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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 29 September 2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendment filed 21 April 2026 in which claims 1 and 3-6 were amended to materially change the scope of the claims, and claims 2 and 7-10 were cancelled has been entered.
Claims 1 and 3-6 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendments to the Specification submitted 21 April 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 09 February 2026.
Drawings
(Previous rejection, withdrawn). Applicant’s amendments to the drawings submitted 21 April 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 09 February 2026.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1, 3, and 6, withdrawn as to claims 2 and 7-9 due to cancellation of the claims). Claims 1, 3, and 6 were rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hayashi as evidenced by McBirney. The rejection is withdrawn due to the addition of new limitations add to claim 1 in the amendment filed 21 April 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 4-5, withdrawn as to claim 10 due to cancellation of the claim). Claims 4-5 were rejected under 35 U.S.C. 103 as being unpatentable over Hayashi as applied to claim 1, 3, and 6 above, and further in view of Akiyoshi. The rejection is withdrawn due to the addition of new limitations add to claim 1 in the amendment filed 21 April 2026.
(new rejection, necessitated by amendment to claim 1). Claims 1, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi and further in view of Fan, et al. (Int J Nanomedicine. 2020 Dec 17;15:10321-10330., hereinafter “Fan”).
Regarding claim 1, Hayashi teaches a vaccine for administration to the pharyngeal tonsils deep in the nasal cavity (pg. 14 ¶0045) comprising a Staphylococcus aureus antigen coated by a cationic nanogel (pg. 12 ¶0040). Hayashi does not teach a specific S. aureus antigen to be used in the vaccine that is between 30-600nms. However, Fan teaches Staphylococcus aureus protoplast-derived particulate vaccines (PDNVs), which are S. aureus with a removed cell wall (Abstract - Methods). These PDNVs are ~200-700nm in diameter (Abstract - Results). As PDNVs size decrease, stability, DC maturation, B cell antibody response, and T cell response all increased (Conclusion). Removing the cell wall from the bacteria also removes a majority of the bacterial toxins while the immunogenic antigens remain (Introduction ¶2). The advantages of the smaller PDNVs as immunogens would lead one of ordinary skill in the art to use PDNVs within the range of the instant claims so that the vaccine would possess the benefits of the smaller PDNVs.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the formalin-killed Staphylococcus aureus (FKSA) or any S. aureus antigen taught by Hayashi for the S. aureus PDNVs taught by Fan. Fan provides motivation by teaching that PDNVs remove the bacterial cell wall from S. aureus which also removes the bacterial toxins and other virulence factors (Introduction ¶2). As well as, the smaller particles having higher stability, and increased DC maturation, B cell antibody response, and T cell response (Conclusion). One of skill in the art would have had a reasonable expectation of success in substituting the FKSA or any S. aureus taught by Hayashi for the S. aureus PDNVs taught by Fan because Hayashi, while exemplifying the whole FKSA as a vaccine antigen, teaches that any S. aureus vaccine antigen can be used in the nanogel vaccine preparation (abstract and Description of embodiments ¶2 in translated) and Fan teaches a S. aureus vaccine antigen.
Regarding claim 3, Hayashi teaches that the nanogel particle size is no larger than a diameter of 200nm, with an optimal diameter much smaller at 30-50 nm (pg. 11 ¶0036) which is smaller than the diameter of some of the S. aureus PDNVs which are between 200-700nm, making the vaccine antigen larger than the nanogel.
Regarding claim 6, Hayashi teaches that the nanogel complex further comprises adjuvants (pg. 13 ¶0041).
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.
(new rejection, necessitated by amendment to claim 1). Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi and Fan as applied to claims 1, 3, and 6 above, and further in view of Akiyoshi.
As discussed above, claims 1, 3, and 6 were rendered prima facie obvious over Hayashi and Fan.
Regarding claim 4, Hayashi does not teach that the vaccine antigen is a VLP, inactivated virus, a protein molecule, 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).
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.
Response to Arguments
Applicant contends on pages 20-21 of the Remarks submitted on 21 April 2026 that the antigen used in Hayashi is FKSA with is 1µm in diameter is larger than the limitation of 20-600nm in claim 1.
In response: Applicant’s arguments with respect to claims 1, 3, and 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Due to the amendment of claim 1 to include the new, material limitation of an upper limitation of antigen size as well as a different lower limitation of antigen size, a new ground of rejection was used.
Applicant contends on pages 21-22 of the Remarks submitted on 21 April 2026 that Akiyoshi does not any disclosure or suggestion regarding the nanogel coating the antigens.
In response: 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). Akiyoshi does not teach coating the antigen rather than encapsulating, but Hayashi does teach coating the antigen
Applicant contends on page 22 of the Remarks submitted on 21 April 2026 that Akiyoshi does not provide a reasonable expectation of success in the nanogel working with antigens with diameters of 30-600nm.
In response: Applicant’s arguments with respect to claims 4-5 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Due to the amendment of claim 1 to include an upper limitation of antigen size, a new ground of rejection was used.
Applicant contends on page 22-24 of the Remarks submitted on 21 April 2026 that the nasal vaccine according to the amended claims has unexpected excellent technical effects.
In response: Applicant’s arguments with respect to claims 4-5 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Due to the amendments requiring nasal administration to include an upper limitation of antigen size, a new ground of rejection was used. Also, in response to applicant's argument that intranasal administration would causes unexpected excellent technical effects, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Especially as Hayashi does not intranasal administration.
Conclusion
NO CLAIMS ARE ALLOWED
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.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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