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 .
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.
Response to Amendment/Arguments
Applicant’s arguments, see, in particular, pgs. 10 of Remarks, filed 01 June 2026, with respect to the rejection(s) of claim(s) Claims 1-2, 6, 9-10, and 13 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection of said claims is made under 35 U.S.C. 103.
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.
Claims 1-2, 4-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2015/031040 to Calanca et al. (herein Calanca as cited on the 2/28/2025 IDS.
Regarding claim 1, Calanca discloses an apparatus 1 (i.e., centrifugal filtration cartridge) (see [0119]; Figs. 10-12) comprising; hollow device 2 (i.e., filter cup) comprising filter 9 that captures a microorganism (see [0118]; Figs. 10-12) and a nozzle that discharges a liquid D that has passed through the filter (see Figs. 11-12); and element 22 (i.e., contamination prevention box) connectable to the filter cup 2 and internally storing a measurement container 26 configured to store the liquid D discharged from the nozzle (see [0111-0120]; [0134-0136]; Figs. 10-12), wherein the contamination prevention box 22 includes a partition wall 21 disposed between the filter cup 2 and an opening surface of the measurement container 26 (see Figs. 10-12), the partition wall 21 has an opening 23 through which the nozzle can pass, and the nozzle has a length in which a top of the nozzle is located below a lower end of the opening and enters inside the measurement container 26 when the contamination prevention box 22 is connected to the filter cup 2 (see Figs. 10-12).
Calanca fails to disclose “a contamination prevention box connectable to the filter cup and internally storing a separate measurement container configured to store the liquid discharged from the nozzle” as recited in the instant claim. Calanca discloses a measurement container 26 that is the hollow portion of the contamination prevention box 22 below the partition wall 21 (see Figs. 10-12). However, per MPEP 2144.04 V C. Making Separable, making claim elements separable would be an obvious choice of one of ordinary skill in the art if there is an art-recognized need for said separation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the contamination prevention box 22 and the measurement container of Calanca to be separate elements for the benefit of having access to a separate container containing the filtrate of the apparatus (see Figs. 10-12).
Regarding claim 2, Calanca discloses all the limitations of claim 1 and discloses wherein a cross-sectional area of the opening is larger than a cross-sectional area of the nozzle and smaller than a cross-sectional area of the opening surface of the measurement container (see Figs. 10-12).
Regarding claim 4, Calanca discloses all the limitations of claim 1, however, fails to disclose “wherein the contamination prevention box stores a plurality of the measurement containers, the partition wall has a plurality of openings provided in respective upper portions of the plurality of measurement containers, and the filter cup has a plurality of nozzles equal in number to the number of the plurality of measurement containers” as recited in the instant claims. However, the limitations as recited in claim 4 merely amount to duplication of elements and their arrangements as disclosed in independent claim 1. MPEP 2144.04 VI. B. Duplication of Parts states that a mere duplication of parts has no patentable significance unless a new or unexpected results is produced. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to duplicate parts so that the contamination prevention box stores a plurality of the measurement containers, the partition wall has a plurality of openings provided in respective upper portions of the plurality of measurement containers, and the filter cup has a plurality of nozzles equal in number to the number of the plurality of measurement containers for the benefit of multiple simultaneous analysis.
Regarding claim 5, Calanca discloses all the limitations of claim 1 and discloses wherein the partition wall 21 couples and locks with filter cup 2 (i.e., creates a seal) closing off opening 23 (see [0111]; Figs. 10-12).
Calanca fails to disclose “wherein … the tip of the nozzle has a needle shape” as recited in the instant claim, however, MPEP 2144.04 IV. B. Changes in Shape states that the courts have held that a particular configuration of a claimed element is a matter of choice which a person of ordinary skill in the rat would have found obvious absent persuasive evidence that the particular configuration of the claimed element was significant. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to have any desired shape of nozzle for the benefit of controlling discharge of liquid.
Regarding claim 6, Calanca discloses all the limitations of claim 1 and wherein the nozzle has an area, and thus thickness, of well below 5 mm (see [0060]; reference 10 of Figs. 3 & 5 and Figs. 10-12).
Regarding claim 7, Calanca discloses all the limitations of claim 1 above, however, fails to disclose “wherein, in a state where the contamination prevention box is connected to the filter cup, a plane including the tip of the nozzle is located at a distance of 1 mm or more below from a lower surface of the partition wall” as recited in the instant claim. Calanca does disclose the partition wall 21 is designed to control the position of the filter cup 2 and thus the nozzle within the contamination prevention box 22 (see [0111]; Figs. 10-12). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to adjust the position of the nozzle, including 1 mm or more from a lower surface of the partition wall, within the contamination prevention box by adjusting the size/shape of the partition wall 21 as desired for the benefit of accommodating a particular shape of the filter cup 2 (see [0111] of Calanca).
