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 .
DETAILED ACTION
Priority
This application is a continuation application of International Application No. PCT/US2021/033776, filed on May 21, 2021, which claims the benefit of priority to U.S. Provisional Application No. 63/028,390, filed on May 21, 2020 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 05/15/2023 is acknowledged. Claims 1, 5-8, 14, 22-25, 30-31, 34, 36, 44, 48, 52, 54, 60-61, 63-65 and 86 are pending and under examination.
Information Disclosure Statement
There was no information disclosure statement (IDS) submitted at the time of this application.
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.
Claim 52 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 52 recites “substantially”. The term “substantially” is not clear in that it is a relative term. Further, the specification does not define the term “substantially” and does not provide a standard for ascertaining the requisite degree, thus a skilled artisan would not be apprised to the metes and bounds of the recitations. Thus, the claims are rendered indefinite.
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, 5, 31, 34, 36, 48, 52, 60-61, 64 and 86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henderson (US PGPUB 20180311338”.
The claims are directed to a microneedle device comprising a plurality of microneedles, wherein the plurality of microneedles comprises: a first microneedle comprising a coronavirus antigen and/or a coronavirus vaccine; and optionally, a second microneedle comprising an influenza antigen and/or an influenza vaccine; wherein the microneedle device is configured to deliver to a subject the coronavirus antigen and/or the coronavirus vaccine and, optionally, the influenza antigen and/or the influenza vaccine in an amount sufficient to induce an immune response.
Regarding claims 1, 5 and 31, 34, 36 and 86, Henderson discloses microneedle devices (and methods of producing microneedle devices) comprising a recombinant alphavirus replicon encoding an exogenous polypeptide, wherein the recombinant alphavirus replicon is coated onto or embedded into a plurality of microneedles. Also described herein are methods of preparing a microneedle device comprising a recombinant alphavirus replicon encoding an exogenous polypeptide (Abstract). Henderson discloses a microneedle device for administering a polypeptide, comprising:(a) a dehydrated composition comprising the polypeptide; and(b) a substrate comprising a sheet and a plurality of microneedles extending therefrom, each of said microneedles comprising a tip, a base, a hinge at the base connecting the microneedle to the sheet, and a well comprising the dehydrated composition, wherein the polypeptide is an antigen associated with an infectious agent, wherein the polypeptide is present in an amount effective to induce an immune response in an individual in need thereof to the polypeptide, wherein the polypeptide comprises a sequence from an influenza virus HA or NA polypeptide; and wherein the polypeptide comprises a sequence from an influenza A virus HA polypeptide or an influenza B virus HA polypeptide (claims 98-102 of Henderson, instant claim 1). Additionally, Henderson in preferred embodiments, the replicon is an RNA molecule. Replicon RNA can substantially amplify the production of an encoded protein, leading to sustained translation and protein production in a target cell. In some embodiments, RNA replicons are based on or derived from viruses. A variety of suitable viruses (e.g., RNA viruses) are available, including, but not limited to, picornavirus, flavivirus, coronavirus (paragraph [0060], instant claim 5); in some embodiments, the polypeptide encoded by the recombinant alphavirus replicon is an antigen derived from a virus… Coronavirus including immunogens derived from a SARS coronavirus (instant claim 31), avian infectious bronchitis (IBV), Mouse hepatitis virus (MEW), and Porcine transmissible gastroenteritis virus (TGEV). In some embodiments, the RNA replicon can comprise the coronavirus immunogen is a spike polypeptide (paragraph [0074], instant claims 34 and 36).
Regarding claim 48, Henderson discloses the microneedle comprises an influenza vaccine comprises an influenza A vaccine (see claims 102 to 109 of Henderson).
Regarding claim 52, Henderson discloses in an embodiment the microneedle device is configured to result in a single dose immunity to a coronavirus and/or influenza virus (paragraph [0059]).
