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
In view of Applicant’s amendments filed 30 June 2026, the previous claims objections are hereby withdrawn.
In view of Applicant’s amendments filed 30 June 2026, the previous rejection of the claims under 35 U.S.C. 102(a)(1) are hereby withdrawn.
In view of Applicant’s amendments filed 30 June 2026, the previous rejection of the claims under 35 U.S.C. 103 have been updated.
Applicants’ arguments filed 30 June 2026 with respect to amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 8-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2017/0327867 to Dohale et al. (herein Dohale) (US publication of European Search Report X reference EP 3394293) in view of United States Patent Application Publication US 2016/0216284 to Misener et al. (herein Misener).
Regarding claim 1, Dohale discloses a cartridge (see Figs. 3A-B) for detecting a target analyte (see [0011]) mounted on a target analyte detection device (see [0012]), comprising: a base comprising a first surface (i.e., top), a second surface (i.e., bottom) opposite the first surface, and side surface connecting between the first surface and the second surface (see Figs. 5-6); a plurality of chambers provided on the base and comprising a threaded cap with vent 517; a sample tank 503; a lysis chamber 505; and a capture filter 521 (i.e., sample chamber) (see Figs. 4-7); and a plurality of channels provided on the base and comprising main channel 512 (i.e., sample channel) connected to the sample chamber (see Figs. 4-7) wherein the sample chamber comprises an injection hole provided on the base, covered by threaded cap with vent 517, and comprising an inlet into which a sample is introduced (see Fig. 5; [0122]); sample tank 503 and lysis chamber 505 (i.e., sample delivery passage) connecting the injection hole (see Fig. 5); and capture filter 521 (i.e., sample filter) provided between the outlet of the sample delivery passage and the sample channel (see Fig. 5), wherein the sample delivery passage comprises an asymmetric longitudinal cross-sectional shape (see Fig. 5).
Dohale fails to teach nor fairly suggest “wherein the base comprises a rack engaged with a pinion of the target analyte detection device on an upper side surface of the base” as recited in instant claim 1.
Misener discloses a cartridge 200 for detecting a target analyte mounted on an analyzer (i.e., target analyte detection device) comprising a base (see [0065]; Fig. 1), wherein the base comprises a plurality of gear teeth 223, 225 (see [0081]; Fig. 4A) (either one could be considered upper side) to be engaged with pinion gears 622, 624 of the target analyte detection device (see [0082]; Fig. 9A-B).
Misener and Dohale are analogous in the art of cartridges for analyte detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Dohale in view of Misener to have the cartridge and target analyte detection device to engage via a rack/pinion system for the benefit of guided translation of the cartridge into and out of the target analyte device (see [0082]).
Regarding claim 2, the combination above discloses the invention of claim 1, and Dohale discloses fluid movement between the sample tank and the lysis chamber can be controlled with a capillary stop valve (see [0146]) and wherein capillary stop valves can be used within the cartridge to cause abrupt changes in angular geometry to change the curvature of the meniscus of the fluid (see 0352-0353]; Figs. 60A-C and 61).
Regarding claim 8, the combination above discloses the invention of claim 1, and Dohale discloses the injection hole is provided on an upper side surface of the base (see Fig. 5), wherein the base is mounted on the target analyte detection device 3002 with the upper surface on which the injection hole is provided facing upward, and wherein the sample delivery passage extends in the direction of gravity (see Figs. 5 & 30; [0109, 0121-0122, 0231])
Regarding claim 9, the combination above discloses the invention of claim 1 and Dohale discloses wherein the sample delivery passage comprises a sample indicator for checking the height of the sample provided in a transparent or translucent portion (see Fig. 29).
Regarding claim 10, the combination above discloses the invention of claim 1 and Dohale discloses wherein the cross-sectional area of the injection hole is provided to be larger than the cross-sectional area of the sample delivery passage as the lysis chamber 505 is part of the sample delivery passage, and wherein the sample delivery passage comprises a gradient narrowing downward between the sample tank 503 and lysis chamber 505, wherein a first part of the narrowing gradient portion could be considered part of the upper portion of the sample delivery passage (see Fig. 5).
