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. 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. 1. Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2019/0314816 to Mai et al. (cited by applicant) Mai et al. teaches a housing (pod) 201 that contains a metering stack 1504 for collecting a target sample for testing, the metering stack 1504 comprising: a top layer 1201; a bottom layer 1230 , 1250; and a channel layer 1220 spacing the top layer 1201 from the bottom layer 1250 . [0071] T he top layer, the bottom layer, and the channel layer together define a channel 1510 having an inlet end 1505 for receiving the target sample . During sample collection, the channel 1510 in the metering stack 1504 can be filled with the target analyte (e.g., blood) by exposing channel inlet 1505 to the target analyte 1502, a main channel portion 1510 connected to the inlet end 1505, a separation portion 1550 , 1531 connected to the main channel portion 1510, and one or more dispensing portions 1530 connected to the separation portion 1550 , 1531, and wherein a vent 1511 is defined within the metering stack 1504 proximate the separation portion 1550 , 1532 of the channel 1510, the vent 1511 allowing air to enter the metering stack into the separation portion . [0071] The a collection volume of the sample is received at the inlet and to the dispensing portions and thereafter through a separation layer 1531 (“dispensing volume”) to the assay pads 1530. Mai et al. teaches a gap 1532 in Fig. 15B which is interpreted as an air gap that is provided in the passage portion around at least the lower portion of the metering stack. [0042] I.) Regarding applicant’s claim 10, as noted above Mai et al. teaches all the elements of claim 10. Therefore, Mai et al. anticipates claim 10. Claim Rejections - 35 USC § 103 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. 2 . Claim 1 is rejected under 35 USC 103 as being unpatentable over Mai et al . in view of U.S. Patent Application Publication No 2018/0306785 to Huang . Mai et al . teaches a housing (pod) 201 that contains a metering stack 1504 for collecting a target sample for testing, the metering stack 1504 comprising: a top layer 1201; a bottom layer 1230 , 1250; and a channel layer 1220 spacing the top layer 1201 from the bottom layer 1250 . [0071] T he top layer, the bottom layer, and the channel layer together define a channel 1510 having an inlet end 1505 for receiving the target sample . During sample collection, the channel 1510 in the metering stack 1504 can be filled with the target analyte (e.g., blood) by exposing channel inlet 1505 to the target analyte 1502, a main channel portion 1510 connected to the inlet end 1505, a separation portion 1550 , 1531 connected to the main channel portion 1510, and one or more dispensing portions 1530 connected to the separation portion 1550 , 1531, and wherein a vent 1511 is defined within the metering stack 1504 proximate the separation portion 1550 , 1532 of the channel 1510, the vent 1511 allowing air to enter the metering stack into the separation portion . [0071] Mai et al, teaches the use of pins 372 that are used to pus h 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 spac es 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 presse s 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 caus es the metering stack to come into contact with the assay stack . 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. 3. Claims 11-17 are rejected under 35 USC 103 as being unpatentable over Mai et al. I.) Regarding applicant’s claim 11, as noted above Mai et al. anticipates claim 10 from which claim 11 depends. Claim 11 recites that inner surface of the collection volume being attractive to the fluid sample. In M ai et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the inner surface of the collection volume attractive (i.e., hydrophilic, hemophilic, etc. ) as disclosed by applicant depending on the type of sample to be collected. Therefore, Mai et al. renders claim 11 obvious. II.) Regarding applicant’s claim 1 2 , as noted above Mai et al. anticipates claim 10 from which claim 1 2 depends. Claim 12 recites that the inlet end of the metering stack protrud es from the passage portion into the collection volume. Mai et al. does not teach that the inlet end of the metering stack protrud es from the passage portion into the collection volume. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Mai et al. and configure the inlet end of the metering stack to protrud e from the passage portion into the collection volume as a matter of design choice for accessing the inlet. Therefore, Mai et al. renders claim 12 obvious. III.) Regarding applicant’s claim 1 3 , as noted above Mai et al. renders claim 1 2 obvious from which claim 1 3 depends. Claim 13 recites that the exterior surface of the inlet end of the metering stack protruding from the passage portion into the collection volume is repellant to the fluid sample. Mai et al. does not teach that the exterior surface of the inlet end of the metering stack protruding from the passage portion into the collection volume is repellant to the fluid sample. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Mai et al. by making the exterior surface of the inlet end of the metering stack repellant to the fluid sample , so as to prevent carry over sample fluid from contaminating testing. Therefore, Mai et al. renders claim 13 obvious. IV.) Regarding applicant’s claim 1 4 , as noted above Mai et al. anticipates claim 10 from which claim 1 4 depends. Claim 14 recites that the inlet end of the metering stack is flush with an inner surface of the collection volume. Mai et al does not teach that the inlet end of the metering stack being flush with an inner surface of the collection volume. It would have been obvious to one of ordinary skill in the art before applicant’ effective filing date to modify Mai et al. so that the inlet end of the metering stack is flush with an inner surface of the collection volum e as a matter of design choice that does not modify the operation of the device. Therefore, Mai et al. renders claim 14 obvious. V.) Regarding applicant’s claim 1 5 , as noted above Mai et al. anticipates claim 10 from which claim 1 5 depends. Claim 15 recites that the inner surface of the passage portion is repellant to the fluid sample. Mai et al. does not that the inner surface of the passage portion is repellant to the fluid sample. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Mai et al and make the inner surface of the passage portion repellant to the fluid sample so that the collected sample will pass to the analysis pads and not remain the in the passage portion. Therefore, Mai et al. renders claim 15 obvious. V I .) Regarding applicant’s claim 1 6 , as noted above Mai et al. anticipates claim 10 from which claim 1 6 depends. Claim 16 recites that the passage portion extend s from about 0.4 mm to about 0.5 mm between the collection volume and the dispensing volume. Mai et al. does not teach that the passage portion extend s from about 0.4 mm to about 0.5 mm between the collection volume and the dispensing volume. 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 configure the passage portion to extend from about 0.4 mm to about 0.5 mm between the collection volume and the dispensing volume based the desired volume of the sample to be collected . Note , changes in size are patentable when they do not preform differently. (MPEP 2144.04(IV)(B)) V II .) Regarding applicant’s claim 1 7 , as noted above Mai et al. anticipates claim 10 from which claim 1 7 depends. Claim 17 recites that the collection volume being angled upwardly from the dispensing volume. In Mai et al. holding the housing at an angle would result in the collection volume to be angled upwardly from the dispending volume. Therefore, Mai et al. renders claim 17 obvious. 4 . Claim s 18 -20 is rejected under 35 USC 103 as being unpatentable over Mai et al. as applied to claim 10 above and further in view of Huang. I.) Regarding applicant’s claim 18, as noted above Mai et al. anticipates claim 10 from which claim 18 depends. Claim 18 recites a support feature within the dispensing volume, the support feature vertically spacing 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 bringing the plurality of dispensing portions into vertical contact with the plurality of assay pads when at least the threshold vertical pressure is applied proximate the plurality of dispensing portions. As noted above, Mai et al. teaches a housing (pod) 201 that contains a metering stack 1504 for collecting a target sample for testing, the metering stack 1504 comprising: a top layer 1201; a bottom layer 1230 , 1250; and a channel layer 1220 spacing the top layer 1201 from the bottom layer 1250 . [0071] T he top layer, the bottom layer, and the channel layer together define a channel 1510 having an inlet end 1505 for receiving the target sample . During sample collection, the channel 1510 in the metering stack 1504 can be filled with the target analyte (e.g., blood) by exposing channel inlet 1505 to the target analyte 1502, a main channel portion 1510 connected to the inlet end 1505, a separation portion 1550 , 1531 connected to the main channel portion 1510, and one or more dispensing portions 1530 connected to the separation portion 1550 , 1531, and wherein a vent 1511 is defined within the metering stack 1504 proximate the separation portion 1550 , 1532 of the channel 1510, the vent 1511 allowing air to enter the metering stack into the separation portion . [0071] 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 dispensing volume, the support feature vertically spacing 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 bringing the plurality of dispensing portions 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 presse s 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 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 causing the metering stack to come into contact with the assay stack . As noted above Mai et al. in view of Huang renders all the elements of claim 18 obvious. Therefore, Mai et al. in view of Huang renders claim 18 obvious. II.) Regarding applicant’s claim 19, as noted above Mai et al. in view of Huang renders claim 18 obvious from which claim 19 depends. Claim 19 recites that the support feature is spaced apart from the passage portion. In Mai et al. in view of Huang providing the pivoting mechanism as taught by Huang would provide the support feature to be spaced apart from the passage portion before applying pressure. Therefore, Mai et al. in view of Huang renders claim 19 obvious. III.) Regarding applicant’s claim 20, as noted above Mai et al. in view of Huang renders claim 18 obvious from which claim 20 depends. Claim 20 recites that the support feature is repellant to the fluid sample. In Mai et al. in view of Huang it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the support feature repellant to the sample fluid to prevent any carryover sample that might contaminate testing. Therefore , Mai et al. in view of Huang renders claim 20 obvious. Allowable Subject Matter 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. 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 includ es 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 support s 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MICHAEL S. GZYBOWSKI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3487 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30-5:00 . 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL STANLEY GZYBOWSKI/ Examiner, Art Unit 1798