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 .
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
On 8/3/2021 US Patent 11,078,266 issued to Mack et al. with claims 1-8. Claims 1-14 are currently pending and are the subject of this Office Action. Claims 9-14 are newly presented in the instant reissue application. This is the first Office Action on the merits of the claims in reissue Application No. 18/229,565.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 11,078,266 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because copies were not provided in the instant reissue application.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was Dec. 5, 2023.
Priority
A copy of foreign priority document EP 15194062 was received in parent application 15/775,283. However, a copy of foreign priority document EP 16172551 could not be located in the file of parent application 15/775,283.
Claim Objections
Claim 2 is objected to because claim 1 recites an "antibody produced by hybridoma cell line DSM ACC3281". However, claim 2 recites the "antibody or fragment thereof according to claim 1". Since the term "antibody" is defined as encompassing fragments (see col. 10, lines 57-61 of the '266 Patent), the recitation of an "antibody" in claim 1 must be construed as embracing fragments thereof. Thus, this issue is raised as an objection, not a 112(b) or 112(d) rejection. However, the claims should be amended for consistency and to avoid confusion caused by differences in the preambles of the claims.
Appropriate correction is required.
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
A. The error statement in the reissue declaration is insufficient. The error statement references new independent claim 9 and new dependent claims 10-14, but patentee does not detail specifically why the new claims are necessary because the original patent was wholly or partially inoperative or invalid. Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error. The current error statement does not specifically identify the changes or amendments contained in the new claims. Thus, it fails to explain why the original patent is wholly or partially inoperative or invalid because the patentee claimed less than it had the right to claim in the patent.
See MPEP § 1414 II, which states, in relevant part:
It is not sufficient for an oath/declaration to merely state "this application is being filed to correct errors in the patent which may be noted from the changes made in the disclosure." Rather, the oath/declaration must specifically identify an error. In addition, it is not sufficient to merely reproduce the claims with brackets and underlining and state that such will identify the error. See In re Constant, 827 F.2d 728, 729, 3 USPQ2d 1479 (Fed. Cir.), cert. denied, 484 U.S. 894 (1987). Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error. (emphasis added)
A statement in the oath/declaration of "…failure to include a claim directed to…" and then reciting all the limitations of a newly added claim, would not be considered a sufficient "error" statement because applicant has not pointed out what the other claims lacked that the newly added claim has, or vice versa. Such a statement would be no better than saying in the reissue oath or declaration that "this application is being filed to correct errors in the patent which may be noted from the change made by adding new claim 10." In both cases, the error has not been identified.
B. The error statement indicates that the newly added claims seek to broaden the scope to which patentee is entitled. However, the error statement does not identify a claim that the reissue application seeks to broaden.
See MPEP § 1414 II, which states, in relevant part:
What is needed for the oath/declaration statement as to error is the identification of “at least one error” relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. (emphasis added)
Although applicants state that "independent claim 9 and dependent claims 10-14 seek to broaden the claims to scope to which the patentee is entitled", this explanation is not sufficiently specific as it does not identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. Applicants have not pointed out what the original claims lacked that the newly added claim(s) has, or vice versa. Applicants are advised that they must be specific in pointing out these differences (i.e., the new or deleted features) and in explaining how they broaden the claims. Further, applicants must clearly point out at least one claim that the reissue application seeks to broaden.
Finally, it is unclear how applicants believe new claims 9-14 to be broader than any of original (patented) claims 1-8 because new claim 9 requires more complementarity-determining regions (CDRs) than original claim 1. Original claim 1 recites an "antibody", which is defined at col. 10, lines 57-61 of the '266 Patent as encompassing "all immunologically effective units or elements such as whole antibodies, fragments, variants, constructs, or conjugates of antibodies, or recombinant antibodies comprising at least one CDR of an active antibody" (emphasis added). New claim 9 recites an "antibody comprising the CDRs of the antibody produced by hybridoma cell line DSM ACC3281" (emphasis added). Since the antibody produced by hybridoma cell line DSM ACC3281 contains 6 CDRs, as with typical natural antibodies, new claim 9 requires an antibody with 6 CDRs. However, based on the definition at col. 10, lines 57-61 of the '266 Patent, the "antibody" recited by original claim 1 could have as few as one CDR. Thus, new claim 9 appears to be narrower, not broader, than original claim 1.
