DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 45-50 are pending and are under examination.
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 45-50 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 45 is indefinite in the recitation of an antibody or antigen bind fragment that binds to NMDAR2B, “optionally having SEQ ID NO: 1”. It is unclear whether the limitations refer to the fact that antibody or antigen binding fragment optionally has SEQ ID NO: 1, or whether the eNMDAR2B optionally has SEQ ID NO: 1. Claim 45 is further indefinite for several other reasons.
The claim recites that the antibody or antigen binding fragment comprises a VH comprising CDR-H1, CDR-H2, and CDR-H3, and VL comprising CDR-L1, CDR-L2 and CDR-L3, wherein the CDRs are defined by particular SEQ ID NOS. listed in (A)-(F). The various options are separated by an and/or. In other words the claim would require selecting at least one SEQ ID NO. For example, a CDR-H1 of SEQ ID NO: 82 could be selected from the list in (A)-(F) to satisfy the claim limitation. However, the claim further requires a two part optional limitation wherein: part (I) lists CDR sets in (i)-(ix), and part (II) recites “an affinity matured variant of any of the foregoing.” What is the metes and bounds of “the foregoing”. Is it only the optional limitations set forth in (i)-(ix)? Would it also apply to the CDR limitations set forth in parts (A)-(F)? Would the claim therefore encompass affinity matured variants of the CDR selected in the prior options (A)-(F)? Or would the claim require selecting at least one sequence from (A)-(F)? The scope of the claimed optional affinity matured variant is unclear and indefinite.
Claim 45 is also indefinite in the recitation of, for example, a CDR-H1 contained in SEQ ID NO: 81. SEQ ID NO: 81 represents a VH region. It is unclear which specific residues are encompassed as the CDR-H1, since different numbering schemes and CDR definitions exist in the art, and the specification does not define the scope of CDRs. For example, would the claims encompass CDRs as defined by IMGT, Kabat, paratome? Would the claims encompass mixing an matching different CDRs using different numbering schemes? The specification discloses exemplary embodiments, for example, SEQ ID NO: 82 as CDR-H1 from SEQ ID NO: 81. However, this is not a limiting definition and the scope of what specific residues would be required for each CDR “contained in” the recited VH and VL SEQ ID Nos. cannot be established.
Claim 45 is also indefinite in the recitation that the CDRs “comprise or consist of” the recited SEQ ID NOs. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation of comprising and the claim also recites consisting of which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 46 is unclear since it uses so many nested optionally limitations that the scope of the claim cannot be established. For example, the claim recites “optionally” an antigen binding fragment according to claim 45, “further optionally” wherein the antigen binding domain comprises an option defined in limitations part i)-iii), followed by numerous other further optionally limitations. Is the further optionally limiting the original recitation of the antigen binding domain, or the “optional” antigen binding domain of claim 45? Each further optionally limitation recited thereafter is also unclear due to the numerous further optionally limitations recited for each. Claim 46 is also indefinite in the recitation of the same CDRs as those contain in the recited SEQ ID NOS for the reasons set forth above. Claim 46 also lacks antecedent basis for “said respective”. The recitation of the particular fusion proteins construct in (i)-(xIii) in combination with parenthetical SEQ ID NO is also unclear since it is a broad recitation coupled with a narrow recitation. For example, would the claim encompass any CD28 as implied in the formula, or would it require the CD28 of the SEQ ID NO: in the parentheses.
Claim 47 lacks antecedent basis for the recitation of “the VH encoding polynucleotide” or “the VL encoding polynucleotide” and also recites nested optionally limitations and recites “the CDRs” as those contained in SEQ ID NO: 81 that render the claims indefinite for the same reason set forth above.
