DETAILED ACTION
Status of Application
Claims 1-10 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group 1, claims 1-6 and 10, drawn in part to an activity measurement method of lysophospholipase D, comprising: measuring lysophospholipase D activity possessed by the lysophospholipase D, and a kit for activity measurement of lysophospholipase D, in a presence of a ferrocyanide, as submitted in communication filed on 08/20/2026 is acknowledged.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/20/2026.
Claims 1-6 and 10 are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to JAPAN 2022-058195 filed on 03/31/2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/30/2025 and 07/11/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claims Objections
Claim 1 is objected to due to the recitation of “in a presence of a ferrocyanide”. It should be amended to recite “in the presence of a ferrocyanide.”. Appropriate correction is required.
Claim 6 is objected to due to the recitation of “wherein a concentration of the ferrocyanide…”. It should be amended to recite “wherein the concentration of the ferrocyanide…”. Appropriate correction is required.
Claim 10 is objected to due to being dependent upon a non-elected invention. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-6, and10 are rejected 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.
Claim 1 (claims 2, 5, and 6 dependent thereon) is indefinite due to the method missing an essential step. It is unclear as to how one could measure the recited enzymatic activity when there is no step that requires an enzymatic reaction. Only if there is an enzymatic reaction, one can measure enzymatic activity. The presence of ferrocyanide by itself is not enough to have an enzymatic reaction with a lysophospholipase D; one would need the substrate. Correction is required.
Claim 10 is indefinite in the recitation of “two or more reagents in which components contained in the composition are distributed” for the following reason: It is unclear how or where the components are distributed in this case. For examination purposes, claim 10 will be interrupted as being directed to a kit that comprises ferrocyanide and a substrate of lysophopholipase D. Correction is required.
Claim Rejections - 35 USC § 103 (AIA )
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.
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.
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kishimoto et al. (JP2004159531A published 06/10/2004; hereby " Kishimoto "), in view of Arai et al. (JPH03228699A published 10/09/1991; hereby “Arai”), and Wang et al. ( International Journal of Clinical and Experimental Medicine 7.11 (2014): 4244; hereby “Wang”) . English translations provided.
Regarding claims 1-6 and 10, Kishimoto teaches a method for measuring lysophospholipase D activity, a reagent for measuring lysophospholipase D (LPLD) activity (Page 1, lines 1-2). Regarding claim 3-4, Kishimoto teaches that the method for measuring LPLD wherein the substrate is lysophosphatidylcholine (Page 3, lines 47-51). Kishimoto teaches that lysophosphatidic acid and choline are produced from lysophosphatidylcholine in the enzyme reaction step (Page 3, lines 47-51). Regarding claim 5, Kishimoto teaches that LPLD is identical to autotaxin (Page 1, lines 9-10). Regarding claim 10, Kishimoto teaches that LPLD activity is measured with a measurement reagent composed of a two-reagent system (Page 3, lines 6-7). Kishimoto teaches to pack the reaction container, a manual, and the like together to form a kit for simplicity (Page 5, lines 49-50). Kishimoto does not teach that their method is in the presence of ferrocyanide.
Arai teaches a reagent composition for clinical diagnosis for measuring lipase activity in serum (Page 1 [0001]). Arai teaches the use of ferrocyanide ion or EDTAFe ion for the purpose of avoiding an inaccurate measurement due to the influence of bilirubin (Page 2 [0001]). Arai teaches that it is preferable to use a ferrocyanide ion, for example, an alkali metal salt such as sodium ferrocyanide, or potassium ferrocyanide (Page 2 [0001]). Arai teaches a reagent composition for measuring lipase activity, comprising 1,2-diglyceride, nonionic surfactant, monoglyceride lipase, glycerol kinase, glycerophosphate oxidase, hydrogen donor and its coupler, peroxidase, iron complex object; wherein the iron complex contains 1 nmole/ml to 15 nmole/ml of ferrocyanide ions (claims 1-2). Wang teaches that a variety of previous investigations have proven that high concentrations of bilirubin exert significant interference on the determination of multiple biochemical substances (Page 4244 [2]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Kishimoto in the presence of ferrocyanide as taught by Arai. A person of ordinary skill in the art is motivated to perform the method of Kishimoto in the presence of ferrocyanide because Wang teaches that bilirubin can interfere with the determination of multiple biochemical substances and Arai provides a solution to the interference of bilirubin when measuring lipase activity. Furthermore, Arai provides the recited concentration of sodium ferrocyanide or potassium ferrocyanide to use that is within the claimed range. Accordingly, one of ordinary skill would combine the teachings of Kishimoto, Arai, and Wang to prevent the inaccurate measurement of lysophospholipase D when measuring lysophospholipase D activity by utilizing ferrocyanide. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is in condition for allowance.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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