DETAILED ACTION
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 .
1. Formal Matters
A. In the response dated 12/22/25, Applicants elected Group I and traversed on the grounds that the Examiner has not shown a serious burden in examining all the claims. This argument has been considered, but is not deemed persuasive for the reasons discussed in the restriction requirement dated 6/24/25. Furthermore, searching a method of treating using the product would potentially require a more significant search and may raise issues not encountered when examining a product claim. Therefore, this restriction is deemed proper and is made FINAL. However, any methods of using an allowable product will be considered for rejoinder.
B. Claims 10-29 are pending. Claims 20-29 are withdrawn as being drawn to a non-elected invention. Claims 10-19 are the subject of this Office Action.
2. Specification
A. The use of at least the terms Alexa FluorTM (paragraphs [050], [074]) and Oregon GreenTM ([051]), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
B. If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
C. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
A. Claim 10 is objected to since it recites “at leat 60%” instead of “at least 60%”.
B. Claim 10 is objected to since it should recite “regions” since antibodies have 6 CDRs.
C. Claim 16 is objected to since there should be a space between “thereof” and “of”.
4. Nonstatutory 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.
A. Claims 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 9-11, 14 and 18 of U.S. Patent No. 12,162,937 (17/559,022). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to antibodies comprising identical CDRs, which bind the same epitopes as used in the methods of the patent.
Instant claims 10-13 are met by patent claims 1, 5, 14 and 18. Instant claim 14 is met by patent claim 6. Instant claim 15 is met by claim 9. Claim 16 is met by claim 10. Claim 17 is met by patent claim 11. Instant claim 18 is met over patent claim 1 since the method of treating recited in the patent claims would require the antibody to be in a pharmaceutical composition.
It is noted that the instant application is not a DIV of the patent and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
B. Claims 10-15, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 8 and 10-12 of U.S. Patent No. 11,912,762 (17/234,315). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to antibodies comprising identical CDRs, which binds the same epitopes, as used in the methods of the patent.
Instant claims 10-13 are met by patent claims 1, 7, 8 and 11. Instant claim 14 is met by patent claim 3. Instant claim 15 is met by claim 10. Claim 17 is met by patent claim 12. Instant claim 18 is met over at claim 1 since the method of treating recited in the patent claims would require the antibody to be in a pharmaceutical composition.
It is noted that the instant application is not a DIV of the patent and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
C. Claims 10-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9 and 11-14 of U.S. Patent No. 11,208,479 (16/823,762). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to antibodies comprising identical CDRs, the antibody being used in the method claims of the patent.
Instant claims 10-13 are met by patent claims 1, 4, 5 and 7. Though instant claim 14 does not recite the method of patent claims 9 and 11, the CDRs are identical and would, therefore, bind the same epitopes. Regardless, the antibodies of instant claims 10 and patent claim 1 would be expected to bind the same epitopes given that they recite identical CDRs. Claim 15 is met by patent claim 12. Claim 16 is met by patent claim 13. Claim 17 is met by claim 14. Claim 18 is met by patent claim 6. Claim 19 is met by patent claim 8.
D. Claims 10-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 7, 9, 11, 12, 15 and 17 of U.S. Patent No. 10,633,442 (15/891,802). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to antibodies comprising identical CDRs.
Instant claims 10-13 are met by patent claim 1(b), 5 and 15. Instant claim 14 is met by patent claim 17. Instant claim 15 is met by patent claim 6. Instant claim 16 is met by patent claim 7. Instant claim 17 is met by patent claim 9. Instant claim 18 is met by patent claim 11. Instant claim 19 is met by patent claim 12.
E. Claims 10-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 14-16 of U.S. Patent No. 9,914,775 (14/912,986) in view of U.S. Patent No. 11,208,479. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to antibodies comprising identical CDRs, the antibody being used in the method claims of the patent.
Claims 10-13 are met by claims 1, 14-16 of the ‘775 patent. The patent does not claim monoclonal antibodies. However, claim 7 of the ‘479 patent does.
Claim 14 is met by claim 6 of ‘775. Claim 15 is met by claim 1 of ‘775 in view of claim 12 of the ‘479 patent. Claim 16 is met by claim 1 of ‘775 in view of claim 13 of the ‘479 patent. Claim 17 is met by claim 1 of ‘775 in view of claim 14 of the ‘479 patent. Instant claim 18 is met over patent claim 1 since the method of treating recited in the patent claims would require the antibody to be in a pharmaceutical composition. Claim 19 is met by claim 1 of ‘775 in view of claim 8 of the ‘479 patent. Though the ‘775 patent is drawn to methods of using an antibody, it would have been obvious to have lyophilized the antibody to increase stability and potency during storage.
It is noted that the instant application is not a DIV of ‘775 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
F. Claims 16 and 19 are rejected over U.S. Patent No. 11,912,762 in view of U.S. Patent No. 11,208,479 (claim 13). The teachings of both patents are discussed above. The ‘762 patent does not claim a detectable label, nor lyophilization. However, claim 13 of ‘479 teaches a detectable label and claim 8 of ‘479 teaches lyophilized antibody compositions. Though the ‘762 patent is drawn to methods of using an antibody, it would have been obvious to have lyophilized the antibody to increase stability and potency during storage
G. Claim 19 is rejected over each of (1) U.S. Patent No. 12,162,937, in view of U.S. Patent No. 11,208,479. The teachings of both patents are discussed above. The ‘937 patent does not claim lyophilization. However, claim 8 of ‘479 teaches lyophilized antibody compositions. Though the ‘937 patent is drawn to methods of using an antibody, it would have been obvious to have lyophilized the antibody to increase stability and potency during storage
5. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647