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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks and amendments filed 29 May 2026.
Claims 1, 3-13, 17-19, 22, 24-25, and 27-29 are pending.
Claims 2, 14-16, 20-21, 23, 26 are cancelled.
No claims are withdrawn from consideration.
No claims are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 8-13, 18-19, 22, 24-25, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Flemming et al. (US 2010/0022416 A1), hereinafter “Flemming”, as evidenced through Pugia (US 2014/0234892 A1), referred to hereinafter as “Pugia”, and Tansey (US 2006/0008388 A1), hereinafter “Tansey”.
Regarding Claim 1, Flemming teaches a microfluidic chip comprising a plurality of microcavities, wherein the plurality of microcavities comprise a plurality of first microcavities having a first volume, a plurality of second microcavities having a second volume greater than the first volume, and a plurality of microcavities having a third volume greater than the second volume ([0065]: “…the present invention may be formed into standard 1536 well micro-titer plates 10, 43,008 well nano-titer plates 12, microscope slides 14 with nano, micro or standard size wells…In addition, various combinations of these different size wells may be used. In addition, the present invention provides a variety of different cells (i.e. the individual wells) configured (e.g., length, width, depth, opening size, shape, and wall angle and shape) for specific applications.” – [0059]: “The multi-well assay modules (e.g., plates) may have any number of wells and/or chambers of any size or shape, arranged in any pattern or configuration…”),
(See Further Fig. 7A showing the cavities 22a-h as being arranged in rows and columns.)
as in Claim 1.
Further regarding Claim 1, Flemming does not specifically teach the microfluidic chip discussed above wherein the plurality of third microcavities are arranged in a plurality of rows along a first direction and in a plurality of columns along a second direction, the plurality of second microcavities are arranged in a plurality of rows along the first direction and in a plurality of columns along the second direction, a row of second microcavities is disposed between two adjacent rows of third microcavities, and a column of second microcavities is disposed between two adjacent columns of third microcavities; in the first direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a row of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a row of second microcavities; in the second direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a column of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a column of second microcavities, such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, as in Claim 1.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of first/second/third microcavities would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the first/second/third microcavities.
Further, the prior art of Tansey teaches a respective microplate (Abstract: “A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells.”) wherein wells of various sized and shaped openings (See Fig. 4 showing the larger, circular wells 22 and the smaller, triangular wells 24; and [0021]: “additional triangular-shaped sectors or wells 24 may be made to hold the kinetic or other reagents”.) and depths (See Fig. 5) are arranged on the microplate 20 to maximize the utilized space ([0001]: “the present invention relates to a microplate assembly and method which permits a more efficient use of space by adding reagent wells adjacent to the multi-wells”) such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, and throughput is improved.
Thus, given this disclosure of Tansey, it is shown that one of ordinary skill in the art would have been motivated to rearrange and optimize through routine experimentation the three different sized wells suggested by Flemming, such as including Applicant’s claimed “wherein the plurality of third microcavities are arranged in a plurality of rows along a first direction and in a plurality of columns along a second direction, the plurality of second microcavities are arranged in a plurality of rows along the first direction and in a plurality of columns along the second direction, a row of second microcavities is disposed between two adjacent rows of third microcavities, and a column of second microcavities is disposed between two adjacent columns of third microcavities; in the first direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a row of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a row of second microcavities; in the second direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a column of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a column of second microcavities, such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased”, so as to optimize the utilized space on the substrate, such as suggested by Tansey, via routine experimentation, thereby improving throughput.
Further, the claimed arrangement would be obvious to try given there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem (as shown by the desire to optimize utilized space as in Tansey), and wherein the claimed regular arrangement of wells represents one solution out of a finite number of predictable potential solutions to the recognized need or problem (limited number of regular arrangements), and wherein one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success by merely re-orienting the wells. – See Tansey Fig. 4 below showing wells 22 and reagent wells 24:
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Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein a ratio of the first volume, the second volume, and the third volume is 1:2~4:3~8, as in Claim 3.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed above, Flemming discloses the usage of wells varying in size, shape, and configuration (see pars. [0059, 0065] for example) for various applications.
