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
The office acknowledges Applicants amendments and arguments filed on 6/24/2026 in response to the office action dated 3/25/2026. Claims 42, 44, 53, 71, and 74 have been amended. Claims 3, 16, 18, 53, and 62-70 have been canceled. Claims 1, 2, 4-15, 17, 19-27, 30-39, 45-52, and 54-61 were previously canceled. In light of the amendment(s) to claim 71, 112(1) and 112(2) rejections are withdrawn Applicants arguments regarding 103 rejection(s) have been fully considered but found not to be persuasive and they are addressed below. The rejections are maintained and the action is made final. Claims 28, 29, 40-44, and 71-75 are pending and are examined to the extent that they read on the elected subject matter.
Response to Applicants Arguments
103 rejection: Garcia Collazo et al. and Kawaguchi-Suzuki et al.
Applicants argue that at the time the instant application was filed, pioglitazone was understood to metabolize to M-IV, which is then further metabolized to M-III. Further argued that given the metabolic pathway disclosed by Maeshida, a person of ordinary skill in the art would not have had a reasonable expectation that administering M-III to a subject would produce M-IV and the state of the art discloses that M-IV metabolizes to M-III, but does not disclose or suggest that M-III metabolizes to M-IV.
Applicant surprisingly found that M-III metabolizes to M-IV after in vivo administration to mice, rats and dogs (Examples 1-3 and 10). A person of ordinary skill in the art would not have had any reason to think that M-III would metabolize to M-IV, and therefore would not have had any reason or motivation to administer M-III to a subject having a disease or disorder, e.g., ALD. Furthermore, it would not have been obvious to administer M-III in order to metabolize it to M-IV and produce the pharmacokinetic parameters recited in independent claims 28 and 71.
The Office alleges that "[a]s to the limitation of wherein compound MIII is metabolized to compound MIV, it is noted that administration of the same agent (effective amount, e.g. 50 mg) to the same set of patients would result in the same effects including the parent (MIII) metabolized to [MIV]." Office Action, p. 14. Applicant respectfully disagrees. As discussed above, at the time of filing it was not known that M-III metabolized to M-IV. It follows that the relative plasma exposure of M-III and M-IV after administration of M-III to a subject was not known at the time of filing. As described in Examples 1-3 and 10, Applicant found that oral administration of M-III results in about 50-85% M-IV exposure and 15-50% M-III exposure, depending on the animal tested. A person of ordinary skill in the art would not have known or been able to predict these relative exposure levels based on the state of the art at the time the application was filed. Accordingly, claims 28, 29, 40-44, and 71-75 are not obvious over Garcia Collazo et al. in view of Kawaguchi-Suzuki, et al.
In response, the scientific teaching provided by the application concerning the mechanism that M-III is metabolized to M-IV, is the outcome of action of a treatment. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979). In other words, not all the properties or mechanism of conversion of M-III to M-IV be appreciated by the prior art. As stated in the rejection a person of ordinary skill in the art would have found it obvious to administer M-III for M-IV in ALD subjects regardless of the inherent mechanism of action would have then necessarily followed.” “[Efficacy is inherent in carrying out the claim steps.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012).
“It is respectfully noted that Examiner is still of the opinion that if M-III is employed to treat the same disease(s), then one of ordinary skill in the art can assume, with a reasonable degree of success, that the same mechanism of action is being engaged. That a person of ordinary skill in the art would not have known of the effect also does not preclude a finding of obviousness. PAR Pharm. v. TWIPharms., Inc., 773 F.3d 1186, 1197 (Fed. Cir. 2014). The examiner notes that the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Although the discovery of a new mechansim of action are no doubt important contributions to scientific and pharmacetuical development, the assement of patentability is based upn the the therapeutic applications and effects of the compounds, not the mechanism or properties by which they exert such a therpeutic effect. In the instant case even though the prior art is silent regarding the above mechanism of action, the end result (i.e. structural steps of the instant claims) is the same regardless of the mechansim of action.
