
Claim 1, 4, 10 – 11, and 60 - 62 of the conflicting application teaches the mRNA comprised of the RBD and NTD domains of SARS-CoV-2 spike protein.
Claims 64 – 67 of the conflicting application teaches the mRNA comprising of a chemical modification that may be 1-methylpseudouridine
Claim 68 - 72 of the conflicting application teaches the mRNA formulated with a LNP that comprises of a combination of a PEG-modified lipid, a non-cationic lipid, a sterol, an ionizable amino lipid. The molar ratio of the LNP can be 40-55 mol % ionizable amino lipid, 30-45 mol % sterol, 5-15 mol % neutral lipid, and 1-5 mol % PEG-modified lipid, with claim 22 further limiting the molar ratio to 40-50 mol % ionizable amino lipid, 35-45 mol % sterol, 10-15 mol % neutral lipid, and 2-4 mol % PEG-modified lipid. Claim 24 and 25 further limit the sterol is cholesterol and the ionizable amino lipid has the structure of Compound 1:
PNG
media_image8.png
308
896
media_image8.png
Greyscale
Claim 73 of the conflicting application teaches the use of mRNA vaccine to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting application and the instant application significantly overlap. These claims make claims 190, 197 – 200, and 203 - 204 of the instant application obvious. While ‘512 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding a SARS-CoV-2 antigen, including a full length or S1 subunit of the spike protein, can be included with mRNAs encoding antigens from influenza and RSV which are formulated with an LNP. Furthermore, the use a mRNA encoding at least a portion of the SARS-CoV-2 spike protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘512 to include an mRNA encoding for a full length or a portion of the SARS-CoV-2 spike protein with the influenza and RSV antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
12.
Claims 190, 197 – 200, and 203 - 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55 – 70, and 73 of U.S. Application No. 18272496in view of Ootsvogels and Ciaramella as discussed above.
Claims 55 – 56 and 61 -64 of the conflicting application teaches the mRNA of a at least one full length coronavirus spike protein.
Claims 57 - 60 of the conflicting application teaches the mRNA comprising of a chemical modification that may be 1-methylpseudouridine.
Claims 65 - 70 of the conflicting application teaches the mRNA formulated with a LNP that comprises of a combination of a PEG-modified lipid, a non-cationic lipid, a sterol, an ionizable amino lipid. The molar ratio of the LNP can be 40-55 mol % ionizable amino lipid, 30-45 mol % sterol, 5-15 mol % neutral lipid, and 1-5 mol % PEG-modified lipid,. Claim 69 and 70 further limit the sterol is cholesterol and the ionizable amino lipid has the structure of Compound 1:
PNG
media_image8.png
308
896
media_image8.png
Greyscale
Claim 73 of the conflicting application teaches the use of mRNA vaccine to elicit an immune response.
As discussed above, Ootsvogels teaches nucleic acid-based combination vaccines for Coronaviridae, Orthomyxoviridae, and Pneumoviridae that can be delivered in a lipid nanoparticle (LNP) to treat or prevent a coronavirus infection along with other viral infections (Abstract). This combination vaccine encodes the mRNA of at least a portion the SARS-CoV2 spike protein, including the S1 protein (Abstract, Claim 1, ¶0101, ¶0102) and at least one further component of an antigenic peptide or protein from at least one further virus such as influenza and/or RSV fusion protein (Abstract, Claim 1, ¶0003, ¶0014, ¶0071, ¶806 - ¶808) in at least one LNP (Claim 1) with a preference for all of the uracil nucleotides of the mRNA replaced by m1ψ nucleotide (¶0411), resulting in ORFs comprising of m1ψ, adenosine, guanosine, and cytidine. Ootsvogels further teaches the combination vaccine comprising of mRNA polynucleotides encoding at least three different influenza virus hemagglutinin (HA) protein as well as also encoding at least three different influenza virus neuraminidase (NA) protein (Claim 1 – 6, ¶0754). These influenza proteins can be from an H1N1 virus, H3N2 virus, and an influenza B/Victoria lineage virus (¶0748, Table 10). Furthermore, Ootsvogels teaches specific HA and NA proteins from well characterized and known H1N1, H3N2, and influenza B/Victoria lineage viruses (Table 8).
The first, second, and third mRNA taught by Ootsvogels can be formulated in a single LNP or where at least two mRNA are formulated in separate LNPs (Claim 18 and 19) with the LNP comprising 40-50% cationic lipid (Claim 1, ¶1283 and ¶1284), 5-15% neutral lipid (which can be a non-cationic lipid (¶1309)), 20-40% cholesterol (¶1307), and 3% PEG-lipid (¶1299).
Ootsvogels teaches administering the combination vaccine to elicit an immune response (Claim 21) and a method for administering the combination vaccine to prevent a respiratory virus infection (Abstract, ¶1526).
The scope of the conflicting application and the instant application significantly overlap. These claims make claims 190, 197 – 200, and 203 - 204 of the instant application obvious. While ‘496 does not teach a combination vaccine, the idea of administering vaccines at the same time is well known in the art. Ootsvogels established that a mRNA encoding a SARS-CoV-2 antigen, including a full length or S1 subunit of the spike protein, can be included with mRNAs encoding antigens from influenza and RSV which are formulated with an LNP. Furthermore, the use a mRNA encoding at least a portion of the SARS-CoV-2 spike protein in conjunction with the LNP and ionizable amino lipid is discussed in both the application and in prior art. Therefore, it would have been prima facie obvious before effective filing date of the claimed invention to have modified the claims of ‘496 to include an mRNA encoding for a full length or a portion of the SARS-CoV-2 spike protein with the influenza and RSV antigens because doing such can lower costs while still effectively treating and/or preventing influenza, RSV, and SARS-CoV-2 infection.
This is a provisional nonstatutory double patenting rejection.
Conclusion
NO CLAIMS ARE ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672