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 .
Reissue: Final Office Action
Procedural Posture
On 08/03/2021: U.S. Patent 11,078,266 issued to Mack et al. with claims 1-8.
On 08/02/2013: Applicants filed U.S. Reissue Patent Application 18/229,565 for U.S. Patent 11,078,266 with claims 1-14.
On 12/01/2026: A non-final Office Action (OA) was mailed rejecting claims 1-14.
On 04/17/2026: Applicants filed a response to the 12/0/26 OA with arguments and amendments.
Status of the Claims
The amendments and arguments filed Apr. 17, 2026 are acknowledged and have been fully considered. Claims 1-14 are now pending and are now under consideration. Claims 2, 5, 6, 8-10, and 14 are amended.
OBJECTIONS/REJECTIONS WITHDRAWN
The objection to claim 2 is withdrawn in light of the claim amendments.
The rejections of claims 1-14 under 35 U.S.C. 251 (designated B and C in the prior OA) are withdrawn in light of the new declaration filed 04/17/2026.
The rejections of claims 5, 6, and 8-14 under 35 U.S.C. 112(a), lack of enablement (designated A, B, and C in the prior OA), are withdrawn in light of the claim amendments.
The rejection of claims 9-14 under 35 U.S.C. 112(b) (designated B in the prior OA) is withdrawn, in light of the claim amendments.
OBJECTIONS/REJECTIONS MAINTAINED
The rejection of claims 1-14 under 35 U.S.C. 251 (designated A in the prior OA) is maintained as discussed below.
The rejection of claims 1-8 under 35 U.S.C. 112(a), lack of written description, is maintained as discussed below.
The rejection of claims 1-8 and under 35 U.S.C. 112(a), lack of enablement (designated A in the prior OA), is maintained as discussed below.
The rejection of claims 1-8 under 35 U.S.C. 112(b) (designated A in the prior OA) is maintained, as discussed below.
Priority
A copy of foreign priority document EP 15194062 was received in parent application 15/775,283. However, a copy of the other foreign priority document, EP 16172551, could not be located in the file of parent application 15/775,283.
Response to Arguments
Applicants state that a copy of the priority document has been submitted with the current response (response, p. 4). However, no copy of the priority document has been filed.
Claim Objections (New)
The amendment filed 04/17/2026 proposes claim amendments that do not comply with 37 CFR 1.173(b) and CFR 1.173(d), which sets forth the manner of making amendments in reissue applications. See also MPEP § 1453.
Specifically 37 CFR 1.173(d) states:
Any changes relative to the patent being reissued which are made to the specification, including the claims, upon filing, or by an amendment paper in the reissue application, must include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined.
The claim amendments to claims 2, 5, 6, 8, 10, and 14 include strikethroughs, which should not be used in reissue claim amendments. Further, claims 9-14 are new claims, and must be completely underlined in each claim listing since amendments in reissue claims are made relative to the claims of the issued patent, not the prior claim set. Furthermore, claims 9-14 should be labeled “new” in the claim identifier throughout prosecution. Finally, 37 CFR 1.173(c) requires, on pages separate from the claim listing, the status of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims; this status document was not provided with the 4/17/26 amendments. As such, the claims do not comply with MPEP § 1453 and 37 CFR 1.173.
As a note for the future, except for the newly added claims (which must be labeled “new” and completely underlined), any second or subsequent claim amendments of patented claims should be accompanied by the claim identifier “twice amended,” “three times amended,” etc., as appropriate. See 37 CFR 1.173(b)(2).
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 new reissue declaration is insufficient. The error statement now indicates that this reissue broadens claim 1 of US 11,078,266. However, the error statement fails to detail how any new claim(s) is/are broader than patented claim 1. 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.
Applicants have not pointed out what the original claims lacked that the newly added claims have, 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.
Finally, applicants point to new claims 9-14 as broader claims, but it is unclear how new claims 9-14 are 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 is inaccurate and therefore cannot be considered to set forth an error correctable by reissue.
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.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive.
The replacement declaration is acknowledged. However, the error statement in the new declaration is still not sufficient. In particular, applicants have not addressed the issue that new claim 9 appears to be narrower, not broader, than original claim 1, as detailed in the prior Office action. Specifically, 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. Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. MPEP 2111.01(IV)(A) (citing Toro Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301, 53 U.S.P.Q.2d 1065, 1069 (Fed. Cir. 1999)). Further, since applicants define "antibody" as encompassing fragments and variants, the "antibody" of claim 1 already appears to encompass "variants" including the subject matter of new claim 9, and it is unclear how any claim (including new claim 9) is broader than patented claim 1.
