DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments and remarks, filed on 1/2/2026, has been entered. The previous prior art rejection has been withdrawn and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-2 and 5-20 are pending with claims 1-2 and 5-14 being examined and claims 15-20 are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Husain et al (US 20160045884 A1; hereinafter “Husain”; already of record), and in further view of Hoffman et al (US 20170018626 A1; hereinafter “Hoffman”; already of record).
Regarding claim 1, Husain teaches a device for detecting a protein-based marker (Husain; Abstract; para [29]), comprising:
a first cover plate (Husain; Fig. 2; para [63]; housing top 140), in which an only one liquid inlet and an only one liquid outlet are provided (Husain; Fig. 2; para [63]; Housing top (140) has an inlet port (150) and an outlet port (160));
a second cover plate attached to the first cover plate to form a chamber (Husain; Fig. 3B; para [111]; The housing base (60) also has a pair of connection rods (110) to connect the housing base (60) to the housing top (140)); and
a square chip in the chamber (Husain; Fig. 3A; para [95, 116]; square chip…the housing base (60) containing the polymer capture film (10) on the film support component (50)), wherein
the square chip comprises a glass substrate (Husain; para [84]; the chip is composed (e.g., mostly or entirely) out of silicon, quartz, glass, or a combination of such materials)) and a micro-hole array layer on a side of the glass substrate (Husain; para [86]; capture-chips that contain a plurality of cell-sized spots or dimples (e.g., mini-wells) that each allow a single cell to be captured from a cell mixture), the micro-hole array layer comprising a plurality of micro-holes arranged in an array, with each of the micro-holes being a nano micro-hole (Husain; para [96]; The wells (e.g., nanowells) in the multi-well devices may be fabricated in any convenient size, shape or volume), and
the only one liquid inlet and the only one liquid outlet are configured such that a solution containing a plurality of magnetic particles enters the chamber via the only one liquid inlet, flows through at least a portion of the plurality of micro-holes of the micro-hole array layer, and discharges from the only one liquid outlet1 (Husain; para [63, 65]; Housing top (140) has an inlet port (150) and an outlet port (160). The inlet port (150) connects to a sample delivery component (190), shown as a syringe in this figure… a housing assembly (45) and a swing arm (210) that has a drain port (220) designed to engage with the outlet port (160)),
the square chip has an array region in which the square micro-hole array layer is formed and a bonding region surrounding the array region (Husain; Fig. 2; para [110]; The slot array component 180 is, in certain embodiments, sized based on the size of the polymer capture film, such that the slots can deliver cell-containing liquid to the top of the holes/channels in the polymer film),
the only one liquid inlet and the only one liquid outlet are disposed in the first cover plate in the bonding region and respectively located at two non-adjacent vertex angles of the square chip (Husain; Fig. 2, 3B; the liquid inlet and outlet is positioned above the bonding region, interpreted as the slot array component 180, and the inlet and outlets are on opposite sides of the square chip).
1 The limitation is directed to the function and/or the manner of operating the only one liquid inlet and the only one liquid outlet, all the structural limitations of the claim has been disclosed by Husain “configured such that a solution containing a plurality of magnetic particles enters the chamber via the only one liquid inlet, flows through at least a portion of the plurality of micro-holes of the micro-hole array layer, and discharges from the only one liquid outlet”. As such, it is deemed that the claimed only one liquid inlet and claimed only one liquid outlet is not differentiated from the only one liquid inlet and the only one liquid outlet of Husain (see MPEP §2114). Thus, the limitation “a plurality of magnetic particles” is not a positively recited limitation and not required.
Husain does not teach the square micro-hole array comprises: a photoresist layer on the side of the glass substrate; a plurality of initial micro-holes in the photoresist layer, and a passivation layer covering a surface, away from the glass substrate, of the photoresist layer between any two initial micro-holes directly adjacent to each other of the plurality of initial micro-holes and covering bottom walls and side walls of the plurality of initial micro-holes to form the plurality of micro-holes.
