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 .
Applicant’s amendment has been considered and entered for the record.
Preliminary Remarks
Applicant’s amendment overcomes the rejection in the previous Office Action. Claims 1-17 and 67-61 are pending further examination upon the merits.
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.
Claims 1, 2, 4-7, 9, 11-17 and 57-61 are rejected under 35 U.S.C. 102a1 as being anticipated by Barbera-Guillen et al. (US 2002/0110905 A1 – hereafter ‘905).
‘905 discloses a culture system (Abstract) that includes the following limitations for claim 1:
“An integrated culture monitoring system”: ‘905 discloses a system for the perfusion of cells (0007]) that also permits the observation of the cell culture ([0032]) where this is being interpreted as the integrated culture monitoring system of the instant application.
“an incubation chamber to contain a culture fluid”: ‘905 discloses reservoirs (reservoirs 10; Fig. 8) that are within a temperature controlled chamber ([0029]; [0041]) and these reservoirs are being interpreted as the incubation chamber of the instant application. Finally, these chambers hold a culture fluid.
“a temperature control device arranged to control temperature of the incubation chamber”: ‘9058 discloses that the housing holding the reservoirs includes an environmental control mechanism that regulates the temperature ([0041]).
“a fluid-handling cartridge”: ‘905 includes a cell culture device (device 14, i.e. the fluid-handling cartridge; [0038]; Fig. 8) that contains cells and the culture fluid.
“a fluid passage operationally coupled to a pump and providing a fluid passage between the incubation chamber and the fluid-handling cartridge”: ‘905 discloses a fluid passage such as tubing (tubing 12a; Fig. 8; [0036]) that is coupled to a pump (pump 12b; Fig. 8) and provides fluid passage between the reservoir and the cell culture device (i.e. the incubation chamber and the cartridge).
“wherein the pump is arranged to pump a sample of the culture fluid from the incubation chamber through the fluid passage into the fluid handling cartridge.”: The pump of ‘905 is arranged to pump a sample from the reservoir to the culture device ([0036]; Fig. 8).
For claim 2, ‘905 discloses a microprocessor ([0037]) that is electronically connected to the temperature control device, cell culture device and pump and is programmed to control the temperature of the system ([0041]).
For claim 4, the reservoir of ‘905 includes a culture fluid ([0014]).
For claim 5, the reservoirs of ‘905 include a culture medium ([0014]).
For claim 6, the reagents are drawn to material operated on by the apparatus which does not structurally define the claimed invention over the prior art. See MPEP §2114.
For claim 7, ‘905 discloses sensors that are connected to the processor that controls the process ([0014]).
For claim 9, the reservoir and culture device are fluidly connected (Fig. 8; [0041]).
For claim 11, ‘905 discloses an optical sensor such as a flow photometer ([0043]).
For claim 12, the turbidity sensors of ‘905 would inherently be a photodiode.
For claim 13, ‘905 discloses that the chamber is formed by two gas permeable membranes (membranes 26; Fig. 5; [0032]) that would be separated by a gap and are fully capable of allowing droplet operations to be performed.
For claim 14, the reservoirs of ‘905 are being interpreted as bottles (Fig. 8; [0037]; [0041]).
For claim 15, ‘905 includes a display ([0044]) that includes a touch screen and therefore is fully capable of displaying an assay result. Moreover, the touch screen reads on a GUI.
For claims 16 and 17, the specific assay is drawn to the manner in which the device is operated and does not provide a structural limitation that defines over the prior art. See MPEP §2114.
For claims 57-59, the specific reagents are drawn to the manner in which the device is operated and does not provide a structural limitation that defines over the prior art. See MPEP §2114.
For claim 60, the cartridge of ‘905 is fully capable of being disposable.
For claim 61, ‘905 discloses that the cells are from biological organs or tissue and therefore include blood or a blood fraction ([0038]).
Therefore, ‘905 meets the limitations of claims 1, 2, 4-7, 9, 11-17 and 57-61.
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 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.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Barbera-Guillen et al. (US 2002/0110905 A1 – hereafter ‘905) in view of Handique et al. (US 2015/0328638 A1 – hereafter ‘638).
‘905 (Barbera-Guillen) differs from claim 3 regarding a digital microfluidic cartridge.
‘638 (Handique) discloses a cartridge that creates microdroplets ([0009]) that is being interpreted as the DMF of the instant application since a DMF cartridge generates droplets for analysis on each individual droplet.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the cartridge of ‘638 within ‘905 in order to process a sample for a diagnostic result. The suggestion for doing so at the time would have been in order to lyse a cell to prepare it for amplification ([0009]).
‘905 differs from the limitation of claim 8.
For claim 8, ‘638 discloses sensors that can be used to detect droplets ([0246]; [0244]).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the earliest effective filing date to include the sensors of ‘638 within ‘905 in order to monitor a droplet in the cartridge. The suggestion for doing so at the time would have been in order to position a droplet at a desired location ([0295]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Barbera-Guillen et al. (US 2002/0110905 A1 – hereafter ‘905) in view of Vacic et al. (US 11,828,766 B2 – hereafter ‘766).
‘905 (Barbera-Guillen) differs with regards to the agitator of claim 10.
‘766 (Vacic) discloses a testing system for performing multi-assay testing sequence (Abstract) that for claim 10 includes a shacking system for shaking the cartridges (col. 29 lines 42-54). This can result in an increase in growth of the cell culture (col. 3 line 35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to incorporate the shaking system of ‘766 within ‘905 in order to improve oxygenation within the chamber. The suggestion for doing so at the time would have been to allow the continuous and more uniform exposure of microorganisms to nutrients in the growth medium (col. 3 lines 30-32).
Response to Arguments
Applicant’s arguments with respect to claim(s) 09/07/2026 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hammons et al. (US 2011/0207209 A1) discloses a culture system that automates the culturing and incubation process.
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 MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