Applicants should provide an error statement that specifically details how any claim(s) is/are broader than patented claim 1 so that any added breadth may properly be considered.
Claim Rejections - 35 USC § 112(a) (Maintained)
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 remain 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; emphases added).
The specification discloses two species of antibodies produced by hybridoma, DSM ACC3281 (P8C11C8-6) and DSM ACC3164 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 the two produced by hybridoma cell lines DSM ACC3281 or DSM ACC3164, both of 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. 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." Ariad Pharms., Inc. v. Eli Lilly & 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.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicant argues that claims 1-8 "are not directed to a very specific antibody structure" (response, p. 6).
The examiner agrees with this statement. That the claims are not directed to a specific antibody structure and, in fact, encompass fragments and variants is the point of this rejection.
Applicants argue that an artisan would understand that an antibody produced by a hybridoma is a whole antibody that comprises all six CDRs (response, pgs. 6-7).
While this statement is factually correct, the claims must be interpreted in light of the specification. Specifically, col. 10, lines 57-61 of the '266 Patent defines an "antibody" 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). Thus, the "antibody" recited in claims 1-8 encompasses fragments and variants (including those with as few as one CDR) of whole antibodies produced by the recited hybridoma. Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. MPEP 2111.01(IV)(A) (citing Toro Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301, 53 U.S.P.Q.2d 1065, 1069 (Fed. Cir. 1999)). The claims are therefore not limited to whole antibodies comprising all six CDRs.
Scope of Enablement
Claims 1-8 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
A. Claims 1-8: 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 applicants’ definition in the specification, is vast and undescribed by the as-filed disclosure.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that the claims have been amended to antibodies that comprise all six CDRs (response, p. 8).
As discussed above in response to the Written Description rejection, while antibodies produced by hybridomas would contain all six CDRs, the instant claims are not limited to whole antibodies comprising all six CDRs. Rather, the definition of "antibody" at col. 10, lines 57-61 clearly allows for fragments and variants having as few as one CDR. Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. MPEP 2111.01(IV)(A) (citing Toro Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301, 53 U.S.P.Q.2d 1065, 1069 (Fed. Cir. 1999)).
While applicants urge that the phrase "comprising at least one CDR" as only referring to recombinant antibodies, the examiner disagrees with this interpretation. One of skill in this art would understand col. 10, lines 57-61 to encompass fragments or variants having at least one CDR as well. Further, applicants' amendment is instructive. Since applicants have amended claim 9 to require six CDRs, however, that limitation cannot be implicit in claim 1.
Claim Rejections - 35 USC § 112(b) (Maintained)
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 1-8 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.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that the claims have been amended to antibodies that comprise all six CDRs (response, p. 8). Applicants argue that an antibody produced by a hybridoma is a whole antibody that comprises all six CDRs (response, pgs. 10-11).
While this statement is factually correct, the claims must be interpreted in light of the specification. Specifically, col. 10, lines 57-61 of the '266 Patent defines an "antibody" 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). Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. MPEP 2111.01(IV)(A) (citing Toro Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301, 53 U.S.P.Q.2d 1065, 1069 (Fed. Cir. 1999)). Thus, the "antibody" recited in claims 1-8 encompasses fragments and variants (including those with as few as one CDR) of whole antibodies produced by the recited hybridoma. The claims are not limited to whole antibodies comprising all six CDRs. If applicants wish to limit claims 1-8 to whole antibodies comprising all six CDRs, the claim language should be amended to unambiguously reflect this scope.
While applicants urge that the phrase "comprising at least one CDR" as only referring to recombinant antibodies, the examiner disagrees with this interpretation. One of skill in this art would understand the plain meaning of col. 10, lines 57-61, as encompassing fragments or variants having at least one CDR as well. Further, applicants' amendment is instructive. Since applicants have amended claim 9 to require six CDRs, then that limitation cannot also be implicit in claim 1.
Summary/Conclusion
Claim 1-14 are rejected; no claims are currently allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 CFR 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at (571) 272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9900.
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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
Prosecution Insights