Detailed Office 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 the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 10 October, 2025. Claims 9, 11-13, 15-23, and 25 (new) are pending in the instant application.
35 U.S.C. § 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 previous rejection of claims 9-13 and 15-24 under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention, is hereby withdrawn in response to Applicants’ amendment.
35 U.S.C. § 112(a)
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.
Written Description
Amended claims 9, 11-13, and 15-17, as well as new claim 25, are rejected under 35 U.S.C. § 112(a) 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. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. 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. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
Determination of adequate written description requires the Examiner to read and analyze the specification for compliance with 35 U.S.C. § 112(a). In particular, each claim should be analyzed to determine its broadest reasonable interpretation consistent with written description. Each claim should be evaluated to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. The entire application should be reviewed including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Finally, the Examiner should determine whether there is sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time of filing.
The amended claims are still broadly directed toward a method of treating a coronavirus-infected (SARS-CoV-1, MERS-CoV, or SARS-CoV-2) patient suffering from endothelial barrier dysregulation comprising administering an anti-adrenomedullin antibody. The antibody is generated by injecting an animal with an ADM peptide or peptide conjugate, isolating and fusing activated B-cells with a myeloma cell line, and culturing the resulting cells (claim 9). Additional methods of mAb generation such as phage display are also contemplated. However, the broadest claims do not provide any structural information with respect to the antibody of interest. The broadest claims are silent with respect to the variable heavy (VH), variable light (VL), complementarity determining regions (CDRs), and framework regions (FRs). Moreover, the term recited coronaviruses still encompass a large genus of genotypically/phenotypically distinct viruses (Kirtipal et al., 2020). The term anti-adrenomedullin antibody also encompasses a large genus of structurally and functionally distinct antibodies. Absent evidence to the contrary, these antibodies would all be expected to contain different amino acid sequences due to different immunoglobulin gene utilization and somatic mutation. Furthermore, the claims (16 and 17) reference antibodies with upwards of 5-20% genetic variation as compared to the recited sequences. Just considering 5% genetic variation of SEQ ID NO.: 6 (AM-VH-C; 219 aa), would encompass upwards of ~2 x 1034 variant antibody sequences.1 Thus, the claims clearly encompass compasses an inordinate number of antibody variants. However, the disclosure only provides a limited number of anti-ADM antibodies and only examines SARS-CoV-2 infection. No additional antibody structures were provided. The unpredictability associated with antibody development has been well-documented (Edwards et al., 2003). This study demonstrated that 1,000 different antibodies could be generated against a single protein. These antibodies were highly diverse as demonstrated by their extensive heavy and light chain germline usage. It has also been well-demonstrated that single or multiple amino acid substitutions in the VH and VL regions can alter antigen binding (Yuan and Parrish, 2000). However, the specification is silent with respect to the identification of additional antibody variants.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude Applicants were not in possession of a sufficient number of antibodies to support the full breadth of the patent protection desired. Amendment of the claim language to identify the binding specificity of the antibody along with the VH/VL amino acid sequences of any given body would obviate the rejection. Alternatively, the antibodies could be identified by binding specificity and the VHCDR1-3 and VLCDR1-3.
Applicants again traverse and submit that the claimed antibodies can be produced using standard antibody methods of production. It was previously argued that product-by-process claim language is acceptable when it has been used to produce the product of interest. This argument is clearly not persuasive. Applicants are directed toward § 2163 of the M.P.E.P. which clearly states that “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” (emphasis added). In this situation, the various methods of production do not provide a reproducible method for obtaining the same antibody. In fact, the skilled artisan wouldn’t be able to predict the structure of any given antibody utilizing the claimed method.
Furthermore, the claims are directed toward the treatment of a patient infected with the genotypically/phenotypically distinct SARS-CoV-1, MERS-CoV, or SARS-CoV-2 coronaviruses. Furthermore, there is no indication in the disclosure that Applicants contemplated treating any disorder other than those associated with SARS-CoV-2 infection. The disclosure fails to provide a correlation between ADM levels and SARS-CoV-1 and MERS-CoV infections. The disclosure fails to discuss the administration of an anti-ADM antibody to these patient populations.
