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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/05/2025 has been entered.
Response to Arguments
Applicant argues that Ymeti does not disclose a “cartridge system adapted for multiplex testing adapted for handling multiple analytes”. The examiner respectfully disagrees. See claim 19 rejection.
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.
Claim(s) 1, 2, 3, 5, 10, 16, 17, 18, 19, 21, 24, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll, K. et al., US 9658222 B2 (hereinafter Moll) and in view of Ymeti, A. et al., US 20120214707 A1 (hereinafter Ymeti).
Regarding claim 1, Moll teaches an optical waveguide interferometer cartridge system for use within a portable interferometric system, the cartridge system adapted to be inserted in an opening of a housing unit of the interferometric system and removed after one or more uses, the cartridge system (fig. 10 is the cartridge system, col 16 lines 14-27) comprising: a cartridge housing (fig. elements 310 and 312 form the housing as shown in fig. 3); an chip (fig. 52 element 10305, col 21 lines 45-47) positioned below a flow cell wafer (this is gasket 10605 with multiple channels, col 24 lines 1-2, col 24 lines 24-27), the chip including one or more waveguide channels (fig. 52 element 10305, col 21 lines 45-47) having “a sensing layer thereon, the sensing layer adapted to selectively bind or otherwise be selectively disturbed by one or more analytes within a test sample composition” (col 24 lines 19-23); and “an alignment means configured to, upon insertion of the cartridge system into a cartridge recess of an optical assembly unit” (the alignment means is element 150 in fig. 1, col 13 lines 51-53), “simultaneously provide optical and microfluidic alignment of the chip and flow cell wafer” (this is shown in fig. 2, element 102 provides simultaneously provide optical and microfluidic alignment of the chip and flow cell wafer, col 13 lines 41-44); wherein the chip and flow cell wafer are contained within the cartridge housing (this is shown in fig. 10).
Moll fails to teach an interferometric chip.
Ymeti, from the same field of endeavor as Moll, teaches an interferometric chip (fig. 1(a), para [0085] 1-9; note that this proper to combine with Moll. Moll flow cell can have multiple channels, one channel for the sample region the other for the reference region).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have an interferometric chip in order to improve the analyte detection (para [0003]).
Regarding claim 2, Moll teaches the optical waveguide interferometer cartridge system of claim 1, wherein the alignment means includes at least one rail portion on a bottom surface of the cartridge housing (the rail corresponds to the space inside the door 1252 where the cartridge is in place, fig. 14 col 19 lines 16-26).
Regarding claim 3, Moll teaches the optical waveguide interferometer cartridge system of claim 2, wherein the at least one rail portion is adapted to engage at least one male key portion on the cartridge housing (the examiner interprets this limitation based of para [00115] of the specification last sentence, wherein the engagement will properly secure the cartridge in the optical system; Moll teaches this limitation, fig. 13 element 1258, col 21 lines 4-15).
Regarding claim 5, Moll does not teach the optical waveguide interferometer cartridge system of claim 1, wherein the waveguide channel is shaped in a serpentine configuration.
Ymeti, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the at least one detection microchannel waveguide channel is shaped in a serpentine configuration (Figs. 3 and 4 shows the channels have serpentine configuration).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the waveguide channel is shaped in a serpentine configuration in order to further improve the accuracy of the signal for the specific binding (para [0106] second to the last sentence).
Regarding claim 10, Moll teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing (fig. 10) comprises: a top portion (fig. 10 element 310, col 15 lines 50-55); a bottom portion (fig. 10 element 312, col 15 lines 50-55); and “a surface defining a through hole on at least one external surface of either the top portion or bottom portion, the through hole adapted to receive at least one fastening means or heat stake for securing the top portion and bottom portion together” (elements 310 and 312 match to form the housing; col 15 lines 50-55).
Regarding claim 16, Moll does not teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for single test composition testing use only.
Ymeti, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for single test composition testing use only (para [0141] last sentence).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for single test composition testing use only in order to prevent cross contamination.
Regarding claim 17, Moll does not teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiple test composition use only.
Ymeti, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiple test composition use only (para [0141] last sentence).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiple test composition use only in order to minimize costs (para [0141] last sentence).
Regarding claim 18, Moll does not teach the optical waveguide interferometer cartridge system of claim 17, wherein the cartridge system includes an external pump.
Ymeti, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 17, wherein the cartridge system includes an external pump (para [0147] col 2 lines 19-25).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have the optical waveguide interferometer cartridge system of claim 17, wherein the cartridge system includes an external pump in order to transport the fluid to the sensing region (para [00138] lines 29-33).
Regarding claim 19, Moll does not teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiplex testing.
Ymeti, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiplex testing (para [0141] lines 24-29).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Ymeti to Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiplex testing in order to detect multiple analytes simultaneously (para [0141] lines 24-29).
Regarding claim 21, Moll teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing comprises a top portion and a bottom portion, the top portion joined to the bottom portion by heat stake posts (elements 310 and 312 in fig. 10 can be welded; col 15 lines 50-53).
Regarding claim 24, Moll teaches the optical waveguide interferometer cartridge system of claim 1, “wherein the cartridge housing comprises at least one male key portion on a bottom surface adapted to engage a corresponding rail portion in the optical assembly unit” (fig. 13 element 1254 keeps element 300 in place, col 19 lines 32-41).
Regarding claim 26, Moll teaches the optical waveguide interferometer cartridge system of claim 1, further comprising a light inlet slot defined in the bottom surface of the cartridge housing, wherein the slot is configured to allow light to enter the interferometric chip (fig. 2 shows element 120 brings light to waveguide 121, col 14 lines 7-14).
