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
Applicant’s amendment of 25 November 2025, in which claim 72 has been amended, is acknowledged.
Claims 72-78 are pending in the instant application.
Claims 72-78 are examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 December 2025 is acknowledged and considered.
Response to arguments of 25 November 2025
In view of Applicant’s amendment of 25 November 2025, the objection to claim 72 is herein withdrawn. Applicant has clarified the claim language.
In view of Applicant’s amendment of 25 November 2025, the rejection of claims 72-78 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Applicant has amended claim 72 to recite that the decreasing of the concentration of uremic substance in blood is in comparison to before starting administration of the effective amount of the alkalinizing agent.
On 25 November 2025, Applicant has amended independent claim 72 by adding the limitation “wherein the mammalian subject is not suffering from metabolic acidosis”.
New and modified rejections are made below, based on Applicant’s amendment of 25 November 2025.
Applicant’s arguments (Remarks of 25 November 2025, pages 7-13) against a possible rejection of claims 72-78, as amended on 25 November 2025, under 35 U.S.C. 103 over Loniewski, in view of Niwa; and over Tanner, in view of Niwa, are acknowledged.
In response, the examiner’s position is that the original Specification as filed does not provide support for the newly added limitation in claim 72, patients with CKD not suffering from metabolic acidosis (see new matter rejection below). Applicant provides a literature reference as post-filing data and argues (page 10, last paragraph, page 11, first paragraph) that the bicarbonate concentration in the serum of patients with CKD in the Examples of the instant Specification was 24.85 mEq/L, which does not indicate a state of metabolic acidosis. The examiner acknowledges this fact, but maintains that, unfortunately, Applicant has failed to provide sufficient support in the original Specification for this newly added limitation in claim 72.
Applicant argues (page 10) that Loniewski teaches on page 531 that further testing and research is needed for CKD patients without metabolic acidosis, which is a subpopulation of patients in newly amended claim 72.
In response, contrary to Applicant’s argument that Loniewski teaches on page 531 that further testing and research is needed for CKD patients without metabolic acidosis, Loniewski does teach (page 533, right column, first paragraph) that NaHCO3 is effective at 3 g/day to treat CKD patients without metabolic acidosis (see obviousness rejection below), and Loniewski teaches that Polycitra is a galenic form and precursor of NaHCO3, commonly used to treat CKD.
Further, Loniewski teaches on page 531, Table 1, that bicarbonate supplementation is effective to treat CKD in the 2/3 Nx rats, which is an animal model of CKD with no metabolic acidosis (page 530, right column, second paragraph).
For these reasons, a new/modified rejection of claims 72-78 is made under 35 U.S.C. 103 over Loniewski, in view of Niwa.
Applicant argues (pages 12-13) that the patients in Tanner are rats suffering from metabolic acidosis, which is a patient population excluded from amended claim 72. For this reason, a rejection to amended claims 72-78 under 35 U.S.C. 103 over Tanner, in view of Niwa, is not made.
Applicant argues (pages 14-15) against the rejection of claims 72-78 on the ground of nonstatutory double patenting over claims of copending Application No. 17/284,862, in view of Niwa, on the grounds that the methods in the reference patent application are different from the instantly claimed method of decreasing uremic substances from blood. This argument is not persuasive, because claims of copending Application No. 17/284,862 recite administration of the same therapeutic agents, a mixture of potassium citrate and Na citrate, in similar/overlapping daily dose, to the same patients, patients suffering from CKD, wherein the mammalian subject is not suffering from metabolic acidosis, as in the instant claims.
Administration of the same therapeutic agents to the same patient population is expected to have inherently the same effect on the concentration of uremic substances in the blood of the patients. The person of ordinary skill in the art would have been motivated to monitor the effectiveness of sodium citrate and potassium citrate in treating CKD in the method of claims of copending Application No. 17/284,862 by measuring the concentration of uremic substance indoxyl sulfate in the blood of patients throughout treatment, because Niwa teaches that indoxyl sulfate is an uremic toxin which accumulates in the serum of chronic kidney disease (CKD) patients and accelerates the progression of CKD. Thus, the person of ordinary skill in the art would have monitored the effectiveness of sodium citrate and potassium citrate in treating CKD by measuring the concentration of uremic substance indoxyl sulfate in the blood of patients, with the expectation that treatment is correlated with a decrease in the concentration of uremic substance indoxyl sulfate in the blood of patients due to increased excretion of indoxyl sulfate from blood into urine of the patient. This rejection is herein maintained.
