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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/26 has been entered.
3. Claims 12, 13, 21-26 and 28-38 are pending upon entry of amendment filed on .
Claims 12, 13, 21-26 and 28-38 are under consideration in the instant application.
3. In light of Applicant’s amendment to the claims filed on 4/1/26, the rejection under 35 U.S.C. 103 (a) (see sections 5-6 of the office action mailed on 10/7/25) has been withdrawn.
4. The following rejections remain.
5. 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-l.jsp.
6. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,533,058.
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to practice the claimed method by reconstituting the lyophilized composition of ‘058 for use in the instantly claimed method. The disclosure of ‘058 in Table 1 teaches that the CD20 antibodies of the claims are used to treat lymphoma and leukemia as well as CD20 being a recognized antigen on lymphomas and leukemia cells. Reconstitution of the lyophilized composition of ‘058 would provide therapeutic index.
Applicant’s response filed on 4/1/26 has been fully considered but they were not persuasive.
Applicant has asserted that the claimed method does not reduce chemotherapy drug related toxicity where as the dependent claims require administration of NK or NK-92 cells in claim 36 of the instant application
Applicant is reminded that the claim 1 does not require administration of NK cells unlike Applicant’s assertion. Applicant argues the limitations that is not recited.
7. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Pat. 10,966,923.
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to practice the claimed method by reconstituting the lyophilized composition of ‘923 patent for use in the instantly claimed method. The disclosure of ‘923 patent in Table 1 teaches that the CD20 antibodies of the claims are used to treat lymphoma and leukemia as well as CD20 being a recognized antigen on lymphomas and leukemia cells. Reconstitution of the lyophilized composition of ‘923 patent would provide therapeutic index.
In light of discussion above in section 6 of this office action, the rejection is maintained.
8. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 43 of U.S. Pat. 10,507,243.
Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass common,overlapping subject matter. The claims of the ‘243 aptent are directed to method of treating cancer by administration of compositions of polypeptide-albumin nanoparticle complexes comprising CD20 antibodies and paclitaxel providing therapeutic index.
In light of discussion above in section 6 of this office action, the rejection is maintained.
9. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Pat. 10,610,484.
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to practice the claimed method by reconstituting the lyophilized composition of ‘484 patent for use in the instantly claimed method. The disclosure of ‘484 patent in Table 1 teaches that the CD20 antibodies of the claims are used to treat lymphoma and leukemia as well as CD20 being a recognized antigen on lymphomas and leukemia cells. Reconstitution of the lyophilized composition of ‘484 patent would provide for therapeutic index.
In light of discussion above in section 6 of this office action, the rejection is maintained.
10. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Pat. 10.993,911.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of ‘911 patent is directed to lyophilized compositions of antibodies which bind an antigen expressed by a cancer cell. The specification of ‘911 patent discloses antigenic targets which include CD20. Reconstitution of the lyophilized composition of ‘911 patent wherein the antigen is CD20 would result in a complex meeting the limitations of the complex in the instant claims. It would have been obvious to practice the claimed method by reconstituting the lyophilized composition of ‘911 patent for use in the instantly claimed method wherein the antigen was CD20 because the disclosure of ‘911 patent in Table 1 teaches that the CD20 antibodies of the claims are used to treat lymphoma and leukemia as well as CD20 being a recognized antigen on lymphomas and leukemia cells providing therapeutic index.
In light of discussion above in section 6 of this office action, the rejection is maintained.
11. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 10,624,846.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘846 patent are directed to lyophilized compositions of antibodies which bind an antigen expressed by a cancer cell wherein the cancer cell is a leukemia cell or a lymphoma cell and it would have been obvious to reconstitute the lyophilized composition of ‘846 patent and use it for treating the cancer. It is well-known in the art that CD20 is a cellular target for leukemia and lymphoma cells and the specification discloses antibodies to CD20. Reconstitution of the lyophilized composition of ‘846 patent provides method encompassed by the claimed inention wherein the antigen is CD20 would result in a complex meeting the limitations of the instant claims and use for treating cancer by giving an antibody complex which binds an antigen expressed by a cancer cell wherein the cancer cell is a leukemia cell or a lymphoma cell would have been prima facie obvious to one of ordinary skill in the art.
In light of discussion above in section 6 of this office action, the rejection is maintained.
12. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Pat. 10,596,112.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘112 patent encompass common subject matter of treating cancer, including lymphoma and leukemia (see claim 65) with a nanoparticle complex comprising albumin, antibodies having an epitope binding portion and paclitaxel, wherein the antibody binds CD20 (see claim 50). Reconstitution of the lyophilized composition of ‘112 patent wherein the antigen is CD20 would result in a complex meeting the limitations of the complex in the instant claims of providing therapeutic index.
In light of discussion above in section 6 of this office action, the rejection is maintained.
13. Claims 12, 13, 21-26 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-8, 10-11,16-17, 19-20, 26, 34, 37, 40, 43, 71 and 73 of copending Application No. 15/452,669 (notice of allowance mailed on 2/19/25).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to methods of treating lymphoma by administration of nanoparticle complexes comprising albumin, paclitaxel and anti-CD20 antibodies inherently providing therapeutic index.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In light of discussion above in section 6 of this office action, the rejection is maintained.
14. No claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
April 24, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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