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 .
Preliminary Amendment
The preliminary amendment dated 05/01/2026 has been entered. Claims 86-110 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/24/2023 is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is April 26, 2021 based on the filing date of PCT/IB2021/000314.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 05/01/2026 is acknowledged.
Claims 96-99, 102, 104-106 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s species election is acknowledged. Applicant elected the Cv2.3194 antibody the sequences of which are as follows:
VH and VL CDRs
Cv2.3194 heavy chain CDR1 = SEQ ID NO: 35
Cv2.3194 heavy chain CDR2 = SEQ ID NO: 36
Cv2.3194 heavy chain CDR3 = SEQ ID NO: 37
Cv2.3194 light chain CDR1 = SEQ ID NO: 38
Cv2.3194 light chain CDR2 = SEQ ID NO: 39
Cv2.3194 light chain CDR3 = SEQ ID NO: 40
VH and VL
Cv2.3194 VH = SEQ ID NO: 7
Cv2.3194 VL = SEQ ID NO: 8
Heavy and light chains
Cv2.3194 Heavy chain = SEQ ID NO: 17
Cv2.3194 Light chain = SEQ ID NO: 18
Cv2.3194 "prime" Heavy chain = SEQ ID NO: 135
Cv2.3194 "prime" Light chain = SEQ ID NO: 18
Heavy chain & Light chain Framework Regions (FR)
Cv2.3194 Heavy chain FR1 = SEQ ID NO: 69
Cv2.3194 Heavy chain FR2 = SEQ ID NO: 70
Cv2.3194 Heavy chain FR3 = SEQ ID NO: 71
Cv2.3194 Heavy chain FR4 = SEQ ID NO: 72
Cv2.3194 Light chain FR1 = SEQ ID NO: 73
Cv2.3194 Light chain FR2 = SEQ ID NO: 74
Cv2.3194 Light chain FR3 = SEQ ID NO: 75
Cv2.3194 Light chain FR4 = SEQ ID NO: 76.
Claims 86, 87, 89-95, 100, 101, 103, and 106-110 read on the elected species.
Claims 88 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species.
Claims 86-87, 89-95, 100, 101, 103, and 106-110 are under examination.
With regard to claims 101, 103 and 106, while these claims recite antigen binding fragment thereof, nucleic acid or vector encoding the antibody or the antigen binding fragment thereof, these claims will be examined as they require the elected antibody of Cv2.3194 and the amino acid sequences therefrom.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference of the material consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 7A) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 89 and 90 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections – Improper Markush Grouping
Claims 86-87, 91-95, 100-101,103 and 106 are rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 86-87, 91-95, 100-101,103 and 106 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use that flows from the substantial structural feature for the following reasons::
The antibodies have distinct amino acid sequences and thus will bind different epitopes.
The following sequences constitute the CDR regions of claim 86 which share no significant structural similarity:
CV2.1169
CDR1
CDR2
CDR3
Heavy
TSAVQ
WIVVGSGNTNYAQKFQ
PYCSGGTCLDGFDI
Light
RASQSVSRSYLA
SASSRAT
QQYGSSPWT
CV2.3194
CDR1
CDR2
CDR3
Heavy
SNYMS
VIYPGGSTFYADSVKG
DLVVYGMDV
Light
RASQSVSSSYLA
GASSRAT
QQGVT
The antibodies of claim 86 have distinct CDR set amino acid sequences thus will bind different epitopes. The claims recite discrete antibody binding domains and do not all share significant structural similarity since it is the entire CDR set that is required to bind the antigen. This is evidenced by the fact that even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff (Proc Natl Acad Sci USA 1982 Vol 79 page 1979). Rudikoff teaches that the alteration of a single amino acid in a single CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (entire article, Abstract).
The sequence differences in the CDRs overall would amount to structural differences in the antibody binding region as a whole, and therefore there would be no structural similarity between the antibodies leading to be functionally equivalent and to their common use.
While the claims recite “a monoclonal antibody directed against the viral Spike RBD of SARS- CoV-2” this is not an art-recognized class of molecules as defined in MPEP 2117 as: that it was known within the art that each member could be substituted one for the other, with the expectation that the same intended result (be functionally equivalent) would be achieved. This is not the case as they are likely to bind different epitopes in the antigen with different biding properties. Therefore, in the instant case, the structurally different antibodies are not art-recognized substitutions for each other.
