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 .
Claim Objections
Claims 5, 7, 11, 13, and 15-16 are objected to because of the following informalities:
Regarding claim 5, ll. 3 recites “to side wall portions”. Applicant may amend the claim to read “the side wall portions“.
Regarding claim 7, ll. 6 recites “the fluid chamber”. Claim 1 already establishes that the first fluid connection opening connects the first fluid channel to the first fluid chamber and not broadly “the fluid chamber”. Applicant may amend the claim to read “the first fluid chamber “.
Regarding claim 11, ll. 2 recites “channels”. Applicant may amend the claim to read “channel“.
Regarding claim 13, ll. 2 recites “a the top wall“. Applicant may amend the claim to read “a top wall“.
Regarding claim 13, ll. 6 recites “increase“. Applicant may amend the claim to read “increases“.
Regarding claim 16, l. 3 recites “outer side“. Applicant may amend the claim to read “outer sides”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-16 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.
Regarding claim 14, ll. 1-2 recites the limitation “top walls”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend lines 1-2 of the claim to read “wherein each of the fluid chambers comprises a top wall consisting of material transparent to visible light”.
Regarding claim 15, ll. 4-5 recite “the top wall“. It is unclear which top wall contains the thickness limitation. Is it only one of the top walls of the fluid chambers, and if so, which one? Applicant may amend the claim to read “each top wall has a consistent thickness between the inner side and the outer side along the entire length of the respective top wall”.
Claim 16 is rejected due to its dependence on claim 15.
Appropriate correction is required.
Claim Interpretation
The claims contain limitations which are directed to intended uses or capabilities of the claimed invention. These limitations are only given patentable weight to the extent which affects the structure of the claimed invention. Please see MPEP 2114. Note that functional limitations are emphasized in italics herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-5,7-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dodgson (US 20070264705 A1), in view of Sollboehmer et al. (EP 1594613 B1, see attached English translation) and De Vries (US 20220203366 A1, entitled to the EFD of 20190318 by provisional application, US 62819965).
Regarding claim 1, Dodgson teaches a microtiter plate having multiple measurement chamber systems (“The wells are optionally spaced regularly in a 1D or a 2D array, for example at positions according to the SBS microplate standard to allow ready interface to a robotic pipettor, as shown in FIG. 7,” wherein Fig. 4b shows two parallel measurement chamber systems; [0030]; “SBS standard 1536 well plate,” [0047]; Fig. 7), each of the multiple measurement chamber systems comprising:
a first fluid chamber (first well 50; [0052]; Fig. 4f) and a second fluid chamber (second well 54, [0052]; Fig. 4f),
a first fluid channel (channel 52; [0050]; Figs. 4e-f) that connects the first fluid chamber to the second fluid chamber (first wells 50 adapted to receive a cellular entity, each in communication via a channel 52 having a second well 54; [0050]; Figs. 4e-f) and that, in vertical cross section perpendicular to an axis of the first fluid channel, is closed on all sides by at least one wall, the wall comprising a top wall portion and a bottom wall portion connected by side wall portions extending between the top wall portion and the bottom wall portion (Fig. 4e, which is a plan view, depicts the opposed lateral side walls defining the width of fluid channel 52 (shown between wells 50 and 54), while Fig. 4f, a cross-section of Fig. 4e, depicts the top and bottom wall portions. Together, the two views Figs. 4e and 4f establish the claimed 3-D enclosed channel. Additionally, “The channel 52…might be formed by…moulding, embossing, laser drilling or ablation, or lamination of appropriate layers to define the structure,” which describes an enclosed structure; [0058]); and
a base plate (substrate 10; [0050]; Fig. 4f) comprising a bottom wall (See lowest boundary of substrate 10), an upper surface of which forms a bottom wall of the fluid chambers and the bottom wall portion of the first fluid channel (one or both of the channels 64 and 66 are formed in the surface of the substrate 10, linking the first and the second wells respectively; [0051]; Fig. 4f),
wherein the first fluid channel comprises an interior (See closed channel 52 (“channels closed along their length”); [0106]) through which a sample fluid in the microtiter plate flows between the first fluid chamber and the second fluid chamber (Flow of liquid to and from the wells might be entirely by means of…flow through channels communicating with the wells; [0046]; See flow direction shown in Fig. 4f), the interior of the first fluid channel being connected at one end via a first connection opening to the first fluid chamber and at another end via a second connection opening to the second fluid chamber (connection to the wells being made by channels within the substrate; [0048]; See first connection opening as the interface between the left side of channel 52 and first well 50 and second connection opening as the interface between the right side of channel 52 and second well 54);
Dodson fails to teach:
measurement of a sample fluid occurs within fluid chambers,
the first fluid channel further comprises a bubble trap, by way of which the movement of gas bubbles that may be in the fluid being tested in the microtiter plate and which gas bubbles move along the top wall portion of the first fluid channel between the connection openings can be stopped, the bubble trap being located in the top wall portion of the first fluid channel,
wherein the bubble trap comprises at least one of (i) a downwardly facing recess in the top wall portion of the first fluid channel that is open toward the fluid channel interior, and (ii) a downwardly directed projection or web that is formed on the top wall portion of the first fluid channel.
