DETAILED ACTION
This office action is in response to applicant’s filing dated July 21, 2026.
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 .
Status of Claims
Claims 20, 22-25, and 42 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed July 21, 2026. Acknowledgement is made of Applicant's cancelation of claims 1-19, 21, and 26-41; and addition of new claim 42.
Claims 20, 22-25, and 42 are presently under examination.
Priority
The present application is a 371 of PCT/JP2020/010232 filed on March 10, 2020, which claims benefit of foreign priority to JAPAN 2019-065393 filed on March 29, 2019.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 21, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
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.
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 20 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tokuda et al (JP2009269887, cited in the IDS filed September 28, 2021, machine translation obtained from WIPO Patentscope February 13, 2025) in view of Nagata et al (JP2007051135, cited in the IDS filed September 28, 2021, machine translation obtained from WIPO Patentscope February 13, 2025).
Regarding claim 20, Tokuda teaches a peritoneal dialysis method characterized by using a dialysate containing an effective amount of a rare sugar or a salt thereof (claim 12); wherein a dialysis fluid containing an effective amount of a rare sugar or a derivative thereof is injected through the catheter into an abdominal membrane of a renal disease patient in which a catheter is planted in the abdominal cavity (claim 13); wherein glucose and electrolyte is further contained in the dialysate (claim 15). Tokuda teaches rare sugar includes D-psicose, L-psicose, or D-allose (claim 2 and [0001]). D-psicose and L-psicose read on allulose as evidenced by STN (CAS# 23140-52-5), which lists DL-psicose as an alternative name for allulose. Moreover, Tokuda teaches the peritoneal dialysate is blended with composition comprising the rare sugar, d-allose, and glucose (claims 1-4). Tokuda teaches a peritoneal dialysis fluid containing a peritoneal degradation inhibitor (claim 5), wherein the peritoneal deterioration inhibitor contains a rare sugar (claim 1); wherein the rare sugar is D-allose (claim 2), further characterized by containing glucose (claim 3), wherein the peritoneal degradation inhibitor is used by being blended in peritoneal dialysate (claim 4). Tokuda teaches rare sugar may be mixed immediately before use or may be mixed in advance in one solution.
Tokuda teaches in peritoneal dialysis, the peritoneal dialysate having a high osmotic pressure is stored in the abdominal cavity surrounded by the peritoneal membrane to remove excess water and waste waste in the living body; that is, in the peritoneal dialysis, excess water in the living body is moved from the peritoneal capillary vessel to the peritoneal dialysis fluid in the abdominal cavity due to an osmotic pressure difference generated between the peritoneal dialysis fluid stored in the abdominal cavity and the body fluid, thereby removing excess water and waste waste in the living body [0003]. Tokuda further teaches in order to create an osmotic pressure gradient necessary for removing excessive moisture and waste from blood, the peritoneal dialysis fluid also contains glucose having a higher concentration than glucose concentration in blood [0008].
Thus, Tokuda teaches a method for regulating an osmotic pressure after intra-injection of an agent comprising an osmotic pressure regulator containing D-glucose and D-psicose, L-psicose, and/or D-allose, wherein peritoneal dialysate is blended with composition comprising the rare sugar, d-allose, and glucose and administering via catheter to the peritoneal cavity of the patient.
Tokuda does not explicitly teach the subject is diabetic.
However, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose, said composition being capable of suppressing rapid blood sugar elevation during carbohydrate and/or saccharide intake, improving diabetes [0009].
As such, since Tokuda teaches a method for regulating an osmotic pressure after intra-injection of an agent comprising an osmotic pressure regulator containing D-glucose and D-psicose, L-psicose, and/or D-allose, and since Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
The prior art is silent regarding “suppressing a blood glucose level increase by continuous absorption of glucose into a body.” However: “suppressing a blood glucose level increase by continuous absorption of glucose into a body” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (D-allose and/or D-allulose) is being administered to the same subjects (a diabetic subject receiving peritoneal dialysate comprising glucose, D-allose and/or D-allulose). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “suppressing a blood glucose level increase by continuous absorption of glucose into a body,” by practicing the method taught by the prior art: “the administration of D-allose and/or D-allulose to a diabetic patient receiving peritoneal dialysate comprising glucose, D-allose and/or D-allulose,” one will also be “suppressing a blood glucose level increase by continuous absorption of glucose into a body,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“suppressing a blood glucose level increase by continuous absorption of glucose into a body”) of the method taught by the prior art (“the administration of D-allose and/or D-allulose to a diabetic patient receiving peritoneal dialysate comprising glucose, D-allose and/or D-allulose”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Regarding claim 22, Tokuda teaches the peritoneal dialysis fluid further comprises glucose and electrolyte (claim 6) which is an electrolyte solution close to the extracellular liquid composition (claim 10).
Regarding claim 23, Tokuda teaches the glucose concentration of 1000 to 4500 mg/dl (claim 7) of the peritoneal dialysate.