However, Hoffman teaches an analogous art of device for performing bioinformatics analysis (Hoffman; Abstract) comprising a micro-hole array layer (Hoffman; Fig. 5e; para [247]; The array 1 includes a multiplicity of wells 38) further comprising: a photoresist layer on the side of a glass substrate; a plurality of initial micro-holes in the photoresist layer (Hoffman; para [304]; a mask with the desired pattern(s) may be used to transfer a pattern onto a photosensitive photoresist material), and a passivation layer covering a surface, away from the glass substrate, of the photoresist layer between any two initial micro-holes directly adjacent to each other of the plurality of initial micro-holes and covering bottom walls and side walls of the plurality of initial micro-holes to form the plurality of micro-holes (Hoffman; para [27, 304]; a passivation layer may be disposed on the surface and/or channel, such as layered or otherwise deposited on the 1D, 2D, or 3D layer and/or on an associated reaction layer on the surface and/or channel…wells formed by photopatterning or photolithographic process). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the square micro-hole array layer of Husain to comprise the photoresist layer as taught by Hoffman, because Hoffman teaches that the photoresist patterns the well by laser, electron beam, or plasma (Hoffman; para [304]). Further, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the square micro-hole array layer of Husain to comprise the passivation layer as taught by Hoffman, because Hoffman teaches that the increases the measurement sensitivity and/or accuracy of the sensor (Hoffman; para [35]).
Regarding claim 5, modified Husain teaches the device according to claim 1, with the first cover plate and the second cover plate.
Modified Husain does not teach the device further comprising a magnetic field generator, wherein the magnetic field generator is on a side of the second cover plate away from the first cover plate, and the magnetic field generator is configured to form a magnetic field at the square micro-hole array layer such that each of the plurality of micro-holes is capable of having a respective one magnetic particle fallen therein under influence of the magnetic field.
However, Hoffman teaches an analogous art of device for performing bioinformatics analysis (Hoffman; Abstract) comprising a magnetic field generator, wherein the magnetic field generator (Hoffman; para [55]) is on a side of the second cover plate away from the first cover plate (Hoffman; Fig. 5e), and the magnetic field generator is configured to form a magnetic field at the micro-hole array layer such that each of the plurality of micro-holes is capable of having a respective one magnetic particle fallen therein under influence of the magnetic field (Hoffman; para [55]; magnetic field component is configured to generate an electric and/or magnetic field so as to interact with the electric and/or magnetic charge properties of each of the plurality of microbeads to attract the microbeads into a reaction location, such as a reaction surface, a channel, a well, a chamber, and/or a sensor of the FET device, such as by using electrophoresis and/or magnetism). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the device of Husain to comprise the magnetic field generator as taught by Hoffman, because Hoffman teaches that the magnetic field component is configured to generate an electric and/or magnetic field so as to interact with the electric and/or magnetic charge properties of each of the plurality of microbeads to attract the microbeads into a reaction location, such as a reaction surface, a channel, a well, a chamber, and/or a sensor of the FET device, such as by using electrophoresis and/or magnetism (Hoffman; para [55]).
Regarding claim 6, modified Husain teaches the device according to claim 1, wherein
the first cover plate has a non-patterned planar shape (Husain; Fig. 2; the limitation requires a “non-patterned planar shape” which is broadly interpreted as any planar surface comprising no patterns which is depicted by the top surface of the housing top as seen in Fig. 2),
the second cover plate is provided therein with a groove (Husain; Fig. 2; para [63]; The film support component (50) is configured to sit in the film support recess (70)), and
the first cover plate covers the groove of the second cover plate to form the chamber together with the second cover plate (Husain; para [110]; the slot array component is, in certain embodiments, sized based on the size of the polymer capture film, such that the slots can deliver cell-containing liquid to the top of the holes/channels in the polymer film).
