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 .
Response to Arguments
Applicant’s arguments, see Page 6, filed 12/2/2025, with respect to the 112(b) rejections of claims 6 and 8 have been fully considered and are persuasive. The 112(b) rejection of 9/5/2025 has been withdrawn.
On Page 7 of the Remarks, the Applicant states that combination of Kim and Gupta does not support a rejection of newly amended claim 1 and its associated claims. Specifically, the Applicant remarks that the prior art does not teach "first and second opposing walls defining a first channel." In response to this argument, the Examiner respectfully disagrees as the walls have been defined as the cover and support, where the channel’s bounds and shape are defined by these layers.
In response to Applicant’s argument that the previous rejection of record does not teach that "the first channel has a multiplicity of corners on one or both of the first and second opposing walls, the multiplicity of corners constricting and expanding a width of the first channel and defining a zigzag profile which affects the capillary flow of blood plasma in order to promote a reaction of the blood plasma with the reactant," the Examiner respectfully agrees. However, after further search and consideration, this claim limitation is now considered unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161).
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.
Claims 1-4, 6, 9-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161).
Regarding claim 1, Kim et al. teaches a device for testing blood plasma for cholesterol (device for testing cholesterol, see Fig. 2C, [0063], [0068], [0106], and [0113]),
including an inlet for blood plasma (sample inlet 336, see Fig. 2C an [0065]),
at least one test region which includes a test for identifying high density lipoprotein (HDL) cholesterol (detection chamber 44/344 used for cholesterol monitoring, see Fig. 2, [0106] and [0113]),
first (316) and second (322) opposing walls defining at a first channel (cover 316 defining channels 340 and 342 on a support layer 322, where the channels are continuous and are therefore are one first channel, see Fig. 2C and [0068] – [0070]), wherein said channel has a first end proximate the inlet and a second end proximate at least one the test region (region 340 is closer to inlet 336, channel 342 is closer to the detection chambers 344, see Fig. 2C),
a transfer element which is formed of a material which allows capillary flow of blood plasma from the inlet along said channel to the test region (photoresist 314 is hydrophilic and therefore allows capillary flow from inlet 336 through channels 340 and 342 to detection chamber 344, see Fig 2C and [0080]), and
a reactant located in said channel (reagent region 340 comprising reagent for capturing analyte epitope, see [0092], [0106], and [0113], where LDL and HDLs are epitopes of lipoproteins),
wherein the first channel has a multiplicity of corners on one or both of the first and second opposing walls (the channel 340/342 forms a corner on the cover layer 316 and support layer 322, see Fig. 2C and [0068],the corners defining a zigzag profile which affects the capillary flow of blood plasma in order to promote the reaction of the plasma with said reactant (channels 340 and 342 are serpentine and have corners and therefore constitute a zigzag profile, see Fig. 2C, where the alteration of the dimensions of the channel changes the capillary flow of the system, see Abstract and [0139]).
While Kim teaches the above and the fact that the channel dimensions can be altered to control the flow of liquid through the channels, the reference does not teach that the multiplicity of corners constrict and expand to create a width of the first channel.
However, in the analogous art of microfluidic devices with serpentine channel structures for reacting fluids, Yang et al. teaches a device with a serpentine channel stretched across a substrate, where the channel has a zig-zag structure with varied channel dimensions, where the channels constrict (shrink channel 23) and expand (expansive channel 22), see Fig. 5 and [0042] – [0054]. Because Kim teaches the alteration of the dimensions of the channels to achieve desired flow rates, the modification to include the shrink and expansive channels of Yang et al. would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Kim to include the shrink and expansive channels of Yang et al. for the benefit of homogenously mixing a fluid for adequate detection, see [0004] and [0054]. The modification of the fluidic channel of Kim et al. to incorporate the wider and narrower portions of Yang et al. would not have deviated from either inventions scope and the results would have been obvious as both inventions are related to microfluidic platforms with microchannels for fluidic operations.
However, while Kim teaches that the device is suitable for cholesterol testing and comprises a reactant to removing an unwanted interferent, Kim et al. does not teach that the reactant reacts with low density lipoprotein (LDL) cholesterol in said blood plasma, and prevents the LDL cholesterol from reaching the test region.