Regarding claim 24, Tokuda teaches the peritoneal dialysate wherein the concentration of the rare sugar in the peritoneal dialysate is 0.1 wt% or more with respect to glucose (claim 8).
Regarding claim 25, Tokuda teaches the peritoneal dialysate contains a saccharide having a concentration of 0.1-10 wt % as a whole (claim 9).
Regarding claim 42, Tokuda further teaches in order to create an osmotic pressure gradient necessary for removing excessive moisture and waste from blood, the peritoneal dialysis fluid also contains glucose having a higher concentration than glucose concentration in blood [0008]. Moreover, Tokuda teaches the peritoneal dialysate is characterized by containing glucose and electrolyte and rare sugar where the concentration of the rare sugar is 0.1 wt% or more with respect to glucose and the dialysis fluid contains a saccharide having a concentration of 0.1 to 10 wt.% as a whole. Thus, Tokuda suggests setting osmotic pressure gradient effective for peritoneal dialysis, setting a ratio between D-glucose and D-allulose having a set saccharide concentration as a whole.
Taken together all this would result in the practice of the method of claims 20, 22-25, and 42 with a reasonable expectation of success.
Response to Arguments
Applicant argues;
The claimed invention is not directed merely to the presence of D-glucose and a rare sugar in a composition, rather requires a preparation step in which the mixing ratio is adjusted for the combined purposes of providing an osmotic pressure effective for peritoneal dialysis and maintaining the patient’s blood glucose level within a target range upon intraperitoneal administration.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Tokuda teaches the glucose concentration of 1000 to 4500 mg/dl (claim 7) of the peritoneal dialysate and the peritoneal dialysate wherein the concentration of the rare sugar in the peritoneal dialysate is 0.1 wt% or more with respect to glucose (claim 8). Moreover, Tokuda further teaches in order to create an osmotic pressure gradient necessary for removing excessive moisture and waste from blood, the peritoneal dialysis fluid also contains glucose having a higher concentration than glucose concentration in blood [0008]. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts taught by Tokuda as a starting point for optimizing the amounts and ratio of D-glucose and D-allose and/or D-allulose to produce a peritoneal dialysis composition effective for both peritoneal dialysis and blood glucose level control from the teachings of the cited art.
Regarding the argument that the rejection does not identify a teaching in Tokuda or Nagata of the claimed ratio adjustment step, as set forth above, clearly suggests a ratio between the rare sugar and glucose and a saccharide amount as a whole. Thus, Tokuda clearly establishes that the ratio and amounts of D-glucose and D-allose and/or D-allulose to produce a peritoneal dialysis composition is a result effective variable and the skilled artisan would have been motivated to optimize the amounts and ratio of D-glucose and D-allose and/or D-allulose and saccharide as a whole to produce a peritoneal dialysis composition effective for both peritoneal dialysis and blood glucose level control since it is known that the amounts and ratio of D-glucose and D-allose and/or D-allulose and saccharide as a whole is a useful for providing osmotic pressure gradient for peritoneal dialysis and D-allulose is useful for suppressing rapid blood sugar elevation and improves diabetes.
Applicant argues:
Tokuda is directed to suppressing peritoneal deterioration, not to controlling blood glucose in a diabetic patient by adjusting the D-glucose/rare-sugar mixing ratio of a peritoneal dialysate. Tokuda explains that peritoneal dialysis fluid contains glucose at a concentration higher than blood glucose concentration to create an osmotic-pressure gradient for removing excess water and waste products from blood, and discusses the possibility that AGEs in peritoneal tissue during long-term peritoneal dialysis may cause structural and functional changes in the peritoneum (paragraph [0008]). Tokuda further explains that a peritoneal deterioration inhibitor may be mixed with a peritoneal dialysis solution and administered intraperitoneally during peritoneal dialysis (paragraph [0029]). These teachings concern use of rare sugar in a peritoneal dialysis solution for peritoneal protection, not adjustment of a D-glucose/D-allose and/or D-allulose mixing ratio to maintain a diabetic patient's blood glucose within a target range.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case, as set forth above, Tokuda teaches a method for regulating an osmotic pressure after intra-injection of an agent comprising an osmotic pressure regulator containing D-glucose and D-psicose, L-psicose, and/or D-allose. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
Applicant argues:
Nagata is cited for teaching that D-allose alone, or a mixture of D-allose and D-psicose, can suppress rapid blood-sugar elevation during carbohydrate and/or saccharide intake and improve diabetes (paragraph [0009]). Nagata further describes rare sugars as active ingredients that can be added to beverages, confectionery, processed foods, and related compositions, and describes use for improving abnormalities of carbohydrate metabolism and/or lipid metabolism (paragraph [0024]). Nagata also frames the invention in relation to dietary restrictions, pharmaceuticals, health foods, and sick foods for diabetes, obesity, and related conditions (paragraph [0025]). These disclosures are materially different from the claimed peritoneal-dialysis method. Nagata does not teach administering D-allose or D-psicose into the peritoneal cavity, does not teach incorporating D-allose or D-allulose into a peritoneal dialysate, does not teach osmotic-pressure regulation of a peritoneal dialysate, and does not evaluate blood- glucose control arising from continuous absorption of glucose through the peritoneum during peritoneal dialysis.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case, as set forth above, Tokuda teaches a method for regulating an osmotic pressure after intra-injection of an agent comprising an osmotic pressure regulator containing D-glucose and D-psicose, L-psicose, and/or D-allose. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
