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. Claims 12, 13, 21-26 and 28-38 are pending upon entry of amendment filed on 9/5/25.
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filed on 9/5/25, the rejection under 35 U.S.C. 112(a) (see sections 4-5 of the office action mailed on 3/7/25) has been withdrawn.
4. The following rejections remain.
5. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. Claims 12, 13, 21-26 and 28-38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. Pub. 2010/0112077(IDS reference) for the reasons set forth in the office action mailed on 3/5/25.
The ‘077 publication teaches treatment of cancer with ABRAXANE (aka the paclitaxel/albumin nanoparticles recited in the claims) and the chimeric anti-CD20 antibody rituximab (see [0099]). Rituximab is a commercially available therapeutic antibody approved by the FDA in 1997 for the treatment of human NHL (a form of lymphoma). The recitation of administering Abraxane meets combining therapeutically effective amount of drug, forming complex required by claim 1. The ‘077 publication refers to such antibodies as encompassed by the term "chemotherapeutic agent" (see [0082]) and discloses that the antibody and nanoparticles can be administered at the same time in the same composition (see [0142],[0236]). The rituximab present (e.g. antibody binds antigen of aberrant cells, specified in example 1-2 of the instant application) in the composition would inherently complex with the ABRAXANE nanoparticles in the composition (as per demonstrated in Example 1 of the specification of the instant application). The ‘077 publication teaches use of paclitaxel in combination with antibody in the claimed methods (see [0135] and [0084]) and that the antibody and nanoparticles can be administered at the same time in the same composition (see [0142],[0236]). The rituximab/paclitaxel present in the composition would inherently complex with the ABRAXANE nanoparticles in the composition. The functional attributes recited in the claims would inherently be found in the prior art because the same composition is administered to the same patient. The particles can be of sizes encompassed by that recited in the claims (see [0040] and [0213]). The particles can be administered intravenously [0152],
Moreover, the ‘077 publication teaches that the nanoparticles and the chemotherapeutic agent may be contained in the same composition (see [0142, 0236]), therefore, it would have been obvious to put both the nanoparticles comprising albumin-bound paclitaxel and the rituximab in the same composition. Given that the prior art nanoparticles comprising paclitaxel and albumin are identical to the claimed nanoparticles comprising paclitaxel and albumin, the composition of the prior art would inherently have the properties of the claimed nanoparticles, absent evidence to the contrary. By putting the nanoparticles and the chemotherapeutic agent(s) in the same composition, the nanoparticle complex would inherently form and therefore, meet the limitations of the instant claims, absent evidence to the contrary. As such, the combining and forming complex achieved by nanoparticles, paclitaxel, albumin and antibody composition provides therapeutic index while reducing side effects.
Applicant’s response filed on 9/5/25 has been considered but they were not persuasive.
Applicant has asserted that the inevitability is critical in inherency and the inherency is not established and the inherency has limited applicability in the context of obviousness.
Unlike Applicant’s assertion, Applicant is reminded that the prior art ABRAXANE is complexed with bevacizumab, albumin carrier, nanoparticles and paclitaxel. Given that the anti-cancer therapeutic antibody includes CD20 antibody (see Rituxan, [0099]) and the antibody binds to its surface antigen, the nanoparticle drugs would be expected to complex as ABRAXANE. Although inevitability has limited applicability in the obviousness, the CD20 antibody would also behave as bevacizumab and form complex required by the claimed invention. As seen in Table 1 of the ‘077 publication, various other antibody is being administered with ABRAXANE. As such, the CD20 antibody is expected to form complex with ABRAXANE and is sufficed inherency issue under obviousness. The rejection is maintained.
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-l.jsp.
8. 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting 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. 10,966,923.
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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting 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 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting 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 1-35 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting 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 1-11 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting 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 1-24 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
14. 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
15. 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.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
16. No claim is allowed.
17. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
18. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Yunsoo Kim
Patent Examiner
Technology Center 1600
October 3, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641