DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 10-14 and 16-20 are pending.
Claims 15 and 21 have been cancelled.
Claims 10 and 16 have been amended.
Claims 10-14 and 16-20 are examined on the merits.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 103
3. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
4. The rejection of claim(s) 10-14 and 16-20 under 35 U.S.C. 103 as being unpatentable over Hwu et al., WO 2017/049199 A1 (published 23 March 2017/ IDS reference #2 on sheet 1 submitted September 30, 2022), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017) is withdrawn in light of Applicant’s amendment to claims 10 and 16 and arguments set forth in the Remarks set forth on pages 6-9, 12 and 13 submitted September 18, 2025. Furthermore, given the primary reference, Hwu reads on liposomal irinotecan, e.g., MM-398, the instant rejection falls. Claims 15 and 21 have been cancelled.
5. The rejection of claim(s) 10 and 16 under 35 U.S.C. 103 as being unpatentable over Cao et al., WO 2016/054555 A2 (published 7 April 2016), and further in view of Drummond et al., US 2018/0110771 A1 (effectively filed July 10, 2017) is withdrawn in light of Applicant’s amendment to claims 10 and 16 and arguments set forth in the Remarks set forth on pages 9 and 10 submitted September 18, 2025. Claims 15 and 21 have been cancelled.
6. The rejection of claim(s) 10-14 and 16-20 under 35 U.S.C. 103 as being unpatentable over Cao et al., WO 2016/054555 A2 (published 7 April 2016), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017) and Drummond et al., US 2018/0110771 A1 (effectively filed July 10, 2017) is withdrawn in light of Applicant’s amendment to claims 10 and 16 and arguments set forth in the Remarks set forth on pages 9-11 submitted September 18, 2025. Furthermore, given the primary reference, Hwu reads on liposomal irinotecan, e.g., MM-398, the instant rejection falls. Claims 15 and 21 have been cancelled.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 102
7. 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.
8. The rejection of claim(s) 10 and 16 is/under 35 U.S.C. 102(a)(1) as being anticipated by Cao et al., WO 2016/054555 A2 (published 7 April 2016) is maintained.
Applicant states “…the rejection is improperly based on selection of each of the elements of applicant’s claims from separate, lengthy lists found in Cao, applicant disagrees that Cao can be interpreted to anticipate Applicant’s claims 10 and 16.”, see Remarks submitted September 18, 2025, page 4, last paragraph (para.).
Applicant argues “…Cao’s basic combination therapy does not include irinotecan, [thereby] the Office action is forced to rely on a side disclosure in Cao…”, see page 5 of the Remarks and in particular, 2nd paragraph. The remainder of Applicant’s arguments continually assert there are lengthy lists of other therapies and various different types of cancers, the Office failed to find actual teachings in Cao of the claimed invention, as well as inferred one of ordinary skill in the art would not have at once envisaged the claimed invention, see pages 5 and 6 of the Remarks.
Applicant’s arguments have been carefully considered, but fail to persuade.
The Examiner has met the criteria for setting forth a proper prima facie obviousness type rejection. Additional teachings within the Cao WO document as cited in Applicant’s Remarks on pages 4-6, does not preclude the instant rejection set forth herein.
Teachings amongst other embodiments do not preclude those teachings from reading on the claim limitations. “[W]hen the species is clearly named, the species claim is anticipated no matter how many other species are additionally named”, see Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “, see MPEP 2123, section II. The prior art references must be considered in their entirety.
Accordingly, the rejection is maintained as the irinotecan (Camptosar®) disclosed in Cao is not in the form of a liposomal preparation.
Cao discloses treating a subject in vivo using an immunomodulatory agent such as an anti-PD-L1 antibody in a pharmaceutical combination with a second agent to treat cancerous growths, see page 6, lines 22-30; page 11, lines 1-3; Pharmaceutical…beginning on page 144; and page 153. The pharmaceutical composition can be prepared with a pharmaceutically acceptable carrier, such as salts, see paragraph bridging pages 145 and 146.The combination therapy includes a chemotherapeutic agent such as irinotecan (Camptosar®), see page 158, lines 7, 8 and 19. It is art known Camptosar® is the brand name for irinotecan hydrochloride.