Dodgson instead teaches that each well is observed through a transparent substrate or lid using a microscope to locate a number of oocytes ([0084]). Dodson also teaches “gas-permeable regions 78 in the channel in the lid,” as a means to remove air pockets from the system ([0052]; Fig. 4f).
Sollboehmer teaches measurement of a sample fluid occurs within fluid chambers (“tests that measure the secretion products released from the cells into the medium…in a microtiter plate. The measurement is preferably carried out by optical measuring methods,” wherein “the wells (wells) are closed with a transparent to the optical examination of the sample”; p. 3, para. 4, ll. 2-4; p. 2, l. 25; See Fig. 4 depicting cells 32 in supernatant 34 within microtiter plate 10 where examination beam path 38 penetrates through for measurement)(Under broadest reasonable interpretation, the Examiner understands “a first fluid chamber and a second fluid chamber,” to form the system “in which measurement of a sample fluid occurs,” and therefore measurement in at least one of these chambers satisfies the claim limitation).
Sollboehmer is considered to be analogous to the claimed invention because it is in the same field of endeavor for the measurement of sample fluid within the wells of a microtiter plate. Both Dodgson and Sollboehmer employ a microtiter plate with a transparent top and bottom that allows for analysis of cell egg samples within each well. However, Dodgson aims to observe the number of oocytes in the liquid sample rather than taking a measurement ([0084]). Despite this, Dodgson discusses maintaining oocytes in a maturation medium within the wells for an equilibrium period during which proteins exchange through diffusion ([0038]-[0039]), while Sollboehmer uses an optical means to measure the secretion products released from the cells into the medium (p. 3, para. 4, ll. 2-4). There is a reasonable expectation of success for employing Sollboehmer’s optical measurement technique to the oocyte sample in Dodgson’s microplate since the base/substrate is already transparent and has “optical properties that can be chosen or controlled easily in the fabrication process,” so as “to give good visibility from below” (Dodson, [0030], [0082]). Additionally, Sollboehmer states that “it is possible to carry out a measurement in or on the cells as well as an examination of the medium” (p. 4, ll. 5-6), which would preserve Dodgson’s intent to observe the number of oocytes. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson to incorporate the teachings of Sollboehmer by providing optical measurement of the sample fluid within the sample well system during or following the equilibrium period because it would provide analytical information regarding the maturation of the oocytes, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Modified Dodson fails to teach:
the first fluid channel further comprises a bubble trap, by way of which the movement of gas bubbles that may be in the fluid being tested in the microtiter plate and which gas bubbles move along the top wall portion of the first fluid channel between the connection openings can be stopped, the bubble trap being located in the top wall portion of the first fluid channel,
wherein the bubble trap comprises at least one of (i) a downwardly facing recess in the top wall portion of the first fluid channel that is open toward the fluid channel interior, and (ii) a downwardly directed projection or web that is formed on the top wall portion of the first fluid channel.