Regarding claims 60 and 61, Henderson discloses in some embodiments, the dissolvable, biosoluble, or biodegradable microneedles are composed of water soluble materials. In some embodiments, these materials include chitosan, collagen, gelatin, maltose, dextrose, galactose, alginate, agarose, cellulose (such as carboxymethylcellulose or hydroxypropylcellulose), starch, hyaluronic acid, or any combinations thereof. In some embodiments, a selected material is resilient enough to allow for penetration of the skin (paragraph [0049]).
Regarding claim 64, Henderson discloses the microneedle further comprises a non-vaccine molecule such that the RNA molecule encodes a GFP reporter molecule (see Figures 3-12).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 6-8, 14, 22-25, 30, 44, 54, 63 and 65 are rejected under 35 U.S.C. 103(a) as being unpatentable over Henderson (US PGPUB 20180311338” in view of Kaplan et al. “Kaplan” (US PGPUB 20130338632). The teachings of Henderson are outlined above and incorporated herein.
The claims are directed to a microneedle device comprising a plurality of microneedles, wherein the plurality of microneedles comprises: a first microneedle comprising a coronavirus antigen and/or a coronavirus vaccine; and optionally, a second microneedle comprising an influenza antigen and/or an influenza vaccine; wherein the microneedle device is configured to deliver to a subject the coronavirus antigen and/or the coronavirus vaccine and, optionally, the influenza antigen and/or the influenza vaccine in an amount sufficient to induce an immune response.
Regarding claims 6-8, 14, 22, 54 and 63, Henderson discloses microneedle devices comprising a recombinant alphavirus replicon encoding an exogenous polypeptide, wherein the recombinant alphavirus replicon is coated onto or embedded into a plurality of microneedles. Also described herein are methods of preparing a microneedle device comprising a recombinant alphavirus replicon encoding an exogenous polypeptide (Abstract). Henderson discloses a microneedle device for administering a polypeptide, comprising:(a) a dehydrated composition comprising the polypeptide; and(b) a substrate comprising a sheet and a plurality of microneedles extending therefrom, each of said microneedles comprising a tip, a base, a hinge at the base connecting the microneedle to the sheet, and a well comprising the dehydrated composition, wherein the polypeptide is an antigen associated with an infectious agent, wherein the polypeptide is present in an amount effective to induce an immune response in an individual in need thereof to the polypeptide, wherein the polypeptide comprises a sequence from an influenza virus HA or NA polypeptide; and wherein the polypeptide comprises a sequence from an influenza A virus HA polypeptide or an influenza B virus HA polypeptide (claims 98-102 of Henderson). Additionally, Henderson in preferred embodiments, the replicon is an RNA molecule. Replicon RNA can substantially amplify the production of an encoded protein, leading to sustained translation and protein production in a target cell. In some embodiments, RNA replicons are based on or derived from viruses. A variety of suitable viruses (e.g., RNA viruses) are available, including, but not limited to, picornavirus, flavivirus, coronavirus (paragraph [0060]); in some embodiments, the polypeptide encoded by the recombinant alphavirus replicon is an antigen derived from a virus… Coronavirus including immunogens derived from a SARS coronavirus, avian infectious bronchitis (IBV), Mouse hepatitis virus (MEW), and Porcine transmissible gastroenteritis virus (TGEV). In some embodiments, the coronavirus immunogen is a spike polypeptide (paragraph [0074]).
Henderson does not explicitly disclose a microneedle device comprising an implantable silk fibroin tip.
