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 .
Claim Status
Claims 2 is cancelled.
Claim 1 is pending. Applicant’s amendment has necessitated a new ground of rejection. Accordingly, this Action is FINAL.
Priority
The certified translation filed 10/20/25 is acknowledged by the Examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/20/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 10/20/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 2 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph. Applicant has cancelled claim 2. Claim(s) 1-2 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uemura et al. (Renal Replacement Therapy 2022 (published July 25); 8(32):9 pages); as being anticipated by Nakayama et al. (US20200101211); as being anticipated by Kobayama et al. (US20090045121); and as being anticipated by Tsujimoto et al. (Ren Replace Ther 2021;7(58):9 pages; published online 10/16/2021). Applicant’s amendments, arguments and benefit of the foreign priority date are sufficient to overcome these rejections.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claim 1 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kobayama et al. (US20090045121) or Nakayama et al. (US20200101211).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a dialysis composition research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from principles of solution chemistry, chemical properties of components, principles of dialysis including the components to dialysis compositions, pharmacology, renal physiology and pathophysiology, biochemistry, research methodologies and state of the art research— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 1, Nakayama et al. disclose a dialysate for hemodialysis that has a dissolved hydrogen concentration of 30-550 ppb made from electrolyzed water that has an activity of reducing fatigue with examples of 186, 205 and 220 ppb taught (Abstract; Figure 1; [0061, 0097-0099]; Table 5; claims 1 and 8) or 30-230 ppb, (Claim 6). With regard to the functional limitations: “having an activity of reducing a persistent feeling of fatigue from hemodialysis , the persistent feeling of fatigue from hemodialysis being a feeling of fatigue eight weeks after a start of hemodialysis using the dialysate”; such is implicit in the dialysate of Nakayama et al.
Regarding claim 1, Kobayama et al. disclose dialysate solutions having dissolved hydrogen concentrations of 100-400 ppb (Claims 1 and 8), with a preferred range of 100-150 ppb [0029] made by electrolysis (Claim 9; Figure 1). With regard to the functional limitations: “having an activity of reducing a persistent feeling of fatigue from hemodialysis , the persistent feeling of fatigue from hemodialysis being a feeling of fatigue eight weeks after a start of hemodialysis using the dialysate”; such is implicit in the dialysate of Kobayama et al.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Nakayama et al. or Kobayama et al. is that the references to not expressly teach a dissolved hydrogen concentration of 120 ppb to 163 ppb. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use 120-163 ppb dissolved hydrogen concentration in the compositions of Nakayama et al. or Kobayama et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Nakayama et al. teaches an overlapping range where 30 ppb is too low reduce fatigue but below 230 ppb is effective to reduce bubble generation in the dialysate and Kobayama et al. teach an overlapping range of 100 to 400 ppb (Claims 6, 8 and 10) with a preferred range of 100-150 ppb [0029] See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In the present case, the prior art ranges are not so broad when compared to the claimed range and the prior art references invite optimization by the ordinary artisan. The functional properties that result are naturally present from employing the compositions of the prior art references. Especially when Nakayama et al. teach and suggest an overlapping range is expected to reduce fatigue including a persistent feeling of fatigue. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Consequently, claim 1 is obvious over Nakayama et al. or Kobayama et al.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 10/20/25 have been carefully considered but are not persuasive.
While Nakayama and Kabayama do not anticipate the claimed subject matter, the references render obvious the claimed subject matter as discussed above. The Examiner has considered Applicant’s examples but the data is not persuasive for the following reasons. First, there is an expectation of reducing fatigue with an overlapping range of dissolved hydrogen dialysate through the teachings of Nakayama. Secondly, to show criticality of a claimed range, "'it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456 (CCPA 1955) (MPEP 2144.05 (II) (A)). In the present case, the art already teaches and suggests a narrow range of dissolved hydrogen dialysate that either encompasses or overlaps the instantly claimed range. The recitation of a function/property inherently possessed by compositions in the prior art does not distinguish a claim drawn to those functions/properties from the prior art compositions. While Nakayama did recognize the benefit of reducing fatigue with the composition, Kabayama did not need to. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).”
It appears that reducing a persistent feeling of fatigue is a natural result inherent in such compositions of the prior art references and the claimed range is not significantly different from the ranges taught by the references. Applicant’s assertion that the claimed range is critical is noted by the Examiner but not persuasive. Just because Nakayama may have measured fatigue at 6 and 12 months with 30 and 80 ppb dissolved hydrogen concentration and not within 8 weeks as claimed, does not change the Examiner’s analysis because the time frames overlap and Nakayama report that even with the lower amounts of 30 and 80 ppb dissolved hydrogen concentration “the percentage of patients who used the dialysate in the experimental group and complained of intense fatigue did not increase even twelve months after the start of the test” [0094]. Table 2 shows a reduction in high/moderate fatigue for the 30 to 80 ppb dialysate. Nakayama further report that (Examiner added emphasis): “the patients using the dialysate containing hydrogen dissolved at a concentration ranging from 30 ppb to 550 ppb had no or slight subjective symptoms of fatigue. In contrast, the patients using the dialysate containing hydrogen dissolved at a concentration lower than 30 ppb had subjective symptoms of fatigue.” [0097] No fatigue was observed for 186 to 227 ppb dialysate (Table 5; [0099]). Thus, the art has already established a functional range boundaries and the instantly claimed range is within that functional range with no evidence of doing anything different from the prior art composition with dissolved hydrogen. It appears to the Examiner that Applicant’s data merely confirms what the prior art already suggested. In other words, the inventors merely used routine research methods to prove what was already believed to be the case. Scientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention. The only reasonable conclusion is that the instantly claimed range, which is encompassed by the prior art references, will also reduce fatigue within 8 weeks. For at least these reasons the claims remain soundly rejected.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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