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 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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (US 20200055054 A1) in view of Stroup (US 4297901 A) (referenced in 892).
Regarding claim 1, Kambez et al. teaches a clamping device (abstract) comprising:
a base (See annotated FIG. 6 below, base - element 670);
a plate on the base (FIG. 6, glass slide – element 616);
a removable barrier component on the plate (microfluidic device – element 612), wherein the removable barrier component is configured to at least partially defines a first region (FIG. 2 – where microfluidic device defines a first region formed from an upper microchannel 34 and lower microchannel 36 [para. 0035]); the removable barrier component including a bottom surface in contact with the plate (FIG. 6 – element 612), a top surface opposite the bottom surface (FIG. 6 – element 612).
a press (movable compression plate – element 614) configured to engage the top surface of the removable barrier component to apply a predetermined pressure to the removable barrier component, the removable barrier component being between the press and the plate (FIG. 6).
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Kambez et al. fails to teach:
A hold down toggle clamp
Regarding limitation I, Stroup et al. teaches a press for injection molding machines (FIG. 1). Stroup et al. specifically teaches using a toggle press mechanism in the apparatus, where the “toggle mechanisms provide a mechanical advantage allowing the use of a hydraulic system having a smaller capacity pump than the hydraulic systems used in a press which is closed directly by a hydraulic cylinder. Toggle mechanisms also provide positive lock capabilities” (Col. 1, lines 20-32).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Stroup et al.’s teaching of a toggle press mechanism in Kambez et al.’s clamping device because the toggle press mechanism provides i) a mechanical advantage allowing the use of a hydraulic system having a smaller capacity pump than the hydraulic systems used in a press which is closed directly by a hydraulic cylinder and ii) positive lock capabilities. This method of improving Kambez et al.’s clamping device was within the ability of one ordinary skill in the art based on the teachings of Stroup et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kambez et al. and Stroup et al. to obtain the invention specified in claim 1.
Regarding claim 23, modified Kambez et al. teaches the apparatus of claim 1. Kambez et al. further teaches an additional embodiment of a clamping system (FIG. 3), where base (element 370) contains an aperture (element 355), where the aperture allows the placement of the glass slide into the base (para. [0069]).
Regarding claim 24, modified Kambez et al. teaches the apparatus of claim 1. Kambez also teaches that the plate is made of glass. (FIG. 6, glass slide – element 616).
Claims 2, 3, 7, 10, 14, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced) as applied to claim 1 above, and further in view of Peters (US 4299920 A).
Regarding claim 2, modified Kambez et al. teaches the apparatus of claim 1. Modified Kambez et al. fails to teach that the removable barrier component is configured to at least partially define a plurality of regions including the first region. Regarding this limitation, Peters teaches a receptacle for cell cultures and biological tests (abstract). Specifically, the wall member used in the receptacle is a detachable, liquid-tight wall member (abstract). The base plate (FIG. 2a, element 3) and wall section (FIG. 2a, element 1) define chambers for cell culturing, with the wall section being pressed to produce adhesion (Col. 1, 5th paragraph), which allow the holes to be sealed in a liquid tight manner on their underside by the base plate (Col. 2, Detailed Description of Invention paragraph, Col. 3, First paragraph). Structurally, the chambers form a plurality of regions (See annotated FIG. 2a below)
It would have been obvious to a person of ordinary skill in the art to use Peters’ teaching of a sealing removable wall section in modified Kambez et al.’s clamping device because the wall section defines chambers for cell culturing, while forming liquid-tight chambers through by pressing the wall section onto the base for adhesion. Thus, it would be obvious to utilize a clamping device in combination with the wall section taught by Peters to define said regions. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Peters. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Peters to obtain the invention as specified in claim 2.
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Regarding claim 3, modified Kambez et al. teaches the apparatus of claim 2. Peters further teaches a removable barrier component (wall section – element 1) further includes a transverse wall between the first region and a second region of the plurality of regions (See annotated FIG. 2a above). The structure resulting in the combination of claim 2 would result in a removable barrier component featuring a transverse wall between regions.
Regarding claim 7, modified Kambez et al. teaches the apparatus of claim 3. Peters further teaches a removable barrier component with a peripheral wall surrounding the first and the second region (See annotated FIG. 2a above).
