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 filed 07/01/2026. Claims 1-20 are pending.
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 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.
1. Mai et al. teaches a housing (pod) 201 that contains a metering stack (the assembly shown in Figs. 15A-15D) for collecting a target sample for testing, the metering stack comprising: a top layer; a bottom layer; and a channel layer spacing the top layer from the bottom layer as shown in Figs. 15A-15D
The top layer, the bottom layer, and the channel layer together define a channel 1525 having an inlet end 1505 for receiving the target sample.
During sample collection, the channel in the metering stack can be filled with the target analyte 1502 (e.g., blood) by exposing channel inlet 1505 to the target analyte 1502, a main channel portion 1510 connected to the inlet end 1505. As shown in Figs. 8, the channel includes plurality of enlarged areas that are positioned over assay pads 1530 that are interpreted as being dispensing portions.
Mia et al. teaches that the channel “may” comprise one of more air vents. [0051] Absent the optional vents air gap would exist.
Mai et al, teaches the use of pins 372 that are used to push the metering stack to come into contact with the assay stack, as shown in Figs. 3C and 3D. [0046]
Mai et al does not teach a support feature within the pod that vertically spaces apart the plurality of dispensing portions from the plurality of assay pads when less than a threshold vertical pressure is applied proximate the plurality of dispensing portions and allowing the plurality of dispensing portions to move relative to the inlet end to come into vertical contact with the plurality of assay pads when at least the threshold vertical pressure is applied proximate the plurality of dispensing portions.
Huang teaches a pivoting mechanism (lid 303) that, as shown in Fig. 7, includes a convex structure 311 that presses down on a soaked sample collecting pad 310 so that the fluid sample is transferred from the sample collecting pad 310 to an analysis membrane 309. [0065]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Mai et al. to use a pivoting mechanism as taught by Huang to push the metering stack to come into contact with the assay stack as a simple substitution of one known element for another to obtain predictable results. The convex structure in the pivoting mechanism of Huang reads on a support feature that allows for vertically spacing apart the metering stack and assay stack until pressure is applied and the causes the metering stack to come into contact with the assay stack.
While Mia et al. teaches moving the assay pads towards the dispensing portions, it would have been obvious to one of ordinary skill in the art to configure Mia et al. in view of Huang to move the dispensing portions toward the assay pads as an alternative manner of bringing the dispensing portions and assay pads together.
I) Regarding applicant’s claim 1, as noted above Mai et al. in view of Huang renders all the limitations of claim 1 obvious.
Therefore, Mai et al. in view of Huang renders claim 1 obvious.
Allowable Subject Matter
Claims 10-20 are allowed.
Claims 2-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 10-20, applicant’s arguments regarding claim 10 were found to be persuasive. The housing (pod) 201 of Mai et al. does not have a collection volume that is configured to initially receive the fluid sample as describe in applicant’s disclosure.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 having a cutout area between the first and second ends of the metering stack and between the first and second sides of the metering stack with the cutout area being connected by a living hinge to the metering stack and the plurality of dispensing portions being positioned on the cutout area as recited in claim 2 or claim 3 that depends from claim 2.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 having the plurality of dispensing portions connecting across a living hinge to the inlet end as recited in claim 4.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 wherein the support feature includes an adhesive material coupling the metering stack to the pod as recited in claim 5.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 wherein the support feature vertically supports the metering stack between the inlet end and the plurality of dispensing portions as recited in claim 6.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 having a collection volume and a dispensing volume, the collection volume being configured to initially receive the fluid sample, the dispensing volume being configured to receive the plurality of assay pads, the inlet end of the metering stack positioned at the collection volume and the plurality of dispensing portions are positioned within the dispensing volume, and the support feature vertically supporting the metering stack within the collection volume of the pod as recited in claim 7.
The prior art of record does not teach or suggest a sample collection unit as recited in claim 1 having an upper surface and a lower surface, the metering stack being received between the upper surface and the lower surface, the upper surface of the pod defining a window vertically aligned with the plurality of dispensing portions, a thickness of the upper surface being reduced within the window as recited in claim 8 or 9 which depends from claim 8.
Response to Arguments
Applicant's arguments filed 07/01/2026 have been fully considered but they are not persuasive as to the rejection of claim 1.
On page 9 of applicant response applicant argues that: should the assay pads 1530 of Mai be interpreted as corresponding to the claimed plurality of dispensing portions as suggested in the Office Action, Mai would not teach assay pads separate of such claimed dispensing portions for the dispensing portions to come into contact with, as claimed.
As noted above, Mai et al. has been relied upon as teaching separate dispensing portions and assay pads and bringing the dispensing portions and assay pads together.
Applicant further argues that Mai et al. "does not teach a support feature within the pod that vertically spaces apart the plurality of dispensing portions . . .allowing the plurality of dispensing portions to move relative to the inlet end. . . ," as claimed.
Huang has been relied upon a support feature. As noted in the Office Action of 04/01/2026, the convex structure in the pivoting mechanism of Huang reads on a support feature that allows for vertically spacing apart the metering stack and assay stack until pressure is applied and the causes the metering stack to come into contact with the assay stack
On page 10 of applicant’s response applicant argues that Huang teaches pressing on the sample collecting pad which is directly saturated with the fluid sample during collection.
This argument persuasive inasmuch as Huang has only been relied upon as teaching the use of a pivoting mechanism.
Further applicant argues that modifying Mai to have the pivoting mechanism taught by Huang would still move the channel inlet 1505 with the receiving chambers 1515 relative to the assay pads 1530.
The combination of Mai et al. and Huang is not based on using the exact structure of the pivoting mechanism of Huang, but on modifying Mai et al. to use a pivoting mechanism as taught by Huang to push the metering stack to come into contact with the assay stack as a simple substitution of one known element for another to obtain predictable results.
Mai et al. teaches several alternative manners to move the metering stack and the assay stack together.
Huang teaches a pivoting mechanism that presses down on pad 310.
One skilled in the art would find it obvious to modify Mia et al. to include a pivoting mechanism to press the metering and assay stacks together. As an example, pivoting mechanisms on both ends of the assay reader 357 in Fig. 3C of Mia et al. would work fine, as would a pivoting mechanism to the same ends of the upper and lower portions of the reader in Fig. 3A. Other configurations could be conceived by those skilled in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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