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 .
Claims Status
The remarks filed on 11/26/2024 are acknowledged.
Claims 1-4, 10-11, 15-25 are pending.
Claims 10 and 16 are amended.
Claims 5-9, and 12-14 are cancelled.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-4, 10-11, 15-17, 18-20, and 24, in the reply filed on 09/14/2024 is acknowledged. The traversal is on the grounds that the Dahlen reference (WO 2017182672) relied upon in the restriction fails to disclose that the second binding domain is human PD1 or a variant thereof and that Group II, drawn to a nucleic acid encoding the bispecific antibody, a vector, and a host cell, and Group III, drawn to a method for treating comprising administering the bispecific antibody, have the same or corresponding technical features as Group I, and thus, Groups I-III are linked to form a single general inventive concept. The arguments are found persuasive in regards to the Dahlen reference alone because Applicant amended the claim after the restriction requirement to require that the second binding domain be human PD1 or a variant thereof, which Dahlen does not teach. However, the special technical feature of a bispecific antibody comprising a first binding domain which targets a surface antigen and a second binding domain which binds to an immune checkpoint protein on the surface of a second target cell, wherein the first binding domain is an antibody comprising a constant region, a heavy chain variable region, and a light chain variable region, the second binding domain is linked to the N-terminal of the heavy chain variable region or the light chain variable region of the first binding domain, wherein the first target cell is a tumor cell, the second target cell is the same cell as the first target cell, or the second target cell is an immune cell; the second binding domain is human PD1 or a variant thereof, is not a special technical feature as it is taught in the prior art, which is demonstrated in the rejections below.
The requirement is still deemed proper and is therefore made FINAL. Therefore,
claims 2, 21-23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 election of the following species in the replies filed on 09/14/2024 and 11/26/2024 are acknowledged: A: the antibody targets two different antigens, wherein one is on the tumor cell and one is on an immune cell, B: EGFR for the growth factor, C: PD-L1 as the immune checkpoint protein, D: amino acids 1-143 of SEQ ID NO: 44 for the second binding domain, E: SEQ ID NOs: 33-35 for the heavy chain CDRs and SEQ ID NOs: 36-38 for the light chain CDRs. Because applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election of species has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species for Group D, amino acids 1-143 of SEQ ID NO: 44, is free of the art, and consistent with MPEP 803.02, the examiner has extended the search and examination to the non-elected species. Therefore, the election of species for Group D is withdrawn. In view of the withdrawal of the election of species requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the election of species requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 2, 21-23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/14/2024. See explanation of election with traverse below.
Therefore, claims 1, 3-4, 10-11, 15-20, and 24 are under examination.
Priority
The instant application is a 371 of PCT/CN2019/112509 and claims priority to Chinese application CN201811230752.1. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Priority is given with the earliest effective filing date of 10/22/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/22/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 recites the limitation “…wherein Fc region of the first binding domain…”. The claim should read as “…wherein the Fc region of the first binding domain…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 3-4, 10-11, 15-17, 18-20, and 24 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.
Claim 1 recites the limitation “A bispecific antibody, comprising: a first binding domain…and a second binding domain…wherein the first binding domain is an antibody… the second binding domain is human PD1 or a variant thereof.” The preamble of the claim states that the invention is to a bispecific antibody which is understood in the art to be an antibody that comprises two antibody fragments with two different antigen binding regions. However, the body of the claim seems to be drawn to an antibody fusion protein that comprises an antibody linked to a protein that is not an antibody (i.e. human PD1 or variant thereof). Therefore, it is unclear what the bispecific antibody is referring to and what it comprises, and thus, the scope of this claim is indefinite.
Further, claim 1 recites that the “first binding domain which targets a surface antigen of a first target cell, and a second binding domain which binds to an immune checkpoint protein on the surface of a second target cell…wherein the second target cell is the same cell as the first target cell.” It is unclear whether the target cell is two separate cells or is the same individual cell. Therefore, the scope of this claim is indefinite.
Claims 3-4, 10-11, 15-17, 18-20, and 24, which depend from claim 1, are therefore indefinite for the same reasons as above.
Claim 3 recites the limitation “wherein the antibody targets two different antigens on the tumor cell and the immune cell”. It is unclear if the claim requires that the antibody target two different antigens on the tumor cell and two different antigens on the immune cell or if the claim requires that the antibody targets two different antigens: one on the tumor cell and one on the immune cell (i.e. wherein the first target cell is a tumor cell and the second target cell is an immune cell). If the claim is requiring that the first target cell is a tumor cell and the second target cell is an immune cell, the Examiner suggests amending the claim to recite “…wherein the first target cell is a tumor cell and the second target cell is an immune cell.”
