DETAILED ACTION
This office action is in response to applicant’s filing dated January 28, 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
Status of Claims
Claims 20, 22-25, and 37-41 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed January 28, 2026. Acknowledgement is made of Applicant's cancelation of claims 20, 22, 23-25; cancelation of claims 1-19, 21, and 26-36; and addition of new claims 37-41.
Election/Restrictions
Newly submitted claims 37-41 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 20 and 22-25 are directed to a method for suppressing a blood glucose level increase and for regulating an osmotic pressure after intra-injection administration of an agent comprising an osmotic pressure regulator containing D-glucose in a diabetic patient.
New claims 37-41 are directed to a method of preparing a peritoneal dialysate for peritoneal dialysis.
Thus, the claims are directed to separate processes.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The separate method groups lack unity of invention because even though the inventions of these groups require the technical feature of a method for suppressing a blood glucose level increase and for regulating an osmotic pressure after intra-injection administration of an agent comprising an osmotic pressure regulator containing D-glucose in a diabetic patient wherein the peritoneal dialysate is prepared by mixing D-glucose and D-allose and/or D-allulose, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tokuda in view of Nagata as set forth in the 103 rejection set forth below.
Moreover, the groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The inventions are drawn to multiple methods, therefore as per 37 CFR § 1.475(a)-(d), applications containing claims drawn to more than one categories of invention (as defined by section (b)) are not considered to have unity of invention (see particularly section (c)). See the following:
37 CFR § 1.475 Unity of invention before the International Searching Authority, the International Preliminary Examining Authority and during the national stage.
(a) An international and a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
(b) An international or a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
As such, the inventions of Groups I-IV do not relate to a single general concept as defined by PCT RULE 13.2 as the inventions are drawn to multiple methods. Accordingly, the species are not so linked to form a single inventive concept.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 37-41 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 20 and 22-25 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 31, 2025 and May 28, 2026 are 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.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 25 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 has been rendered moot in view of the amendment of claim 25. Thus, the rejection is withdrawn.
Claim Objections
The objection of claims 20, 27, and 30 has been rendered moot in view of the amendment of claim 20 and cancelation of claims 27 and 30. Thus, the objection has been withdrawn.
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).
Taken together all this would result in the practice of the method of claims 20 and 22-25 with a reasonable expectation of success.
Response to Arguments
Applicant argues;
The claimed invention is not a mere addition of D-glucose and D-allose and/or D-allulose to a dialysate, but rather requires mixing D-glucose and D-allose and/or D-allulose at a ratio effective for both peritoneal dialysis and blood glucose level control.
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.
Applicant argues:
Tokuda does not explicitly teach the subject is diabetic. None of the cited references specifically teaches the preparation of a dialysate in the claimed manner or the benefits therefrom. While it is acknowledged that Tokuda discloses a peritoneal dialysis solution containing D-allose, and Nagata discloses a composition effective for diabetic patients containing D-allose and suppressing a rapid blood glucose increase upon sugar intake, the alleged combination of the references still does not teach or suggest the presently claimed technical solution. More specifically, Nagata teaches a composition comprising D-allose to suppress a rapid rise in blood glucose levels upon carbohydrate and/or sugar intake. In the experiment (Examples) of Nagata, u-gelatinized starch and rare sugars were dissolved in distilled water and orally administered to rats. There is nothing in Nagata that suggests control of an osmotic pressure of a dialysate.
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:
While D-allulose may be known as an active component in a hypoglycemic agent and an antidiabetic, it has not been known that the blood glucose level increase by D-glucose absorption is effectively suppressed when the rare sugar is added together with D-glucose as the osmotic pressure regulator for a peritoneal dialysate where glucose is continuously absorbed into the body through peritoneal dialysis (see the background art section; paragraph [0009] of the present specification as originally filed). The use of D-allose or D-allulose in dialysis according to the present invention can solve various problems due to a D-glucose-containing dialysate, including a blood glucose level increase and infection risk, when the glucose is used as a main osmotic agent. D-allose (D-allulose) and D-glucose have substantially the same osmotic pressure when used in the same amount and thus, the combination of D-glucose and D-allose (D- allulose) is useful to produce a dialysate having both effective osmotic pressure and rare sugar effects only by adjusting their mixing ratio. None of the cited references suggests the claimed method and the benefits therefrom. It is impermissible simply to engage in a hindsight reconstruction of the claimed invention, using the applicant's structure as a template and selecting elements from the references to fill the gaps. In re Gorman, 983 F.2d 982, 987 (Fed. Cir. 1991).
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 2145. X. A. states, "Applicants may argue that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, “[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for guidance regarding establishment of a prima facie case of obviousness.”
In the instant case, the obviousness rejection is based on the combined teachings of Tokuda and Nagata. 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. Therefore, the instant obviousness rejection is based on teachings known in the art at the time of the instant invention and not solely on the applicant's disclosure.
Regarding the argument that it has not been known that the blood glucose level increase by D-glucose absorption is effectively suppressed when the rare sugar is added together with D-glucose as the osmotic pressure regulator for a peritoneal dialysate where glucose is continuously absorbed into the body through peritoneal dialysis, Nagata explicitly teaches that D-allose alone or a mixture of D-allose and D-psicose has an effect of suppressing abrupt blood sugar elevation during carbohydrate and/or saccharide intake. Thus, the skilled artisan would have a reasonable expectation that D-allose alone or a mixture of D-allose and D-psicose would reduce blood glucose increase when administered together with D-glucose as the osmotic pressure regulator for peritoneal dialysate since it is known that these rare sugars suppress abrupt blood sugar elevation during carbohydrate and/or saccharide intake.
Conclusion
Claims 20 and 22-25 are rejected.
No claims are allowed.
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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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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