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 filed February 10, 2026 have been fully considered but they are not persuasive. Applicant has argued that the combination of Hoke et al., in view of Curran et al., do not meet the claim limitations. The Examiner respectfully disagrees.
Applicant has pointed to paragraph 0070 of Curran et al., and argued that the reference requires blood samples that do not contain an anticoagulant. After reviewing paragraph 0070 of Curran et al., the Examiner notes that the “blood not containing an anti-coagulant” is an alternative and not a required sample. Paragraph 0070 states that the sample can also be whole blood, serum plasma, fresh blood, urine, and saliva. As such, Applicant’s argument that reference to Curran et al., requires a blood sample that does not contain an anticoagulant is not persuasive.
Applicant has also argued that reference to Curran et al., does not teach the same blood sample being used for all the test recited in the claim. The Examiner notes that Applicant’s arguments are not commensurate with the scope of the claims as independent claim 30 does not recite a single blood sample being utilized for a plurality of tests. Furthermore, the Examiner notes that a single blood sample can be utilized for multiple tests, thus Applicant’s arguments again are not persuasive. Therefore, in light of the teachings of the prior art, and the arguments presented here, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the claims are not in condition for allowance.
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.
Claim(s) 5, 6, 18-20, 24, 25, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke et al., (WO 2013/116702) in view of Curran et al., (US 2016/0003819).
Regarding claims 30 and 31, Hoke et al., teach a sample collection device with blood stabilizing agents comprising a test tube, capillary tube, or syringe (sample container, paragraphs (0023, 0024) containing heparin and iloprost (anticoagulant and anti-platelet agent, (paragraphs 0032-0034), and mixing the blood sample with the reagents in the tube (blood sample preparation, paragraph 0026). The Examiner notes that by introducing the blood sample into the container, the blood is mixed with the reagents in the container. Hoke et al., also teach a method of measuring a parameter of blood comprising collecting whole blood or plasma in a container comprising an anticoagulant and a antiplatelet agent wherein the blood parameter is measured at a time subsequent to collecting the sample (paragraph 0010) wherein the parameter may be a platelet count (paragraph 0064). Hoke et al., do not teach determining blood gas parameters, basic metabolic panel, and a platelet count.
Curran et al., teach a rapid test device wherein the device can be utilized to perform a metabolic panel, blood gas, (paragraph 0102) and a platelet count (paragraph 0104). Curran et al., also teach the metabolic panel including measurements of sodium, potassium, and glucose (paragraph 0102). Curran et al., teach that it is advantageous to perform a metabolic panel, blood gas, and platelet count as a means of providing full panels of clinical chemistry and hematology without the need to send samples to a central lab for testing (paragraph 0109).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Hoke et al., wherein a metabolic panel, blood gas, and platelet count are measured in order to provide a full panel of clinical chemistry and hematology without sending the sample to a central lab as taught by Curran et al.
Regarding claims 5 and 6, Hoke et al., teach iloprost as the prostaglandin analog (paragraph 0034).
Regarding claims 18 and 24, Hoke et al., teach containers having a volume of 250 µl to 10 ml (paragraph 0030).
Regarding claims 19 and 20, Hoke et al., teach iloprost as the prostaglandin analog (paragraph 0034).
Claim(s) 21-23 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke et al., (WO 2013/116702) in view of Curran et al., (US 2016/0003819) as applied to claims 30 and 31 above, and further in view of Stocker et al., (US 5,187,102).
Regarding claims 21 and 23, Hoke et al., in view of Curran et al., do not teach a wall coating matrix on an internal surface for releasing heparin.
Stocker et al., teach inhibitors for anticoagulant pretreatment of blood samples wherein receptacles for collecting blood samples are coated with an anticoagulant (column 5 lines 4-12, Column 6 lines 46-53). Stocker et al., teach that it is advantageous to coat a container with an anticoagulant solution as a means of preventing microbial contamination of the anticoagulant solution (column 3 lines 19-27).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Hoke et al., in view of Curran et al., wherein a sample container is coated with an anticoagulant solution in order to prevent microbial contamination of the anticoagulant solution as taught by Stocker et al
Regarding claims 22 and 26, Hoke et al., in view of Curran et al., do not teach a sample without EDTA or citrate.
Stocker et al., teach the addition of citrate salts as anticoagulants leads to formation of insoluble calcium salts thereby reducing accuracy of results (column 3 lines 50-57). Stocker et al., also teach that EDTA is inadequate for anticoagulant pretreatment of blood samples (column 4 lines 18-22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hoke et al., in view of Curran et al., wherein EDTA or citrate salts are not mixed with the blood sample in order to prevent reduced platelet adhesivity and the formation of insoluble calcium salts as taught by Stocker et al.
Conclusion
THIS ACTION IS MADE FINAL. 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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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