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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 11/22/2024 is acknowledged.
Claim 17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/22/2024.
Status of Claims
Withdrawn: 17
Examined Herein: 1-16, 18
Priority
Priority to PRO 63/111,962 filed on 11/10/2020, PCT/US21/58784 filed on 11/10/2021, and PCT/US21/58849 filed on 11/10/2021 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/25/2022, 11/29/2023, 12/23/2024, 4/14/2025, 5/5/2025, 7/1/2025, and 12/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings filed on 11/10/2021 are accepted.
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.
Claims 1-8, 10-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 2019/0125902 A1, Published 5/2/2019), in view of Dorshow (US 2018/0110881 A1, Published 4/26/2018) and Roethlisberger (If Euhydric and Isotonic Do Not Work, What Are Acceptable pH and Osmolality for Parenteral Drug Dosage Forms?, 11/23/2016, Journal of Pharmaceutical Sciences, 106:446-456).
With respect to claim 1 and 14, Rajagopalan discloses a method for determining glomerular filtration rate (GFR) in a patient in need thereof, said method comprising:
Subcutaneously, intramuscularly, or intravenously administering to said patient about 0.1 mg to about 50 mg of a compound of Formula I or a pharmaceutically acceptable salt thereof as provided in an about 0.1 mg/mL to an about 50 mg/mL solution; [Rajagopalan, 0015, 0088, 0096]
measuring a concentration, including the plasma concentration, of the compound of Formula I in said patient; [Rajagopalan, 0015, 0022-0027]
determining the GFR in said patient using the concentration of the compound measured; [Rajagopalan, 0015, 0022-0027]
wherein Formula I is,
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each of X1 and X2 is independently -CO2R1, -CONR1R2, -CO(AA) or -CONH(PS);
each of Y1 and Y2 is independently selected from the group consisting of -NR1R2 and
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;
Z1 is a single bond -CR1R2-, -O-, -NR1-, -NCOR1-, -S-, -SO-, or -SO2-;
each of R1 to R2 are independently selected from the group consisting of H, -CH2(CHOH)aH, -CH2(CHOH)aCH3, -CH2(CHOH)aCO2H, -(CHCO2H)aCO2H, -(CH2CH2O)cH, -(CH2CH2O)cCH3, -(CH2)aSO3H, -(CH2)aSO3-, -(CH2)aSO2H, -(CH2)aSO2-, -(CH2)aNHSO3H, -(CH2)aNHSO3-, (CH2)aNHSO2H, -(CH2)aNHSO2-, -(CH2)aPO4H3, -(CH2)aPO4H2-, -(CH2)aPO4H2-, -(CH2)aPO43-, -(CH2)aPO3H2, -(CH2)aPO3H-, and –(CH2)aPO32-;
AA is a peptide chain comprising one or more amino acids selected from the group consisting of natural and unnatural amino acids, linked together by peptide or amide bonds and each instance of AA may be the same or different than each other instance;
PS is a sulfated or non-sulfated polysaccharide chain comprising one or more monosaccharide units connected by glycosidic linkages; and
‘a’ is a number from 1 to 10, “c” is a number from 1 to 100, and each of 'm' and 'n' are independently a number from 1 to 3. [Rajagopalan, 0015]
In one embodiment the compound of formula I is:
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[Rajagopalan, 0123]
With respect to claim 2, Rajagopalan discloses the concentration of Formula I in said patient is measured over a measurement time window. [Rajagopalan, 0015 and 0080]
With respect to claim 5, Rajagopalan discloses the solution further comprises at least one pharmaceutically acceptable excipient selected from the group consisting of antibacterial agents, antioxidants, buffering agents, osmolarity adjusting agents, pH adjusting agents, preservatives, stabilizing agents, surfactants, tonicity modifying agents, viscosity adjusting agents, and combinations thereof. [Rajagopalan, 0082]
With respect to claim 6, Rajagopalan discloses the at least one pharmaceutically acceptable excipient may be phosphate buffered saline. [Rajagopalan, 0083-0084]
With respect to claim 7, Rajagopalan discloses the patient has a GFR of below 90 as determined in a previous measurement. [Rajagopalan, 0099]
With respect to claim 8, Rajagopalan discloses the solution is packaged in a pre-filled syringe. Specifically, Rajagopalan discloses the solution is packaged in a sterilized container wherein, the container is a syringe. [Rajagopalan, 0092]
With respect to claim 10, Rajagopalan discloses a sensor is attached to at least one body site of said patient to detect transdermal fluorescence and thereby measure the concentration of the compound of Formula I. [Rajagopalan, 0073, 0077]
With respect to claim 11, Rajagopalan discloses determining the GFR in said patient using the concentration of the compound measured comprises quantifying and displaying on a mobile computing device the transdermal fluorescence detected by the sensor. [Rajagopalan, 0060, 0071, 0114]
With respect to claim 12, Rajagopalan discloses both X1 and X2 are -CO(AA). [Rajagopalan, 0051]
With respect to claim 13, Rajagopalan discloses the α-amino acid is a D-α-amino acid. [Rajagopalan, 0052]
With respect to claim 15, Rajagopalan discloses the pharmaceutically acceptable salt is a cationic or anionic salt. [Rajagopalan, 0059]
With respect to claim 16, Rajagopalan discloses the pharmaceutically acceptable salt is a selected from the group consisting of a sodium salt, a choline salt and a meglumine salt. [Rajagopalan, 0059]
With respect to claim 18, the limitation “…wherein the patient is able to self-administer the compound of Formula I or a pharmaceutically acceptable salt thereof outside of a hospital or clinical setting” does not limit the scope of claim 1. This claim language does not require a step to be performed or limit the claim to a particular structure. As a result, this limitation simply expresses the intended result of a process step positively recited and is not given patentable weight.
