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 .
Response to Amendment
The Amendment filed June 30, 2026, has been entered. Examiner acknowledges the cancellation of claims 3-6, 8 and 9 as well as the addition of new claims 17-20. Claims 1-2, 7, 10-20 remain pending in the application. The amendments necessitate reconsideration of the prior grounds of rejection. The previous rejections of canceled claims 3-6, 8 and 9 are moot. New and/or revised grounds of rejection responsive to the amended and newly presented claims are set forth below.
Response to Arguments
Applicant’s arguments filed June 30, 2026, including the Declaration of Dr. Melissa M. Reynolds submitted under 37 C.F.R. § 1.132, have been fully considered. Dr. Reynolds provides evidence that MIL-100(Fe) exhibited approximately 68.6 nmol/mg p-cresyl sulfate uptake, as compared with approximately 23.6 nmol/mg for Applicant’s MOF-808 and 10.3 nmol/mg for the literature-reported MOF-808, and further explains that conventional structural parameters did not reliably correlate with p-cresyl sulfate uptake. The Declaration and the asserted unexpected results have been accorded appropriate weight.
The arguments are not persuasive as to claim 1. Although the evidence supports that the particular magnitude of uptake obtained for MIL-100(Fe) was greater than Applicant initially expected, the prior art as a whole provided reason to select MIL-100(Fe) as an adsorbent and reason to expect favorable adsorption of anionic organic species. Farha teaches adsorption of p-cresyl sulfate by MOFs in dialysis applications; Yang expressly teaches MIL-100(Fe) as a high-capacity sorbent for uremic toxin in artificial-kidney applications; and Liu teaches that oxygen-containing anionic groups, including phosphate groups, can directly coordinate with Fe sites of MIL-100(Fe). The additional prior art relied upon below further demonstrates that MIL-100(Fe) was known to exhibit substantial adsorption of anionic organic compounds from aqueous solution and that its iron centers materially affect adsorption behavior. Thus, the Declaration’s distinction of Yang’s particular nitrogen-iron interaction does not establish that a person of ordinary skill would have lacked a reasonable expectation of adsorption by other coordination mechanisms. The evidence of unexpected results has therefore been considered together with the evidence of obviousness but is not sufficient to overcome the rejection for the reasons set forth below.
Applicant further argues that claims 2, 7, 10, 12-16, and 20 are allowable by virtue of their dependence from claim 1. This argument is not persuasive because claim 1 remains rejected. To the extent these claims contain additional limitations, those limitations are addressed separately in the rejections below.
Applicant’s arguments concerning amended claim 11 are persuasive with respect to the previous rejection over Farha in view of Rao. As amended, claim 11 requires separate uptake determinations producing specified linear relationships and a multivariate linear regression producing a linear uptake function having independently determined coefficients, whereas Rao employs a central composite design and a second-order regression model containing quadratic and interaction terms. Accordingly, the previous rejection of claim 11 over Farha and Rao is withdrawn.
Claim Rejections - 35 USC § 112
Claims 1, 2, 7, 10, 12-16 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation reciting that the iron-based metal-organic frameworks have “a p-cresyl sulfate uptake capacity of at least 60 nmol per milligram or iron-based metal-organic framework when measured in an aqueous solution of 100 µM p-cresyl sulfate at 24° C. for 24 hours” is indefinite because the conditions recited for determining the claimed uptake capacity do not specify the volume of the p-cresyl sulfate solution or the mass of the iron-based metal-organic framework used in the measurement. The specification identifies the MIL-100(Fe) mass, p-cresyl sulfate content, and solution volume as key parameters affecting p-cresyl sulfate uptake and separately varies these parameters to determine their respective effects on uptake. The specification further states that uptake increases with solution volume and MIL-100(Fe) mass (pars [0065-0067] and Figs. 6A-6C). Thus, merely specifying a p-cresyl sulfate concentration of 100 µM, a temperature of 24° C., and an exposure time of 24 hours does not define the conditions necessary to determine whether a given MIL-100(Fe) material possesses the recited uptake capacity. Claims 2, 7, 10, 12-16 and 20 are rejected due to their dependency upon claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 7, 10, 12-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Farha (WO-2020086496-A1) in view of Yang ("Metal–organic framework MIL-100(Fe) for artificial kidney application"), Tsai ("Adsorptive removal of acid orange 7 from aqueous solution with metal–organic framework material, iron (III) trimesate") and further in view of Jun ("Effect of Central Metal Ions of Analogous Metal–Organic Frameworks on Adsorption of Organoarsenic Compounds from Water: Plausible Mechanism of Adsorption and Water Purification").
