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 .
Status of Application, Amendments and/or Claims
1. Claims 80, 85, 88-92 and 95 have been amended, claims 1-79, 81-84, 86-87, 93-94 and 97-115 have been canceled, and new claims 116-133 have been added as requested in the preliminary amendment April 14, 2022.
2. Claims 80, 85, 88-92, 95-96 and 116-133 are pending and under examination in the present application.
Information Disclosure Statement
3. The information disclosure statement (IDS) filed 05/10/2022 has been considered and the references therein are of record.
Nucleotide and/or Amino Acid Sequence Disclosures
4. 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 specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). In particular, the amino acid sequence “GGCCCC” (called G2C4) is present in paragraph [0023] at pp. 11 and 14; twice in paragraph [0031] at p. 30; [0125] at p. 75; [0178] at p. 96; twice in [0216] at pp. 115 and 116; [0372] at p. 167; and claim 116 section (d). Additionally, Table 7A at paragraph [0502] and paragraph [0504] contain amino acid sequences that require sequence identifiers. Applicant is reminded to check the remainder of the specification for any other instances of nucleotide and/or amino acid sequences that are not identified by a SEQ ID NO.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
Claim Objections
5. Claim 116 is objected to because of the following informalities: the claim recites acronyms that are not spelled out in their first use in the claims (i.e., IAPP, TDP-43, FUS, PrPSc). It would be remedial to amend the claim language in claim 116 such that the acronyms are clearly defined. Appropriate correction is required.
6. Applicant is advised that should claim 88 be found allowable, claim 89 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. In the instant case, the antibody of claim 88 is being administered to an individual, and thus any effect of the antibody to decrease cell surface levels of CD33 would occur in vivo, as in claim 89. 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.
7. Claim 80, 85, 88-92, 95-96, and 116-133 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. This is a written description rejection.
Claims 80, 85 and 88 are drawn to methods of inducing or promoting the functionality or proliferation of one or more immune cells in an individual in need thereof (claim 80), decreasing the activity, functionality, or survival of tumor-imbedded immunosuppressor dendritic cells, tumor-imbedded immunosuppressor macrophages, or non-tumorigenic myeloid-derived suppressor cells in an individual in need thereof (claim 85), and decreasing cell surface levels of CD33 on one or more cells in an individual in need thereof (claim 88), wherein the methods each comprise administering an antibody that binds to a CD33 protein, wherein the antibody decreases cell surface levels of CD33 to a greater extent than anti-CD33 antibody lintuzumab. Dependent claims further recite that the claimed antibody: decreases cell surface levels of CD33 with an EC50 that is lower than that of anti-CD33 antibody lintuzumab (claim 90) or the anti-CD33 antibody gemtuzumab (claims 91-92); inhibits one or more CD33 activities (claim 116); binds to one or more peptide sequences or epitopes with human or mammalian CD33 (claims 117-118), competes with one or more antibodies for binding to CD33, or binds essentially the same CD33 epitope as one or more antibodies, the antibodies being defined by their HVR, VH and/or VL sequences (claim 119); binds an inhibitory Fc receptor (claims 122-123); comprises HVR sequences with at least 90% homology to an amino acid sequence of a specific HVR sequence (claims 131); increases phagocytosis by microglia (claim 132), or inhibits interaction between human CD33 and one or more CD33 ligands (claim 133). The claims are thus drawn to methods of using a genus of antibody molecules claimed functionally but with limited or no defined structure.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The factors to be considered when analyzing claims for compliance with the written description requirement include: actual reduction to practice; disclosure of drawings or structural chemical formulas; sufficient relevant identifying characteristics (e.g., disclosure of complete or partial structure, physical and/or chemical properties, structure/function correlation); method of making the claimed invention; level of skill and knowledge in the art; and predictability in the art. See MPEP §2163.
Moreover, with respect to antibodies, the Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
The recitation of an anti-CD33 antibody that decreases cell surface levels of CD33 to a greater extent than anti-CD33 antibody lintuzumab (or gemtuzumab), or that decreases cell surface levels of CD33 with an EC50 lower than that of the anti-CD33 antibodies lintuzumab or gemtuzumab, or that: binds a particular epitope on CD33, competes with selected anti-CD33 antibodies or binds essentially the same epitope as the selected anti-CD33 antibodies, comprises HVR sequences having 90% homology to particular HVR sequences, inhibits CD33 cell surface clustering, activity, or interaction between CD33 and one or more ligands, or inhibits microglial phagocytosis all represent functional characteristics with limited or no structure. The claims thus encompass the therapeutic use of a genus of antibody molecules that bind the requisite antigen, CD33. While generically the structure of an antibody or antigen-binding fragment may be known, the structure of the specific immunoglobulin domains that comprise the antibody can vary substantially within the above given claimed recitations. Thus, the genus is highly variant because a significant number of structural differences between genus members is permitted.