Claim 87 is included in this rejection as it is drawn to a human neutralizing monoclonal antibody against SARS-CoV-2, which specifically binds to the RBD and is a competitive inhibitor of binding to the RBD of at least one of the following antibodies Cv2.1169; and Cv2.3194; said human neutralizing antibody, comprising: a) a heavy chain variable domain comprising: a HCDR1 of SEQ ID NO: 23, a HCDR2 of SEQ ID NO: 24, and a HCDR3 of SEQ ID NO: 25, and a light chain variable domain comprising: a LCDR1 of SEQ ID NO: 26, a LCDR2 of SEQ ID NO: 27 and a LCDR3 of SEQ ID NO: 2, or b) a heavy chain variable domain comprising: a HCDR1 of SEQ ID NO: 35, a HCDR2 of SEQ ID NO: 36 and a HCDR3 of SEQ ID NO: 37, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs; and a light chain variable domain comprising: a LCDR1 of SEQ ID NO: 38, a LCDR2 of SEQ ID NO: 39, and a LCDR3 of SEQ ID NO: 40, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs. Since the antibodies of claim 86 are recited in this claim and as explained above these antibodies bind different epitopes, the neutralizing antibodies cannot neutralize both Cv2.1169; and Cv2.3194 at the same time, providing further rationale for Cv2.1169; and Cv2.3194 being an improper Markush grouping.
Dependent claims 86-87, 91-95, 100-101,103 and 106 are rejected for failing to resolve the improper Markush grouping.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
2. Claim 87 recites the limitation " A human neutralizing monoclonal antibody against Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) " in line 1-2. However, the limitation is recited as “said human neutralizing antibody” in line 12 There is insufficient antecedent basis for this limitation in the claim as the term “monoclonal” is missing.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
3. Claims 107 and 109 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 107 and 109 depend on claim 86. Claim 86 is drawn to “variants comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs for the heavy and the light chain variable domains” for the elected species.. Claim 107 recites the limitation: “comprises a heavy chain variable region comprising an amino acid sequence having at least 90 % identity with SEQ ID NO: 7, and a light chain variable region comprising an amino acid sequence having at least 90 % identity with SEQ ID NO: 8’. Claim 109 recites the limitation: “which comprises a heavy chain amino acid sequence having at least 90 % identity with SEQ ID NO: 17 or 135 and a light chain amino acid sequence having at least 90 % identity with SEQ ID NO: 18”.
Claim 86 allows for up to 2 mutations for each CDR (that is, 6 mutations) for each heavy variable (VH) and for each light variable (VL) chains. However, SEQ ID NO: 7 is 117 amino acid (aa) long. A sequence that is 90% identical to SEQ ID NO: 7 would have about 12 aa changed. A sequence that is 90% identical to SEQ ID NO: 8 (104 aa) would have about 10 aa changed. A sequence that is 90% identical to SEQ ID NO: 17 (446 aa) would have about 44 aa changed. A sequence that is 90% identical to SEQ ID NO: 18 (211 aa) would have about 21 aa changed. Therefore, claims 107 and 109 are broader in scope as they allow for more mutations in the elected species antibody VH and VL than claim 86 allows. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
4. Claims 86-87, 91-95, 100-101,103, 106-110 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the elected Cv2.3194 antibody being a neutralizing antibody against some variants of SARS-CoV-2, does not reasonably provide enablement for which of the amino acids in the claimed CDR sequences can be substituted, still be at least 90% identical sequence to SEQ ID NO:s 7 and 8 (including the CDRs), still be able to function as neutralizing antibodies. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Claim 86 is drawn to a monoclonal antibody directed against the viral Spike protein RBD of SARS- CoV-2 comprising:
a heavy chain variable domain comprising all three of: a heavy chain CDR1 of SEQ ID NO: 23, a heavy chain CDR2 of SEQ ID NO: 24 and a heavy chain CDR3 of SEQ ID NO: 25, or variants thereof comprising up to 1 amino acid mutation in the sequence of 1, 2 or 3 CDRs; and a light chain variable domain comprising all three of: a light chain CDR1 of SEQ ID NO: 26, a light chain CDR2 of SEQ ID NO: 27 and a light chain CDR3 of SEQ ID NO: 28, or variants thereof comprising up to 1 amino acid mutation in the sequence of 1, 2 or 3 CDRs; or
a heavy chain variable domain comprising all three of: a heavy chain CDR1 of SEQ ID NO: 35, a heavy chain CDR2 of SEQ ID NO: 36 and a heavy chain CDR3 of SEQ ID NO: 37, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs; and a light chain variable domain comprising all three of: a light chain CDR1 of SEQ ID NO: 38, a light chain CDR2 of SEQ ID NO: 39 and a light chain CDR3 of SEQ ID NO: 40, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs.
