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 Warning
Applicant is advised that should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Both claims depend on claim 10 and are identical in scope and language.
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) 1-2, 4, 10-13 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) and Katz et al (US 2016/0303166, October 2016, 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 through catheter by hepatic arterial infusion (HAI) followed by systemic administration of PD-1 antagonist.
Strem teach liver metastasis of uveal melanoma, which is a subtype of ocular melanoma (see paragraph [0002]).
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 HAI based on teachings of Yu, Strem 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 HAI by catheter, because Katz teach using HAI for treatment of liver metastasis. The administration of the agonist can be followed up by systemic administration of PD-1 antagonist as taught by Yu.
Claim(s) 1, 3, 5-9 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) and Jaroch et al (US 2019/0298983, October 2019, cited from IDS).
Teachings of Yu are discussed above.
Yu do not teach treatment of liver metastasis of uveal melanoma specifically or administering the agonist by portal vein infusion (PVI) using catheter comprising a one-way valve responding dynamically to local pressure changes or via pressure-enabled drug delivery with a rate of infusion of about 1 cc/min for about 25 min.
Teachings of Strem are discussed above.
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]).
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 based on teachings of Yu, Strem and Jaroch. 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. The rate and timing of administration can be determined by ordinary optimization, arriving at instant invention.
Conclusion
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.
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, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
Prosecution Insights