Claim 4 recites the limitation “preferably.” MPEP 2173.05(d) states,
“description of examples or preferences is properly set forth in the specification rather
than the claims. If stated in the claims, examples and preferences may lead to
confusion over the intended scope of a claim.” In this case, the “preferably” makes it
unclear if the limitations succeeding the “preferably” are required claim limitations or not. Therefore, the scope of this claim is indefinite.
Claim 19 recites the limitation “…wherein the peptide linker has the amino acids set forth in L1 of SEQ ID NO: 30, L2 of SEQ ID NO: 32, or L3 of SEQ ID NO: 85.” For example, it is unclear if L1 is a portion of SEQ ID NO: 30 or if the linker is the sequence set forth in SEQ ID NO: 30. Therefore, the scope of this claim is indefinite. If the entire sequence of SEQ ID NOs: 30, 32, and 85 are the linkers, the Examiner suggests amending the claim to recite “…wherein the peptide linker comprises the sequence set forth in SEQ ID NO: 30, SEQ ID NO: 32, or SEQ ID NO: 85.”
Claim 20 recites the limitation “…wherein Fc region of the first binding domain is selected from amino acids 223-448 of SEQ ID NO: 2.” The “selected from amino acids 223-448” makes it unclear if this requires the entire amino acid sequence of residues 223-448 of SEQ ID NO: 2, or if only two consecutive recited amino acids within residues 223-448 of SEQ ID NO: 2 are required. Therefore, the scope of this claim is indefinite.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 10-11, 15-17, 18-20, and 24 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.
Claim 1 is drawn to a bispecific antibody, comprising: a first binding domain which targets a surface antigen of a first target cell, and a second binding domain which binds to an immune checkpoint protein on the surface of a second target cell, wherein the first binding domain is an antibody comprising a constant region, a heavy chain variable region, and a light chain variable region, the second binding domain is linked to N-terminal of the heavy chain variable region or the light chain variable region of the first binding domain, wherein the first target cell is a tumor cell, the second target cell is the same cell as the first target cell, or the second target cell is an immune cell; the second binding domain is human PD1 or a variant thereof.
The specification does not define “variant” and the art recognized definition of variant is something different from the original form. The specification also does not provide any examples of “variants” of human PD1, nonetheless, variants of PD1 that maintain the function of binding to an immune checkpoint protein. The specification further does not provide any guidance on which residues could be modified in the human PD1 sequence while still maintaining the function.
The specification is not deemed sufficient to reasonably convey to one skilled in the art that the inventors, at the time the invention was made, had possession of a genus of human PD1 variants that retain the function of binding to an immune checkpoint protein.
One means of providing adequate written description and evidence of
possession of a claimed genus is through providing sufficient distinguishing identifying
characteristics of the genus. The factors to be considered include disclosure of
complete or partial structure, physical and/or chemical properties, functional
characteristics, structure/function correlation, methods of making the claimed product,
or any combination thereof. In this case, the genus of “variants” is defined only by desired function: bind to an immune checkpoint protein on the surface of a target cell. Claim 1 does not require any particular structure for the variant nor can one of skill in the art envisage such a structure when provided only with a desired function. While claim 16 does require some structure, Applicant provides no guidance as to which amino acids could be modified while still maintaining the desired function.
See MPEP §2163(I)(A) which states:
"A biomolecule sequence described only by a functional characteristic, without
any known or disclosed correlation between that function and the structure of the
sequence, normally is not a sufficient identifying characteristic for written description
purposes, even when accompanied by a method of obtaining the claimed sequence."
In this case, making deletions, insertions, or substitutions to a polypeptide sequence, while requiring the polypeptide to still maintain its function, is highly unpredictable. Bhattacharya et al., 2017 (instant PTO-892) teaches that the range of possible effects of even single variations at the protein level are significantly greater than currently assumed by existing software prediction methods, and that correct prediction of consequences remains a significant challenge (page 18, third paragraph). Fenton et al., 2020 (instant PTO-892) teaches that while it is well known that most substitutions at conserved amino acid positions (which they call “toggle” switches) abolish function, it is also true that substitutions at nonconserved positions (which they call “rheostat” positions) are equally capable of affecting protein function, and that each substitution has a different functional outcome, and the set of substitutions spans a range of outcomes [see Abstract]. Further, Guo et al., 2004 (instant PTO-892) teaches that the effects of mutations on protein function are largely additive [page 9207, left column, third paragraph], supporting that when multiple mutations are introduced, there is even less predictability. Thus, it is clear that the structure of variants of proteins does not predictably correlate with the function thereof.