Claim 87 is included in this rejection as it is drawn to a human neutralizing monoclonal antibody against SARS-CoV-2, which specifically binds to the RBD and is a competitive inhibitor of binding to the RBD of at least one of the following antibodies Cv2.1169; and Cv2.3194; said human neutralizing antibody, comprising: a) a heavy chain variable domain comprising: a HCDR1 of SEQ ID NO: 23, a HCDR2 of SEQ ID NO: 24, and a HCDR3 of SEQ ID NO: 25, and a light chain variable domain comprising: a LCDR1 of SEQ ID NO: 26, a LCDR2 of SEQ ID NO: 27 and a LCDR3 of SEQ ID NO: 2, or b) a heavy chain variable domain comprising: a HCDR1 of SEQ ID NO: 35, a HCDR2 of SEQ ID NO: 36 and a HCDR3 of SEQ ID NO: 37, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDRs.; and a light chain variable domain comprising: a LCDR1 of SEQ ID NO: 38, a LCDR2 of SEQ ID NO: 39, and a LCDR3 of SEQ ID NO: 40, or variants thereof comprising up to 2 amino acid mutations in the sequence of 1, 2 or 3 CDR.
Claims 91-95, 100-101, 103, 106-110 are dependent on claim 86 and are included for failing to resolve this rejection. Claims 107-110 recite different percentages of identity for different areas of the antibodies, including the CDRs.
The specification discloses the characterization of the elected Cv2.3194 antibody. Fig. 3B and 4D show that this antibody competitively inhibit the binding of other antibodies to SARS-CoV-2 tri-S and S-RBD proteins but does not inhibit the binding to areas outside the RBD. Affinity and neutralization activity is summarized in Tables 5 and 6. Cv2.3194 also shows polyreactivity, (potential of the SARS-CoV-2 neutralizers to bind with low-affinity unrelated ligands), (Fig, 5 and table 5) and was able to block the interaction of the ACE2 ectodomain with RBD proteins from the viral variants tested (Fig. 3G). The specification does not disclose which amino acids within the 6 CDRs sequences, the heavy and light chain variable domains or the heavy and light chains can be substituted and still retain the binding efficacy to the RBD and neutralizing capability against SARS-CoV-2.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The claims are directed to a broad class of neutralizing antibodies (claims 86 and 87), only defined by its function “binding RBD and neutralizing capability against SARS-CoV-2”, with a partial structure at best (claim 86) or none (claim 87). However, the specification did not give the skilled in the art enough information to choose candidate antigen binding structures from the vast number of options of millions of candidates, and therefore required scientists to engage in a great deal of experimentation and failure. “That is not enablement”—it is a “hunting license.”
In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR. This decision reaffirmed the prior decision made by the Federal District Court in Amgen Inc. v. Sanofi, Aventisub LLC., 987 F.3d 1080 (Fed. Cir. 2021).
The Court clarified that the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class." Id. at 610-11. However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable." Id.
The specification may require a reasonable amount of experimentation to make and use the invention and what is reasonable will depend on the nature of the invention and the underlying art. For example, "it may suffice to give an example (or a few examples) if the specification also discloses some general quality … running through the class that gives it a peculiar fitness for the particular purpose" and "disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset." Id. at 611 (internal quotations omitted). However, the Supreme Court found that Amgen failed to enable all that it claimed, even if allowing for a reasonable degree of experimentation. Id. at 613; see also Baxalta Inc. v Genentech, Inc., 81 F.4th 1362, 1367, 2023 USPQ2d 1103 (Fed. Cir. 2023) ("[t]he facts of this case are more analogous to—and are, in fact, indistinguishable from—those in Amgen. We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors."). Moreover, "[w]e see no meaningful difference between Wands' ‘undue experimentation’ and Amgen's ‘[un]reasonable experimentation’ standards. Id. at footnote 4. See also Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024), which explains that regardless of the technology the Wands factors should be used when assessing enablement.
