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 preliminary amendment filed on January 10, 2025 is acknowledged. Claims 1-8 and 11-15 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 9, 2025 and May 4, 2026 have been considered by the examiner.
Claim Objection
Claims 1-8 and 11-15 are objected to for the recitation of “characterized in that”. Applicant is suggested to amend the claims to recite the “wherein” clause instead.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vermeij et al. (US Patent Application Publication US 2020/0368346) in view of Turner et al., (US Patent Application Publication US 2013/0315952).
Vermeij teaches a composition comprising a liquid vaccine composition comprising a live virus and a pharmaceutically acceptable carrier, the carrier being a natural deep-eutectic solvent (NADES), and the vaccine having a water activity of at most 0.8, wherein the liquid vaccine composition has a water amount of up to 50% w/w (see paragraphs [0012], [0017]. [0019], [0020-0022], [0040-0041],
Claim 2. Vermeij teaches NADES formed from proline, sorbitol and water (see paragraph [0053-0054]).
Claim 3. Vermeij teaches liquid vaccine composition according to claim 2, characterized in that the proline, sorbitol and water are present in the NADES in molar ratios of proline: sorbitol : water that are between 1:1:1 and 1:1:10 (see Table 3 and paragraphs [0067-0080], [0208], [0213], [0220]).
Claims 4 and 12. Vermeij teaches additive comprised at 0.05 - 0.5% w/w (see paragraph [0035]).
Claims 6, 7, and 13-15. Vermeij teaches live enveloped virus selected from: a Paramyxovirus and a Coronavirus wherein Paramyxovirus is selected from: a canine para-influenza virus (CPI) and a canine distemper virus (CDV) (see paragraph [0011], [0032], [0089], [0097-0100]).
Claim 8. Vermeij teaches methods for preparing the liquid vaccine composition comprising preparing NADES, admixing NADES with the additive and admixing the virus (see paragraph [0129-0133]).
Claim 11. Vermeij teaches method for vaccinating a human comprising administering of a liquid vaccine composition to the human (see claims 1-8 and 13-15).
Vermeij does not teach the vaccine comprising an additive selected from methionine, ectoine, and hydroxyectoine.
Turner teaches using hydroxyectoine in viral vaccine compositions for the purposes of facilitate dispersal of the powder from a device, to increase the shelf-life of the vaccine composition, or to improve the stability of the vaccine composition during lyophilization (see paragraph [0156]).
It would have been prima facie obvious to provide the liquid vaccine composition of Vermeij comprising Turner’s hydroxyectoine because Turner teaches using hydroxyectoine in viral vaccine compositions for the purposes of facilitating dispersal of the powder from a device, to increase the shelf-life of the vaccine composition, or to improve the stability of the vaccine composition during lyophilization (see paragraph [0156]).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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