Regarding claim 1, Farha discloses a method for removing uremic toxins from blood, the method comprising: exposing blood to metal-organic frameworks (Farha claim 1, par. [0026]); allowing the metal-organic frameworks to bind at least one uremic toxin in the blood (Farha, "uremic toxins are adsorbed by the metal-organic framework" claim 1); and separating the metal-organic frameworks from the blood after the metal-organic frameworks binds to the at least one uremic toxin (Farha claim 1 and par. [0033]), wherein after allowing the metal-organic frameworks to bind the at least one uremic toxin, at least 60 wt.% of p-cresyl sulfate is present in a bound state (Farha par. [0049] demonstrates removal of 93% of p-cresyl sulfate by NU-1000 from an HAS-containing solution). Farha further evaluates saturation uptake of p-cresyl sulfate by contacting 1.5mg of MOF with 2.5mL of a 0.1 mM aqueous p=cresyl sulfate solution at 24 °C for 24 hours, thereby expressly teaching the p-cresyl sulfate concentration, temperature, and exposure time as conditions for evaluating MOF adsorption of p-cresyl sulfate (Farha par. [0058]).
Farha does not disclose that the metal-organic frameworks are Iron 1,3,5-benzenetricarboxylate (MIL-l00(Fe)), nor does Farha expressly disclose that MIL-100(Fe) has a p-cresyl sulfate uptake capacity of at least 60 nmol per milligram when measured in an aqueous solution of 100 μM p-cresyl sulfate at 24° C for 24 hours.
Yang teaches the use of the specifically claimed MIL-100(Fe) for the removal of a uremic toxin in an artificial-kidney application. Yang describes MIL-100(Fe) as a “crystalline three-dimensional iron(III) trimesate” having mesoporous cages, accessible windows, large surface area, and physiological stability, and states that MIL-100(Fe) was selected as the sorbent because it is non-toxic, stable under physiological conditions, and possesses nano-sized channels and a large surface area suitable for toxin adsorption (Yang p. 40824). Yang further demonstrates rapid adsorption of the uremic toxin creatinine, reaching equilibrium in less than two hours at 37° C, and reports an adsorption capacity of 190.5 mg/g at physiological temperature, substantially greater than previously reported creatinine sorbents (Yang, pp. 40824-40825), teaching the specific iron-BTC framework recited in claim 1 as a high-capacity adsorbent specifically selected for uremic toxin removal in an artificial-kidney application.
Tsai further teaches that MIL-100(Fe) exhibits substantial adsorption of an aromatic anionic compound bearing a sulfur-oxygen functional group from aqueous solution. Specifically, Tsai adsorbs Acid Orange 7 (AO7), an aromatic anionic dye having a sulfonate group as illustrated in Fig. 1, onto MIL-100(Fe). In an experiment performed using 30 ppm AO7, 0.4 mg/mL MIL-100(Fe), 298 K, and a 24-hour equilibrium time, Tsai reports 96.22% decolorization at pH 3 (Tsai pp. 3219-3220, Fig. 2). Tsai separately reports an experimental equilibrium adsorption amount of 74.73 mg/g for 30 ppm AO7 in its kinetic study (Tsai, p. 3223, Table 1), and reports a Langmuir maximum adsorption capacity of 409.84 mg/g at 25° C (Tsai, p. 3224, Table 2), teaching that MIL-100(Fe) is capable of high-capacity adsorption of an aromatic anionic sulfur-oxygen-containing compound from water, including under a 24-hour adsorption period at approximately room temperature.
