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 .
Applicant’s amendment, filed on 1/30/2026, is acknowledged.
Claims 18-22 and 24-33 are cancelled.
Claims 1-17, 23, and 34-38 are currently pending.
Claim 1 is the only independent claim.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-17, 23, and 34-38, directed to an anti-BCMA antibody, and the Species of the CDR sequences of claim 5 and the VH/VL sequences of claim 4, filed on 1/30/2026, is acknowledged.
Claims 6-8 and 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and/or species.
Claims 1-5, 9, 15-17, 23, and 34-38 are under examination reading on an anti-BCMA antibody with the CDR sequences of claim 5 and VH/VL sequences of claim 4.
Priority
Applicant’s claim for the benefit of a prior-filed European Patent Application No. 22305784.5, filed May 27, 2022, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/02/2024, 10/31/2025, and 1/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
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 – Nucleotide and/or amino acid sequences appearing in the drawings 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.
Figure 1 contains multiple sequences without the corresponding sequence identifiers either in the Figure 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
The use of the term: HyClone™ (pg. 28), GIBCO® (pg. 28), ClonePix® (pg. 28), MabSelect™ (pg. 31), Milli-Q® (pg. 31, 33), and SpectraMax® (pg. 32), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claims 9 and 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 2, 3, 16, 17, 23, and 35-38 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 the antibody structures with the HCDR1-3 of SEQ ID NO: 1, 2, and 3, respectively, and the LCDR1-3 found in each of anti-BCM CA10 VL_parent, VL_v1, VL_V2, VL_V3, VL_V4, VL_V5, VL_V6, VL_V7, does not reasonably provide enablement for the genera of antibody structure recited in claims 1 and 2. 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 and use the invention commensurate in scope with these claims.
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.
Breadth of claims and nature of invention:
Claims 1, 3, 16, 17, 23, and 35-38 recite a broad genus of anti-BCMA antibodies with the HCDR1-3 of SEQ ID NO: 1, 2, and 3, respectively and the broad genus of LCDR1-3 sequence combinations recited in the claims, all with the function of “specifically binds to BCMA”. This genus includes 786 different LCDR1-3 sequence combinations all with the function of “specifically binds to BCMA”. Claim 3 is included because the recited variation of the VL domains does not further limit the potential CDR sequences recited in claim 1.
Claim 2 recites a genus of anti-BCMA antibodies HCDR1-3 of SEQ ID NO: 1, 2, and 3, respectively and a genus of 36 different LCDR1-3 sequence combinations, all with the function of “specifically binds to BCMA”.
The specification discloses identification of anti-BCMA antibodies obtained from hybridomas isolated from human transgenic mice immunized with human BCMA (Example 1).
Amount of direction and existence of working examples:
Example of different anti-BCMA antibodies that were found during the hybridoma screen are disclosed in Tables 1 and 2:
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452
911
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346
913
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777
908
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208
911
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The HCDR1-3 of all of these antibodies are SEQ ID NO 1, 2, and 3, respectively. The antibodies also contain the following LCDR1-3: SEQ ID NO: 5, 9, and 13, respectively; SEQ ID NO: 4, 9, and 13, respectively; SEQ ID NO: 6, 10, and 14, respectively; SEQ ID NO: 7, 11, and 15, respectively; and SEQ ID NO: 8, 12, and 15, respectively.
Level of predictability, state of prior art, and quantity of experimentation needed:
Claims 1 and 2 are directed to genera of antibodies comprising the LCDR combinations recited in claims 1 and 2, which includes 786 and 36 different sequences, respectively, all with the recited function of “specifically binds to BCMA”.
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.”
The specification discloses one HCDR1-3 combinations, and 5 LCDR1-3 combinations that give rise to antibodies with the function of “specifically binds to BCMA”. The instant specification does not disclose any guidance on which amino acid sequence structures would predictably give rise to antibodies with the function of “specifically binds to BCMA”.
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 claims are directed to large classes of antibodies comprising the HCDR1-3 of SEQ ID NO: 1-3, respectively and the LCDR1-3 sequence combinations recited in instant claims 1 and 2 with the recited functions of “specifically binds to BCMA”.
The instant claims are directed to a class of antibodies that include “a ‘vast’ number” of additional structures in which the instant specification fails to describe. It would be necessary to first generate and then screen each candidate antibody to determine whether it met the functional limitations of “specifically binds to BCMA”. 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 other LCDR sequence combinations recited in the claims would have the function of “specifically binds to BCMA”. The only structure-function relationship guidance the specification provides is to disclose individual monospecific antibodies with these functions.
