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 .
Claim Status
Claims 5, 8-9, 12, 14, 17-18, 20-21, 26-28, 32 and 34-36 have been cancelled.
Claims 1-4, 6-7, 10-11, 13, 15-16, 19, 22-25, 29-31 and 33 are currently pending.
Claims 1-4, 6-7, 10-11, 13, 15-16, 19, 22-25, 29-31 and 33 are being examined in this application.
Priority
This application is filed under 35 U.S.C 371 of PCT/US2022/034582 (filed on 06/22/2022), which claims priority to US provisional applications 63/302,473 (filed 01/24/2022) and 63/214,114 (filed 06/23/2021).
Information Disclosure Statement
The IDS filed on 1/11/24 and 3/22/24 have been considered. See the attached PTO 1449 forms.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Rejections - 35 USC § 112
112(b) Rejection
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 1-4, 6-7, 10-11, 13, 15-16, 19, 22-25, 29-31 and 33 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 “a first coronavirus spike protein”, and “a second coronavirus spike protein”, which implies that there are two different spike proteins on the coronavirus envelope. However, coronavirus is only known to have one type of spike protein with multiple copies. This recitation conflicts with what’s known in the art for coronavirus, and thus renders the claim unclear and indefinite.
Similarly, claim 10 recites the “the first coronavirus spike protein and the second coronavirus spike protein are… different coronavirus spike proteins.” It is not clear how a single coronavirus type can have different “spike proteins.”
Claim 4 recites “the neutralizing polypeptide is a neutralizing antibody or a non-neutralizing antibody”, which seems to create a conflict, since the term “neutralizing” is defined by the instant specification to mean “… capable of keeping an infectious agent, such as a virus, from infecting a cell” and provides an example of “neutralizing antibody” (Spec., [0072]). The instant specification defines that term “non-neutralizing antibody” as “…has little to no ability of keeping an infectious agent, such as a virus, from infecting a cell…” which is in conflict with the claimed language of “the neutralizing polypeptide is… a non-neutralizing antibody.” It is not clear how a neutralizing polypeptide at the same time be non-neutralizing antibody. Thus, the metes and bounds of the claim is unclear, and renders the claim indefinite.
Claim 11 recites “the neutralizing polypeptide and the antibody that specifically binds an epitope in a conserved region of the second coronavirus spike protein,” which the “neutralizing polypeptide… that specifically binds… the second…” lacks clear antecedent basis. Claim 1 from which claim 11 depends recites “a neutralizing polypeptides that binds… a first…” Claim 1 does not recite the neutralizing polypeptide binds to the second spike protein.
112(a) Rejection(s)
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.
Written Description Rejection
Claims 6, 7, 13, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite fusion protein comprising a neutralizing polypeptide that binds to a coronavirus spike protein and an antibody against a coronavirus spike protein.
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Each of claims 6, 7, 13, and 16 is drawn to a genus of amino acid sequences. Each claim recites “…comprising an amino acid sequence that shares at least 90% identity to a particular SEQ ID NO for claims 6, 13 and 16, and at least 40% identity to the spike protein sequence of claim 7. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of amino acid sequences that would have the same function. In addition, no representative numbers of species for each claimed genus of sequence is provided to show possession of the claimed genus of antibodies or fragments thereof, or protein/fragments thereof.
To provide evidence of possession of a claimed genus, the specification must provide 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. (see MPEP 2163 II). In this case, the instant application did not provide the core sequences that would provide the functions (including binding to Spike protein epitope, binding of the spike protein to the antibody, binding of the polypeptide to the spike protein, treating coronavirus infection or provide vaccination etc). The only examples are the sequences with the 100% matching sequences especially the CDRs. The instant specification has not provided any examples where the CDRs were mutated (that would still have at least 90% identity to claimed sequences) would still have the same binding affinity and therapeutic effects.
Therefore, applicants are not in possession of the entire claimed genus of fusion protein, antibodies, and/or neutralizing polypeptides, as well as the binding target spike proteins (as expressed by any coronavirus).
Claim Rejections - 35 USC § 102
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.
Wang
Claims 1-4, 6-7, 10-11, 13, 19, 22-25, 29-31 and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al (WO2021/189245; filed on 3/24/2020; or earlier; Machine Translation also attached Citation below refer to the Machine Translation copy).
Wang et al, throughout the publication, teach bifunctional fusion protein binding to a coronavirus comprising anti-SARS-CoV/CoV2 antibody and ACE2 (e.g. Abstract).
