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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks on November 21st, 2025. Claims 1-6, 8, 10-12, 14, 52, 54-56, 72, and 73 are pending. Claims 7, 9, 13, 15-51, and 57-71 are canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14, 52, 54-56, 72, and 73 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitations herein within independent claims 14 and 55 to the flowing (as in the step of cl. 14) and the computer configured action of flowing (as in the system of cl. 55) the first oil at a first flow rate, the second oil at a second flow rate, and the inlet liquid at a third flow rate so as to direct the flow of the inlet liquid to a region of interest of a/the sample of the reaction chamber is indefinitely provided for.
Such functionality for this particular directing to an ROI of the sample is indefinitely provided by way of choosing flow rates alone, absent the knowledge of the location and size of the sample within the reaction chamber.
Choices of these 1st-3rd flow rates alone do not suffice to provide for the sought directed flow to an ROI of the sample as claimed as these choices made in and of themselves do not provide for such “steering” of the flow to particularly contact an ROI of the sample if the sample’s particular location/size within the reaction chamber is not previously provided.
Merely knowing that the sample is generally within the reaction chamber does not suffice as one does not know in what manner to “steer” these fluids to an ROI of the sample by way of relative flowrates thereof. The location/size/shape of the sample within the confines of the reaction chamber informs the directing/”steering” required by the flows to particularly reach and contact a particular ROI thereof this positioned sample.
This is likewise seen in Applicant’s disclosure (see pars.[0034,0214,0217], fig. 2, for example).
In fig. 2 and the exemplary discussion therewith, a particular region of interest is defined as the depicted, stylized diamond shape 207 that equally bifurcates the central longitudinal axis of the reaction and has a depicted relative size to that of the chamber as a whole, in which given a predefined target (i.e. size/shape/location) within the reaction chamber, flow rates may be chosen so as to ‘hit’ this target in the desired fashion (i.e. in instances partly, but not fully).
This is likewise seen in par.[0217] in which the various flow rates can be determined depending on the region of interest 217 of the sample selected by the user.
It appears Applicant intends to provide a particular location/size/shape of the sample or means of previously ascertaining such (i.e. an imaging step of the reaction chamber that informs the sample location/size/shape) before the step of flowing 1st-3rd fluids as in the method and computing device of cls. 14/55.
This likewise applies to the “second region of interest” as in cls. 52/72.
Further, as in cl. 14, the recitation “the area of the sample” lacks proper antecedent basis wherein it Appears applicant intends to recite “an area…” This is likewise seen in cl. 55 with respect “the area of the reaction chamber.” Applicant appears to desire to initially provide an area to the reaction chamber in its first instance and specify something on the order of “a totality of the area.”
Clarification is required.
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.
Claim(s) 1-6, 8, and 10-12, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hiddessen et al. (US 2018/0147573), hereafter Hiddessen.
With regard to claim 1, Hiddessen discloses a device comprising a first directing channel (upper channel 1804 in fig. 48A) comprising a first directing channel proximal portion (i.e. adjacent oil reservoir 1802) extending to a first directing channel distal portion (i.e. adjacent the intersecting point 1810), a first oil disposed (the oil from reservoir 1802 provided to upper channel 1804) in the first directing channel, a second directing channel (lower channel 1804) comprising a second directing channel proximal portion (i.e. adjacent oil reservoir 1802) extending to a second directing channel distal portion (i.e. adjacent the intersecting point 1810), a second oil (the oil from reservoir 1802 provided to lower channel 1804; wherein Examiner further asserts that “first” and “second” oils are drawn to nominal designations thereof that are equivocally disclosed herein by the above-discussed provided oils to each of the upper180 and lower channels 1804, and wherein such oils may be of the same oil as presently claimed). Hiddessen further discloses an inlet channel 1808 comprising an inlet channel proximal portion (i.e. adjacent reservoir 1806) extending to an inlet distal portion (i.e. adjacent intersection 1810), and a reaction chamber 1814 extending from a first end to a second end, and wherein the inlet distal portion is disposed between the first directing distal portion and the second directing distal portion as seen in fig. 48A wherein the inlet channel is disposed between and sandwiched on either side by the distal portions of each of the respective first and second directing channels. Hiddessen further discloses that the first directing channel, second directing channel, and inlet channel are in fluidic communication with the first end of the reaction chamber (pars.[0581-0583+], figs. 28, 47,48A, 48B, for example). With regard to the waste outlet, Hiddessen discloses that the emulsion in the above-discussed reaction chamber may flow through a detection/analysis sites and ultimately then to a waste receptacle (par.[0246], fig. 7), and similarly as in fig. 35 by way of a waste outlet to the chamber provided by way of a fluid transfer device for collecting/removing the emulsion (par.[0336], fig. 35), and wherein such waste outlet in either sense are in fluidic communication with the second end of the reaction chamber opposite the first end as afforded by the common fluidic communication throughout as in fig. 7 and as in the fluidic communication afforded at the second end of the emulsion reaction chamber 1388 (analogous to that of 1814 discussed above) to that fluidic connection with the fluid transfer device 1420 that provides the waste outlet (see also figs. 50-53 and accompanying disclosure to likewise cartridge for producing droplet emulsions and processing thereof and ultimately leading to a waste outlet, all of which are in fluidic communication with one another).