The instant claims simply direct skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the antibody structures 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.
Applicant is relying upon certain biological activities such as antibodies that target BCMA and a limited number of species of antibodies with defined structures (e.g. amino acid sequences) to support an entire genus of diverse and structurally unrelated inhibitory antibody. Yet the instant specification does not provide sufficient guidance and directions as to the structural features of the inhibitory antibody and the correlation between the structure and the desired antigen binding and inhibitory function.
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 make and use the invention of instant claims 1, 2, 3, 16, 17, 23, and 35-38. The specification does enable one with ordinary skill to make the antibody clone 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.
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.
Claims 3, 16, and 34 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 3 and 34 are indefinite because the claims recite “…at least about 90% identical…”. The specification discloses (pg. 14): “The term "about" or "approximately" means within about 20%, such as within about 10%, within about 5%, or within about 1 % or less of a given value or range.” Therefore, claims 3 and 19 is also indefinite because the term “at least about” used to limit sequence identity leads to a broader range followed by a narrower range for each recited percent sequence identity. For example, “at least about 90%” is construed to be at least 70% (broader range) up to at least 99% (narrower range) sequence identity given the disclosed definition of “about”.
Claims 3 is additionally indefinite because there a multiple instances where the claims recite a broad range of either sequence identity, followed by a narrower range. For instance, claim 3 recites “…at least about 90% identical or at least 95% identical…”.
Amending the claims to recite one value for percent sequence identity will resolve these issues.
Claim 16 is indefinite because the claim recites “…a chimeric or humanized antibody…”. However, the instant specification discloses that the instant claimed antibodies are generated from human Ig transgenic mice (Example 1, pg. 27), which generate antibodies with a human variable region. It is currently unclear how an antibody with a human variable region and human CDRs can be a humanized antibody, which is mouse antibody CDRs grafted into a human antibody scaffold. Amending the claim to remove “or humanized” would resolve this issue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 9, 15, 17, 23, 34, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (herein Pat ‘555). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘555 claims antigen binding domains comprising a VH and a VL (i.e., “an antibody or antigen binding fragment thereof”) with binding specificity to BCMA (claim 1), wherein the anti-BCMA antibody comprises the VH of SEQ ID NO: 49 and the VL of SEQ ID NO: 55 (claim 2).
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 16:
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
Qy 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
SEQ ID NO: 55 is 100% identical to instant SEQ ID NO: 24 (i.e., the limitations of instant claims 1-5, 9, 15, and 34):
Qy 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
Qy 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
Regarding claim 17, Pat ‘555 claims multispecific antibodies binding BCMA and NKp46 (claim 1).
Regarding claim 23, Pat ‘555 claims pharmaceutical compositions comprising the antibodies (claim 17).
Regarding claim 36, Pat ‘555 claims the antibodies further comprising Fc regions comprising full length heavy chains (claims 5 and 11).
The invention encompassed by Pat ‘555 anticipates the instantly claimed invention.
Claims 1-5, 9, 15-17, 23, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Moutel et al. (BMC Biotechnol. 2009 Feb 26;9:14. doi: 10.1186/1472-6750-9-14).
The invention encompassed by Pat ’555 is discussed supra. Pat ‘555 does not claim a chimeric antibody (i.e., the limitations of instant claim 16) or a human antibody (i.e., the limitations of instant claim 35).
Moutel et al., in the same field of endeavor, teaches fusion of scFv antibody fragments to each of human, mouse, and rabbit IgG Fc regions (Abstract): “[t]his series enables the fusion of single chain Fv antibodies with human, mouse or rabbit Fc so that a given antibody is no longer restricted to a particular species…”
Moutel et al. teaches motivation to fuse these different Fc regions to a scFv (pg. 5): “[b]y fusing scFv to Fc domains, not only are we endowing recombinant antibodies with the same power as natural antibodies for classical immunological methods, but we also generate new and unique tools… Here, since we developed a series of vectors that allow not only fusion of scFv to human Fc but also to mouse or rabbit IgGs in a single sub-cloning step (see Figure 1), there no longer exists a species barrier in co-immunolabeling applications.”
It would have been obvious to one of ordinary skill in the art to have modified the invention of Pat ‘555 in view of Moutel et al. to make an anti-BCMA antibody fused to each of a human, mouse, and rabbit antibody Fc region with a reasonable expectation of success, as Moutel et al. teaches methods of doing so. One would have been motivated to make this change for the purposes of generating anti-BCMA antibodies with a rabbit, mouse, or human Fc to use in co-immunolabeling applications to remove the species barrier.