Herein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide Flemming with a ratio of volumes of the at least three types of microcavities with different volumes such as 1:2~4:3~8 so as to hold specifically sized cells/beads, or so as to provide wells of appropriately sized volume for different chemical reactions using different volumes of reagent; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Further regarding Claim 3, Flemming does not explicitly teach the at least three types of microcavities of different volumes as having a volume ratio of 1:2~4:3~8. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed volume ratio of 1:2~4:3~8cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/depth) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein the plurality of first microcavities, the plurality of second microcavities, and the plurality of third microcavities have a same depth ([0091]: “...the wells may be made out of one monolithic structure where well depth is controlled by etch time and acid concentration.” – As the overall plate is etched with acid, thereby simultaneously forming each of the wells, the etch depth must thereby be the same for each of the wells. – See also Fig. 1A showing each of the wells having a same depth given they must all fully penetrate the first layer 20 to open to the substrate 18.), as in Claim 4.
Further regarding Claim 4, Flemming does not specifically teach the microfluidic chip discussed above wherein a ratio of an area of a bottom of a first microcavity of the plurality of first microcavities, an area of a bottom of a second microcavity of the plurality of second microcavities, and an area of a bottom of a third microcavity of the plurality of third microcavities is 1:4:8, as in Claim 4.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed above, Flemming discloses the usage of wells varying in size, shape, and configuration (see pars. [0059, 0065] for example) for various applications.
Herein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide Flemming with a ratio of volumes of the at least three types of microcavities with different volumes such as 1:4:8 so as to hold specifically sized cells/beads, or so as to provide wells of appropriately sized volume for different chemical reactions using different volumes of reagent; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Further regarding Claim 4, Flemming does not explicitly teach the at least three types of microcavities of different volumes as having a bottom area ratio of 1:4:8. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed bottom area ratio of 1:4:8 cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/bottom area) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein a shape of an orthographic projection of the bottom of the first microcavity, a shape of an orthographic projection of the bottom of the second microcavity and a shape of an orthographic projection of the bottom of the third microcavity on the microfluidic chip are circular (Fig. 1A and [0066]: “The wells 22a, 22b and 22c are generally circular in shape having a generally circular opening 24a, 24b and 24c and generally circular bottom.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein a radius of the bottom of the first microcavity is 20 µm~30 µm, a radius of the bottom of the second microcavity is 40 µm~60 µm, and a radius of the bottom of the third microcavity is 56.57 µm~84.85 µm, as in Claim 6.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed above, Flemming discloses the usage of wells varying in size, shape, and configuration (see pars. [0059, 0065] for example) for various applications.
Herein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide Flemming with dimensions of wells such as wherein a radius of the bottom of the first microcavity is 20 µm~30 µm, a radius of the bottom of the second microcavity is 40 µm~60 µm, and a radius of the bottom of the third microcavity is 56.57 µm~84.85 µm so as to hold specifically sized cells/beads, or so as to provide wells of appropriately sized volume for different chemical reactions using different volumes of reagent; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Further regarding Claim 6, Flemming does not explicitly teach the at least three types of microcavities of different volumes wherein a radius of the bottom of the first microcavity is 20 µm~30 µm, a radius of the bottom of the second microcavity is 40 µm~60 µm, and a radius of the bottom of the third microcavity is 56.57 µm~84.85 µm. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed radius of the bottom of the first microcavity being 20 µm~30 µm, a radius of the bottom of the second microcavity being 40 µm~60 µm, and a radius of the bottom of the third microcavity being 56.57 µm~84.85 µm cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/radius of the bottom area) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 8, the prior art meets the limitations of Claim 4 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein the plurality of first microcavities, the plurality of second microcavities and, the plurality of third microcavities are arranged in an array, as in Claim 8.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of first microcavities, second microcavities, and third microcavities would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the first microcavities, second microcavities, and third microcavities.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as wherein the first microcavities, the second microcavities and the third microcavities are arranged in an array, in a first direction, a row of second microcavities is arranged between two adjacent rows of third microcavities, and in a second direction, a column of second microcavities is arranged between two adjacent columns of third microcavities so as to optimize the use of space and maximize the number of cavities of the chip, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein a distance between centers of the bottoms of two adjacent first microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent first microcavities in the second direction, wherein a distance between the centers of the bottoms of two adjacent second microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent second microcavities in the second direction, and wherein a distance between the centers of the bottoms of two adjacent third microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent third microcavities in the second direction, as in Claim 9.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of first microcavities, second microcavities, and third microcavities would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the first microcavities, second microcavities, and third microcavities.