Dodson instead teaches “gas-permeable regions 78 in the channel in the lid,” as a means to remove air pockets from the system ([0052]; Fig. 4f).
De Vries teaches a fluid channel (The Examiner interprets the fluid channel to include “channels 154, 156,” and “bubble trap 116” in between; [0058]; Figs. 9-12; Provisional, [0052], [0046]; Fig. 9-12), further comprises a bubble trap (bubble trap 116; [0058]; Figs. 9-12; Provisional, [0052]; Figs. 9, 11-12), by way of which the movement of gas bubbles that may be in the fluid being tested and which gas bubbles move along the top wall portion of the first fluid channel between the connection openings can be stopped (“beams 702, 704, and therefore these beams could also be considered barriers that inhibit or prevent bubbles in the calibration fluid from entering the channel 156. Advantageously, these barriers in the bubble trap 116 could inhibit bubbles in the calibration fluid from flowing to the sensing region 118, which is in fluid communication downstream of the channel 156,” wherein another part of the bubble trap are “The bubble trapping sections 706, 708, 710 are distinct volumes of the chamber 700 that could confine and/or partially enclose any or all bubbles that enter the chamber 700”; [0082], [0079]; Figs. 9, 11-12; Provisional, [0057],[0054]; Figs. 9, 11-12),
the bubble trap being located in the top wall portion of the first fluid channel (“The top of the channels 154, 156 are defined by respective walls of surfaces 736, 738, which are shown in FIG. 11,” and wherein the top of the fluid channel, which includes channels 154, 156 and the bubble trap, extends to include the top surface 502 of the fluidic device 500 in Fig. 12; [0077]; Fig. 11; Provisional, [0052]; Fig. 11),
wherein the bubble trap comprises at least one of (i) a downwardly facing recess in the top wall portion of the fluid channel that is open toward the fluid channel interior (See bubble trapping sections 706, 708, 710 in Figs. 9,11-12), and
(ii) a downwardly directed projection or web that is formed on the top wall portion of the first fluid channel (Each of the transverse beams 702, 704 is adjacent to the top of the chamber 700 and extends substantially perpendicular to a direction of flow; [0078]; Figs. 9, 11-12; Provisional, [0053]; See Figs. 9,11-12).
De Vries is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic devices with bubble management for performing optical measurement on fluid samples. Modified Dodgson already acknowledges bubbles as undesirable in its sample fluid path and incorporates gas-permeable regions to release them (Dodgson, [0052]; 78 in Fig. 4f). Modified Dodgson also relies upon optical microscope observation and measurement through a transparent lid that covers the wells (Dodgson, [0030]; Sollboehmer, p. 2, l. 25), while De Vries teaches that bubbles in an optical sensing region of the system can interfere with sensors and reduce reliability and repeatability of the measurements ([0074]; Provisional, [0049]). Thus, positioning De Vries’s bubble trapping structure in Modified Dodgson’s fluid path would predictably capture or divert bubbles away from the regions used for optical observation and represents an alternative means for controlling bubbles that Dodgson already recognizes as an unwanted interference. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson in view of Sollboehmer to incorporate the teachings of De Vries by adding a bubble trap within the first fluid channel because it would reduce bubble related interference with microscope observation and optical measurement of the cellular entities while maintaining Dodgson’s desired continuous liquid path, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 2, Modified Dodgson teaches the microtiter plate as claimed in claim 1, further comprising an inlet chamber (inlet port 68; Dodgson, [0052], Fig. 4f) for each of the measurement chamber systems (Fig. 4b of Dodgson shows two parallel measurement chamber systems with inlet ports 68 and 72) for providing a sample fluid to each of the measurement chamber systems (Since “fluid can flow from the inlet port to the outlet port,” the apparatus is functionally capable of providing a sample fluid to each of the measurement chamber systems; Dodgson, [0029]) and
an outlet chamber (outlet port 74; Dodgson, [0052], Fig. 4f) for each of the measurement chamber systems (Fig. 4b of Dodgson shows two parallel measurement chamber systems with outlet ports 74 and 70) for removing the sample fluid from each of the measurement chamber systems (Since the apparatus is capable of “displacing liquid through the outlet,” the apparatus is functionally capable of removing the sample fluid from each of the measurement chamber systems; Dodgson, [0040]).