However, while the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class which included "a ‘vast’ number of additional antibodies" that Amgen had not described by their amino acid sequences. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613.
In Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit explicitly applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement, for purposes of 35 U.S.C. 112(a), to make and use the full scope of the claimed invention. The court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. See also the following cases across various technology areas: McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019).
Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification. The two processes, the “roadmap” and “conservative substitution” did not save Amgen. According to the Court, these amounted to “little more than two research assignments” which forced scientists to conduct “painstaking experimentation” to see what worked. (citing Incandescent Lamp). The Court therefore held that Amgen’s specification did not enable the claims.
This case is akin to the issue in Amgen Inc. v. Sanofi, Aventisub LLC, in which the court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Sanofi-Aventisub at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. While the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class that included “a ‘vast' number of additional antibodies” that Amgen had not described by their amino acid sequences. Id. at 1256. The Supreme Court found that Amgen sought to monopolize an entire class of antibodies by their function, which was much broader than the 26 exemplary antibodies disclosed by their amino acid structure.
In the instant case, the specification discloses the elected Cv2.3194 antibody, which is able to bind the RBD and neutralizing SARS-CoV-2
The instant claims are directed to a class of neutralizing antibodies, or antigen binding thereof, that include “a ‘vast’ number of additional antigen binding structures, in which the instant specification fails to describe the amino acid sequences of. It would be necessary to first generate and then screen each candidate antibody and fragments thereof, with the recited function) to determine whether it met the functional limitations of “binding RBD and neutralizing capability against SARS-CoV-2”. The Federal Circuit concluded that there was a lack of enablement, which was affirmed by the Supreme Court in Amgen.
The instant specification does not disclose any common structural feature delineating which antigen binding structures (claims 86 and 87), will have the function of “binding RBD and neutralizing capability against SARS-CoV-2”, or how to distinguish structures with this function from structures without. The only structure-function relationship guidance the specification provides is to disclose the CDR sequences of the heavy chain (CDR1 (SEQ ID NO: 35), CDR2 (SEQ ID NO: 36) and a CDR3 (SEQ ID NO: 37)) and of the light chain (CDR1 (SEQ ID NO: 38), CDR2 (SEQ ID NO: 39) and a CDR3 (SEQ ID NO: 40) of the elected Cv2.3194 antibody.
The instant claims simply direct skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the antigen binding CDRs they elected to disclose and that “[u]nder Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Id. at *8, *10.
The Supreme Court’s 2023 decision in Amgen v. Sanofi, which mainly involves the enablement requirement, states that “where a patentee purports to invent an entire genus, it must enable the entire genus”; “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies – and it is the latter that petitioners claim as their invention”; S. Ct.
Additionally, in its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023) the Federal Circuit found the facts of this case to be "materially indistinguishable from those in Amgen." Baxalta, 2023 WL 6135930, at *4. According to the Federal Circuit, claim 1 covers "millions of potential candidate antibodies" (id.) that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The court, however, noted that the specification discloses the amino acid sequence of just 11 of those antibodies. And like the roadmap in the patents at issue in Amgen, "the '590 patent's roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the [11] antibodies they elected to disclose." (Id.) Missing from the specification, according to the Federal Circuit, was "'a quality common to every functional embodiment' ... that would allow a skilled artisan to predict which antibodies will perform the claimed functions" (id.; quoting Amgen Inc. v. Sanofi., 598 U.S. 594, 614 (2023)), such as a common structural or other feature that would allow the antibodies to perform the claimed functions, or an explanation as to why the 11 antibodies do so and others do not. (Baxalta, 2023 WL 6135930, at *4). And the Federal Circuit was not persuaded by Baxalta's argument that its disclosed hybridoma-and screening process "predictably and reliably generates new claimed antibodies every time it is performed" (id.), because "it is undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions." (Id.).