Rajagopalan does not disclose administering 3 mg to about 250 mg of a compound of Formula I as an about 60 mg/ml to an about 150 mg/ml solution. Rajagopalan also does not disclose the administration produces a plasma concentration of the compound that is substantially similar to a plasma concentration produced by intravenous administration of an identical amount of the compound.
However, with respect to claim 1, 3, and 4, Dorshow discloses a method comprising administering to a subject the compound of Formula I. [Dorshow, 0175] Dorshow further discloses the administered dose of the compound of Formula I may vary from ~ 0.1 mg/kg to ~ 500 mg/kg. [Dorshow, 0256]
Modifying the method disclosed by Rajagopalan by administering to the patient ~ 0.1 mg/kg to ~ 500 mg/kg of the compound of Formula I, results in the method of claim 1 comprising subcutaneously, intramuscularly, or intravenously administering to said patient about 0.1 mg/kg to about 500 mg/kg of a compound of Formula I or a pharmaceutically acceptable salt thereof.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Rajagopalan by administering to the patient ~ 0.1 mg/kg to ~ 500 mg/kg of the compound of Formula I and have a reasonable expectation of success because Rajagopalan discloses a method comprising administering to a patient a compound of Formula I. Dorshow discloses a method comprising administering to a subject a compound of Formula I. Dorshow further discloses the compound may be administered at a dose of from about 0.1 mg/kg to about 500 mg/kg. So, Rajagopalan discloses a method comprising administering to a patient a compound of Formula I and Dorshow discloses this compound may be administered at a dose of f~ 0.1 mg/kg to ~ 500 mg/kg. Thus, the combined teachings of Rajagopalan and Dorshow suggest the compound of Formula I may be administered at ~ 0.1 mg/kg to ~ 500 mg/kg in the method disclosed by Rajagopalan. Therefore, it is reasonable to expect the method disclosed by Rajagopalan may be modified by administering to the patient ~ 0.1 mg/kg to ~ 500 mg/kg of a compound of Formula I. One would have been motivated to do so because the selection of a known dose based on its suitability for its intended use is prima facie obvious. In the instant case, Rajagopalan and Dorshow both disclose administering the compound of Formula I. Dorshow discloses the compound may be administered at a dose of from about 0.1 mg/kg to about 500 mg/kg. Therefore, selection of a known dose, ~ 0.1 mg/kg to ~ 500 mg/kg, based on its suitability as a dose for the compound of Formula I for its intended use in a method comprising administering a compound of Formula I, is prima facie obvious.
Still, Rajagopalan and Dorshow do not disclose administering the dose compound of Formula I as an about 60 mg/ml to an about 150 mg/ml solution. Rajagopalan and Dorshow also do not disclose the administration produces a plasma concentration of the compound that is substantially similar to a plasma concentration produced by intravenous administration of an identical amount of the compound.
However, with respect to claim 1, 3 and 4, it would be obvious to one of ordinary skill in the art to modify the method disclosed by Rajagopalan and Dorshow so that the dose of the compound of Formula I is administered as an about 60 mg/ml to an about 150 mg/ml solution because generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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." MPEP 2144.05(II)(A) The general conditions of the claim are disclosed by Rajagopalan and Dorshow, as described above. Therefore, it is not inventive to discover the workable concentration of the solution comprising the compound of Formula I by routine experimentation.