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as wherein a distance between centers of the bottoms of two adjacent first microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent first microcavities in the second direction, wherein a distance between the centers of the bottoms of two adjacent second microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent second microcavities in the second direction, and wherein a distance between the centers of the bottoms of two adjacent third microcavities in the first direction is equal to a distance between the centers of the bottoms of two adjacent third microcavities in the second direction so as to optimize the use of space and maximize the number of cavities of the chip, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 10, the prior art meets the limitations of Claim 9 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein an intersection of the third microcavities in two adjacent rows and the third microcavities in two adjacent comunms comprises four third microcavities, lines connecting centers of the bottoms of the four third microcavities form a square, one second microcavity is arranged at a center of the four third microcavities, and a center of the bottom of the second microcavity coincides with a midpoint of a diagonal of the square, and wherein in the first direction or the second direction, one first microcavity is arranged between any two adjacent third microcavities, a center of the bottom of the first microcavity coincides with a midpoint of a line connecting centers of the bottoms of the two adjacent third microcavities, and in the first direction or the second direction, one first microcavity is arranged between any two adjacent second microcavities, a center of the bottom of the first microcavity coincides with a midpoint of a line connecting centers of the bottoms of the two adjacent second microcavities, as in Claim 10.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of first microcavities, second microcavities, and third microcavities would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the first microcavities, second microcavities, and third microcavities.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as wherein an intersection of the third microcavities in two adjacent rows and the third microcavities in two adjacent columns comprises four third microcavities, lines connecting centers of the bottoms of the four third microcavities form a square, one second microcavity is arranged at a center of the four third microcavities, and a center of the bottom of the second microcavity coincides with a midpoint of a diagonal of the square, and wherein in the first direction or the second direction, one first microcavity is arranged between any two adjacent third microcavities, a center of the bottom of the first microcavity coincides with a midpoint of the line connecting centers of the bottoms of the two adjacent third microcavities, and in the first direction or the second direction, one first microcavity is arranged between any two adjacent second microcavities, a center of the bottom of the first microcavity coincides with a midpoint of the line connecting centers of the bottoms of the two adjacent second microcavities so as to optimize the use of space and maximize the number of cavities of the chip, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein an area of an orthographic projection of the plurality of microcavities on the microfluidic chip accounts for 76.82% of an area of the microfluidic chip, as in Claim 11.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative area of an orthographic projection of the plurality of microcavities accounting for 76.82% of an area of the microfluidic chip would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the relative area of an orthographic projection of the plurality of microcavities accounting for 76.82% of an area of the microfluidic chip.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as that a relative area of an orthographic projection of the plurality of microcavities accounts for 76.82% of an area of the microfluidic chip so as to optimize the use of space and maximize the number of cavities of the chip to maximize throughput while avoiding overcrowding and disruption of the structural integrity of the plate, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein a ratio of the first volume, the second volume, and the third volume is 1:2:3, as in Claim 12.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed above, Flemming discloses the usage of wells varying in size, shape, and configuration (see pars. [0059, 0065] for example) for various applications.
Herein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide Flemming with a ratio of volumes of the at least three types of microcavities with different volumes such as 1:2:3 so as to hold specifically sized cells/beads, or so as to provide wells of appropriately sized volume for different chemical reactions using different volumes of reagent; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Further regarding Claim 12, Flemming does not explicitly teach the at least three types of microcavities of different volumes as having a volume ratio of 1:2:3. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed volume ratio of 1:2:3 cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/depth) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 13, the prior art meets the limitations of Claim 12 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein the plurality of first microcavities, the plurality of second microcavities, and the plurality of third microcavities have a same depth ([0091]: “...the wells may be made out of one monolithic structure where well depth is controlled by etch time and acid concentration.” – As the overall plate is etched with acid, thereby simultaneously forming each of the wells, the etch depth must thereby be the same for each of the wells. – See also Fig. 1A showing each of the wells having a same depth given they must all fully penetrate the first layer 20 to open to the substrate 18.), as in Claim 13.
Regarding Claim 18, the prior art meets the limitations of Claim 12 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein an area of an orthographic projection of the plurality of microcavities on the microfluidic chip accounts for 72.90% of an area of the microfluidic chip, as in Claim 18.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative area of an orthographic projection of the plurality of microcavities accounting for 72.90% of an area of the microfluidic chip would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the relative area of an orthographic projection of the plurality of microcavities accounting for 72.90% of an area of the microfluidic chip.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as that a relative area of an orthographic projection of the plurality of microcavities accounts for 72.90% of an area of the microfluidic chip so as to optimize the use of space and maximize the number of cavities of the chip to maximize throughput while avoiding overcrowding and disruption of the structural integrity of the plate, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 19, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein a ratio of the first volume, the second volume, and the third volume is 1:2:4, as in Claim 19.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed above, Flemming discloses the usage of wells varying in size, shape, and configuration (see pars. [0059, 0065] for example) for various applications.