Regarding claim 3, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein if the bubble trap comprises the recess, the recess, in cross section, extends over the entire width or breadth of the top wall portion of the first fluid channel (The width of the bubble trapping sections 706, 708, 710 is substantially similar to the width of the chamber 700; De Vries, [0054]; See Figs.9, 11-12).
Regarding claim 4, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein if the bubble trap comprises a projection, the projection covers a portion of an inner surface of the top wall portion of the first fluid channel (As shown in FIG. 11, the beam 702 includes a top surface 728…Similarly, the beam 704 includes a top surface 730…The top surfaces 728, 730 are substantially co-planar with the top of the chamber 700 and the top surface 102 of the substrate 100; De Vries, [0053]; See Fig. 9).
Regarding claim 5, Modified Dodgson teaches the microtiter plate as claimed in claim 4, wherein the projection sealingly covers the portion of the inner surface of the top wall portion of the first fluid channel and to side wall portions of the first fluid channel (The beams 702, 704 also include respective upstream walls or surfaces 714, 718, which are substantially perpendicular to the top of the chamber 700 and to the top surfaces 728, 730; De Vries, [0053]; See Fig. 9 which shows the transverse beams extending between the lateral sides of chamber and connected to bubble trapping sections 706, 708, 710 which are substantially similar to the width of the chamber 700), the side wall portions of the first fluid channel extending between the connection openings of the first fluid channel, so that, to the sides of and above the projection, no gas bubbles are able to move past the projection or web (trap the air bubbles between the surfaces 714, 718, 722 and the top of the chamber. For example, the air bubble 1206 has collided with the surface 714 and is confined to the bubble trapping section 706; De Vries, [0058]; Fig. 12).
Regarding claim 7, Modified Dodgson teaches the microtiter plate as claimed in claim 2, wherein if the bubble trap comprises the recess, a height of the recess of the bubble trap at a highest point of the recess is at least one of:
greater than a maximum height of the first fluid channel;
greater than a height of the first connection opening which connects the first fluid channel to the fluid chamber in the direction from the inlet chambers to the outlet chambers (“The top of the channels 154, 156 are defined by respective walls of surfaces 736, 738, which are shown in FIG. 11,” wherein the top of channel 154 is the first connection opening and “the top of the chamber 700…defines the top boundary of the bubble trapping sections 706, 708, 710,” wherein the top of the chamber 700 is the highest point of the recess; De Vries, [0077],[0079]; See elevation from 736 to 700 in Figs. 11-12); and
greater than a height of the first fluid chamber in the direction from the inlet chambers to the outlet chambers.
Regarding claim 8, Modified Dodgson teaches the microtiter plate as claimed in claim 1, further comprising a plurality of fluid channels that connect a plurality of fluid chambers in succession in a fluid flow direction of the sample fluid (“Channels 76 connect the second well 54 of the first pair of wells to the first well 50 of a second pair, so connecting the wells in series from the inlet port 68 to the outlet port 74,” wherein Fig. 4f is a cross section of Fig. 4e and shows an arrow pointing right for fluid flow; Dodgson, [0052], [0050]; Figs. 4e-f), wherein each of the fluid channels comprises a bubble trap (“a means to remove air pockets from the system…regions 78 in the channel in the lid, preferably above the wells,” which are substituted as the bubble removal part of reference De Vries and would be positioned within the channels instead of above the wells; Dodgson, [0052]; Fig. 4f) .
Regarding claim 9, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein the first fluid channel is tubular in structure and the top wall portion is a portion of the tubular structure corresponding to a top of the tubular structure, the bottom wall portion is a portion of the tubular structure corresponding to a bottom of the tubular structure, and the side wall portions are portions of the tubular structure corresponding to sides of the tubular structure (“channels closed along their length,” wherein “The channels may have…a rounded profile”; Dodgson, [0106], [0085]; See side walls of channel 52 between wells 50 and 54 of Fig. 4e and top and bottom wall portions in Fig. 4f).