The error statement in the declaration appears to be inaccurate and therefore cannot be considered to set forth an error correctable by adding claims 9-14 by reissue.
C. Although the application for the original patent appears to have been filed under 37 CFR 1.46 (i.e., the assignee is listed as the applicant on the ADS in the underlying application), the box indicating this to be the case is not checked in the instant reissue declaration.
CLAIM REJECTIONS - 35 USC § 251
Claims 1-14 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office Action.
Broadening Reissue
The instant reissue application was filed on 8/2/2023, which is within two years of the issue date of US Patent 11,078,266 (issued on 8/2/2021); and has clear intent to broaden a claim. However, it is unclear which, if any claim(s), is/are broader than the original claims (see the rejections under 35 U.S.C. 251 designated "A" and "B" above).
Claim Rejections - 35 USC § 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
Claims 1-8 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claim 1 recites a certain anti-hIL-3 antibody. Applicants define "antibody" as "all immunologically effective units or elements such as whole antibodies, fragments, variants, constructs, or conjugates of antibodies, or recombinant antibodies comprising at least one CDR of an active antibody" (col. 10, lines 57-61; emphasis added).
The specification discloses two species of antibodies (produced by hybridoma (DSM ACC3281, or P8C11C8-6) and (DSM ACC3164, or clone 13) ('266 col 16, lines 58-30; col. 17, lines 13-16) that fall within the instant claims. The specification teaches that these two disclosed hybridoma cell lines have been deposited with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) (col. 22, lines 8-14). The specification teaches that the antibody of the invention can be of any origin, e.g., human, mouse, goat, rabbit, and that humanized antibodies are particularly preferred ('266, col. 19, lines 5-13). The specification teaches that to produce a humanized antibody, the CDRs and other regions of an antibody produced in a non-human mammal can be replaced with human sequences ('266, col. 19, lines 39-47). The antibody of the invention can be any anti-hIL-3 antibody, fragment, variant, construct, or conjugate thereof, which comprises the CDRs of the or recombinant antibodies produced by hybridoma cell lines DSM ACC3281 or DSM ACC3164 (col. 18, lines 4-9). Thus, while allowing for an enormous variety of antibody variants (which may comprise only one CDR of an active antibody), the only antibodies actually disclosed are those produced by hybridoma cell lines DSM ACC3281 or DSM ACC3164, which comprise all six CDRs.
However, the specification does not provide any guidance as to the structures of said antibodies that correlate with the defined functions (col. 10, lines 50-61). The specification describes the antigen to which the claimed antibody must bind, but provides no description of how binding of an antibody to that antigen would correlate with any of the desired functions. Binding to IL-3 at some antigen epitopes may not result in the desired activity (e.g., an inhibitory effect on hIL-3), binding at different epitopes/sequences may not affect conformation or activity with the same functional outcome. The specification as originally filed does not disclose any variant antibodies or antigen binding fragments at all, let alone a version comprising only one CDR, that are able to bind and have an inhibitory effect on hIL-3. The specification does not include examples or discussion regarding variant antibodies or fragments thereof having fewer than six CDRs. The exemplified hybridoma-produced antibodies contain all six CDRs. The specification fails to disclose the complementarity-determining regions (CDRs) or any other coding nucleotide or amino acid sequences of the antibodies produced by the hybridoma cell lines.