Regarding claim 8, Calanca discloses all the limitations of claim 1 above, however, fails to disclose “wherein, in a state where the contamination prevention box is connected to the filter cup, a plane including the tip of the nozzle is located at a distance of 1 mm or more below from the opening surface of the measurement container” as recited in the instant claim. Calanca does disclose the partition wall 21 is designed to control the position of the filter cup 2 and thus the positions of the nozzle within the measurement container (see [0111]; Figs. 10-12). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to adjust the position of the nozzle, including 1 mm or more from the opening surface of the measurement container, by adjusting the size/shape of the partition wall 21 as desired for the benefit of accommodating a particular shape of the filter cup 2 (see [0111] of Calanca).
Regarding claim 9, Calanca discloses all the limitations of claim 1 and wherein there is a gap between a side surface of the nozzle and the opening 23 where the contamination prevention box 22 is connected to the filter cup 2 (see Figs. 10-12).
Regarding claim 10, Calanca discloses all the limitations of claim 1 and discloses a holder, the combination of the measurement container 26 and partition wall 21, that holds the filter cup 2 and a covering device 11 (i.e., lid) connectable to a contamination prevent box 20 that covers an upper side of filter cup 2 (see [0107]; Figs. 13-14).
Regarding claim 13, Calanca discloses the centrifugal filtration device of claim 1 and discloses a microbial test method (see [0141]; Figs. 10-12) thus disclosing the preparing step of claim 13. Calanca discloses the method further comprises: pipetting a test sample into the filter cup 2 (see [0127, 0141]; Fig. 10); connecting the filter cup 2 to the measurement container 26 (see [0141]; Figs. 10-12); and installing the centrifugal filtration cartridge 1 in a centrifuge in a state wherein the filter cup 2 and the measurement container 26 are connected to each other, and performing centrifugal filtration with the filter (see [0141]; Figs. 11-12).
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2015/031040 to Calanca et al. (herein Calanca as cited on the 2/28/2025 IDS in view of United States Patent Application Publication US 2016/0341641 to Williams et al. (herein Williams as cited on the 02/28/2025 IDS.
Regarding claim 3, Calanca discloses all the limitations of claim 1 and discloses what could be considered a first box of the measurement container above the partition wall 21 and a second box of the measurement container below the partition wall 21 (see Figs. 10-12).
Calanca fails to disclose “the first box and the second box are configured to be separable” as recited in the instant claim.
Williams discloses an apparatus for collection, filtration and concentration of biological samples (see abstract) comprising: a filter cup 10; a filter (see [0026]); a nozzle 15; and a contamination prevention box, the combination of 6, 7, 12, 13, & 14 for storing a measurement box, the combination of 6, 12, & 14, wherein 6 (i.e., first box) and 12 (i.e., second box) are configured to be separable (see Figs. 1, 3, & 9).
Williams and Calanca are analogous in the field of centrifugal filtration cartridges. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the measurement container of Calanca to be comprised of a first and second box configurable to separable for the benefit of providing both a sampling portion and a processing portion which reduces sample handling, thereby decreasing the possibility of contamination of the sample and the contact environment (see [0044] of Williams).
Regarding claim 11, the combination of references above render obvious the invention of claim 3, including the measurement container 6, 12, & 14 and the first 6 and second 12 boxes of Williams (see Figs. 1, 3, & 9 of Williams) and thus the combination of references render obvious “wherein the measurement container protrudes from the second box when the first box and the second box are separated” as recited in the instant claim as element 14 of the measurement container protrudes from second box 12 when the first box 6 and second 12 are separated (see Fig. 1 of Williams). Furthermore, Williams discloses this design is advantageous for reducing spilling and preventing contamination and would thus be obvious to one of ordinary skill the art before the effective filing date (see [0034] of Williams).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2015/031040 to Calanca et al. (herein Calanca as cited on the 2/28/2025 IDS in view of United States Patent Application Publication US 2016/0341641 to Williams et al. (herein Williams as cited on the 02/28/2025 IDS and in further view of United States Patent Application Publication US 2020/0164376 to Gedig et al. (herein Gedig).
Regarding claim 12, the combination of references above render obvious the invention of claim 1, however fails to disclose “a waste liquid container connectable to the filter cup in a state where the contamination prevention box is removed therefrom” as recited in the instant claim.
Gedig discloses a flow cell for the selective enrichment of particles from a fluid sample (see abstract), wherein the flow cell comprises a filter element 25 (see [0052]) that is connected to a waste conduit 26 (see Fig. 6A; [0070]).
Gedig is analogous in the art of particle separation for analysis using filtration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to make the filter cup of Calanca in view of Williams connectable to a waste liquid container for the benefit of removing undesirable sample components (see [0070] of Gedig).
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 KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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