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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Remarks
This Office Action fully acknowledges Applicant’s remarks and amendments filed 10 November 2025.
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No claims are withdrawn from consideration.
Claims 28 and 29 are newly added.
Claim Rejections - 35 USC § 112
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, 3-13, 17-19, 22, 24-25, and 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent Claims 1 and 27 recite, in relevant part, “a first microcavity with a smallest volume, a second microcavity with a middle volume and a third microcavity with a largest volume” wherein this recitation renders the scope of the claim unclear. The claim does not particularly define whether the comparison is made among all microcavities in the plurality of microcavities, among only three selected microcavities, or among categories or groups of microcavities. Thus, as written, it is unclear whether the “first microcavity” mist be the smallest of all microcavities in the device, or merely one example of a smaller cavity; and similarly, whether the “third microcavity” must be uniquely the largest cavity or simply larger than the other two related cavities. Further, the “second microcavity” does not particularly point to the “middle volume” aspect as being a middle volume between that of the first and second microcavities. Applicant may wish to amend the claims with a recitation on the order of “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”.
Further to this end, the instant independent Claims 1 and 27 reciting these microcavities only recite them in singular form “a first/second/third microcavity”. As such, these single microcavities are not capable of being arranged in alternating rows/columns/groups as recited in Claims 1, 8, 10, and 27-29 as a single item is not capable of being alternated; a plurality of first/second/third microcavities are needed to afford such an alternating arrangement and satisfy what appears to be Applicant’s intent of having a plurality of first/second/third microcavities arranged along the columns/rows/groups in the first/second/third directions.
Claims 8-10 recite the limitations "the first microcavities”, “the second microcavities”, and “the third microcavities”. There is insufficient antecedent basis for these limitations in the claim.
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”, and as evidenced through Pugia (US 2014/0234892 A1), referred to hereinafter as “Pugia”.
Regarding Claim 1, Flemming teaches a microfluidic chip comprising a plurality of microcavities, wherein the plurality of microcavities comprise a first microcavity with a smallest volume, a second microcavity with a middle volume and a third microcavity with a largest 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…”),
the plurality of microcavities are arranged in a plurality of rows in a first direction and in a plurality of columns in a third direction parallel to a diagonal direction of the microfluidic chip (See Figs. 7A-B and the annotated Fig. 7A below.),
wherein a plurality of rows of microcavities comprise a first row of microcavities and a second row of microcavities which are alternately arranged, and wherein a plurality of columns of microcavities comprise a first column of microcavities and a second column of microcavities which are alternately arranged (See Figs. 7A-B. Note that the first/second designation to the rows/columns is merely nominal, not requiring any particular structural difference. Thus, the rows and columns of Flemming satisfy the “alternating” requirement as said rows/columns are fully capable of designation as first/second.),
as in Claim 1.
Further regarding Claim 1, Flemming does not specifically teach the microfluidic chip discussed above wherein the first microcavity and the third microcavity are alternately arranged along the first direction in the first row of microcavities, and the first microcavity and the second microcavity are alternately arranged along the first direction in the second row of microcavities, and the first column of microcavities comprises one or more first microcavities, and the second column of microcavities comprises the second microcavity and the third microcavity alternately arranged along the third direction, 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.
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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 volumes of the first microcavity, the second microcavity, and the third microcavity 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 first microcavity, the second microcavity and the third microcavity 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 the first microcavity, an area of a bottom of the second microcavity, and an area of a bottom of the third microcavity 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 first microcavities, the second microcavities and the third microcavities are arranged in an array, in the first direction, a row of second microcavities is arranged between two adjacent rows of third microcavities, and in a second direction, a group of second microcavities is arranged between two adjacent groups of third microcavities, 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 groups 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, 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 the ratio of volumes of the first microcavity, the second microcavity, and the third microcavity 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 first microcavity, the second microcavity and the third microcavity 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 volumes of the first microcavity, the second microcavity, and the third microcavity 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 the first microcavity, an orthographic projection of the bottom of the second microcavity and 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 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 first microcavity with a smallest volume, a second microcavity with a middle volume and a third microcavity with a largest 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…”),
the plurality of microcavities are arranged in a plurality of rows in a first direction and in a plurality of groups in a second direction, wherein a plurality of rows of microcavities comprise a first row of microcavities and a second row of microcavities which are alternately arranged, and wherein a plurality of groups of microcavities comprise a first group of microcavities and a second group of microcavities which are alternately arranged (See Figs. 7A-B. Note that the first/second designation to the rows/groups is merely nominal, not requiring any particular structural difference. Thus, the rows and columns of Flemming satisfy the “alternating” requirement as said rows/groups are fully capable of designation as first/second.),
as in Claim 27.
Further regarding Claim 27, Flemming does not specifically teach the microfluidic chip discussed above wherein the first microcavity and the third microcavity are alternately arranged along the first direction in the first row of microcavities, and the first microcavity and the second microcavity are alternately arranged along the first direction in the second row of microcavities, and the first microcavity and the second microcavity are alternately arranged along the second direction in the first group of microcavities, and the first microcavity and the third microcavity are alternately arranged along the second direction in the second group of microcavities, 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…”.