With regard to claims 2-6, Hiddessen discloses the device of claim 1 further comprising at least one reagent channel (i.e. at least one reagent chamber 2160a-e comprising at least one reagent reservoir as in cl. 3 and the respective connected fluid line thereto each constituting the reagent channel(s) as in cl. 2; and likewise with respect to the plurality as it pertains to reagent reservoirs 2160a-e and their respective fluid lines) in fluid communication with the at least one inlet channel 2182 of sample chamber 2154 (pars.[0610-0615], figs 51-53, for example). With regard to claim 6, and from the above discussion, each reagent channel of the plurality of reagent channels is in fluid communication with the inlet channel 2182.
With regard to claim 8, Hiddessen further comprises an inlet region (i.e. a region adjacent to emulsion reaction chamber 1814), wherein the first directing distal portion, the second directing distal portion, and the inlet distal portion are in fluidic communication with the inlet region and the inlet region is in fluid communication with the reaction chamber (fig. 48A, for example).
With regard to claim 10, Hiddessen discloses a first directing reservoir in fluid communication with the first directing proximal portion (i.e. reservoir 1802).
With regard to claim 11, Hiddessen discloses at least one valve (i.e. selector valve to the inlet channel for sample as in par.[0603]) disposed along at least one of the first directing distal portion, the second directing distal portion, and the inlet channel (par.[0603], figs. 50-53, for example). With regard to claim 12, Hiddessen discloses the device further comprises at least one valve 880 disposed along the waste outlet (par.[0269), fig. 11, for example).
Allowable Subject Matter
Claims 14, 52, 54-56, 72, and 73 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, as best understood, does not teach or fairly suggest a method as recited in claim 14, which provides flowing the first oil from the first directing channel to the reaction chamber at a first flow rate, flowing the second oil from the second directing channel to the reaction chamber at a second flow rate, and flowing an inlet liquid from the inlet channel to the reaction chamber at a third flow rate, wherein the first flow rate, second flow rate, and third flow rate direct flow of the inlet liquid to a first region of interest of the sample in the reaction chamber and wherein the first region of interest is smaller than the area of the sample.
Further, the prior art of record does not teach or fairly suggest, as best understood, a system as recited in claim 55, which includes a computing device operatively linked to the device and to the controller, and wherein the computing device is configured to control the third flow, first flow, and second rate, as recited therein, to direct flow of the inlet liquid to a first region of interest of a sample in the reaction chamber, and wherein the first region of interest is smaller than the area of the reaction chamber.
Response to Arguments
Applicant’s arguments with respect to the pending claims 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.
As discussed above, and in view of the amendments to the claims, claims 14, 52, 54-56, 72, and 73 are rejected under 35 USC 112 b/2nd paragraph.
Further, and in view of the amendments to the claims, claims 1-6, 8, and 10-12 are herein rejected under 35 USC 102a1 as being anticipated by Hiddessen et al. (US 2018/0147573).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hiddessen (US 2012/0152369) discloses droplet emulsion formation by way of opposing carrier oil flows to an aqueous sample inlet flow that is relevant to Applicant’s field of endeavor.
Abell (US 2012/0091004) discloses microfluidic systems for creating and assessing droplet emulsion formations that is relevant to Applicant’s field of endeavor.
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798