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 .
Applicant’s reply and claim amendments have overcome the objections to the claims and the rejection under 35 USC § 102.
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.
Claim 16 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant points to the instant amendment to claim 16 and asserts that the claim is not indefinite.
The claim amendment has been fully considered, but does not treat the issue. Claim 16 requires “further comprises inactivating the pathogen by attenuation.” The SARS-CoV-2 is inactivated, i.e., killed, in step b) of claim 1 from which claim 16 depends. An attenuated virus is weakened or disabled, i.e., live. Attenuation does not result in inactivation, i.e., killed/ inactivated. The phrase, “inactivating the pathogen by attenuation”, is nonsensical.
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.
Claims 1, 5-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kratzel et al. (BioRxiv. 2020 Mar 17: 2020-03, of record), Risson. “Inactivated vaccine for SARS-CoV-2”. Nature Reviews Immunology. In Brief Published 30 April 2020; 20 (6): 353-353, of record), Zuccotti et al. (Expert Opinion on Drug Safety. 2011; 10 (4): 499-502, of record) and Malley et al. (USPgPub 2012/0251577, of record).
In reply to the rejection of record, applicant points out that claims 1, 8, and 17 have been amended to require “removing the ethanol”, which is not addressed in the teachings of Kratzel and Risson. Applicant asserts that the claims are now allowable.
Applicant’s arguments and the instant claim amendments have been fully considered, but are found unpersuasive for the reasons set forth herein.
Kratzel et al. teach efficient inactivation of SARS-CoV-2 by exposing the virus to formulations of ethanol, ranging from 0% to 80%, with an exposure time of 30 seconds. See Figures 1A and 2A and corresponding legends, “Results”, “Discussion”, and WHO I formulation under “Chemicals”. These teachings are pertinent against instant claims 1, 5, 8, and 9. Under “Viral strains and cell culture”, Kratzel et al. teach that the SARS-CoV-2 is obtained from a Vero cell culture, as required by instant claims 7 and 13. The ethanol-inactivated SARS-CoV-2 of Kratzel et al. is ethanol-killed in Figures 1A and 2A and is therefore, replication-incompetent, as required by instant claims 15-17.
Kratzel et al. do not teach that the inactivated SARS-CoV-2 formulation is formulated as a vaccine, as required in instant claims 1, 8, or that the virus is obtained from a patient sample, as required by instant claims 6 and 12, or that the vaccine further comprises a pharmaceutically acceptable carrier, as required by instant claim 8, and further comprises an adjuvant, as required by instant claim 14, or inoculating an organism with the vaccine, as recited in claim 17.
Risson teach a patient-derived SARS-CV-2 isolate that is subsequently inactivated. Risson describes macaques administered the inactivated SARS-CV-2, plus alum. After challenge, vaccinated macaques exhibited no symptoms and presented a rapid decrease in viral load.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have formulated the ethanol-inacvtivated-SARS-CoV-2 of Kratzel et al. as a vaccine for administration to induce an immune response such as no symptoms and a rapid decrease in viral load upon encounter with a virulent SARS-CoV-2, as demonstrated by Risson. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success for formulating the ethanol-inacvtivated-SARS-CoV-2 of Kratzel et al. as a vaccine for administration to induce an immune response such as no symptoms and a rapid decrease in viral load, as demonstrated by Risson because Kratzel et al. show no cytotoxicity in any of the ethanol-inactivated SARS-CoV-2 compared with 2-propanol--inactivated SARS-CoV-2, see Figures 1A and 2A compared with Figures 1B and 2B.
Alternatively, or in addition, one of ordinary skill in the art prior to the instant effective filing date would have been motivated to have formulated the inacvtivated-SARS-CoV-2 of Risson with ethanol, as taught by Kratzel et al., for ease and rapid inactivation of SARS-CoV-2 in 30 seconds. See Figures 1A and 2A and corresponding legends, “Results”, “Discussion”, and WHO I formulation under “Chemicals” of Kratzel et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success for formulating inacvtivated-SARS-CoV-2 of Risson with ethanol, as taught by Kratzel et al. because Kratzel et al. show no cytotoxicity in any of the ethanol-inactivated SARS-CoV-2 compared with 2-propanol-inactivated SARS-CoV-2, see Figures 1A and 2A compared with Figures 1B and 2B and SARS-inactivation by alternative chemicals, i.e., ethanol used by Kratzel e al. and β-propiolactone used by Risson et al., are functional equivalents. See MPEP § 2144.06 (II).
Neither Kratzel et al. nor Risson teach removing ethanol, as recited in instant claims 1, 8, and 17.
In paragraphs [0035, 0044, and 0045], Malley et al. teach removing the ethanol after inactivation.
Zuccotti et al. review safety issues with ethanol as an excipient in medicines intended for pediatric use, see the entire document.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have removed the ethanol of Kratzel et al. and Risson because Malley et al. emphasize removal of the ethanol used to inactivate the vaccine component in paragraphs [0035 and 0045] and further characterizes ethanol as noxious in paragraph [0044]. In addition, Zuccotti et al. review acute and chronic toxicities of ethanol present as a component in medicinals for children and enfants. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have removed the ethanol in the inactivated SARS-CoV-2 vaccine of Kratzel et al. and Risson to reduce or eliminate cytotoxicity and harmful hazards to children and enfants, discussed by Zuccotti et al.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kratzel et al., Risson, Zuccotti et al., and Malley et al. as applied to claims 1, 5-9, and 12-17 above, and further in view of Qu et al. (Vaccine. 2005; 23: 924-931, of record).
In reply to the rejection of record, applicant reasons that since instantly amended claim 17 is allowable, dependent claim 20 is also allowable.
Applicant’s arguments have been fully considered, but are found unpersuasive. Claim 17 is rendered prima facie obvious over the combined teachings of Kratzel et al., Risson, Zuccotti et al., and Malley et al. Claim 20, dependent from claim 17, is also determined prima facie obvious for reasons set forth herein.
See the teachings of Kratzel et al., Risson, Zuccotti et al., and Malley et al. None of the references teach oral administration of the vaccine.
Qu et al. teach a method of administering an inactivated SARS-CoV intranasally, see the abstract, sections 1.1 and 1.4.
One of ordinary skill in the art prior to the effective filing date would have been motivated to have orally administered the inactivated SARS-CoV-2 of Kratzel et al., Risson, Zuccotti et al., and Malley et al. to induce a mucosal immune response against SARS-CoV-2. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of inducing an immune response against SARS-CoV-2 upon oral administration because Qu et al. teach mucosal immunizations of inactivated viruses is routine in the first paragraph on page 929 and induce mucosal immune responses against SARS.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671