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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 12, 2025 has been entered.
DETAILED ACTION
The amendment filed September 12, 2025 in response to the Office Action of March 12, 2025 is acknowledged and has been entered.
Claim 20 has been amended.
Claim 11-19 has been cancelled.
Claim 29-35 has been added.
Claims 20-22, and 25-35 are pending and under consideration.
It is noted that paragraph [0047] and FIG. 21 of the instant publication US 2024/0269254 A1 show increased overall survival and tumor reduction in IV administration of rMVA-CD40L (MVA-AH1A5-p15e-TRP2-CD40L) combined with anti-PD1 checkpoint blockade in C57BL/6 mice bearing MC38 colon cancer (also see Example 17). Prior art does not teach or suggest a recombinant MVA expressing the specific combination of TAAs (AH1A5, p15e and TRP2) and CD40L. Prior art does not teach or suggest administering the claimed recombinant MVA with an anti-PD-1 antibody for reducing tumor size and/or increasing survival in a subject with colon cancer.
The objection to claim 11 set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the cancellation of the claim.
The objection to the Specification set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the amendment to the Specification filed September 12, 2025.
The 112(b) rejection set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the cancellation of the claims.
The 112(d) rejection set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the cancellation of the claim.
The 103 rejection set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the claim amendments and Applicant’s arguments filed September 12, 2025.
The Double Patenting rejection set forth in the previous Office Action of March 12, 2025 is hereby withdrawn in view of the claim amendments.
MAINTAINED/MODIFIED REJECTIONS
Claim Rejections - 35 USC § 112
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.
Claims 25 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to wherein the MVA is MVA-BN® or a derivative of MVA-BN® as deposited with the ECACC under number V00083008. To be enabled one of skill in the art must be able to have access to the deposited MVA-BN® upon grant of the patent.
The specification teaches that MVA-BN® was deposited in compliance with the Budapest Treat. See p. 36-[0140].
Given that deposit was made under the provisions of the Budapest Treaty, applicant must file of an affidavit or declaration by applicants, assignees, or a statement by an attorney of record over his or her signature and registration number stating that the deposits have been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposits will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. See MPEP 2404.01 and Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990). This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves these specific matters to the discretion of each State. For each deposit made pursuant to these regulations, the specification shall contain (MPEP § 1.809(d):
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically
identify it and to permit examination; and
(4) The name and address of the depository.
Response to Arguments
For the 112(a) rejection, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. Because applicant has not filed an affidavit or declaration, the rejection is maintained for the reasons of record.
NEW REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-22, and 25-35 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites both a product (a combination comprising (a) a recombinant modified Vaccinia Ankara (MVA) and (b) an anti-PD-1 antibody) and a process (wherein ((a) and (b) are to be administered as a combination treatment), which renders the claim indefinite. It is unclear whether the claimed “a combination therapy” is directed to the product (the claimed combination) or to the process (a method using the combination). While it is proper to have a product by process claim or recite intended used of the product, however, in this case, the claim recites steps of using the product. A product and process in the same claim is indefinite. See MPEP2173.05(p).
Claims 21, 22, and 25-28 are also rejected because these claims depend on claim 20.
The new claim 29 is drawn to administering the combination therapy of claim 20 which renders the claim indefinite because it is unclear if the method just comprises administering MVA/PD-1 antibody combination of claim 20, or also performing the steps of claim 20 in addition to the steps of claim 29.
Claims 30-35 are also rejected because these claims depend on claim 29.
Response to Arguments
For the 112(b) rejection, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. Because the new claim 29 recites administering the combination therapy of claim 20 and both claims 20 and 29 recite administering steps, it is still unclear whether the method of claim 29 just comprises administering MVA/PD-1 antibody combination of claim 20, or also performing the steps of claim 20 in addition to the steps of claim 29.
Thus, the 112(b) rejections are proper.
Related Prior Art
Rountree (Rountree et al., WO 2015/069571, Publication Date: 2015-05-14, #1 reference in IDS of 08/24/2021, of record) teaches that MVA was engineered for use as a viral vector for recombinant gene expression or as a recombinant vaccine ([006]). Rountree teaches that the MVA expressing the tumor associated antigens, such as 5 alpha reductase, alpha- fetoprotein, AM-1 , APC, April, BAGE, beta-catenin, Bell 2, bcr-abl, CA-125, CASP-8/FLICE, Cathepsins, CD 19, CD20, CD21 , CD23, CD22, CD33 CD35, CD44, CD45, CD46, CD5, CD52, CD55, CD59, CDC27, CDK4, CEA, c-myc, Cox-2, DCC, DcR3, E6/E7, CGFR, EMBP, Dna78, farnesyl transferase, FGF8b, FGF8a, FLK-l/KDR, folic acid receptor, G250, GAGE-family, gastrin 17, gastrin-releasing hormone, GD2/GD3/GM2, GnRH, GnTV, GP1, gpl00/Pmell7, gp-100-in4, gpl5, gp75/TRP-l , hCG, heparanse, Her2/neu, HMTV, Hsp70, hTERT, IGFR1 , IL-13R, iNOS, Ki67, KIAA0205, K-ras, H-ras, N-ras, KSA, LKLR-FUT, MAGE-family, mammaglobin, MAP 17, melan- A/MART- 1 , mesothelin, MIC A B, MT-MMPs, mucin, NY-ESO-1 , osteonectin, pl5, P170/MDR1 , p53, p97/melanotransferrin, PAI-1, PDGF, uPA, PRAME, probasin, progenipoientin, PSA, PSM, RAGE-1 , Rb, RCAS1 , SART-1, SSX-family, STAT3, STn, TAG- 72, TGF-alpha, TGF-beta, Thymosin-beta-15, TNF-alpha, TRP-1, TRP-2, tyrosinase, VEGF, ZAG, pl6INK4, and glutathione-S-transferase. See [0035], [0083] and [0094]. Rountree teaches a method of treating cancer patients, using a combination of (a) a recombinant orthopoxvirus comprising a nucleic acid encoding a polypeptide of at least one tumor antigen; (b) at least one of anti-PD-1 antagonist. It is contemplated that (a) and (b) are administered as a combination ([027]). Rountree teaches that MVA-BN-HER2 treatment and anti-PD-1 (an anti-PD-1 antibody) slow tumor growth and increase survival in a mice solid CT26-HER-2 model. The combination is better than either treatment alone (Fig. 9; Example 11). MAV-BN-HER2, anti-PD-1 and anti-LAG-3 treatment leads to complete tumor regression in mice with CT26-HER2 tumor (Figs. 12 and 13; Example 14). Rountree teaches as set forth above. However, Rountree does not teaches the MAV comprising a nucleic acid encoding CD40L or the TAA combination of AH1A5, p15e and TRP2.
Lauterbach (Lauterbach et al., WO 2014/037124 A1, Publication Date: 2014-03-13, #2 reference in IDS of 08/24/2021) teaches that CD40/CD40L plays central role in co-stimulating CD8+ T-cell responses. MVA encoding CD40L showed superior immunogenicity in vitro and in vivo ([008]). Lauterbach teaches that CD40L-adjuvanted MVA can induce antigen-specific multi-functional CD8+ T-cell responses. The recombinant MVA-CD40L is a prime candidate vector for the development of therapeutic vaccines against diseases such as cancer ([008]). Thus, the combination of Rountree and Lauterbach teach a MVA expressing CD40L, TRP-2, and in combination with an anti-PD-1 antibody for cancer treatment. However, the combined references do not teach the claimed TAA combination of AH1A5, p15e and TRP2.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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/CHENG LU/ Examiner, Art Unit 1642
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