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 .
Response to Amendment
The amendment filed 08 May 2026 in which claims 1, 4-6, 8-9, 12, 17-20, and 22 were amended and claims 2-3, 7, 10-11, and 23 were cancelled has been entered.
Claims 1, 4-6, 8-9, 12-13, and 17-22 are under examination on the merits.
Claim Objections
(Previous objection, withdrawn as to claims 4-6, 8, 12, 17-20, and 22 and withdrawn due to cancellation of claims 2-3, 7, and 23). Applicant’s amendments to claims 4-6, 8, 12, 17-20, and 22 submitted on 29 April 2026 have overcome the objections previously set forth in the Non-Final Office Action mailed 08 January 2026. The rejection for claims 2-3, 7, and 23 is withdrawn due to cancellation of the claims submitted 08 May 2026.
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.
(Previous rejection, withdrawn as to claims 1, 4-5, and 21-22 and withdrawn due to cancellation of claims 2 and 23). Claims 1, 2, 4-5, and 21-23 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The rejection is withdrawn due to Applicant’s amendment to claim 1 and cancellation of claims 2 and 23 submitted on 08 May 2026.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(Previous rejection, withdrawn due to cancellation of claim 10). Claim 10 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li. The rejection is withdrawn due to Applicant’s cancellation of claim 10 submitted on 08 May 2026.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(Previous rejection, withdrawn as to claims 1, 5, 8, and 20 due to amendment of claim 1 and withdrawn due to cancellation of claims 2 and 11). Claims 1, 5, 8, and 20 were rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Wrenn. The rejection is withdrawn due to Applicant’s amendment to claim 1 and cancellation of claims 2 and 11 submitted on 08 May 2026.
(Previous rejection, withdrawn as to claims 6, 18-19, and 21-22 due to amendment of claim 1 and withdrawn due to cancellation of claims 3 and 7). Claims 6, 18-19, and 21-22 were rejected under 35 U.S.C. 103 as being unpatentable over Li and Wrenn in view of Huang. The rejection is withdrawn due to Applicant’s amendment to claim 1 and cancellation of claims 3 and 7 submitted on 08 May 2026.
(Previous rejection, withdrawn as to claims 4 due to amendment of claim 1 and withdrawn due to cancellation of claim 23). Claims 4 was rejected under 35 U.S.C. 103 as being unpatentable over Li and Wrenn in view of Kwan. The rejection is withdrawn due to Applicant’s amendment to claim 1 and cancellation of claim 23 submitted on 08 May 2026.
(Previous rejection, withdrawn as to claims 9 and 13 due to amendment of claim 1). Claims 9 and 13 were rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Huang. The rejection is withdrawn due to Applicant’s amendment to claim 1 submitted on 08 May 2026.
(Previous rejection, withdrawn as to claim 12 due to amendment of claim 1). Claim 12 was rejected under 35 U.S.C. 103 as being unpatentable over Li and Huang in view of Kwan. The rejection is withdrawn due to Applicant’s amendment to claim 1 submitted on 08 May 2026.
(Previous rejection, withdrawn as to claims 17 due to amendment of claim 1). Claim 17 was rejected under 35 U.S.C. 103 as being unpatentable over Li and Wrenn in view of DeMuth and Maman. The rejection is withdrawn due to Applicant’s amendment to claim 1 and cancellation of claims 2 and 11 submitted on 08 May 2026.
(New rejection, necessitated by amendment to claim 1). Claims 1, 5, 8-9, 13, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Deng, et al. (Nat Commun. 2018 Jan 24;9(1):359., hereinafter “Deng”) and in further view of Li, Galogahi, et al. (Journal of Science: Advanced Materials and Devices, Volume 5, Issue 4, 2020, Pages 417-435., hereinafter “Galogahi”), and He, et al. (Adv. Mater. Technol. 2019, 4, 1800687., hereinafter “He”).
Regarding claims 1, 9, and 19, Deng teaches a vaccine composition (Abstract) comprising a plurality of substantially spherical (Results ¶5) polypeptide particles diluted in DPBS (Immunization and Influenza A Virus Challenge). The particles comprise a polypeptide shell that is comprised of cross-linked polypeptide particles wherein hemagglutinin is cross-linked within the polypeptide shell (Figure 1C). Deng does not teach a water immiscible liquid core. However, Li teaches polypeptide particles with a cross-linked polypeptide shell with a water-immiscible liquid core (Abstract and ¶0016-0019).
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 combined the teachings of Deng for a vaccine comprising a polypeptide shell that contained antigen cross-linked within the shell and Li for a cross-linked polypeptide shell surrounding a water-immiscible core. Galogahi and He provide motivation by teaching that creation of a liquid core allows for a higher loading capacity (He, pg.1 column 2) and that an oily provides an adequate inner space for encapsulating hydrophobic components (Galogahi, pg. 422 column 1). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Deng, Li, Galogahi, and He because they all teach polypeptide particles with a core-shell structure.
The instant specification defines “substantially spherical” in claim 1 is defined by the specification as “particles which are not capable of generating inertial cavitation on response to ultrasound” and can have varying shapes including ellipsoidal. Absence of evidence to the contrary the spherical particles in the reference application Deng are also “substantially spherical.”
Regarding claim 5, Deng teaches that the polypeptide particles have a mean particle size of 178nm-228.5nm (pg. 4 column 1).