The instant specification teaches the production and characterization of several monoclonal antibodies directed against CD33. Two of these monoclonal antibodies, 2F5 and 6C7 were compared to commericial antibodies gemtuzumab and lintuzumab for binding to human primary dendritic cells, and were found to have lower EC50 values than the commercial antibodies (see [0488] and Figures 5H and 5I). However, none of the other disclosed monoclonal antibodies of the invention appear to have been evaluated for an EC50 value in this assay, and therefore their EC50 values in comparison to the commercial anti-CD33 antibodies is not known. Thus, the specification at best provides only two species of antibodies that fall within the present functionally-claimed genus of antibody molecules.
The light chain variable domain (VL) and heavy chain variable domain (VH) hypervariable region (HVR) sequences for these antibodies, as well as humanized sequences, are also disclosed. Additionally, the CD33 binding region for the disclosed antibodies was also determined (Tables 7A and 7B); the amino acid residues at positions 49 and 52 of CD33 are taught to be critical for CD33 binding for some, but not all, of the disclosed antibodies. Note that dependent claim 131, for example, encompasses not only the 2F5 antibody (choice (c)), but also the (a) 2E12, (b) 2F.1, (d) 6A3a, (e) 6A3b, and (f) 637.2 antibodies. Each of these antibodies comprises different heavy chain and light chain HVRs and/or unique combinations of HVRs (Tables 1 and 2). Epitope mapping for these other antibodies was not performed. Thus, there does not appear to be an apparent structure-function correlation between the particular structure of an anti-CD33 antibody, the function of binding to any particular epitope of CD33, and the function of decreasing CD33 cell surface levels.
Therefore, apart from the specific 2F5 and 6C7 antibodies and their respective HVR sequences disclosed by the specification, the artisan cannot envision all of the possible antibody molecules that have the requisite functions of the claimed invention. The relevant art recognizes, for example, that the diversity of antibodies binding to any particular target antigen or epitope is extremely broad, and therefore there is no way to reasonably predict the structure of the antigen-binding region of an antibody based upon the structure of an antigen or epitope alone (see, for example, Lloyd et al. Protein Eng. Design & Select, 2009, 22(3):159-168; and Edwards et al. J. Mol. Biol. 2003, 334:103-118; both listed on 05/10/2022 IDS). Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus nor guidance as to which of the myriad of molecules encompassed by the claimed antibodies would meet the limitations of the claims.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014, Appeal No. 13-1338 at page 26). Therefore, the full breadth of the claims do not meet the written description provision of 35 U.S.C. 112(a).
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.
8. Claims 80, 85, 88-92, 95-96 and 116-133 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.
The recitations that the administered antibody “decreases cell surface levels of CD33 to a greater extent than anti-CD33 antibody lintuzumab” in claims 80, 85 and 88 and “decreases cell surface levels of CD33 to a greater extent than anti-CD33 antibody gemtuzumab” in claim 91 are relative phrases which render the claims indefinite. The term “greater extent” with respect to a decrease in cell surface levels of CD33 is a relative phrase because it depends entirely on the cell type and the specific testing conditions under which the surface levels of CD33 are measured. Such conditions are not defined by the claim, and therefore one of ordinary skill in the art would not be reasonably apprised of the scope of the invention given the indefiniteness of a “greater extent” than lintuzumab (or gemtuzumab). The metes and bounds of the claims therefore cannot be readily determined.
Regarding claims 90 and 92, the claims each recite the limitation that the claimed anti-CD33 antibody “decreases cell surface levels of CD33 with an EC50 that is lower than that of anti-CD33 antibody lintuzumab” (claim 90) or “gemtuzumab” (claim 92). However, this recitation renders the claims indefinite because this functional limitation is a subjective measure and therefore does not clearly set forth the metes and bounds of the claims. In particular, the term EC50 refers to the concentration of an antibody which induces a response halfway between the baseline and maximum as a function of exposure time (see Wikipedia entry for “EC50”, 09/16/2019; ref #5 on 05/10/2022 IDS). However, as noted by the Wikipedia reference, a drug (or agent or antibody) does not have a single value of EC50 due to different tissues or cells having different sensitivities to the drug. In addition to the time exposure component, EC50 is dependent upon a number of variables, including species, tissue and cell type, and genetics. Therefore, an antibody having an EC50 lower than lintuzumab or gemtuzumab under one set of testing conditions may not have an EC50 that is lower than these anti-CD33 antibodies under a different set of testing conditions. Accordingly, the metes and bounds of the claims are highly variable and dependent upon the specific testing parameters used to determine the EC50 value. See also MPEP 2173.05(g) regarding indefinite functional language in claims.
