Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
2. The amendment filed on 6/18/2025 has been entered into the record and has been fully considered. Claims 52-55, and 65 have been amended. Claims 52-69 are pending in the instant application.
Withdrawn Objection/Rejections
3. Upon consideration of amendment of claim 65 to appropriately depend from claim 64, the rejection under 35 U.S.C. 112, second paragraph, is withdrawn.
4. Upon consideration of amendment of claims to recite a polynucleotide encoding VHCDR1-3 and VLCDR1-3 (claim 52); VH and VL (claim 53), the rejections under 35 U.S.C. 102(a) and 102(b) are withdrawn. The cited references do not teach the claimed VHCDR1-3 or the VH sequences.
5. Upon consideration of amendment of claims, the objection is withdrawn.
New Rejections - Double Patenting
6. 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).
7. 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.
8. 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.
9. Claims 52-55, 58-61, and 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20 of US patent 8,906,367.
10. Although the conflicting claims are not identical, they are not patentably distinctfrom each other because both sets of claims recite nucleic acids encoding antibodies comprising the CDRs as set forth in SEQ ID NOs: 20-22 and 23-25; wherein the heavy and light chain nucleic acids (first and second) are in the same vector. Claim 16 of ‘367 patent is drawn to a method of making an antibody, comprising culturing a cell containing nucleic acid encoding an antibody comprising the CDRs as set forth in SEQ ID NOs: 20-22 and 23-25. As the methods of using nucleic acids in claims 16-20 of the ‘367 patent anticipate instant claims to the nucleic acids themselves, a double patenting rejection is appropriate. See MPEP 804(II)(B).
11. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,906,367.
12. Claims 56-57, 62-63 and 66-69 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16-20 of US patent 8,906,367 in view of Karu et al (ILAR Journal 37: 132-141, 1995). Note that instant claims 52-55, 58-61 and 64-65 are anticipated by claims 16-20 of the ‘367 patent for reasons stated above.
The only differences between the two sets of claims are:
i) Instant claims 56-57, and 62-63 recite that the polynucleotide is a polyribonucleotide and a vector comprising the same, while ‘367 patent claims do not recite polyribonucleotide. However, this would be obvious in view of Karu et al., providing an introduction to deriving and expressing recombinant antibodies (Introduction, last para). The review article teaches antibody genes can comprise mRNA or total RNA (page 134, col 1, last para; col 2, para 1; Figure 3A legend).
ii) Claims 66-69 recite the inclusion of regulatory elements in the DNA construct (vector), while ‘367 claims are silent on this aspect. However, the recited elements used in recombinant polynucleotides were obvious in view of Karu et al. Karu et al teach that the vector (construct) comprises transcriptional promoters, ribosome-binding, translational stop sequences (termination codon), and leader sequence (Figure 3A legend).
13. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,906,367.
Conclusion
14. No claims are allowed.
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/A. D./
Examiner, Art Unit 1675
14 November 2025
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644