Regarding claim 12, modified Husain teaches the device according to claim 1 (the square micro-hole array of Husain is modified to comprise the photoresist layer and the passivation layer as taught by Hoffman discussed above in claim 1), with the passivation layer. Modified Husain does not teach wherein the passivation layer has a thickness in a range of 2500 Å to 3500 Å. Hoffman teaches the passivation layer may have a thickness of about 50 nanometers (Hoffman; para [27]). However, there is no established criticality or evidence showing an unexpectedly good result occurring form the claimed parameters. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have thickness in a range between 2500 Å to 3500 Å, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, it has been held that where the general conditions of a 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 233. MPEP 2144.05.II.
Regarding claim 14, Husain teaches a detection device configured to detect a protein-based marker (Husain; Abstract; para [222]), comprising:
a first cover plate (Husain; Fig. 2; para [63]; housing top 140), in which an only one liquid inlet and an only one liquid outlet are provided (Husain; Fig. 2; para [63]; Housing top (140) has an inlet port (150) and an outlet port (160));
a second cover plate attached to the first cover plate to form a chamber (Husain; Fig. 3B; para [111]; The housing base (60) also has a pair of connection rods (110) to connect the housing base (60) to the housing top (140)); and
a square chip in the chamber (Husain; Fig. 3A; para [95, 116]; square chip…the housing base (60) containing the polymer capture film (10) on the film support component (50)) and comprises a glass substrate (Husain; para [84]; the chip is composed (e.g., mostly or entirely) out of silicon, quartz, glass, or a combination of such materials)) and a square micro-hole array layer on a side of the glass substrate (Husain; para [86]; capture-chips that contain a plurality of cell-sized spots or dimples (e.g., mini-wells) that each allow a single cell to be captured from a cell mixture), the square micro-hole array layer comprising a plurality of micro-holes arranged in a square array, with each of the micro-holes being a nano micro-hole (Husain; para [96]; The wells (e.g., nanowells) in the multi-well devices may be fabricated in any convenient size, shape or volume); and
the only one liquid inlet and the only one liquid outlet are configured such that a solution containing a plurality of magnetic particles enters the chamber via the only one liquid inlet, flows through at least a portion of the plurality of micro-holes of the square micro-hole array layer, and discharges from the only one liquid outlet1 (Husain; para [63, 65]; Housing top (140) has an inlet port (150) and an outlet port (160). The inlet port (150) connects to a sample delivery component (190), shown as a syringe in this figure… a housing assembly (45) and a swing arm (210) that has a drain port (220) designed to engage with the outlet port (160)), and
the square chip has an array region in which the square micro-hole array layer is formed and a bonding region surrounding the array region (Husain; Fig. 2; para [110]; The slot array component 180 is, in certain embodiments, sized based on the size of the polymer capture film, such that the slots can deliver cell-containing liquid to the top of the holes/channels in the polymer film),
the only one liquid inlet and the only one liquid outlet are disposed in the first cover plate in the bonding region and respectively located at two non-adjacent vertex angles of the square chip (Husain; Fig. 2, 3B; the liquid inlet and outlet is positioned above the bonding region, interpreted as the slot array component 180, and the inlet and outlets are on opposite sides of the square chip).
1 The limitation is directed to the function and/or the manner of operating the only one liquid inlet and the only one liquid outlet, all the structural limitations of the claim has been disclosed by Husain “configured such that a solution containing a plurality of magnetic particles enters the chamber via the only one liquid inlet, flows through at least a portion of the plurality of micro-holes of the micro-hole array layer, and discharges from the only one liquid outlet”. As such, it is deemed that the claimed only one liquid inlet and claimed only one liquid outlet is not differentiated from the only one liquid inlet and the only one liquid outlet of Husain (see MPEP §2114). Thus, the limitation “a plurality of magnetic particles” is not a positively recited limitation and not required.
