DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The claims dated 11/11/2025 are under consideration.
The amendments and arguments presented in the papers filed 11/11/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 8/11/2025 listed below have been reconsidered as indicated.
a) The objection of claim 17 is withdrawn in view of the amendments to the claim.
b) The rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendments to claim 6.
c) The rejections of claim(s) 1, 3 and 5-6 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nelson (US 6,613,525 B2) are withdrawn in view of the amendments to claim 1.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection are detailed below and this action is made FINAL.
Priority
The present application is given an effective filing date of 5/24/2010 corresponding to the filing date of the 12/785,667 application.
The 61/291627, 61/205626, 61/198222 and 61/196953 provisional applications and 12/475311 and 12/474897 applications do not disclose a plurality of separate flow chambers as required by present claim 1.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Claim Interpretation
Claim 1 is broadly interpreted as containing the following structural elements: a reagent source; and a flowcell with a fluidics interface member mounted on and sealingly attached to a housing; and a plurality of separate flow chambers each with an inlet and an outlet and a detector array disposed therein.
Claim 2 recites “the outlet is disposed diagonally opposite the inlet”. In order to have “diagonally opposite” locations, the flow chamber must not be circular, elliptically or oval, because they are geometric shapes that do not have diagonally opposite points. The structure of the flow chambers in Fig. 7 are encompassed the claim as they not circular, elliptically or oval and have inlets and outlets that are in “corners”, where the “corners” of the flow chambers are diagonally opposite of one another.
Claim 6 recites “a passage to waste in fluid communication with the reagent source and the wash solution source bypassing each flow chamber of plurality of separate flow chamber”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim as been amended to specify that a “detector array” is disposed in each flow chamber. The Remarks dated 11/11/2025 do not identify any specific support for this limitation. The specification uses the term “sensory array” (para. 27) and the term “detector” is not used in any manner.
Claims 2-20 ultimately depend from claim 1 and are rejected for the same reason.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3 and 5-6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nelson (US 6,613,525 B2; cited on the 11/7/2024 IDS) in view of Yeung (WO 96/36872).
The following are new rejections necessitated by the amendments to the claims.
Regarding claims 1 and 3, Nelson teaches an apparatus having a reagent source in the form of a reservoir (item 231).
Nelson further teaches the apparatus includes a plurality of separate flow chambers disposed over a sensor array comprised of a plurality of detectors (items 253, 255, 257 and 260). The flow chambers have interior walls etched in a substrate and a top surface formed by attachment of the fluidics interface to a housing in the form of a planar cover plate (col. 10, lines 52-67; col. 11, lines 1-23).
Each flow chamber has an inlet and an outlet. The inlet is in fluid communication with the reagent source and the outlet is in fluid communication with waste (items 262, 264, 266 and 268).
Nelson teaches a valve is included with each inlet (col. 8, lines 30-67; Fig. 1), meaning that a valve is disposed between the inlet and the wash solution source.
The apparatus of Nelson as depicted as a whole in Fig. 22 is a single large flow cell that defines the plurality of flow chambers over the sensor array.
See, e.g. Fig. 22; col. 3, line 66 to col. 4, line 3; and col. 26, line 17 to col. 27, line13.
Nelson fails to specify the type of detectors that are used in the plurality of detectors.
However, Yeung teaches detectors used with capillary electrophoresis, which is the process employed by the device of Nelson (col. 10, 12 and 13).
Yeung teaches detectors include image array detectors used with capillaries (p. 7, 8, ), including a two-dimensional array detector (p. 11, 20). Yeung further teaches the pixels of the array may be coupled to the interior portion of the passage (p. 22).
It would have been prima facie obvious the ordinary artisan to have used the image array detectors of Yeung as the generic detectors in the device of Nelson. It would have been prima facie obvious to have disposed the image array detector in the flow chamber in order to have been able to track an analyte as it passes through the flow chambers.
Regarding claim 2, while Nelson teaches the above apparatus, Nelson does not teach for each flow chamber, the outlet is disposed diagonally opposite the inlet.
However, the configuration of the inlet and outlets of the flow chambers represents a change in design, shape and rearrangement of parts that is prima facie obvious relative to the prior art of Nelson. See MPEP 2144.04. One would have been motivated to place the inlet and outlets diagonal from one another such that a fluid introduced into the flow chamber has to traverse a majority of the flow chamber by flowing from one location to a location opposite it before it can leave the flow chamber.
Regarding claim 5, when the valve of the wash solution is closed the flow of other solutions is permitted to enter passage because their respective valves are each open.
Regarding claim 6, Nelson teaches a passage (item 240) to waste (item 241) in fluid communication with the reagent source and the wash solution source that bypasses the flow chamber (Fig. 22).
Claim 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nelson (US 6,613,525 B2; cited on the 6/21/2021 IDS) in view of Yeung (WO 96/36872) and in further view of Huang (US 2004/0146849 A1; cited on the 6/21/2021 IDS).
Regarding claim 4, the combination of Nelson and Yeung renders obvious the elements of claim 1 as required by claim 4.
Nelson does not teach a reference electrode in electrical communication with an inlet of the wash solution source.
However, Huang teaches a biochip chip systems (Abstract) that include microfluidics, valves and pumping mechanisms to induce fluid flow (para. 359) and is therefore considered to be a fluidics system. Huang teaches the use of reference electrodes that maintain a constant potential difference that is independent of the electrical current driven through the reference electrode (para. 368). Huang further teaches this electrode configuration accomplishes noise reduction within the assay.
It would have been obvious to a person of ordinary skill in the art at the time the claimed invention was made to have modified the fluidic system taught by Nelson by incorporating the reference electrode of Huang to arrive at the instantly claimed fluidic system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a fluidic system having the added advantage of reducing noise within the assay as explicitly taught by Huang. In addition, it would have been obvious to the ordinary artisan that the known technique of including a reference electrode in a system as described by Huang could have been applied to the fluidics system of Nelson with predictable results because the known technique of incorporating a reference electrode predictably results in the ability to reduce noise within the assay.
Response to the traversal of the 103 rejections
The Remarks argue Nelson does not teach “each flow chamber having a detector array disposed therein” and Huang fails to cure this deficiency (p. 7).
The arguments have been fully considered but are not persuasive because the arguments do not address the teachings of the Yeung reference as applied above.
Conclusion
No claims allowed.
Claims 7-15 require the fluidic circuit described in claim 1 of US Patent 11,951,474, and thus are free of the prior art.
Claims 16-18 require the fluidic circuit of claim 1 of US Patent 9,550,183, and thus are free of the prior art.
Claims 19-20 require the fluidic circuit of claim 1 of US Patent 8,546,128, and thus are free of the prior art.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682