The specification does not reasonably provide enablement to use the invention of claims 86-87, 91-95, 100-101, 103, 106-110 as they are currently written. The specification does reasonably provide enablement to make and use the invention discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
5. Claim 86-87, 91-95, 100-101,103, 106-110 is 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 87 recites “human neutralizing monoclonal antibody (mAb)” that is capable of competing with Cv2.1169 and Cv2.3194 for the binding to the RBD, which encompasses a genus of agents because the CDRs of this neutralizing mAb can comprise up to 2 mutations in any of the CDR amino acid sequence and the framework regions are not defined. The claim does not require that the genus of the claims possess any particular well defined structure or other distinguishing feature that is characteristic of the genus as a whole because of the possibility of mutations in the sequence of the CDRs. Therefore, the claims is drawn to a genus of “mAb” for which there is inadequate written description.
Claim 86 recitation has been discussed above. Claims 86 and its dependent claims are included in this rejection as they do not resolve the issue of the neutralizing monoclonal antibody comprising up to 2 mutations in any of the CDR amino acid sequence (see recitation (b) in claim 87) which is basically how Cv2.3194 is defined in claim 86.
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 (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), 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 applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
In the instant case, the only identifying characteristic present in the claim is a recitation of requisite activity (capable of competing with Cv2.1169 and Cv2.3194 (recitation (b) of claim 87) for the binding to the RBD; or capable of binding the RBD for claims 86 and its dependent claims). There is not even identification of any particular portion of a structure that must be conserved for the said activities. Regarding the genus of the claims the specification describes a few specific species within the genus claimed (Figures 3B and 4D show that the antibodies Cv2.3235, Cv2.5213, Cv2.1353, Cv2.3194 and Cv2.1169 of the present disclosure competitively inhibit the binding of each other to SARS-CoV-2 tri-S and S-RBD proteins. If any of these antibodies fits into the claimed CDR description would require a side to side sequence comparison among all of them). From the specification, it is clear that Applicant is in possession of the above species of mAb The claims, however are not limited to those species but also includes any mAb with up to 2 mutations in the CDR sequence and with any framework region sequence, and the specification fails to provide a representative number of species within the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, or representative number of species, the specification does not provide adequate written description of the claimed genus.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
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.
6. Claims 86, 91, 101, 103 and 106-110 are rejected under 35 U.S.C. 103 as being unpatentable over AbCellera (US 2021/0292393 A1 Filed Dec 9, 2020).
AbCellera teaches antibody sequences with the following alignments (see highlights for the % of identity) below for instant SEQ ID NOs: 7, 8, 17 and 18 and for the HCDRs SEQ ID NOs. Please also see the highlight in the sequences for the heavy and light variable domain CDRs
Instant SEQ ID NO: 35-36-37 (HCDRs) and SEQ ID NO: 3487
Title: US18288115_35FUS36FUS37
Perfect score: 157
Sequence: 1 SNYMSVIYPGGSTFYADSVKGDLVVYGMDV 30
US-17-116-588-3487
Sequence 3487, US/17116588
Publication No. US20210292393A1
GENERAL INFORMATION
APPLICANT: AbCellera Biologics Inc.
TITLE OF INVENTION: Anti-Coronavirus Antibodies and Methods of Use
FILE REFERENCE: 2705-0015WO01
CURRENT APPLICATION NUMBER: US/17/116,588
CURRENT FILING DATE: 2020-12-09
PRIOR APPLICATION NUMBER: 62/987,313
PRIOR FILING DATE: 2020-03-09
PRIOR APPLICATION NUMBER: 63/010,999
PRIOR FILING DATE: 2020-04-16
PRIOR APPLICATION NUMBER: 63/030,530
PRIOR FILING DATE: 2020-05-27
PRIOR APPLICATION NUMBER: 63/036,089
PRIOR FILING DATE: 2020-06-08
PRIOR APPLICATION NUMBER: 63/080,351
PRIOR FILING DATE: 2020-09-18
PRIOR APPLICATION NUMBER: 63/085,042
PRIOR FILING DATE: 2020-09-29
PRIOR APPLICATION NUMBER: 63/116,483
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 5574
SEQ ID NO 3487
LENGTH: 117
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 74.1%; Score 116.4; Length 117;
Best Local Similarity 35.5%;
Matches 27; Conservative 1; Mismatches 2; Indels 46; Gaps 2;
Qy 1 SNYM--------------SVIYPGGSTFYADSVKG------------------------- 21
|||| |||| ||||:|||||||
Db 31 SNYMTWVRQAPGKGLEWVSVIYSGGSTYYADSVKGRFTISRDSSKNTLYLQMNSLRAEDT 90
Qy 22 -------DLVVYGMDV 30
||| |||||
Db 91 AVYYCARDLVYYGMDV 106
Instant SEQ ID NO: 7 and SEQ ID NO: 3487
Title: US-18-288-115-7
Perfect score: 609
Sequence: 1 EVQLVESGGGLIQPGGSLRL..........DLVVYGMDVWGQGTTVTVSS 117
Sequence 3487, US/17116588
Publication No. US20210292393A1
GENERAL INFORMATION
APPLICANT: AbCellera Biologics Inc.