Applicants have demonstrated that administration of MIV results in MIII. In examples 1-3, 10 Applicants have demonstrated evidence that M-III metabolizes to M-IV after in vivo administration to mice, rats and dogs. However Applicants have not provided any evidence of unexpected results showing side by side comparison of administration of M-III to that of M-IV for superior therapeutic or unexpected therapeutic effects. As to Applicants arguments that ‘A person of ordinary skill in the art would not have known or been able to predict these relative exposure levels based on the state of the art at the time the application was filed’, it is noted that the exposure effects are the pharmacological effects obtained upon administration of the compound.
Garcia Collazo’s teach administration of MIV to ALD subjects. Hence such administration of the same agent, herein MIV at the same amount effective to provide the pharmacokinetic effects would result in the formation of MIII and back to the conversion of MIV though the mechanism or action has not been recognized by the prior art. It is the inherent property of the compound, herein MIV to metabolize to MIII and in the body to be metabolized to MIV after in vivo administration. It is noted that as to the amount, the instant specification teach a wide range in the examples (1-3, 10). In Example 10 administration of 3 mg/kg of MIN-102 (MIV) or MIII (Beagle dogs) is taught. It is noted that 3 mg/kg in dogs in conversion to humans is equivalent to 1.623 mg/kg (3 mg x0.541). For an average adult human weighing 70 kg, it would be 114 mg, which falls within the range that is taught by the prior art. In examples 1-3 (specification) it is taught that the active agent MIII or MIV, the amount administered to mice were 50 mg/kg, 4.5 mg and to rats, and 10 mg/kg respectively. For an average adult human weighing 70 kg, it would be 337 mg, 42 mg and 113 mg respectively, which falls within the range that is taught by the prior art. Garcia Collazo is explicit in teaching that the dose of the active agent will depend on the nature and degree of the condition, the age and condition of the patient, and other factors known to those skilled in the art. The reference teaches that a typical daily dosage is from 0.1 to 200 mg, preferably from 20 to 200 mg, e.g. for an adult 10-100 mg given as a single dose with no further dosing or in multiple doses, for example one to three times per day. The compounds described herein may also be administered in daily doses of from 80 to 600 mg. An appropriate “effective” amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation. It would have been obvious to administer the amount of the active agent as in the instantly claimed method to provide the pharmacokinetic effects as claimed.
ODP over US 9,782,395:
Applicants argue that at least the reasons discussed in the response to the 35 U.S.C. § 103 rejection above, claims 28, 29, 40-44, and 71-75 are not obvious over the '395 and/or '126 patents in view of Garcia Collazo et al. and Kawaguchi-Suzuki, et al.
The above response to the arguments in regards to Garcia Collazo et al. and Kawaguchi-Suzuki, et al. apply here as well. The rejection is maintained.
Claim Rejections - 35 USC § 103
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) 28-29, 40-44, 71-75 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Collazo et al. (US 20160235729) and Kawaguchi-Suzuki et al. (J of Chromatography, 2014, 219-223).
Garcia Collazo et al. teach the use of 5-(4-(2-(5-(1-hydroxyethyl)pyridine-2-yl)ethoxy) benzyl)thiazolidine-2,4-dione (MIV) in the treatment of adrenoleukodystrophy (ALD) (See claims 28 and 35). The reference teaches that this compound is MIV, and it is a metabolite of compound pioglitazone [0019]. The reference teaches pioglitazone’s utility has been demonstrated in the treatment of X-ALD based on pre-clinical data (US2013/0274295). It is taught that clinical trials using pioglitazone for ALD have failed to show clinical benefits and the drug has been associated with unwanted side effects including cardiovascular effects, fluid retention, weight gain and bladder cancer ([0015], [0016]). Further taught is that the compound MIII is also a metabolite of pioglitazone [0018].
The structures of pioglitazone and its metabolites MIV and MIII are given below in table 1. Garcia Collazo is explicit in teaching that the metabolite MIV is useful in treating ALD.
