DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see page 5, filed 21NOV2025, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Sherman in view of Lipton.
As required by the amended Claims, the required concentration of nitrite in the dialysate flowing in the dialysate channel, Sherman teaching a range of up to 1 µM [0230]. Lipton, as cited below, explores a variety of nitrite ranges during various conditions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1-3 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20180256637 A1 (Sherman) in view of US 20050074485 A1 (Lipton).
Regarding claims 1 and 2, Sherman teaches a dialyzer (Fig. 1)) comprising:
a dialysis unit (80) including a blood channel and a dialysate channel (Sherman Annotated Fig. 1, wherein the blood channel and dialysate channels are considered to extend through the dialysis unit 80);
a dialysate [0031];
a dialysate supply channel (60) configured to supply a dialysate to the dialysate channel;
a dialysate discharge channel configured to discharge the dialysate from the dialysate channel (Sherman Annotated Fig. 1);
a blood supply channel configured to supply blood to the blood channel, and a blood discharge channel configured to discharge the blood from the blood channel (Sherman Annotated Fig. 1);
wherein the blood channel and the dialysate channel are in contact with each other via a dialysis membrane (90) [0021] the dialysate flowing through the dialysate channel contains nitrite ions.
Sherman fails to teach a concentration of the nitric oxide in the dialysate is 0.5 to 10 µM or a concentration of the nitrite ions in the dialysate is 40 to 120 µM.
Lipton teaches a dialysis system wherein the concentration of nitrite ions is between 40 and 120 µM (Fig. 3) [0093].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the concentration of nitrite ions in the dialysate of Sherman with the ranges taught by Lipton as Sherman teaches a desire to prevent a plurality of conditions by controlling nitrite levels [0012].
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Sherman Annotated Fig. 1
Regarding claim 3, Sherman teaches the dialyzer according to Claim 1.
Sherman further teaches the dialysis unit or the dialysate supply channel includes a material that releases the nitric oxide and/or the nitrite ions, namely sodium nitrite [0012, 0013, 0132].
Regarding claims 11-13, Sherman teaches a dialyzer comprising:
a dialysis unit (80) including a blood channel and a dialysate channel (Sherman Annotated Fig. 1, wherein the blood channel and dialysate channels are considered to extend through the dialysis unit 80);
a dialysate supply channel (60) configured to supply a dialysate to the dialysate channel;
a dialysate discharge channel configured to discharge the dialysate from the dialysate channel (Sherman Annotated Fig. 1);
a blood supply channel configured to supply blood to the blood channel, and a blood discharge channel configured to discharge the blood from the blood channel (Sherman Annotated Fig. 1); and
means for controlling the concentration of nitrite [0103], and a concentration of the nitrite ions in the dialysate channel
wherein the means for controlling the concentration includes a material (the carrier solution described in [0102] or [0103]) that releases nitric oxide and/or nitrite ions into the dialysate; and
wherein the means for controlling a concentration includes a flow meter configured to meter the nitric oxide into the dialysate (as would necessarily be required to deliver the flow rates as described in [0103]).
Sherman fails to teach a concentration of the nitric oxide in the dialysate is 0.5 to 10 µM or a concentration of the nitrite ions in the dialysate is 40 to 120 µM.
Lipton teaches a dialysis system wherein the concentration of nitrite ions is between 40 and 120 µM (Fig. 3) [0093].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the concentration of nitrite ions in the dialysate of Sherman with the ranges taught by Lipton as Sherman teaches a desire to prevent a plurality of conditions by controlling nitrite levels [0012].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Lipton and further in view of US 20060068031 A1 (Miller et al.).
Regarding claim 4, Sherman teaches the dialyzer according to Claim 1.
Sherman fails to teach a nitric oxide gas supply source, a flow meter connected to the nitric oxide gas supply source, and a nitric oxide gas supply path for supplying the nitric oxide gas to the dialysate.
Miller teaches a blood treatment system (Fig. 9) comprising a nitric oxide gas supply source (7), a flow meter (8) connected to the nitric oxide gas supply source, and a nitric oxide gas supply path for supplying the nitric oxide gas to the blood of the patient (9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dialysate nitric oxide control system of Sherman in view of Miller with the nitric oxide gas supply and metering of Miller as it would be obvious to try when considering known methods to maintain nitric oxide at acceptable levels for treatment [Miller 0068] with a reasonable expectation of providing nitric oxide to the dialysate MPEP 2143 I.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Lipton and further in view of US 6911427 B1 (Stamler).
Regarding claim 5, Sherman teaches a concentration of the nitrite ions in the dialysate is 40 to 120 µM as described in claim 1, but fails to teach the dialysate contains nitric oxide and nitrite ions, and a concentration of the nitric oxide in the dialysate is 0.5 to 10 µM.
Stamler teaches a formulation for use in a dialysate (Col. 19, ll. 9-13) wherein a concentration of the nitric oxide in the dialysate is 0.5 to 10 µM through teaching a range where the concentration of nitric oxide added was 5 µM (Col. 44, ll. 13-15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dialysate of Sherman with nitric oxide at the concentration taught by Stamler to control the interactions between nitric oxide and the patient’s blood and thereby preventing detrimental side effects (Col. 2, ll. 11-23).
Conclusion
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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/ Examiner, Art Unit
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781