DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a Continuation of 19/016,557 filed 01/10/2025 which is a Continuation of 18/671,648 filed on 05/22/2024 now abandoned, which is a Continuation of 18/486,083 filed on10/12/2023 now abandoned which is a Continuation of 18/162,571 filed on 01/31/2023 now abandoned which is a Continuation of 17/096,637 filed on 11/12/2020 now abandoned which is a Continuation of 16/882,206 filed on 05/22/2020 now U.S. Patent No. 10864197 which is a Continuation of 16/340,848 filed on 04/10/2019 now abandoned which is a national stage entry of PCT/US2017/056538 filed on 10/13/2017 which claims priority to U.S. Provisional Application No. 62/423,079 filed on 11/16/2016 and U.S. Provisional Application No. 62/407,860 filed on 10/13/2016.
Response to Amendment
No amendments to the claims were made by Applicant’s reply filed on December 4, 2025. Claims 1-44 are canceled. Claims 45-74 are currently pending.
Response to Arguments
The terminal disclaimer filed on December 4, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on U.S. Application No. 19/253,120 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on December 4, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,864,197 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the previous double patenting rejections over U.S. Application No. 19/253,120 and U.S. Patent No. 10,864,197 are hereby withdrawn.
Due to the abandonment of copending Application No. 19/016,557, the previous double patenting rejection over U.S. Application No. 19/016,557 is hereby withdrawn.
The declaration under 37 CFR 1.130(a) filed on December 4, 2025 is sufficient to remove the Komers et al. (Am J Physiol Regul Integr Comp Physiol 310: R877–R884, 2016. First published March 23, 2016) reference as prior art based on the 102(b)(1) exception as being disclosed by inventor or obtained from inventor.
However, the removal of the Komers reference is not sufficient to overcome the rejection under 35 USC 103 over the remaining references. Komers et al. was included as a secondary reference to provide evidence that the method rendered obvious over the teachings of Zhang et al. will necessarily result in decreases in proteinuria. Since Zhang et al. teaches administration of the same compound as claimed, the same results or effects which is reducing proteinuria will necessarily occur. Thus decreasing proteinuria is an inherent effect of the administration of the claimed compound. The fact that the inventor 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). In addition, it is not necessary that the prior art suggests the same advantage or result discovered by applicant when the steps of the claim are the same as those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“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.”); In re Lintner, 458 F.2d 1013 (CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). Here, the latent property identified by Applicant is reducing proteinuria which will necessarily occur by following the teachings and suggestions of the prior art and administering the claimed compound to a subject with IgA nephropathy.
Applicant's arguments filed December 4, 2025 with respect to the remaining references have been fully considered but they are not persuasive. Applicant argues that the Mere Presence of Applicant's Claimed Dosages in the Prior Art Cannot Serve as the Basis for a Finding of Prima Facie Obviousness Based on Routine Optimization Absent More. Applicant further argues in a recent court decision In Janssen Pharms., Inc. v. Teva Pharms., the Federal Circuit recently held that Janssen's paliperidone palmitate dosing regimen comprising first (150 mg-eq.) and second (100 mg-eq.) loading doses was not obvious even though a published clinical trial protocol disclosed administration of at least three equal doses of 50, 100, or 150 mg- eq. of paliperidone palmitate at specified time intervals, and another reference disclosed a range containing 100 mg-eq. and 150 mg-eq paliperidone palmitate.
These arguments are found not persuasive because generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916) (a patent based on a change in the proportions of a prior product or process (changing from 4-10% oil to 1% oil) must be confined to the proportions that were shown to be critical (1%)); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205 (CCPA 1946) ("Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies."); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) ("It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree."); In re Wells, 56 F.2d 674, 675, 12 USPQ 430 (CCPA 1932) ("Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes."); E.I. DuPont de Nemours & Company v. Synvina C.V., 904 F.3d 996, 1006, 128 USPQ2d 1193, 1201 (Fed. Cir. 2018.)("[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 693, 2023 USPQ2d 448 (Fed. Cir. 2023) ("A difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘a new property dissimilar to the known property,’ rather than producing a predictable result but to an unexpected extent.").
