DETAILED CORRESPONDENCE
This office action is in response to applicant’s filing dated February 6, 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 6, 2026 has been entered.
Status of Claims
Claims 17-45 are pending in the instant application. Acknowledgement is made of Applicant's remarks filed August 18, 2025. Claims 1-16 were previously canceled.
Priority
The present application is a DIV of 15/765,310 filed April 2, 2018, which is a national stage entry of PCT/US2016/055414 filed on October 5, 2016, which claims benefit of US Provisional Application No. 62/241,280 filed on October 14, 2015. The effective filing date of the instant application is October 14, 2015.
Maintained Objections and/or Rejections
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.
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 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 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 17-45 stand rejected under 35 U.S.C. 103 as being unpatentable over Devito et al (WO 2011/139832 A2, cited in a previous Office Action) in view of Zyvox® Prescribing Information (Pfizer, Pharmacia & Upjohn Company, Revised 09/2013, pp 1-25, hereinafter Zyvox®, cited in a previous Office Action), Sirturo™ Prescribing Information (Janssen Therapeutics, December 2012, pp 1-21, hereinafter Sirturo™, cited in a previous Office Action), Diacon et al (Lancet, 2012; 380:986-93, cited in a previous Office Action), Lee et al (N Engl J Med, 2012; 367(16):1508-1518, cited in a previous Office Action) and Pantaleo et al (WO 2012/085652 A2, cited in a previous Office Action).
Regarding claims 17 and 37, Devito teaches a method of treating a mycobacterial infection, for example an infection caused or mediated by Mycobacterium tuberculosis, and in particular an infection caused or mediated by a resistant or highly virulent strain of a mycobacterium, in a patient comprising administering a pharmaceutically effective amount of an antibiotic compound or tautomer thereof or pharmaceutically acceptable salt or prodrug of said compound or tautomer to a patient (page 9, 2nd paragraph); wherein the antibiotic compound or tautomer thereof or pharmaceutically acceptable salt or prodrug of said compound or tautomer is selected from an oxazolidinone antibiotic compound (page 11, last full paragraph); wherein oxazolidinone antimicrobial compounds include linezolid (page 16, 2nd paragraph). Devito further teaches a composition further comprising an additional pharmaceutical agent, particularly, one or more compounds typically used for treating, preventing, or reducing the risk of an infection caused or mediated by Mycobacterium tuberculosis or a nontuberculous mycobacterium and in particular those infections caused or mediated by resistant or highly virulent strain of a mycobacterium (page 12, 3rd paragraph) wherein the additional compounds include nitroimidazoles like PA-824 and new generation diarylquinolines like TMC207 (page 12, last paragraph). PA-824 is equivalent to pretomanid as evidenced by SciFinder (CAS Registry #187235-37-6) which lists PA-824 as an alternative name for pretomanid. TMC207 is equivalent to bedaquiline as evidenced by SciFinder (CAS Registry #843663-66-1) which lists TMC 207 as an alternative name for bedaquiline.
While the reference may not be anticipatory insofar as one must select linezolid from various oxazolidinone antimicrobial compounds and PA-824/pretomanid and TMC 207/bedaquiline from various additional pharmaceutical agents typically used for treating an infection caused or mediated by Mycobacterium tuberculosis as taught in Devito, it remains that it would have been obvious to a person of ordinary skill in the art, to have selected linezolid from the list of oxazolidinone antimicrobial compounds, and PA-824/pretomanid and TMC 207/bedaquiline from the list of additional pharmaceutical agents in order to arrive at a composition useful for an infection caused or mediated by Mycobacterium tuberculosis. The skilled person would have been motivated to do so by the unambiguous disclosure of each particular species of oxazolidinone antimicrobial compounds and additional pharmaceutical agents taught individually and alternatively as equally useful in a method of treating an infection caused or mediated by Mycobacterium tuberculosis. This conclusion is supported by the fact that it has long been held in patent prosecution that a reference should be considered as expansively as is reasonably possible in determining the full scope of the contents within its four corners.
Regarding claim 18, DeVito teaches formulations of the present invention suitable for oral administration can be in the form of discrete units such as capsules, gelatin capsules, tablets (page 24, lines 3-4).