Regarding claim 10, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein the top wall portion is a top wall corresponding to a top of the first fluid channel, the bottom wall portion is a bottom wall located directly below the top wall and corresponding to a bottom of the first fluid channel, and the side wall portions are side walls connecting the top wall to the bottom wall and corresponding to sides of the first fluid channel (“channels closed along their length,” wherein “The channels may have…a rounded profile”; Dodgson, [0106], [0085]; See side walls of channel 52 between wells 50 and 54 of Fig. 4e and top and bottom wall portions in Fig. 4f).
Regarding claim 11, Modified Dodgson teaches the microtiter plate as claimed in claim 2, wherein the inlet chamber is connected to the first fluid chamber by an inlet fluid channels [sic] (inlet channel 64 Dodgson, [0053]; Figs. 4e-f), and via which the sample fluid is supplied to the measurement chamber system (“medium is flowed from the inlet well 68 through the inlet channel 64 to the first wells,” wherein the measurement occurs within the wells; Dodgson, [0053]; Figs. 4e-f).
Regarding claim 12, Modified Dodgson teaches the microtiter plate as claimed in claim 2, wherein the outlet chamber is connected to the second fluid chamber in the direction from the inlet chamber to the outlet chamber by an outlet fluid channel (See inlet chamber 68 with flow direction leading to the second fluid chamber 54 which is connected to outlet fluid channel 66 which is connected to outlet chamber 74 as shown in Figs. 4e-f of Dodgson), and via which the sample fluid is removed from the measurement chamber system (displacing liquid through the outlet; Dodgson, [0040]).
Regarding claim 14, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein the top walls of the fluid chambers consist of material transparent to visible light (“the lid 20 is transparent, and the upper surface of the channel formation 32 in the lid is of good optical quality so that the cellular entities can be observed from above,” where “the channel 32 can be formed in the surface of the substrate 10, the lid then having a flat profile over the position of the wells”; Dodgson, [0030],[0032],[0051]), and the top walls of the fluid chambers each have the same thickness as each other (The lid 60 then has a flat profile at the position of the wells; Dodgson, [0051],[0032]; See equal thickness of lid 20 above wells 12 in Fig. 1a).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dodgson (US 20070264705 A1), in view of Sollboehmer et al. (EP 1594613 B1, see attached English translation) and De Vries (US 20220203366 A1, entitled to the EFD of 20190318 by provisional application, US 62819965), as applied to claim 1 above, and in further view of Vaisman et al. (US 20170045438 A1) and Xia et al. (US 10532357 B1, EFD of 2019-04-26).
Regarding claim 6, Modified Dodgson teaches the microtiter plate as claimed in claim 1.
Modified Dodgson fails to teach the first fluid channel decreases in height and increases in width in a direction of flow of the sample fluid from the first fluid chamber to the second fluid chamber at least in a first section of the first fluid channel such that, in said first section of the first fluid channel, an inner side of the top wall portion of the first fluid channel extends so as to be inclined to the horizontal.
Vaisman teaches the first fluid channel decreases in height and increases in width in a direction of flow of the sample fluid from a first fluid chamber to a second fluid chamber (“The central acquisition channel may increase in width and decrease in depth along the flow axis,” wherein the central acquisition channel receives fluid between chambers or left bypass channel 30 and right bypass channel 34 as shown in Fig. 4 and explained in paragraph [0067]; [0014]).