Application 17/906,389 is abandoned. As a result, the provisional rejection of claims 72-78 on the ground of nonstatutory double patenting over claims of copending Application No. 17/906,389, in view of Niwa, is herein withdrawn.
Applicant’s amendment of 25 November 2025 necessitated the following new and/or modified rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 72-78 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 72, as amended on 25 November 2025, recites “wherein the mammalian subject is not suffering from metabolic acidosis”. As such, independent claim 72 is drawn to a method for decreasing a concentration of uremic substance/indoxyl sulfate in blood, or for promoting an excretion of uremic substance/indoxyl sulfate into urine in a mammalian subject suffering from chronic kidney disease, wherein the mammalian subject is not suffering from metabolic acidosis,
the method comprising administering to the subject an effective amount of an alkalinizing agent which is a mixture of sodium citrate or a hydrate thereof, and potassium citrate or a hydrate thereof, at 1 to 6g/day, by continuous administration for 6 weeks or more.
The original Specification does not disclose that the patient population is a mammalian subject suffering from chronic kidney disease, who is not suffering from metabolic acidosis, as now claimed.
The Specification discloses the term “metabolic acidosis” once, namely in [0004] which states: “because a concentration of bicarbonate ions (HC03-) in blood decreases and metabolic acidosis develops in patients with advanced CKD, an alkalinizing agent such as sodium bicarbonate or a citric acid preparation is administered.”
It is known that a normal bicarbonate level in blood is between 22 and 29 mEq/L. Mild to moderate metabolic acidosis is usually in the 12–22 mEq/L range. Levels below 12 mEq/L may indicate severe metabolic acidosis, which requires urgent treatment.
The Specification teaches [0049] that the pharmaceutical composition provided by the present invention is administered to a patient with low-severity, early-stage chronic kidney
diseases. In one embodiment, the pharmaceutical composition provided by the present invention is administered to a patient with chronic kidney disease of stage G3b or lower, preferably stage G2 or lower.
In one embodiment, the pharmaceutical composition provided by the present invention is administered to a patient with chronic kidney disease in stage G2 or more and stage G3b or less (for example, stage G2 and stage G3a; or stage G2, stage G3a and stage G3b).
In one embodiment, the pharmaceutical composition provided by the present invention is administered to a patient with chronic kidney disease in stage G3b or less and microalbuminuria, preferably administered to a patient with kidney disease in stage G2 and chronic albuminuria,
In one embodiment, the pharmaceutical composition provided by the present invention is administered to a patient with chronic kidney disease in stage G2 or more and stage G3b or less (for example, stage G2 and stage G3a; or stage G2, stage G3a and stage G3b) and which is microalbuminuria.
The Specification teaches (Examples, [0108]) that 47 patients with chronic kidney disease in stage G2 to G3b (defined as eGFR 30 to 89 ml/min/1.73m2) were administered a combination preparation of hydrates of potassium citrate and sodium citrate.
Thus, the Specification clearly defines the patient population as mammalian subjects who suffer from chronic kidney disease stage G2 to G3b defined as eGFR 30 to 89 ml/min/1.73m2. There is no reference to the blood bicarbonate levels in these patients.
There is no teaching in the Specification regarding the bicarbonate levels in the blood of these patients treated with citrate who suffer from chronic kidney disease stage G2 to G3b defined as eGFR 30 to 89 ml/min/1.73m2. The Specification provides absolutely no information regarding these patients having a bicarbonate blood concentration that is normal, between 22 and 29 mEq/L, or below 22 mEq/L, which would correspond to metabolic acidosis. Further, there is absolutely no teaching in the Specification that CKD patients with metabolic acidosis are excluded from treatment.
