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 .
Claim Objections
Claims 2-8, 12, 17-20, and 22-23 are objected to because of the following informalities: dependent claims should start with the article “the” rather than “a/an.” Appropriate correction is required.
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.
Claims 1, 2, 4-5, and 21-23 are 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 omitted elements are: vaccine components. The claims recites a polypeptide particle in a carrier or dilutant, with no immunogens.
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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li, et al. (CN106984247, hereinafter “Li”).
Regarding claim 10, Li discloses a polypeptide particle with a water-immiscible core and a polypeptide shell made of an adjuvant, bovine serum albumin (¶0016-0017).
Accordingly, Li anticipates the claimed invention.
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 1, 2, 5, 8, 11, and 20 are rejected under U.S.C. 103 as being unpatentable over Li in view of Wrenn, et al. (US 2019/0008987 A1, hereinafter “Wrenn”).
As discussed above, claim 10 was anticipated by Li. Regarding claim 1, Li teaches a polypeptide particle with a water-immiscible liquid core and a polypeptide shell (Abstract and ¶0016), and that these polypeptides can be used for drug delivery into a subject (¶0021). Li does not teach that the polypeptide particle is in a pharmaceutically acceptable carrier or diluent.
However, Wrenn teaches a pharmaceutically acceptable carrier (¶0063).
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 Li of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell that can be used for drug delivery with the teachings of Wrenn of pharmaceutically acceptable carriers. Wrenn provides motivation by teaching that the pharmaceutically acceptable carriers facilitate administration of compounds into a subject (¶0063). One of skill in the art would have had reasonable expectation of success at combining Li and Wrenn because they both teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
Regarding claim 2, Li teaches a crosslinked film constructed with polymer molecules as a shell where the polymer can be a polypeptide (¶0006 and 0016).
Regarding claim 5, Li teaches that the polypeptide particles have a diameter (defined as the mean particle size in the specification of the instant claim) of 500nm – 10µm (¶).
Regarding claims 8,11, and 20 Li teaches that the polypeptide shell is made of an adjuvant, i.e., bovine serum albumin (¶0016).
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.
Claims 3, 6-7, 18-19, and 21-22 are rejected under U.S.C. 103 as being unpatentable over Li and Wrenn as applied to claim 1 above, and further in view of Huang, et al. (PLoS One, August 2010, Volume 5, Issue 8, e12279, IDS-FOR, filed, 02/26/2024, hereinafter “Huang”).
As discussed above, claim 1 was rendered obvious by Li and Wrenn.
Regarding claim 3, Li and Wrenn do not teach that the polypeptide is a pathogenic antigen.
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).
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 Li and Wrenn of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell with a pharmaceutically acceptable carrier with the teachings of Huang of the polypeptide being hemagglutinin from H5N1. Huang provides motivation by teaching that utilizing the hemagglutinin from H5N1 as the polypeptide for a nanoparticle allows for the use of the nanoparticle as a vaccine (pg.3, column 1). One of skill in the art would have had reasonable expectation of success at combining Li, Wrenn, and Huang because they all teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
Regarding claim 6, Huang teaches wherein the oil core comprises the adjuvant squalene (Figure 1 and pg. 2, column 2).
Regarding claim 7, Huang teaches wherein the antigen is hemagglutinin from H5N1 (pg. 3 column 1).
Regarding claim 18, Huang teaches wherein the oil core comprises the adjuvant squalene (Figure 1 and pg. 2, column 2).
Regarding claim 19, Huang teaches wherein the antigen is hemagglutinin from H5N1 (pg. 3 column 1).
Regarding claim 21, Huang discloses that the vaccine when given to mice elicited sustainable antigen-specific serological protective antibodies (pg. 6 column 1).
Regarding claim 22, Huang discloses that the vaccine was administered intramuscularly (pg. 9 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.
Claims 4 and 23 are rejected under U.S.C. 103 as being unpatentable over Li and Wrenn as applied to claim 1 above, and further in view of Kwan, et al. (WO 2015/075442, IDS-FOR, filed, 02/26/2024, hereinafter “Kwan”).
As discussed above, claim 1 was rendered obvious by Li and Wrenn.
Regarding claim 4, Li and Wrenn 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 Li and Wrenn 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 Li, Wrenn, and Kwan because they all teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
Regarding claim 23, Li teaches wherein the nanoparticle is spherical or ellipsoidal (¶0015).
The instant specification defines “substantially spherical” in claim 23 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 Li are also “substantially spherical.”
Accordingly, the claimed invention was 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.
Claims 9 and 13 are rejected under U.S.C. 103 as being unpatentable over Li and further in view of Huang.
Regarding claim 9, Li teaches a polypeptide particle comprising a water immiscible core and a polypeptide shell. Li does not teach that the polypeptide is a pathogenic antigen. However, Huang teaches a polypeptide particle with an oil core and HA H5N1 antigens entrapped around the core (pg. 3, column 1).
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 Li of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell with the teachings of Huang of the polypeptide being hemagglutinin from H5N1. Huang provides motivation by teaching that utilizing the hemagglutinin from H5N1 as the polypeptide for a nanoparticle allows for the use of the nanoparticle as a vaccine (pg.3, column 1). One of skill in the art would have had reasonable expectation of success at combining Li and Huang because they all teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
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)and Huang teaches a polypeptide particle with an oil core and HA H5N1 antigens entrapped around the core (pg. 3, 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.
Claim 12 is rejected under U.S.C. 103 as being unpatentable over Li and Huang as applied to claim 9 above, and further in view of Kwan.
As discussed above, claim 9 was rendered obvious by Li and Huang.
Regarding claim 12, Li and Huang do not teach that surface indentations are less than 50nm or that the polypeptide is a pathogenic antigen.
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) and Huang teaches wherein the antigen is hemagglutinin from H5N1 (pg. 3 column 1).
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 Li and Huang of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell with the polypeptide being hemagglutinin from H5N1with the teachings of Kwan of allowing small imperfections on the surface. Kwan provides motivation for the small imperfections 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 Li, Huang, and Kwan because they all teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
Accordingly, the claimed method was 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.
Claim 17 is rejected under U.S.C. 103 as being unpatentable over Li and Wrenn as applied to claims 1 and 3 above, and further in view of DeMuth (US 2012/0027837, hereinafter “DeMuth”) and Maman (Hum Vaccin Immunother 2015 Jun 15;11(9):2132-2141, hereinafter “Maman”).
As discussed above, claims 1 and 3 were rendered obvious by Li and Wrenn.
Regarding claim 17, Li and Wrenn 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 Li and Wrenn of a polypeptide particle with a water-immiscible liquid core and a polypeptide shell with a pharmaceutically acceptable carrier 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 combining Li, Wrenn, DeMuth, and Maman because they all teach methods of drug or vaccine delivery to subjects.
Accordingly, the claimed method was 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
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672