Vaisman is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic devices for controlling sample fluid flow and performing optical measurement. After teaching the claimed increase in channel width paired with a decrease in channel height, Vaisman explains that choice of cross-sections are optimized to minimize shear stresses on the fluid flow before optical measurement ([0016],[0038]; Fig. 4). Figs. 4e-f of Dodgson shows medium flowing through a succession of channels and well pairs to expose oocytes to common fluid conditions, while expressing the desire “that the cellular entities will not be affected by flow through the channel” ([0031]). Dodgson even provides motivation to vary the dimensions of channel 52 to retain the oocytes by minimizing flow resistance, providing a reasonable expectation of success when adopting Vaisman’s channel dimensions (See Dodgson, [0058]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson in view of Sollboehmer and De Vries to incorporate the teachings of Vaisman by decreasing the height and increasing the width of the first channel (52 of Figs. 4e-f) because it would facilitate controlled fluid flow with reduced disturbance to the cellular entities by minimizing shear stress prior to optical measurement, and this involves applying a known technique to a known device ready for improvement to yield predictable results (See MPEP 2143(I)(D)).
Modified Dodgson is silent to teaching the first fluid channel decreases in height and increases in width in a direction of flow of the sample fluid from the first fluid chamber to the second fluid chamber at least in a first section of the first fluid channel such that, in said first section of the first fluid channel, an inner side of the top wall portion of the first fluid channel extends so as to be inclined to the horizontal (Emphasis added).
Xia teaches that in a first section of a fluid channel, an inner side of the top wall portion of the fluid channel extends so as to be inclined to the horizontal (a ramp, a step, or constriction is disposed on a top surface (122) of the flow focusing channel (120)…which reduces the height reduction of the portion of the flow focusing channel (120); col. 7, ll. 18-22; Fig. 4D).
Xia is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic devices for controlling sample fluid flow through microchannels. Vaisman already teaches the design of decreasing channel height for reduction of shear stress, while Xia describes a way for this to be achieved by implementing a height decrease from the top of the channel. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson in view of Sollboehmer, De Vries, and Vaisman to incorporate the teachings of Xia by decreasing the height of the top wall portion a first section of the first channel so as to be inclined to the horizontal (52 of Figs. 4e-f) because it is a known way of physically implementing the channel geometry that Vaisman already teaches, and this involves use of known technique to improve similar devices in the same way (See MPEP 2143(I)(C)).
Claims 13, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dodgson (US 20070264705 A1), in view of Sollboehmer et al. (EP 1594613 B1, see attached English translation) and De Vries (US 20220203366 A1, entitled to the EFD of 20190318 by provisional application, US 62819965), as applied to claim 1 above, and in further view of Ingber et al. (US 20170158997 A1) and Vaisman et al. (US 20170045438 A1).
Regarding claim 13, Modified Dodgson teaches the microtiter plate as claimed in claim 1, wherein the microtiter plate has at least two fluid chambers (See multiple wells 12, 50, and 54 of Figs. 1a and 4f of Dodgson), each of which is upwardly closed by a the [sic] top wall (The lid 60 then has a flat profile at the position of the wells; Dodgson, [0051],[0032]; See lid 20 as top wall above wells 12 in Fig. 1a).
Modified Dodgson fails to teach an inner height of each successive fluid chamber in a direction of flow of the sample fluid is less than the inner height of a previous fluid chamber,
and a fluid channel which decreases in height and increase in width in the direction of flow of the sample fluid from the previous fluid chamber to the successive fluid chamber in at least one section of the fluid channel.
Ingber teaches an inner height of each successive fluid chamber in a direction of flow of the sample fluid is less than the inner height of a previous fluid chamber (a first structure defining a first microfluidic chamber having a height; a second structure defining a second microfluidic chamber having a height, wherein the height of the first chamber is greater than the height of the second chamber; [0016]).