Regarding claim 11, the combination above discloses the invention of claim 10 and Dohale discloses wherein the sample delivery passage comprises a gradient narrowing downward between the sample tank 503 and lysis chamber 505, wherein a second part of the narrowing gradient portion could be considered part of the lower portion of the sample delivery passage (see Fig. 5).
Claims 3, 5-6, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2017/0327867 to Dohale et al. (herein Dohale) (US publication of European Search Report X reference EP 3394293) in view of United States Patent Application Publication US 2016/0216284 to Misener et al. (herein Misener) and in further view of United States Patent Application Publication US 2012/0171758 to Peterson et al. (herein Peterson) (US publication of European Search Report X reference EP 1208189).
Regarding claim 3, the combination of references above discloses the invention of claim 2, and Dohale discloses wherein the sample delivery passage extends in a vertical direction (see Fig. 5). However, Dohale fails to disclose “the sample delivery passage … comprises the asymmetrical shape in the cross-section in a horizontal direction” as recited in the instant claim.
Peterson discloses a cartridge comprising a sample delivery passage 65 that extends in a vertical direction and comprises the asymmetrical shape in the cross-section in the horizontal direction (see Fig. 3; ([0055]))
Peterson and Dohale are analogous in the art of cartridges for analyzing a fluid sample. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sample delivery passage of Dohale in view of Peterson to have an asymmetrical shape in the cross-section in the horizontal direction for the benefit of liquid level control (see [0055] of Peterson).
Regarding claim 5, the combination of references above discloses the invention of claim 3, however, Dohale fails to disclose “wherein the sample delivery passage comprises one side with a smaller radius of curvature and the other side with a larger radius of curvature” as recited in the instant claim.
Peterson discloses a cartridge comprising a sample delivery passage 65 that comprises one side with a smaller radius of curvature 155 and the other side with a larger radius of curvature, wherein the outlet (valve 107) of the sample delivery passage is located in the portion with a larger curvature radius (see Figs. 3, 8, & 13; [0055]).
Peterson and Dohale are analogous in the art of cartridges for analyzing a fluid sample. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sample delivery passage of Dohale in view of Peterson to comprise one side with a smaller radius of curvature 155 and the other side with a larger radius of curvature for the benefit of liquid level control (see [0055] of Peterson).
Regarding claim 6, the combination of references above discloses the invention of claim 5, however, Dohale fails to disclose “wherein the sample delivery passage comprises a ratio of curvature radius of one side with smaller radius of curvature and the other side with the larger radius of curvature set in the range of 1:2 to 1:2.5” as recited in the instant claim.
Peterson discloses a cartridge comprising a sample delivery passage 65 that comprises one side with a smaller radius of curvature 155 and the other side with a larger radius of curvature (see Figs. 3 & 13; [0055]). While Peterson is silent to the exact dimensions of the radius of curvature of sample delivery passage 65, Peterson does disclose that the ratio of radius of curvature in valves of the cartridge is an important factor in controlling fluid flow (see [0094]). The MPEP 2144.05 II. Routine Optimization defines a result effective variable as a variable which achieves a recognized result. In this instance the result effective variable is the ratio of radius of curvature which has a recognized result of controlling fluid flow through passage. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the ratio of radius of curvature of the sample delivery passage 65 to reach desired fluid flow control. Therefore, it would be obvious for the radius of curvature between the one side of the sample delivery passage of Dohale in view of Peterson vs. the other side to be 1:2 to 1:2.5 for the benefit ideal fluid flow control (see [0055-0094]; Figs. 3 & 13) of Peterson).
Regarding claim 12, the combination of references above discloses the invention of claim 8, however, Dohale fails to disclose “wherein the injection hole is provided on a portion expanding in thickness direction of the upper side surface of the base, and wherein the width of the injection hole is configured larger than the thickness of the base” as recited in the instant claim.