Fusing the anti-BCMA antibody of Pat ‘555 to a mouse or rabbit Fc region would yield a chimeric antibody (i.e., the limitations of instant claim 16), and fusing the antibody to a human Fc region would yield a human antibody (i.e., the limitations of instant claim 35), as the claimed anti-BCMA antibody VH and VL regions are human (see Example 1).
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘555 in view of Moutel et al.
Claims 1-5, 9, 15, 17, 23, and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,195,555 (Pat ‘555, supra) in view of Schlothauer et al. (Protein Eng Des Sel. 2016 Oct;29(10):457-466. doi: 10.1093/protein/gzw040).
The invention encompassed by Pat ’555 is discussed supra. Pat ‘555 does not claim a human antibody (i.e., the limitations of instant claim 35), or IgG1/IgG4 Fc regions (i.e., the limitations of instant claims 36-38).
Schlothauer et al., in the same field of endeavor, teaches generation of recombinant human IgG1 and IgG4 antibodies that do not bind to Fcγ receptors (Abstract): “[w]e describe here two new, engineered hIgG Fc domains, hIgG1-P329G LALA and hIgG4-P329G SPLE, with completely abolished FcγR and C1q interactions…”
Schlothauer et al. teaches that reducing binding to Fcγ receptors reduces unwanted side effects when the antibody is used in clinical applications (Introduction): “[a]brogation of Fc/FcγR and complement protein C1q interactions can be desired to prevent unwanted side effects such as infusion reactions and cell as well as tissue damage introduced by FcγR-mediated immune effector functions.”
It would have been obvious to one with ordinary skill in the art to have modified the invention of Pat ‘555 in view of Schlothauer et al. to have made human IgG1 or IgG4 versions of the anti-BCMA antibody of Pat ‘555 (i.e., the limitations of instant claims 35-38) with reduced effector functions, as Schlothauer et al. teaches these Fc regions to be used in antibodies. One would have been motivated to make this change for the purposes of making anti-BCMA antibodies with reduced effector functions to reduce unwanted side effects in therapeutic applications of the antibody.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘555 in view of Schlothauer et al.
Claims 1-5, 9, 15, 17, 34, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (herein App ‘830). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘830 claims nucleic acids encoding, and methods of making, anti-BCMA binding proteins comprising a VH and a VL (i.e., “an antibody”, claim 24), wherein the VH has the amino acid sequence of SEQ ID NO: 49 and the VL has the amino acid sequence of SEQ ID NO: 55 (claim 37).
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 24:
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSNFGMHWVRQAPGRGLEWVAVIWSDETNRYY 60
Qy 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTVSRDNVKSTVYLQMNSLISEDTAVYYCARDQQYCSSDSCFTWFDPWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
SEQ ID NO: 49 is 100% identical to instant SEQ ID NO: 24 (i.e., the limitations of instant claims 1-5, 9, 15, and 34):
Qy 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QTVVTQEPSLTVSPGGTVTLTCASSTGTVTPSNYANWVQQKPGQAFRGLIGDNNSRPPGT 60
Qy 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PARFSASLLGGKAALTLSGVQPEDEAEYYCALWFGNQWVFGGGTKLTVL 109
Regarding claim 17, App ‘830 additionally claims nucleic acids comprising multi-specific antibodies comprising an anti-BCMA arm and an anti-NKp46 arm (claim 24).
Regarding claim 36, App ‘830 claims the antibodies further comprising Fc regions comprising full length heavy chains (claim 40).
It would have been obvious to one of ordinary skill in the art to have made the antibodies using the nucleic acids and methods of production claimed by App ‘830 with a reasonable expectation of success, as App ‘830 claims such methods. One would have been motivated to do so to produce the claimed anti-BCMA Antibodies.
The invention encompassed by the instant claims is a prima facie obvious variant of the instant claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 9, 15-17, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Moutel et al. (supra).
The invention encompassed by the instant claims is a prima facie variant of the invention claimed by App ‘830 in view of Moutel et al. for the same reasons discussed for Pat ‘555 supra. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 9, 15, 17, 23, and 34-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 27, 29, 31, 32, and 36-50 of copending Application No. 18/960,830 (App ‘830, supra) in view of Schlothauer et al. (supra).
The invention encompassed by instant claims 1-5, 9, 15, 17 and 34-38 is a prima facie variant of the invention claimed by App ‘830 in view of Schlothauer et al. for the same reasons discussed for Pat ‘555 supra.
Regarding claim 23, Schlothauer et al. teaches pharmaceutical compositions comprising an effector-silent antibody in HSP buffer (“SPR FcγR capture setup”) section.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641