There is support in the Specification for patient population as mammalian subjects who suffer from chronic kidney disease, including patients with CKD stage G2 to G3b defined as eGFR 30 to 89 ml/min/1.73m2, but there is no recitation in the Specification of mammalian subjects who suffer from chronic kidney disease who are not suffering from metabolic acidosis, as now claimed.
Disclosure in an application that merely renders the later-claimed (by amendment) invention obvious is not sufficient to meet the written description requirement of 35 USC 112, first paragraph. Lockwood, v. American Airlines, Inc. 41 USPQ.2d 1961 at 1966 (CAFC, 3/4/97)
When an explicit limitation in a claim is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill in the art would have understood at the time of the patent application was filed, that the description required that limitation.
The Specification contains no disclosure of patient population as mammalian subjects who suffer from chronic kidney disease, and who are not suffering from metabolic acidosis, as the patient population to be treated. The amendment to claim 72 constitutes new matter because there is no explicit or implicit support for the added limitations. Cancellation of the new matter is required.
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.
Claims 72-78 are rejected under 35 U.S.C. 103 as being unpatentable over Loniewski et al. (Kidney International 2014, 85, 529-535, cited in PTO-892 of 25 June 2021), in view of Niwa, T. (Nagoya J. Med. Sci. 2010, 72, 1-11, cited in PTO-892 of 14 April 2022).
Loniewski teaches (page 533, right column, first paragraph) administering alkalinizing agent NaHCO3 to patients with chronic kidney disease (CKD) without metabolic acidosis, to treat said patients/ to suppress the progression of chronic kidney disease in said patients. Loniewski teaches (page 533, right column, first paragraph) that in CKD patients without acidosis, NaHCO3 was administered at a dose of 0.5 mEq., i.e. 42 mg/kg b.w. daily, where patients weighing 70 kg received approximately 3 g NaHCO3 divided in three doses.
Thus, Loniewski teaches that alkalinizing agent NaHCO3 is effective to treat chronic kidney disease (CKD) in CKD patients without metabolic acidosis, at a dose of NaHCO3 3 g/day.
Loniewski also teaches (page 533, under Dosage) that the optimum daily dose of NaHCO3 recommended is calculated according to a formula that takes into account the measured serum HCO3- levels in a CKD patient; serum HCO3- levels are to be monitored in time and dosage adjusted accordingly.
Loniewski teaches (Table 4) that Polycitra, which is an oral pharmaceutical composition which is a mixture of alkalinizing agents Na citrate 1mEq/ml and K citrate 1 mEq/ml, is an oral bicarbonate precursor, and a galenic form of NaHCO3 (page 533, right column, second paragraph).
Loniewski teaches (page 533, right column, first paragraph under Galenic forms, also Table 4) administering alkalinizing agent Polycitra, which is an oral pharmaceutical composition which is a mixture of alkalinizing agents Na citrate 1mEq/ml and K citrate 1 mEq/ml, to CKD patients to suppress the progression of chronic kidney disease.
Thus, Loniewski teaches a method for suppressing the progression of chronic kidney disease (CKD) in a mammalian subject in need thereof, comprising administering to a mammalian subject in need thereof a pharmaceutical composition which is a mixture of alkalinizing agents Na citrate and K citrate.
Loniewski teaches (page 533, right column, last paragraph, page 534, right column, first paragraph, also Table 5) Na citrate and K citrate (Table 5) as alkalinizing agents.
Lonieski teaches (Abstract, also Table 1, reference by Phisitkul, delayed GFR decline) that alkalization attenuates kidney injury and slows glomerular filtration rate decline in CKD.
Loniewski teaches (Table 2, reference by Goraya) administering NaHCO3 to CKD2 patients, which are patients with stage G2 CKD, as in instant claim 73.
Loniewski teaches (Table 2, reference by Phisitkul) administering oral sodium citrate at a dose equivalent to 1 mEq NaHCO3/kg b.w. daily, to patients with eGFR 20-60 ml/min per 1.73 m2, which are patients with stage G3a and stage G3b CKD, included in the patient population of instant claim 73, to treat CKD. The duration of treatment is 24 months.
Loniewski does not specifically teach a method of treating CKD in CKD patients without acidosis by administering to the patients Polycitra, or that Polycitra contains a mixture of potassium citrate monohydrate and sodium citrate dihydrate, as in instant claims 72, 78.
