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 Status
Claims 1-18, 21-25, 27-35 and 37-39 are pending with claims 1-18 and 38-39 being examined and claims 21-25 and 27-35 deemed withdrawn. Claims 19-20, 26, 36 and 40 are canceled.
Response to Amendment
As to the remarks filed on 04/07/2026, the Examiner has found the Applicant’s arguments persuasive in some ways and will be addressed below.
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 1-11, 13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al. (US 20050042766 A1; hereinafter “Ohman” previous of record) in view of Lane (US 20120037544 A1).
Regarding claim 1, Ohman teaches a diagnostic consumable for use in the analysis of a fluid sample (Ohman; [0018]), the diagnostic consumable comprising:
a substrate (Ohman; fig. 9. 2) having a sample preparation stage (Ohman; fig. 9.2), the sample preparation stage comprising:
i) an inlet port (Ohman; fig. 9. 7 illustrates a drop of fluid) for receiving a fluid sample;
ii) an outlet port (Ohman; [0060] “exit aperture”) for dispensing a prepared fluid sample (Ohman; [0060] “flow reaches the exit); and
iii) a channel (Ohman; [0060] “a channel structure”) extending from the inlet port to the outlet port (Ohman; fig. 9.7 and [0060] ”a channel comprising a plurality of micro-posts” can be seen from the inlet 7 to what would be the exit aperture), the channel comprising a bottom surface (Ohman; fig. 9. 2) and opposed sidewalls (Ohman. [0060] “the structure (channel) has a bottom substrate and a cover, the substrate also forming sidewalls), wherein each of the opposed sidewalls inclines vertically outward from the bottom surface of the channel (Ohman; [0056] “the sidewalls are more or less vertical”, and “the substrate forms the sidewalls). Examiner will interpret the “sidewalls are more or less vertical” as each of the opposed sidewalls being inclined vertically outward.
Having opposed outward vertically inclined sidewalls allows to manipulate fluid flow and control flow resistance,
the channel also comprising array of micro-projections extending into the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port (Ohman; fig. 9.7 and [0060]), the array of micro-projections having disposed and dried thereon, a fluid comprising a material for mixing with the fluid sample as the fluid sample is flowed through the channel to generate the prepared fluid sample (Ohman: [0072] “the substrate has reactive substances attached to its surface to which substances can react).
Ohman fails to teach at least one of the micro-projections tapers inward from a bottom of the at least one micro-projection to a top of the at least one micro-projection, the top of the at least one-micro-projection having a smaller cross-sectional area than the bottom of the at least one micro-projection.
However, Lane teaches the analogous art of a microfluidic device for (Lane; [0034]) that includes an array of posts (Lane; fig. 2B.10) wherein the array of posts are truncated conical shaped (Lane; fig. 4B and [0016] and [0042] “posts have a tapered configuration”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ohman’s array of micro-projections to have a tapered configuration as taught by Lane because lane teaches a microarray of micro-projections that have a tapered configuration (Lane; [0042]). This would provide two different gap sizes between the posts (Lane; [0044]).
Regarding claim 2, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein the micro-projections of the array are arranged with a generally uniform spacing (Ohman; fig. 9. 1 illustrate the micro-projections with a generally uniform spacing).
Regarding claim 3, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein the micro-projections of the array are disposed in staggered rows along at least a portion of the length of the channel, each row being arranged substantially transverse to a direction of flow through the channel (Ohman; fig. 1 illustrates the micro-projections disposed in staggered rows along at least a portion of the channel).
Regarding claim 4, modified Ohman teaches the diagnostic consumable of claim 3 (see above), wherein the staggered rows of micro-projections are disposed over substantially the entire length of the channel between the inlet port and the outlet port (Ohman; [0022] “the flow path consists of a plurality of micro-posts”).
Regarding claim 5, modified Ohman teaches the diagnostic consumable of claim 3 (see above), wherein the staggered rows of micro-projections comprises a first row of micro-projections and a second row of micro-projections disposed adjacently downstream from the first row of micro-projections relative to the direction of flow through the channel, the second row of micro-projections being offset in a direction transverse to the direction of flow through the channel, relative to the first row of micro-projections, such that micro-projections in the second row are disposed substantially midway between micro-projections in the first row (Ohman; fig. 1 illustrates staggered rows of micro-projections where the first and second row are adjacent, wherein the second row is offset to the first row and disposed substantially midway from one row to the other. (Ohman; [0051] teaches “the microstructures form the fluid path”).
