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 .
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (US 2018/0169229, June 2018, cited from IDS) and in further view of Strem et al (WO 2019/222533, November 2019, cited from IDS), Katz et al (US 2016/0303166, October 2016, cited from IDS) and Jaroch et al (US 2019/0298983, October 2019, cited from IDS).
Yu teach TLR9 agonist of SEQ ID NO: 45 (see paragraph [0097]), which is identical to instant SEQ ID NO: 1, and administration of such agonist as a part of combination therapy with PD-1 antagonist for treating cancer (see Abstract), and specifically metastatic melanoma (see paragraph [0170]). Yu teach that the agonist can be administered in the amount of 0.5 mg (see paragraph [0192]). Yu teach that the other part of the combination therapy is administration of nivolumab (see paragraph [0189]). Yu teach administration of the agonist first, followed by administration PD-1 antagonist such as nivolumab (see paragraph [0176]), wherein such PD-1 antagonist can be administered intravenously (see paragraph [0188]).
Yu do not teach treatment of liver metastasis of uveal melanoma specifically or administering the agonist via pressure-enabled drug delivery through a catheter device comprising a one-way valve responding dynamically to local pressure changes with a rate of infusion of about 1 cc/min for about 25 min through a device by hepatic arterial infusion (HAI) followed by systemic administration of PD-1 antagonist or through device by portal vein infusion (PVI).
Strem teach liver metastasis of uveal melanoma, which is a subtype of ocular melanoma (see paragraph [0002]).
Jaroch teach PVI device comprising catheter for administering therapeutic agent (see paragraphs [0011, 0021-0025]). The agent can be administered to liver (see paragraph [0057]). The PVI device comprises one-way valve responding dynamically to local pressure changes (see paragraphs [0018-0019]) and allows pressure-enabled drug delivery (see paragraphs [0022- 0024]).
Katz teach treatment of liver metastasis using HAI device (see Abstract, paragraphs [0009, 0020]). Such device can be catheter (see paragraph [0020]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat liver metastasis of uveal melanoma by administering TLR9 agonist of instant SEQ ID NO: 1 using PVI device or HAI device based on teachings of Yu, Strem, Jaroch and Katz. One of the ordinary skill in the art would be motivated to do so because Yu teach treatment of metastatic melanoma by administering such agonist and Strem teach a subtype of such metastasis, liver metastasis of uveal melanoma, which can be treated using agonist taught by Yu. Such agonist can be administered using PVI device for drug delivery to liver described by Jaroch or HAI device taught by Katz. The rate and timing of administration can be determined by ordinary optimization, arriving at instant invention.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant argues that Katz reference does not teach administration of the claimed oligonucleotide to liver. In response the reference teach a method of direct administration of drugs to liver, such administration can be applied to any drug, including instantly claimed oligonucleotide.
Concerning Strem reference Applicant argues that the reference does not teach treatment with toll-like receptor agonist. In response the reference was cited to show that uveal melanoma produces metastases to liver. The other reference in obviousness rejection, by Yu, teach treatment of metastatic melanoma by the claimed toll-like receptor agonist, making it obvious to treat such metastases from uveal melanoma taught by Strem by the same toll-like receptor agonist taught by Yu.
Concerning Jaroch reference Applicant argues that the reference does not teach treatment of uveal melanoma liver metastasis by administering toll-like receptor agonist of instant SEQ ID NO: 1. In response it is pointed out that the rejection is of obviousness type, and other references teach the elements not taught by Jaroch. Jaroch teach a device for therapeutic drug delivery, which can be applied to delivery of instant toll-like receptor agonist with a reasonable expectation of success. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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