Regarding claims 8 and 20, Li teaches that the polypeptide shell is made of an adjuvant, i.e., bovine serum albumin (¶0016).
Regarding claim 13, Li teaches a method of producing a polypeptide particle comprising providing a water-immiscible phase, mixing said water-immiscible phase with an aqueous solution of at least one polypeptide, and cross-linking the polypeptide to generate a particle having a core comprising the water-immiscible phase and a shell comprising the at least one polypeptide (¶0007-0011), wherein the polypeptide shell is made of an adjuvant, i.e., bovine serum albumin (¶0016).
Regarding claim 21 and 22, Deng teaches administering the polypeptide shell vaccine to mice and then passively transferring immune sera to naïve mice before challenge (pg. 10, column 1 and Figure 6), protective antibodies were generated after vaccination as the mice that were transferred sera from vaccinated mice survived the viral challenge (Figure 6). Deng does not teach a water immiscible liquid core. However, Li teaches polypeptide particles with a cross-linked polypeptide shell with a water-immiscible liquid core (Abstract and ¶0016-0019).
Regarding claim 22, Deng teaches intramuscular injection (pg. 10, column 1).
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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Deng, Li, Galogahi, and He as applied to claims 1, 5, 8-9, 13, and 19-22 above and further in view of Kwan.
As discussed above, claims 1, 5, 8-9, 13, and 19-22 were rendered prima facie obvious over Deng, Li, Galogahi, and He.
Regarding claims 4 and 12, Deng, Li, Galogahi, and He do not teach that surface indentations are less than 50nm.
However, Kwan teaches that nanoparticles may have small/shallow imperfections/indentations on their surface having an opening and depth of less than 20 nm (pg. 8, lines 16-24).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Deng, Li, Galogahi, and He with the teachings of Kwan of allowing small imperfections on the surface. Kwan provides motivation by teaching that small imperfections advantageously do not encapsulate a gas pocket (pg.8, lines 16-24). One of skill in the art would have had reasonable expectation of success at combining Deng, Li, Galogahi, He, and Kwan because they all teach polypeptide particles with a core-shell structure.
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 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Deng, Li, Galogahi, and He as applied to claims 1, 5, 8-9, 13, and 19-22 and further in view of Huang.
As discussed above, claims 1, 5, 8-9, 13, and 19-22 were rendered prima facie obvious over Deng, Li, Galogahi, and He.
Regarding claim 6, Deng, Li, Galogahi, and He do not teach that the water-immiscible core comprises one or more adjuvants. However, Huang teaches a particle with a water immiscible core surrounded by polypeptide antigens wherein the antigen is hemagglutinin from H5N1 and wherein the particle can be used as a vaccine (pg. 3 column 1) and the oil core comprises the adjuvant squalene (Figure 1 and pg. 2, column 2).
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 modified the teachings of Deng, Li, Galogahi, and He of a vaccine comprising a polypeptide shell cross-linked with antigen around a water-immiscible core with the teachings of Huang for the oil core comprising an adjuvant. Huang provides motivation by teaching that adding an adjuvant to a vaccine elicits a robust a broadened immune response (Abstract, Background). One of skill in the art would have had a reasonable expectation of success in combining Deng, Li, Galogahi, He, and Huang because they all teach polypeptide particles with a core-shell structure.
Regarding claim 18, Huang teaches wherein the oil core comprises the adjuvant squalene (Figure 1 and pg. 2, column 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.
(New rejection, necessitated by amendment to claim 1). Claim 17 is rejected under U.S.C. 103 as being unpatentable over Deng, Li, Galogahi, and He as applied to claims 1, 5, 8-9, 13, and 19-22 above, and further in view of DeMuth and Maman.
As discussed above, claims 1, 5, 8-9, 13, and 19-22 were rendered prima facie obvious by Deng, Li, Galogahi, and He.
Regarding claim 17, Deng, Li, Galogahi, and He do not teach that the polypeptide particle with a water-immiscible liquid core and a polypeptide shell with a pharmaceutically acceptable carrier is co-administered with a DNA or RNA vaccine
However, DeMuth teaches that combined nanoparticles and DNA vaccines can be co-delivered via injection into the skin of mice (¶0141).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Deng, Li, Galogahi, and He of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell which comprises cross-linked antigen with the teachings of DeMuth of co-delivering nanoparticles and DNA vaccines via injection. Maman provides motivation by teaching that merging various antigens into one product reduce burden on the health care industry and increase coverage rate (Abstract). One of skill in the art would have had reasonable expectation of success at Deng, Li, Galogahi, He, DeMuth, and Maman because they all teach methods of drug or vaccine delivery to subjects.
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 7-15 of the Remarks submitted 08 May 2026 that current claim 1 as amended incorporates a pathogenic antigen protein within the polypeptide shell which is not taught by Li or Wrenn, either individually or in combination.
In response: Applicant’s arguments with respect to claims 1, 4-6, 8-9, 12-13, and 17-22 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.
Applicant contends on pages 10-12 of the Remarks submitted 08 May 2026 that as Huang does not teach a polypeptide particle with a polypeptide shell with cross-linked polypeptides, that one of skill in the art would not have combined Li, Wrenn, and Huang.
In response: Applicant’s arguments with respect to claims 6, 18-19, and 21-22 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.
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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