Herein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide Flemming with a ratio of volumes of the at least three types of microcavities with different volumes such as 1:2:4 so as to hold specifically sized cells/beads, or so as to provide wells of appropriately sized volume for different chemical reactions using different volumes of reagent; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Further regarding Claim 19, Flemming does not explicitly teach the at least three types of microcavities of different volumes as having a volume ratio of 1:2:4. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed volume ratio of 1:2:4 cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/depth) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 22, the prior art meets the limitations of Claim 19 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein shapes of an orthographic projection of a bottom of a first microcavity of the plurality of first microcavities, an orthographic projection of a bottom of a second microcavity of the plurality of second microcavities, and an orthographic projection of a bottom of a third microcavity of the plurality of third microcavities on the microfluidic chip are circular (Fig. 1A and [0066]: “The wells 22a, 22b and 22c are generally circular in shape having a generally circular opening 24a, 24b and 24c and generally circular bottom.”), as in Claim 22.
Regarding Claim 24, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein an area of an orthographic projection of the plurality of microcavities on the microfluidic chip accounts for 24.67%~68.43% of an area of the microfluidic chip, as in Claim 24.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative area of an orthographic projection of the plurality of microcavities accounting for 24.67%~68.43% of an area of the microfluidic chip would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the relative area of an orthographic projection of the plurality of microcavities accounting for 24.67%~68.43% of an area of the microfluidic chip.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the cavities of the microfluidic chip of Flemming such as that a relative area of an orthographic projection of the plurality of microcavities accounts for 24.67%~68.43% of an area of the microfluidic chip so as to optimize the use of space and maximize the number of cavities of the chip to maximize throughput while avoiding overcrowding and disruption of the structural integrity of the plate, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 25, the prior art meets the limitations of Claim 24 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein the area of the orthographic projection of the plurality of microcavities on the microfluidic chip accounts for 40.18% of the area of the microfluidic chip, as in Claim 25.
However, Mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of arranged as in a hexagonal dense arrangement wherein a relative area of an orthographic projection of the plurality of microcavities accounts for 40.18% of an area of the microfluidic chip would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the relative arrangement of arranged as in a hexagonal dense arrangement wherein a relative area of an orthographic projection of the plurality of microcavities accounts for 40.18% of an area of the microfluidic chip
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the microcavities of the microfluidic chip of Flemming such as arranged as in a hexagonal dense arrangement wherein a relative area of an orthographic projection of the plurality of microcavities accounts for 40.18% of an area of the microfluidic chip so as to optimize the use of space and maximize the number of cavities of the chip to maximize throughput while avoiding overcrowding and disruption of the structural integrity of the plate, for example; and would have a reasonable expectation of success therein. This is further seen as an obvious engineering design choice for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Regarding Claim 27, Flemming teaches a microfluidic chip comprising a plurality of microcavities, wherein the plurality of microcavities comprise a plurality of first microcavities having a first volume, a plurality of second microcavities having a second volume greater than the first volume, and a plurality of third microcavities having a third volume greater than the second volume ([0065]: “…the present invention may be formed into standard 1536 well micro-titer plates 10, 43,008 well nano-titer plates 12, microscope slides 14 with nano, micro or standard size wells…In addition, various combinations of these different size wells may be used. In addition, the present invention provides a variety of different cells (i.e. the individual wells) configured (e.g., length, width, depth, opening size, shape, and wall angle and shape) for specific applications.” – [0059]: “The multi-well assay modules (e.g., plates) may have any number of wells and/or chambers of any size or shape, arranged in any pattern or configuration…”),
as in Claim 27.