It would have been routine optimization to arrive at the claimed invention because dosing and concentration are known parameters routinely modified in the art. Moreover, the method disclosed by Rajagopalan and Dorshow is limited by the maximum allowable injection volume for subcutaneous (SC) and intramuscular (IM) administration and by a subject’s required dose, which is effectively fixed based on clinical need. Despite these limitations, concentration, dose, and volume are interdependent parameters. So, adjusting the concentration of a solution allows both volume and dose requirements to be satisfied simultaneously.
A person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed concentration of the solution because Rajagopalan discloses the compound of Formula I may administered subcutaneously (SC) or intramuscularly (IM) in an ~0.1 mg/mL to ~ 50 mg/mL solution. [Rajagopalan, 0056] Dorshow discloses the administered dose of the compound of Formula I may vary from ~ 0.1 mg/kg to ~ 500 mg/kg. [Dorshow, 0256] Roethlisberger discloses the maximum injection volumes for SC and IM administration are 3 mL and 5 mL, respectively. [Roethlisberger, Page 449, Table 4] According to the method disclosed by Rajagopalan and Dorshow, a patient requiring a dose of 300 mg must be administer 6 mL of the 50 mg/mL solution. However, this volume exceeds the maximum allowable volume for SC and IM administration. On the contrary, increasing the concentration of the solution allows a compound to be administered at a higher dose within an appropriate injection volume. For example, a patient requiring a dose of 300 mg may be administered 2 mL of a 150 mg/mL solution via SC or IM, which is within the volume limits for these routes. Therefore, it would have been routine to adjust the concentration of the solution disclosed by Rajagopalan and Dorshow to administer a necessary dose of the compound of Formula I without exceeding the injection volume limits of the SC and IM administration routes. Furthermore, a person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed concentration by calculating the necessary solution concentration, as exemplified above, given the dose and SC/IM injection volume limitations set forth in the method disclosed by Rajagopalan and Dorshow.
Accordingly, modifying the method disclosed by Rajagopalan and Dorshow so that the ~ 0.1 mg/kg to ~ 500 mg/kg dose of the compound of Formula I is administered as an about 60 mg/ml to an about 150 mg/ml solution, results in the method of claim 1, 3, and 4. Furthermore, identical compositions must have identical properties and the method disclosed by Rajagopalan and Dorshow comprises administering the same compound, via the same route, at the same dose and concentration as claimed. Therefore, the method would be expected to yield the same functional characteristics, including the administration producing a plasma concentration of the compound that is substantially similar to a plasma concentration produced by intravenous administration of an identical amount of the compound.
Claims 1-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan, Dorshow and Roethlisberger, as applied to claim 1-8, 10-16 and 18 above, and further in view of Young (US 2006/0030819 A1, Published 2/9/2006).
With respect to claim 1, Rajagopalan, Dorshow and Roethlisberger disclose the teachings above.
Rajagopalan, Dorshow and Roethlisberger do not disclose the solution is subcutaneously or intramuscularly administered to said patient by an auto-injector.
However, with respect to claim 9, Young discloses an automatic injector or auto-injector is a device designed to allow a user to self-administer a pre-measured dose of a medicament composition subcutaneously or intramuscularly. [Young, 0006]
Modifying the method disclosed by Rajagopalan, Dorshow and Roethlisberger by administering the solution subcutaneously or intramuscularly by an auto-injector, results in the method of claim 9.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Rajagopalan, Dorshow and Roethlisberger by administering the solution subcutaneously or intramuscularly by an auto-injector and have a reasonable expectation of success. Rajagopalan/Dorshow/Roethlisberger disclose a method comprising subcutaneously or intramuscularly administering to a patient medicament, a solution comprising a compound of Formula I. Young discloses an auto-injector may be used to administer a medicament subcutaneously or intramuscularly. So, Rajagopalan/Dorshow/Roethlisberger disclose a method comprising the step of subcutaneously or intramuscularly administering a medicament and Young discloses this step may be carried out using an auto-injector. Thus, the combined teachings of Rajagopalan/Dorshow/Roethlisberger and Young suggest the subcutaneous or intramuscular administration of the solution in the method disclosed by Rajagopalan/Dorshow/Roethlisberger may be carried out using an auto-injector. Therefore, it is reasonable to expect that the method disclosed by Rajagopalan/Dorshow/Roethlisberger may be modified by administering the solution subcutaneously or intramuscularly by an auto-injector. One would have been motivated to do so because it is prima facie obvious to combine references when