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It is noted that MIII is 5- [[4-[2-[5-acetylpyridin-2-yl]ethoxy] phenyl]methyl]-1,3-thiazolidine-2,4-dione (the compound administered in the instant claims) and MIV is 5-(4-(2-(5-(1-hydroxyethyl)pyridine-2-yl)ethoxy) benzyl)thiazolidine-2,4-dione.
The reference teaches that a typical daily dosage is from 0.1 to 200 mg, preferably from 20 to 200 mg, e.g. for an adult 10-100 mg given as a single dose with no further dosing or in multiple doses, for example one to three times per day. The compounds described herein may also be administered in daily doses of from 80 to 600 mg. The dose of the active agent will depend on the nature and degree of the condition, the age and condition of the patient, and other factors known to those skilled in the art [0076]. The reference teaches oral administration and the dosage form include suspensions ([0075], claims 48-49). Exemplary pharmaceutically acceptable salts include the salts of hydrochloric acid [0072].
Kawaguchi-Suzuki et al. teach that hydroxypioglitazone and ketopioglitazone are active metabolites of pioglitazone (page 220, Fig. 1).
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It is noted that hydroxypioglitazone is MIV and ketopioglitazone is MIII compound.
The prior art do not teach treating ALD with the compound 5- [[4-[2-[5-acetylpyridin-2-yl]ethoxy] phenyl]methyl]-1,3-thiazolidine-2,4-dione (MIII) as in the instant claims.
A person skilled in the art would have found it obvious before the effective filing date of the invention from Garcia Collazo that (i) the compound used in the instant claim, 5- [[4-[2-[5-acetylpyridin-2-yl]ethoxy] phenyl]methyl]-1,3-thiazolidine-2,4-dione, is the compound MIII and it is a metabolite of pioglitazone and (ii) another metabolite of pioglitazone, MIV (5-(4-(2-(5-(1-hydroxyethyl) pyridine-2-yl)ethoxy) benzyl)thiazolidine-2,4-dione) is used in the method of treating ALD (iii) the parent compound pioglitazone has been associated with side effects and have failed to show positive results in clinical trials in regards to treating ALD (iv) Kawaguchi-Suzuki teach that hydropioglitazone (MIV) is converted to MIII (See Fig. 1). From the prior art teachings a person skilled in the art would have found it obvious to use metabolite MIII for metabolite MIV of pioglitazone to treat ALD. A person skilled in the art would have been motivated to do so is to achieve similar or better therapeutic benefits compared to the MIV compound in subjects with ALD. As to the limitation of wherein compound MIII is metabolized to compound MIV, it is noted that administration of the same agent (effective amount, e.g. 50 mg) to the same set of patients would result in the same effects including the parent (MIII) metabolized to 5-[[4-[2-[5-(1-hydroxyethyl) pyridin-2-yl]ethoxy]phenyl]methyl]-1,3- thiazolidine-2,4-dione (MIV).
As to the effective amount, the instant specification teach “By an “effective” amount or a “therapeutically effective amount” of a drug or pharmacologically active agent is meant a nontoxic but sufficient amount of the drug or agent to provide the desired effect. The amount that is “effective” will vary from subject to subject, depending on the age and general condition of the individual, the particular active agent or agents, and the like. Thus, it is not always possible to specify an exact “effective amount.” However, an appropriate “effective” amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation” [0337]. Thus, the dose of the active agent will depend on the nature and degree of the condition, the age and condition of the patient, and other factors known to those skilled in the art. A typical daily dose of Compound (1), or a pharmaceutically acceptable salt, for an adult is from about 10 mg to about 500 mg [0380].