Regarding claim 10, modified Kambez et al. teaches the apparatus of claim 3. Peters further teaches a removable barrier component with at least partially defining a third region (See annotated FIG. 2a above).
Regarding claim 14, modified Kambez et al. teaches the apparatus of claim 1. Peters teaches a removable barrier component defined by a plurality of apertures, which would structurally define a first region (See annotated FIG. 3a below). Wall member used in the receptacle is a detachable, liquid-tight wall member (abstract), as base plate (FIG. 3a, element 3) and wall section (FIG. 3a, element 1) define chambers for cell culturing, with the wall section being pressed to produce adhesion (Col. 1, 5th paragraph), which allow the holes to be sealed in a liquid tight manner on their underside by the base plate (Col. 2, Detailed Description of Invention paragraph, Col. 3, First paragraph).
It would have been obvious to a person of ordinary skill in the art to use Peters’ teaching of a sealing removable wall section with apertures in modified Kambez et al.’s clamping device because the wall section defines chambers (apertures) for cell culturing, while forming liquid-tight chambers through by pressing the wall section onto the base for adhesion. Thus, it would be obvious to utilize a clamping device in combination with the wall section taught by Peters to define regions from the apertures. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Peters. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Peters to obtain the invention as specified in claim 14.
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Regarding claim 25, modified Kambez et al. teaches the apparatus of claim 1. Peters further teaches a removable barrier component, where the wall section (element 1) used in the receptacle is a detachable, liquid-tight to the base plate (abstract), which allows a plurality of chambers (element 2) to be formed (Col. 2, Detailed Description of Invention paragraph). Structurally, the wall member forms a joint with the plate by forming a liquid tight seal with base plate (element 3), specifically when pressed (Col. 1, 3rd paragraph of Summary of Invention). This seal isolate cell cultures into specific areas (Col. 1, 2nd paragraph – Background).
It would have been obvious to a person of ordinary skill in the art to use Peters’ teaching of a liquid sealing removable wall section in modified Kambez et al.’s clamping device because cell cultures can therefore be isolated through applying pressure through the clamping device with the liquid sealing removable wall section. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Peters. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Peters to obtain the invention as specified in claim 25.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Peters (already referenced) as applied to claim 3 above, and further in view of Farmer (US 3715280 A).
Regarding claim 4, modified Kambez et al. teaches the apparatus of claim 3. Modified Kambez et al. fails to disclose the specific wall thickness used in the removable barrier component. Farmer teaches a dividing member (element 12), with a wall thickness of 0.5 – 2 mm (Col. 3, 1st paragraph), as the dividing member divides the cultures into various test areas to provide simultaneous tests (abstract). Farmer specifically teaches that the dimensions (wall thickness - 0.5 – 2 mm) to be particularly suitable for the purposes of the invention (Col. 3, 1st paragraph). Furthermore, it has been established in MPEP § 2144.05.I in the case that the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. The claimed range of a thickness of greater than or equal to about 0.1 mm to less than or equal to about 50 mm overlaps with Farmer’s disclosed range of wall thickness of 0.5 – 2 mm. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to use the claimed thickness range taught by Farmer in modified Kambez et al.’s barrier because it is particularly suitable in dividing cultures for simultaneous testing, as disclosed in Farmer.
Regarding claim 5, modified Kambez et al. teaches the apparatus of claim 4. Farmer teaches a dividing member (element 12), with a wall thickness of 0.5 – 2 mm (Col. 3, 1st paragraph), as the dividing member divides the cultures into various test areas to provide simultaneous tests (abstract). Farmer specifically teaches that the dimensions (wall thickness - 0.5 – 2 mm) to be particularly suitable for the purposes of the invention (Col. 3, 1st paragraph). The claimed range of a thickness greater than or equal to about 0.5 mm to less than or equal to 5 mm overlaps the range disclosed by the prior art. It has been established in MPEP § 2144.05.I in the case that the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to use the claimed thickness range taught by Farmer in modified Kambez et al.’s barrier because it is particularly suitable in dividing cultures for simultaneous testing, as disclosed in Farmer.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Peters (already referenced) as applied to claim 3 above, and further in view of Chen (CN 110894459 A with attached MT from prior office action).