Breast cancer can be treated with the combination, see page 153, lines 21-27; and page 154, lines 3-9.
9. Claim(s) 10-13 and 16-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dranoff et al., WO 2017/019896 A1 (effective filing date 28 July 2016). Dranoff discloses methods of treating breast cancer with a combinatorial approach, wherein the combination comprises one or more therapeutic agents including an inhibitor of an immune checkpoint molecule, PD-L1, with irinotecan, see page 6, lines 23-32; page 9, lines 1-25; page 11, lines 1-21; page 140, lines 9-19; page 143, lines 20-26. The anti-PD-L1 antibody may be MDPL320A (atezolizumab), MSB0010718C (avelumab), MEDI-4736 (durvalumab), see page 142, lines 18-23; and page 143, lines 11-26.
Claim Rejections - 35 USC § 103
10. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
11. Claim(s) 10-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al., WO 2016/054555 A2 (published 7 April 2016), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017). Cao teaches treating a subject in vivo using an immunomodulatory agent such as an anti-PD-L1 antibody in a pharmaceutical combination with a second agent to treat cancerous growths, see page 6, lines 22-30; page 11, lines 1-3; Pharmaceutical…beginning on page 144; and page 153. The pharmaceutical composition can be prepared with a pharmaceutically acceptable carrier, such as salts, see paragraph bridging pages 145 and 146.The combination therapy includes a chemotherapeutic agent such as irinotecan (Camptosar®), see page 158, lines 7, 8 and 19. It is art known Camptosar® is the brand name for irinotecan hydrochloride.
Breast cancer can be treated with the combination, see page 153, lines 21-27; and page 154, lines 3-9.
Cao does not teach the anti-PD-L1 antibody is atezolizumab, avelumab, durvalumab, KN035, CX-072, LY3300054 and FAZ053.
However, Korman teaches “the PD-1 pathway inhibitor is an anti-PD-L1 antibody is atezolizumab, durvalumab, avelumab, LY3300054, CX-072, FAZ053, KN035, see page 5, section 0014.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Cao and Korman to implement a variety of different PD-L1 antibodies as these antibodies bind to the same epitope region and share functional properties, see Abstract; and pages 32-34.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both, Cao and Korman, PD-L1 antibodies with an additional anticancer therapeutic can contribute to tumor shrinkage, suppression of tumor growth and enhanced response rate in the treatment of breast cancer, see Cao in its entirety; and Korman in its entirety and in particular, VII. Outcomes on page 42.
12. Claim(s) 10-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dranoff et al., WO 2017/019896 A1 (effective filing date 28 July 2016), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017). Dranoff teaches methods of treating breast cancer with a combinatorial approach, wherein the combination comprises one or more therapeutic agents including an inhibitor of an immune checkpoint molecule, PD-L1, with irinotecan, see page 6, lines 23-32; page 9, lines 1-25; page 11, lines 1-21; page 140, lines 9-19; page 143, lines 20-26. The anti-PD-L1 antibody may be MDPL320A (atezolizumab), MSB0010718C (avelumab), MEDI-4736 (durvalumab), see page 142, lines 18-23; and page 143, lines 11-26.
Dranoff does not teach the anti-PD-L1 antibody is KN035, CX-072, LY3300054 and FAZ053.
However, Korman teaches “the PD-1 pathway inhibitor is an anti-PD-L1 antibody is CX-072, FAZ053 or KN035, see page 5, section 0014.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dranoff and Korman to implement a variety of different PD-L1 antibodies as these antibodies bind to the same epitope region and share functional properties, see Abstract; and pages 32-34.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both, Dranoff and Korman, PD-L1 antibodies with an additional anticancer therapeutic can contribute to tumor shrinkage, suppression of tumor growth and enhanced response rate in the treatment of breast cancer, see Dranoff in its entirety; and Korman in its entirety and in particular, VII. Outcomes on page 42.
Conclusion
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
14. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. 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.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
December 9, 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643