In the analogous art of multiple analyte testing devices, Gupta teaches a device made of a solid substrate ([0022]) wherein the channel comprises a reagent to precipitate the LDL within the sample prior to reaching the HDL test line, see Fig. 9, [0029], [0032] and [0049].
The modification of an analyte sensor to include a reagent to precipitate LDL in a cholesterol test was known and obvious in the art before the effective filing date of the instant invention as exemplified by Gupta. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the reactant of Kim et al. to comprise the LDL precipitating agent of Gupta for the benefit of removing LDL from the sample to improve the visual response to the HDL cholesterol in the sample, see [0049] in Gupta. Further, the modification of Kim et al. to include the LDL precipitating reagent of Gupta would have been successful as both references are drawn to multi-analyte testing devices for cholesterol.
Regarding claim 2, modified Kim et al. teaches the device as claimed in claim 1, wherein the corners define an irregular zigzag profile (channels 340 and 342 are serpentine with different lengths and have corners and therefore constitute an irregular zigzag profile, see Fig. 2C).
Regarding claim 3, modified Kim et al. teaches the device as claimed in claim 1, wherein the corners define an interior angle from 70-90° and an exterior angle from 90-140° (the interior corners are at right, or 90° angles, see Fig. 2C, while the exterior angles are 90° as the channel is a quadrilateral).
Regarding claim 6, modified Kim et al. teaches the device as claimed in claim 1, wherein a total number of corners is at least 14 (the amount of corners in channel 340 is 16, see Fig. 2C).
Regarding claim 9, modified Kim et al. teaches the device as claimed in claim 1, and additionally teaches that the device can comprise multiple mixing regions with channels when they are present (see [0022]) and wherein the transfer element allows capillary flow of blood plasma from the inlet along said channel to said test region (plasma flows from filter to inlet to additional detection chamber 344, see Fig. 2C, [0089], [0098]), but does not teach that the device includes a test region which includes a test for identifying total cholesterol and additionally including a second channel, wherein the second channel has a first end proximate the inlet and a second end proximate said test region.
However, the analogous reference of Gupta teaches a device comprising a secondary channel for monitoring total cholesterol with a first end near an inlet and other end near the total cholesterol region, see Fig. 9 and [0049].
The modification of an analyte sensor to include a second channel comprising a reagent to detect cholesterol in a blood test was known and obvious in the art before the effective filing date of the instant invention as exemplified by Gupta. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device of Kim et al. to include the secondary channel including a region for monitoring total cholesterol of Gupta for the benefit of detecting an unwanted contaminant within a sample, see [0049] in Gupta. Further, the modification of Kim et al. to include the total cholesterol monitoring channel of Gupta would have been successful as both references are drawn to multi-analyte testing microfluidic devices for cholesterol.
Regarding claim 10, modified Kim et al. teaches the device as claimed in claim 9, and additionally teaches that the device can comprise multiple mixing regions with channels when they are present (see [0022] in Kim et al.) and wherein the transfer element allows capillary flow of blood plasma from the inlet along said channel to said test region (plasma flows from filter to inlet to additional detection chamber 344, see Fig. 2C, [0089], [0098] in Kim et al.), but does not teach that the device includes a test region which includes a test for identifying triglycerides and additionally including a third channel, wherein said channel has a first end proximate the inlet and a second end proximate said test region.
However, the analogous reference of Gupta teaches a device comprising a third channel for monitoring total cholesterol with a first end near an inlet and other end near the triglyceride region 24, see Fig. 9 and [0049].
The modification of an analyte sensor to include a third channel comprising a reagent to detect triglycerides in a blood test was known and obvious in the art before the effective filing date of the instant invention as exemplified by Gupta. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the device of Kim et al. to include the tertiary channel including a region for monitoring total triglycerides of Gupta for the benefit of detecting an analyte related to adverse health effects within a sample, see [0049] in Gupta. Further, the modification of Kim et al. to include the triglyceride monitoring channel of Gupta would have been successful as both references are drawn to multi-analyte testing microfluidic devices for cholesterol and its related compounds.
Regarding claim 11, modified Kim et al. teaches the device as claimed in claim 10, additionally including a region of said transfer element between the inlet and the end of each channel proximate the inlet (the photoresist 314 is located between the inlet 366 and the channels 340 and 342, see Fig. 2C of Kim et al.).