The claims are also broadly directed toward a therapeutic method employing a broad genus of anti-ADM antibodies. The broadest claims do not recite any specific structural information. Insufficient guidance is provided with respect to the molecular determinants modulating antigen-antibody binding interactions. While the disclosure does provide some limited antibody structures, these are insufficient to support the full breadth of the claimed genus. A series of murine and human anti-ADM clones were identified on pages 69 and 70. Amino acid sequences for a limited number of these clones were provided. The VHCDRs and VLCDRs were well-conserved amongst the clones sequenced. In particular, VHCDRs comprised the following amino acid sequences: VHCDR1-GYSFSRYW; VHCDR2-ILPGSGST; and VHCDR3-TEGYEYDGFDY. The following VLCDRs were identified: VLCDR1-QSIVYSNGNTY; VLCDR2-RVS; and VLCDR3-FQGSHIPYT. Additional VH and VL CDRs were not provided.
As previously set forth, the disclosure does not support a genus directed toward any sundry anti-ADM antibody. It has been well-documented that the skilled artisan cannot predict a priori the structure of any given antibody (Edwards et al., 2003). As previously set forth this study demonstrated that 1,000 different antibodies could be generated against a single protein. These antibodies were highly diverse as demonstrated by their extensive heavy and light chain germline usage. Moreover, both the CDRs and FRs contribute to antigen-antibody binding. The disclosure of a closely related and limited number of clones, all bearing the same VHCDRs and VLCDRs, is insufficient to support the full breadth of the claimed genus.
Furthermore, even where antibody structures have been provided in the claims, the claims still encompass a large genus of antibody variants. The claims encompass antibody variants with upwards of 20% amino acid sequence variation. For the anti-ADM mAb AM-VH-C (SEQ ID NO.: 6), this includes up to ~44 amino acid substitutions, insertions, or deletions. While CDRs were provided, there was no discussion about which amino acids can tolerate substitutions and which portions of the antibody can tolerate insertions or deletions. The disclosure fails to describe the generation, isolation, and characterization of a suitable number of variants, particularly those with therapeutic properties. It has also been well-demonstrated that single or multiple amino acid substitutions in the VH and VL regions can alter antigen binding (Yuan and Parrish, 2000). However, the specification is silent with respect to the identification of additional antibody variants.
Finally, satisfactory disclosure of a "representative number" of species depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, such as antibody generation, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 U.S.P.Q.2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 U.S.P.Q.2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.). Applicants’ arguments have been carefully considered but are not deemed to be persuasive for the reasons of record set forth supra.
Claims 18-23 stand rejected under 35 U.S.C. § 112(a) 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. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. 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. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
Determination of adequate written description requires the Examiner to read and analyze the specification for compliance with 35 U.S.C. § 112(a). In particular, each claim should be analyzed to determine its broadest reasonable interpretation consistent with written description. Each claim should be evaluated to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. The entire application should be reviewed including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Finally, the Examiner should determine whether there is sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time of filing.
The amended claims are broadly directed toward a method of treating a patient with compromised lung function and/or acute respiratory distress syndrome (ARDS), and also suffering from endothelial barrier dysregulation comprising administering an anti-adrenomedullin antibody. The antibody is generated by injecting an animal with an ADM peptide or peptide conjugate, isolating and fusing activated B-cells with a myeloma cell line, and culturing the resulting cells. However, the broadest claims do not provide any structural information with respect to the antibody of interest. The broadest claims are silent with respect to the variable heavy (VH), variable light (VL), complementarity determining regions (CDRs), and framework regions (FRs). The term anti-adrenomedullin antibody encompasses a large genus of structurally and functionally distinct antibodies. Absent evidence to the contrary, these antibodies would all be expected to contain different amino acid sequences due to different immunoglobulin gene utilization and somatic mutation. Furthermore, the claims (22 and 23) reference antibodies with upwards of 5-20% genetic variation as compared to the recited sequences. Just considering 5% genetic variation of SEQ ID NO.: 6 (AM-VH-C; 219 aa), would encompass upwards of ~2 x 1034 variant antibody sequences.2 Thus, the claims clearly encompass compasses an inordinate number of antibody variants. However, the disclosure only provides a limited number of anti-ADM antibodies and only examines SARS-CoV-2 infection. No additional antibody structures were provided. The unpredictability associated with antibody development has been well-documented (Edwards et al., 2003). This study demonstrated that 1,000 different antibodies could be generated against a single protein. These antibodies were highly diverse as demonstrated by their extensive heavy and light chain germline usage. It has also been well-demonstrated that single or multiple amino acid substitutions in the VH and VL regions can alter antigen binding (Yuan and Parrish, 2000). However, the specification is silent with respect to the identification of additional antibody variants.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude Applicants were not in possession of a sufficient number of antibodies to support the full breadth of the patent protection desired. Amendment of the claim language to identify the binding specificity of the antibody along with the VH/VL amino acid sequences of any given body would obviate the rejection. Alternatively, the antibodies could be identified by binding specificity and the VHCDR1-3 and VLCDR1-3.
