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
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional applications 63/373,597 (filed on 08/26/2022) and 63/514,711 (filed on 07/20/2023).
Claim Status
Claims 1-4, 8, 11-14, 17, 19-22, 26, and 29-32 are pending, all of which have been considered on the merits.
Specification
The Specification is objected to because the title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short to sufficiently assist readers in deciding whether there is a need for consulting the full patent text for details. Correction is required. See MPEP § 608/01 (b).
The Specification is objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R. § 1.84 (u)(1) (see also MPEP §608.02 (V)).
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-4, 8, 11-14, and 17 are objected to because of the following informalities:
The preamble of the claims should read “The method” rather than “A method” as the claims are dependent.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 8, 11-14, 17, 19-22, 26, and 29-32 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.
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.”
Instant claims 1, 8, 14, 19, 26, and 32 are drawn to an immunogenic composition comprising mRNAs that encode a single Spike protein, which has written description support. However, the instant claims also broadly encompass an immunogenic composition comprising mRNAs that encode immunogenic fragments or immunogenic variants of the spike protein.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the proteins encoded by the mRNAs to elicit an immune response to the spike protein.
Immunogenic fragments or immunogenic variants encompass a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the spike protein that are immunogenic fragments or variants to be able to elicit an immune response.
While the instant claims are drawn to a large genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice immunogenic compositions with the full-length spike protein. However, this is not representative of the extremely large genus of proteins since only the full-length protein is supported and not the innumerable sequences contained within a genus of all immunogenic fragments and variants of the spike protein.
The data generated for the immunogenic composition comprising mRNA that encode the full-length spike protein cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins, because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Chen, et al. (Curr Trop Med Rep. 2020 Mar 3; 7(2):61-64, hereinafter “Chen”) provides a review of the state of the art in SARS-CoV-2 vaccines. SARS-CoV-2 vaccines that use the spike glycoprotein do not use only portions of these proteins, rather the intact proteins are used (pg. 62 column 2). While Applicant may have possession of mRNAs that encode portions of these proteins, as the portions have not been shown to elicit an immune response, these fragments would not be considered immunogenic compositions.
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.
Claims 1-4, 8, 11-14, 17, 19-22, 26, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch, et al. (WO 2021156267 A1, FOR-IDS, filed, 07/12/2024, hereinafter “Rauch”) and further in view of Chatterjee, et al. (Viruses. 2023 Jan 5;15(1):167., hereinafter “Chatterjee”) and Tan, et al. (N Engl J Med. 2021 Oct 7;385(15):1401-1406., hereinafter “Tan”).
Regarding claim 1, Rauch teaches a method of inducing an immune response in a subject (Item 193 and Item 1) that has been previously vaccinated with a SARS-CoV-2 vaccine [variant 1] (Item 195) by administering a second SARS-CoV-2 vaccine [variant 2] (Item 193, Item 1, and Item 213) that comprises mRNA encoding spike protein from a sarbecoronavirus isolate that is different from variant 1 (Item 6 and pg. 18 lines 17-27) and that the S protein is encoded as a S protein-multimerization subunit fusion (Item 24, pg. 31 line 24, and pg. 32 line 5).
Rauch further teaches that the 2nd vaccine [variant 2] can adapted to comprise mRNA that encodes a spike protein from any SARS-CoV-2 isolate (pg. 18 lines 17-27). Rauch does not teach that the 2nd vaccine is a “mutationally diverse” variant of the 1st vaccine. However, Chatterjee teaches the Omicron variant of SARS-CoV-2 (Abstract).
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the SARS-CoV-2 Wuhan isolate S protein taught by Rauch for the omicron variant S protein taught by Chatterjee. Rauch teaches that the vaccine can be made with any isolate of SARS-CoV-2 and Chatterjee provides motivation by teaching that the Omicron variant has a high immune escape capacity and would be a good candidate for SARS-CoV-2 vaccines (pg. 20, ¶1). One of skill in the art would have had a reasonable expectation of success in substituting the Wuhan isolate taught by Rauch for the Omicron variant taught by Chatterjee because they would teach coronaviruses and coronavirus vaccines.
Rauch and Chatterjee do not teach that the method induces a pan-variant immune response. However, Tan teaches that a SARS-CoV-2 vaccine (BNT162b2) induces pan-sarbecoronavirus neutralizing antibodies (Summary).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Rauch and Chatterjee for a method of inducing an immune response with two separate “mutationally diverse” SARS-CoV-2 vaccines and the teachings of Tan for the production of pan-sarbecoronavirus neutralizing antibodies after SARS-CoV-2 vaccination. Tan provides motivation by teaching that pan-sarbecoronavirus neutralizing antibodies can help prevent the next emerging coronavirus outbreak as the antibodies are neutralizing against zoonotic coronaviruses as well (Summary). One of skill in the art would have had a reasonable expectation of success in combining the teachings of Rauch, Chatterjee, and Tan because they all teach coronaviruses and coronavirus vaccines.