In the instant case, Applicant has not provided any unexpected or surprising results as compared to the prior art with respect to their specific treatment regimen. Furthermore, as opposed to the Jansen case cited by Applicant, the claims of the instant application recite starting with a low dosage and increasing the dosage after a period of time. It is noted that the claims of the instant application are drawn to the treatment of patients having a UP/C ratio of greater than 1.0 g/g and thus patients having kidney disease. Zhang et al. teaches the treatment of IgA nephropathy with sparsentan with a minimal dosage of 200 mg/day (claim 1). Since the patient has kidney disease, it would have been obvious and within the skill of an ordinary artisan to start the patient with the lowest dose which is 200 mg as taught by Zhang et al. and increase the dosage as needed to prevent any adverse effects. Thus, it would be unreasonable to start the dosing low and increase the dose overtime with caution to prevent adverse effects which is contrary to the Jansen case which is directed to starting with a high dosage of an antipsychotic drug and reducing the dosage. Thus the rejected claims do not fall into the paradigm established by the Jansen case argued by Applicant. Furthermore, this case cited by Applicant is not precedential and thus does not serve as authority when considering other similar cases.
Applicant’s arguments with respect to the Nam reference are found not persuasive since Nam is a secondary reference provided in the rejection to cure the deficiency of Zhang which does not specifically teach treating a subject having a baseline UP/C ratio greater than 1.0 g/g. However, Nam teaches patients having IgA nephropathy, with a baseline UPCR ≥ 1.0 g/g and maintain said UPCR have an increased risk of kidney injury. Thus based on the teachings of Zhang et al., one would have been motivated to choose any patient with IgAN for treatment, but especially those having an increased risk of kidney injury including those having a baseline UPCR ≥ 1.0 g/g and thus having increased levels of proteinuria as taught by Nam. Thus since the methods of claims 45, 56 and 67 are rendered obvious as detailed above, the effects achieved by the methods as claimed are also rendered obvious. Thus reducing the subject’s UP/C ratio by 40% or more as claimed relative to baseline, in the time frame as claimed is rendered obvious since the same method rendered obvious over the prior art teachings will necessarily produce the same results and effects as claimed.
Even though Applicant’s arguments are found not persuasive, upon further search and consideration, the previous rejection under 35 USC 103 has been modified and detailed below. This action is non-final.
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.
Claims 45-74 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. U.S. Patent No. 9,993,461 B2 (priority date of March 31, 2009) (Provided on IDS) in view of Nam et al. (Nam KH, Kie JH, Lee MJ, Chang T-I, Kang EW, Kim DW, et al. (July, 8 2014) Optimal Proteinuria Target for Renoprotection in Patients with IgA Nephropathy. PLoS ONE 9(7): e101935) and Kohan (Kidney International, Vol. 54 (1998), pp. 646–647).
Claims 45-74 of the instant application claim a method of treating a subject with IgA nephropathy (IgAN) to slow kidney function decline, and reduce proteinuria comprising (i) orally administering an initial dose of 200 mg of sparsentan to the subject once a day for a period of 14 days; and (ii) after the initial 14-day period, orally administering a subsequent dose of 400 mg of sparsentan to the subject once a day, wherein said subject has a baseline UP/C ratio greater than 1.0 g/g, and wherein the subject’s UP/C ratio is reduced by 40% or more relative to the subject’s baseline UP/C ratio.
Zhang et al. teaches a biphenyl sulfonamide compound which is a dual angiotensin and endothelin receptor antagonist, pharmaceutical compositions containing such compound, and methods of using such compound in the treatment of endothelin-dependent or angiotensin II-dependent disorders and other diseases (column 1 lines 5-17).
Zhang et al. teaches that angiotensin II (AngII) and endothelin-1 (ET-1) are two of the most potent endogenous vasoactive peptides currently known and are believed to play a role in controlling both vascular tone and pathological tissue remodeling associated with a variety of diseases including diabetic nephropathy, heart failure, and chronic or persistently elevated blood pressure (column 1 lines 20-26). Zhang et al. teaches that currently, angiotensin receptor blockers (ARBs), which block the activity of AngII, are widely used as a treatment for diabetic nephropathy, heart failure, chronic or persistently elevated blood pressure, and there is a growing body of data that demonstrates the potential therapeutic benefits of ET receptor antagonists (ERAs) in blocking ET-1 activity (column 1 lines 26-34). Zhang et al. teaches that it is also known that AngII and ET-1 work together in blood pressure control and pathological tissue remodeling, for example, ARBs not only block the action of AngII at its receptor, but also limit the production of ET-1, and similarly, ERAs block ET-1 activity and inhibit the production of AngII (column 1 lines 35-40). Zhang et al. teaches that simultaneously blocking AngII and ET-1 activities may offer better efficacy than blocking either substance alone (column 1 lines 40-43).
