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 .
Status of the Claims
Claims 1-16 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
IDS
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: Search Reports, PCT Written Opinion.
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Furthermore, the listing of references in the specification or claims is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Rejections - 35 USC § 112(b)
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 5 is rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 recites “wherein the vaccine is packaged in the cartridge directly from the synthesizing”. It is unclear where and when the “synthesizing” and “packaging” steps occur, e.g., it is unclear whether the claim encompasses vaccines synthesized in one container and then moved/packaged into a cartridge. Furthermore, it is unclear what the “synthesizing” step entails, e.g., whether the “synthesizing” step encompasses generation of the DNA/RNA/peptide, or if it merely encompasses combining the laboratory produced DNA/RNA/peptide with buffer to produce the vaccine1. Therefore, there is insufficient antecedent basis for this limitation in the claims.
Priority
The effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63/218,896), namely July 06, 2021.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shiku2 in view of Eapen3, Levine4, and Alberer5
Shiku discloses: a needleless injector for injecting a DNA solution into an injection target area without using any injection needle, the needleless injector comprising: an injector assembly and an injector housing, wherein the DNA solution is charged into the injector assembly. The injector assembly, the injector assembly being a cartridge and being detachable with respect to the housing and being a unit which is used once and discarded every time when the DNA solution is discharged. Further, Shiku discloses a method for introducing a DNA vaccine or DNA including a region coding for an antigen into a living body of a mammal (except for human) by using the needleless injector, wherein the DNA solution is pressurized by the combustion of the igniter powder in the ignition device so that the DNA solution is discharged to the injection target area. The antigen encoded by the DNA being NY-ESO-1 antigen, a tumor neoantigen and the vaccine is being used to treat a tumor. It can be concluded from the experiments, that the DNA is in a free form, i.e. a naked nucleic acid molecule (see Shiku entire document, e.g., at the abstract, claims, examples, para. [0013]-[0020], [0030]-[0071]; reads on instant claims 1-3, 6-14 and 16).
The prior art of Shiku differs from the instantly claimed invention as follows: Shiku does not expressly disclose: a method of manufacturing a packaged vaccine, wherein the vaccine is packaged in the cartridge directly from the synthesizing; wherein the vaccine comprises RNA.
Eapen discloses a manufacturing process of a personalized vaccine wherein the entire process of manufacturing, up to and including dispensing said composition into containers for patient delivery, is carried out within a completely closed system (see Eapen, entire document, e.g., at abstract, claims). Eapen further discloses the importance and industry need for a streamlined process for manufacturing personalized vaccines which ensures rapid turnaround, minimizes production time and, at the same time, is in line with the standards established for drug manufacture, all of which is met by manufacture within a fully enclosed system (see Eapen, e.g., at para. [002], [008], [009]).
Levine teaches and suggests the importance of pre-filled vaccine injector to provide ease of use and avoid potential contamination (see Levine, e.g., at p. D121 col. 1).
Alberer teaches a mRNA vaccine against rabies, wherein said vaccine is administered via needle-syringe or needle-free injection devices and it was demonstrated herein, that needleless administration leads to an improved antibody response and that uptake of mRNA by cells was higher when it was administered via a needle-free injection (see Alberer, entire document, e.g., at abstract, introduction, discussion). Alberer further teaches that the mRNA encoding the rabies glycoprotein as vaccine antigen is used in free form (see Alberer, e.g., at p. 2 col. 1) and that RNA molecules can be used in prophylactic vaccines encoding bacterial and viral antigens, or in therapeutic cancer vaccines when targeting tumor antigens (see Alberer, e.g., at abstract)
Obviousness Analysis:
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 arrived at the presently claimed invention in view of the prior art because it amounts to no more than: combining the prior art elements of the cited references according to known methods to yield predictable results e.g., incorporating the disclosures of Eapen and Levine into the known method of Shiku, as methods for manufacturing and packaging personalized vaccines are known in the art, along with the advantages of enclosed production systems and pre-filled vaccine cartridges; namely for the purpose of ease of use and avoiding contamination (see MPEP 2143(I)(A),(G)); and simple substitution of one known element for another, e.g., mRNA for DNA, to obtain predictable results, e.g., production of a nucleic acid-based vaccine (see MPEP 2143(I)(B)).
Furthermore, MPEP 2143(I)(C) and (F) also apply, as the improvement and market incentives for doing so are known in the art, i.e., enclosed systems and pre-filling vaccine cartridges to streamline manufacturing and treatment processes as well as abiding by strict drug manufacture regulations.
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the methods of the instant invention, as the prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, claims 1-16 are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Copending Application No.: 18/575,953 (US20240325659)
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/575,953 (reference application) in view of Eapen, Levine, and Alberer (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-16, the reference application claims a method of administering a naked nucleic acid molecule to a subject via a needleless injector, wherein the naked nucleic acid is mRNA (see reference claims 1-14), and is known in the prior art, as set forth above. Furthermore, although the reference claims do not recite the particular manufacturing and packaging methods, this deficiency is remedied by the prior art teachings/disclosures set forth in references, Eapen, Levine, and Alberer, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, as enclosed systems and pre-filling vaccine cartridges to streamline manufacturing and treatment processes as well as abiding by strict drug manufacture regulations. See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the present claims are directed to obvious variants of the reference claims.
Conclusion
Claims 1-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00 AM to 6:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 The instant specification discloses embodiments wherein the vaccine consists of the DNA, RNA or peptide, and a buffer (see para. [033]), wherein the DNA/RNA/peptide is a naked nucleic acid molecule (see para. [032]) that may be produced in the laboratory for use in, or as the result of, genetic engineering (see para. [033]).
2 US20180168789A1; cited on the IDS
3 US20170204361A1
4 Levine, Myron M. "“IDEAL” vaccines for resource poor settings." Vaccine 29 (2011): D116-D125.
5 ALBERER MARTIN ET AL: "Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomized, prospective, first in-
human phase 1 clinical trial", THE LANCET, vol. 390, no. 10101, 1 September 2017 (2017-09-01), pages 1511-1520,
XP055968862, AMSTERDAM,NL ISSN: 0140-6736, DOI: 10.1016/S0140-6736(17)31665-3; cited on IDS
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