The specification does not disclose any anti-hIL-3 variants or fragments of antibodies, let alone any such molecules comprising only a single CDR of the parental antibody that have the function applicants define as the “antibody” as having. The specification does not sufficiently describe the necessary structural characteristics of the claimed variant/fragment antibodies comprising fewer than six CDRs, such as a single CDR, to show possession of this genus of compounds. Further, the specification lacks sufficient guidance as to the amino acid sequence of the CDRs that could be predictably altered or removed while retaining the binding specificity of the parent antibody, such that one skill in the art would understand that applicants were in possession of the claimed invention. In view of the claimed broad genus of antibody variants/fragments of the parental antibody and the absence of sufficient disclosure of relevant identifying characteristics of the broadly claimed variant/fragment antibodies, applicants have failed to establish a "reasonable structure-function correlation" either within the specification or by reference to the knowledge of one skilled in the art.
For example, it is recognized in the art that an antigen binding site of an antibody is formed by six CDRs. For example, see Lu (Lu, R.-M., et al. J. Biomed. Sci. (2020), 27(1); 1-30). Lu teaches that antibody engineering has dramatically evolved since the first FDA approval of a monoclonal antibody in 1986 (abstract). One advance in the design and approval of therapeutic antibodies was the generation of the CDR grafting technique, where all of the CDR sequences of a non-human antibody are transplanted into a human framework sequences, allowing the antibody to maintain the binding activity to the antigen (p. 6, 1-2; Fig. 2; p. 11). All of the CDRs are generally required to achieve the affinity of the parent antibody (p. 22, 1st col.). Similarly, Al Qaraghuli (Al Qaraghuli, M. M., et al. Sci. Rep. (2020), 10(1); 13696-13706) teaches the variable regions of antibodies are responsible for antigen recognition. Specifically, the antigen recognition process is accomplished by the six CDRs, occasionally supported by a few residues from the conserved framework regions (p. 13696).
Thus, despite decades of research on the basis of antibody binding, the fundamental tenet that antibodies generally require all six CDRs to maintain specific binding has not changed over time. An adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that applicants were in possession of the claimed genus. See MPEP 2163. In this case, actual reduction to practice of a functional antibody with fewer than all of the CDRs has not been disclosed by applicants in the specification. Applicants have not shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete. Applicants have also not described distinguishing identifying characteristics sufficient to show that applicants were in possession of the claimed invention (i.e., the full scope of antibodies as claimed, with less than all six CDRs (such as one CDR) at the time the application was filed. Accordingly, the specification lacks written description for the subject matter of claims 1-8.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to MPEP §2163. In particular, an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plan for obtaining the chemical invention claimed. An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106). Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP §2163. However, if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP §2163.
A more recent Federal Circuit decision, Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), describes how when an antibody is claimed 35 U.S.C. § 112(a) requires adequate written description of the antibody itself not just a description of the sequence to which the antibody binds. See Amgen, 872 F.3d at 1378-79.
Applicant is alerted that "a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus." AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010). A "generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus." Id. at 1349. “[M]erely drawing a fence around a perceived genus is not a description of the genus.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). “One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus.” Id. “Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” Id.
Scope of Enablement
Claims 1-14 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
A. Claims 1-14: The specification is enabling for making and using antibodies or antigen-binding fragments thereof that specifically bind and have an inhibitory effect on hIL-3, wherein said antibodies (or antigen-binding fragments) comprise all six CDRs. However, the specification does not reasonably provide enablement for making and using antibodies (or antigen-binding fragments thereof) comprising fewer than all six CDRs such as a single CDR. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As discussed in the written description rejection above, the specification discloses two hybridoma-produced monoclonal antibodies (the deposited mAbs) that bind to and have an inhibitory effect on hIL-3 ('266 col 16, lines 58-30; col. 17, lines 13-16). The disclosed antibodies comprise all six CDRs. The specification fails to disclose or discuss antibodies or antigen binding fragments thereof comprising less than all six CDRs, such as a single CDR, with the function applicants define as being characteristic of the claimed antibody.