The recited genus of “variants” encompasses a broad genus of variant human PD1 polypeptides that are not deemed to be predicative of all possible variant polypeptides of PD1 that retain the function of binding to an immune checkpoint protein. Therefore, the skilled artisan cannot envision all variant polypeptides that retain the same function as wild-type HIFα. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v.
American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he
description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are
adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species
to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Accordingly, one of skill in the art would conclude that the claimed invention encompasses a broad genus of variant polypeptides of human PD1 that bind to an immune checkpoint protein. Due to the lack of teachings in the instant specification, and the teachings in the art, one of skill in the art would not conclude that Applicant was in possession of the claimed genus of variants of human PD1.
Claims 3-4, 10-11, 15-17, 18-20, and 24, which depend from claim 1, are therefore deficient for the same reasons as above.
Claim Interpretation
In view of the 112(b) rejections above, the Examiner is interpreting the claim limitation of “bispecific antibody” as being an antibody fusion protein, which comprises an antibody (i.e. anti-EGFR as set forth in the election of species) fused to a human PD1 protein or variant thereof. Support for this interpretation is provided in the specification on page 10, fifth paragraph, which describes that the present disclosure uses an anti-EGFR antibody as a scaffold, and fuses PD-1 or fragment of anti-PD-L1 at N-terminal of its heavy chain or light chain to form an antibody fusion protein which may respectively bind to EGFR and PD-L1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 4, 10, 11, 15-16, 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO2017136820; instant PTO-892) in view of UniProt, 2017 (instant PTO-892).
Regarding claims 1, 3, 4, 10, and 11, Wu teaches multispecific binding proteins that in one embodiment are Fabs-in-tandem immunoglobulins (FIT-Ig) and are capable of binding two or more antigens [0016]. Wu further teaches that the binding proteins are capable of binding antigens or cell surface proteins [0017] and that the binding protein is capable of binding the target pair of EGFR (surface antigen) and PD-L1 (immune checkpoint protein) [0028; 0064]. Wu also teaches that the binding proteins comprise heavy and light chains derived from the panitumumab (anti-EGFR antibody) and the PD-L1 antibody 1B12 [0064]. Wu further teaches the binding protein comprises a first polypeptide of VLA-CL-VHB-CH1-Fc, a second polypeptide of VHA-CH1, and a third polypeptide of VLB-CL, wherein antigen A is EGFR, and antigen B is PD-L1 [0064]. Wu teaches the structure of a FIT-Ig made up of three constructs [Figure 1A]. See below:
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The left side of the figure depicts that the binding domain that binds to PD-L1 is linked to the N terminus of the heavy chain variable region of the first binding domain. Wu also teaches that the binding protein is capable of binding one or more epitopes on one or more tumor cell surface proteins that is involved with immune checkpoint pathways such as PD-L1 [0204] and also teaches that the antibody inhibits natural ligands by binding to targeted tumor cells [00366]. While the two binding proteins of Wu are disclosed as binding to target tumor cells, the anti-PDL1 binding domain would also necessarily bind to immune cells, such as T or B cells, because PD-L1 is expressed on immune cells. This is evidenced by Latchman et al., 2004 (instant PTO-892) who teaches that PD-L1 is expressed on resting and up-regulated on activated B, T, myeloid and dendritic cells [page 10691, left column, first paragraph]. Thus, this meets the limitation of wherein the first target cell is a tumor cell and the second target cell is an immune cell.
However, Wu does not specifically teach that the second binding domain is human PD1.
UniProt teaches human Programmed cell death protein 1 (PD1), which binds to its ligand programmed cell death protein 1 ligand 1 (PDCD1L1) [page 1, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anti-PDL1 binding portions of the multispecific binding protein of Wu to be the human PD1 of UniProt. One would have been motivated to make this modification because both the anti-PDL1 binding portion of Wu and the human PD1 of UniProt bind to PDL1. It is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06 (II)).
Claim 15 is included in this rejection because Wu teaches that the binding protein can further comprise an Fc region, which can be a variant Fc region that exhibits modified effector function [0018]. Therefore, this meets the limitation of the first binding domain having both Fc effector function and function of binding to a cell surface antigen (i.e. EGFR).
