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 .
Specification
The specification is objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)).
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hayashi, et al. (WO 2020/027318 A1, translation uploaded by Examiner, hereinafter “Hayashi”) as evidenced by McBirney, et al. (Biomed Opt Express. 2016 Sep 14;7(10):4034-4042, hereinafter “McBirney”).
Regarding claims 1 and 7, Hayashi discloses a vaccine comprising an antigen coated by a cationic nanogel (pg. 12 ¶0040).
Regarding claims 2 and 8, Hayashi discloses Staphylococcus aureus as a vaccine antigen (pg. 9 ¶0028). S. aureus has a diameter of 600 nm as evidenced by McBirney, (pg. 4039, Results and Discussion ¶2), which is larger than 20nm.
Regarding claim 3 and 9, Hayashi discloses that the nanogel particle size is no larger than a diameter of 200nm (pg. 11 ¶0036) which is smaller than the diameter of S. aureus at 600nm as evidenced by McBirney (pg. 4039, Results and Discussion ¶2), making the vaccine antigen larger than the nanogel.
Regarding claim 6, Hayashi discloses that the nanogel complex further comprises adjuvants (pg. 13 ¶0041).
Accordingly, Hayashi anticipates the claimed inventions.
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 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.
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.
Claims 4, 5, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi as applied to claims 1-3 and 6-9 above, and further in view of Akiyoshi, et al. (WO 2010050578 A1, translation uploaded by Examiner, hereinafter “Akiyoshi”).
As discussed above, claims 1-3 and 6-9 were anticipated by Hayashi.
Regarding claims 4 and 10, Hayashi does not teach that the vaccine antigen is a VLP, inactivated virus, a protein molecule larger than 20nm, or a polymer. However, Akiyoshi teaches a nanogel vaccine can be used for many different microorganisms including viruses, bacteria, and fungi (pg. 8 ¶0035) and that the molecular weight of a vaccine antigen is not limited in a nanogel vaccine (pg. 8 ¶0035).
It would have been prima facie obvious before the effective filing date of the invention for one of ordinary skill in the art to have combined the teaching of Hayashi of a vaccine antigen coated with a nanogel with the teachings of Akiyoshi that there is no limit on the molecular weight of vaccine antigens and that nanogels are not limited to one microorganism. Akiyoshi provides motivation by teaching that different vaccine antigens produce different vaccines for separate microorganism mediated infections (Abstract). One of skill in the art would have had reasonable expectation of success at combining Hayashi and Akiyoshi because they both teach mucosal nanogel vaccines.
Regarding claim 5, Hayashi does not teach the molar ratio to which the antigen and nanogel are complexed. However, Akiyoshi teaches mixing the antigen with the nanogel in a molar ratio of up to 1:100 (Pg. 8 ¶0036).
Routine optimization of Hayashi’s ratio of antigen to nanogel would have led to the claimed range of a molar ratio of 1:15 to 1:200 because Akiyoshi and Hayashi teach that the mixing ratio of the antigen and the cationic nanogel is appropriately adjusted depending of the type of antigen and the cationic nanogel being used (Akiyoshi, Pgs. 12-13 ¶0040 and Hayashi, pgs. 8 ¶0036) and Akiyoshi teaches that these molar ratios can be concentrations of 1:1 to 1:100 (Pgs. 12-13 ¶0040). The person of ordinary skill in the art would have found it obvious to optimize the mixing ratio by starting optimization from molar ratios taught by Akiyoshi because Akiyoshi and Hayashi teach that the mixing ratio of the antigen and the cationic nanogel is appropriately adjusted depending of the type of antigen and the cationic nanogel being used (Akiyoshi, Pgs. 12-13 ¶0040 and Hayashi, pgs. 8 ¶0036).
It would further be obvious that the molar ratios of antigen to nanogel in a composition are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2.
Accordingly, the claimed inventions were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672