Husain does not teach wherein the device comprising a magnetic field generator on a side of the second cover plate away from the first cover plate, wherein the magnetic field generator is configured to form a magnetic field at the square micro-hole array layer such that each of the plurality of micro-holes is capable of having a respective one magnetic particle fallen therein under influence of the magnetic field, and the square micro-hole array layer comprises: a photoresist layer on the side of the glass substrate; a plurality of initial micro-holes in the photoresist layer; and a passivation layer covering a surface, away from the glass substrate, of the photoresist layer between any two initial micro-holes directly adjacent to each other of the plurality of initial micro-holes and covering bottom walls and side walls of the plurality of initial micro-holes to form the plurality of micro-holes.
However, Hoffman teaches an analogous art of device for performing bioinformatics analysis (Hoffman; Abstract) comprising a magnetic field generator, wherein the magnetic field generator (Hoffman; para [55]) is on a side of the second cover plate away from the first cover plate (Hoffman; Fig. 5e), and the magnetic field generator is configured to form a magnetic field at the micro-hole array layer such that each of the plurality of micro-holes is capable of having a respective one magnetic particle fallen therein under influence of the magnetic field (Hoffman; para [55]; magnetic field component is configured to generate an electric and/or magnetic field so as to interact with the electric and/or magnetic charge properties of each of the plurality of microbeads to attract the microbeads into a reaction location, such as a reaction surface, a channel, a well, a chamber, and/or a sensor of the FET device, such as by using electrophoresis and/or magnetism) comprising a micro-hole array layer (Hoffman; Fig. 5e; para [247]; The array 1 includes a multiplicity of wells 38) further comprising: a photoresist layer on the side of a glass substrate; a plurality of initial micro-holes in the photoresist layer (Hoffman; para [304]; a mask with the desired pattern(s) may be used to transfer a pattern onto a photosensitive photoresist material), and a passivation layer covering a surface, away from the glass substrate, of the photoresist layer between any two initial micro-holes directly adjacent to each other of the plurality of initial micro-holes and covering bottom walls and side walls of the plurality of initial micro-holes to form the plurality of micro-holes (Hoffman; para [27, 304]; a passivation layer may be disposed on the surface and/or channel, such as layered or otherwise deposited on the 1D, 2D, or 3D layer and/or on an associated reaction layer on the surface and/or channel…wells formed by photopatterning or photolithographic process). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the device of modified Husain to comprise the magnetic field generator as taught by Hoffman, because Hoffman teaches that the magnetic field component is configured to generate an electric and/or magnetic field so as to interact with the electric and/or magnetic charge properties of each of the plurality of microbeads to attract the microbeads into a reaction location, such as a reaction surface, a channel, a well, a chamber, and/or a sensor of the FET device, such as by using electrophoresis and/or magnetism (Hoffman; para [55]). Additionally, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the square micro-hole array layer of Husain to comprise the photoresist layer as taught by Hoffman, because Hoffman teaches that the photoresist patterns the well by laser, electron beam, or plasma (Hoffman; para [304]). Further, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the square micro-hole array layer of Husain to comprise the passivation layer as taught by Hoffman, because Hoffman teaches that the increases the measurement sensitivity and/or accuracy of the sensor (Hoffman; para [35]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Husain in view of Hoffman, and in further view of Goto (WO 2016159068 A1; hereinafter “Goto”; already of record; English translation previously attached).
Regarding claim 2, Husain teaches the device according to claim 1, wherein a depth or a diameter of the micro-hole is larger than a diameter of the magnetic particle and smaller than twice the diameter of the magnetic particle (Husain; para [9, 33]; the single cell to be captured is from 5-100 μm in diameter…the top opening of each of the individual channels is about 5 μm to about 80 μm in diameter), such that each of the plurality of micro-holes is capable of containing one magnetic particle, each of the plurality of micro-holes has a diameter in a range from 4 µm to 5 µm (Husain; para [33]; the top opening of each of the individual channels is about 5 μm to about 80 μm in diameter). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the diameter of the micro-hole to be the range of about 5 μm that corresponds to the claimed range. See MPEP 2144.05(I). Additionally, the examiner notes that the “magnetic particle” is not a positively recited limitation and not required as discussed above in claim 1. However, modified Husain teaches that the diameter of the well could be changed according to the diameter of the sample. Thus, it would have been obvious to have chosen micro-hole diameter that corresponds to the microbeads of Hoffman.