Kaplan, however, discloses a microneedle or microneedle device includes a microneedle body extending from a base to a penetrating tip formed from a silk fibroin-based material, which is easy to fabricate and highly biocompatible. The microneedle device can include one or more microneedles mounted to a substrate. The silk fibroin can include active agents to be transported into or across biological barriers such as skin, tissue and cell membranes. The silk fibroin microneedles can be fully or partially biodegradable and/or bioerodible (instant claims 6, 54 and 63). The silk fibroin is highly stable, affords room temperature storage and is implantable. The silk fibroin structure can be modulated to control the rate of active agent delivery (Abstract). Kaplan also discloses the microneedle further comprising at least one active agent; wherein the active agent is selected from the group consisting of proteins, peptides, antigens, immunogens, vaccines, antibodies or portions thereof, antibody-like molecules, enzymes, nucleic acids, siRNA, shRNA, aptamers, viruses, bacteria, small molecules, cells, hormones, antibiotics, therapeutic agents, diagnostic agents, and any combinations thereof (paragraph [0013] and claims 1-4 of Kaplan, instant claim 63).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a microneedle device comprising a plurality of microneedles, wherein the plurality of microneedles comprises: a first microneedle comprising a coronavirus antigen and/or a coronavirus vaccine; and optionally, a second microneedle comprising an influenza antigen and/or an influenza vaccine; wherein the microneedle device is configured to deliver to a subject the coronavirus antigen and/or the coronavirus vaccine and, optionally, the influenza antigen and/or the influenza vaccine in an amount sufficient to induce an immune response as disclosed by Henderson whereby the microneedle device comprises a silk fibroin tip applied to the base as disclosed by Kaplan. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Kaplan discloses the silk fibroin can include active agents to be transported into or across biological barriers such as skin, tissue and cell membranes. The silk fibroin microneedles can be fully or partially biodegradable and/or bioerodible. The silk fibroin is highly stable, affords room temperature storage and is implantable. The silk fibroin structure can be modulated to control the rate of active agent delivery (Abstract and paragraph [0013] of Kaplan). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 23-25 and 30, with respect to the plurality being the same, formulated into the same or separate microneedle; at least one different antigen; and a percentage of microneedles comprising the antigen. It is not inventive and considered routine and obvious to one of ordinary skill in the art to generate the microneedle with routine experimental variables as routine optimization. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine the appropriate percentage of the protein in the composition of the methods disclosed by the prior art by routine experimentation procedures known in the art. One of ordinary skill in the art would be motivated with a reasonable expectation of success in order to enhance the immune response in a subject.
Regarding claim 44, with respect to the individual microneedles comprising different influenza antigens, Henderson discloses the microneedles comprising different influenza antigens, but does not explicitly state one antigen per microneedle. However, it is not inventive and considered routine and obvious to one of ordinary skill in the art to generate the microneedle with routine experimental variables as routine optimization whether a needle comprises one or more antigens. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine a needle comprising one or more antigens from the methods disclosed by the prior art by routine experimentation procedures known in the art. One of ordinary skill in the art would be motivated with a reasonable expectation of success in order to enhance the immune response in a subject.
Regarding claim 65, Henderson does not explicitly teach a controlled or sustained release of an antigen.
Kaplan, however, discloses the degradation of the microneedle controls release of the active agent distributed therein (claim 13 of Kaplan).
It would have been obvious to one of ordinary skill in the art to generate a microneedle device comprising a plurality of microneedles, wherein the plurality of microneedles comprises: a first microneedle comprising a coronavirus antigen and/or a coronavirus vaccine; and optionally, a second microneedle comprising an influenza antigen and/or an influenza vaccine; wherein the microneedle device is configured to deliver to a subject the coronavirus antigen and/or the coronavirus vaccine and, optionally, the influenza antigen and/or the influenza vaccine in an amount sufficient to induce an immune response as disclosed by Henderson whereby the microneedle device comprises a silk fibroin tip applied to the base whereby the degradation of the microneedle controls release of the active agent as disclosed by Kaplan. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Kaplan discloses the controlled release of active drugs for the advantage of having a biocompatible silk fibroin-based microneedle that is mechanically robust, stabilizes the activity of active agents in the microneedle, and allows programmable degradability of the microneedle for controlled drug release behavior; and since active agents such as antibiotics can be stabilized in the silk fibroin-based microneedles, control of infections at the site of injection can be also beneficial (paragraph [0008] of Kaplan).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672