Claim(s) 7, 9, 20, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll and Ymeti, as applied to claim(s) 1, and further in view of Shastry, A. et al., US 20190187162 A1 (hereinafter Shastry).
Regarding claim 7, the modified device of Moll fails to teach the optical waveguide interferometer cartridge system of claim 1, further comprising at least one mixing bladder, the mixing bladder positioned upstream of the flow cell wafer and configured to aid in mixing buffer and test sample to form the test sample composition.
Shastry, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, further comprising at least one mixing bladder, the mixing bladder positioned upstream of the flow cell wafer and configured to aid in mixing buffer and test sample to form the test sample composition (fig. 4 and fig. 7 element 103, para [0159] lines 1-4; element 103 is positioned upstream with respect to the chip channel 109 as shown in fig. 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Shastry to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, further comprising at least one mixing bladder, the mixing bladder positioned upstream of the flow cell wafer and configured to aid in mixing buffer and test sample to form the test sample composition in order to achieve uniform distribution of reagents within the sample (para [0162]).
Regarding claim 9, the modified device of Moll fails to teach the optical waveguide interferometer cartridge system of claim 1, further comprising at least one pump adapted to control test composition movement throughout a microfluidic system located within the cartridge system.
Shastry, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, further comprising at least one pump adapted to control test composition movement throughout a microfluidic system located within the cartridge system (fig. 7 pump 400, para [0154] lines 1-4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Shastry to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, further comprising at least one pump adapted to control test composition movement throughout a microfluidic system located within the cartridge system in order to transport the fluid through the fluid channels (para [0154] lines 1-4).
Regarding claim 20, the modified device of Moll does not teach the optical waveguide interferometer cartridge system of claim 1, adapted for containment of the test sample composition for disposal.
Shastry, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, adapted for containment of the test sample composition for disposal (fig. 7 waste well 207, para [0183] lines 1-4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Shastry to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, adapted for containment of the test sample composition for disposal in order to contain the fluid afte measurement (para [0183] lines 1-4).
Regarding claim 27, the modified device of Moll does teach the optical waveguide interferometer cartridge system of claim 1, further comprising a micropump adapted to manipulate movement of the test sample composition throughout the cartridge system.
Shastry, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, further comprising a micropump adapted to manipulate movement of the test sample composition throughout the cartridge system (fig. 7 pump 400, para [0154] lines 1-4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Shastry to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, further comprising a micropump adapted to manipulate movement of the test sample composition throughout the cartridge system in order to transport the fluid through the fluid channels (para [0154] lines 1-4).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll and Ymeti, and Shastry as applied to claim(s) 7, and further in view of Dykes, C. et al., US 20140170667 A1 (hereinafter Dykes).
Regarding claim 8, Moll, when modified by Ymeti and Shastry, fails to teach the optical waveguide interferometer cartridge system of claim 7, wherein the mixing bladder includes a temperature control means to control humidity and test sample composition temperature within the interferometric system.
Dykes, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 7, wherein the mixing bladder includes a temperature control means to control humidity and test sample composition temperature within the interferometric system (para [0139] lines 7-13, para [0146] lines 5-8; humidity depends on temperature; this is a general teaching).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Dykes to Moll, when modified by Ymeti and Shastry, to have encourage binding of one or more particles with target contained in the sample (para [0139] lines 7-13).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll and Ymeti, as applied to claim(s) 1, and further in view of Martin, R. et al., US7508622B2 (hereinafter Martin).
Regarding claim 22, the modified device of Moll does teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes an electronic communication means comprising a plurality of metal contacts located on an external surface of the cartridge housing.
Martin, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes an electronic communication means comprising a plurality of metal contacts located on an external surface of the cartridge housing (fig. 3 element 116, col 7 lines 36-39; this is a general teaching).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Martin to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes an electronic communication means comprising a plurality of metal contacts located on an external surface of the cartridge housing in order to access the non-tape storage medium (Abstract lines 2-5).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll and Ymeti, as applied to claim(s) 1, and further in view of Saulenas, W. et al., US 20140378939 A1 (hereinafter Saulenas).
Regarding claim 23, the modified device of Moll does teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes at least one vent port covered by a vent cover made from expanded polytetrafluoroethylene.
Saulenas, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes at least one vent port (para [0039] lines 1-9) covered by a vent cover made from expanded polytetrafluoroethylene (para [0042] lines 1-10).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Saulenas to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing includes at least one vent port (para [0039] lines 1-9) covered by a vent cover made from expanded polytetrafluoroethylene in order to have a cover material that are porous plastics and that are compatible with sterilization process (para [0042] lines 1-10).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll and Ymeti, as applied to claim(s) 1, and further in view of Taurino, W. et al., WO 2019238704 A1 (hereinafter Taurino).
Regarding claim 25, the modified device of Moll does teach the optical waveguide interferometer cartridge system of claim 1, further comprising a mixing bladder including a temperature control means in the form of a metal coil wrapped around the mixing bladder.
Taurino, from the same field of endeavor as Moll, teaches the optical waveguide interferometer cartridge system of claim 1, further comprising a mixing bladder including a temperature control means in the form of a metal coil wrapped around the mixing bladder (fig. 1 elements 126 and 128, p. 10 last para lines 1-2; p. 9 para 15 last sentence).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Taurino to the modified device of Moll to have the optical waveguide interferometer cartridge system of claim 1, further comprising a mixing bladder including a temperature control means in the form of a metal coil wrapped around the mixing bladder in order to heat the mix chamber (p. 2 para 1 lines 4-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERTO FABIAN JR whose telephone number is (571)272-3632. The examiner can normally be reached M-F (8-12, 1-5).
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/ROBERTO FABIAN JR/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877