TITLE OF INVENTION: Anti-Coronavirus Antibodies and Methods of Use
FILE REFERENCE: 2705-0015WO01
CURRENT APPLICATION NUMBER: US/17/116,588
CURRENT FILING DATE: 2020-12-09
PRIOR APPLICATION NUMBER: 62/987,313
PRIOR FILING DATE: 2020-03-09
PRIOR APPLICATION NUMBER: 63/010,999
PRIOR FILING DATE: 2020-04-16
PRIOR APPLICATION NUMBER: 63/030,530
PRIOR FILING DATE: 2020-05-27
PRIOR APPLICATION NUMBER: 63/036,089
PRIOR FILING DATE: 2020-06-08
PRIOR APPLICATION NUMBER: 63/080,351
PRIOR FILING DATE: 2020-09-18
PRIOR APPLICATION NUMBER: 63/085,042
PRIOR FILING DATE: 2020-09-29
PRIOR APPLICATION NUMBER: 63/116,483
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 5574
SEQ ID NO 3487
LENGTH: 117
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 95.2%; Score 580; Length 117;
Best Local Similarity 94.0%;
Matches 110; Conservative 5; Mismatches 2; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLIQPGGSLRLSCAASGITVTSNYMSWVRQAPGKGLEWVSVIYPGGSTFYA 60
||||||||||||||||||||||||||:||:||||:||||||||||||||||| ||||:||
Db 1 EVQLVESGGGLIQPGGSLRLSCAASGVTVSSNYMTWVRQAPGKGLEWVSVIYSGGSTYYA 60
Qy 61 DSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDLVVYGMDVWGQGTTVTVSS 117
||||||||||||:||||||||||||||||||||||||||| ||||||||||||||||
Db 61 DSVKGRFTISRDSSKNTLYLQMNSLRAEDTAVYYCARDLVYYGMDVWGQGTTVTVSS 117
Please note that HCDR1 is 100% identical, HCDR2 has 2 mutations and HCDR3 has 1 mutation (sequence highlights) as required by instant claim 86. Claim 86 allows for up to 2 mutations for each CDR (that is, 6 mutations) for each heavy variable (VH) and for each light variable (VL) chains
For Instant SEQ ID NO: 8 and SEQ ID NO: 1128
Title: US-18-288-115-8
Perfect score: 534
Sequence: 1 EIVLTQSPGTLSLSPGERAT..........AIYYCQQGVTFGGGTKVEIK 104
US-17-116-588-1128
(NOTE: this sequence has 3 duplicates in the database searched)
Sequence 1128, US/17116588
Publication No. US20210292393A1
GENERAL INFORMATION
APPLICANT: AbCellera Biologics Inc.