From Garcia Collazo a skilled artisan would have found it obvious to administer an effective amount, e.g. 10-500 mg of compound MIII (a metabolite of pioglitazone) orally to treat ALD in patients. As to the parameters, AUC, Cmin would be achieved upon administration of the same agent as claimed in the same effective amount to the same set of subjects, herein ALD in the administration dosage regimen as claimed. Further the AUC and concentration are well-known results effective variables in the art as evidenced by use in the cited reference (Collazo, p 10, [0125-0129], figs. 1-3). The dosage regimen of administration of at least 5 days is within the skill of an artisan (e.g. physician) based on the health condition and other factors and it is routine. Thus claims 28-29, 42-44 would have been obvious over the prior art Garcia Collazo. As to claim 40, the prior art teach the use of pharmaceutically acceptable HCl salt. Hence a skilled artisan would have found it obvious to use the HCl salt of the compound of instant claim 28 to treat ALD subjects. As to claim 41, the prior art teach using suspensions of the compound MIV for oral administration and the dosage amount ranging from 10-500 mg. Hence a skilled artisan would have found it obvious to administer a suspension comprising MII, 5-15 mg (the compound of the instant claims) to treat ALD. As to claims 71-75 a person skilled in the art would have found it obvious from Garcia Collazo to orally administer an effective amount (e.g. 50 mg- 500 mg) of compound MIII to subject with ALD, for e.g. once per day. A skilled artisan would have been motivated to arrive at the claimed method is with a reasonable amount of success and to provide therapeutic benefits to ALD patients. As to the limitations of the active agent administered is being metabolized to MIV administration of the same agent in an effective amount with the same dosage regimen to the same set of patients, herein ALD would result in the same pharmacokinetic effects when measured after 5 days. It is obvious that administration of the same agent to the same set of subjects with an effective amount (for example. 50-500 mg as in instant claim 75) would result in the same plasma concentrations as instantly claimed. Further a skilled artisan would have measured the plasma concentrations after specific dosage regimen is to evaluate the effectiveness of the medication, measure therapeutic window, for personalized dosing and to monitor the stability by maintaining a stable plasma concentration. Thus the claimed methods would have been obvious over the prior art teachings.
Note: The scope of enablement rejection on claims 3, 28 and 71 and its depending claims for the treatment of myriad of diseases with 5- [[4-[2-[5-acetylpyridin-2-yl]ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione has not been made as the examination in this action has been made based on the elected species.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28-29, 40-44, 71-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 18, 20-22 of U.S. Patent No. 9782395 (‘395) or claims 1-4, 6, 7, 8, 19-24, 26 of US 10179126 (‘126) in view of Garcia Collazo et al. (US 20160235729) and Kawaguchi-Suzuki et al. (J of Chromatography, 2014, 219-223).
The instant methods are directed to:
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The dependent claims are limited to specific pharmacokinetic parameter amounts, salt of the active agent, oral suspension and amount, plasma concentration and specific genus and sub-genus of disorders to be treated.
‘395 reference claims are directed to a method of treatment of a central nervous system disorder, comprising administering to a subject in need thereof a dosage form comprising an effective amount of a compound of formula (1) or a pharmaceutically acceptable salt thereof, wherein the central nervous system disorder is adrenoleukodystrophy (ALD or X-ALD).
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The dependent claims are limited to specific stereoisomers, dosage amount (0.1-200 mg), and dosage forms.
‘126 reference claims are directed to a method of treatment of a central nervous system disorder, comprising administering to a subject in need thereof a dosage form comprising an effective amount of a compound of formula (1) or a pharmaceutically acceptable salt thereof, wherein the central nervous system disorder is selected from the group consisting of a neurodegenerative disease, including leukodystrophy.
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The dependent claims are limited to specific genus and sub-genus of disorders to be treated, oral dosage form that includes an oral suspension.
The refernece claims do not teach treating ALD with the active agent as in the instant claims.
Garcia Collazo et al. teachings discussed as above.