Further regarding Claim 27, Flemming does not specifically teach the microfluidic chip discussed above wherein the plurality of first microcavities, the plurality of second microcavities, and the plurality of third microcavities are arranged in a plurality of rows along a first direction, a row of second microcavities is disposed between two adjacent rows of third microcavities; in the first direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a row of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a row of second microcavities; and wherein the plurality of microcavities are also arranged in a plurality of groups in a third direction parallel to a diagonal direction of the microfluidic chip, a plurality of groups of microcavities comprise a first group of microcavities and a second group of microcavities which are alternately arranged, the first group of microcavities comprises some of the plurality of first microcavities, the second group of microcavities comprises some of the plurality of second microcavities and some of the plurality of third microcavities that are alternately arranged along the third direction, such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, as in Claim 27.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Herein, one skilled in the art would find it obvious that the relative arrangement of the different sized microcavities would not substantially impact the function of the microfluidic device apart from routine and well-understood optimization such as placing certain cavities next to one another such as to minimize the distance a pipette head needs to travel to perform a dilution; such an arrangement thereby providing no specific criticality to the fundamental functioning of the device.
Further, Flemming does not specifically teach away from applying an arrangement wherein the plurality of microcavities comprise three types of microcavities with different volumes, and at least two types of microcavities with different volumes among the three types of microcavities with different volumes are alternately arranged in a first direction; and instead teaches that one may optimize the arrangement of cavities of the device for any desired purpose – [0059]: “The multi-well assay modules (e.g., plates) may have any number of wells and/or chambers of any size or shape, arranged in any pattern or configuration…”.
Further, the prior art of Tansey teaches a respective microplate (Abstract: “A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells.”) wherein wells of various sized and shaped openings (See Fig. 4 showing the larger, circular wells 22 and the smaller, triangular wells 24; and [0021]: “additional triangular-shaped sectors or wells 24 may be made to hold the kinetic or other reagents”.) and depths (See Fig. 5) are arranged on the microplate 20 to maximize the utilized space ([0001]: “the present invention relates to a microplate assembly and method which permits a more efficient use of space by adding reagent wells adjacent to the multi-wells”) such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, and throughput is improved.
Thus, given this disclosure of Tansey, it is shown that one of ordinary skill in the art would have been motivated to rearrange and optimize through routine experimentation the three different sized wells suggested by Flemming, such as including Applicant’s claimed “wherein the plurality of first microcavities, the plurality of second microcavities, and the plurality of third microcavities are arranged in a plurality of rows along a first direction, a row of second microcavities is disposed between two adjacent rows of third microcavities; in the first direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a row of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a row of second microcavities; and wherein the plurality of microcavities are also arranged in a plurality of groups in a third direction parallel to a diagonal direction of the microfluidic chip, a plurality of groups of microcavities comprise a first group of microcavities and a second group of microcavities which are alternately arranged, the first group of microcavities comprises some of the plurality of first microcavities, the second group of microcavities comprises some of the plurality of second microcavities and some of the plurality of third microcavities that are alternately arranged along the third direction, such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased”, so as to optimize the utilized space on the substrate, such as suggested by Tansey, via routine experimentation, thereby improving throughput.
Further, the claimed arrangement would be obvious to try given there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem (as shown by the desire to optimize utilized space as in Tansey), and wherein the claimed regular arrangement of wells represents one solution out of a finite number of predictable potential solutions to the recognized need or problem (limited number of regular arrangements), and wherein one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success by merely re-orienting the wells.
Regarding Claim 28, the prior art meets the limitations of Claim 27 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein the plurality of third microcavities are also arranged in a plurality of columns along a second direction, the plurality of second microcavities are also arranged in a plurality of columns along the second direction, a column of second microcavities is disposed between two adjacent columns of third microcavities; and wherein in the second direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a column of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a column of second microcavities, as in Claim 28.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Herein, one skilled in the art would find it obvious that the relative arrangement of the different sized microcavities would not substantially impact the function of the microfluidic device apart from routine and well-understood optimization such as placing certain cavities next to one another such as to minimize the distance a pipette head needs to travel to perform a dilution; such an arrangement thereby providing no specific criticality to the fundamental functioning of the device.
Further, Flemming does not specifically teach away from applying an arrangement wherein the plurality of microcavities comprise three types of microcavities with different volumes, and at least two types of microcavities with different volumes among the three types of microcavities with different volumes are alternately arranged in a first direction; and instead teaches that one may optimize the arrangement of cavities of the device for any desired purpose – [0059]: “The multi-well assay modules (e.g., plates) may have any number of wells and/or chambers of any size or shape, arranged in any pattern or configuration…”.