Claims 49-50 are indefinite for the use of multiple different nested “optionally” limitations which renders the scope of the claim unclear and indefinite. While the use of optionally as alternative language, such as containing A, B, and optionally C, can be considered definite, the instant claims set for a list of several distinct optionally limitations that vary in scope and ambiguity arises as to the scope of the claims. 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. For example, claim 50 is directed to a method of treating a subject, and then recites a preference in an optional limitation that the method is for treating cancer, and then a further preference in a further optionally limitation that the cancer is selected from particular types. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Claim 50 encompasses a genus of treatment methods with a genus of antibodies. Antibodies are broadly claimed and could be agonists or antagonists with different functions. For example, if antagonist function is required for treatment cancer, the use of “optionally” a method of treating cancer could imply that the scope of the antibodies would be limited to those that at least function to treat cancer as optionally required. Or would the claims encompass non-cancer treating antibodies? Claim 49 recites numerous nested optionally limitations creating broad ranges and narrow ranges and is also indefinite for the same reasons. As another example, see part (iv) of claim 49, where it cannot be established which elements correspond to which limitations or which limitations are intending to be optional. For example, is the “antibody or antibody fragment against a cancer antigen or the than NMDAR2B part of the optional limitation? Is it a separate chemotherapeutic or therapeutic agent? In part iii(, are the optionally agents require to be chemotherapeutic agents, or are they merely alternative embodiments to the chemotherapeutic agents? It is also noted that claim 49 recites in part (iv) “PO-L1” and it is not clear what this refers to. Is it meant to refer to PD-L1?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 46 is directed to a CAR comprising an antigen binding domain that binds to human NMDAR2B, “optionally wherein the antigen binding domain is an Ab or Ab fragment according to claim 45”. The limitations that refer to claim 45 are optional and not required elements, and therefore claim 46 fails to include all the limitations of the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 40-45 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of antibodies or fragments thereof that bind to NMDAR2B, or CAR comprising an antigen binding domain that binds to human NMDAR2B.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, 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 MPEP 2163.
The instant claims are directed to a genus of antibody or antibody fragments that bind to NMDAR2B, wherein the antibodies or fragments are defined by a partial structure, a single CDR. The claims also encompass affinity mature variant of any of the foregoing, which would include CDR variants. The claims also NMDAR2B antibodies having a genus of different CDRS from distinct antibodies. For example, SEQ ID NO: 82-84 represent CDRH1-3 from a particular antibody VH, but the present claims encompass paring SEQ ID NO: 82 as VHCDR1 with SEQ ID NO: 103 as VHCDR2, wherein said SEQ ID NO: 103 is from a completely different antibody. Overall, the claims encompasses an enormous genus of structurally distinct antibodies with different CDR sequences. For example, the claims would encompass an anti-NMDAR2B antibody with a defined CDRL1 of SEQ ID NO: 87, wherein the other 5 CDR can have any amino acid sequence. The claims would encompass antibodies having numerous substitutions, deletions, or additions to any of the CDRs, i.e. “affinity matured variants”. Claim 46 is directed to a CAR comprising any antigen binding domain that binds to human NMDAR2B, optionally comprising a sequence having 80% identity the certain scFV SEQ ID NOS:, or those that compete for binding to said scFV. Claim 46 is not limited to antibody binding domains, and would broadly encompass any structure that function to bind to human NMDAR2B. The optional limitations of scFV having at least 80% identity would encompass variants including those with CDR substitutions, additions and deletions. Furthermore, competing scFV would encompass a large genus of structurally distinct antibodies that bind the same epitope, or even those that bind a distinct epitope but compete for binding via steric interference, for example. Thus claims require that the antibodies and antigen binding domains or antibodies that function to bind to NMDAR2B, or function to compete for binding to NMDAR2B. Claim 50 encompasses a further functional genus that can treat a subject, including for cancer treatment.