Applicants again traverse and submit that the claimed antibodies can be produced using standard antibody methods of production. It was argued that product-by-process claim language is acceptable when it has been used to produce the product of interest. This argument is clearly not persuasive. Applicants are directed toward § 2163 of the M.P.E.P. which clearly states that “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” (emphasis added). In this situation, the various methods of production do not provide a reproducible method for obtaining the same antibody. In fact, the skilled artisan wouldn’t be able to predict the structure of any given antibody utilizing the claimed method.
The claims are also broadly directed toward a therapeutic method employing a broad genus of anti-ADM antibodies. The broadest claims do not recite any specific structural information. Insufficient guidance is provided with respect to the molecular determinants modulating antigen-antibody binding interactions. While the disclosure does provide some limited antibody structures, these are insufficient to support the full breadth of the claimed genus. A series of murine and human anti-ADM clones were identified on pages 69 and 70. Amino acid sequences for a limited number of these clones were provided. The VHCDRs and VLCDRs were well-conserved amongst the clones sequenced. In particular, VHCDRs comprised the following amino acid sequences: VHCDR1-GYSFSRYW; VHCDR2-ILPGSGST; and VHCDR3-TEGYEYDGFDY. The following VLCDRs were identified: VLCDR1-QSIVYSNGNTY; VLCDR2-RVS; and VLCDR3-FQGSHIPYT. Additional VH and VL CDRs were not provided.
Clearly, the disclosure does not support a genus directed toward any sundry anti-ADM antibody. It has been well-documented that the skilled artisan cannot predict a priori the structure of any given antibody (Edwards et al., 2003). As previously set forth this study demonstrated that 1,000 different antibodies could be generated against a single protein. These antibodies were highly diverse as demonstrated by their extensive heavy and light chain germline usage. Moreover, both the CDRs and FRs contribute to antigen-antibody binding. The disclosure of a closely related and limited number of clones, all bearing the same VHCDRs and VLCDRs, is insufficient to support the full breadth of the claimed genus.
Moreover, even where antibody structures have been provided in the claims, the claims still encompass a large genus of antibody variants. The claims encompass antibody variants with upwards of 20% amino acid sequence variation. For the anti-ADM mAb AM-VH-C (SEQ ID NO.: 6), this includes up to ~44 amino acid substitutions, insertions, or deletions. While CDRs were provided, there was no discussion about which amino acids can tolerate substitutions and which portions of the antibody can tolerate insertions or deletions. The disclosure fails to describe the generation, isolation, and characterization of a suitable number of variants, particularly those with therapeutic properties. It has also been well-demonstrated that single or multiple amino acid substitutions in the VH and VL regions can alter antigen binding (Yuan and Parrish, 2000). However, the specification is silent with respect to the identification of additional antibody variants.
Finally, as previously set forth, satisfactory disclosure of a "representative number" of species depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, such as antibody generation, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 U.S.P.Q.2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 U.S.P.Q.2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.). Applicants’ arguments have been carefully considered but are not deemed to be persuasive for the reasons of record set forth supra.
Action Is Final
Applicants’ amendment necessitated any and all new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See M.P.E.P. § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 24 January, 2026
1 These calculations were performed as follows: TV=(NY)(X!)/(Y!)((X-Y-1)!), wherein, TV=the total number of variant sequences, N=the number of amino acids or nucleotides that can be substituted (i.e., if any of the 20 naturally occurring amino acids can be substituted, N=19; if any of the four naturally occurring nucleotides can be substituted, N=3), Y=the number of amino acids/nucleotides in the parent sequence that can be substituted (i.e., if the amino acid sequence is 100 aa in length and 10% genetic variation is allowed, Y=10 [100@10%]), and X=the total sequence length of the sequence of interest.
2 These calculations were performed as follows: TV=(NY)(X!)/(Y!)((X-Y-1)!), wherein, TV=the total number of variant sequences, N=the number of amino acids or nucleotides that can be substituted (i.e., if any of the 20 naturally occurring amino acids can be substituted, N=19; if any of the four naturally occurring nucleotides can be substituted, N=3), Y=the number of amino acids/nucleotides in the parent sequence that can be substituted (i.e., if the amino acid sequence is 100 aa in length and 10% genetic variation is allowed, Y=10 [100@10%]), and X=the total sequence length of the sequence of interest.