Loniewski does not specifically teach administering Polycitra to a subject who suffers from stage G2 chronic kidney disease, to suppress progression of CKD.
Loniewski does not teach that Polycitra is administered at 1 to 6 g/day, or that each of potassium citrate and sodium citrate is administered at 0.5 to 1.5 g/day, as in instant claims 72, 74.
Loniewski does not teach continuous administration for 6 weeks, as in instant claims.
Niwa teaches (Abstract) that indoxyl sulfate, an uremic toxin, is accumulated in the serum of chronic kidney disease (CKD) patients. Niwa teaches (page 1, Introduction) that uremic toxins such as indoxyl sulfate are involved in a variety of symptoms in patients with advanced CKD. Niwa teaches (page 2, first paragraph) that indoxyl sulfate is an uremic toxin that accelerates the progression of CKD. Thus, Niwa implicitly teaches that suppressing progression of chronic kidney disease ameliorates uremic symptoms by reducing the accumulation of uremic toxin indoxyl sulfate in the serum of the CKD patient.
It would have been obvious for a person of ordinary skill in the art to use the teachings of Loniewski and Niwa to arrive at the instantly claimed invention.
The person of ordinary skill in the art would have been motivated to administer to a CKD patient without metabolic acidosis a pharmaceutical composition comprising an effective amount of an alkalinizing agent which is a mixture of potassium citrate monohydrate and sodium citrate dihydrate, because Loniewski teaches a method for treating chronic kidney disease in a human patient suffering from CKD without acidosis by administering NaHCO3, and Loniewski also teaches that Polycitra, which is a composition comprising a mixture of alkalinizing agents Na citrate, K citrate (1:1 molar), is an oral bicarbonate precursor, and a galenic form of NaHCO3, effective to suppress the progression of chronic kidney disease. Thus, the person of ordinary skill in the art would have administered to a patient suffering from chronic kidney disease without acidosis a mixture of potassium citrate monohydrate and sodium citrate dihydrate, with the expectation that such a mixture of hydrates of two alkalinizing agents present in Polycitra, Na citrate and K citrate, can be used interchangeably with NaHCO3 to effectively suppress progression of chronic kidney disease in said patient.
Since Loniewski teaches administration of NaHCO3 or of its galenic form a mixture of potassium citrate and sodium citrate (Polycitra), to patients suffering from chronic kidney disease (CKD), to suppress progression of CKD/treat CKD, the hydrates of the alkalinizing agents, upon administration, are expected to elicit the same effect on CKD and on uremic symptoms of CKD due to accumulation of uremic toxin indoxyl sulfate in blood.
Further, with respect to claim 73, the person of ordinary skill in the art would have administered the mixture of potassium citrate monohydrate and sodium citrate dihydrate to a subject suffering from stage G2 to G3b chronic kidney disease, because Loniewski teaches that Polycitra (potassium citrate and sodium citrate mixture 1:1 molar, Table 4) is a galenic form of NaHCO3 (page 533, right column, second paragraph, Table 4), Loniewski teaches administering NaHCO3 to CKD patients without acidosis to treat CKD, Loniewski teaches administering NaHCO3 to CKD2 patients to treat CKD, and Loniewski further teaches administering sodium citrate to CKD stage G3a or CDK stage G3b patients to treat CKD. Thus, the person of ordinary skill in the art would have administered to CKD2 patients without acidosis Polycitra, or a mixture of potassium citrate monohydrate and sodium citrate dihydrate, with the expectation that Polycitra or a mixture of potassium citrate monohydrate and sodium citrate dihydrate, and NaHCO3 will act interchangeably as bicarbonate precursors effective to suppress progression of chronic kidney disease in the subject suffering from stage G2 to G3b chronic kidney disease.