A person skilled in the art would have found it obvious before the effective filing date of the invention would have found it obvious to arrive at the claimed invention from the reference claims and prior art because (i) reference claims and the prior art teach 5-(4-(2-(5-(1-hydroxyethyl) pyridine-2-yl)ethoxy) benzyl)thiazolidine-2,4-dione) in treating ALD or leukodystrophy (ii) the prior art is explicit in teaching the metabolites of pioglitazone as 5- [[4-[2-[5-acetylpyridin-2-yl]ethoxy] phenyl]methyl]-1,3-thiazolidine-2,4-dione (MIII) and (5-(4-(2-(5-(1-hydroxyethyl) pyridine-2-yl)ethoxy) benzyl)thiazolidine-2,4-dione) (MIV) and (iii) the parent compound pioglitazone has been associated with side effects and have failed to show positive results in clinical trials in regards to treating ALD (iv) Kawaguchi-Suzuki teach that hydropioglitazone (MIV) is converted to MIII (See Fig. 1). From the combined teachings a skilled artisan would have found it obvious to use metabolite MIII for metabolite MIV of pioglitazone to treat ALD to achieve similar or better therapeutic benefits compared to the MIV compound in subjects with ALD. As to the limitation of wherein compound MIII is metabolized to compound MIV, it is noted that administration of the same agent (effective amount, e.g. 50 mg) to the same set of patients would result in the same effects including the parent (MIII) metabolized to 5-[[4-[2-[5-(1-hydroxyethyl) pyridin-2-yl]ethoxy]phenyl]methyl]-1,3- thiazolidine-2,4-dione (MIV).
As to the effective amount, the instant specification teach “By an “effective” amount or a “therapeutically effective amount” of a drug or pharmacologically active agent is meant a nontoxic but sufficient amount of the drug or agent to provide the desired effect. The amount that is “effective” will vary from subject to subject, depending on the age and general condition of the individual, the particular active agent or agents, and the like. Thus, it is not always possible to specify an exact “effective amount.” However, an appropriate “effective” amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation” [0337]. Thus, the dose of the active agent will depend on the nature and degree of the condition, the age and condition of the patient, and other factors known to those skilled in the art. A typical daily dose of Compound (1), or a pharmaceutically acceptable salt, for an adult is from about 10 mg to about 500 mg [0380].
From Garcia Collazo a skilled artisan would have found it obvious to administer an effective amount, e.g. 10-500 mg of compound MIII (a metabolite of pioglitazone) orally to treat ALD in patients. As to the parameters, AUC, Cmin would be achieved upon administration of the same agent as claimed in the same effective amount to the same set of subjects, herein ALD in the administration dosage regimen as claimed. Further the AUC and concentration are well-known results effective variables in the art as evidenced by use in the cited reference (Collazo, p 10, [0125-0129], figs. 1-3). The dosage regimen of administration of at least 5 days is within the skill of an artisan (e.g. physician) based on the health condition and other factors and it is routine. Thus claims 28-29, 42-44 would have been obvious over the prior art Garcia Collazo. As to claim 40, the prior art teach the use of pharmaceutically acceptable HCl salt. Hence a skilled artisan would have found it obvious to use the HCl salt of the compound of instant claim 28 to treat ALD subjects. As to claim 41, the prior art teach using suspensions of the compound MIV for oral administration and the dosage amount ranging from 10-500 mg. Hence a skilled artisan would have found it obvious to administer a suspension comprising MII, 5-15 mg (the compound of the instant claims) to treat ALD. As to claims 71-75 a person skilled in the art would have found it obvious from Garcia Collazo to orally administer an effective amount (e.g. 50 mg- 500 mg) of compound MIII to subject with ALD, for e.g. once per day. A skilled artisan would have been motivated to arrive at the claimed method is with a reasonable amount of success and to provide therapeutic benefits to ALD patients. As to the limitations of the active agent administered is being metabolized to MIV administration of the same agent in an effective amount with the same dosage regimen to the same set of patients, herein ALD would result in the same pharmacokinetic effects when measured after 5 days. It is obvious that administration of the same agent to the same set of subjects with an effective amount (for example. 50-500 mg as in instant claim 75) would result in the same plasma concentrations as instantly claimed. Further a skilled artisan would have measured the plasma concentrations after specific dosage regimen is to evaluate the effectiveness of the medication, measure therapeutic window, for personalized dosing and to monitor the stability by maintaining a stable plasma concentration. Thus the claimed methods would have been obvious over the reference claims and the prior art teachings.
Conclusion
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 UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627
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