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 .
This is an FINAL REJECTION in response to applicant’s claim amendments and arguments filed 5/7/2025. Claims 1 and 18 are currently amended. Claims 10-17 were previously withdrawn without traverse from consideration pursuant the response to restriction filed on October 15, 2024. Claims 1-20 are pending review in this correspondence.
Response to Amendment
Rejection of claims 1-9 and 18-20 as being unpatentable over Bransky et al (US 2014/0033809 A1) in view of Petersen et al (US 2002/0042125 A1) is withdrawn in view of applicant’s amendments to claims 1 and 18.
Rejection of claim 4 as being unpatentable over Bransky et al (US 2014/0033809 A1) and Petersen et al (US 2002/0042125 A1) in view of Shi et al (US 2016/0361715 A1) is withdrawn in view of applicant’s amendments to claim 1.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-3, 6, 8, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al (US 2002/0185183 A1).
With respect to claim 1, O’Connor discloses a cartridge device for measuring at least one item in a sample, the at least one item being selected from the group consisting of an analyte and a target particle in a sample, the cartridge device comprising:
a first reagent chamber (722A, See Figs. 7A-B) configured for accommodating a first reagent (See Paras. 0079-0082);
a mixing chamber (functional feature 710A-N, See Fig. 7A) configured for mixing at least a portion of the sample with at least a portion of the first reagent to form a first sample mixture (See Para. 0079 for discussion of how the functional feature can be a mixer); and
the cartridge device further comprises a second reagent chamber (722N, See Figs. 2A-B) configured for accommodating a second reagent (See Paras. 0079-0082).
The embodiment depicted by Figs. 7A-B of O’Connor fails to disclose a first detection area comprising an optically transparent area, the first detection area being configured for measuring the analyte in the first sample mixture; and
a second detection area comprising a flow cell, the flow cell being configured for forming a sample stream of at least a portion of the first sample mixture and the second detection area being configured for measuring the target particle in the first sample mixture; wherein
the cartridge device is configured for forming a second sample mixture comprising at least a portion of the first sample mixture and the second reagent in the mixing chamber; and further wherein
the cartridge device is configured for measuring either a second analyte from the second sample mixture in the first detection area or a second target particle from the second sample mixture in the second detection area.
Figs. 6A-D of O’Connor depicts the specifics of a microfluidic separation device, wherein a sample is injected into separation channels 45A-45N and then eight solvent mixture substreams are then injected through vias 54 and 58 into the separation channels 45A-45N (See Para. 0071). The sample and solvent mixture continue downstream through vias (60) to optical detection windows (32A; this optical window is being interpreted as the recited optical detection area; Para. 0067 discusses how the windows facilitate optical detection using an optical detector such as a conventional UV-VIS detector). Output channel segment 70N in combination with optical window 32N is being interpreted as the recited second detection area comprising a flow cell (See Para. 0067 and Fig. 6B). These segments direct fluid to fluidic port 30 that is used (1) during the packing process to exhaust solvent from the device, and (2) during operation of the separation device to exit mobile phase solvent and sample from the device following separation (See Para. 0067). It should further be noted that Para. 0049 discusses how independent outputs allow products of the operation(s) to be analyzed, collected, disposed of, or transferred to other functional features, laboratory instruments, or other desirable locations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the first through sixth layers of the microfluidic separation device embodied by Fig. 6A of O’Connor into the microfluid device embodied by Figs. 7A-B of O’Connor such that the combined sample and solvent mixture can be subject to optical detection and then discharged via independent outputs to allow products of the mixture(s) to be analyzed, collected, disposed of, or transferred to other functional features, laboratory instruments, or other desirable locations (See Paras. 0049 and 0067 of O’Connor).
Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by O’Connor and the apparatus of O’Connor is capable of the recitation of claim 1. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of O’Connor (see MPEP §2114).
With respect to claim 2, O’Connor teaches that the flow cell comprises an optically transparent area configured for measuring an optical signal from a target particle in a sample stream (Output channel segment 70N in combination with optical window 32N is being interpreted as the recited second detection area comprising a flow cell, See Para. 0067 and Fig. 6B).
With respect to claim 3, O’Connor teaches a collecting channel configured for collecting a predetermined volume of the sample (See Para. 0080 for discussion of how the fluid samples are supplied to the device 700 through input ports 715A-N, and then travels through the input vias 716B-N; input vias 716B-N are being interpreted as the collecting channel).
With respect to claim 6, It should further be noted that neither the “first reagent” or the “second reagent” recited in claim 1 has not been positively recited. Claim 1 states that each of the first reagent chamber and the second reagent chamber are for accommodating first and second reagents, respectively, and therefore, each of the reagent chambers only needs to be capable of holding a fluorescent staining agent that selectively stains the target particle.