Regarding Claim 28, the prior art meets the limitations of Claim 27 as discussed above. Further, Flemming teaches the microfluidic chip discussed above wherein the plurality of microcavities are also arranged in a plurality of columns in a third direction parallel to a diagonal direction of the microfluidic chip, and wherein a plurality of columns of microcavities comprise a first column of microcavities and a second column of microcavities which are alternately arranged, the first column of microcavities comprises one or more first microcavities (See Figs. 7A-B and the annotated Fig. 7A below. 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 28.
Further regarding Claim 28, Flemming does not specifically teach the microfluidic chip discussed above wherein the second column of microcavities comprises the second microcavity and the third microcavity alternately arranged along the third direction, 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 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.
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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 second direction, and wherein a plurality of groups of microcavities comprise a first group of microcavities and a second group of microcavities which are alternately arranged (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.
Further regarding Claim 29, Flemming does not specifically teach the microfluidic chip discussed above wherein the first microcavity and the second microcavity are alternately arranged along the second direction in the first group of microcavities, and the first microcavity and the third microcavity are alternately arranged along the second direction in the second group of microcavities, as in Claim 29.
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.
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 first microcavity, the second microcavity and the third microcavity 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
Amended Independent Claim 1
Applicant’s arguments are on the grounds that the cited prior art allegedly fails to teach the claimed arrangement of first/second/third microcavities as positioned along alternating rows/columns in a closest packed arrangement so that space on the substrate is maximally efficiently utilized. Applicant points out that Flemming does not specify any particular arrangement of its three different sized wells.
Applicant’s arguments are not persuasive because the claimed invention merely recites a particular arrangement of wells that are otherwise structurally and functionally identical to those taught by the prior art. The prior art of Flemming commensurately teaches wells of three different size formed in a substrate as a microfluidic chip performing the same intended function of receiving liquid samples. The claimed alternating arrangement does not modify the structure or operation of the wells themselves, nor does it result in a different functional relationship among the cells. (And, as discussed in the body of the action, Flemming teaches that any arrangement of the wells is permissible.) A change in spatial arrangement of known elements that perform the same functions as previously taught constitutes a mere rearrangement of parts, which is considered herein as an obvious matter of design choice – see MPEP 2144.04(VI)(C). Thus, as the claimed wells operate in an identical manner as the prior art regardless of their arrangement in alternating rows/columns, the arrangement does not impart patentable distinction.
Additionally, improving spatial efficiency or increasing packing density is a well-known engineering objective and does not establish criticality or unexpected results. Such optimization constitutes routine engineering design and does not rise to the level of patentable invention. To prove patentable distinction, Applicant must show that the claimed arrangement of wells provides a new function, different mode of operation, or otherwise unexpected results relative to the prior art.
Further, Applicant’s arguments, particularly citing the arrangement of first/second/third microcavities portrayed through the instant drawings Fig. 3, is not commensurate in scope with the claims. As discussed in the 35 USC 112 section above in the body of the action, Applicant’s instant claims merely recite singular first/second/third microcavities not capable of being arranged in alternating rows/columns/groups as singular elements. As such, the arrangement shown through the instant Fig. 3 argued by Applicant is not afforded by the present recitations of the instant claims, thereby rendering Applicant’s arguments as moot.
Thus, Examiner maintains the rejection of Claim 1, and dependents thereof, under 35 USC 103 as unpatentable over at least Flemming.
Amended Independent Claim 27
Similarly as above, Applicant’s arguments are on the grounds that the cited prior art allegedly fails to teach the claimed arrangement of first/second/third microcavities as positioned along alternating rows/columns in a closest packed arrangement so that space on the substrate is maximally efficiently utilized. Applicant points out that Flemming does not specify any particular arrangement of its three different sized wells.
Applicant’s arguments are not persuasive because the claimed invention merely recites a particular arrangement of wells that are otherwise structurally and functionally identical to those taught by the prior art. The prior art of Flemming commensurately teaches wells of three different size formed in a substrate as a microfluidic chip performing the same intended function of receiving liquid samples. The claimed alternating arrangement does not modify the structure or operation of the wells themselves, nor does it result in a different functional relationship among the cells. (And, as discussed in the body of the action, Flemming teaches that any arrangement of the wells is permissible.) A change in spatial arrangement of known elements that perform the same functions as previously taught constitutes a mere rearrangement of parts, which is considered herein as an obvious matter of design choice – see MPEP 2144.04(VI)(C). Thus, as the claimed wells operate in an identical manner as the prior art regardless of their arrangement in alternating rows/columns, the arrangement does not impart patentable distinction.
Additionally, improving spatial efficiency or increasing packing density is a well-known engineering objective and does not establish criticality or unexpected results. Such optimization constitutes routine engineering design and does not rise to the level of patentable invention. To prove patentable distinction, Applicant must show that the claimed arrangement of wells provides a new function, different mode of operation, or otherwise unexpected results relative to the prior art.
Thus, Examiner maintains the rejection of Claim 1, and dependents thereof, under 35 USC 103 as unpatentable over at least Flemming.
Dependent Claims
Applicant argues that claims depending from the allegedly allowable Claims 1 and 27 are allowable by virtue of their dependence on Claims 1 and 27. However, as discussed above, independent Claims 1 and 27 are maintained rejected under 35 USC 103 over Flemming. Thus, dependents of Claims 1 and 27 are not allowable merely for their dependency on Claims 1 and 27.
New Claims
Claims 28-29 are newly added herein. Claims 28-29 are rejected under 35 USC 103 as unpatentable over Flemming.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798