Modified Husain does not teach wherein each of the plurality of micro-holes has a depth in a range from 3 µm to 5 µm.
However, Goto teaches an analogous art of microfluidic device for analyzing aqueous liquid (Goto; pp 1, para [1]), comprising: a first cover plate (Goto; Fig. 1B; pp 6, para [8]; a lid member 1200), in which a liquid inlet and a liquid outlet are provided (Goto; Fig. 1B; pp 6, para [8]; flow path inlet 1210 A flow path outlet 1220); a second cover plate attached to the first cover plate to form a chamber (Goto; Fig. 1B; pp 6, para [8]; a bottom member 1100); a micro-hole array layer (Goto; Fig. 1B; pp 6, para [9]; the microwell array) comprising a plurality of micro-holes arranged in an array (Goto; Fig. 1B; pp 6, para [9]; a pattern mask of a design such that a hole of a target pattern is opened is used at a place where a microwell is desired to be formed; examiner interprets the holes/spacing as seen in Fig. 1B as the micro-holes) wherein each of the plurality of micro-holes has a depth in a range from 3 µm to 5 µm (Goto; Fig. 1B; pp 3, para [10]; When the well is cylindrical, the diameter may be 3 to 10 μm for the purpose of enclosing an aqueous liquid containing biomolecules. Further, the depth may be 3 to 10 μm. The dimensions of the well can be determined in consideration of the amount of the aqueous liquid to be contained in the well and the preferable ratio of the size of the carrier to the size of the carrier such as the bead to which the biomolecule is attached). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum depth to a range of 3 µm to 5 µm which would allow the carrier to which the biomolecule is attached to be contained within the well (Goto; pp 3, para [10]). (MPEP § 2144.05 (II)).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Husain in view of Hoffman, and in further view of.
Regarding claim 7, modified Husain teaches the device according to claim 6, with the first cover plate and the second cover plate.
Modified Husain does not teach the second cover plate further has a connection region surrounding the chamber and being attached to the first cover plate, and the first cover plate is adhered to the second cover plate with an adhesive in the connection region.
However, Fang teaches an analogous art of a microfluidic device (Fang; Abstract) comprising a second cover plate with a connection region surrounding the chamber and being attached to a first cover plate (Fang; Fig. 5; para [74]; bonding second substrate 112 to surface 104 of first substrate 102 to enclose the array of wells 122 in a cavity; examiner interprets the surface 104 to be the connection region), and a first cover plate is adhered to a second cover plate with an adhesive in the connection region (Fang; Fig. 5; para [30]; Second substrate 112 can be bonded to first substrate 102 by adhesive bonding; laser bonding (or laser welding); anodic bonding; acid- and/or pressure-assisted, low temperature bonding; another suitable bonding technique; or a combination thereof). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first cover plate and the second cover plate of modified Husain to comprise the adhesive connection region as taught by Fang, because Fang teaches that the bonding provides a fluid-tight hermetic bond to prevent leaking (Fang; para [30]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Husain in view of Hoffman, and in further view of Horita (JP 2006030160 A; hereinafter “Horita”; English translation attached; already of record).
Regarding claim 8, modified Husain teaches the device according to claim 7, wherein the second cover plate is made of a material of organic glass (Husain; para [32, 120]; The base support layer may comprise a material such as glass). Husain teaches organic glass as materials may be combination of glass polymers.
Modified Husain does not teach wherein the first cover plate is made of a material of organic glass, and the adhesive is an ultraviolet adhesive.