With respect to claim 8, It should further be noted that neither the “first reagent” or the “second reagent” recited in claim 1 has not been positively recited. Claim 1 states that each of the first reagent chamber and the second reagent chamber are for accommodating first and second reagents, respectively, and therefore, each of the reagent chambers only needs to be capable of holding a hemolytic agent that lyses erythrocytes.
With respect to claim 18, O’Connor teaches a cartridge device for measuring at least one item in a sample, the at least one item being selected from the group consisting of an analyte and a target particle in a sample, the cartridge device comprising:
a reagent chamber (722A, See Figs. 7A-B) configured for accommodating a reagent (See Paras. 0079-0082); and
a mixing chamber (functional feature 710A-N, See Fig. 7A) configured for mixing at least a portion of the sample with at least a portion of the reagent to form a first sample mixture (See Para. 0079 for discussion of how the functional feature can be a mixer).
While the embodiment depicted by Figs. 7A-B of O’Connor does disclose the incorporation of an additional reagent chamber (722N, See Figs. 2A-B) configured for accommodating a second reagent (See Paras. 0079-0082), this embodiment fails to disclose a first detection area comprising an optically transparent area, wherein the first detection area is configured for measuring the analyte in the first sample mixture; and
a second detection area comprising a flow cell, wherein the flow cell is configured for forming a sample stream of at least a portion of the first sample mixture and the second detection area is configured for measuring the target particle in the first sample mixture;
wherein:
the reagent comprises a hemolytic agent that lyses erythrocytes; and
the cartridge device is configured for forming a second sample mixture comprising at least a portion of the first sample mixture and a second reagent in the mixing chamber.
Figs. 6A-D of O’Connor depicts the specifics of a microfluidic separation device, wherein a sample is injected into separation channels 45A-45N and then eight solvent mixture substreams are then injected through vias 54 and 58 into the separation channels 45A-45N (See Para. 0071). The sample and solvent mixture continue downstream through vias (60) to optical detection windows (32A; this optical window is being interpreted as the recited optical detection area; Para. 0067 discusses how the windows facilitate optical detection using an optical detector such as a conventional UV-VIS detector). Output channel segment 70N in combination with optical window 32N is being interpreted as the recited second detection area comprising a flow cell (See Para. 0067 and Fig. 6B. These segments direct fluid to fluidic port 30 that is used (1) during the packing process to exhaust solvent from the device, and (2) during operation of the separation device to exit mobile phase solvent and sample from the device following separation (See Para. 0067). It should further be noted that Para. 0049 discusses how independent outputs allow products of the operation(s) to be analyzed, collected, disposed of, or transferred to other functional features, laboratory instruments, or other desirable locations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the first through sixth layers of the microfluidic separation device embodied by Figs. 6A-B of O’Connor into the microfluid device embodied by Figs. 7A-B of O’Connor such that the combined sample and solvent mixture can be subject to optical detection and then discharged via independent outputs to allow products of the mixture(s) to be analyzed, collected, disposed of, or transferred to other functional features, laboratory instruments, or other desirable locations (See Paras. 0049 and 0067 of O’Connor).
With respect to the limitation that “the reagent comprises a hemolytic agent that lyses erythrocytes”, it should be noted that the reagent has not been positively recited. Rather, applicant should note the limitations of “a reagent” is directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by the combined embodiments of O’Connor and the modified apparatus of O’Connor is capable of the recitation of claim 18. As such, it is deemed that the claimed apparatus is not differentiated from the modified apparatus of O’Connor (see MPEP §2114).
Additionally, applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by O’Connor and the apparatus of O’Connor is capable of the recitation of claim 18. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of O’Connor (see MPEP §2114).
With respect to claim 19, applicant should also note that a claim is only limited by positively recited elements, and thus, the inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (See MPEP § 2115, In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935)).
With respect to claim 20, It should further be noted that “the reagent” (“a reagent” from claim 18) has not been positively recited. Claim 18 states “for accommodating a reagent” and therefore, the reagent chamber only has to be capable of holding a fluorescent staining agent that selectively stains target particles.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al (US 2002/0185183 A1) in view of Shi et al (US 2016/0361715 A1) (provided by applicant in IDS dated 10/6/2023).
Refer above for the combined teachings of O’Connor.
With respect to claim 4, modified O’Connor fails to explicitly teach that the flow cell is a sheathless flow cell and configured for forming the sample stream without a sleeving or sheath flow.
