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 02/25/2026 has been entered. Claims 1-4, 6, 24, 26, 31-34, 36, 40, 50, 56, 58-59, 64, 73-79 are pending.
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 October 27, 2020 based on the filing date of the GB2017058.5 application.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 02/025/2026 is acknowledged.
Claims 31-33, 50, 56, 58-59, 64 and 73-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-4, 6, 24, 26, 34, 36, 40 and 77-79 are under examination.
Applicant’s species election is acknowledged. Applicant elected an IgG1 comprising a constant region of SEQ ID NO: 418. Applicant further elects an additional therapeutic agent being an antibody that specifically binds to the receptor binding domain (RBD) of the S1 subunit of the SARS-CoV-2 spike protein and competes for binding to the SARS-CoV- 2 spike protein with the human ACE2 receptor.
The requirement is deemed proper and is therefore made FINAL.
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 deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 2A-B, 3A-Z, 15-22, 23A-C, 24A-C, 25-26 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.
Specification and Claim objections
1. Claims 36, 40 are objected because the only periods allowed in a claim are those that follow abbreviations and at the end of a claim, as stated in MPEP § 608.01(m). The periods to be removed are those in “a.”, “b.”, “c.”, “d.” and “e.”
2. Claims 3-4 and 77 are objected because these claims recite either SEQ ID NO; 18 or 28 and they are skipped sequences in the Sequence Listing as seen below. Both SEQ ID NOs 18 and 28 are three amino acids long and the amino acid sequence is only found in the specification and not in the Sequence Listing.
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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.
3. Claim 1, 2-4, 6, 24, 26, 34, 36, 36, 40, 77-79 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention
Claims 1, 2-4, 6, 24, 34, 36, 36, 40, 77-79 is rendered indefinite since the term antibody is defined to include both polyclonal and monoclonal antibodies (definition, page 141). This gives the claim and its dependents multiple interpretations. First, all CDRs could be present on one molecule. Second, the CDRs in the polyclonal antibody could be divided amongst multiple antibody molecules since polyclonal antibodies have multiple and different antibody species. Recitation’s clarity is improved by the following changes: adding “monoclonal” to the limitation.
Appropriate correction is required. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
4. Claim 26 recites the term "preferably", which renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention or not. See MPEP § 2173.05(d).
Furthermore, all uses in claim 26 of a constant region sequence of renders the claim indefinite as it gives the claim multiple interpretations. One being the full sequence is required, another being only a partial sequence is required.
Appropriate correction is required.
5. Claim 2 recites the limitation: “…wherein the antibody comprises a variable heavy (VH) domain sequence comprising complementarity determining regions (CDRs) HCDR1, HCDR2 and HCDR3, and a variable light (VL) domain sequence comprising complementarity determining regions;…”. This recitation needs to be modified for clarity so it reads on the full length sequences: “…. wherein the antibody comprises the variable heavy (VH) domain sequence comprising complementarity determining regions (CDRs) HCDR1, HCDR2 and HCDR3, and the variable light (VL) domain sequence comprising complementarity determining regions;….”
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.
5. Claims 1-4, 6, 24, 34, 36, 40 and 77-79 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.
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 1 is drawn to “a neutralizing spike antibody” that is capable of competing for binding to the SARS-CoV-2 spike with a human ACE2 receptor, which encompasses a genus of agents. Claims 2-4, 6, 24, 34, 36, 40 recite the antibody, CDR sequences, VH and VL sequences. Claim 77 is drawn to an antibody that specifically binds to a S2 subunit of a SARS-CoV-2 spike protein, wherein the antibody comprises a variable heavy (VH) domain comprising complementarity determining regions (CDRs) HCDR1, HCDR2 and HCDR3, and a variable light (VL) domain comprising complementarity determining regions (CDRs) LCDR1, LCDR2 and LCDR3, with the recited CDRS defined by their corresponding SEQ ID NO. Claim 2-4, 6, 24, 34, 36, 40 are dependent from Claim 1 and claims 78 and 79 are dependent on claim 77. These dependent claims do not materially limit the genus of antibodies, especially regarding the nature of the antibody (the antibody as defined encompasses intact polyclonal antibodies, intact monoclonal antibodies, antibody fragments (such as Fab, Fab', F(ab')2, and Fv fragments), single chain Fv (scFv) mutants, multispecific antibodies such as bispecific antibodies (including dual binding antibodies), chimeric antibodies, humanized antibodies, human antibodies, fusion proteins comprising an antigen determination portion of an antibody, and any other modified immunoglobulin molecule comprising an antigen recognition site so long as the antibodies exhibit the desired biological activity (specification (page 141)). and which mutations within the antibodies as defined confer a reduced affinity or activity for their receptors and this reduced activity or affinity is restorable by the one or more of the targeting moieties and are therefore included in the rejection. These claims do not require that the genus of the claims possess any particular structure or other distinguishing feature that is characteristic of the genus as a whole. Therefore, the claims are drawn to a genus of “antibodies” for which there is inadequate written description. Therefore, the claims can also be interpreted as having less than 6 CDR per antibody molecule. For example, but not limited to this example, the polyclonal embodiment of claims 3 and 77, not all six CDRs need be on the same antibody molecule.
