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 Objections
Claims 1 and 34 are objected to because of the following informalities: the text “C12-22alkoxy)” is objected to as the parenthesis is open-ended. Appropriate correction is required.
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 1-10, 19, 34, 63, 73, 80, 91, 102, and 111 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 claims 1, 34, and dependent claims thereof, the parenthetical phrase(s) “(in which the lipid…C12-22alkoxy)” and/or “(in which a lipid…C12-22alkoxy)” render(s) the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1, 34, 63, and dependent claims thereof, the phrase “such as” renders the claim indefinite because it is unclear whether the limitations after the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 73, variable(s) Base, Y, R, R1, R1A, R2, R3, R5, and R8’ are not defined in the claim. Thus, one would not have been apprised of the metes and bounds of the claimed compound.
Regarding claim 80, variable(s) R, R1, R1A, R2, R3, R5, R8, R8’ and Y are not defined in the claim. Thus, one would not have been apprised of the metes and bounds of the claimed compound.
Regarding claim 91, variable(s) R, R1, R1A, R2, R3, R5, R8’ and Y are not defined in the claim. Thus, one would not have been apprised of the metes and bounds of the claimed compound.
Regarding claims 102 and 111, variable(s) Base, R1, R1A, R2, R3, and R4, are not defined in the claim. Thus, one would not have been apprised of the metes and bounds of the claimed compound.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Compound(s)
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and/or
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fail(s) to include all the limitations of claim 1 as claim 1 requires a hydrogen at the 4’-carbon of the compound. In other words, compounds containing -F at the 4’-carbon is not within the scope of a compound of Formula A. 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 (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) 1-2, 5-14, 19, 34, 63, 73, and 117 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. US 2012/0263678 A1 (Cho).
Claims 1-2, 5-14, and 19 are drawn to a method for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of Formula (A) to a patient in need of treatment or prevention thereof.
Claim 34 is drawn to a method for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of Formula (A) to a patient in need of treatment or prevention thereof.
Claim 63 is drawn to a for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of Formula (A) or Formula (Al) to a patient in need of treatment or prevention thereof.
Claim 73 is drawn to a method for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of Formula (B) or (B1) to a patient in need of treatment or prevention thereof.
Claim 117 is drawn to a method for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of one of the following formulas to a patient in need of treatment or prevention thereof:
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or a pharmaceutically-acceptable salt or prodrug thereof.
Cho provides compounds of Formula I:
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nucleosides, nucleoside phosphates and prodrugs thereof, wherein R6 is CN, ethenyl, 2-haloethen-1-yl, or (C2-C8)-alkyn-1-yl (Abstract). The compounds, compositions, and methods provided are useful for the treatment of Flaviviridae virus infections. Cho also comprises compounds of Formula I that inhibit viral nucleic acid polymerases, particularly HCV RNA-dependent RNA polymerase (RdRp), rather than cellular nucleic acid polymerases [0010]. Without wishing to be bound by theory, the compounds of the invention may inhibit viral RNA-dependent RNA polymerase and thus inhibit the replication of the virus. Compounds of Cho are useful for treating Flaviviridae infections, including hepatitis C, in humans and other animals.
In an embodiment, the compound of Formula I is a compound selected from a group comprising:
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,
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, and
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or a pharmaceutically acceptable salt thereof [0259]. In an embodiment, the pharmaceutical compositions further comprise at least one additional therapeutic agent selected from the group consisting of interferons, ribavirin analogs, NS3 protease inhibitors, NS5a inhibitors, NS5b polymerase inhibitors, alpha-glucosidase 1 inhibitors, cyclophilin inhibitors, hepatoprotectants, other nucleoside inhibitors of HCV, non-nucleoside inhibitors of HCV, and other drugs for treating HCV [0299].
The compounds of Cho are formulated with conventional carriers and excipients, which will be selected in accord with ordinary practice [0456]. Tablets will contain excipients, glidants, fillers, binders and the like. Aqueous formulations are prepared in sterile form, and when intended for delivery by other than oral administration generally will be isotonic. Cho teaches that the effective dose of active ingredient depends at least on the nature of the condition being treated, toxicity, whether the compound is being used prophylactically (lower doses) or against an active viral infection, the method of delivery, and the pharmaceutical formulation, and will be determined by the clinician using conventional dose escalation studies [0486]. For example, the daily candidate dose for an adult human of approximately 70 kg body weight will range from 1 mg to 1000 mg, preferably between 5 mg and 500 mg, and may take the form of single or multiple doses. Cho teaches that suitable routes include oral, rectal, nasal, topical (including buccal and sublingual), vaginal and parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intrathecal and epidural), and the like [0488]. It will be appreciated that the preferred route may vary with, for example, the condition of the recipient.
Thus, Cho teaches or reasonably suggests a method comprising administering a compound recited in paragraph [0259] (e.g.,
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or
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) to a patient having or at risk of having a Flaviviridae infection. Cho further teaches or reasonably suggests that the pharmaceutical compositions further comprise at least one additional therapeutic agent selected from the group consisting of interferons, ribavirin analogs, NS3 protease inhibitors, NS5a inhibitors, NS5b polymerase inhibitors, alpha-glucosidase 1 inhibitors, cyclophilin inhibitors, hepatoprotectants, other nucleoside inhibitors of HCV, non-nucleoside inhibitors of HCV, and other drugs for treating HCV. Cho teaches or reasonably suggests all of the instantly claimed elements.
Cho differs from the instantly claimed invention in that Cho does not explicitly teach all of the claimed elements in a singular embodiment; however, 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. In the instant case, it would have been prima facie obvious to administer a compound of Cho as recited in paragraph [0259] to a patient having or at risk of having a Flaviviridae infection as doing such was reasonably suggested by Cho.
Conclusion
Claims 1-14, 19, 34, 63, 73, 80, 91, 102, 111, and 117 pending. Claims 1-14, 19, 34, 63, 73, 80, 91, 102, 111, and 117 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, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/