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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claims filed 3/1/23. Claims 1-17 are pending and under examination.
Priority
The instant application has been filed as a continuation-in-part. There does not appear to be any clear identification regarding what Applicant understands to be the new matter introduced into this application that is not supported by the priority documents. However, the U.S. Patent and Trademark Office does not normally examine the papers to determine whether the applicant is in fact entitled to the right of priority and does not grant or refuse the right of priority, except when the application is involved in an interference or derivation proceeding, when necessary to overcome the date of a reference relied upon by the examiner, or when deemed necessary by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 14 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim must depend from other claims only in the alternative. See MPEP § 608.01(n). In this case, the “and” portion of “and/or” means the claim is not depending only in the alternative. Accordingly, the claim 14 has not been further treated on the merits.
Claim 15 is objected to because of the following informalities: “any one of claim 1” should simply be “of claim 1” as it refers only to a single claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 10, 12, and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states “the antibody or the antigen-binding fragment thereof according to claim 1”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 is self-referential (“according to claim 1”), which on its face is indefinite. Moreover, there is no previous recitation of “an antibody” and as such “the antibody” does not have proper antecedent basis. Claims depending from claim 1 (2-8, 10, 12, and 15-17) do not correct this deficiency and are indefinite for the same reason.
Therefore, claims 1-8, 10, 12, and 15-17 are indefinite. Ordinarily, for the purpose of compact prosecution, the Examiner would treat these indefinite claims as depending from the first independent claim and make interpretations so as to provide reasonable prosecution of these claims. However, the very first claim depends from itself, i.e., there is no earlier independent claim. Claim 9 is the only independent claim. However, claim 9 is a nucleic acid encoding an antibody requiring CDRs of SEQ ID NOs: 1-6. Attempting to treat the other claims as depending from claim 9 introduces numerous additional problems. For example, claim 4 would recite the same CDR sequences (1-6) or CDRs which are not the ones required by claim 9. This introduces issues under §112(a), (b) and (d). Moreover, there would be a written description rejection if claim 4 is defined solely by the function of competition, but interpreting the claim to depend from claim 9 would mean that the CDRs of claim 9 are required and therefore there would be no written description problem as all six CDRs are fully defined. As such, it is entirely unclear if there should be a written description rejection of claim 4 or not and there is no clear interpretation to be made. Moreover, an antibody with the same CDRs would necessarily compete with itself, making this interpretation of claim 4 meaningless. Claim 5 part 2 is the same antibody as claim 9, so this interpretation would also result in rejections that may or may not be actually warranted. Claim 8 would not add any additional limitations as claim 9 is already a nucleic acid molecule. Claims 10/11 and 12/13 would simply be duplicates. Claims such as 15-17 would not make sense as they refer to administering an antibody while claim 9 is a nucleic acid, not an antibody. Finally, claim 1 clearly requires some additional limitations because claim 1 does not describe the antibody other than the function, which is already a function of the antibody encoded by claim 9 but not a function of the nucleic acid, to which claim 9 is limited.
For these reasons, no substantive examination of claims 1-8, 10, 12, and 15-17 beyond the 112(b) rejection can be made because there is no reasonable interpretation of “claim 1 according to claim 1” that would not introduce a significant number of additional rejections that may or may not be warranted depending on what the additional limitations are meant to be.
Claims 9, 11, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 states that the CDRs “comprise an amino acid sequence as set forth in” a specific SEQ ID. There are two interpretations of this phrase. The plain meaning of the phrase is that the CDRs comprise any dipeptide in the claimed sequences. For example, KI is “an amino acid sequence” set forth in SEQ ID NO: 5. However, the specification does not provide examples or discussion of fragmented CDR sequences. While the specification is not read as a limitation of the claims, the specification is used to inform interpretation of the claims. The second interpretation is that the CDRs are the whole of the SEQ IDs while allowing for additional residues on either end (“comprises”). This appears to be more consonant with the instant disclosure, but is not unequivocal.
Therefore, claims 9, 11, and 13 are indefinite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 11, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12304967 in view of Weers (US 20160130362; form 892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Reference claim 1 is directed to a fusion protein which comprises a tumor-antigen binding domain. That binding domain is an anti-CD38 antibody (reference claim 4) and the antibody has the same CDRs as instant claim 9 (reference claim 5). Thus, reference claim 5 anticipates the instant antibody.
The reference claims do not claim a nucleic acid encoding the antibody of reference claim 5.
However, the fact that nucleic acids encode proteins is well-established in the art at the time of filing. Weers also claims a nucleic acid encoding a CD38 antibody (claim 90). It would have been obvious at the time of filing to one of ordinary skill to produce a nucleic acid encoding the antibody of the reference claims because this is a well-known method, e.g., Weers, of encoding an antibody.
Regarding claim 11, Weers also teaches the nucleic acid encoded in a vector (claim 91), rendering such a composition obvious for the same reasons.
Regarding claim 13, Weers discloses the vector comprising the nucleic acid encoding the peptide, where the vector is in a host cell (paragraph 115, 116), rendering such a composition obvious for the same reasons.
Claims 9, 11, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11713357 in view of Weers (US 20160130362). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Reference claim 1 is directed to an anti-CD38 antibody with the same CDRs as instant claim 9 (reference claim 1). Thus, reference claim 1 anticipates the instant antibody.
The reference claims do not claim a nucleic acid encoding the antibody of reference claim 1.
However, the fact that nucleic acids encode proteins was well-established in the art at the time of filing. Weers also claims a nucleic acid encoding a CD38 antibody (claim 90). It would have been obvious at the time of filing to one of ordinary skill to produce a nucleic acid encoding the antibody of the reference claims because this is a well-known method, e.g., Weers, of encoding an antibody.
Regarding claim 11, Weers also teaches the nucleic acid encoded in a vector (claim 91), rendering such a composition obvious for the same reasons.
Regarding claim 13, Weers discloses the vector comprising the nucleic acid encoding the peptide, where the vector is in a host cell (paragraph 115, 116), rendering such a composition obvious for the same reasons.
Allowable Subject Matter
No prior art rejection has been set forth in this action. Claim 1 and dependent claims thereof were not examined for prior art as no reasonable interpretation of the limitations of those claims can be made (see above). Claim 9 requires the CDRs to have six specific sequences. Under the interpretation where the whole of those SEQ IDs are required, no prior art was discovered disclosing antibodies with the same CDRs. The CDRs are responsible for the binding properties of an antibody and, importantly, are highly unpredictable when altered by even a single amino acid; see, e.g., Kussie (form 892). Thus, without disclosure of the exact sequences or a clear motivation to arrive at the claimed sequences, the claimed antibody is non-obvious over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675