For claims 1-4, Wang et al, teach “bifunctional fusion protein” comprising anti-SAR-CoV or SARS-CoV-2 antibody that binds to the spike protein and the ACE2 (e.g. [0026]-[0028]). The “ACE2” reads on the polypeptide that binds to a receptor binding domain (RBD), the ACE2 receptor ectodomain of claims 2-3, and neutralizing antibody of claim 4.
The fusion protein (i.e. linked proteins) of the reference would necessarily or inherently has a peptide linker since any fragments in between the ACE2 and the antibody (e.g. Figure 1) would read on the peptide linker.
For claims 6-7, the recitation of the “conserved region” of the coronavirus spike protein is a recitation of intended use. The reference teaches the antibody binds to the spike protein of SARs-CoV-2 (p2, left-right bridging para.), which spike protein would have sequence identity of at least 40% with SEQ ID NO:337.
For claims 10-11, the reference teaches antibodies bind to spike proteins o anti-SAR-CoV or SARS-CoV-2 (e.g. [0027]) , and the dual function fusion protein bind simultaneously to the spike protein and the ACE2 binding site noncompetitively (e.g. claim 4; [0029]; [0027]).
For claim 13, the reference teaches SEQ ID NO:12 (e.g. claim 5; [0037]), which contains the amino acid sequence for ACE2 that shares at least 99% identity with the instant SEQ ID NO:270.
For claim 19, the reference teaches a fusion protein of ACE2 and anti-spike antibody that can bind to SARs-CoV/CoV2, which is structurally the same as the instant claim 1 fusion protein, and thus would inherently possess the property of increased neutralization potency.
For claims 22-25 and 29, the reference teaches making vectors, host cells for and method of producing the fusion protein (e.g. Claims 8-10).
For claims 30-31 and 33, the reference teaches pharmaceutical applications of the dual fusion protein for treating SARs-CoV that contain pharmaceutical excipients (e.g claims 11+; [0039]).
MABPharm
Claims 1-4, 6-7, 30-31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MABPharm (Voluntary Announcement that CMAB020 invention patent application has been submitted to the China National Intellectual Property Administration and an exclusive licensing with SORRENTO Therapeutics, INC. for CMAB020. Downloaded from Sina.com.cn; //stock.finance.sina.com.cn/hkstock/go.php/CompanyNoticeDetail/code/02181/aid/984121/.phtml; 3/24/2020; Machine translation also attached).
MABPharm, throughout the publication, teach fusion protein, CMAB020 (or STI-4920) comprising two arms, where one arm has human monoclonal antibody targeting SARs-CoV2, SARs-CoV, or SARs-like coronavirus S protein (i.e. Spike protein), and the other arm is the truncated ACE2 protein that can bind to a different epitope of the Spike protein. The reference’s teaching read on the instant claims 1-4.
The CMAB020 fusion protein (i.e. linked proteins) of the reference would necessarily or inherently has a peptide linker since any fragments in between the truncated ACE2 and the antibody would read on the peptide linker.
For Claims 6-7, the recitation of the “conserved region” of the coronavirus spike protein is a recitation of intended use. The reference teaches the antibody binds to the spike protein of SARs-CoV-2 (p2, left-right bridging para.), which spike protein would have sequence identity of at least 40% with SEQ ID NO:337.
For claims 30-31 and 33, the reference teaches the fusion protein is for clinical use as a pharmaceutical composition for treating SARs-CoV (entire reference), and would necessarily contain a pharmaceutical carrier.
Narang
Claims 1-4, 6-7, 10, 30-31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Narang (Sorrento Collaborates with Mabpharm on Development and Commercialization of ACE-MAB to Potentially Treat COVID-19. PharmaShots Newswire Press Release. 3/24/2020; cited in IDS).
The instant claims recite a fusion protein comprising a neutralizing polypeptide that binds to a receptor binding domain (RBD) of a first coronavirus spike protein, a peptide linker, and an antibody that specifically binds an epitope in a conserved region of a second coronavirus spike protein.
Narang, throughout the publication, teach a fusion protein, ACE-MAB.
For Claims 1-4, Narang, throughout the publication, teach a fusion protein, ACE-MAB, where the MAB is “a fully human antibody that targets the pike protein of SARS-CoV-2 with high affinity” (reads on the antibody), and the ACE is a “truncated ACE2 protein that binds to a different epitope of the spike protein (i.e, polypeptide that binds to a receptor binding domain (RBD), the ACE2 receptor ectodomain of claims 2-3, and neutralizing antibody of claim 4). (p.2, para 5).
