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 .
1. The Election filed November 14, 2025, in response to the Office Action of August 15, 2025, is acknowledged and has been entered. Applicants elected without traverse Group V and Species II of an IV bag covered by a light protective sleeve and IV tubing within a light-protective sleeve.
Claims 1, 2, 6, 7, 9-11, 14-16, 23, 24, 26, 30-32, 34, 35, 37-39 are pending. Claims 1, 2, 6, 7, 9-11, 14-16, 23, 24, and 26 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claims 30-32, 34, 35, and 37-39 are currently under prosecution.
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.
2. Claim 38 is 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 38 recites the limitation "the liquid formulation". There is insufficient antecedent basis for this limitation in the claim.
Examiner suggests amending claim 38 to depend from claim 35 or 37.
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.
3. Claim(s) 30-32, 34, 35, 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Blayney et al (JAMA Oncol, 2020, 6(11):e204429, internet pages 1-8) Supplement 1 Trial Protocol; in view of WO 2020/037285, Mohanlal et al, published February 20, 2020; MediPak Product Data Sheet for Amber UVLI® IV bag covers (June 2021); and MediPak Product Data Sheet for Amber UVLI® tubing covers (June 2021).
Blayney teaches a method of administering plinabulin to a subject in need thereof (p. 10-11; section 10.1, p. 54-56), wherein protection from light must be maintained throughout the drug administration process (section 10.2.2, p. 57);
wherein plinabulin is provided as a liquid solution in 40% Kolliphor HS 15® (formerly known as polyoxyl 15 hydroxystearate, or Solutol HS-15®) / 60% propylene glycol in an amber vial containing 80 mg in 20 mL (= 4 mg/mL = a concentration of 40mg/10mL) (p. 35; section 10.2.1, p. 57); and
wherein plinabulin is diluted into dextrose 5% in distilled water (D5W) for intravenous (IV) infusion (p. 35).
Blayney does not teach their light protection maintained throughout the drug administration process comprises amber sleeves covering the IV bag and tubing that block at least 85% of UV/visible light between 290 nm to 450 nm.
Mohanlal teaches a method of administering plinabulin to a subject in need thereof, the method comprising:
providing plinabulin in a light-protected bag for IV administration at a concentration of 4mg/mL;
wherein providing plinabulin in a light-protected bag comprises injecting the plinabulin by amber syringe to an amber sleeve covered D5W IV bag as a liquid formulation ([131]; Example 1; [142]; Example 2).
Like Blayney, Mohanlal teaches plinabulin is to be protected from light at all times ([131]; Table 3; [142]).
MediPak Data Sheet for Amber UVLI® IV bag covers and MediPak Product Data Sheet for Amber UVLI® tubing covers demonstrate that amber colored coverings were commercially available to protect drugs for IV administration in IV bags and IV tubing. The MediPak data sheets also indicate the sleeves block over 90% of harmful UV light between 290 nm and 450 nm. MediPak teaches this exceeds the United States Pharmacopoeia Standard of blocking light.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to protect plinabulin from light through the administration process in the method of Blayney by utilizing the method and sleeves of Mohanlal and MediPak. One would have been motivated to, and have a reasonable expectation of success to, because (1) Blayney teaches plinabulin must be protected from light throughout the drug administration process and teaches administration of plinabulin by IV in a D5W solution; (2) Blayney teaches and recognizes plinabulin is provided in a light-protected amber vial; (3) Mohanlal teaches protecting plinabulin during IV administration by transferring the plinabulin to a light-protected D5W IV bag; and (4) MediPak teaches light protecting amber sleeves were commercially available for IV bags and IV tubing for administration of drugs requiring light protection, and the amber sleeves successfully block over 90% of harmful UV light between 290 nm and 450 nm.
In the test of whether it is “obvious to try” there must be:
(1) a finding in the art at the time of filing of the invention that there had been a recognized problem or need in the art;
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
Given: (1) Blayney and Mohanlal both recognize the need to protect plinabulin from light throughout the IV administration process; (2) Blayney and Mohanlal both recognize amber colored vials and sleeves protect plinabulin from light during the administration process; and (3) MediPak teaches amber colored sleeves for IV bags and tubing were readily and commercially available for IV administration of drugs, and that they successfully exceed standards for blocking light; one of skill in the art could have pursued providing plinabulin in amber sleeve-covered IV bags and IV tubing for light protection during IV administration with a reasonable expectation of success.
4. Conclusion: No claim is allowed.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/Primary Examiner, Art Unit 1642