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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 5/11/2026 in which claims 2-4 are cancelled; claims 1, 5 and 7-10 are amended and claims 11 is newly added.
Claims 1 and 5-11 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/CN2022/086215, filed on 4/12/2022. The instant application claims foreign priority to CN 202110405657.6 and CN 202111027057.7 filed on 4/15/2021 and 9/2/2021, respectively. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 10/11/2023.
Withdrawn Rejections
All rejection(s) of record for claim(s) 2-4 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 5/11/2026, with respect to the rejection of claims 8 and 10 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant amended the claims to remove the terms "such as", “preferably” and “in particular”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 5/11/2026, with respect to the rejection of claims 8 and 10 under 35 U.S.C. 112(a), for lack of enablement, has been fully considered and is persuasive. Applicant amended the claims to narrow scope to be fully enabled by the specification. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 5/11/2026, with respect to the rejection of
Claims 1 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Yokozeki et al. (US 4,835,104; 1989);
Claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al. (US 2013/0324495A1);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Szer et al. (Polska, 1966);
Claims 1 and 6-10 under 35 U.S.C. 102(a)(1) as being anticipated by Beigelman et al. (US 2020/0277321A1);
Claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Borretzen et al. (WO 1992/09276 A1);
Claims 1 and 6-9 under 35 U.S.C. 102(a)(1) as being anticipated by Reddy et al. (WO 2006/033709);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Capello et al. (J. Mol. Cat. B, 2005);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Cramer et al. (Tet. Lett., 1963);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Petrova et al. (Tet. Lett., 2010);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Pav et al. (Org. Biomol. Chem., 2011);
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Mikhailopulo et al. (Biomed. Mass Spec., 1982); and
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Beigelman et al. (WO 2012/040124), has been fully considered and is persuasive. Applicant has amended claim 1 to be of narrower scope such that the above cited prior art does not anticipate the claims. The rejections are hereby withdrawn.
Applicant’s response with respect to the provisional rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending application 18/858054, has been fully considered and is persuasive. The terminal disclaimer filed on 5/11/2026 is sufficient to overcome the provisional non-statutory double patenting rejection. The rejection is hereby withdrawn.
Maintained Objection
Claim 5 is objected to as being of improper form by failing to end with a period. Appropriate correction is required.
Rejections/Objections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 5/11/2026, wherein instant independent claim 1 is amended to alter the breadth and scope of the claim, wherein the remaining pending claims depend from said independent claims, and claim 11 is newly added. Therefore, new grounds of rejection have been made or rejections from the previous Office Action have been modified.
Claim Objection
Claim 7-11 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(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depicts numerous compounds that are outside the scope of those defined by base claim 1. Specifically, the following compounds are outside the scope of formulas I-III, I-IV, I-V or I-VI: A5, A6, A42, A47 thru A53, B5 thru B12, B42 thru B44, C7 thru C12, C26 thru C33, C49, C56 thru C58, and C64 thru C66. Base claim 1 limits the structural variables as follows: R1=R4=R7=H; R5=H, C1-20 alkanoyl (optionally substituted by 1-3 halogens), or C3-20 cycloalkanoyl (optionally substituted by 1-3 halogens); R8=H, D or halogen and R13=C1-20 alkanoyl or C3-20 cycloalkanoyl. The compounds listed above in claim 5 violate the definition of one or more of R1, R4, R5, R7, R8 or R13, such that the scope of claim 5 is broader than claim 1. For instance: 1) compound A6 depicts R5 as an amino C3 alkanoyl group; 2) compound A48 depicts R1 as deuterium and R13 as an oxo C2 alkanoyl group; and 3) compound C64 depict R5 as an aza cyclobutanoyl group. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy et al. (WO 2006/033709, reference of record).