Peterson discloses an injection hole 300 provided on a portion expanding in a thickness direction of an upper surface of a base 1200, and wherein the width of the injection hole 300 is configured larger than the thickness of the base 1200 (see Fig. 1).
Peterson and Dohale are analogous in the field of cartridges for target analyte detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cartridge of Dohale for the injection hole to be provided on a portion expanding in a thickness direction of an upper surface of the base, and wherein the width of the injection hole is configured larger than the thickness of the base in view of Peterson. MPEP 2143 I. A. Combining prior art elements according to known methods to yield predictable results discloses that if the prior art discloses the claimed invention, however not in a single reference, with the only difference between the prior art and the claimed invention being the lack of combination of elements in a single prior art reference, and the combined elements would function similarly and predictability then a case of obvious exits. In this instance Dohale fails to teach the claimed configuration of claim 12, however Peterson does. Thus, it would be obvious to modify the configuration of Dohale in view of Peterson in view of MPEP 2143.I. A. for the benefit of having of having a more compact cartridge.
Regarding claim 14, the combination of references above discloses the invention of claim 1. The combination of references fails to explicitly disclose “wherein both the rack and the injection hole are provided on the upper side surface of the base, so as to not overlap”, however the placement of these components is a matter of design choice that would be obvious to one of ordinary skill in the art (see MPEP 2144.04 IV. C. Rearrangement of Parts).
Regarding claim 15, the combination of references above discloses the invention of claim 1. Dohale discloses the upper side of the base has two surfaces at different heights (see fig. 5). The combination of references fails to explicitly disclose “wherein the injection hole is located below the rack”, however the placement of these components is a matter of design choice that would be obvious to one of ordinary skill in the art (see MPEP 2144.04 IV. C. Rearrangement of Parts).
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication US 2017/0327867 to Dohale et al. (herein Dohale) (US publication of European Search Report X reference EP 3394293) in view of United States Patent Application Publication US 2016/0216284 to Misener et al. (herein Misener); in view of United States Patent Application Publication US 2012/0171758 to Peterson et al. (herein Peterson) (US publication of European Search Report X reference EP 1208189); and in further view of United States Patent Application Publication US 2022/0371019 to Mei et al. (herein Mei) (US publication of European Search Report Y reference EP 4091716).
Regarding claim 4, the combination of references above discloses the invention of claim 3, and however Dohale fails to disclose “wherein the outlet of the sample delivery passage comprises an inclined surface in a longitudinal direction” as recited in the instant claim.
Mei discloses a sample delivery passage 111 wherein the outlet of the sample delivery passage 111 comprises an inclined surface in a longitudinal direction (see Fig. 5).
Mei and Dohale are analogous in the art of cartridges for fluid analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outlet of the sample delivery passage of Dohale to comprise an inclined surface in a longitudinal direction for the benefit of direct fluid to the outlet of the sample delivery passage and reduce residual volume of liquid in the sample delivery passage (see [0174] of Mei).
Regarding claim 7, the combination of references above discloses the invention of claim 5, however, fails to disclose “wherein the outlet of the sample delivery passage comprises an inclined surface in a longitudinal direction” as recited in the instant claim.
Mei discloses a sample delivery passage 111 wherein the outlet of the sample delivery passage 111 comprises an inclined surface in a longitudinal direction (see Fig. 5).
Mei, Peterson, Dohale are analogous in the art of cartridges for fluid analysis. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outlet of the sample delivery passage of Dohale in view of Peterson, wherein the outlet is located on the side with the larger radius of curvature, to comprise an inclined surface in the longitudinal direction such that one side with the smaller radius of curvature extends relatively downward than the other side with the larger radius of curvature for the benefit of direct fluid to the outlet of the sample delivery passage and reduce residual volume of liquid in the sample delivery passage (see [0174] of Mei).
Conclusion
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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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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