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 .
The elected claims are allowable. The restriction requirement, as set forth in the Office action mailed on 6/4/25, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Claims 26 and 30-32 are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 because there are sequences in figure 4, for example, that do not contain a SEQ ID NO. The replacement drawings filed on 1/2/06 recite SEQ ID NOs for fragments embedded in the larger sequence, but the larger sequence requires a SEQ ID NO as well.
A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows.
The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
Drawings
The drawings filed on 10/10/22 and 1/2/06 are objected to because they contain sequences that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), but each sequence does not contain a SEQ ID NO., as explained in the “Sequence Compliance” section above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Allowable Subject Matter
Claims 1, 8, 10, 12-19, 22, 25, 43, and 44 are allowed.
Claims 45 and 46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26, 30-33, and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite wherein the human-associated virus caused disease or syndrome is an infection caused by a coronavirus, wherein the coronavirus is selected from MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2.
The specification does not adequately describe the genus of derivatives of MERS-CoV, SARS-CoV, SARS-CoV-2 having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2 that function as claimed. The specification does not adequately describe the structure required for the function. The specification discloses MERS-CoV, SARS-CoV, SARS-CoV-2, which are species that are not representative of the entire claimed genus. Without further description of the required structure for the function, one would not be able to readily recognize which sequences are necessarily included or excluded from the instant genus; and which sequences necessarily have the recited function.
Additionally, the specification does not adequately describe the genus of human-associated diseases or syndromes that are caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2. Without further description of the genus, one would not be able to readily envision which human-associated diseases or syndromes are caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2.
Claims 26 and 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating SARS-CoV-2 via delivery of AAV comprising specific gRNAs, does not reasonably provide enablement for a method of treating any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The instant claims are directed to a method of treating any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2.
The specification does not draw an adequate nexus between delivery of the instantly recited composition and the treatment of any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2.
The specification demonstrates reduction of SARS-CoV2 titer in vitro after delivery of AAV comprising specific gRNAs. Reduction of SARS-CoV2 is not commensurate in scope with a method of treating any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2.
With regards to delivery, Luther et al. (EXPERT OPINION ON DRUG DELIVERY, 2018, VOL. 15, NO. 9, 905–913) teach: Introduction of the CRISPR/Cas9 machinery into a higher-level organism is a challenge. Delivery of the editing machinery into the cells, the cytosol and then the nucleus is the first obstacle that must be considered when evaluating strategies. There are certain shortcomings which severely hinder applicability, especially when considering the potential for translatability (page 910).
The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of treating any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2 via broad systemic delivery of a naked guide RNA as claimed encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of the instantly recited composition in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful treatment of any human-associated disease or syndrome caused by any MERS-CoV, SARS-CoV, SARS-CoV-2, and derivatives thereof having at least 50% genomic sequence similarity to one of MERS-CoV, SARS-CoV, or SARS- CoV-2. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the molecule in vivo, delivery of the molecule to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
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 Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636