Reddy et al. discloses a compound of formula (I) and pharmaceutical compositions thereof comprising carriers (Claims 1 and 17), where the variables are as defined in claim 1:
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Reddy further discloses that: (¶0121, 0129)
X' is O, S, S-O, or NR20, wherein R20 is H or optionally substituted alkyl, aryl, arylalkyl, C3-6 cycloalkyl, OH, OR20', or O(C=O)R20', wherein R20' is H, lower alkyl or C3-6 cycloalkyl;
Y is -O-, -S-, -N-, -C(R20' )-, or -CH2-;
R18 is independently H, C1-4 alkyl, C2-4 alkenyl, or C2-4 alkynyl; wherein said C1-4 alkyl is optionally substituted with amino, hydroxy, or 1 to 3 fluorine atoms, C1-4 alkylamino, dialkylamino, C3-6 cycloalkylamino, halogen, or alkoxy;
R17 is H, halogen, alkyl optionally substituted with 1 to 3 fluorine atoms, C1-10 alkoxy optionally substituted with C1-3 alkoxy or 1 to 3 fluorine atoms, C2-6 alkenyloxy, C1-4 alkylthio, C1-8 alkylcarbonyloxy, aryloxycarbonyl, azido, amino, alkylamino, or dialkylamino;
R16 and R15 are independently H, C1-4 alkyl, C2-4 alkenyl, or C2-4 alkynyl; wherein said C1-4 alkyl is optionally substituted with amino, hydroxy, or 1 to 3 fluorine atoms, and said C2-4 alkenyl and C2-4 alkynyl are each optionally substituted with one or more of C1-3 alkoxy, carboxy, C2-6 alkenyloxy, C1-4 alkylthio, C1-8 alkylcarbonyloxy, aryloxycarbonyl, azido, amino, alkylamino, or dialkylamino;
Z' is -CH(R23)-OH, -O-, -CH(R23)-O-, C1-4 cycloalkyl, -OC(R23)2PO3H2, -CH2C(R23)2PO3H2, C2-4 alkenyl, C2-4 alkynyl, C1-4 cycloalkylene, C2-4 alkenylene, or C2-4 alkynylene; wherein R23 is H, F, methyl, ethyl, hydroxymethyl, fluoromethyl, -CH2N3, -CH2-NR21R22, -CH2-, or-CH2-NH2;
Z" is absent, or Z" is R24(C=O)-, R24-O-(C=O)-, or an ester of an L-amino acid such as an L-valine ester R24CH(NH2)(C=O)-, wherein R24 is optionally substituted C1-6 alkyl, cycloalkyl, aryl, or aralkyl; or Z" is
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; and
B represents a purine or pyrimidine base or analogue or derivative thereof. B will be preferably linked to the ribose ring of Formula I at the 9- or 1- position, respectively, of the purine or pyrimidine base B. By "purine or pyrimidine base or analogue or derivative thereof' is meant a purine or pyrimidine base found in native nucleosides, or an analogue thereof…Such purine or pyrimidine bases, analogues, and derivatives will be well known to those skilled in the art. (see also pp. 31-36)
Reddy exemplifies the following compounds as particular embodiments of formula (I): (¶0664, 0686; Claim 7)
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.
Reddy also discloses that the nucleoside analogs of formula (I) are used in a method of treating a viral infections including HCV. (Claims 18-25)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to envision numerous nucleoside analogs based on formula (I) of Reddy by selecting any combination of structural variables suggested by Reddy, thereby arriving at the instant invention. For instance, starting from exemplified embodiment 31.7 of Reddy, it would be obvious to modify this structure based on the suggested structural variables of Reddy to yield structures within the scope of claim 5. Particularly, substituting the 4’ methyl group with hydrogen and modifying the base to substitute the amine group with NHOH, results in a compound identical to compound A1 of claim 5.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection of, has been fully considered but is not persuasive.
Applicant argues that one would not be motivated to modify Reddy to arrive at the instant invention. Applicant argues, citing Takeda, 492 F.3d at 1359, 83 USPQ2d at 1176, that the fact pattern in the instant case is similar in that it is not “obvious to try” when the teaching is a broad swath of millions of compounds. Applicant also argues that Reddy is directed towards treating HCV whereas the instant claims are directed towards treating SARS-CoV-2. Applicants’ argument is not persuasive because the fact pattern in Takeda is different in that the court found that the prior art cited by the Office contained a teaching away from the suggested modifications, rendering the claims at issue non-obvious. However, there is no teaching away in the instant case and the Office is not suggesting selecting from among millions of compounds. Reddy exemplifies a lead compound, which only requires two modifications to yield a compound within the instant claim scope, where the necessary modifications are taught by Reddy as within the scope of the envisioned changes (i.e. substituting a methyl group with a hydrogen at the 4’ position). Such limited modifications do not encompass millions of compounds but encompass a much smaller number of compounds that are within the scope of the standard of “a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. With respect to the therapeutic methods taught by the prior art, such teaching is not relevant to the questions of whether the claimed compounds are non-obvious over the compounds suggested by Reddy. The rejected claims are directed to compounds and compositions thereof, not to methods for therapeutic use. Thus, it is only the structure of the claimed compounds compared to the structures of the compounds suggested by Reddy that are relevant to the conclusion of obviousness.
The rejection is still deemed proper and is maintained.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 5-8 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over US 18/879388. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Claims 1-10 of ‘388 are directed towards the use of a compound having formula (I), where compounds such as 48-51 are specifically envisioned.
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Although the claims of ‘388 are directed to a use, a use is not structurally limiting so the claims of ‘388 are analyzed as being directed towards compounds. As such, the compounds of ‘388 lie within the scope of the compounds instantly claimed in formula I-VI. Claims 11-20 of ‘388 are directed to a method of treating a coronavirus by administering compounds that lie within the scope of instant formula I-VI, as such the instant method claims are also an obvious variant of ‘388.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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