some advantage or expected beneficial result would have been produced by their combination. In the instant case, Young discloses an auto injector allows a user to self-administer a medicament. [Young, 0006] Therefore, one would have been motivated by the expectation that the aforementioned modification would allow a patient to self-administer the solution comprising a compound of Formula I.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are not persuasive because Applicant appears to misunderstand the basis of the rejection. Specifically, Applicant asserts the following:
“The Office's position effectively assumes that concentration scaling inherently drives SC pharmacokinetics toward IV equivalence.” [Remarks 2/24/2026, Page 10, Paragraph 1]
“The Office's rejection relies on the general principle that discovering an optimum value within a known range is obvious when the result is predictable. However, that principle applies only where the result is reasonably expected. Here, the claimed limitation requires that SC or IM administration produce plasma concentrations substantially similar to intravenous administration. This is not merely an adjustment of formulation parameters but a specific route-dependent pharmacokinetic outcome. As confirmed in the Dorshow Declaration, such equivalence was not contemplated, predicted, or expected in the field of renal tracer development.” [Remarks 2/24/2026, Page 11, Paragraph 2]
These assertions imply that Applicant interprets the basis of the instant rejection as a finding that it would be obvious to optimize the concentration of the solution (comprising the dose of compound of Formula (I)) disclosed by Rajagopalan and Dorshow in order for the method to achieve IV-equivalent pharmokinetics. Accordingly, Applicant’s remarks are largely drawn to the position that pharmokinetics are unpredictable and the result of this optimization is not contemplated by the prior art to cure the nature of the unpredictability. Therefore, it is not reasonable to expect the concentration of the solution can be optimized so that the method could achieve IV-equivalent pharmokinetics.
For example, Applicant asserts the following:
“As stated in the Dorshow Declaration, route-equivalent pharmacokinetics were neither contemplated nor addressed in Rajagopalan.4 IV administration was understood to provide predictable plasma input functions, whereas SC and IM administration were expected to introduce absorption-related distortions. Thus, Rajagopalan does not provide a scientific basis for expecting that increasing concentration beyond 50 mg/mL would cause subcutaneous pharmacokinetics to converge toward intravenous behavior.” [Remarks 2/24/2026, Page 9, Paragraph 2]
“A person of ordinary skill in art would understand that increasing formulation concentration does not eliminate absorption-limited kinetics.” [Remarks 2/24/2026, Page 9, Paragraph 4]
“The mere disclosure of broad dose ranges in Dorshow relates to achieving sufficient fluorescence for imaging purposes and does not address how the compound enters systemic circulation following SC or IM injection, nor whether absorption-limited kinetics would distort the elimination-phase profile required for accurate GFR determination.” [Remarks 2/24/2026, Page 10, Paragraph 2]
“Thus, while Roethlisberger may explain why one might increase concentration to reduce injection volume, it does not provide any teaching or suggestion that such increase would produce the claimed pharmacokinetic equivalence.” [Remarks 2/24/2026, Page 11, Paragraph 1]
However, the instant rejection is actually based on the finding that it would be obvious to optimize the concentration of the solution to satisfy volume and dose requirements set forth by the maximum allowable injection volume for SC and IM administration. Accordingly, modifying the method disclosed by Rajagopalan and Dorshow so that the ~0.1 mg/kg to ~500 mg/kg dose of the compound of Formula I is administered as an ~60 mg/ml to an ~150 mg/ml solution, results in the method of claim 1, 3, and 4.
This method is substantially similar to the claimed method in that the same compound is administered via the same route, at the same dose and concentration as claimed. For this reason, it is reasonable to expect method disclosed by Rajagopalan and Dorshow would yield the same functional characteristics as the claimed method. The plasma concentration produced from optimizing the concentration of the solution is a downstream consequence thereof, not the target or recognized result of optimization. Routine optimization does not require the Office to further forecast the downstream consequences of a recognized result.
Ultimately, Applicant’s arguments are not persuasive because they are directed to the unpredictability of pharmacokinetics, which is immaterial to the rationale underlying instant rejection. The modified method disclosed by Rajagopalan and Dorshow is substantially similar to the claimed method and would be reasonably be expect to yield the same functional characteristics as the claimed method. The prior art does not need to contemplate or forecast the pharmacokinetic effect of modifying the cited references for this expectation to be reasonable.
Oath/Declaration
The declaration under 37 CFR 1.132 filed 2/24/2026 is insufficient to overcome the rejection of Claims 1-16 and 18 under 35 U.S.C 103 as set forth in the last Office action because it fails to set forth facts that rebut the Office's prima facie case of obviousness.