Furthermore, with respect to claims 72, 74, the person of ordinary skill in the art would have determined the therapeutically effective dose of sodium citrate and potassium citrate as Polycitra or the corresponding hydrates administered in the method, because Loniewski teaches that Polycitra (mixture of sodium citrate and potassium citrate 1:1 molar) is a galenic form of NaHCO3, and NaHCO3 is effective to treat CKD in CKD patients without acidosis at an average dose of NaHCO3 of 3 g/day. Thus, the person of ordinary skill in the art would have calculated the dose of Polycitra (mixture of sodium citrate and potassium citrate 1:1 molar) or the corresponding dose of sodium citrate dihydrate and potassium citrate monohydrate, equivalent to a dose of NaHCO3 of 3 g/day, with the expectation of achieving therapeutic effect. Such a determination of effective dose of active ingredients in a method of treatment is routine and well within the skill of the artisan.
Further, the person of ordinary skill in the art would have been motivated to monitor the effectiveness of sodium citrate and potassium citrate in treating CKD by measuring the concentration of uremic substance indoxyl sulfate in the blood of patients throughout treatment, because Niwa teaches that indoxyl sulfate is an uremic toxin which accumulates in the serum of chronic kidney disease (CKD) patients and accelerates the progression of CKD. Thus, the person of ordinary skill in the art would have monitored the effectiveness of sodium citrate and potassium citrate in treating CKD by measuring the concentration of uremic substance indoxyl sulfate in the blood and urine of patients, with the expectation that treatment is correlated with a decrease in the concentration of uremic substance indoxyl sulfate in the blood of patients due to increased excretion of indoxyl sulfate from blood into urine of the patient.
Further, determining the length of treatment in a method of treatment, in order to achieve therapeutic effect, is well within the skill of the artisan.
As such, claims 72-78 are rejected as prima facie obvious.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 72-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 25, 27, 29, 31, 33, 35, 36 of copending Application No. 17/284,862 (published as US 2021/0386696, cited in PTO-892 of 23 March 2023, notice of allowance mailed), in view of Niwa, T. (Nagoya J. Med. Sci. 2010, 72, 1-11, cited in PTO-892 of 14 April 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of claims 15, 25, 27, 29, 31, 33, 35, 36 of copending Application No. 17/284,862 anticipates or renders obvious the instant claims.
Claims 15, 25, 27, 29, 31, 33, 35, 36 of copending Application No. 17/284,862 are drawn to a method for renal protection in a mammalian subject suffering from chronic kidney disease, comprising administering to a subject in need of the renal protection an effective amount of a pharmaceutical composition comprising a mixture of sodium citrate or a hydrate thereof and potassium citrate or a hydrate thereof, wherein the renal protection is, for example, (v) suppression of the decrease in osmotic pressure of urine, wherein the mammalian subject is not suffering from metabolic acidosis; claim 29 recites a dose of 1 to 1.5 g per day, which is encompassed by the dose in instant claims 72, 74; claim 32 recites that the mammalian subject suffering from chronic kidney disease is a patient with chronic kidney disease of stage G2 or more and G3b or less, which overlaps with the patient population in instant claim 73.
Thus, claims of copending Application No. 17/284,862 recite administration of the same therapeutic agents, a mixture of potassium citrate and Na citrate, in similar/overlapping daily dose, to the same patients, patients suffering from CKD, wherein the mammalian subject is not suffering from metabolic acidosis, as in the instant claims.
Niwa is as above.
It would have been obvious for a person of ordinary skill in the art to use the teachings of claims of copending Application No. 17/284,862 and Niwa to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to monitor the effectiveness of sodium citrate and potassium citrate in treating CKD in the method of claims of copending Application No. 17/284,862 by measuring the concentration of uremic substance indoxyl sulfate in the blood of patients throughout treatment, because Niwa teaches that indoxyl sulfate is an uremic toxin which accumulates in the serum of chronic kidney disease (CKD) patients and accelerates the progression of CKD. Thus, the person of ordinary skill in the art would have monitored the effectiveness of sodium citrate and potassium citrate in treating CKD by measuring the concentration of uremic substance indoxyl sulfate in the blood of patients, with the expectation that treatment is correlated with a decrease in the concentration of uremic substance indoxyl sulfate in the blood of patients due to increased excretion of indoxyl sulfate from blood into urine of the patient.
Conclusion
Claims 72-78 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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, JEFFREY S. LUNDGREN can be reached on (571) 272-5541. 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.
/IRINA NEAGU/Primary Examiner, Art Unit 1629