Regarding the amounts of linezolid of instant claims 20-26, Devito teaches generally an effective amount of dosage of active compound will be in the range of from about 0.01 to 100 mg/kg of body weight/day (page 28, 2nd full paragraph) and oxazolidinones were dosed orally at 50 mg/kg (page 35, 4th paragraph). Assuming an average weight of an adult is 60 kg, an amount of 0.01 to 100 mg/kg is equivalent to 0.6 mg to 6 g of linezolid. Moreover, Zyvox® teaches ZYVOX Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablets (page 13; 1st paragraph) and ZYVOX for oral suspension is supplied as an orange-flavored granule/powder for constitution and each 5mL contains 100 mg of linezolid (13, 2nd paragraph). Moreover, Zyvox® teaches dosage and administration for pediatric patients is 10 mg/kg oral every 8 hours and for adults and adolescents 600 mg oral every 12 hours or 400 mg oral every 12 hours (page 1, left, table). 600 mg every 12 hr reads on 600 mg bid or 1200 mg. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding the amount of bedaquiline of instant claims 30 and 31, Devito does not teach the instantly claimed amounts. However, Sirturo™ teaches each tablet contains bedaquiline fumarate drug substance which is equivalent to 100 mg of bedaquiline (page 11, 2nd paragraph); and SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB) (page 1, 1st paragraph); and dosage and administration is 400 mg once daily (page 1, 2nd paragraph). 400 mg once daily reads on 400 mg.
Regarding the amount of pretomanid of instant claim 33, Devito does not teach the instantly claimed amounts. However, Diacon teaches 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial (title); a 14-day EBA study in treatment naïve patients with sputum-microscopy smear-positive fully drug-susceptible pulmonary tuberculosis assessing various combinations of the new antituberculosis agents bedaquiline, PA-824, and moxifloxacin and the established agent pyrazinamide with a view to developing appropriate combinations for longer-term studies, leading to a tuberculosis regimen for management of drug-susceptible and MDR disease (page 987, left, 2nd paragraph); PA-824 was administered 200 mg a day (page 987, Panel 1).
Devito does not explicitly teach the oxazolidinone antimicrobial compound, linezolid, is administered in a first period of time and bedaquiline and pretomanid are administered for a second period of time, wherein the first period of time is shorter than the second period of time and wherein the first period of time is one to two months of instant claim 17 or the dosing regimens of instant claims 19, 26-29, 32, 34, 35, 42, 44 and 45.
However, Lee teaches linezolid is effective at achieving culture conversion among patients with treatment-refractory XDR (extensively drug-resistant) pulmonary tuberculosis, but patients must be monitored carefully for adverse events (Abstract, conclusions); if adverse events occurred that were considered to be related to linezolid, a reduction in the dose or a rechallenge at a dose of 300 mg per day was allowed after a limited drug holiday (page 1510, left, 2nd paragraph). Lee teaches patients were randomly assigned to receive linezolid in addition to their existing regimen, either immediately or after a 2 month delay (page 1509, right, 2nd paragraph); patients continued taking linezolid 600 mg per day until they had negative sputum smears for 2 consecutive weeks or until they had received 4 months of linezolid treatment, whichever came first (page 1509, right, last paragraph).
Moreover, Pantaleo teaches methods for differentiating between mammals having active and latent tuberculosis disease (page 1, lines 9-10); a method of monitoring active tuberculosis disease comprising administering an antibiotic; isolating mononuclear cells from the individual 4 weeks, 3 months and 6 months after initiation of therapy and modifying the administration of the antibiotic therapy after 4 weeks, 3 months or 6 months following the initiation of the antibiotic therapy (claim 5) wherein the antibiotic therapy includes linezolid (claim 10) and R207910 and combinations thereof (claim 10). Pantaleo teaches R207910 is also known as TMC207 (page 15, lines 17-18). Thus, Lee and Pantaleo establish that it was known in the art to monitor antibiotic therapy in a method of treating tuberculosis and to adjust the therapy including drug holidays and changing drugs based on linezolid adverse effects and differentiating between active and latent tuberculosis disease.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and dosing regimens of linezolid, bedaquiline, and pretomanid suggested by the prior art as a starting point to optimize the amounts and dosing regimen for administering linezolid, bedaquiline, and pretomanid in a method for treating tuberculosis as taught by the cited art since the cited art teaches that these amounts of linezolid, bedaquiline, and pretomanid are suitable for use as part of a combination therapy for treating tuberculosis and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 36 and 40-43, Lee teaches linezolid is effective at achieving culture conversion among patients with treatment-refractory XDR (extensively drug-resistant) pulmonary tuberculosis (Abstract, conclusions); Sirturo™ teaches SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB) (page 1, 1st paragraph).
Regarding claims 38 and 39, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).).