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 for binding to the SARS-CoV-2 spike with a human ACE2 receptor for claim 1 and specifically binding to a S2 subunit of a SARS-CoV-2 spike protein for claim 77). There is not even identification of any particular portion of a structure that must be conserved for said activity. Regarding the genus of the claims the specification describes the sequence of specific species within the claimed genus found in the Specification tables and drawings. However the functional activity of all the sequences listed, combinations, permutations and fragments thereof is unknown. It is also unknown, for instance, which are the epitopes where these antibodies bind (since it is the entire CDR set that is required to bind 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 1979n IDS NPL citation 49). 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).) and the different binding properties among them, or how many CDRs an antibody has since fragments are part of the Antibody definition. The table E19-1 describes some neutralization data and ACE2 inhibition data for some antibodies listed in the table but the data ranges are very wide (page 302). The claims, however are not limited to those species but also includes a wide range of antibodies as per the antibody definition, 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.
6. Claims 1-4, 24, 34, 36, 40, are 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 neutralizing monoclonal antibodies comprising the HCDR1 (SEQ ID NO:180), the HCDR2 (SEQ ID NO: 181), the HCDR3 (SEQ ID NO: 182) in the VH domain (SEQ ID NO: 179), and the LCDR1 (SEQ ID NO:185), the LCDR2 (SEQ ID NO: 18), and the LCDR3 (SEQ ID NO: 186) in the VL domain (SEQ ID NO: 184) and able to compete for binding to the SARS-CoV-2 spike protein with a human ACE2 receptor, does not reasonably provide enablement for antibody fragments, a single VH or single CDRs, less than 6 CDRs, or mutated CDRs or polyclonal 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.
The specification discloses that IMPI-037 is an antibody comprising the HCDR1 (SEQ ID NO:180), the HCDR2 (SEQ ID NO: 181), the HCDR3 (SEQ ID NO: 182) in the VH domain (SEQ ID NO: 179), and the LCDR1 (SEQ ID NO:185), the LCDR2 (SEQ ID NO: 18), and the LCDR3 (SEQ ID NO: 186) in the VL domain (SEQ ID NO: 184), (page 179, third paragraph). This antibody is shown to have 100% protection against SARS-CoV-2 in K18 hACE2 transgenic mouse model. IMPI-037 also has a strong neutralizing activity in vivo and as described in Example 10 and it is resistant to mutations present in the Beta virus strain (Table E-11-1, page 292, last paragraph). Results from the HTRF study (Example 3) confirmed that IMPI-037 is able to compete with ACE2 (page 28). The specification does not disclose which amino acids within the 6 CDRs sequences can be substituted and still retain the ability to compete for binding to the SARS-CoV-2 spike with a human ACE2 receptor.
The specification does not reasonably provide enablement for which of the amino acids in the claimed CDR sequences can be substituted (instant claim 2), with the VH and VL comprising up to 5 unspecified substitutions or still be at least 90% identical sequence, unidentified fragments like a single VH or single CDR, less than 6 CDRs, or mutated CDRs and still be able to compete for binding to the SARS-CoV-2 spike with a human ACE2 receptor.
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 antibodies, only defined by its function “be able to compete for binding to the SARS-CoV-2 spike with a human ACE2 receptor”, with a partial structure at best. 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.
The instant claims are directed to a class of antibodies that include “a ‘vast’ number of additional antigen binding structures, (fragments. polyclonal antibodies, etc.as per the definition of “antibody”) in which the instant specification fails to describe the amino acid sequences of these structures. 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 “be able to compete for binding to the SARS-CoV-2 spike with a human ACE2 receptor”. 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 1-2), will have the function of “be able to compete for binding to the SARS-CoV-2 spike with a human ACE2 receptor”, or how to distinguish structures with this function from structures without. The only structure-function relationship guidance the specification provides is to disclose the neutralizing monoclonal antibody CDR sequences of the light chain (CDR1 (SEQ ID NO: 185), CDR2 (SEQ ID NO: 18) and a CDR3 (SEQ ID NO: 186)) and of the heavy chain (CDR1 (SEQ ID NO: 18), CDR2 (SEQ ID NO: 181) and a CDR3 (SEQ ID NO: 182).
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 1-4, 24, 34, 36, 40 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.
Moreover, claims not containing elements critical or essential to the practice of the invention, such as antibodies or antibody fragments not having all of the relevant functional complementarity determining regions (CDRs) in the proper site on an appropriate antibody heavy or light chain framework, are not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
Note that an enabling disclosure for the preparation and use of only a few analogs of a product does not enable all possible analogs where the characteristics of the analogs are unpredictable. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. (18 USPQ 2d 1027 (CAFC 1991 )).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moese (US 2023/0242624 A1)
Claim 1 recites: “A neutralizing antibody that specifically binds to the receptor binding domain (RBD) of a SARS-CoV-2 spike protein, wherein the antibody competes for binding to the SARS-CoV-2 spike protein with a human ACE2 receptor.”
Moese teaches a recombinant human-derived monoclonal antibody, or an antigen-binding fragments thereof, wherein the antibody is capable of binding to the RBD of the Spike protein of SARS-CoV-2 (claim 1). This antibody can inhibit the binding of the RBD to hACE2 (competes with hACE2) and it is a neutralizing antibody (claim 26). Moese also teaches that, while recent publications report on identifying neutralizing monoclonal anti-SARS-CoV-2 antibodies, the current mindset suggests that either polyclonal antibody or monoclonal antibody cocktails directed against the coronavirus causing COVID-19 are required in order to successfully combat with the disease [0005], which read on the neutralizing antibody of instant claim 1 being a polyclonal, a monoclonal or an antigen binding fragment of either one.
Therefore, instant claim 1 is anticipated by Moese.
Conclusion
No claims are allowed.
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.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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