Ingber is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic devices for controlling sample fluid flow through microchannels. The teachings of Ingber are concerned with the culture and/or support of living cells ([0003]) and explains that “the heights of the first chamber and the second chamber can vary to suit the needs of desired applications (e.g., to provide a low shear stress, and/or to accommodate cell size)”. Ingber’s findings conclude that “subjecting the cells to a low shear stress (e.g., a fluid flow) can facilitate maintenance of cell viability” ([0058]). Likewise, Figs. 4e-f of Dodgson shows oocyte culture medium flowing through a succession of channels and well pairs to expose oocytes to common fluid conditions, while expressing the desire “that the cellular entities will not be affected by flow through the channel” ([0031]). Dodgson already recognizes that channel geometry should be selected to control the effects of fluid flow while handling living cells by teaching that varying the dimensions of channel 52 to retain the oocytes can minimize flow resistance, providing a reasonable expectation of success when adopting Ingber’s chamber dimensions (See Dodgson, [0058]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson in view of Sollboehmer and De Vries to incorporate the teachings of Ingber by configuring the first chamber to have a greater height than the second chamber because it would facilitate controlled fluid flow with reduced disturbance to the cellular entities by minimizing shear stress, and this involves applying a known technique to a known device ready for improvement to yield predictable results (See MPEP 2143(I)(D)).
Modified Dodgson fails to teach a fluid channel which decreases in height and increase [sic] in width in the direction of flow of the sample fluid from the previous fluid chamber to the successive fluid chamber in at least one section of the fluid channel,
Vaisman teaches a fluid channel which decreases in height and increases in width in the direction of flow of the sample fluid from the previous fluid chamber to the successive fluid chamber in at least one section of the fluid channel (“The central acquisition channel may increase in width and decrease in depth along the flow axis,” wherein the central acquisition channel receives fluid between chambers or left bypass channel 30 and right bypass channel 34 as shown in Fig. 4 and explained in paragraph [0067]; [0014]).
Vaisman is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic devices for controlling sample fluid flow and performing optical measurement. After teaching the claimed increase in channel width paired with a decrease in channel height, Vaisman explains that choice of cross-sections are optimized to minimize shear stresses on the fluid flow before optical measurement ([0016],[0038]; Fig. 4). Figs. 4e-f of Dodgson shows medium flowing through a succession of channels and well pairs to expose oocytes to common fluid conditions, while expressing the desire “that the cellular entities will not be affected by flow through the channel” ([0031]). Dodgson even provides motivation to vary the dimensions of channel 52 to retain the oocytes by minimizing flow resistance, providing a reasonable expectation of success when adopting Vaisman’s channel dimensions (See Dodgson, [0058]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell handling apparatus taught by Dodgson in view of Sollboehmer, De Vries, and Ingber to incorporate the teachings of Vaisman by decreasing the height and increasing in width of the first channel (52 of Figs. 4e-f) because it would facilitate controlled fluid flow with reduced disturbance to the cellular entities by minimizing shear stress prior to optical measurement, and this involves applying a known technique to a known device ready for improvement to yield predictable results (See MPEP 2143(I)(D)).
Regarding claim 15, Modified Dodgson teaches the microtiter plate as claimed in claim 13, wherein the top walls of the fluid chambers each have an inner side that faces the interior of the respective one of the fluid chambers, and an outer side that faces outwards from the microtiter plate, wherein the top wall has a consistent thickness between the inner side and the outer side along the entire length of the top wall (“The lid 60 then has a flat profile at the position of the wells,” which necessarily creates an inner side that faces the interior of the respective one of the fluid chambers, and an outer side that faces outwards from the microtiter plate; Dodgson, [0051],[0032]; See equal thickness of lid 20 above wells 12 along the entire height of the lid in Fig. 1a).
Regarding claim 16, Modified Dodgson teaches the microtiter plate as claimed in claim 15, wherein the inner sides of the top walls of the fluid chambers, facing the interior of the respective fluid chambers, and/or the outer side of the top walls of the fluid chambers, extend parallel to the base plate of the microtiter plate or parallel to an outer side of the base plate (See Fig. 1a which shows the bottom of lid 20 to be parallel to the base plate or substrate 10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kim et al., 2017 (instant PTO-892) teaches a bubble trap with both recesses and projections within a microfluidic device (See paras. [0042], [0048], and Figs. 3-4).
Murayama, 2013 (instant PTO-892) teaches a bubble trap with recesses that descend stepwise in a sample liquid flow channel for sample measurement (Abstract, Fig. 6).
No claims are allowed.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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