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 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 1-8, 11, 13-15, 17, 20-21, 24, and 26-28 are 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.
Regarding claim 1, clause “selected from…or D-amino acid ester”, “selected from…or -S(=O)2R7”, and/or “selected from…or a deuterium substitute of any of them” read upon an improper Markush group as the last two members of the group are not separated by the term “and”. Thus, one would not have been apprised of the metes and bounds of variable R2, R3, R4, R5, R6, R7, and R8 that applicant intends to be part of the claimed invention. When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper. At least one of the deficiencies is not rectified in claims 2-8, 11, 13-15, 17, 20-21, 24, and 26-28.
Regarding claim 2, the text “selected from the group…a substituted or non-substituted C4-C5 heterocycle” renders the claim indefinite as it is unclear where one Markush group ends and where another starts. Thus, one would not have been apprised of the metes and bounds of the pharmaceutically acceptable salts applicant intends to be part of the claimed invention.
Regarding claim 13, the last two members of the listed compounds is not separated by the term “and”. Thus, the claim reads upon an improper Markush group.
Regarding claims 14, 17, 21, 26, and 28, the term “includes” and/or “include” renders the claim indefinite as it is unclear whether the text appearing after said term is part of the claimed invention. For the purposes of applying prior art, the examiner interprets the invention as not being limited by the text appearing after said term(s).
Regarding claims 21 and 28, the parenthetical phrase “(B.1.1.7)”, “(B.1.351..B.1.351.3)”, “(B.1.617.2…AY.3)”, “(P.1,…P.1.2)”, (B.1.525)”, (P.3)”, “(B.1.617.1)”, and/or “(C.37)” renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of applying prior art, the examiner interprets the invention as not being limited by the text appearing after said term(s) within the parentheses.
Regarding claim 24, the clause “selected from the group…or fish” reads upon an improper Markush group as the last two members of the group are not separated by the term “and”. When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-7 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Clarke et al. WO 2017/049060 A1 (Clarke).
Clarke generally to methods and compounds for treating Coronaviridae virus infections, particularly methods and nucleosides and prodrugs thereof for treating SARS virus and MERS virus [0002]. Provided is a method for treating a Coronaviridae infection in a human in need thereof comprising administering a therapeutically effective amount of a compound of Formula I:
PNG
media_image1.png
328
398
media_image1.png
Greyscale
.
See [0019], [0131]. In another embodiment of the method of treating a Coronaviridae infection comprising administering a compound of Formula I, the compound is
PNG
media_image2.png
452
412
media_image2.png
Greyscale
or a pharmaceutically acceptable salt or ester thereof [0159]. Clarke discloses the antiviral activity of Compound 1 against MERS-CoV and SARS-CoV and cytotoxicity (Table 4).
PNG
media_image3.png
200
576
media_image3.png
Greyscale
Compound 1
PNG
media_image4.png
134
160
media_image4.png
Greyscale
is embraced by instant Formula (I), wherein R1 = R2 = R9 = H and R3 = R4 = R5 = OH.
Clarke teaches all of the instantly claimed elements. Thus, claims 1-7 and 14-15 are anticipated.
Claim(s) 1-8 and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111961057A .
CN 111961057A provides a method for treating coronavirus infections in cats or other animals by administering a nucleoside of formula (I) and corresponding prodrug, solvate, or pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising said compounds (Abstract).
PNG
media_image5.png
82
212
media_image5.png
Greyscale
CN 111961057A teaches that, preferably, the structure is selected from one of the following compounds:
PNG
media_image6.png
544
594
media_image6.png
Greyscale
See page 3.
The highlighted compound(s) is embraced by instant Formula (I). Thus, claims 1-8 and 11-15 are anticipated.
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.
Claim(s) 17, 20-21, 24, and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke et al. WO 2017/049060 A1 (Clarke) as applied to claims 1-7 and 14-15 above.
Clarke differs from the instantly claimed invention in that Clarke does not explicitly teach (e.g., exemplify) a method comprising administering an effective amount of Compound 1; however, this deficiency would have been prima facie obvious.
It would have prima facie obvious to select Compound 1 from the finite list of compounds disclosed by Clarke in paragraph [0159]. It would have been further obvious to administer a pharmaceutical composition comprising Compound 1 to a subject having, suspected of having, or at risk of having MERS-CoV or SARS-CoV as Clarke teaches that the compound(s) of the invention are useful in the treatment of MERS-CoV or SARS-CoV. In considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.
Thus, claims 17, 20-21, 24, and 26-28 would have been obvious based upon the preponderance of evidence.
Claim(s) 17, 20-21, 24, and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 111961057A as applied to claims 1-8 and 11-15 above.
CN 111961057A differs from the instantly claimed invention in that CN 111961057A does not explicitly teach (e.g., exemplify) a method comprising administering an effective amount of a highlighted compound of page 3; however, this deficiency would have been prima facie obvious.
It would have prima facie obvious to select a highlighted compound from the finite list of compounds disclosed by CN 111961057A on page 3. It would have been further obvious to administer a pharmaceutical composition comprising a highlighted compound to a subject having, suspected of having, or at risk of having a coronavirus as CN 111961057A teaches that the compound(s) of the invention are useful in the treatment of a coronavirus. In considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.
Thus, claims 17, 20-21, 24, and 26-28 would have been obvious based upon the preponderance of evidence.
Conclusion
Claims 1-8, 11-15, 17, 20-21, 24, and 26-28 are pending. Claims 1-8, 11-15, 17, 20-21, 24, and 26-28 are rejected. No claims are allowed.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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, Shaojia Jiang can be reached at (571) 272-0627. 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.
/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/