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 .
Response to Arguments
Applicant’s arguments, filed 12/30/25, with respect to the rejection(s) of claims 1-14 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicant has amended the rejected claims to address the rejections set forth in Paragraphs 4-5 of the Non-Final Rejection mailed 10/01/25. See also page 5 of Applicant’s Remarks. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Applicant’s arguments, filed 12/30/25, with respect to the rejection of claims 1-14 under 35 U.S.C. 102 (a)(1) as being anticipated by Glezer et al. (US 2004/0189311) have been fully considered and are persuasive. Applicant has amended claim 1 to recite wherein said device further comprises a fifth layer, said fifth layer comprises a substrate coated with a layer of conductive material, and said conductive material is ablated to form insulative areas on said fifth layer; wherein said fifth layer comprises two insertion monitoring electrodes, and when said device is assembled, said insertion monitoring electrodes are exposed and not covered by any other layer of said device” and then argued that Glezer does not teach the features of amended claim 1 including the fifth layer and features including the insertion monitoring electrodes that are exposed and not covered by any other layer of the device. See pages 5-6 of Applicant’s Remarks. The Examiner agrees; therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Claim Interpretation
The Examiner notes that the claims recite a device comprising at least a first layer and MAY comprised a second, third, fourth and fifth layers. The Examiner further submits that the claims use open language in reciting the device and therefore may contain more layers than the layers recited in the claim. In addition, the various layers (second, third, etc.) each include features which are provided in the specific layer in a manner that identifies the layer. For these reasons, the Examiner has not rejected claims that recite a layer (third, fourth, fifth) without a corresponding number of other layers under 35 U.S.C. 112(b). The Examiner has simply identified the layers being claimed based on the recited layer features. For example, the Examiner has NOT rejected claim 1 as unclear based on the use of the term “fifth layer” – when there are no second layer, third layer or fourth layer recited in the claim. The Examiner has instead search for a device having the features recited in the fifth layer to reject claim 1 – as claim 1 as currently written actually only requires two layers. The Examiner also applied devices having up to five layers – see Glezer et al. (US 2004/0189311) – to claims having the additional layers.
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.
Claim 13 is 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. Claim 13 recites the limitation "said working area” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Inventorship
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 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.
Claims 1-5 and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al. (US 2004/0189311) in view of Veiseh et al. (US 20200101455). Glezer teaches an assay cartridge comprising detection chambers having electrodes with immobilized assay reagents. The embodiments of the device most relevant to the instant claims are shown in Figures 14a-14c and described in Paragraphs 0236-0242.
Regarding claim 1 and 5 - As shown in Figure 14b, Glezer teaches a device comprising a first layer (cap insert 1414), said first layer (cap insert 1414) comprises a sample receiving inlet (opening that connects to sample chamber 1420), and at least one fluid channel (conduits 14400, 1460, 1461, 1470, 1482), extending from and in fluidic communication with said sample receiving inlet (via sample chamber 1420), the terminus of each fluid channel is in fluid communication with a vent (vent ports 1450, 1451, 1452, 1453, 1480, 1487) sealed by a hydrophobic vent material (hydrophobic filter or membrane - see Paragraph 0220). Glezer does not teach a fifth layer comprises a substrate coated with a layer of conductive material, and said conductive material is ablated to form insulative areas on said fifth layer; wherein said fifth layer comprises two insertion monitoring electrodes, and when said device is assembled, said insertion monitoring electrodes are exposed and not covered by any other layer of said device.
Veiseh teaches a biosensing imaging system. The portions of the device most relevant to the instant claims are shown in Figures 2-5 and described in Paragraphs 0059-0092. As shown in Figures 2-5, Veiseh teaches a multilayer device (12) comprised of a well structure layer (14) having a plurality of wells (18) and bottom substrate (16) having a plurality of sensors connected by multiplexed circuitry (20) corresponding to the bottoms of the wells (18). The bottom substrate (16) also includes a plurality of external connectors in the form of electrodes (connectors 22) that are placed on an upper surface of the bottom substrate (16) that is uncovered by the well structure layer (14) for communicating with an external device. See Paragraphs 0080 and 0199-0200. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the electrodes from Veiseh with the device of Glezer. One of ordinary skill in the art at the time would add the external connectors in order to communicate with and transfer data and information to or from an external device.