Jun additionally teaches that the high adsorption ability of MIL-100(Fe) toward anionic organic compounds is associated specifically with the iron metal sites rather than merely with the organic linker or general pore characteristics. Jun compares analogous MIL-100-Al, MIL-100-Cr, and MIL-100-Fe frameworks and finds that “only the MIL-100-Fe was highly effective” in adsorbing the aromatic organoarsenic compounds ASA and ROX, despite the analogous structures of the three MIL-100 materials (Jun p. 349). Jun reports maximum adsorption capacities of 366 mg/g for ASA and 387 mg/g for ROX on MIL-100-Fe (Jun Table 1), and further explains that adsorption occurs through the oxygen-containing anionic arsenate functionality, with FTIR showing as As-O-Fe interaction. Jun expressly teaches that MIL-100 species such as MIL-100-Fe possess coordinatively unsaturated sites or open metal sites and that coordination by chemical species containing non-bonding electron pairs “can readily occur” at those sites (Jun pp. 349-351). Thus, Jun teaches that anionic oxygen-bearing organic species can strongly adsorb to MIL-100(Fe) through coordination involving its exposed iron sites, providing an adsorption mechanism that is not dependent upon the nitrogen-containing Lewis-base functionality of creatinine discussed by Yang.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to employ MIL-100(Fe), as taught by Yang, as the metal-organic framework in Farha’s method for removing p-cresyl sulfate. Farha expressly teaches MOF adsorption of p-cresyl sulfate in dialysis context and evaluates p-cresyl sulfate saturation uptake using a 100 μM aqueous solution at 24° C for 24 hours; Yang teaches the exact claimed MIL-100(Fe) as a high-capacity, physiologically stable sorbent specifically suited for removal of uremic toxins in an artificial-kidney application; Tsai demonstrates that MIL-100(Fe) strongly adsorbs an aromatic anionic sulfur-oxygen-containing compound from aqueous solution under approximately room-temperature, 24-hour conditions; and Jun demonstrates that MIL-100(Fe) preferentially and strongly adsorbs anionic oxygen-bearing organic compounds through interactions involving coordinatively unsaturated iron sites. A person of ordinary skill in the art seeking a high-capacity MOF for the p-cresyl sulfate removal method of Farha therefore would have had reason to select MIL-100(Fe) and a reasonable expectation that MIL-100(Fe) would strongly adsorb p-cresyl sulfate under Farha’s expressly disclosed 100 μM, 24° C, 24 hour adsorption conditions, including an uptake capacity of at least 60 nmol per milligram.
Regarding claim 2, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 1, wherein after allowing the iron-based metal-organic frameworks to bind the at least one uremic toxin, at least 70 wt.% of p-cresyl sulfate is present in a bound state (Farha par. [0049] “After adding 20 mg ofNU-1000, 93% of p-cresyl sulfate in the solution was removed by NU-1000”; Table 4 further reports 88%, 93%, and 96% of p-cresyl sulfate using 10, 20, and 30mg of adsorbent, respectively).
Regarding claim 7, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 1, wherein the blood is exposed to about 700 milligrams (mg) to about 800 mg of the iron-based metal-organic frameworks (Farha par. [0049], teaching that the predicted removal fraction is a function of adsorbent mass and expressly evaluating 2.5, 10, 20, and 30 mg of MOF, with increased MOF mass producing increased removal of p-cresyl sulfate; Tsai p. 3221 Fig. 4, expressly varying the dosage of MIL-100(Fe), determining that adsorbent dosage affects both removal and adsorption quantity, and selecting an appropriate MIL-100(Fe) dosage based on those effects). Because the claimed 700-800 mg amount is not tied to a particular blood volume or initial toxin burden, one of ordinary skill would have found it obvious to scale the known amount of MIL-100(Fe) according to the quantity of blood and toxin to be treated in order to obtain the desired removal, the amount of adsorbent being an art-recognized result-effective variable.