Regarding claim 6, modified Ohman teaches the diagnostic consumable of claim 5 (see above), wherein: a separation distance, measured transverse to the direction of flow through the channel, between adjacent micro- projections in each of the first and second rows is substantially equal; and the micro-projections in the first and second rows have a cross-sectional dimension, measured transverse to the direction of flow through the channel, that is greater than or equal to the separation distance between adjacent micro-projections in each of the first and second rows (Ohman; fig. 2 illustrates a cross section of the flow path, and fig. 1 illustrates the separation between the first and second row of micro-projections is substantially equal).
Regarding claim 7, modified Ohman teaches the diagnostic consumable of claim 6 (see above), wherein: the staggered rows of micro-projections further comprises a third row of micro-projections disposed adjacently downstream from the second row of micro-projections; and micro-projections in the third row are substantially aligned, in the direction of flow through the channel, with micro-projections in the first row (Ohman fig. 1 and fig. 2 illustrates a third row of micro-projections adjacent and aligned to the first and second row in the direction of the flow channel).
Regarding claim 8, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein: the channel has a bottom surface, a top surface generally opposed to the bottom surface (Ohman; fig. 9. 2, 6), and generally opposed side surfaces extending between the bottom surface and the top surface (Ohman; [0060] “the substrate forms the sidewalls (not shown)”); a height of the channel being defined as a distance between the bottom surface of the channel and the top surface of the channel; and the micro-projections extend into the channel at least a portion of the height of the channel between the bottom surface and the top surface of the channel (Ohman; fig. 9. 1, 2, 6 illustrates the height of the channel is defined by the distance between the substrate, the cover and defined by the micro-projections, and [0055] “flow path or channel is formed by column like micro structures or micro posts, protruding from surface of said support”).
Regarding claim 9, modified Ohman teaches the diagnostic consumable of claim 8 (see above), wherein the micro-projections extend the height of the channel between the bottom surface and the top surface of the channel (Ohman; fig. 9. 1, 2, 6 illustrates the micro-projections extend the height of the channel).
Regarding claim 10, modified Ohman teaches the diagnostic consumable of claim 9 (see above), wherein: either the top surface or the bottom surface of the channel is formed by a cover layer affixed to one side of the substrate (Ohman; fig. 9. 6), and the micro-projections extend from the other of the top surface and the bottom surface of the channel to the cover layer (Ohman; fig. 9. 1, 2, 6 illustrates the micro-projections extend from the top of the substrate and bottom surface of the channel to the cover layer).
Regarding claim 11, modified Ohman teaches the diagnostic consumable of claim 1 (see above), further comprising a fluid displacement element (Ohman; [0011] “external auxiliary equipment, such as spinning of a disk”) in fluid communication with the channel (Ohman; [0011] “the external auxiliary equipment is in communication with the channel), the fluid displacement element enabling an external stimulus to be applied to the diagnostic consumable to pump the fluid sample through the channel (Ohman; [0011]).
Regarding claim 13, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein the material disposed on the array of micro- projections comprises a reagent that reacts with the fluid sample as the fluid sample is flowed through the channel. Ohman teaches the sample be exposed to some surface bound moiety for a specified time, in order for a particular reaction to proceed (Ohman; [0059]), and adding a liquid reagent to the channel input aperture (Ohman; [0060]). It would have been obvious to add the liquid reagent to the channel prior to the sample to provide the liquid reagent to be disposed on the micro-projections in order to react with the fluid sample.
Regarding claim 16, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein the substrate comprises a molded plastic substrate (Ohman; [0086]).
Regarding claim 17, modified Ohman teaches the diagnostic consumable of claim
1 (see above), wherein the micro-projections comprise micro-pillars (Ohman; Abstract).