Claim 16 is included in this rejection because UniProt teaches the sequence of the extracellular region of human PD1 [see page 4] that encompasses the Ig-like-V-type domain [see page 9], which is the region that binds to PD-L1 as evidenced by Lin et al., 2008 (instant PTO-892), who teaches that PD-1 and PD-L1 interact through the conserved front and side of their Ig variable (IgV) domains [see Abstract]. The sequence of the extracellular region of UniProt has 100% sequence identity to SEQ ID NO: 6 of the instant claim. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically chosen the sequence as taught by UniProt for the second binding domain (i.e. human PD1) because it comprises the region known to interact (bind) to PD-L1. Further, one would have been motivated to use this sequence for second binding domain (i.e. human PD1) because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Claim 18 is included in this rejection because Wu teaches that the binding protein may further comprise one or more linkers linking two or more of the components of the binding protein [00259] and that the linker may be between the VL-CL of the first binding domain and the VH-CH1 of the second binding domain [00261].
Claim 24 is included in this rejection because Wu teaches pharmaceutical compositions comprising the binding protein [00205].
Claims 1, 3, 4, 10, 11, 15-16, 18-19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO2017136820; instant PTO-892) in view of UniProt, 2017 (instant PTO-892), as applied to claims 1, 3, 4, 10, 11, 15-16, 18, and 24 above, and further in view of Wang (WO2017041001; instant PTO-892).
The teachings of Wu and UniProt are above.
However, Wu and UniProt do not specifically teach the peptide linker comprises the sequence of SEQ ID NO: 30.
Regarding claim 19, Wang teaches immunoglobulin fusion proteins which comprise a therapeutic peptide and an immunoglobulin region [0004], wherein the therapeutic peptide may be attached to an immunoglobulin region via a linker which can be SEQ ID NO: 143 [0008; Page 118, Table 7].
SEQ ID NO: 143 of Wang has 100% sequence identity to SEQ ID NO: 30 of the instant claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the linker of Wu to specifically be the linker as taught by Wang. One would have been motivated to make this modification because Wang teaches that this linker can be used to link a peptide to an immunoglobulin region. One would further have been motivated to have used this sequence for the linker because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Claims 1, 3, 4, 10, 11, 15-18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO2017136820; instant PTO-892) in view of UniProt, 2017 (instant PTO-892), as applied to claims 1, 3, 4, 10, 11, 15-16, 18, and 24 above, and further in view of Jakobovits (US 20060183887; instant PTO-892).
The teachings of Wu and UniProt are above.
However, Wu and UniProt do not specifically teach that the heavy chain variable region of the first binding domain comprises SEQ ID NOs: 33-35 for the heavy chain CDRs 1-3, respectively, or that the light chain variable region of the first binding domain comprises SEQ ID NOs: 36-38 for the light chain CDRs 1-3, respectively.
Regarding claim 17, Jakobovits teaches SEQ ID NO: 54, which is disclosed as the light chain of an antibody that binds to EGFR [0053; Figure 31; page 68, SEQ ID NO: 54 sequence listing], and SEQ ID NO: 53, which is disclosed as the heavy chain of an antibody that binds to EGFR [0051; Figure 29; pages 67-68, SEQ ID NO: 53 sequence listing].
SEQ ID NO: 54 of Jakobovits comprises CDRs with 100% sequence identity to SEQ ID NOs: 36-38 of the instant claim, respectively, and SEQ ID NO: 53 of Jakobovits comprises CDRs with 100% sequence identity to SEQ ID NOs: 34-35 of the instant claim, respectively.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EGFR binding portion of the binding protein of Wu to specifically comprise the CDRs for the light and heavy chain variable regions, as taught by Jakobovits. One would have been motivated to make this modification because Jakobovits teaches that these CDR sequences bind to EGFR. One would have been further motivated to use these sequence for the heavy chain and light chain CDRs because they are known sequences in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Claims 1, 3, 4, 10, 11, 15-16, 18, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO2017136820; instant PTO-892) in view of UniProt, 2017 (instant PTO-892), as applied to claims 1, 3, 4, 10, 11, 15-16, 18, and 24 above, and further in view of Young (WO2016168773; instant PTO-892).
The teachings of Wu and UniProt are above.
However, Wu and UniProt do not specifically teach that the Fc region of the first binding domain comprises residues 223-448 of SEQ ID NO: 2.
Regarding claim 20, Young teaches SEQ ID NO: 179, which is disclosed as a IgG1 Fc region mutant [see page 1 and pages 208-209; Table 54].
SEQ ID NO: 179 of Young has 100% sequence identity to residues 223-448 of SEQ ID NO: 2 of the instant claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Fc region of Wu to be the Fc region (i.e. SEQ ID NO: 179) of Young. One would have been motivated to use this sequence for the Fc region because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675