Regarding claim 10, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 1, wherein the method is performed until the p-cresyl sulfate concentration of the blood is equal to or less than 10 μM (Farha [0049] 20μg p-cresyl sulfate in 1ml solution with a 93% reduction in p-cresyl sulfate after performing the method which would relate to a final concentration of 7.44μM).
Regarding claim 12, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 1, further comprising: prior to exposing the blood to the iron-based metal-organic frameworks, removing the blood from a patient (Farha par. [0026] “hemodialysis of blood samples taken from patients”); and after separating the blood from the iron-based metal-organic frameworks, returning the blood to the patient (Farha par. [0002] referring to “extracorporeal renal replacement therapies by diffusion, such as hemodialysis”; a person of ordinary skill would understand extracorporeal hemodialysis to involve removing blood from the patient, treating the blood outside the body, and returning the treated blood to the patient).
Regarding claim 13, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 12, wherein exposing the blood to the iron-based metal-organic frameworks includes exposing the blood to the iron-based metal-organic frameworks within a machine external to the patient (Farha par. [0002] referring to “extracorporeal renal replacement therapies by diffusion, such as hemodialysis”; [0026] “hemodialysis of blood samples taken from patients”; thereby teaching treatment of the removed blood using an extracorporeal dialysis apparatus external to the patient).
Regarding claim 14, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 13, wherein the machine external to the patient includes a dialysis machine (Farha par. [0026] “hemodialysis”).
Regarding claim 15, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 12, wherein exposing the blood to the iron-based metal-organic frameworks includes contacting the blood and the iron-based metal-organic frameworks for at least ten seconds and less than 30 minutes during each pass of the blood through the iron-based metal-organic frameworks (Farha par. [0033] “by passing the sample over the MOFs”; par. [0037] teaching that high toxin-removal percentages can be achieved with “exposure times of, for examples, 10 minutes or less - including exposure times of five minutes or less and one minute or less”).
Regarding claim 16, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 1, further comprising: removing the blood from a patient (Farha par. [0026] “hemodialysis of blood samples taken from patients”) prior to exposing the blood to the iron-based metal-organic frameworks; and returning the blood to the patient after separating the blood from the iron-based metal-organic frameworks (Farha par. [0026] hemodialysis is a process by which blood is treated extra-corporeally and then after treatment the blood is returned to the body), wherein exposing the blood to the iron-based metal-organic frameworks consists of exposing the blood to the iron-based metal-organic frameworks within a dialysis machine (Farha par. [0026] “hemodialysis”).
Regarding claim 20, Farha in view of Yang, Tsai and Jun discloses or renders obvious the method of claim 12, wherein the iron-based metal-organic frameworks are contained within a dialyzer of a dialysis machine (Yang p. 40827 recommending fabrication of “MOF films or MOFs-based dialysis membranes for hemodialysis”; a dialysis membrane is disposed within the dialyzer through which the patient’s blood is treated, thereby suggesting incorporation of the MIL-100(Fe) adsorption material into the dialyzer), and wherein the blood is directed through the dialyzer and returned to the patient as a continual flow process (Farha pars. [0026] and [0033] teaching “hemodialysis of blood samples taken from patients” and exposure of the sample to the MOFs “by passing the sample over the MOFs”; when Yang’s MOF-based dialysis membrane is employed in Farha’s hemodialysis process, the blood would be circulated through the MOF-containing dialyzer and returned to the patient in the ordinary continual extracorporeal flow of hemodialysis).
Claims 11 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Farha (WO-2020086496-A1) in view of Yang ("Metal–organic framework MIL-100(Fe) for artificial kidney application") and further in view of Kober ("D-optimal experimental designs for precise parameter estimation of adsorption equilibrium models") and Balci ("Adsorption of Bisphenol-A by Eucalyptus bark/magnetite composite: Modeling the effect of some independent parameters by multiple linear regression").