TITLE OF INVENTION: Anti-Coronavirus Antibodies and Methods of Use
FILE REFERENCE: 2705-0015WO01
CURRENT APPLICATION NUMBER: US/17/116,588
CURRENT FILING DATE: 2020-12-09
PRIOR APPLICATION NUMBER: 62/987,313
PRIOR FILING DATE: 2020-03-09
PRIOR APPLICATION NUMBER: 63/010,999
PRIOR FILING DATE: 2020-04-16
PRIOR APPLICATION NUMBER: 63/030,530
PRIOR FILING DATE: 2020-05-27
PRIOR APPLICATION NUMBER: 63/036,089
PRIOR FILING DATE: 2020-06-08
PRIOR APPLICATION NUMBER: 63/080,351
PRIOR FILING DATE: 2020-09-18
PRIOR APPLICATION NUMBER: 63/085,042
PRIOR FILING DATE: 2020-09-29
PRIOR APPLICATION NUMBER: 63/116,483
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 5574
SEQ ID NO 1128
LENGTH: 107
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 95.8%; Score 511.5; Length 107;
Best Local Similarity 94.4%;
Matches 101; Conservative 2; Mismatches 1; Indels 3; Gaps 1;
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60
Qy 61 GRFSGSGSGTDFTLTISRLEPEDFAIYYCQQ---GVTFGGGTKVEIK 104
||||||||||||||||||||||||:||||| |:|||||||||||
Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYHLGLTFGGGTKVEIK 107
Please note that LCDR1 is 100% identical, LCDR2 is 100% identity and HCDR3 has 2 mutation (sequence highlights) as required by instant claim 86. Claim 86 allows for up to 2 mutations for each CDR (that is, 6 mutations) for each heavy variable (VH) and for each light variable (VL) chains
For Instant SEQ ID NO: 17 and SEQ ID NO: 5353
Title: US-18-288-115-17
Perfect score: 2370
Sequence: 1 EVQLVESGGGLIQPGGSLRL..........MHEALHNHYTQKSLSLSPGK 446
US-17-116-588-5353
(NOTE: this sequence has 3 duplicates in the database searched)
Sequence 5353, US/17116588
Publication No. US20210292393A1
GENERAL INFORMATION
APPLICANT: AbCellera Biologics Inc.
TITLE OF INVENTION: Anti-Coronavirus Antibodies and Methods of Use
FILE REFERENCE: 2705-0015WO01
CURRENT APPLICATION NUMBER: US/17/116,588
CURRENT FILING DATE: 2020-12-09
PRIOR APPLICATION NUMBER: 62/987,313
PRIOR FILING DATE: 2020-03-09
PRIOR APPLICATION NUMBER: 63/010,999
PRIOR FILING DATE: 2020-04-16
PRIOR APPLICATION NUMBER: 63/030,530
PRIOR FILING DATE: 2020-05-27
PRIOR APPLICATION NUMBER: 63/036,089
PRIOR FILING DATE: 2020-06-08
PRIOR APPLICATION NUMBER: 63/080,351
PRIOR FILING DATE: 2020-09-18
PRIOR APPLICATION NUMBER: 63/085,042
PRIOR FILING DATE: 2020-09-29
PRIOR APPLICATION NUMBER: 63/116,483
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 5574
SEQ ID NO 5353
LENGTH: 447
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 96.3%; Score 2281.5; Length 447;
Best Local Similarity 96.4%;
Matches 431; Conservative 6; Mismatches 9; Indels 1; Gaps 1;
Qy 1 EVQLVESGGGLIQPGGSLRLSCAASGITVTSNYMSWVRQAPGKGLEWVSVIYPGGSTFYA 60
|||||||||||:|||||||||||||| ||:|||||||||||||||||||||| |||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTVSSNYMSWVRQAPGKGLEWVSVIYSGGSTFYA 60
Qy 61 DSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDLVVYGMDVWGQGTTVTVSSAST 120
|||||||||||||||||||||||||||||||||||||| :| ||||| ||||||||
Db 61 DSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDSGDQLLDYWGQGTLVTVSSAST 120
Qy 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
Qy 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV 240
|||||||||||||||||||||||||||||||||:||||||||||||||||||||||||||
Db 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSV 240
Qy 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY 300
Qy 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK-QPREPQVYTLPPSRDELTK 359
|||||||||||||||||||||||||||||||||||||||| ||||||||||||||:|:||
Db 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK 360
Qy 360 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG 419
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG 420
Qy 420 NVFSCSVMHEALHNHYTQKSLSLSPGK 446
|||||||||||||||||||||||||||
Db 421 NVFSCSVMHEALHNHYTQKSLSLSPGK 447
For Instant SEQ ID NO: 18 and SEQ ID NO: 5326
Title: US-18-288-115-18
Perfect score: 1087
Sequence: 1 EIVLTQSPGTLSLSPGERAT..........EVTHQGLSSPVTKSFNRGEC 211
Sequence 5326, US/17116588
Publication No. US20210292393A1
GENERAL INFORMATION
APPLICANT: AbCellera Biologics Inc.