Note that all claims dependent from claims 80, 85 and 88 have been included in this rejection as they all contain the indefinite limitation(s), yet nothing in addition that would aid in clarifying the 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.
9. Claims 80, 85, 88-92 and 116-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,136,390. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the therapeutic administration of the same anti-CD33. In particular, the anti-CD33 antibody of the patented claims has the HVR and VH sequences of the 2F5.1 antibody, which is choice (b) of present claim 131. Thus, the anti-CD33 antibody of the patented claims is a species which anticipates the genus of anti-CD33 antibodies of the present claims. The patented claims further recite the same limitations of the present claims regarding antibody class and isotype, substitutions to Fc regions, binding to Fc-gamma receptor IIB, cell types that express the CD33 protein, antibody binding region/epitope, type of antibody or antibody fragment, and effects of the antibody on CD33 activity or interactions. Thus, the patented claims anticipate or render obvious the invention of present claims 80, 85, 88-92 and 116-133.
10. Claims 80, 85, 88-92, 116-121, 124-130 and 132-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-11 and 16 of U.S. Patent No. 11,174,313. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the therapeutic administration of an anti-CD33 antibody that decreases cell surface levels of CD33 to a greater extent than the anti-CD33 antibodies lintuzumab and gemtuzumab. In particular, the anti-CD33 antibody encompassed by the patented claims is the C-67 antibody, which is evidenced to reduce the surface level expression of CD33 to a greater extent than either gemtuzumab or lintuzumab (see Fig. 13 of the patent). Thus, the C-67 antibody of the patented claims is a species that anticipates the genus of antibodies of the presently claimed invention. In addition, the patented claims recite the same limitations regarding the antibody and/or its effects on CD33 activity, such as antibody class and isotype, substitutions to Fc regions, antibody epitope, and type of antibody or antibody fragment. Thus, the patented claims anticipate or render obvious the invention of present claims 80, 85, 88-92, 116-121, 124-130 and 132-133.
11. Claims 95-96 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-26 of U.S. Patent No. 11,136,390; and
claims 1-3, 5-11 and 16 of U.S. Patent No. 11,174,313,
each in view of Walker et al. (Neurobiol Aging, 2015 Feb, 36(2):571-582; listed on IDS).
The reasons why the claims of the ‘390 and ‘313 patents anticipate the invention of the present claims is discussed above. In addition, both patents have claims directed to the treatment of an individual having Alzheimer’s disease (AD) using the anti-CD33 antibody of the patents. However, the patented claims do not recite that the individual comprises a variant of CD33, such as the SNP rs3865444AC or SNP rs3865444CC polymorphisms.
Walker et al. teach that the rs3865444 genotype is present in individuals having AD and may contribute to disease pathology. Walker teaches that patients having the rs3865444 C/C or C/A genotypes had over higher levels of CD33 protein in their brains, and particularly within the cortex (see Figs. 5 and 6A).
Accordingly, it would have been obvious to one of ordinary skill in the art to have treated an AD patient having either the rs3865444 C/C or C/A polymorphism as taught by Walker according to the method of the patented claims and thereby arrive at the presently claimed invention. The artisan would have been motivated by the teachings of Walker who demonstrates that AD patients having these polymorphisms can have higher levels of CD33 within their brains, and thus administering an anti-CD33 antibody that decreases CD33 cell surface levels would be particularly therapeutically beneficial to these patients. This is because the artisan has good reason to pursue the known options within his or her technical grasp to obtain predictable results. Such would amount to the combining of prior art elements according to known teachings to arrive at a predictable outcome.
12. Claims 80, 85, 88-92, 95-96, 116-121, 124-130 and 132-133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 84, 100-101, 116 and 118-124 of copending Application No. 17/752,606 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the therapeutic administration of an anti-CD33 antibody having the same functional activity and binding properties, such as decreasing cellular levels of CD33 and/or inhibiting the interaction between CD33 and one or more CD33 ligands. Further, the co-pending claims recite that the individual being treated comprises a variant of CD33, such as the polymorphisms of present claim 96. The co-pending claims also recite the same limitations as in the present claims regarding the claimed antibody including substitutions to the Fc region, type of antibody or antibody fragment, antibody class or isotype, or binding affinity. Additional limitations of the present claims amount to inherent effects of the antibody upon administration to an individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claims are allowed.
Advisory Information
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675