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 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues:
At p. 6 para 5 to p. 8 para 6 regarding the combination of Moll and Ymeti.
Examiner response:
The examiner respectfully disagrees. In this office action, the examiner uses Ymeti as the primary reference, which has the interferometric sensing device. The CPH holder of Ymeti represents the cartridge which holds the sensing device. The examiner applies the teaching of Moll to explicitly disclose a cartridge housing with a reasonable motivation, which is to properly align and secure the cartridge in the optical system. See rejection below.
With the reasons above. Ymeti is proper to combine with Moll.
Applicant argues:
At p. 8 last para to p. 10 para 4 regarding the teaching of Shastry.
Examiner response:
The examiner respectfully disagrees. Fig. 8F of the instant application shows the other elements integrated into the cartridge. This means all these elements are an extension of the cartridge which has its own function to allow proper sensing of the sample in the optical measurement.
Thus, the reference of Shastry is a general teaching approach and proper to combine with Ymeti and Moll.
Applicant argues:
At p. 10 para 8 to p. 11 last para regarding the teaching of Dykes.
Examiner response:
The examiner respectfully disagrees. Again, similar to Shastry's arguments above, the teaching of Dykes is a general teaching approach and proper to combine with Ymeti and Moll.
Applicant argues:
At p. 12 para 3 to p. 13 para 4 regarding Martin.
Examiner response:
Again, examiner respectfully disagrees. The electronic communication means is an extension device attached to the cartridge. Therefore, this is a general teaching approach and appropriate to combine with Ymeti and Moll.
Applicant argues:
At p. 13 para 7 to p. 14 para 6 regarding the teaching of Saulenas.
Examiner response:
The examiner respectfully disagrees. Like in Martin above, the polytetrafluoroethylene is an additional element in the cartridge, thus it is proper to combine with the references in claim 1.
Applicant argues:
At p. 14 last para to p. 16 last para regarding the teaching of Taurino.
Examiner response:
The examiner respectfully disagrees. Similar to Shastry, a metal coil wrapped around the mixing bladder is another additional element in the cartridge. Therefore, Taurino is appropriate to combine with the references in claim 1.
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 Ymeti, A. et al., US 20120214707 A1 (hereinafter Ymeti) and in view of Moll, K. et al., US 9658222 B2 (hereinafter Moll).
Regarding claim 1, Ymeti 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 comprising: a housing (this is the CPH as shown in fig. 10B; para [0141] lines 1-6; the holder is the housing which holds the sensing chip); “an interferometric chip positioned below a flow cell wafer, the interferometric chip including one or more waveguide channels having a sensing layer thereon” (this is shown in fig. 5, para [0077]), the sensing layer adapted to selectively bind or otherwise be selectively disturbed by one or more analytes within a test sample composition (this is shown in fig. 2A-E); the flow cell wafer positioned above the interferometric chip and including at least one detection microchannel aligned with the one or more waveguide channels such that the test sample composition flows across the sensing layer (this is shown in figs. 6-7); and “an alignment means configured to, upon insertion of the holder system into a holder recess of an optical assembly unit” (this is the opening of the POD where the CPH is placed as shown in fig. 11), “automatically and without user adjustment simultaneously provide optical alignment of the interferometric chip with an optical detection path and microfluidic alignment of the flow cell wafer with a fluidic interface” (this is shown in figs.9 and 11, the LOC/CPH is inserted in the POD, this means the POD “automatically and without user adjustment simultaneously provide optical alignment of the interferometric chip with an optical detection path and microfluidic alignment of the flow cell wafer with a fluidic interface”; para [0139] lines 1-8; para [0144] lines 1-11), “wherein the interferometric chip is configured to detect the one or more analytes based on a phase shift in an interference pattern resulting from a refractive index change at the sensing layer” (p. 7 col 2 lines 3-7), and wherein the interferometric chip and flow cell wafer are contained within the housing (this is the CPH as shown in fig. 10B; para [0141] lines 1-6; the holder is the housing which holds the sensing chip).
Ymeti does not explicitly teach a cartridge housing.
Moll, from the same field of endeavor as Ymeti, teaches a cartridge housing (fig. 84 col 64 lines 24-27).
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 Moll to Ymeti to have a cartridge housing in order to protect the elements inside the housing (fig. 84 col 64 lines 24-27).
Regarding claim 2, Ymeti does not teach 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. Regarding claim 3, Ymeti does not teach 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.
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), 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).
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 Moll to Ymeti to have 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 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 in order to properly align and secure the cartridge in the optical system.
Regarding claim 5, Ymeti 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).
Regarding claim 10, Ymeti does not teach the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing comprises: a top portion; a bottom portion; 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.
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).
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 Moll to Ymeti to have the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge housing comprises: a top portion; a bottom portion; 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 in order to hold and secure the chip during measurement.
Regarding claim 16, Ymeti 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).
Regarding claim 17, Ymeti 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).
Regarding claim 18, Ymeti 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).
Regarding claim 19, Ymeti teaches the optical waveguide interferometer cartridge system of claim 1, wherein the cartridge system is adapted for multiplex testing (para [0141] lines 24-29).
Regarding claim 21, Ymeti does not teach 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.
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).
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 Moll to Ymeti to have 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 in order to hold and secure the chip during measurement.
Regarding claim 24, Ymeti does not teach 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”.
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).
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 Moll to Ymeti to have “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” in order to properly align and secure the cartridge in the optical system.
Regarding claim 26, Ymeti does not teach 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.
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).
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 Moll to Ymeti to have 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 in order to perform optical measurement and detect analytes in the sample.
Claim(s) 7, 9, 20, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ymeti and Moll, 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 Ymeti 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 Ymeti, 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 Ymeti 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 Ymeti 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 Ymeti, 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 Ymeti 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 Ymeti 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 Ymeti, 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 Ymeti 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 after measurement (para [0183] lines 1-4).
Regarding claim 27, the modified device of Ymeti 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 Ymeti, 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 Ymeti 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 Ymeti, Moll, 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, Ymeti, when modified by Moll 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 Ymeti, 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 Ymeti, when modified by Moll 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 Ymeti and Moll, 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 Ymeti 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 Ymeti, 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 Ymeti 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 Ymeti and Moll, 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 Ymeti 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 Ymeti, 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 Ymeti 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 Ymeti and Moll, 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 Ymeti 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 Ymeti, 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 Ymeti 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERTO FABIAN JR whose telephone number is (571)272-3632. The examiner can normally be reached M-F (8-12, 1-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KARA GEISEL can be reached at (571)272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERTO FABIAN JR/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877
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