The ACE-MAB fusion protein (i.e. linked proteins) of the reference would necessarily or inherently has a peptide linker since any fragments in between the truncated ACE2 and MAB (antibody) would read on the peptide linker.
For Claims 6-7, the recitation of the “conserved region” of the coronavirus spike protein is a recitation of intended use. The reference teaches the antibody (MAB) binds to the spike protein of SARs-CoV-2 (p.2, para 5), which spike protein would have sequence identity of at least 40% with SEQ ID NO:337.
For Claims 10-11, the ACE2 and MAB of the reference bind to the Spike protein noncompetitively, as evidenced by Wang et al. (discussed above) since the Narang fusion protein is the same as the one disclosed in Wang et al.
For claims 30-31 and 33, the reference teaches the fusion protein is for clinical use as a pharmaceutical composition for treating SARs-CoV (entire reference), and would necessarily contain a pharmaceutical carrier.
Qian
Claims 1-4, 6-7, 10, 30-31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qian (Ig-like ACE2 protein therapeutics: A revival in development during the COVID-19 pandemic. MABS. Vol. 12(1): 1-3; Published online 7/7/2020; Posted online 6/16/2020. See the attached last page of the attached copy of the reference.).
Qian et al, throughout the publication, teach various fusion proteins developed for treating COVID-19 (e.g. Abstract).
For Claims 1-4, Qian et al, teach various fusion proteins including ACE2-Ig, STI-4398, STI-4920 (Anti-spike antibody/truncated ACE2 bispecific fusion) (e.g. p.2, Table 1), which the STI-4920 reads on the instant claimed fusion polypeptide with the Anti-spike antibody, and the “truncated ACE2” as the polypeptide that binds to a receptor binding domain (RBD), the ACE2 receptor ectodomain of claims 2-3, and neutralizing antibody of claim 4.
The STI-4920 fusion protein (i.e. linked proteins) of the reference would necessarily or inherently has a peptide linker since any fragments in between the truncated ACE2 and the antibody would read on the peptide linker.
For Claims 6-7, the recitation of the “conserved region” of the coronavirus spike protein is a recitation of intended use. The reference teaches the antibody binds to the spike protein of SARs-CoV-2 (p2, left-right bridging para.), which spike protein would have sequence identity of at least 40% with SEQ ID NO:337.
For Claims 10-11, the ACE2 and MAB of the reference bind to the Spike protein noncompetitively, as evidenced by Wang et al. (discussed above) since the Qian fusion protein (STI-4920) is the same as the one disclosed in Wang et al.
For claims 30-31 and 33, the reference teaches the fusion protein is for clinical use as a pharmaceutical composition for treating SARs-CoV (entire reference), and would necessarily contain a pharmaceutical carrier.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Wang and Stamatatos
Claims 1-4, 6-7, 10-11, 13, 15-16, 19, 22-25, 29-31 and 33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wang et al (WO2021/189245; filed on 3/24/2020; or earlier; Machine Translation also attached Citation below refer to the Machine Translation copy), in view of Stamatatos et al (WO2021/222128; filed on 4/26/2021 or earlier 4/27/2020).
Wang et al, throughout the publication, teach bifunctional fusion protein binding to a coronavirus comprising anti-SARS-CoV/CoV2 antibody and ACE2, as discussed above.
Wang et al do not explicitly teach the antibody that binds to the spike protein comprises the specific heavy or light chain amino acid sequences of claims 15 and 16.
However, Stamatatos et al, teach “neutralizing monoclonal antibodies against COVID-19” (SARs-CoV-2) (e.g. Abstract). Stamatatos teaches SEQ ID NO:53 as the heavy chain variable region of an anti-spike antibody (e.g. p.2. ll. 15+; Claims 1, 4; p. 10, ll 30+), which matches the instant SEQ ID NO:1, 153, 171 and 189, and SEQ ID NO:54 as the light chain variable region of the anti-spike antibody (e.g. p.2. ll. 15+; claims 1, 4; p. 10, ll 30+), which matches the instant SEQ ID NO:77, 215, 233 and 242. The reference also teaches antibodies can be bispecific (e.g. p7, ll. 25) and fusion proteins with ACE2 and Fc (e.g. p.6, lines 25+). The reference also teaches the need for identifying/generating anti-SARS-CoV2 antibodies (such as neutralizing antibodies) for the development of effective vaccine, therapeutic intervention, and screening tools. (e.g. p.2, lines 4+).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fusion protein taught by Wang et al with the antibodies of Stamatatos for the purpose of generating effective vaccine and/or treatment for SARS-CoV or SARS-CoV2 or other coronaviruses. In addition, because both the Wang reference and Stamatatos reference teach making and using antibodies against the Spike protein of coronavirus are known and routine in the art, it would have been obvious to one skilled in the art to substitute one type of antibodies (ones taught by Wang) for the other antibodies (ones taught by Stamatatos) to achieve the predictable result of generating a fusion protein of bispecific binding function, and desired neutralization potency based on the specific antibodies and ACE2 sequence used.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since both Wang and Stamatatos have demonstrated generating bispecific antibodies and/or fusion proteins with different binding specificity are known and routine in the art .
Narang, Stamatatos & Towler
Claims 1-4, 6-7, 10, 11, 13, 15-16, 19, 22-25, 29, 30-31 and 33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Narang (Sorrento Collaborates with Mabpharm on Development and Commercialization of ACE-MAB to Potentially Treat COVID-19. PharmaShots Newswire Press Release. 3/24/2020; cited in IDS), in view of Stamatatos et al (WO2021/222128; filed on 4/26/2021 or earlier 4/27/2020) and Towler et al (The Journal of Biological Chemistry. Vol. 279(17): 17996-18007; 2004).
Narang, throughout the publication, teach a fusion protein, ACE-MAB, as discussed above.
Narang et al do not explicitly teach the sequence of ACE2 receptor such as SEQ ID NO:270 as recited in claim 13. The reference also does not explicitly teach the antibody that binds to the spike protein comprises the specific heavy or light chain amino acid sequences of claims 15 and 16. The reference also does not explicitly teach the inherent property of increased potency of claim 19. The reference also does not explicitly teach vector, host cells, and method of making the fusion protein of claims 22-25 and 29.
However, Stamatatos et al, teach “neutralizing monoclonal antibodies against COVID-19” (SARs-CoV-2) (e.g. Abstract). Stamatatos teaches SEQ ID NO:53 as the heavy chain variable region of an anti-spike antibody (e.g. p.2. ll. 15+; Claims 1, 4; p. 10, ll 30+), which matches the instant SEQ ID NO:1, 153, 171 and 189, and SEQ ID NO:54 as the light chain variable region of the anti-spike antibody (e.g. p.2. ll. 15+; claims 1, 4; p. 10, ll 30+), which matches the instant SEQ ID NO:77, 215, 233 and 242 of claims 15-16. The reference also teaches antibodies can be bispecific (e.g. p7, ll. 25) and fusion proteins with ACE2 and Fc (e.g. p.6, lines 25+). The reference also teaches the need for identifying/generating anti-SARS-CoV2 antibodies (such as neutralizing antibodies) for the development of effective vaccine, therapeutic intervention, and screening tools. (e.g. p.2, lines 4+). The reference also teaches the routine methods of generating vectors and host cells for making the antibodies (e.g. pp.7-8, bridging para; p.15), which reads on the vector, host cells, and method of making the fusion protein of claims 22-25 and 29.
Towler et al., throughout the reference teach ACE2 protein and its sequence (e.g. Abstract; pp.17998), which the sequence match SEQ ID NO:270 of claim 13. The reference also teaches the ACE2 is the cell receptor to which the coronavirus’ spike protein binds and blocking binding would prevent infection (e.g. Abstract; p.17996; 18006, left col., para 4).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fusion protein taught by Wang et al with the antibodies of Stamatatos for the purpose of generating effective vaccine and/or treatment for SARS-CoV or SARS-CoV2 or other coronaviruses. In addition, because both the Wang reference and Stamatatos reference teach making and using antibodies against the Spike protein of coronavirus are known and routine in the art, it would have been obvious to one skilled in the art to substitute one type of antibodies (ones taught by Narang) for the other antibodies (ones taught by Stamatatos) to achieve the predictable result of generating a fusion protein of bispecific binding function, and desired neutralization potency based on the specific antibodies and ACE2 sequence used.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate/make the fusion protein of Narang using the standard and routine techniques of cloning with DNA vector, expressing using host cells, etc as taught by Stamatatos.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Narang, Stamatatos and Towler have demonstrated generating bispecific antibodies and/or fusion proteins with different binding specificity are known and routine in the art.
Conclusion and Correspondence
No claims are allowed.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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