Dorshow asserts “For a scientist working in renal tracer development, IV-equivalent plasma exposure following subcutaneous or intramuscular administration would not be expected based on conventional pharmacokinetic principles. The default expectation is that SC and IM administration produce delayed and attenuated plasma profiles relative to IV dosing.” [Declaration 2/24/2026, Paragraph 12]
As stated in the OA of 10/21/2025, it was known in the art prior to the filing of the instant invention that therapeutic compounds could exhibit a similar plasma concentration across IV and SC/IM routes. Therefore, it is questionable whether the default expectation is that SC and IM administration produce delayed and attenuated plasma profiles relative to IV dosing.
Dorshow asserts “The observation that compound of Formula I exhibit IV-like plasma exposure following SC or IM administration at high concentration was therefore empirical and unexpected.” [Declaration 2/24/2026, Paragraph 12]
Applicant’s arguments are not persuasive at least because Applicant has not demonstrated the compounds of Formula (I) exhibit IV-like plasma exposure following SC or IM administration at high concentration. The data provided by the Applicant thus far has been limited to MB-102 only. Formula (I) is broad genus and Applicant has not demonstrated that every species of Formula (I) exhibit IV-like plasma exposure following SC or IM administration at high concentration.
Moreover, Applicant states that compounds of Formula I exhibit IV-like plasma exposure following SC or IM administration at high concentration. Rajagopalan discloses the exact same genus of Formula (I). By the Applicant’s own logic, the compounds of Formula (I) disclosed by Rajagopalan also possess this property.
Dorshow asserts “It could not be predicted from compound structure, dose range, or formulation concentration alone. Administration of an identical amount of a compound by different routes does not imply identical plasma exposure, because the route of administration determines the rate and extent of entry into systemic circulation.” [Declaration 2/24/2026, Paragraph 12]
Applicant’s argument is not persuasive because unpredictability does not preclude obviousness. Conclusive proof of efficacy is not required to show a reasonable expectation of success, only at least some degree of predictability is required. Identical compositions must have identical properties and the method disclosed by Rajagopalan and Dorshow comprises administering the same compound, at the same dose, at the same concentration, and via the same route as claimed (rather than an identical amount by different routes as purported by Applicant). Therefore, the method would be expected to yield the same functional characteristics, including the administration producing a plasma concentration of the compound that is substantially similar to a plasma concentration produced by intravenous administration of an identical amount of the compound. This assertion by the Office is a reasonable expectation of success, not a prediction.
Dorshow asserts “The Office Action relies on Roethlisberger to support the assertion that higher- concentration formulations for subcutaneous or intramuscular administration would have
been routine. From a scientific standpoint, this reliance is misplaced. Roethlisberger is a formulation tolerability review, not a pharmacokinetics reference, and it does not address, let alone predict, systemic plasma concentration-time behavior following different routes of administration.” [Declaration 2/24/2026, Paragraph 13; See also Paragraph 14-15]
Applicant’s argument is not persuasive because the reason or motivation to modify a reference that is different from the Applicant’s is permissible. One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings. Accordingly, a POSITA would have been motivated to modify the concentration formulations for reasons other than “formulation tolerability review, ” pharmacokinetics, and “systemic plasma concentration-time behavior following different routes of administration.” The rationale in arriving at the claimed invention contended by the Applicant does not render the rationale contended by the Examiner inapplicable because they are different.
Dorshow asserts “In particular, none provide a scientific rationale for expecting that SC or IM administration at 60-300 mg/mL would overcome absorption-limited kinetics and reproduce IV plasma concentration-time profiles. The observation that compound of Formula I, when administered subcutaneously or intramuscularly at high concentration, produces plasma concentrations substantially similar to IV administration was therefore empirical, unexpected, and contrary to conventional pharmacokinetic expectations as reflected in the cited literature, including Roethlisberger.” [Paragraph 13; See also Paragraph 14-15]
Ultimately, Applicant’s arguments are unpersuasive because:
Applicant has provided no evidence demonstrating that the claimed solution exhibits a similar plasma concentration across IV and SC/IM routes, whereas a solution outside of the claimed range does not. The mere assertion of this is not substantiated without supporting evidence.
Furthermore, the data provided in the specification and the declaration of 10/7/2025 describe MB-102 only. Applicant has provided no evidence that demonstrates that every species of Formula (I) achieves this same result.
Applicant states the claimed invention represents an empirical discovery. However, It was already known in the art that therapeutic compounds, such as the compound of Formula I, could exhibit a similar plasma concentration across IV and SC/IM routes. Therefore, it appears Applicant empirically confirmed that the claimed compound possesses this property, rather than discovered it.
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.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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