Taken together, all this would result in the composition of claims 17-45 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Devito et al. discloses methods and pharmaceutical compositions for treating mycobacterial infections, which necessarily include an oxazolidinone antibiotic compound that necessarily includes radezolid. Devito et al. provides disclosure with regard to nonlimiting examples of useful oxazolidoione antimicrobial including radezolid. Applicant submits that considering Devito et al. expansively would lead a skilled artisan indisputably to the conclusion that the methods and pharmaceutical compositions for treating mycobacterial infections thereof must include an oxazolidinone antibiotic compound that necessarily includes radezolid. The method of Applicant's claims does not include radezolid, as the anti-bacterial agents consist of linezolid, bedaquiline and pretomanid, and optionally pyrazinamide, or a pharmaceutically acceptable salt of each thereof.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 2123 states:
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
In the instant case, the examiner acknowledges that Devito teaches nonlimiting examples of oxazolidinone antimicrobials include radezolid (see page 15, last bridge paragraph). However, Devito further teaches other oxazolidinone antimicrobial compounds useful herein include linezolid and torezolid (See page 16, 2nd paragraph). Thus, Devito explicitly teaches linezolid as one of 3 oxazolidinone antimicrobial compounds useful in the disclosed compositions. The fact that Devito teaches radezolid is preferred embodiment does not constitute a teaching away of the use of linezolid.
Applicant argues:
Applicant submits that it is not at all clear how a skilled artisan would, or otherwise could, interpret the results summarized in Table 1 of Devito et al. as somehow indicating that linezolid and radezolid are equivalent or otherwise interchangeable. In light of the results summarized in Table 1 of Devito et al., linezolid must be used at a concentration (>50 g/ml) that is at least 162 times greater than that of radezolid (0.31 g/ml) to achieve the same LORA IC90 result.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The examiner acknowledges that Devito teaches radezolid is more potent than linezolid. However, Devito teaches other oxazolidinone antimicrobial compounds useful herein include linezolid and torezolid (See page 16, 2nd paragraph). Thus, Devito explicitly teaches linezolid as one of 3 oxazolidinone antimicrobial compounds useful in the disclosed compositions. The fact that Devito teaches radezolid is preferred embodiment does not constitute a teaching away of the use of linezolid.
Applicant argues:
In Table Ia of the Fotouhi Declaration demonstrate improved results with LZD50 and LZD100 as compared to AZD125 (125 mg Radezolid), under the same in vivo conditions, as would be unambiguously recognized and understood by a skilled artisan. The Week 8 results for JPaL50 (0.39) are 72.7% better than for JPaAz125 (1.43), where the Az (Radezolid) is present at a level that is 2.5 times (250%) greater than that of the L (Linezolid). It is submitted that these results are unambiguously and undeniably representative of a significant and exceptional synergistic effect associated with and provided by the anti-bacterial agents of the presently claimed invention.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 716.02 states:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). In the instant case, Devito teaches the combination of compounds can be a synergistic combination (page 4, 1st paragraph). Thus, Devito suggests combining the disclosed agents for a synergistic effect. Thus, it is not unexpected that combining linezolid, bedaquiline, and pretomanid would result in a synergistic effect.
Moreover, it does not appear that the differences between the combinations are so great as to be unexpected. In particular, in a review of the Declaration, the differences between the groups in Graphs A and B:
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do not appear to be so great as to be unexpected and of both statistical and practical significance.
Moreover, in a review of the data for JPaL50 and JPaL100 in which it appears that JPaL50 has a greater effect than JPaL100 (0.39±0.26 vs 0.66±0.39). The data provides comparison to JPaAz125. As noted in the response, JPaAz125 has a greater amount than that in JPaL50. It is not clear from the data provided if the results disclosed are due to differences in amounts of the compounds tested.
Moreover, MPEP 716.02(c) states:
"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989). In the instant case, as set forth above, Devito suggests a composition for treating a mycobacterial infection in a patient comprising a pharmaceutically effective amount of an antibiotic compound, linezolid; further comprising an additional pharmaceutical agent, PA-824 and TMC207. Moreover, Devito teaches the combination of compounds can be a synergistic combination (page 4, 1st paragraph). Thus, Devito suggests combining the disclosed agents for a synergistic effect. Thus, it is not unexpected that combining linezolid, bedaquiline, and pretomanid would result in a synergistic effect. The fact that the combination of linezolid, PA-824/pretomanid and TMC 207/bedaquiline is useful for treating mycobacterial infection caused or mediated by Mycobacterium tuberculosis and that the combination has a synergistic effect is not unexpected. Thus, the teachings of cited references support the obviousness rejection set forth above.