However, Horita teaches an analogous art of a reaction container (Horita; para [1]) comprising a first cover plate made of a material of organic glass (Horita; para [9]; the cover plate is formed of glass), and an adhesive is an ultraviolet adhesive (Horita; para [20]; cover plate 2 is formed of a transparent material, and the adhesive of the adhesive layer 12 is an ultraviolet curable adhesive). It would have been obvious to one of ordinary skilled in the art by the effective filing date to have modified the first cover plate of modified Husain to be glass as taught by Horita, because Horita teaches that the ultraviolet rays for adhesion can be efficiently and uniformly cured through the transparent material (Horita; para [37]). Further, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the adhesive of modified Husain to be the ultraviolet adhesive as taught by Horita, because Horita teaches that the ultraviolet rays cure the adhesive layer to accurately connect the base and cover plate (Horita; para [43]).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Husain in view of Hoffman, and in further view of Savran et al (US 20190143328 A1; hereinafter “Savran”; already of record).
Regarding claim 9, modified Husain teaches the device according to claim 1, wherein
each of the first cover plate and the second cover plate has a non-patterned planar shape (Husain; Fig. 2; the limitation requires a “non-patterned planar shape” which is broadly interpreted as any planar surface comprising no patterns which is depicted by the top surface of the housing top and the bottom surface of the base as seen in Fig. 2).
Modified Husain does not teach wherein the device further comprises a connection layer between the first cover plate and the second cover plate and defining the chamber, and an orthographic projection of the connection layer on the second cover plate does not overlap an orthographic projection of the square chip on the second cover plate.
However, Savran teaches an analogous art of microfluidic systems (Savran; Abstract) comprises a first cover plate and a second cover plate (Savran; Fig. 3C-1; para [149]; the micro-well chip 360 and a transparent sheet 380 to form a chamber); a connection layer between the first cover plate and the second cover plate and defining the chamber (Savran; Fig. 3C-1; para [149]; spacer 370 is placed between the micro-well chip 360 and a transparent sheet 380 to form a chamber where a fluid sample containing target entities is introduced for a cell extraction operation), and an orthographic projection of the connection layer on the second cover plate does not overlap an orthographic projection of the chip on the second cover plate (Savran; Fig. 3C-1; para [149]; spacer 370 is placed between the micro-well chip 360 and a transparent sheet 380; examiner interprets the sidewall of spacer to be the orthographic projection as seen in Fig. 3C-1, because the spacer extends upward/orthogonal between the two cover plates/layers). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the sidewall of modified Husain to be a connection layer as taught by Savran as this is a known and suitable substation for bonding the first cover plate and the second cover plate in the art. One would have a reasonable expectation of success by changing the bonding of the first cover plate and the second cover plate of modified Husain to comprise the connection layer as Savran teaches this arrangement is a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 10, modified Husain teaches the device according to claim 9, wherein upper and lower surfaces of the connection layer are bonded to the first cover plate and the second cover plate by plasma bonding. The Applicant is advised that the limitations “upper and lower surfaces of the connection layer are bonded to the first cover plate and the second cover plate by plasma bonding” are product-by-process limitations. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Thus, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I). The process of bonding does not structurally change the fluidic device, so modified Husain teaches the structure implied by the connection layer as claimed.
Regarding claim 11, modified Husain teaches the device according to claim 10 (the device of modified Husain is modified to comprise the connection layer as taught by Savran discussed above in claim 9), wherein each of the first cover plate and the second cover plate is made of a material of inorganic glass (Husain; para [120]; The base support layer may comprise a material such as glass, quartz, silicon, or an inert substrate), and the connection layer is made of a material of polydimethylsiloxane (Savran; para [150]; the spacer 370 is constructed from PDMS).
Modified Husain does not teach wherein the first cover plate is made of a material of organic glass.
However, Savran teaches an analogous art of microfluidic systems (Savran; Abstract) comprises a first cover plate (Savran; Fig. 3C-1; para [149]; the micro-well chip 360 and a transparent sheet 380 to form a chamber), wherein the first cover plate is made of a material of organic glass (Savran; para [133]; he top layer (and in some implementations the bottom layer) is made of, or includes a window of, a transparent material such as glass). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the material of the first cover plate of modified Husain to be glass as taught by Savran as this is a known and suitable material for the first cover plate in the art. One would have a reasonable expectation of success by changing the material of the first cover plate of modified Husain to be glass as Savran teaches this material is a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Husain in view of Hoffman, and in further view of Handique et al (US 20170157610 A1; hereinafter “Handique”; already of record).