Regarding claim 2 - Glezer further shows a second layer (cartridge body 1411) operably coupled to the first layer (cap insert 1414) in Figure 14b and recites dry reagents in the conduits in Paragraphs 0237-0241.
Regarding claims 3 and 4 - Glezer further shows a third layer (upper shorter layer of 1410 containing chambers 1430, 1431) operably coupled with said first layer (cap insert 1414) in Figure 14b and teaches coating areas of the layers with hydrophobic and hydrophilic materials in Paragraphs 0110-0111, 0123, and 0203. Glezer further teaches dry reagents in the conduits in Paragraphs 0237-0241 The dry reagents which would render the area having the reagent hydrophilic.
Regarding claims 9, 12 and 14 - Glezer teaches dedicated working and counter electrodes in Paragraphs 0107-0116 and the claims. The Examiner submits Glezer also includes additional electrodes which may be used as reference electrodes and fluid fill electrodes. See also cover layer (1407) in Figure 14b and Paragraphs 0232-0248.
Regarding claim 10 and 11 - Glezer discloses electrical access regions (1432 and 1433) that allow access to the conductive layer (1423) in Figure 14b and Paragraphs 0241.
Regarding claim 13 - The Examiner submits that when the device is assembled as shown in Figure 14b, the working area (conductive layer 1423) of the fifth layer (cover layer 1407) is in fluid communication with the first layer (cap insert 1414).
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al. (US 2004/0189311) in view of Veiseh et al. (US 20200101455), and further in view of Crivelli et al. (US 2017/0152081). Glezer and Veiseh, as combined above in Paragraphs 11-17, teach every element of claims 15-20 except for the adapter for operable coupling to a container.
Regarding claims 15 and 17 - Crivelli teaches methods and mechanisms for delivering material from a container to a digital fluidics cartridge. The embodiment of the device most relevant to the instant claims is shown in Figures 25A-25D and described in Paragraphs 0160-0171. As shown in Figures 25A-25D, Crivelli teaches a liquid storage and delivery mechanism (2500) that includes a flow control plate (2510) having an adapter (housing 2530) for receiving a shell (2503) with a reservoir (2508) containing a reagent. The material contained in the reservoir (2508) is delivered to the cartridge (unlabeled) under the flow control plate (2510) after engagement with a piercing element (piercer 2518) to pierce the closure lid (2504) of the reservoir and release the liquid. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the housing (2530) from Crivelli with the combined device of Glezer and Veiseh. One of ordinary skill in the art at the time would add the housing to modified Glezer in order to receive containers of material in the inlet port as taught by Crivelli.
Regarding claim 16 - Crivelli teaches that the shell (2503) includes a plurality of ribs (2520) for mating with an inner surface (notch 2534) of the housing (2530). See Paragraph 0163-0166. In Paragraph 1064, Crivelli teaches that the ribs (2520) slide within the notches (2534) to guide and manage movement of the shell (2503) in the housing (2530). The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the rib features from Crivelli with the device of Glezer. One of ordinary skill in the art at the time would add the shell ribs (2520) and housing notches (2534) to Glezer in order to guide and manage the movement of the shell (2503) in the housing (2530).
Regarding claims 18 and 20 - The Examiner considers the bottom portion of the interior passage (2528) to meet the limitation of a blocking element that prevents material from escaping. See Figure 25D which shows the body (2506) fully inserted into the housing (2530).
Regarding claims 19 and 20 - Crivelli discloses a piercing element (piercer 2518) in Figures 25A-25D and Paragraph 0167-0169.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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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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/DWAYNE K HANDY/Examiner, Art Unit 1798 May 30, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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