Zhang et al. teaches the compound of formula I has the following structure:
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which is sparsentan (as identified on page 11 of the instant specification). Zhang et al. teaches that the compound of formula I and salts thereof are antagonists of both endothelin (especially, ET-1) and angiotensin II (especially, subtype AT1) receptors (“dual angiotensin endothelin receptor antagonists”) and are useful in treatment of conditions associated with increased ET levels and/or increased angiotensin II levels and of all endothelin-dependent or angiotensin II-dependent disorders (column 13 lines 19-25).
Zhang et al. further teaches that the compound of formula I is also useful in the treatment of disorders related to renal, glomerular and mesangial cell function, including acute (such as ischemic, nephrotoxic, or glomerulonephritis) and chronic (such as diabetic, hypertensive or immune-mediated) renal failure, diabetic nephropathy, glomerular injury, renal damage secondary to old age or related to dialysis, nephrosclerosis (especially hypertensive nephrosclerosis), nephrotoxicity (including nephrotoxicity related to imaging and contrast agents and to cyclosporine), renal ischemia, primary vesicoureteral reflux, glomerulosclerosis and the like (column 13 lines 35-45). Zhang et al. specifically teaches that the compound of formula I is also useful in the treatment of diabetic nephropathy, IGA-induced nephropathy, and hypertension-induced nephropathy (column 13 lines 47-50).
Zhang et al. teaches that the dosing regimen of the compound of formula I is administered for a period of time, which time period can be, for example, from at least about 4 weeks to at least about 8 weeks, from at least about 4 weeks to at least about 12 weeks, from at least about 4 weeks to at least about 16 weeks, or longer (column 26 line 65-column 27 line 7).
Claims 1-5 and 7-11 of Zhang et al. claim a method of treating a disorder selected from the group consisting of glomerulosclerosis and IGA nephropathy, comprising administering to a subject in need thereof an effective amount of a compound of Formula I (sparsentan) or a pharmaceutically acceptable salt thereof, wherein the amount of the compound of Formula I, or pharmaceutically acceptable salt thereof, administered to the subject is from 200 mg/day to 800 mg/day; wherein the amount is 200 mg/day, 400 mg/day or 800 mg/day; wherein the disorder is IGA nephropathy.
Thus Zhang et al. specifically teaches and claims a method of treating a subject with IgA nephropathy (IgAN) comprising orally administering 200 mg per day of sparsentan to the subject and orally administering 400 mg per day of sparsentan to the subject to treat the IgA nephropathy.
Zhang does not teach treating a subject having a baseline UP/C ratio greater than 1.0 g/g. Zhang does not teach that the subject’s UP/C ratio is reduced by 40% or more relative to the subject’s baseline UP/C ratio. Zhang et al. does not specifically teach that treatment will reduce proteinuria and slow kidney function decline. Zhang et al. does not teach administering an initial dose of 200 mg of sparsentan to the subject once a day for a period of 14 days; and after the initial 14-day period, orally administering a subsequent dose of 400 mg of sparsentan to the subject once a day.
Nam et al. teaches that IgA nephropathy (IgAN) is slowly progressive and 20–30% of patients with IgAN will require renal replacement therapy within 20–25 years after disease onset (page 1). Nam et al. teaches that risk factors associated with progression of IgAN include proteinuria which is considered a strong predictor of adverse renal outcome (page 1). Nam et al. teaches that reducing proteinuria is of paramount importance to improve prognosis in these patients with IgAN and other glomerular diseases (page 1). Nam et al. teaches that proteinuria is a target for renoprotection in kidney diseases (abstract). Nam et al. teaches that time-averaged proteinuria (TA-P) was calculated from measurements of spot urine protein-to-creatinine ratio (UPCR) (abstract and page 2). Nam et al. teaches that the UPCR measurement was performed because UPCR is easily performed in the outpatient setting and can be reliably used to monitor proteinuria (page 9). Nam et al. measures UPCR in IgAN patients with a baseline UPCR < 1.0 g/g and a baseline UPCR ≥ 1.0 g/g (Table 5 page 8). Nam et al. demonstrates that patients with a baseline UPCR ≥ 1.0 g/g and maintain said UPCR have an increased risk of kidney injury and those with a baseline UPCR < 1.0 g/g who maintain said UPCR have a decreased risk of kidney injury (page 7 figure 3). Nam et al. teaches that to date, it has been suggested that proteinuria should be decreased to 1.0 g/day in IgAN because risk of progression increases markedly beyond this point (page 7).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Zhang et al. which teaches a method of treating IGA nephropathy, comprising administering to a subject in need thereof an effective amount of a compound of Formula I (sparsentan) or a pharmaceutically acceptable salt thereof, wherein the amount of the compound of Formula I, or pharmaceutically acceptable salt thereof, administered to the subject is from 200 mg/day to 800 mg/day, with the teachings of Nam et al. which teaches that IgA nephropathy (IgAN) is slowly progressive and 20–30% of patients with IgAN will require renal replacement therapy within 20–25 years after disease onset and patients with a baseline UPCR ≥ 1.0 g/g and maintain said UPCR have an increased risk of kidney injury. Thus based on the teachings of Zhang et al., one would have been motivated to choose any patient with IgAN, and especially those having an increased risk of kidney injury including those having a baseline UPCR ≥ 1.0 g/g and thus having increased levels of proteinuria.