The state of the art is such antibody variable regions are composed of a heavy and light chain, each involved in providing for binding specificity. Variability in the antigen binding site is achieved by V(D)J recombination via heavy and light chain pairing, with the most diverse regions being the 6 CDR regions in the heavy and light chain. While the heavy chain is the most diverse, light chains are also important for binding specificity of antibodies, and swapping light chains can change the antigen specificity of the antibody (see Townsend et al., 2016, pages 1-2, in particular). Furthermore, the light chain repertoire is extremely diverse being encoded by kappa and lambda gene segments, each with different V and J genes. For example, Townsend teaches analysis of 29,000 distinct light chains having significant differences in physiochemical properties. See also Janeway, which teaches that the antibody repertoire in humans is at least 1011, with a large degree of diversity in both heavy and light chains. For kappa light chains, there are approximately 40 functional V gene segments and five J gene segments, and thus potentially 200 different Vkappa regions. Janeway teaches that for lambda light chains, there are approximately 30 functional V lambda segments and four J gene segments yielding 12 possible V lambda regions, so in all 320 different light chains can be make as a result of combination different light chain gene segments. These can also be further varied by a process of somatic hyper mutation. Furthermore, the diversity of the immunoglobulin repertoire is mediated in part by different combination so heavy and light chain V regions that pair to form a unique antibody binding site. See, for example, Rabia, 2018, which teaches that the maximal chemical diversity of antibody CDRs is unimaginably large and is extremely challenging to define the sequence determinant of antibody specificity (see page 4). Furthermore, the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). For example, the CDRH3 of SEQ ID NO: 54 of the present claims is found in a large genus of different antibodies, with different functions that bind to a genus of structurally and functional distinct proteins including FZD7, EGFR, CD3, LRP4, and others (See attached search results). As another example, see US 20210179729, which teaches an antibody having a VH with CDRs identical to SEQI DNO: 72-74 of the present claims, and a VL with CDR1-2 that are identical to SEQ ID NO: 77-78 of the present claims. Even though the antibody 5 of 6 CDRs, as the NMDAR2B binding antibodies of the instant claims, the antibody functions to specifically bind to a completely different antigen, CDCP1. These examples demonstrate that a single CDR, or even 5 CDRS, is not a sufficient structure that correlates with antigen binding function.
Additionally, regarding treating as subject, the development of candidate antibodies involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (see Scott et al, pages 278-279, of record). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (see Scott et al., 2012, page 278, in particular.
The specification does not provide a correlation between structure and function for the antigen binding domains or antibodies as broadly claimed. The specification discloses certain species of antibodies having particular VH/VL pairs with defined CDRH-1-3 andCDRL-1-3. However, these are not sufficiently representative of the claims which encompass a genus of antibodies with as little as a single defined CDR, or a genus of structurally different “antigen binding regions”. Furthermore, no species of competing antibodies are disclosed.
The instant application has not provided a sufficient description showing possession of the necessary 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 genus of antibodies or antigen binding domains encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
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.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Given the claimed broadly class of antibodies and antigen binding domains, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making antibodies with the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibodies and antigen binding domains to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Claims 45-50 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:
An antibody or antigen binding antibody fragment thereof, wherein the antibody or antibody fragment binds to NMDAR2B and comprises a VH and VL, each with three defined CDRs (for example with a CDR-H1, CDR-H2 and CDR-H3 comprising the amino acid sequences set forth in SEQ ID Nos: 82, 83, and 84, respectively, and with a CDRL-1, CDR-L2 and CDRL-3 comprising the amino acid sequences set for in SEQ ID Nos: 87, 88, and 89, respectively,
does not reasonably provide enablement for:
An antibody or antigen binding antibody fragment thereof, wherein the antibody or antibody fragment binds to NMDAR2B comprising a VH comprising CDRH1-H3 and a VL comprising CDRL1-3, wherein (for example) CDR-H1 comprises SEQ ID NO: 82; or affinity matured variants thereof, or CAR comprising an antigen binding domain that binds to human NMDAR2B, or methods of treating a subject with said antibody or antigen binding fragment or said CAR.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The instant claims are directed to a genus of antibody or antibody fragments that bind to NMDAR2B, wherein the antibodies or fragments are defined by a partial structure, a single CDR. The claims also encompass affinity matured variant of any of the foregoing, which would include CDR variants. The claims also NMDAR2B antibodies having a genus of different CDRS from distinct antibodies. For example, SEQ ID NO: 82-84 represent CDRH1-3 from a particular antibody VH, but the present claims encompass paring SEQ ID NO: 82 as VHCDR1 with SEQ ID NO: 103 as VHCDR2, wherein said SEQ ID NO: 103 is from a completely different antibody. Overall, the claims encompasses an enormous genus of structurally distinct antibodies with different CDR sequences. For example, the claims would encompass an anti-NMDAR2B antibody with a defined CDRL1 of SEQ ID NO: 87, wherein the other 5 CDR can have any amino acid sequence. The claims would encompass antibodies having numerous substitutions, deletions, or additions to any of the CDRs, i.e. “affinity matured variants”
The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). For example, the CDRH3 of SEQ ID NO: 54 of the present claims is found in a large genus of different antibodies, with different functions that bind to a genus of structurally and functional distinct proteins including FZD7, EGFR, CD3, LRP4, and others (See attached search results). As another example, see US 20210179729, which teaches an antibody having a VH with CDRs identical to SEQI DNO: 72-74 of the present claims, and a VL with CDR1-2 that are identical to SEQ ID NO: 77-78 of the present claims. Even though the antibody 5 of 6 CDRs, as the NMDAR2B binding antibodies of the instant claims, the antibody functions to specifically bind to a completely different antigen, CDCP1. These examples demonstrate that a single CDR, or even 5 CDRS, is not a sufficient structure that correlates with antigen binding function.
