DETAILED ACTION
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 .
Applicant’s Response Dated August 10, 2026
In the Response dated August 10, 2026, claims 1 and 11 were amended, and claims 3 and 13 were canceled. Claims 1-2, 4-5, 7-12, 14-15, and 17-22 are pending. An action on the merits of claims 1-2, 4-5, 7-12, 14-15, and 17-22 is contained herein.
The rejection of claims 1-2, 4-5, 7-12, 14-15, and 17-22 under 35 U.S.C. 103 as being unpatentable over Dietrich US 2019/0249258 A1 (Dietrich) and Daver, Naval, et al. "Hypomethylating agents in combination with immune checkpoint inhibitors in acute myeloid leukemia and myelodysplastic syndromes." Leukemia 32.5 (2018): 1094-1105 (Daver) in combination is maintained for the reasons of record as set forth in the Office Action dated February 10, 2026.
Rejections Set Forth in the Office Action Dated February 10, 2026
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 7-12, 14-15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich US 2019/0249258 A1 (Dietrich) and Daver, Naval, et al. "Hypomethylating agents in combination with immune checkpoint inhibitors in acute myeloid leukemia and myelodysplastic syndromes." Leukemia 32.5 (2018): 1094-1105 (Daver) in combination.
Applicant's arguments filed August 10, 2026 have been fully considered but they are not persuasive. Applicant has amended claims 1 and 11 to recite "wherein the one or more immune checkpoint genes is selected from the group consisting of carcinoembryonic antigen-related adhesion molecule 1 (CEACAM1), Galectin 9, PDL2, V-domain Ig suppressor of T cell activation (VISTA), B7-H3, B7-H4, B7-2 (CD86), (CD80), HHLA2, CD155, and Galectin 3. Applicant submits that no combination of the cited art can account for the presently claimed immune checkpoint inhibitors.
The examiner respectfully disagrees.
Regarding the clause “wherein the one or more immune…and Galectin 3”, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. In the instant case, Dietrich reasonably suggests a method wherein the one or more co-stimulatory genes comprises CD40. As set forth of page 8 of the Office Action dated February 10, 2026, Dietrich teaches a method for individualized selection of a pharmaceutical compound for immunotherapeutic treatment of a patient with a malignant disease, the method comprising performing a DNA methylation analysis of at least one immunoregulatory gene of cells of the malignant disease and/or T lymphocytes interacting with said cells of the malignant disease, wherein said immunoregulatory gene encodes an immune checkpoint selected from 137 proteins and their receptors, MHC:peptide complex binding co-receptors, members of the tumor necrosis factor receptor superfamily TNFRSF9, CD40, TNFRSF4, TNFRSF18 and CD27, members of the immunoglobulin superfamily TIGIT, BTLA, HAVCR2, BTNL2 and CD48, and the adenosine-binding adenosine 2A receptor, and selecting the pharmaceutical compound on the basis of the result of said DNA methylation analysis. See claim 31.
Further, as set forth on page 5 of the Office Action dated February 10, 2026, Dietrich teaches, in a variant, the immunoregulatory gene is selected from the genes encoding the B7 protein and its receptor CD80 and CTLA4 [0089]. Dietrich further teaches that a preferred method comprises the use of DNA methylation analysis of the CTLA4 and/or CD80 gene to predict the response to pharmaceutical compounds which are capable of modifying, in particular inhibiting, the immunoregulatory effect of CTLA4 and/or CD80. See [0094]. Dietrich further teaches that a preferred embodiment of the method comprises using the DNA methylation analysis of the CD86 gene to determine the response to a pharmaceutical compound capable of inhibiting the immunoregulatory effect of the ligand encoded by CD86 and/or the receptors encoded by CTLA4 and/or CD28. See [0099]. Dietrich further teaches that the gene PDCD1LG2 or programmed cell death 1 ligand 2 is also known under the synonyms Btdc, PDL2, CD273, PDCD1L2, B7-DC, bA574F11.2, PD-L2 and B7DC. PDCD1LG2 is an immunoregulatory gene encoding a B7 protein, which is an immune checkpoint in the sense of the invention. See [0092]. Thus, the rejection is maintained based upon the preponderance of evidence.
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 1-2, 4-5, 7-12, 14-15, and 17-22 are 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.
Regarding claims 1 and 11, the parenthetical phrase “(CD80)” renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). The deficiency is not cured in the depending claims. For the purposes of applying prior art, the examiner interprets the parenthetical phrase to be part of the claimed invention.
Conclusion
Claims 1-2, 4-5, 7-12, 14-15, and 17-22 are pending. Claims 1-2, 4-5, 7-12, 14-15, and 17-22 are rejected. No claims are allowed.
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.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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