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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A copy of Japanese Application JP2020-219441 has been filed with a priority date of 28 December 2020.
Claim Objections
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 9, Kraus discloses the invention of claim 1 and discloses adding a protein C inhibitor to analyze thrombomodulin activity in a test assay (see [0067]) and comparing functions of protein C and protein S are evaluated by comparing analysis results with that obtained when thrombomodulin is not added (see Example 5).
However, none of the prior art teaches nor fairly suggests “wherein functions of protein C and protein S are evaluated by comparing the analysis result with that obtained when the protein C inhibitor is not added” as recited in the instant claim.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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 6 recites the limitation "the tissue factor or tissue thromboplastin" in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears the claim should depend from claim 4 instead of claim 1, from claim 6 currently depends, as the limitation of “a tissue factor or tissue thromboplastin” is introduced in claim 4.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 7, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication US 2002/0019021 to Kraus as cited on the 26 September 2023 IDS.
Regarding claim 1, Kraus discloses a method for determining the anticoagulatory potential of a sample by adding thrombomodulin and thromboplastin (i.e., extrinsic blood coagulation activator) in a coagulation test using a blood sample in vitro (see [0001], [0040], [0049]). Kraus discloses the method further comprising the addition of heparin sulfate (i.e., heparin-like substance) (see [0056]).
Regarding claim 4, Kraus discloses the invention of claim 1 and wherein the thromboplastin is derived from tissues (see [0054]).
Regarding claim 7, Kraus discloses all the limitations of claim 1 and discloses using thrombomodulin recombinantly (i.e., soluble thrombomodulin) (see [0025], [0028], [0030], [0056], 0092]).
Regarding claim 13, Kraus discloses the invention of claim 1 and Kraus discloses wherein functions of protein C and protein S are evaluated by comparing analysis results with that obtained when thrombomodulin is not added (see Example 5).
Claim Rejections - 35 USC § 103
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 2-3, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2002/0019021 to Kraus as cited on the 26 September 2023 IDS.
Regarding claim 2, Kraus discloses the invention of claim 1 and discloses wherein heparin itself is the heparin-like substance (see [0092]), however, Kraus fails to explicitly disclose the heparin is unfractionated heparin as recited in the instant claim. However, Kraus does teach unfractionated heparin is a known anticoagulant used as a modifier of thrombomodulin activity (see [0067]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use unfractionated heparin as the heparin-like substance as a suitable anticoagulant as evidenced by Kraus (see MPEP 2144.07 Art Recognized Suitability for an Intended Purpose).
Regarding claim 3, Kraus discloses the invention of claim 1 and discloses the heparin-like substance is heparin sulfate (i.e., heparan sulfate) (see [0089]), however, Kraus fails to disclose wherein the heparan sulfate is added to a final concentration of 0.4 to 15 µ/mL as recited in the instant claim.
However, MPEP 2144.05 II. B. “There Must Be an Articulated Rationale Supporting the Rejection”, defines a result-effective variable which achieves a recognized result, wherein determination of the optical or workable ranges of said variable would be considered routine optimization and thus an obvious finding. In this instance, the final concentration of heparan sulfate has a recognized result of increasing anti-coagulability (see [0091]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the final concentration of heparan sulfate to a final concentration of 0.4 to 15 µ/mL as recited in the instant claim to achieve the desired anticoagulation effect (see MPEP 2144.05 II. Routine Optimization).
Regarding claim 6, Kraus discloses the invention of claim 1 and wherein the thromboplastin is derived from tissues (see [0054]), however, Kraus fails to disclose “wherein the … tissue thromboplastin and the heparin-like substance are added in a concentration such that a blood clotting time is 60 to 700 seconds” as recited in the instant claim.