Further, the prior art of Tansey teaches a respective microplate (Abstract: “A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells.”) wherein wells of various sized and shaped openings (See Fig. 4 showing the larger, circular wells 22 and the smaller, triangular wells 24; and [0021]: “additional triangular-shaped sectors or wells 24 may be made to hold the kinetic or other reagents”.) and depths (See Fig. 5) are arranged on the microplate 20 to maximize the utilized space ([0001]: “the present invention relates to a microplate assembly and method which permits a more efficient use of space by adding reagent wells adjacent to the multi-wells”) such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, and throughput is improved.
Thus, given this disclosure of Tansey, it is shown that one of ordinary skill in the art would have been motivated to rearrange and optimize through routine experimentation the three different sized wells suggested by Flemming, such as including Applicant’s claimed “wherein the plurality of third microcavities are also arranged in a plurality of columns along a second direction, the plurality of second microcavities are also arranged in a plurality of columns along the second direction, a column of second microcavities is disposed between two adjacent columns of third microcavities; and wherein in the second direction, one of the plurality of first microcavities is disposed between any two adjacent third microcavities in a column of third microcavities, and one of the plurality of first microcavities is disposed between any two adjacent second microcavities in a column of second microcavities”, so as to optimize the utilized space on the substrate, such as suggested by Tansey, via routine experimentation, thereby improving throughput.
Further, the claimed arrangement would be obvious to try given there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem (as shown by the desire to optimize utilized space as in Tansey), and wherein the claimed regular arrangement of wells represents one solution out of a finite number of predictable potential solutions to the recognized need or problem (limited number of regular arrangements), and wherein one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success by merely re-orienting the wells.
Regarding Claim 29, the prior art meets the limitations of Claim 1 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein the plurality of microcavities are also arranged in a plurality of groups in a third direction parallel to a diagonal direction of the microfluidic chip, and wherein a plurality of groups of microcavities comprise a first group of microcavities and a second group of microcavities which are alternately arranged the first group of microcavities comprises some of the plurality of first microcavities, the second group of microcavities comprises some of the plurality of second microcavities and some of the plurality of third microcavities that are alternately arranged along the third direction (See Figs. 7A-B and the annotated Fig. 7A above. Note that the first/second designation to the rows/columns/groups is merely nominal, not requiring any particular structural difference. Thus, the rows and groups of Flemming satisfy the “alternating” requirement as said rows/columns/groups are fully capable of designation as first/second.),
as in Claim 29.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Flemming, as applied to Claims 1, 3-6, 8-12, 18-19, 23-25, and 27 above, in view of Vestal (US 2018/0188241 A1), referred to hereinafter as “Vestal”, and as evidenced through Pugia.
Regarding Claim 7, the prior art meets the limitations of Claim 4 as discussed above. Further, Flemming does not specifically teach the microfluidic chip discussed above wherein the depths of the first microcavity, the second microcavity and the third microcavity are 30 pm-70 pm, as in Claim 7.
However, Vestal teaches a respective microwell array for bead and/or cell capture wherein the depth of the wells is about 40 µm, appropriately sized such that only one bead/cell is contained within the well ([0031]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to fabricate the wells of Flemming to a depth of about 40 µm, such as suggested by Vestal, so as to ensure only one bead/cell is contained within each well for single bead/cell analysis (wherein it is noted that Flemming is similarly interested in single bead/cell analysis [0010-0011]), wherein this point falls completely within the claimed range, thereby anticipating the claimed range; and would have a reasonable expectation of success therein.
Further regarding Claim 7, Flemming does not explicitly teach the at least three types of microcavities of different volumes wherein the depths of the first microcavity, the second microcavity and the third microcavity are 30 µm~70 µm. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed three types of microcavities wherein the depths of the first microcavity, the second microcavity and the third microcavity are 30 µm~70 µm cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/depth) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Flemming in view of Fan, as applied to Claims 13-16 above, and in further view of Vestal, and as evidenced through Pugia. Vestal has been discussed above.
Regarding Claim 17, the prior art meets the limitations of Claim 13 as discussed above. Further, Flemming/Fan does not specifically teach the microfluidic chip discussed above wherein the depths of the plurality of first microcavities, the plurality of second microcavities, and the plurality of third microcavities are 30 pm-70 pm, as in Claim 17.
However, Vestal teaches a respective microwell array for bead and/or cell capture wherein the depth of the wells is about 40 µm, appropriately sized such that only one bead/cell is contained within the well ([0031]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to fabricate the wells of Flemming/Fan to a depth of about 40 µm, such as suggested by Vestal, so as to ensure only one bead/cell is contained within each well for single bead/cell analysis (wherein it is noted that Flemming is similarly interested in single bead/cell analysis [0010-0011]), wherein this point falls completely within the claimed range, thereby anticipating the claimed range; and would have a reasonable expectation of success therein.