Regarding claim 11, Farha discloses a method for predicting adsorptive capacity of a metal-organic framework for p-cresyl sulfate, the method comprising: measuring uptake of p-cresyl sulfate by the metal-organic framework (Farha par. [0061] “by using an Agilent HPLC 1100”) while varying the concentration of the uremic toxin in the solution and holding constant the mass of the metal-organic frameworks and the volume of the solution to determine uptake of the uremic toxin by the metal- organic framework as a function of the concentration of p-cresyl sulfate in the solution (Farha par. [0061] “Adsorption isotherm studies were conducted to calculate the maximum adsorption capacity of an adsorbent” wherein adsorption isotherms were constructed by exposing a fixed mass of NU-1000 to a fixed volume of aqueous solution at “a designated concentration of uremic toxins”; after equilibrium, “The initial and equilibrium concentrations were measured” and the amount of uremic toxin uptake was determined according to Eq. 6; see also par. [0062], using the resulting adsorption measurements to model and determine adsorption capacity according to Langmuir or Freundlich adsorption models).
Farha does not disclose that the metal-organic framework is an iron-based metal-organic framework having benzenetricarboxylate (BTC) linkers. Farha further does not disclose separately measuring uptake while varying the mass of the iron-based metal-organic framework and holding p-cresyl sulfate concentration and solution volume constant; separately measuring uptake while varying solution volume and holding MOF mass and p-cresyl sulfate concentration constant; that each of the three uptake determinations produces a linear relationship between the respective varied parameter and p-cresyl sulfate uptake; or performing multivariate linear regression to produce a linear uptake function in which solution volume, p-cresyl sulfate content, and iron-based metal-organic framework mass are independent variables each having an independently determined coefficient and predicting adsorptive capacity using the resulting linear uptake function.
Yang teaches an iron-based metal-organic framework having BTC linkers suitable for adsorption of uremic toxins. Specifically, Yang teaches MIL-100(Fe) as a “crystalline three-dimensional iron(III) trimesate” and teaches employing MIL-100(Fe) as a sorbent for removing a uremic toxin in an artificial-kidney application because of its physiological stability, accessible channels, large surface area and adsorption properties (Yang p. 40824). Yang further experimentally determines adsorption capacity of MIL-100(Fe) as a function of adsorbate concentration and teaches evaluating its adsorption kinetics and adsorption isotherms, teaching the specifically claimed class of iron-based BTC metal-organic framework as a material whose uremic-toxin adsorption capacity is desirably measured and predicted.
Kober teaches that, for liquid-phase adsorption experiments, the actual dependent variables controlled by the experimenter are initial adsorbate concentration, solution volume, and adsorbent mass. Kober explains that “the actual independent variables are liquid phase volume, V, adsorbent mass, M, and initial bulk concentration, C0 since they are the ones chosen by the experimenter,” and emphasizes that correctly defining these independently controlled variables is important for obtaining useful experimental designs (Kober pp. 1-2). Kober therefore expressly identifies the same three underlying experimental quantities recited by claim 11, adsorbate amount/concentration, solution volume, and adsorbent mass, as the independently controllable variables for determining adsorption behavior. Kober further teaches that these variables affect the adsorption mass balance and should be used as the independent variables in experimentally modeling an adsorption system. The claimed p-cresyl sulfate content is directly determined from the initial p-cresyl sulfate concentration and solution volume, such that use of p-cresyl sulfate content rather than concentration in the resulting predictive model represents the amount of adsorbate present as determined from two of Kober’s expressly identified experimental variables.