Regarding claim 18, modified Ohman teaches the diagnostic consumable of claim 1 (see above), wherein the substrate further comprises a prepared fluid sample collection vessel (Ohman; [0061] “flow sink”), the prepared fluid sample collection vessel comprising: an inlet port fluidly connected to the outlet port of the sample preparation stage for receiving the prepared fluid sample; and a chamber for containing the prepared fluid sample. the closed channel ending in an open region or zone (Ohman; [0060]-[0061]). Ohman teaches pad 10 in contact with the exit aperture acts as a flow sink (collection vessel) which has two ends, one end would be the inlet port and the other ends the outlet port, and fig. 9, 1, 7, 10 illustrates the closed channel ending in an open region).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al. (US 20050042766 A1; hereinafter “Ohman” previous of record) in view of Lane (US 20120037544 A1), further in view of Dubrow et al. (US 7303727 B1; hereinafter “Dubrow” previous of record).
Regarding claim 12, modified Ohman teaches the diagnostic consumable of claim 11 (see above) to include a fluid displacement element (see above).
Modified Ohman fails to teach the fluid displacement element comprises a vacuum port downstream of the channel, the vacuum port configured for application of a vacuum source to pump the fluid sample through the channel. However, Dubrow teaches the analogous art of a diagnostic consumable “microfluidic device” (Dubrow; Col. 8 line 30) wherein the fluid displacement element (Dubrow; fig. 2 and Col. 13 lines 1-2 “fluid direction component is a vacuum pump”) that includes a vacuum port (Dubrow; fig. 12A. 1200) downstream of the channel (Dubrow; fig. 12A. 1206 illustrates the microchannel with a vacuum port downstream the channel) the vacuum port configured for application of a vacuum source to pump the fluid sample through the channel (Dubrow; Col. 13. Lines 1-11 “the fluid direction component draws aliquots of fluidic material into the capillary element”). To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ohman’s fluid displacement element to include a vacuum port downstream of the channel as taught by Dubrow because Dubrow teaches a vacuum pumping system connected to a port (Dubrow; Col. 26. Lines 66-67 to Col. 27 lines 1-4). This would allow for applying pressure to the microchannel.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al. (US 20050042766 A1; hereinafter “Ohman” previous of record) in view of Lane (US 20120037544 A1), further in view of Killard et al. (US 20120107851 A1; hereinafter “Killard” previous of record).
Regarding claim 14, modified Ohman teaches the diagnostic consumable of claim 13 (see above) wherein the fluid sample is whole blood (Ohman; [0076]), and the prepared fluid sample comprises hemolyzed blood. Ohman teaches the use of centrifugal force [0011] which is known in the art to hemolyze blood.
Modified Ohman fails to teach the reagent disposed on the array of micro-projections comprises a hemolytic reagent. However, Killard teaches the analogous art of diagnostic test device (Killard; 0033]) wherein the micro-projections include a hemolytic agent (Killard; [0143]). To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ohman’s micro-projections to include a hemolytic reagent as taught by Killard because Killard teaches the micro-projections include a hemolytic agent (Killard’ [0033]). This would allow to maximize surface area distribution of the material , thereby maximizing interaction and mixing of the sample with the material.
Regarding claim 15, modified Ohman teaches the diagnostic consumable of claim 13 (see above) to include micro-projections (see above), wherein: the fluid sample is whole blood (Ohman; [0076] teaches the biological sample is blood which the analytes in the blood sample will be measured, implying the biological sample is whole blood).
Modified Ohman fails to teach a reagent disposed on the array of micro-projections comprises a coagulant; and the prepared fluid sample comprises a mixture of the whole blood and the coagulant. However, Killard teaches the analogous art of diagnostic test device (Killard; [0033]) wherein a layer of clotting agent is applied to the micro-pillar surface (Killard; [0143]). To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ohman’s micro-projections to include a clotting agent applied to the micro-pillar surface as taught by Killard because Killard teaches a layer of clotting agent is applied to the micro-pillar surface (Killard; [0142]). Applying a clotting agent to the micro-pillars would allow clotting of the sample.
Response to Arguments
Applicant’s arguments, filed on 04/07/2026, with respect to the prior art rejections over Ohman in view of Lane, Dubrow, Killard, Ding and Chen have been fully considered and are in some ways persuasive.