Regarding claim 6, modified Kambez et al. teaches the apparatus of claim 3, but fails to teach a port fluidly connecting the first and second regions. Chen teaches a microbial culture dish, which includes partitions or walls (element 2). The walls contain air blowing hole (element 201), which allow air to be blown on scattered cultured medium, preventing accumulation in the corners and causing nutrient excess during microbial culture (para. [0031] of MT). Air blowing hole (element 201) fluidly connects two separate culture regions (See FIG. 1).
It would have been obvious to a person of ordinary skill in the art to use Chen’s teaching of air blowing holes in modified Kambez et al.’s clamping device because air blowing holes prevent accumulation of culture medium in the corners, preventing nutrient excess in regions of the culture. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Chen. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Chen to obtain the invention as specified in claim 6.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Peters (already referenced) as applied to claim 2 above, and further in view of Keye (US 3787290 A).
Regarding claim 8, modified Kambez et al. teaches the apparatus of claim 2. Modified Kambez et al. fails to teach that the first and second regions are different in terms of volume. Keye teaches a tray (element 22) formed with depressions cavities, compartments, or zones (element 24 – FIG. 1) of various volumes (See annotated FIG. 1). Keye further teaches that this structurally allows most probable number assays to be performed (Col. 7, 3rd paragraph) by diluting the sample serially and observing which dilutions do not produce growth in nutrient media (Col 2. 6th paragraph). “In this method, instead of diluting the fluid whose bacterial concentration is desired, one plants replicate samples of different volumes of the fluid in nutrient media and observes which samples produce evidence of growth, and which do not” (Col 2. 6th and 7th paragraph).
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It would have been obvious to a person of ordinary skill in the art to use Keye’s teaching of different volumes in modified Kambez et al.’s removable barrier because the different volumes allow most probable number assays to be performed through serial dilutions in the tray – enabling observation of which samples produce growth and which do not. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Keye. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Keye to obtain the invention as specified in claim 8.
Regarding claim 9, modified Kambez et al. teaches the apparatus of claim 2, but fails to teach a second region nested within the first. Keye teaches another embodiment of the tray (See FIG. 3 - element 44) featuring regions nested within each other (concentric squares). Keye teaches the function of the tray (element 44) as identical to the tray described previously (element 22): enabling different sample volumes to be tested. Furthermore, Keye teaches that the design is more economical of incubator and storage space and easier to manufacture. (Col 9. 5th paragraph and Col. 10, 1st paragraph).
It would have been obvious to a person of ordinary skill in the art to use Keye’ teaching of concentric or nested volumes in modified Kambez et al.’s clamping device because in addition to allowing different sample volumes to be tested, concentric volumes are easier to manufacture. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Keye. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Keye’ to obtain the invention as specified in claim 9.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced) as applied to claim 1 above, and further in view of Keye (US 3787290 A).
Regarding claim 11, Kambez et al. teaches the apparatus of claim 1, but fails to teach a plurality of removable barrier components configured to be independently and sequentially disposed on the plate, wherein the plurality of removable barrier components includes the removable barrier component and a second removable barrier component. Nevertheless, it has been established that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04 VI). It would have been obvious to one of ordinary skill in the art to duplicate the removable barrier component to create a plurality of removable barrier components disposed on the plate.
Regarding the limitation that the second removable barrier component at least partially defines a second region different from the first region, Keye invention features compartments (FIG. 3, element 40) present in their tray (element 44), each with various sizes in regions. Compartments (element 40) vary in volume, with the compartments in a nested formation. Keye further teaches that this structurally allows most probable number assays to be performed (Col. 7, 3rd paragraph) by diluting the sample serially and observing which dilutions do not produce growth in nutrient media (Col 2. 6th and 7th paragraph). Thus, the varying volumes amount to regions of different sizes.
It would have been obvious to a person of ordinary skill in the art to use Keye’s teaching of differing volumes in Kambez et al.’s barrier component because using different sized regions would allow most probable number assays and dilutions to be performed in the barrier component. This method of improving Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Keye. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Keye to obtain the invention as specified in claim 11.
Regarding claim 12, modified Kambez et al. teaches the apparatus of claim 11. Keye further teaches compartments (FIG. 3, element 40) with regions in a nested formation (element 44). As seen in FIG. 3 and FIG. 4, these regions are surrounded in first, second, and third orthogonal directions. Thus, the structure resulting from the combination of the references of claim 11 would encompass a barrier component with regions are surrounded in first, second, and third orthogonal directions.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), as applied to claim 1 above, and further in view of Scheidt (US 3165450 A).