Applicant argues:
Devito et al. fails to provide a teaching, suggestion, or motivation, with a reasonable expectation of success, of a composition and/or method useful in the treatment of tuberculosis, in which linezolid is administered for a shorter period of time (of one to two months) than bedaquiline and pretomanid. Applicant has discovered that, contrary to the conventional understanding that it is necessary to continuously administer antibacterial agents over a period of many months to obtain the desired antibacterial effect, linezolid in a multi-agent dosage form can be administered for one to two months and still retain sterilizing activity. Further, limiting linezolid to the first month of treatment did not significantly increase the rate of relapse after 2 or 3 months of treatment. Applicant submits that these results indicate that the use of linezolid once daily for the first one to two months of treatment and/or front-loading therapy with higher doses for even shorter periods may enable linezolid to contribute important bactericidal and sterilizing activity before the onset of potentially irreversible neuropathy develops. As shown in Table 3, one to two months of linezolid administration significantly increased the bactericidal activity of bedaquiline plus pretomanid. Notably, no relapse was observed irrespective of whether linezolid was continued throughout or discontinued after one or two months, and the addition of linezolid for at least one month resulted in fewer relapses after three months of treatment (see paragraph [0086] of the published specification).
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 716.02 states:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Devito teaches the combination of compounds can be a synergistic combination (page 4, 1st paragraph). Thus, Devito suggests combining the disclosed agents for a synergistic effect. Thus, it is not unexpected that combining linezolid, bedaquiline, and pretomanid would result in a synergistic effect. Moreover, it does not appear that the differences between the combinations are so great as to be unexpected.
Applicant argues:
Lee et al. is directed to the treatment of chronic drug-resistant tuberculosis with linezolid. Lee et al. provides disclosure with regard to the administration of linezolid for at least 2 months of treatment, but this is after at least 6 months of a prior failing regimen treatment prior to enrollment (that did not involve the administration of bedaquiline and pretomanid, and optionally pyrazinamide). Since Lee et al. is directed to treatment of drug-resistant tuberculosis with linezolid alone, it is not at all clear how or why a skilled artisan would consider combining such disclosure with Devito et al. and/or one or more of the other cited documents, and additionally picking and choosing from amongst the laundry lists of compounds disclosed by Devito et al., to arrive at Applicant's presently claimed invention.
Pantaleo et al. discloses a method for differentiating between mammals having active and latent Tuberculosis disease. Pantaleo et al. discloses that the antibiotic can be selected from linezolid. Pantaleo et al. does not disclose or suggest using linezolid in combination with bedaquiline and pretomanid. Pantaleo et al. does not provide any disclosure or suggestion with regard to administering multiple antibiotics in stages involving: a first period of time (during which linezolid is administered); and a second period of time (during which bedaquiline and pretomanid are administered), where the first period of time is shorter than the second period of time, and where the first period of time (during which linezolid is administered) is one to two months.
ZYVOX relates to linezolid as film-coated compressed tablets. Zyvox does not address, cure, or otherwise overcome the deficiencies of Devito et al. alone or in combination with one or more of the other cited references. In particular, Zyvox does not provide sufficient teaching, suggestion, or motivation that would lead a skilled artisan to somehow arrive at the presently claimed invention, or the unexpected, desirable, and surprising results provided thereby.
Diacon et al. discloses multiple-agent combinations for treating tuberculosis over the first 14 days of treatment, such as a combination of bedaquiline and pretomanid. Diacon et al. provides no disclosure or suggestion with regard to single or multiple-agent compositions that include linezolid. Diacon et al. provides no disclosure or suggestion with regard to multiple-agent compositions that are administered in stages involving a first period of time (such as during which linezolid is administered) and a second period of time (such as during which bedaquiline and pretomanid are administered), where the first period of time is shorter than the second period of time, and where the first period of time (such as during which linezolid is administered) is one to two months.
SIRTURO discloses pharmaceutical compositions that contain only bedaquiline, as the active pharmaceutical ingredient, in various dosage amounts.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case, as set forth above, Devito teaches a method of treating a mycobacterial infection caused or mediated by Mycobacterium tuberculosis in a patient comprising administering a pharmaceutically effective amount of an oxazolidinone antibiotic compound, including linezolid; further comprising administering pretomanid and bedaquiline.
The teachings of Zyvox® were relied upon to establish amounts of linezolid known in the art for treating human subjects. The teachings of Sirturo™ were relied upon to establish amounts of bedaquiline known in the art useful for treating pulmonary multi-drug resistant tuberculosis (MDR-TB). The teachings of Diacon were relied upon for establishing amounts of pretomanid and bedaquiline utilized in combination for treating MDR-TB. The teaching of Lee and Pantaleo were relied upon to establish that it was known in the art to monitor antibiotic therapy in a method of treating tuberculosis and to adjust the therapy including drug holidays and changing drugs based on linezolid adverse effects and differentiating between active and latent tuberculosis disease. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and dosing regimens of linezolid, bedaquiline, and pretomanid suggested by the prior art as a starting point to optimize the amounts and dosing regimen for administering linezolid, bedaquiline, and pretomanid in a method for treating tuberculosis as taught by the cited art since the cited art teaches that these amounts of linezolid, bedaquiline, and pretomanid are suitable for use as part of a combination therapy for treating tuberculosis and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
Claims 17-45 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628