Given the unpredictability in the art, it would require undue experimentation to make the claimed genus of antibodies having as little as a single defined CDR, wherein the antibody can function to bind to NMDAR2B. Doing so would require a trial and error process involving varying the 5 other CDRs, which could be millions of different possible antibodies, with no expectation that any particular antibody would function to bind NMDAR2B.
Regarding claim 46, the claim encompass the same genus of antibodies as claim 45, which are not enabled for the reasons set forth above. However, claim 46 also broadly encompass any antigen binding domain (of any structure) that can function to bind to human NMDAR2B for use in a CAR. For example, this might encompass binding domains of different structures such as a small peptide or a ligand. The state of the art is such that protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340) teach that the prediction of protein function from sequence and structure is a difficult problem, because homologous proteins often have different functions. Thus, making and using the genus fo “antigen binding domains” that can function in a CAR to bind o human NMDAR2B would be highly unpredictable
Furthermore, claim 50 is directed to treating any subject with said antibody or CAR. The claims would broadly encompass treating subjects with different diseases having different etiologies and pathological mechanisms. Even if limited to treating cancer, the state of the art is such that doing so with NMDAR2B binding agents would be extremely unpredictable. For example, Tuzun teaches that anti-NMDAR antibodies can be extremely toxic, and can result in encephalitis and death due to the deposition in the central nervous system. Regarding the use of a CAR for treating subjects, the state of the art is such that doing so with CAR that target antigens that are expressed on non-malignant cells is extremely difficult due to toxicities associated with on-target off-tumor toxicity (See Flugel, 2023). Making and using CAR requires a large amount of experimentation and is highly unpredictable, since CAR treatment is influenced by a myriad of factors, including the number of administered cells, antigen expression densities, CAR design and mode of administration (see Flugel). Therefore, using the genus of antibodies and CAR for treating a subject, as broadly recited in the instant claims would be highly unpredictable.
Based on the breadth of the claims and the unpredictability of the art, the instant specification must provide a sufficient and enabling disclosure, commensurate in scope with the instant claims. The specification discloses certain species of antibodies having particular VH/VL pairs with defined CDRH-1-3 andCDRL-1-3 that function to bind to NMDAR2B. However, this is not commensurate in scope with the instant claims, which encompass an enormous genus of different antibodies having as little as a single CDR from said antibodies, or any “antigen binding domain” that binds to NMDAR2B. No guidance is provided in the specification regarding which other CDR sequences can be paired with a single CDR recited in the claims to provide for NMDAR2B binding, nor is any guidance provided regarding other types of “binding domains”. Regarding the treatment methods, the only examples provided involve treating cancer in a mouse model with infenprodil, which is a small molecule NMDA receptor antagonist. This is not commensurate in scope with the instant claims which encompass a genus of antibodies, including agonist antibodies, for example, or a genus of CAR comprising said antibodies, for treating any subject. No examples or guidance are provided for using any NMDA receptor antibodies to treat any subject. Thus, based on the breadth of the claims, the unpredictability of the art, and the lack of guidance provided by the instant specification, it would require undue experimentation to make and use the antibodies and CAR as broadly claimed.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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