Regarding claim 13, modified Kambez et al. teaches the device of claim 1. Modified Kambez et al. fails to teach that the removable barrier component defines a plurality of wedge-shaped regions including the first region. Scheidt teaches a culturing device with partitions (FIG. 1, element 9), which form segregated chambers (FIG. 1, element 10). These segregated chambers for wedged-shaped region Scheidt teaches that this design is specifically adapted for a Petri dish. (Col 2. 10th paragraph – “while the invention…”)
It would have been obvious to a person of ordinary skill in the art to use Scheidt’s teaching of wedged-shaped regions in modified Kambez et al.’s clamping device specifically for creating segregated cell cultures adapted for a Petri dish design. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Scheidt. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Scheidt to obtain the invention as specified in claim 13.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), as applied to claim 1, and in further view of Zhou et al. (CN 113278522 A) (with attached MT from prior office action and referenced in 892).
Regarding claim 15, Kambez et al. teaches the apparatus of claim 1, but fails to teach a removable cover defining an interior region, the removable cover configured to engage the base to enclose the plate, the removable barrier component, and the press within the interior region. Zhou et al. teaches a cell culture device, where bottom plate (element 42 – structurally the base), cell culture pore plate (element 43 – structurally the barrier component), and press (element 44 – cover plate) are enclosed by antibacterial cover (element 41) (para. [0041] of MT), specifically when applying compressive force stimulus to the culture (para. [0039]).
It would have been obvious to a person of ordinary skill in the art to use Zhou et al.’s teaching of a cover plate in Kambez et al.’s clamping device because the cover plate provides an antibacterial enclosure, or sealed environment, when applying compressive force stimulus to the culture. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Zhou et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Zhou et al to obtain the invention as specified in claim 15.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Zhou et al. (already referenced) as applied to claim 15 above, and further in view of Briche (EP 3492575 A1).
Regarding claim 16, modified Kambez et al. teaches the apparatus of claim 15, but fails to teach a removable cover defines a vent configured to permit air transfer top and from the interior region of the removable cover. Briche teaches a petri dish that includes a removable cover (lid – element 200) that contains vents (element 222). “The vents 222 allow air to pass between the lid 200 and the base 300” (para. [0023]). Briche further teaches that exchange of external air is important since cells need oxygen to grow (para. [0023]).
It would have been obvious to a person of ordinary skill in the art to use Briche’s teaching of vents in removable covers in modified Kambez et al.’s clamping device because the vent allows external air to be exchanged for the cells. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Briche. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Briche to obtain the invention as specified in claim 16.
Regarding claim 17, modified Kambez et al. teaches the apparatus of claim 15, but fails to teach that the base defines a vent configured to permit air transfer to and from the interior region of the removable cover. Briche teaches a base (element 300) containing base vent (element 322) – which allows air to pass between adjacent stacked petri dishes (para. [0036]). Briche further teaches that exchange of external air is important since cells need oxygen to grow (para. [0023]).
It would have been obvious to a person of ordinary skill in the art to use Briche’s teaching of base vents in modified Kambez et al.’s clamping device because the vent allows external air and oxygen to be exchanged for the cells. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Briche. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Briche to obtain the invention as specified in claim 17.
Claims 18, 19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced) as applied claim 1 above, and further in view of Ji et al. (CN 105331537 B and attached Machine Translation).
Regarding claim 18, Kambez et al. teaches the apparatus of claim 1. Modified Kambez et al. fails to teach a barrier cap configured to be between the removable barrier component and the press. Ji et al. teaches a cell culture device (para. [0002] of MT), where orifice plate cover (See annotated FIG. 1, element 2) structurally acts as a barrier cap for orifice plate (FIG. 1, element 1 – structurally the removable barrier component), and is located between the orifice plate (element 1) and driving rod and transmission plate (element 5 and 12, respectively – structurally the press). Ji et al. further teaches that “the arrangement of the transmission plate 12 increases the contact area between the transmission rod 5 and the orifice plate cover 2, and the transmission is more stable and firm” (para. [0040] of MT).