Regarding claim 12, modified Kim et al. teaches the device as claimed in claim 1, wherein the transfer element has a hydrophobic region and a hydrophilic region which are patterned so as to define the first channel and the at least one test region (the photoresist 314 surface is hydrophilic to define the channels 340 and 342 and the detection chamber 344, see Fig. 2C, [0080] and contains hydrophobic interaction regions, see [0068] in Kim et al.)
Regarding claim 13, modified Kim et al. teaches the device as claimed in claim 12, wherein each channel and test region is formed from the hydrophilic region (the photoresist 314 surface is hydrophilic to define the channels 340 and 342 and the detection chamber 344, see Fig. 2C, [0080] in Kim et al.).
Regarding claim 15, modified Kim et al. teaches the device as claimed in claim 1, additionally including a filter for separating blood plasma from whole blood, the filter being located on an opposite side of the inlet to the first channel (filter 366 for filtering blood to provide plasma to the inlet chamber 366, see [0089] and [0098] in Kim et al.).
Regarding claim 16, modified Kim et al. teaches the device as claimed in claim 1, which has a single transfer element which is substantially planar, and wherein the capillary flow of blood plasma is in the plane of the transfer element (single planar photoresist 314 for flowing blood via capillary action, see Fig. 2C and see [0089] and [0098] in Kim et al.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161) as applied to claim 1 above, and further in view of Wang et al. (Machine Translation of CN 107376750A).
Regarding claim 4, Kim et al. teaches the device as claimed in claim 1, comprising a first channel, but does not teach that the first channel provides an arc from the first end to the second end. However, in the analogous art of microfluidic platforms, Wang et al. teaches a microfluidic system wherein the first channel provides an arc from the first end to the second end (the channel is shaped as an arc from one end to an entrance to the serpentine structure, see Fig. 1 and [0012]). While the invention of Kim et al. does not teach that the channel is in the shape of an arc from one end to another, the invention of Kim et al. teaches the use of channels to alter the speed and flow of the fluid that is analyzed.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the channel of Kim et al. to incorporate the arc-shaped channel of Wang et al. for the benefit of improving the mixing efficiency between the sample and a stored reagent for downstream analysis, see [0012] in Wang et al. Further, the modification of the microfluidic substrate of Kim et al. to incorporate the arc shaped passageway as shown by Wang et al. would have had the expected result of generating a microfluidic substrate for fluidic operations, as required by the instant invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161) as applied to claim 1 above, and further in view of Kersaudy-Kerhoas et al. (US 20210016284).
Regarding claim 5, modified Kim et al. teaches the device as claimed in claim 1, wherein the channel includes a density of corners (see Fig. 2C), but does not teach that the density of corners is of at least two corners for each mm of a length of the first channel.
However, in the analogous art of microfluidic devices using serpentine channels, Kersaudy-Kerhoas et al. teaches a microfluidic device (Abstract)wherein the channel comprises at least two corners for each mm of the length of the channel (the conduit lC is 3.57mm with at least 8 corners shown, having a density of 2 corners for each mm of length of channel, see Fig. 3 and [0167]).
The modification of a microfluidic channel to include more than one corner per mm of length was known as evidenced by Kersaudy-Kerhoas et al. and would not have deviated from the scope of the invention as all disclosures are drawn to improving microfluidic devices. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the microfluidic channel 340 of Kim et al. to include at least 2 corners per mm as exemplified by Kersaudy-Kerhoas et al. for the benefit of increasing a flow rate or a pressure of a liquid within a microfluidic channel (see [0229] in Kersaudy et al.). The modification of the serpentine channel of Kim et al. to include the density of corners of Kersaudy et al. would have resulted in successfully facilitating the flow of fluid through a microfluidic platform for further processing.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1), (Gupta (US 20050214161), and Kersaudy-Kerhoas et al. (US 20210016284) as applied to claim 5 above, and further in view of Taylor et al. (US 2010/0158756).
Regarding claim 7, modified Kim et al. teaches the device as claimed in claim 5, wherein the width, length, and height of the channels can be varied to reach a specific flow rate, see [0077] – [0078] in Kim et al., but does not explicitly teach that average width of the channel is from 18% to 21% of the length of the channel, the maximum width of the channel does not exceed 1.9 times the average width,
the minimum width of the channel is not less than 48% of the average width, and the depth of the channel is about 7% of the average width.