However, MPEP 2144.05 II. B. “There Must Be an Articulated Rationale Supporting the Rejection”, defines a result-effective variable which achieves a recognized result, wherein determination of the optical or workable ranges of said variable would be considered routine optimization and thus an obvious finding. In this instance, the concentration of tissue thromboplastin and the heparin-like substance has a recognized result of prolonging coagulation time (see [0050], [0091]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the concentration of the tissue thromboplastin and heparin-like substance to a blood clotting time of 60 to 700 seconds as recited in the instant claim to achieve the desired prolongation of coagulation time (see MPEP 2144.05 II. Routine Optimization).
Regarding claim 8, Kraus discloses the invention of claim 1, however, Kraus fails to disclose “wherein a final concentration of thrombomodulin is from 9nM to 200 nM” as recited in the instant claim.
However, MPEP 2144.05 II. B. “There Must Be an Articulated Rationale Supporting the Rejection”, defines a result-effective variable which achieves a recognized result, wherein determination of the optical or workable ranges of said variable would be considered routine optimization and thus an obvious finding. In this instance, the final concentration of thrombomodulin has a recognized result on coagulation time (see [0053]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the final concentration of thrombomodulin to a final concentration of 9nM to 200 nM as recited in the instant claim to achieve the desired coagulation time of the test assay (see MPEP 2144.05 II. Routine Optimization).
Claims 5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2002/0019021 to Kraus as cited on the 26 September 2023 IDS in view of United States Patent Application Publication US 2019/0004031 to Hosokawa et al. (herein Hosokawa) as cited on the 26 September 2023 IDS.
Regarding claim 5, Kraus discloses the invention of claim 1, however, fails to disclose “[the] method … further comprising adding a contact factor inhibitor” as recited in the instant claim.
Hosokawa discloses a method for analyzing thrombogenic capacity or blood coagulation capacity, the method comprising adding calcium, a blood coagulation factor XII (FXII) inhibitor, and a kallikrein inhibitor to blood collected tube containing sodium citrate; to allow initiation of blood coagulation reaction and wherein heparin, heparin sulfate, and tissue factor are further added to the blood and thrombogenic capacity or blood coagulation capacity is analyzed (see abstract).
Hosokawa and Kraus are analogous in the field of analyzing blood coagulation. Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date to add FXII and/or Kallikrein (i.e., contact factor inhibitor) for the benefit of maintaining platelet function in good condition (see [0022] of Hosokawa).
Regarding claim 10, Kraus discloses the invention of claim 1 and discloses blood coagulation is evaluated by adding calcium, the extrinsic blood coagulation activator, the thrombomodulin, and the heparin-like substance (see [0031-0040], [0056]).
Kraus fails to disclose “wherein the blood sample is subjected to anticoagulation treatment with citric acid” as recited in the instant claim.
Hosokawa discloses a method for analyzing thrombogenic capacity or blood coagulation capacity (see abstract), wherein the blood collection tube comprises citric acid (see [0012]).
Hosokawa and Kraus are analogous in the field of analyzing blood coagulation. Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date to subject the blood sample to anticoagulation treatment with citric acid for the benefit of a more sensitive blood coagulation test (see [0012] of Hosokawa).
Regarding claims 11-12, Kraus discloses the invention of claim 1, however, fails to disclose “wherein a contact factor inhibitor is further added to the blood sample” as recited in the instant claim.
Hosokawa discloses a method for analyzing thrombogenic capacity or blood coagulation capacity, the method comprising adding calcium, a blood coagulation factor XII (FXII) inhibitor, and a kallikrein inhibitor to blood collected tube containing sodium citrate; to allow initiation of blood coagulation reaction and wherein heparin, heparin sulfate, and tissue factor are further added to the blood and thrombogenic capacity or blood coagulation capacity is analyzed (see abstract).
Hosokawa and Kraus are analogous in the field of analyzing blood coagulation. Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date to add FXII and/or Kallikrein (i.e., contact factor inhibitor) to the blood sample for the benefit of maintaining platelet function in good condition (see [0022] of Hosokawa).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797