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 .
Status of the Claims
Claims 1-24 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/15/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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) 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over SOMMADOSSI (US 10,946,033 B2, published 3/16/21, IDS 1/15/26) in view of BASICMEDICAL KEY (Basicmedical Key, Pharmacologic Response and Drug Dosage Adjustments (6/18/16), available at https://basicmedicalkey.com/pharmacologic-response-and-drug-dosage-adjustments/#s0010 (last accessed 8/25/26), 4 pages).
Additionally, Claim(s) 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over SOMMADOSSI (US 2019/0201433 A1, published 7/4/19, IDS 1/15/26) in view of BASICMEDICAL KEY (Basicmedical Key, Pharmacologic Response and Drug Dosage Adjustments (6/18/16), available at https://basicmedicalkey.com/pharmacologic-response-and-drug-dosage-adjustments/#s0010 (last accessed 8/25/26), 4 pages).
Additionally, Claim(s) 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over SOMMADOSSI (WO 2018/048937 A1, published 3/15/18) in view of BASICMEDICAL KEY (Basicmedical Key, Pharmacologic Response and Drug Dosage Adjustments (6/18/16), available at https://basicmedicalkey.com/pharmacologic-response-and-drug-dosage-adjustments/#s0010 (last accessed 8/25/26), 4 pages).
The above 3 rejections rely upon the same disclosure- being the PCT, US PGPUB, and issued US Patent- of the same document, all rejections are consolidated and discussed only with reference to the issued US Patent.
The instant claims are drawn generally to a method of treating Dengue viral infections with a compound of the formula
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.
Sommadossi teaches treatment of human infected with Dengue fever via administration of
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or
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or pharmaceutically acceptable salt thereof (e.g. claims 17 and 19), where the Dengue fever virus serotype is 2 or 3 (e.g. claims 20-23). Sommadossi additionally teaches compounds used in the methods are in the genus
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, where R7 is phenyl, R8 is H, R9a,9b are methyl or hydrogen, R10 is isopropyl (e.g. claim 5). Pharmaceutically acceptable salts include examples such as sulfate, nitrate, bicarbonate, and carbonate salts. (coulumn 266, lines 65-67). “Pharmaceutically acceptable salts may be obtained using standard procedures well known in the art, for example by reacting a sufficiently basic compound such as an amine with a suitable acid affording a physiologically acceptable anion.” (column 266-267, lines 67+). Additionally, Sommadossi teaches that the virus serotype treated is 1, 2, 3, or 4 (e.g. column 279, lines 20-23). Sommadossi additionally teaches that the therapeutically effective amounts, “will vary with the infection or condition to be treated, its severity, the treatment regimen to be employed, the pharmacokinetics of the agent used, as well as the patient or subject (animal or human) to be treated, and such therapeutic amount can be determined by the attending physician or specialist.” (column 280, lines 55-61). Further, “It is well within the routineers’ skill to modify the route of administration and dose regimen of a particular compound in order to manage the pharmacokinetics of the present compounds for maximum beneficial effect in patients.” (column 281, lines 10-14).
Further, “The amount of the compound included within the therapeutically active formulations… is an effective amount for treating the RNA virus infection…. In general, a therapeutically effective amount the compound in pharmaceutical dosage form usually ranges from about 0.001 mg/kg to about 100 mg/kg per day or more, more often, slightly less than 0.1 mg/kg to more than about 25 mg/kg per day of the patient or considerably more, depending upon the compound used, the condition or infection treated and the route of administration. The active nucleoside compound according to the present invention is often administered in amounts ranging from about 0.1 mg/kg to about 15 mg/kg per day of the patient, depending upon the pharmacokinetics of the agent in the patient. This dosage range generally produces effective blood level concentrations of active compound which may range from about 0.001 to about 100, about 0.05 to about 100 micrograms/cc of blood in the patient.” (column 281, lines 28-49). Additionally, “Often, to treat, prevent or delay the onset of these infections and/or to reduce the likelihood of an RNA virus infection, or a secondary disease state, condition or complication of an RNA virus infection, the compositions will be administered in oral dosage form in amounts ranging from about 250 micrograms up to about 500 mg or more at least once a day, for example, at least 25, 50, 100, 150, 250 or 500 milligrams, up to four times a day.” (column 281, lines 50-57). With regards to the dosage form, “Enteric coated oral tablets may also be used to enhance bioavailability of the compounds for an oral route of administration. The most effective dosage form will depend upon the bioavailability/pharmacokinetics of the particular agent chosen as well as the severity of disease in the patient. Oral dosage forms are particularly typical, because of ease of administration and prospective favorable patient compliance.” (column 282, lines 26-33).
The difference between the instant claims and the prior art is that while the prior art discloses treating the same condition with the same compounds in the same patient population, and provides teachings on selecting dosing amounts and regimens, it does not specifically teach the dose or regimen claimed.
Basicmedical Key teaches that drug dosing is commonly based on average pharmacokinetic parameters but must often be adjusted to maintain plasma concentrations within the therapeutic window. It further teaches that therapeutic drug monitoring is used to tailor dosage regimens when patient-specific factors cause drug exposure to deviate from the desired range, and that oral dose size and dosing interval may be adjusted to keep concentrations above the minimum effective concentration and below the minimum toxic concentration. (throughout).
In light of the teachings of Sommadossi regarding the amount given, stating that it can be “… up to 500 mg or more at least once a day…” (emphasis added), indicating that the doses are not limited to an upper threshold, and that Basicmedical Key teaches dosing regimens and parameters are routinely optimized, one of skill in the art would have administered the compound as necessary to achieve the appropriate therapeutic window, including doses as instantly claimed, being suggested by Sommadossi as “…or more” and the suggestion to administer the compounds “at least once a day” and “up to 4 times a day”. Further, Sommadossi provides the direct teachings to optimize the dosing and therapeutic regimen in that itteaches that the therapeutically effective amounts, “will vary with the infection or condition to be treated, its severity, the treatment regimen to be employed, the pharmacokinetics of the agent used, as well as the patient or subject (animal or human) to be treated, and such therapeutic amount can be determined by the attending physician or specialist.” (column 280, lines 55-61). Further, “It is well within the routineers’ skill to modify the route of administration and dose regimen of a particular compound in order to manage the pharmacokinetics of the present compounds for maximum beneficial effect in patients.” (column 281, lines 10-14).
Thus, in light of the teachings in Sommadossi regarding doses, treatment regimens, and optimization, along with the art recognition that optimization of dosing regimens is routinely practiced, it would have been obvious to one of ordinary skill in the art at the time of the invention to determine optimum and operable conditions, because such conditions are recognized result-effective variables that are routinely identified and optimized through routine experimentation. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see MPEP § 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew D Kosar whose telephone number is (571)272-0913. The examiner can normally be reached Monday-Friday, 7am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625
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