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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 August 2026 has been entered.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6, 7, 14, 16, 23 and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mae (US 7,507,387).
Regarding claim 1, Mae discloses a helical mixer assembly comprising: an inlet assembly having a blood sample inlet (25 and/or 26) and a liquid reagent inlet (27 and/or 28), the inlet assembly being configured to receive a blood sample via the blood sample inlet and a liquid reagent via the liquid reagent inlet; and a helical mixer having an outlet (32 and/or 34) configured to output a mixture of the blood sample and the liquid reagent; a helical flow path (22 or a subportion thereof) extending between the inlet assembly and the outlet and including a series of windings, wherein the helical mixer is configured to mix the blood sample with the liquid reagent to thereby create a mixed blood sample, wherein the helical mixer is closed between the inlet assembly and the outlet (see Fig. 1); and a temperature controlling element (40,44) having a winding of the series of windings revolved therearound.
Regarding claim 3, the helical mixer is configured to receive the blood sample having a volume in a range from 1 µl to 60 µl (see col. 11, lines 30-35).
Regarding claim 6, the helical flow path has a same diameter along an entire length of the helical flow path (see Fig. 1).
Regarding claim 7, the helical mixer comprises a tube forming the helical flow path, wherein the tube is made of a polymer material (see “resin material such as fluorine resin and acrylic resin” at col. 5, line 62).
Regarding claim 14, the helical mixer is configured to not activate platelets and/or white blood cells in the blood sample (see col. 5, lines 60-65).
Regarding claim 16, the helical mixer is configured for microfluidics (see col. 1, lines 15-34 and col. 12, lines 32-35).
Regarding claim 23, Mae discloses a helical mixer assembly comprising a helical mixer having an inlet (the space where 22A and 22B connect in the embodiment of Fig. 7) configured to receive a blood sample and a liquid reagent at an inlet mass flow rate; an outlet (32) configured to output a mixture of the blood sample and the liquid reagent at the inlet mass flow rate; a helical flow path (22A) extending between the inlet and the outlet, wherein the helical mixer is configured to mix the blood sample with the liquid reagent to thereby create a mixed blood sample at a mix rate of the inlet mass flow rate; and a temperature controlling element (40,44) having the helical flow path revolved therearound; and at least one incubator (22B) positioned along at least one of the inlet or the outlet.
Regarding claim 26, the temperature controlling element being configured to cool the helical flow path (see Fig. 1).
Regarding claim 27, the temperature controlling element is configured to cool the helical flow path (see Fig. 1).
Regarding claim 28, the at least one incubator is capable of being used in the claimed manner, the temperature being a matter of a use depending on temperature of the fluids fed to jackets (36, 38) as well as the other passages, and the flow rates.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Gordon (US 2021/0062801).
Regarding claim 25, Gordon discloses a helical mixer assembly comprising a helical mixer comprising: an inlet (from 335) configured to receive a blood sample and a liquid reagent; an outlet (to 360) configured to output a mixture of the blood sample and the liquid reagent; a helical flow path (410) extending between the inlet and the outlet, wherein the helical mixer is configured to mix the blood sample with the liquid reagent to thereby create a mixed blood sample, wherein the helical mixer is closed between the inlet and the outlet; and a flow direction mechanism including a peristaltic pump (350), wherein the flow direction mechanism is configured to change a flow direction of the helical mixer to thereby change a direction of the mixed blood sample from a first direction to a second direction opposite of the first direction (see [0020]).
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.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387). The helical mixer assembly of Mae was discussed above:
Regarding claim 2, the diameter values in col. 11 line 22 and col. 12 lines 34 to 35 would have suggested a value in the claimed range to one of ordinary skill in the art before the effective filing date.
Regarding claim 4, while it is not expressly stated that the path has a circular cross section, the references to “circle-equivalent” and illustration of circular cross sections in Figs. 2 and 3, would have suggested a circular cross section to one of ordinary skill in the art before the effective filing date.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387) in view of Kingsford (US 2007/0019503). The helical mixer assembly of Mae was discussed above. Mae does not disclose the polymer being a fluorinated ethylene propylene. Kingsford teaches the polymeric material being a fluorinated ethylene propylene (see [0055]). Kingsford teaches making a helical mixer of polymeric fluorinated ethylene propylene and explains that the benefit of resisting corrosion is realized (see [0054] and [0055]). It would have been obvious for one of ordinary skill in the art before the effective filing date to have made the mixer of a polymeric fluorinated ethylene propylene to resist corrosion as taught by Kingsford, especially considering that Mae suggests fluorinated resins in col. 5, line 62.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387) in view of Lederer (US 3,838,719). The helical mixer assembly of Mae was discussed above. A peristaltic pump, which is the corresponding structure to the flow direction mechanism according the specification, is not disclosed. Lederer (US 3,838,719) a peristaltic pump and explains the flow reversing aspect (see col. 7 line 58 to col. 8 line 11). It would have been obvious for one of ordinary skill in the art before the effective filing date to have provided a peristaltic pump to control flow.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387) in view of Bocksruker (US 4,246,871). The helical mixer assembly of Mae was discussed above. Conductive paste is not disclosed. Bocksruker teaches a conductive paste (34) that contacts the temperature controlling element to thereby distribute heat between the helical flow path and the temperature controlling element. It would have been obvious to one of ordinary skill in the art before the effective filing date to have utilized a conductive paste as taught by Bocksruker to improve a flow of heat.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387) in view of Lederer (US 3,838,719). The helical mixer assembly of Mae was discussed above. A peristaltic pump, which is the corresponding structure to the flow direction mechanism according the specification, is not disclosed. Lederer (US 3,838,719) a peristaltic pump and explains the flow reversing aspect (see col. 7 line 58 to col. 8 line 11). It would have been obvious for one of ordinary skill in the art before the effective filing date to have provided a peristaltic pump to control flow.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 2021/0062801) in view of Hvidtfeldt (US 2003/0029254). The helical mixer assembly of Gordon was discussed above. A blood gas sensor is not disclosed. Hvidtfeldt teaches a blood gas sensor (see [0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have included a blood gas sensor as taught by Hvidtfeldt because Gordon explains that the assembly should be used for processing biological material (see [0002]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Mae (US 7,507,387) in view of Lederer (US 3,838,719) as applied to claim 25 above, and further in view of Hvidtfeldt (US 2003/0029254). A blood gas sensor is not disclosed. Hvidtfeldt teaches a blood gas sensor (see [0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have included a blood gas sensor as taught by Hvidtfeldt because Mae explains that the assembly should be used in pharmaceutical industry (see col. 1, line 9).
Response to Arguments
Applicant’s arguments are moot due to the new grounds for rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID L SORKIN whose telephone number is (571)272-1148. The examiner can normally be reached 7am-3:30pm.
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DAVID L. SORKIN
Examiner
Art Unit 1774
/DAVID L SORKIN/Primary Examiner, Art Unit 1774
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