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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/23/2026 has been entered.
Status of the Claims
2. Claims 1-19 are the original claims filed on 10/31/2022. In the Preliminary Amendment of 5/8/2023, Claims 1-19 are canceled and new Claims 20-39 are added. Claims 20-39 are all the claims. In the Response of 5/6/2025, Claims 20, 25-29, and 35-39 are amended. Claims 20-39 are all the claims. In the Response of 9/25/2025, claim 20 is amended. Claims 20-39 are all the claims. In the Response of 2/23/2026, claim 20 is amended and claims 21-24, 26-29, 31-34 and 36-39 are canceled. No claims are amended in the Response of 7/23/2026.
Claims 20, 25, 30 and 35 are pending.
Priority
3. USAN 18/051,307, filed 10/31/2022, and having 2 RCE-type filing therein, is a Divisional of 16/362,940, filed 03/25/2019, now U.S. Patent # 11513122, 16/362,940 is a Continuation of PCT/EP2017/074150, filed 09/25/2017, and claims foreign priority to 17166789.2, filed 04/18/2017, and claims foreign priority to 16190591.4, filed 09/26/2016.
Information Disclosure Statement
4. As of 9/10/2026, a total of one (1) IDS is filed: 10/31/2022. The corresponding initialed and dated 1449 form is considered and of record.
Specification
5. The amendment to the specification on 7/23/2026 is considered and entered. Both clean substitute and marked-up copies of the specification are filed.
Withdrawal of Rejections
Double Patenting
6. The rejection of Claims 20, 25, 30 and 35 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11513122 is withdrawn.
The replacement Application Data Sheet filed 2/23/2026 changing the status of the instant application from a continuation to a divisional is entered. The filing receipt of 4/15/2026 is the recordation of the status change.
Rejections Maintained
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
7. The rejection of Claims 20, 25, 30 and 35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained.
The grounds for rejection set forth in the Office Action of 4/15/2026 are maintained for reasons of record for the question of original description support for the two final “wherein” clauses of claim 20.
Applicants allege the “wherein” clause for “said treating” finds support at the last paragraph, page 3; pages 4-5; last paragraph, page 6; paragraph bridging pages 20-21; and Example 3.
Response to Arguments
Notably support for the limitation includes that the DCs express PD-L1 and inhibition of the PD-1 axis through PD-L1 blockade e.g., using the anti-PD-L1 antibody, atezolizumab, is what directly activates DCs (see p. 3, lines 23-27; and p. 4, lines 4-8). Also see Figure 1A for comparison of PD-1 and PD-L1 expression in the human DC. To the extent claims 30 and 35 refer to the patient being PD-L1+, there is no limitation that the DC-related gene signature identifies the DC being PD-L1+.
DC gene signature for PD-L1 expression (and expression) is a critical essential feature of the claimed invention based on Applicants very own citation of examples for the “wherein” clause in the specification. See for example MPEP 2163 stating in part:
"The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art."
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence."
MPEP 2163.05 stating in part:
"A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement."
Applicants allege the “wherein” clause for “said therapeutically effective amount” finds support at page 3; pages 4-5; last paragraph, page 6; page 19, lines 20- 25; paragraph spanning pages 19-20, particularly page 19, line 34 and page 20, line 12; page 25, lines 21-23; and Example 3.
Response to Arguments
Notably support for the limitation includes that the DCs express PD-L1 and inhibition of the PD-1 axis through PD-L1 blockade e.g., using the anti-PD-L1 antibody, atezolizumab, is what directly activates DCs (see p. 3, lines 23-27; and p. 4, lines 4-8). The specification provides explicit support that DC expression of PD-L1 and blocking by an anti-PD-L1 inhibitor directly contributes to DC activation
[0010] It is further demonstrated herein that, upon maturation of DCs, PD-1 expression is downregulated. However, PD-L1 expression increases, which leads to binding of PD-L1 to CD80 on the surface of DCs, sequestering CD80 and preventing binding of CD80 to CD28 for co-stimulation on T cells. Administration of PD-L1 antibodies relieves the CD80 sequestration, enabling further co-stimulation of anti-cancer T cells through CD80/CD28 interaction. This represents the first demonstration of how the PD-L1/PD-1 pathway biologically inhibits DCs in tumor, and functions as an immune checkpoint in anti-cancer T cell priming and activation.
To the extent claims 30 and 35 refer to the patient being PD-L1+, there is no limitation that the DC-related gene signature identifies the DC being PD-L1+.
The rejection is maintained.
Conclusion
8. No claims are allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached on Mon-Fri 9 AM-5 PM.
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, Wu Julie 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.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
Prosecution Insights