Shi teaches cartridges for testing biological samples (See Abstract) wherein the flow cell is a sheathless flow cell and configured for forming the sample stream without a sleeving or sheath flow (See Paras. 0109-0112 and Fig. 23B for discussion/depiction of how the cartridge includes sheathless microfluidic channel 23007 for performing cytometer analysis of WBCs, i.e. flow cell, wherein the sample flows through channel 23007, individual cells can be measured by methods such as optical sensing in flow cytometry).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flow cell as a sheathless flow cell and configured for forming the sample stream without a sleeving or sheath flow as taught by Shi into the device for modified O’Connor for the purpose of providing a disposable cartridge device with a flow channel that minimizes coincidence error during analysis (See Shi, Para. 0112).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al (US 2002/0185183 A1) in view of Moles (US 6,293,012 B1).
Refer above for the combined teachings of O’Connor.
With respect to claim 5, O’Connor fails to teach that the first reagent chamber comprises a first valve component and the second reagent chamber comprise a second valve component.
Moles teaches a an easily assembled and manufactured microfluidic analyzer module that is adapted for easy interchangeability with a previously utilized module, wherein the module is constructed of a plurality of directly bonded polymer layers in a sandwich laminate structure wherein the interfacial surface areas of the laminate have been etched or other formed into a network of communicating microflow channels (See Col. 1, line 65 – Col. 2, line 10). A thin, polymeric valve layer is also provided as part of the laminate structure. The valve layer is securely bonded over the sandwich construction over all surface areas except those in which valving action must occur. That is, in those areas of the sandwich in which valving action is needed to selectively block or open communication between channels of the network, an overlying flexible polymer valve is provided with flexing of the polymer valve against the underlying laminate layer surface functioning to open or block channel communication (See Col. 2, lines 38-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the polymeric valve layer of Moles over the layer containing the first and second reagent chambers of modified O’Connor to ensure that communication between the chambers and channels can be selectively blocked or opened as needed (See Col. 2, lines 38-4 of Moles).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al (US 2002/0185183 A1) in view of Bransky et al (US 2014/0033809 A1).
Refer above for the combined teachings of O’Connor.
With respect to claim 7, O’Connor fails to teach the incorporation of a pneumatic port configured for interfacing with a pneumatic pressure source, wherein the pneumatic pressure source is configured for transferring at least one article inside the cartridge device, the at least one article being selected from the group consisting of the sample, the first reagent, the second reagent, the first sample mixture, and the second sample mixture.
Bransky teaches a cartridge device for measuring at least one item in a sample, the at least one item being selected from the group consisting of an analyte and a target particle in a sample (See Para. 0097 and Fig. 2 regarding cartridge 204 for analyzing a sample fluid), wherein the flow of the output fluid inside the analyzing unit is driven by a suction force generated by the vacuum pump 104, which may be a part of the analyzing system 101. The vacuum pump is coupleable to the analyzing unit through a fourth opening in the analyzing compartment, connected via the fourth channel 1006 to the fifth opening 1008 in the waste container 1005 (See Para. 0155). The pump 104 serves for generating a pressure gradient, such as vacuum, that drives a flow of a sample fluid inside the cartridge (See Para. 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the vacuum pump of Bransky to an output of O’Connor to ensure that the flow of fluid is controlled through the cartridge (See Paras. 0093 and 0155 of Bransky).
With respect to claim 9, although O’Connor does teach a fluid conduit connected to the flow cell (See channels 45A-N in Fig. 6B of O’Connor; also see Para. 0067), there is no teaching that the fluid conduit comprises a designated sensing area configured for measuring a sensing signal to detect when a sample mixture enters or exits the designated sensing area.
Bransky teaches a fluid conduit (third channel 1004, See Para. 0168) connected to the flow cell, wherein the fluid conduit comprises a designated sensing area configured for measuring a sensing signal to detect when a sample mixture enters or exits the designated sensing area (See Para. 0168 for discussion of how the analyzing chamber 1101 is coupled to third channel 1004 and is configured for determination of hemoglobin level, such as with the use of spectrometer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the analyzing chamber and spectrometer of Bransky into the fluid conduit of O’Connor to enable detection of desired fluids and/or components prior to entering the flow cell (See Para. 0168 of Bransky).
Response to Arguments
Applicant’s arguments filed May 7, 2025, with respect to the rejection(s) made under Bransky et al (US 2014/0033809 A1) have been fully considered and are persuasive based on the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration and in view of applicant’s amendments, a new ground(s) of rejection was made above.
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 BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.I.F/Examiner, Art Unit 1796 August 8, 2025
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796