The state of the engineered antibody art is highly unpredictable, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains and surrounding framework regions of antibodies. This unpredictability of single amino acid changes in an antibody is shown by Winkler and Herold. Winkler (Winkler, K., et al. J. Immunol. (2000), 165(8); 4505-4514) teaches that single amino acid changes in antibody side chains can result in unpredictable and substantial changes in antibody specificity (abstract, 4513). Herold (Herold, E. M., et al. Sci. Rep. (2017), 7; 12276) studied the contributions of the framework regions and CDRs of the antibody Fv module (abstract). Herold teaches that three hyper-variable regions (CDRs) in each of the variable light (VL) and variable heavy (VH) chains comprise the residues interacting with antigens. Herold teaches that residues within the framework regions as well as interface contributing residues of the CDRs influence the VH/VL interface, which is critical for antigen binding (p. 1). Further, CDR1 and CDR3 residues are especially important contributors to the VH/VL interface. Herold concludes that the contribution of various Fv residues is unpredictable, noting that binding to the antigen is affected by each CDR loop differently and changes in loop mobility can in principle affect antigen binding affinity in an unpredictable way (p. 14).
Additionally, Lu and Al Qaraghuli (both discussed in the Written Description rejection above) show the unpredictability in the recombinant or engineered antibody technology. Thus, it is highly unpredictable that antibodies that contain less than all of the CDRs (e.g., a single CDR) of the parent monoclonal antibody would retain the epitope-binding function and affinity of the parent antibody. Despite the progress made toward understanding the interactions of antibodies and antigens, because of the unpredictable nature of the art, much information concerning the specificity and/or affinity of any given antibody cannot be gleaned by routine and conventional experimentation, but instead must be gathered by rigorous and undue experimentation. For these reasons, one of skill in the art would be subject to undue and unreasonable experimentation to make antibodies commensurate in scope with the claimed antibodies comprising fewer than all of the CDRs of the antibodies produced by hybridoma cell lines DSM ACC3281 or DSM ACC3164. In this case, the specification lacks sufficient guidance as to the CDRs or amino acids therein that could be predictably removed/altered while retaining the binding specificity of the parent antibody, such that one of skill in the art would be subject to undue and unreasonable experimentation to make antibodies commensurate in scope with the claimed antibodies comprising fewer than all of the CDRs of the antibodies produced by the disclosed hybridoma cell lines.
The Supreme Court recently visited the question of enablement in the context of claimed antibody genera in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023). The Court found there that while the patent holder exemplified 26 antibodies with the necessary function, the claims were directed to a “‘vast’ number of additional antibodies” that were not described in the disclosure. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613; see MPEP 2164.01(a). Such is the case here because the genus of antibodies in claim 1, given applicant’s definition in the specification, is vast and undescribed by the as-filed disclosure.
B. Claims 5-6: The specification is enabling for a method of obtaining anti-hIL-3 antibodies comprising immunizing an animal with a glycosylated hIL-3 peptide according to claim 5. However, the specification does not reasonably provide enablement for obtaining the anti-hIL-3 antibody as defined in claim 1 using the method described in claim 5. Claim 6 is rejected based on its dependency from claim 5. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 5 recites a "method of obtaining an anti-hIL-3 antibody as defined in claim 1", but requires a method distinct from that required by claim 1. Claim 1 recites an antibody produced by hybridoma cell line DSM ACC3281. Claim 1 is therefore a product-by-process claim that requires an anti-hIL-3 antibody produced by a process involving a specific hybridoma cell line (DSM ACC3281). Hybridoma cell lines make only a single specific monoclonal antibody that recognizes a single epitope (e.g., see col. 22, lines 20-24 of the '266 Patent), and the antibody of claim 1 is defined specifically by the hybridoma cell line which makes it.