However, in the analogous art of microfluidic devices comprising variable geometry channels, Taylor et al. teaches that an average width of the channel is from 18% to 21% of the length of the first channel (the average width to length ratio is 5:1, or 20%, see [0083]),
A maximum width of the first channel does not exceed 1.9 times the average width (the largest width is within 50% of the average width, see [0084]),
a minimum width of the first channel is not less than 48% of the average width (the smallest width is within 50% of the average width, see [0084]),
and a depth of the first channel is about 7% of the average width (a channel wherein the width-to-height ratio is 15:1, or about 7%, see [0082]).
The modification of a microfluidic platform comprising meandering sections to include the claimed channel dimensions was known in the art as exemplified by the prior art of Taylor et al. Further, the invention of Kim et al. was ready for improvement as the channel dimensions are capable of variation to achieve a variety of flow conditions on the microfluidic chip (see [0077] – [0078]). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the channels of Kim et al. to have the dimensions outlined by Taylor et al. for the benefit of improving fluid manipulation and storage within a microfluidic channel, see [0003] in Taylor et al. Further, the results would have been obvious as the modification of a microfluidic channel to include varied dimensions would have facilitated fluid flow and mixing on a microfluidic platform.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161) as applied to claim 6 above, and further in view of Taylor et al. (US 2010/0158756).
Regarding claim 8, modified Kim et al. teaches the device as claimed in claim 6, wherein the width, length, and height of the channels can be varied to reach a specific flow rate, see [0077] – [0078] in Kim et al., but does not explicitly teach that an average width of the first channel is from 18% to 21% of the length of the first channel, a maximum width of the first channel does not exceed 1.9 times the average width,
a minimum width of the first channel is not less than 48% of the average width, and a depth of the first channel is about 7% of the average width.
However, in the analogous art of microfluidic devices comprising variable geometry channels, Taylor et al. teaches that an average width of the first channel is from 18% to 21% of the length of the first channel (the average width to length ratio is 5:1, or 20%, see [0083]),
a maximum width of the first channel does not exceed 1.9 times the average width (the largest width is within 50% of the average width, see [0084]),
a minimum width of the first channel is not less than 48% of the average width (the smallest width is within 50% of the average width, see [0084]),
and a depth of the first channel is about 7% of the average width (a channel wherein the width-to-height ratio is 15:1, or about 7%, see [0082])
The modification of a microfluidic platform comprising meandering sections to include the claimed channel dimensions was known in the art as exemplified by the prior art of Taylor et al. Further, the invention of Kim et al. was ready for improvement as the channel dimensions are capable of variation to achieve a variety of flow conditions on the microfluidic chip (see [0077] – [0078]). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the channels of Kim et al. to have the dimensions outlined by Taylor et al. for the benefit of improving fluid manipulation and storage within a microfluidic channel, see [0003] in Taylor et al. Further, the results would have been obvious as the modification of a microfluidic channel to include varied dimensions would have facilitated fluid flow and mixing on a microfluidic platform.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2010/0261286) in view of Yang et al. (US 20060285433 A1) and (Gupta (US 20050214161) as applied to claim 13 above, and further in view of Esch (US 2015/0174573)
Regarding claim 14, Kim et al. teaches the device as claimed in claim 13, comprising the transfer element (photoresist), but does not teach that the element is formed from a porous membrane.
However, in the analogous art of using photoresists to construct microfluidic platforms, Esch teaches a device where a transfer element is formed from a porous membrane (microporous membrane constructed from existing microfluidic chamber photoresist, see Fig. 11 and [0057]).
The modification of a previously non-porous photoresist membrane to include a porous material as a liner for a microfluidic chamber was known in the art as evidenced by Esch (see [0057]). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified of the prior art of Kim et al. comprising a photoresist layer to include the porous construction of Esch for the benefit of mimicking the structure of tissue to prevent certain metabolites from the sample from passing through the assay, see [0048] in Esch. Further, the modification of the photoresist of Kim et al. to further incorporate the porous structure of Esch would have facilitated the expected result of flowing fluid from an inlet through a meandering channel as the pores of Esch overcome the previously identified issue of maintaining uniformity across production (see [0074] in Esch).
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.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758