With respect to the rejection of claim 1, over Ohman in view of Lane. Applicant argues the combination of Ohman and lane would not result in Applicant’s invention as recited “the channel comprising a bottom surface and opposed sidewalls wherein each of the opposed sidewalls inclines vertically outward from the bottom surface of the channel”.
Examiner disagrees. Ohman teaches a groove in a substrate that defines a flow path (channel), the substrate also forming sidewalls (Ohman; [0060]) that has a bottom and opposed sidewalls that are more or less vertical (see claim 1 above). (Ohman; “the sidewalls are more or less vertical”). Examiner will interpret the “sidewalls are more or less vertical” as each of the opposed sidewalls being inclined vertically outward.
Applicant argues that “more or less vertical side walls” as disclosed in Ohman would not meet the claim limitation since the expression “more or less vertical” includes multiple geometries.
In response, the Examiner respectfully disagrees. The expression “more or less vertical sidewalls” is interpreted to cover sidewalls that are substantially vertical. Thus, Ohman is considered to meet the limitation with respect to the orientation of the sidewalls recited in the claim. A drawing is not required since the ordinary artisan would understand the meaning of the expression “more or less vertical”, and would consider all that the expression conveys to the ordinary artisan.
Applicant further argues that Ohman does not disclose or illustrate any sidewall inclining outward from a bottom surface of a channel, and that a person of ordinary skill would not predictably modify opposed sidewalls such that each inclines vertically outward.
Examiner disagrees. It would have been obvious to one of ordinary skill in the art to try, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2141. III. Rationales to Support Rejection under 35 U.S.C 103).
Applicant disagrees with the Examiner’s rationale “obvious to try”. However, Ohman teaches more or less vertical side walls that together with the bottom forming channel through capillary action induce or maintains the flow. The more or less vertical side walls characteristic to induce or maintain a flow would have motivated a person of skill in the art to try, choosing from a finite number of side wall inclination combinations to induce or maintain flow in the channel, with a reasonable expectation of success.
Applicant further argues Ohman does not identify any functional significance associated with such an outward inclination.
Examiner notes that Ohman teaches sidewalls that are more or less vertical (see claim 1 above) and any functional significance associated with such an outward inclination is a matter of intended use.
Allowable Subject Matter
Claims 37-39 are allowed.
The following is an examiner’s statement of reasons for allowance:
Claim 37 recites, among other things a diagnostic consumable comprising: a substrate having a sample preparation stage, the sample preparation stage comprising: an inlet port, an outlet port, a channel extending from the inlet port to the outlet port, the channel comprising an array of micro-projections extending into the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port, wherein the channel comprises opposed sidewalls and at least one of the opposed sidewall is formed by at least two partial micro-projections wherein spacing between the at least two partial micro-projections is greater than a larger cross-sectional dimension of a micro-projection.
Ohman teaches a diagnostic consumable comprising: a substrate having a sample preparation stage, the sample preparation stage comprising: an inlet port, an outlet port, a channel extending from the inlet port to the outlet port, the channel comprising an array of micro-projections extending into the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port, wherein the channel comprises opposed sidewalls.
Ohman fails to teach at least one of the opposed sidewalls is formed by at least two partial micro-projections wherein spacing between the at least two partial micro-projections is greater than a larger cross-sectional dimension of a micro-projection, and there is no motivation to modify Ohman to provide these structures.
With respect to claim 38, Ohman does not teach or fairly suggest a diagnostic consumable for use in the analysis of a fluid sample, the diagnostic consumable comprising: a substrate having a sample preparation stage, the sample preparation stage comprising: i) an inlet port for receiving a fluid sample; ii) an outlet port for dispensing a prepared fluid sample; and iii) a channel extending from the inlet port to the outlet port, the channel comprising a top surface, a bottom surface, and a first array of micro-projections extending from the top surface into the channel toward the bottom surface less than full height of the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port, and there is no motivation to modify Ohman to provide these structures.
With respect to claim 39, Ohman does not teach or fairly suggest the diagnostic consumable of claim 38, wherein the channel further comprises a second array of micro-projections extending from the bottom surface into the channel, wherein the first or the second array of micro-projections has disposed and dried thereon a fluid comprising a material for mixing with the fluid sample as the fluid sample is flowed through the channel to generate the prepared fluid sample, and there is no motivation to modify Ohman to provide these structures.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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