In contrast, the process recited in claim 5, in which "an animal" is immunized with a glycosylated-hIL-3 peptide (or active part thereof) would produce polyclonal antibodies that recognize multiple epitopes on the glycosylated-hIL-3 peptide antigen. Further, claim 5 embraces immunization with an "active part" of glycosylated-hIL-3, which allows for an even greater variety of antibodies to be produced. Since different "active parts" will have different configurations (each different active part is essentially a different antigen that will present different epitopes), they will generate different antibodies as a result. Moreover, claim 5 does not limit the species of animal immunized with the glycosylated-hIL-3 peptide (or active part thereof), while the hybridoma cell line of claim 1 was produced by immunizing mice (see col. 22, lines 27-39 of the '266 Patent). In other words, hybridoma DSM ACC3281 produces a murine antibody, while claim 5 is not limited to immunization of mice. Different animals will produce different (polyclonal) antibodies when immunized with the glycosylated-hIL-3 peptide antigen. Finally, the process recited in claim 5 does not involve the creation of any hybridoma cell lines, let alone the specific hybridoma cell line required by claim 1. As such, claim 5 does not allow one to produce the antibody required by claim 1, and claim 5 does not comport with claim 1.
C. Claims 8 and 14: The specification is enabling for a method of inhibiting hIL-3 activity in a patient comprising administering the hIL-3 antibody of claim 1 to the patient. However, the specification does not reasonably provide enablement for decreasing hIL-3 expression levels in a patient comprising administering the hIL-3 antibody of claim 1 to the patient (for claim 8). Similarly, the specification does not reasonably provide enablement for decreasing hIL-3 expression levels in a patient comprising administering the hIL-3 antibody of claim 9 to the patient (for claim 14). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There is no evidence that the IL-3 protein participates in facilitating its own expression from mRNA, and hence no evidence that an anti-hIL-3 antibody (raised against hIL-3 protein) would have any effect on hIL-3 expression levels. Interleukins, including IL-3, are made and secreted under certain circumstances, and have a variety of effects on other cells (see col. 2, lines 46-55 of the '266 Patent). As such, they are not even present within the cell, let alone within the nucleus where translation from mRNA (expression) occurs.
Accordingly, in view of the state of the prior art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the unpredictability of the art and the breadth of the claims, one of skill in the art would be subject to undue and unreasonable experimentation to make and use antibodies commensurate in scope with the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-14 are rejected 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.
A. Claims 1-8 are indefinite in the recitation "antibody produced by hybridoma cell line DSM ACC3281". The antibody produced by hybridoma cell line DSM ACC3281 is presumed to have six CDRs as with typical natural antibodies. However, the term "antibody" is defined at col. 10, lines 57-61 of the '266 Patent as encompassing "all immunologically effective units or elements such as whole antibodies, fragments, variants, constructs, or conjugates of antibodies, or recombinant antibodies comprising at least one CDR of an active antibody" (emphasis added). This definition appears to be at odds with the antibody produced by hybridoma cell line DSM ACC3281. Thus, it is unclear whether the "antibody" recited in claim 1 actually requires all six CDRs as would be the case with the antibody produced by hybridoma cell line DSM ACC3281, or whether the claim allows for variants and fragments thereof per the definition at col. 10, lines 57-61 of the '266 Patent.
B. Claims 9-14 are indefinite in the recitation "the CDRs of the antibody produced by hybridoma cell line DSM ACC3281" in claim 9. As stated in the 35 USC 112(b) rejection "A" above, it is unclear precisely what molecule is required by claim 1 (such as a full-length antibody containing all six CDRs, or a variant/fragment thereof comprising as few as one CDR). Thus, it is unclear if the antibody of claim 9 requires all 6 CDRs that are inherent to the antibody produced by hybridoma cell line DSM ACC3281, or whether it allows for the subset (variants/fragments with as few as one CDR) that may be encompassed by claim 1 based on the definition at col. 10, lines 57-61 of the '266 Patent. Said in another way, since claim 9 recites "the CDRs" (plural), it is unclear if claim 9 requires more than one CDR.
For the purposes of this Office Action, claims 1 and 9 will be interpreted to require all 6 CDRs as would be inherent in the antibody produced by hybridoma cell line DSM ACC3281.
Conclusion
Claims 1-14 are rejected. No claims are currently allowable.
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/Kevin S Orwig/
Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991