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
Pursuant to the preliminary amendment dated 10/11/2023, claims 6-10 are amended. No claims are newly added or canceled.
Claims 1-10 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.
Information Disclosure Statement
The information disclosure statement (IDS) dated 11/1/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 5 is objected to as being of improper form by failing to end with a period. Appropriate correction is required.
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.
Claims 3, 8 and 10 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The terms "such as", “preferably” and “in particular” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
Claim Rejections - 35 USC § 112(a) - Enablement
The following is a quotation 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.
Claims 7-10 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating any viral infections, does not reasonably provide enablement for preventing any viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to a method of treating or preventing disease caused by any viral infection, by administering a nucleoside analog. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of prevention and the nature of the viral infection. The specification does not define “prevention, Thus, the term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002, PTO-892) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the claimed method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which reduces the occurrence of, or eliminates, viral infections. The full scope of the claims also encompasses eliminating any viral infection.
Amount of guidance/Existence of working examples:
The working examples provide data in Table 3 that a selection of the claimed compounds are effective at inhibiting the growth of RSV. There is no data showing effective growth inhibition or treatment for any virus other than RSV, when the claimed compounds are administered. There is no data for any nucleoside analog administration showing elimination of any virus. State of the prior art/Predictability or unpredictability of the art: One of skill in the art recognizes that the use of nucleoside analogs for treatment of viral infections is a mature field with a wealth of data demonstrating the anti-viral effectives of nucleoside analogs, Thus, one of skill would reasonably expect that the claimed nucleoside analogs would be effective in inhibiting growth of viruses in general and that treating viral infections would also be expected to be effective. However, one of skill would not reasonably expect that any of the of broadly claimed nucleoside analogs would be effective to eliminate any viral infection.
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of a representative number of the broadly claimed nucleoside analogs, to both healthy individuals and individuals having a representative number of the broadly claimed viral infections, to determine if the claimed compounds can be used in the fully claimed scope to prevent such infections. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the state/unpredictability of the art and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yokozeki et al. (US 4,835,104; 1989, PTO-892).
Yokozeki et al. discloses a compound of formula VII (Col. 6):
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Yokozeki also discloses that the nucleoside analog may be used in a method to treat viral infection, such as AIDS. (Col. 10, Ln. 10-16)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al. (US 2013/0324495A1, PTO-892).
Fischer et al. discloses a compounds of formulas 2 and 3 (¶0121), and pharmaceutical compositions thereof comprising carriers (Claim 13):
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Szer et al. (Polska, 1966, PTO-892).
Szer et al. discloses the following compounds:
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 3 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beigelman et al. (US 2020/0277321A1, PTO-892).
Beigelman et al. discloses a compounds of formulas 5-4 and 5-6 (Figure 5), and pharmaceutical compositions thereof comprising carriers (¶0162, 0167):
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Beigelman further discloses that the nucleoside analogs are used in methods of treating viral infections, including Hepatitis C, dengue, Zika, SARS, HRSV, pneumonia, common cold, etc. (¶0007, 0015, 0017, 0029)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borretzen et al. (WO 1992/09276 A1, PTO-892).
Borretzen et al. discloses a compounds of formulas BZU-d1 and BZU (Table 4), and pharmaceutical compositions thereof comprising carriers (p. 13):
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 2 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reddy et al. (WO 2006/033709, IDS).
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 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)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capello et al. (J. Mol. Cat. B, 2005, IDS).
Capello et al. discloses compound 2: (Scheme 1)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cramer et al. (Tet. Lett., 1963, IDS).
Cramer et al. discloses compounds II-1 and II-3 thru II-6: (Tables 1, 2)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petrova et al. (Tet. Lett., 2010, PTO-892).
Petrova et al. discloses compounds 1a thru 1e: (Scheme 2)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pav et al. (Org. Biomol. Chem., 2011, PTO-892).
Pav et al. discloses compounds 15a thru 15d: (Scheme 2)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mikhailopulo et al. (Biomed. Mass Spec., 1982, IDS).
Mikhailopulo et al. discloses compounds 10-12: (Figure 1)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beigelman et al. (WO 2012/040124, IDS).
Beigelman et al. discloses compounds 19-2 and 19-3: (Example 21)
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Accordingly, the instant claims are anticipated by the prior art.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy et al. (WO 2006/033709, IDS).
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)
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 claims 4 and/or 5. In one, of many, examples, within formula (I) selecting X’=Y=O; R15=R16=R18=H; R17=F; B to be cytidine, Z’= -O-, and Z”= R24(C=O), where R24 is isopropyl, arriving at instant compound D2 of claim 5.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
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 1-10 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 and 8-18 of copending application 18/858054. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The instant claims are of a scope where the nucleoside analog is limited to having a bicyclic core structure formed at the 2 and 3 positions of the sugar. In contrast, ‘054 is more broadly claimed where the 2 and 3 positions of the sugar are not necessarily connected into a ring. However, claim 1 of ‘054 has a proviso where the 2 and 3 positions of the sugar are connected with a carbonyl group to form a five membered ring. The other variables of the instant claims and ‘054 are of overlapping scope. Thus, the instant claims and those of ‘858 are obvious variants of one another.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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.
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/DALE R MILLER/Primary Examiner, Art Unit 1693