Although Zhang et al. does not specifically teach that treatment will reduce proteinuria and slow kidney function decline, prior to the effective filing date as taught by Zhang et al., sparsentan was known in the art as an antagonist of both endothelin (especially, ET-1) and angiotensin II (especially, subtype AT1) receptors (“dual angiotensin endothelin receptor antagonists”).
Kohan teaches the benefit of angiotensin II and endothelin inhibition in kidney disease (page 646). Kohan teaches ET receptor inhibition markedly preserved renal function, but did not affect arteriolopathy or interstitial fibrosis. In contrast, ACEI reduced structural injury, but failed to protect the glomerular filtration rate. Thus, these studies suggest that there may indeed be merit to combined inhibition of ET and Ang II action in the treatment of progressive renal failure (page 646). Kohan teaches neither ET or ANG II inhibition alone significantly affected serum creatinine or proteinuria, while combination therapy markedly protected against functional deterioration and reduced the degree of proteinuria (page 646). Thus, Kohan teaches the combined inhibition of Ang II and ET-1 action may be better than inhibition of either agent alone in preserving renal structure and function in chronic proteinuric renal failure (page 646).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat a subject with IgA nephropathy (IgAN) comprising orally administering 200 mg per day of sparsentan to the subject and orally administering 400 mg per day of sparsentan to the subject to treat the IgA nephropathy, according to the teachings of Zhang et al. with a reasonable expectation that administration of sparsentan which is a dual angiotensin endothelin receptor antagonist would decrease proteinuria in patients with IgA since Kohan teaches that it was well-known in the art prior to the effective filing date of the claimed invention that dual inhibition of angiotension and endothelin receptor antagonist would lead to the significant reduction in proteinuria in patients with kidney disease.
Thus a person of ordinary skill in the art following the teachings of Zhang et al. and administering sparsentan for the treatment of IgA nephropathy would reasonably expect said administration to lead to the reduction in proteinuria and thus slowing of kidney function decline as claimed.
Although Zhang et al. does not specifically teach administering an initial dose of 200 mg of sparsentan to the subject once a day for a period of 14 days; and after the initial 14-day period, orally administering a subsequent dose of 400 mg of sparsentan to the subject once a day, Zhang et al. specifically teaches administering to the subject from 200 mg/day to 800 mg/day; wherein the amount is 200 mg/day, 400 mg/day or 800 mg/day for the treatment of IGA nephropathy.
Thus Zhang et al. teaches administering the same amounts of the compounds as claimed, i.e. 200 mg/day and 400 mg/day. Although Zhang et al. does not teach starting with a lower dosages followed by administering a higher dosage, it is within the skill of an ordinary artisan to determine an appropriate treatment regimen such that optimal results are achieved. Furthermore, it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Thus in the absence of secondary considerations such as unexpected results or a demonstration of criticality, orally administering an initial dosage of 200 mg followed by administering 400 mg after 14 days is rendered obvious over the cited prior art teachings.
Thus since the methods of claims 45, 56 and 67 are rendered obvious as detailed above, the effects achieved by the methods as claimed are also rendered obvious. Thus reducing the subject’s UP/C ratio by the amounts as claimed in the time frame as claimed and reducing the subject’s UP/C ratio by the amounts as claimed as compared to treatment with irbesartan as claimed are rendered obvious since the same method rendered obvious over the prior art teachings will necessarily produce the same results and effects as claimed. Furthermore since the prior art teaches administration of the same amount of the compound as claimed, reducing the subject’s risk of edema relative to treatment with an angiotensin receptor blocker as claimed is also rendered obvious.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-44 are canceled. Claims 45-74 are rejected. No claims are allowed.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM