DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 07/08/2024 is acknowledged.
Claims 22-41 are pending.
3. 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.
4. Claims 22-41 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.
(i) Claim 22 is indefinite in the recitation of “CH3 domain,” because its nature is unknown. The meaning of “CH3 domain” is defined in the context of antibody arts, but since it is not clear that the claim relates to antibody arts, the term may be interpreted as referring to e.g. a methyl group.
(ii) Claim 25 is indefinite in the recitation of “light chain polypeptides,” for the same reasons as articulated in subsection (i) above.
(iii) Claims 22 and 38 are indefinite in the recitation of a nucleic acid encoding a polypeptide “complex,” for the following reasons: A nucleic acid may encode one or more polypeptides, as a person of skill in the art would be aware. Once expressed, the polypeptides may or may not form complexes. Therefore, a skilled artisan would not be reasonably apprised of the meaning of nucleic acid encoding a complex.
(iv) Claims 22, 31 and 38 are indefinite in the recitation of a polypeptide which is “linked” to an amino acid residue, because the nature of the “linkage” is not defined (e.g. direct or indirect, covalent or non-covalent, etc.). Applicant is invited to consider using the term “fused,” as in claim 28.
(v) Claim 26 is indefinite in the recitation of a polypeptide which is a “ligand,” because it does not meaningfully limit the genus of polypeptides within the scope of the claim. A “ligand” is any compound that binds to any other compound (or “receptor”), and therefore, in the context of the claim, a ligand may be almost any polypeptide, since almost any polypeptide may bind to something, such as e.g. to an antibody.
(vi) Claims 23-41 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 22-26 and 28-41 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Himmler et al. (US 20110046355).
Himmler teaches dimeric antigen-binding Fc fragments (Fcab) wherein certain regions of the molecule are replaced with different amino acid sequences. Examples include Her2-biding molecules wherein the AB loop of the CH3 region, 358-LTKNQ-362, is replaced with YEGSS (SEQ ID NO: 31) (e.g. [0295] and Table 4).
This molecule is within the scope of polypeptide complex recited in claim 22, because it is an Fc dimer, and as such comprises a first polypeptide comprising a first CH3 domain and a second polypeptide comprising a second CH3 domain. It further comprises a third polypeptide, YEGSS (SEQ ID NO: 31) linked to a first amino acid residue 357 and to a second amino acid residue 363, wherein five amino acid residues (LTKNQ) in a wildtype CH3 domain between the first and the second amino acid residues in the first CH3 domain are deleted.
The third polypeptide binds Her2, and as such is an antigen-binding polypeptide; therefore, the Fcab taught by Himmler is also within the scope of polypeptide complex recited in claims 26, 31 and 38.
Himmler’s Fcabs are recombinantly produced, i.e. Himmler’s teachings include nucleic acids encoding the Fcabs, host cells and methods of producing the Fcabs, thereby anticipating claims 22-24, 26, and 31-41.
Claim 25 is anticipated, because Fcabs are parts of antibody molecules, and as such comprise light chains (e.g. [0155]).
Claim 28 is anticipated, because Fcabs, as homodimers, comprise a second CH3 domain with AB loop substituted by a different sequence, i.e. a fourth polypeptide.
Claims 29 and 30 are anticipated, because Himmler teaches that Fcabs can be fused to other proteins (e.g. [0127], [0165]), and a skilled artisan would at once envisage C-terminal fusions as one of two possible types of fusions.
7. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 22-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11987615.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘615, which are directed to nucleic acid encoding the same polypeptides as recited in instant claims.
Claim 1 of US ‘615 anticipates at least instant claims 22, 31 and 38-39;
the limitations of instant claims 23-24, 36-37 and 40-41 are recited in US ‘615 claims 5-6;
the limitations of instant claims 25-26 and 32-35 and are recited in US ‘615 claims 2-3; and
the limitations of instant claims 27-30 are recited in US ‘615 claims 4 and 7-17.
9. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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