Further regarding Claim 17, Flemming does not explicitly teach the at least three types of microcavities of different volumes wherein the depths of the first microcavity, the second microcavity and the third microcavity are 30 µm~70 µm. However, as the size of a microcavity is directly related to the number of cells/beads able to be captured therein (as seen through Pugia para. [0016]), the microcavity size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed three types of microcavities wherein the depths of the first microcavity, the second microcavity and the third microcavity are 30 µm~70 µm cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the size (width/depth) of the three types of microcavities so as to achieve the desired number of cells/beads (or cell/bead types as discussed above) captured therein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Response to Arguments
35 USC 112(b)
Applicant’s amendments sufficiently overcome the 35 USC 112(b) rejections of Claims 1, 27, and 8-10 set forth by the previous correspondence. As such, those rejections of Claims 1, 27, and 8-10 under 35 USC 112(b) are withdrawn.
Amended Independent Claim 1
Applicant’s arguments are on the alleged grounds that none of the cited prior art teaches the particular arrangement of microcavities (Such as shown through Applicant’s instant Fig. 3) optimized to maximize the surface/spatial usage/efficiency of the cavities relative to the substrate, and that such increased efficiency is a substantial change over the prior art which does not amount to mere rearrangement of elements. Applicant contends there is no motivation in the prior art for one to arrive at the specific arrangement of microcavities as in Claim 1.
However, Applicant’s arguments are not persuasive because Tansey (newly added herein as necessitated by Applicant’s amendments) teaches a respective microplate (Abstract: “A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells.”) wherein wells of various sized and shaped openings (See Fig. 4 showing the larger, circular wells 22 and the smaller, triangular wells 24; and [0021]: “additional triangular-shaped sectors or wells 24 may be made to hold the kinetic or other reagents”.) and depths (See Fig. 5) are arranged on the microplate 20 to maximize the utilized space ([0001]: “the present invention relates to a microplate assembly and method which permits a more efficient use of space by adding reagent wells adjacent to the multi-wells”) such that a ratio of an area of the plurality of microcavities to an area of the microfluidic chip is increased, and throughput is improved. Thus, one of ordinary skill in the art would find it obvious in view of Tansey to optimize the arrangement in Flemming so as to maximize the spatial usage of the wells within the chip, wherein one of ordinary skill would seek to optimize via routine experimentation the positions of the respective sized wells such as including the arrangement of amended Claim 1.
Further therein, the claimed arrangement of amended Claim 1 would be obvious to try given there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem (as shown by the desire to optimize utilized space as in Tansey), and wherein the claimed regular arrangement of wells represents one solution out of a finite number of predictable potential solutions to the recognized need or problem (limited number of regular arrangements which would achieve the closest-packed arrangement), and wherein one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success by merely re-orienting the wells.
Thus, Examiner sets forth the rejection of Claim 1 and dependents thereof as unpatentable under 35 USC 103 over at least Flemming in view of Pugia and Tansey, newly cited herein as necessitated by Applicant’s amendments.
Amended Independent Claim 27
Similarly as above, regarding Claim 27, Applicant argues on the alleged grounds that the particular claimed arrangement is not taught in the prior art, and no motivation is present which would lead one to arrive at the claimed arrangement.
However, as discussed above, Tansey provides motivation for one of ordinary skill in the art wherein, when applied to the three different sized wells of Flemming, one of ordinary skill in the art would find it obvious to optimize through routine experimentation to achieve a closest-packed arrangement of wells so as to optimize the surface area/spatial usage of the chip by the wells, wherein the claimed arrangement merely represents one of a finite number of regularly/patterned arranged wells.
Thus, Examiner sets forth the rejection of Claim 27 and dependents thereof as unpatentable under 35 USC 103 over at least Flemming in view of Pugia and Tansey, newly cited herein as necessitated by Applicant’s amendments.
Dependent Claims
Applicant argues on the alleged grounds that the dependent claims depend from the allowable Claims 1 or 27. However, as discussed, Claims 1 and 27 are rejected in view of Flemming, Pugia, and the newly added prior art of Tansey. Thus, claims depending from Claims 1 and 27 are not allowable merely by virtue of dependence.
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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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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