TITLE OF INVENTION: Anti-Coronavirus Antibodies and Methods of Use
FILE REFERENCE: 2705-0015WO01
CURRENT APPLICATION NUMBER: US/17/116,588
CURRENT FILING DATE: 2020-12-09
PRIOR APPLICATION NUMBER: 62/987,313
PRIOR FILING DATE: 2020-03-09
PRIOR APPLICATION NUMBER: 63/010,999
PRIOR FILING DATE: 2020-04-16
PRIOR APPLICATION NUMBER: 63/030,530
PRIOR FILING DATE: 2020-05-27
PRIOR APPLICATION NUMBER: 63/036,089
PRIOR FILING DATE: 2020-06-08
PRIOR APPLICATION NUMBER: 63/080,351
PRIOR FILING DATE: 2020-09-18
PRIOR APPLICATION NUMBER: 63/085,042
PRIOR FILING DATE: 2020-09-29
PRIOR APPLICATION NUMBER: 63/116,483
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 5574
SEQ ID NO 5326
LENGTH: 214
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 97.4%; Score 1058.5; Length 214;
Best Local Similarity 96.7%;
Matches 207; Conservative 2; Mismatches 2; Indels 3; Gaps 1;
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60
Qy 61 GRFSGSGSGTDFTLTISRLEPEDFAIYYCQQ---GVTFGGGTKVEIKRTVAAPSVFIFPP 117
||||||||||||||||||||||||:||||| :||||||||||||||||||||||||
Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSLTFGGGTKVEIKRTVAAPSVFIFPP 120
Qy 118 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 177
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 178 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 211
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
AbCellera teaches that in some embodiments, the anti-SARS-CoV-2 antibody) or antigen-binding fragment thereof comprises a heavy chain variable region having an amino acid sequence that is at least 60%, 70%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% identical to
one of the heavy chain variable region sequences explicitly disclosed in SEQ ID NOs: 660-1320 and 2751-4180 (includes SEQ ID NO: 3487) and a light chain variable region having an amino acid sequence that is at least 60%, 70%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% identical to one of the light chain variable region sequences explicitly disclosed in SEQ ID NOs:
660-1320 (includes SEQ ID NO: 1128) and 2751-4180 [0024]. These antibodies can be monoclonal ([1464] and [1480]), can bind to the RBD [1588] are neutralizing antibodies ([0026] and [1400]) and are cross-reactive with the SARS-CoV spike protein and SARS-CoV-2 spike protein [1398-1399] as required by instant claim 86. In addition, all five classes of antibodies (i.e. IgA, IgD, IgE, IgG, and IgM) and all isotypes (i.e., IgG1, IgG2, IgG3, IgG4, IgA1, and IgA2), as well as variations thereof, are within the scope of the present disclosure, preferred embodiments belonging to the IgG class [1467] as required by instant claim 91. A pharmaceutical composition comprising one or more anti-SARS-CoV-2 antibodies described herein [1585], pharmaceutical packs and kits comprising one or more containers and comprising one or more doses of anti-SARS-CoV-2 antibody [1616] and anti-SARS-CoV-2 antibodies disclosed herein may be used in conjunction with, or comprise, diagnostic or therapeutic devices [1621] are also taught (instant claims 101,103 and106).
AbCellera does not teach an antibody comprising both the variable and light chains of the instant invention together in the same antibody
It would have been obvious to one of ordinary skill in the art to combine the CDRs and variable chains taught by AbCellera to generate a collection of neutralizing antibodies (including those of the instant invention) that will retain the same properties (monoclonal, bind to the RBD and are cross-reactive with the spike protein, belonging to the IgG or IgA class, etc.). These antibodies can be a part of pharmaceutical compositions, kits or diagnostic or therapeutic devices. One of ordinary skill would have been motivated to do so because all these sequences are characterized and claimed in the same prior art reference and all the information needed for these antibodies is taught by AbCellera. Therefore, a person of ordinary skill in the art can readily combine the sequences of AbCellera resulting in neutralizing antibodies with a reasonable expectation of success as the techniques to combine these sequences are known in the art.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 86-87, 91-95, 100, 101, 103, and 106-110 are rejected
Claims 89 and 90 are objected as being dependent on a rejected claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IMMA BARRERA whose telephone number is (571) 272-0674. The examiner can normally be reached Monday - Friday 9 to 5.
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, Michael Allen can be reached on (571) 270-3497. 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.
/IMMA BARRERA/
Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1671
Prosecution Insights