Regarding claim 13, modified Husain teaches the device according to claim 1, wherein a size of the micro-hole array layer along a direction parallel to the glass substrate (Husain; Fig. 2; examiner notes that the microchip comprising the micro-hole array layer extends parallel to the substrate based on the orientation).
Modified Husain does not teach wherein the size is one third to one half of a size of the glass substrate along the direction.
However, Handique teaches an analogous art of a system for isolating and analyzing single cells (Handique; Abstract; para [28]; The system 100 is preferably defined on a substrate, more preferably a microfluidic chip), comprising: a chip comprises a glass substrate (Handique; Fig. 1; para [31]; the substrate 105 can be composed of any one or more of: glass) and a micro-hole array layer on a side of the glass substrate (Handique; Fig. 1; para [31]; the substrate 105 has a broad surface 106, and functions to provide a medium at which the set of wells 112 can be defined); the micro-hole array layer wherein the size is one third to one half of a size of the glass substrate along the direction (Handique; Fig. 1; para [34, 55]; the substrate 105 in the specific example has dimensions of 3 inches by 1 inch… a well is substantially equal in length, e.g., exactly equal length, equal to within 10-100 microns). Examiner notes that Handique teaches that there can be any suitable number of wells (Handique; para [35]). It would have been an obvious matter of choice to select a number of wells with a length of 10-100 microns to be the size of one third to one half of a size of the glass substrate, which is 3 inches (Handique; para [34]), since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. MPEP §2144.04 (IV)(A). Specifically, the length of the array being 1/3 to 1/2 the size of the glass substrate is dependent on the number of wells present.
Response to Arguments
Applicants’ arguments, see pages 10-11, filed 1/2/2026, with respect to the 112(a) rejection is found to be persuasive.
Applicants’ arguments filed, 1/2/2026, have been considered and the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The non-persuasive arguments are addressed below.
In the Applicants’ arguments, on page 12-13, the Applicant argues that Husain in view of Handique fails to teach the new claim limitations. Examiner respectfully disagrees. The limitations of “a square chip” and “two non-adjacent vertex angles” are taught by Husain. Specifically, Husain teaches the square chip has an array region in which the square micro-hole array layer is formed and a bonding region surrounding the array region (Husain; Fig. 2; para [110]; The slot array component 180 is, in certain embodiments, sized based on the size of the polymer capture film, such that the slots can deliver cell-containing liquid to the top of the holes/channels in the polymer film), the only one liquid inlet and the only one liquid outlet are disposed in the first cover plate in the bonding region and respectively located at two non-adjacent vertex angles of the square chip (Husain; Fig. 2, 3B; the liquid inlet and outlet is positioned above the bonding region, interpreted as the slot array component 180, and the inlet and outlets are on opposite sides of the square chip).
In the Applicants’ arguments, on page 14, the Applicant argues that Husain in view of Handique in view of Goto fail to teach the new claim amendments. The examiner respectfully disagrees. Husain teaches wherein a depth or a diameter of the micro-hole is larger than a diameter of the magnetic particle and smaller than twice the diameter of the magnetic particle (Husain; para [9, 33]; the single cell to be captured is from 5-100 μm in diameter…the top opening of each of the individual channels is about 5 μm to about 80 μm in diameter), such that each of the plurality of micro-holes is capable of containing one magnetic particle, each of the plurality of micro-holes has a diameter in a range from 4 µm to 5 µm (Husain; para [33]; the top opening of each of the individual channels is about 5 μm to about 80 μm in diameter). The claim requires “a depth or a diameter” and Husain teaches the new claim limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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