Balci further teaches separately determining the effects of adsorption parameters by varying a selected parameter while holding other experimental parameters constant and then applying multiple linear regression (MLR) to predict adsorption capacity. For example, Balci varies initial BPA concentration while holding adsorbent dosage, temperature, and pH constant, and separately varies adsorbent dosage while holding initial BPA concentration, temperature, and pH constant (Balci pp. 346-347, Figs. 5-6). Balci expressly teaches that MLR is used “to determine the cumulative effects of several independent variables on the dependent variable” and defines the linear model as Y = a0 + a1X1 + … + anXn + ϵ" wherein Xi are independent variables and the ai are regression coefficients (Balci p. 342). Balci then applies this technique specifically to adsorption capacity and obtains the linear predictive function qe,pred = -288.665 + 1.871X1 + 3.681X2 + 5.775X3 + 1.093X4 – 446.189X5, wherein each independent adsorption variable has its own separately determined coefficient (Balci pp. 350-351, Table 5). Therefore, Balci teaches representing the contribution of independently varied adsorption parameters as first-order linear relationships and combining the respective independently determined coefficients by multivariate linear regression to produce a linear function for predicting adsorption capacity.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to employ the iron-based BTC metal-organic framework taught by Yang in Farha’s method of determining p-cresyl sulfate adsorption capacity and to characterize and predict that adsorption capacity using the experimental and statistical techniques taught by Kober and Balci. Farha already teaches determining p-cresyl sulfate uptake as a function of experimentally varied adsorbate concentration for purposes of calculating adsorption capacity; Yang identifies iron(III) trimesate MIL-100(Fe) as a suitable uremic-toxin adsorbent whose adsorption capacity is desirably characterized; Kober teaches that initial adsorbate concentration, solution volume, and adsorbent mass are the actual independently controlled variables governing adsorption experiments; and Balci teaches determining the effects of independently varied adsorption parameters and applying multivariate linear regression to those parameters to produce a linear predictive adsorption-capacity function having a separate coefficient for each independent variable. A person of ordinary skill in the art seeking to quantitatively characterize the contribution of the recognized experimental variables to p-cresyl sulfate uptake would therefore have had reason to separately vary the respective variables while holding the others constant, determine their relationships to uptake, and combine their first-order contributions using Balci’s known multivariate linear-regression technique to predict the adsorption capacity of the iron-based BTC framework, with a reasonable expectation of obtaining a predictive linear uptake function.
Regarding claim 17, Farha in view of Yang, Kober and Balci discloses or renders obvious the method of claim 11, further comprising providing the iron-based metal-organic framework in a dialysis device in an amount determined by the predicted adsorptive capacity produced from the multivariate linear regression (Yang p. 40827 recommending fabrication of “MOF films or MOFs-based dialysis membranes for hemodialysis”; Balci pp. 350-351 using multivariate linear regression to predict adsorption capacity as a function of independent variables including adsorbent usage, with adsorbent dosage assigned is own independently determined coefficient; Balci pp. 346-347 further determining the amount of adsorbent sufficient to achieve a desired removal efficiency, including determining that 0.2g was sufficient for approximately 90% removal; Kober pp. 1-2 identifying adsorbent mass as an independently controlled variable governing adsorption behavior).
Regarding claim 18, Farha in view of Yang, Kober and Balci discloses or renders obvious the method of claim 11, wherein the iron-based metal-organic framework is Iron 1,3,5-benzenetricarboxylate (MIL-100(Fe)) (Yang p. 40824 “MIL-100(Fe) is a crystalline three-dimensional iron(III) trimesate”).
Regarding claim 19, Farha in view of Yang, Kober and Balci discloses or renders obvious the method of claim 11, further comprising determining, from the uptake function, a mass of the iron-based metal-organic framework sufficient to reduce a p-cresyl sulfate concentration of blood to equal to or less than 10 μM (Balci pp. 350-351 teaching multivariate linear regression uptake function in which adsorbent usage is an independent variable having its own determined coefficient, thereby permitting adsorption capacity to be predicted as a function of adsorbent amount; Kober pp. 1-2 identifying adsorbent mass, solution volume, and initial adsorbate concentration as the independently controlled variables of an adsorption system; Farha par. [0049] predicting the fraction of p-cresyl sulfate removed as a function of MOF mass and confirming that 20mg NU-1000 removes 93% of p-cresyl sulfate from a solution initially containing 20 µg/mL p-cresyl sulfate, leaving approximately 1.4 µg/mL, or approximately 7.4 µM, which is less than the claimed 10 µM concentration).
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 WILLIAM ADDISON GEISBERT whose telephone number is (703)756-5497. The examiner can normally be reached Mon-Fri 7:30-5:00 EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby RAMDHANIE can be reached at (571)270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.A.G./ Examiner, Art Unit 1779
/Bobby Ramdhanie/ Supervisory Patent Examiner, Art Unit 1779
Prosecution Insights