Applicant argues:
The Office Action states that it would have been obvious to use Tokuda's amounts as a starting point for optimizing the amounts and ratio of D-glucose and D-allose and/or D-allulose to produce a peritoneal dialysis composition effective for both peritoneal dialysis and blood glucose level control. Applicant respectfully submits that this conclusion is unsupported by the cited teachings. Tokuda's concentration disclosures are directed to peritoneal dialysis and peritoneal deterioration, not patient-specific glycemic control. Nagata's blood-glucose disclosures are directed to oral carbohydrate and/or saccharide intake, not peritoneal administration and not osmotic-pressure regulation of a dialysate. The cited references therefore do not provide an articulated reason why a person of ordinary skill would have selected and coordinated the D- glucose and D-allose and/or D-allulose amounts in the claimed manner, nor do they provide a reasonable expectation that an oral postprandial rare-sugar effect would translate to maintenance of a target blood glucose range during peritoneal dialysis while preserving the osmotic pressure required for dialysis.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Tokuda teaches a method for regulating an osmotic pressure after intra-injection of an agent comprising an osmotic pressure regulator containing D-glucose and D-psicose, L-psicose, and/or D-allose. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
As set forth above, Tokuda teaches the glucose concentration of 1000 to 4500 mg/dl (claim 7) of the peritoneal dialysate and the peritoneal dialysate wherein the concentration of the rare sugar in the peritoneal dialysate is 0.1 wt% or more with respect to glucose (claim 8). Moreover, Tokuda further teaches in order to create an osmotic pressure gradient necessary for removing excessive moisture and waste from blood, the peritoneal dialysis fluid also contains glucose having a higher concentration than glucose concentration in blood [0008]. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
Applicant argues:
The Office Action also states that suppressing a blood glucose level increase by continuous absorption of glucose into a body would naturally flow from administering the same or similar compounds to a diabetic patient receiving a peritoneal dialysate comprising glucose and D-allose and/or D-allulose. Applicant respectfully disagrees. Claim 20 does not merely recite a newly discovered property of administering a known composition. Claim 20 recites an affirmative preparation step: mixing D-glucose and D-allose and/or D-allulose and adjusting their mixing ratio to provide a dialysate having an osmotic pressure effective for peritoneal dialysis and to maintain the patient's blood glucose level within a target blood glucose range upon administration. The cited references do not teach or suggest that ratio-adjustment process. The rejection therefore relies on Applicant's disclosure as the roadmap for coordinating osmotic-pressure effectiveness and glycemic control in a peritoneal dialysate.
In the present invention, the saccharide concentration is set to provide the osmotic pressure required for peritoneal dialysis, while the mixing ratio between D-glucose and D-allose and/or D- allulose is adjusted to achieve blood-glucose control without materially impairing the dialysis- effective osmotic pressure. This coordinated preparation approach is not disclosed or taught in the cited art.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The Examiner notes that Tokuda teaches a method of directly administering a peritoneal degradation inhibitor into the abdominal cavity includes, for example, a method of mixing with the peritoneal dialysis fluid to be administered into the abdominal cavity during peritoneal dialysis, a method of directly administering the liquid peritoneal degradation inhibitor into the abdominal cavity via the peritoneal dialysis catheter, and the like [0025] and as a method for directly administering to the abdominal cavity, the peritoneal dialysate can be mixed with the peritoneal dialysate and administered into the abdominal cavity during peritoneal dialysis [0035]. Thus, Tokuda explicitly teaches mixing the composition. Moreover, as set forth above, Tokuda teaches the glucose concentration of 1000 to 4500 mg/dl (claim 7) of the peritoneal dialysate and the peritoneal dialysate wherein the concentration of the rare sugar in the peritoneal dialysate is 0.1 wt% or more with respect to glucose (claim 8). Moreover, Tokuda further teaches in order to create an osmotic pressure gradient necessary for removing excessive moisture and waste from blood, the peritoneal dialysis fluid also contains glucose having a higher concentration than glucose concentration in blood [0008]. As set forth above, Nagata teaches a composition containing a mixture of D-allose alone or a mixture of D-allose and D-psicose suppresses rapid blood sugar elevation during carbohydrate and/or saccharide intake and improves diabetes. As set forth above, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of regulating an osmotic pressure taught by Tokuda to treat a diabetic patient with an expectation of success, since the prior art establishes that allose and psicose/allulose are useful regulating an osmotic pressure and for reducing blood sugar elevation and improving diabetes.
Conclusion
Claims 20 and 22-25 are rejected.
No claims are allowed.
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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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