Regarding claim 2, Rauch teaches that the S protein-multimerization subunit fusion is a protein-ferritin subunit fusion (Item 24, pg. 32 line 5, and pg. 37 S_woTM+ferritin).
Regarding claim 3, Rauch teaches that the second mRNA vaccine is a lipid nanoparticle (Item 254).
Regarding claim 4, Rauch teaches that the second vaccine can be any SARS-CoV-2 isolate (pg. 18 lines 17-27) and Chatterjee teaches the Omicron variant is a SARS-CoV-2 variant (Abstract).
Regarding claim 8, Rauch teaches that the S protein comprises the K986P and V987P stabilizing mutations (Item 13 and pg. 37 S_stab-PP-wotTM+ferritin).
Regarding claim 11, Rauch teaches that the first vaccine is an adenovirus vector vaccine (Item 200).
Regarding claim 12, Tan teaches that SARS-CoV-2 vaccines induce a pan-sarbecoronavirus response which includes a response against a sarbecoronavirus which is not variant 1 or 2 (Summary).
Regarding claim 13, Rauch teaches that the 2nd vaccine is a monovalent vaccine (pg. 115 line 3).
Regarding claim 14, Rauch teaches that the 2nd vaccine is a multivalent vaccine (Item 76), the S protein that is encoded is as a S protein-multimerization (Item 24, pg. 32 line 5, and pg. 37 S_woTM+ferritin) and that any SARS-CoV-2 isolate can be used in the 2nd vaccine (pg. 18 lines 17-27) and Tan teaches that there are many “mutationally diverse” variants of SARS-CoV-2, e.g. Gamma and Delta (Introduction ¶1).
Regarding claim 17, the instant claim recites at least 4 months between administration of the 1st SARS-CoV-2 vaccine and the 2nd. Rauch teaches that the first vaccine was administered at least 3 months before the 2nd vaccine (Item 205) which would reasonably overlap with and be encompass the claimed “at least 4 months” recited by claim 17. In the case where the claimed ranges “overlap or lie inside range disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 357, 191 USPQ 90 (CCPA 1976).
Regarding claim 19, Rauch teaches an immunogenic composition comprising mRNA encoding a spike protein from a sarbecoronavirus (Item 1) which is administered to a subject who has received at least one dose of a previous SARS-CoV-2 vaccine (Item 193), wherein the S protein is encoded as a S protein-multimerization subunit fusion (Item 24, pg. 31 line 24, and pg. 32 line 5). Rauch does not teach a pan-sarbecoronavirus response induced by the vaccines. However, However, Tan teaches that a SARS-CoV-2 vaccine (BNT162b2) induces pan-sarbecoronavirus neutralizing antibodies (Summary).
Regarding claim 20, Rauch teaches that the S protein-multimerization subunit fusion is a protein-ferritin subunit fusion (Item 24, pg. 32 line 5, and pg. 37 S_woTM+ferritin).
Regarding claim 21, Rauch teaches that the second mRNA vaccine is a lipid nanoparticle (Item 254).
Regarding claim 22, Rauch teaches that the second vaccine can be any SARS-CoV-2 isolate (pg. 18 lines 17-27) and Chatterjee teaches the Omicron variant is a SARS-CoV-2 variant (Abstract).
Regarding claim 26, Rauch teaches that the S protein comprises the K986P and V987P stabilizing mutations (Item 13 and pg. 37 S_stab-PP-wotTM+ferritin).
Regarding claim 29, Rauch teaches that the first vaccine is an adenovirus vector vaccine (Item 200).
Regarding claim 30, Tan teaches that SARS-CoV-2 vaccines induce a pan-sarbecoronavirus response which includes a response against a sarbecoronavirus which is not variant 1 or 2 (Summary).
Regarding claim 31, Rauch teaches that the 2nd vaccine is a monovalent vaccine (pg. 115 line 3).
Regarding claim 14, Rauch teaches that the 2nd vaccine is a multivalent vaccine (Item 76), the S protein that is encoded is as a S protein-multimerization (Item 24, pg. 32 line 5, and pg. 37 S_woTM+ferritin) and that any SARS-CoV-2 isolate can be used in the 2nd vaccine (pg. 18 lines 17-27) and Tan teaches that there are many “mutationally diverse” variants of SARS-CoV-2, e.g. Gamma and Delta (Introduction ¶1).
Accordingly, the claimed inventions were 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.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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