It would have been obvious to a person of ordinary skill in the art to use Ji et al.’s teaching of a barrier cap in Kambez et al.’s clamping device because the barrier cap increases contact area and provides a more stable and firm transmission of pressure. This method of improving Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Ji et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Ji et al. to obtain the invention as specified in claim 18.
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Regarding the limitation “configured to align to press, the removable barrier component, and plate along a press access.”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Ji et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to teach a barrier cap configured to be between the removable barrier component (Ji et al. - FIG. 1, element 1) and press (Ji et al. – FIG. 4, element 5 and 12).
Regarding claim 19, modified Kambez et al. teaches the apparatus of claim 18. Modified Kambez et al. further teaches a barrier cap configured to engage the entirety of the top surface of the removable barrier component. Ji et al. further teaches a barrier cap configured to engage the entirety of the top surface of the removable barrier component specifically in FIG. 1, wherein the cover (FIG. 1, element 2- structurally the barrier cap) covers the orifice plate (FIG. 1, element 1 – structurally the barrier component). The structure resulting from the combination of the references of claim 18 would encompass a barrier cap configured to engage an entirety of the top surface of the removable barrier component of claim 19
Regarding claim 21, modified Kambez et al. teaches the apparatus of claim 18. Modified Kambez et al. fails to teach that the removable barrier component and barrier cap are an integrally formed unitary structure, as Ji et al. teaches the barrier component and barrier cap as separated. However, it has been held that it would be obvious to make integral (MPEP 2144.04 V). Modifying Ji et al.’s barrier cap in modified Kambez et al.’s removable barrier component by integrally forming them instead of separating them would predictably result in enabling transmission of the pressure to both components.
Regarding claim 22, modified Kambez et al. teaches the apparatus of claim 18. Modified Kambez et al. further teaches a barrier cap with a recess that is configured to receive at least a portion of the removable barrier component (See annotated FIG. 1 above – Ji et al.). The structure resulting from the combination of the references of claim 18 would encompass a barrier cap defining a recess configured to receive at least a portion of the removable barrier component.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Ji et al. (already referenced) as applied claim 18 above, and further in view of Wannlund (US 5035866 A).
Regarding claim 20, modified Kambez et al. teaches the apparatus of claim 18, but fails to teach that the barrier cap defines an opening in fluid communication with the first region. Wannlund teaches an upper plate (element 24 – FIG. 2 – structurally the barrier cap) and lower plate (element 26 – removable barrier device), which each include a plurality of test wells (element 28 – FIG. 2), each including reactions cups. The upper plate is fluidly connected to lower plate by orifices (element 40). Wannlund teaches hat the plurality of test wells feature the reactions cups, where the lower reaction cup has the final reactant, and upper cup has a penultimate reactant therein, as liquid flowing above can be discharged below through the orifices. (Col 3. Lines 27-35).
It would have been obvious to a person of ordinary skill in the art to use Wannland’s teaching of an upper plate in fluid communication with a lower plate in modified Kambez et al.’s clamping device and removable barrier component because the fluid communication would enable liquid above in the cap to be discharged below. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Wannland. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Wannland to obtain the invention as specified in claim 20.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced) as applied to claim 1, and further in view of Jervis et al. (US 7919319 B2) (listed in IDS).
Regarding Claim 26, modified Kambez et al. teaches the apparatus of claim 1, but fails to teach that the plate and removable barrier component are configured to receive a pliable material there between. Jervis et al. teaches a cell culture apparatus (FIG. 1), where plates 22 and 28 slightly compress cells (element 36) in between them. Jervis et al. teaches that this compression physically constrain cell (monolayer) to keep them in niche chamber 30 (Col. 10 – Lines 60-67) Thus, the cells are confined by the base and cover plates (element 22 and 28) to a predefined space for cell culture growth. (Col. 10 – Lines 60-67)
It would have been obvious to a person of ordinary skill in the art to use Jervis et al.’s teaching of placing cells (pliable material) between plates in Kambez et al.’s clamping device and removable barrier component because compression (such as through a clamping device) can be used to constrain cells in a confined space for cell culture growth. This method of improving Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Jervis et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Jervis et al. to obtain the invention as specified in claim 26.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced), Stroup et al. (already referenced), Jervis et al. (already referenced) as applied to claim 26 above, and further in view of Peters (already referenced).
Regarding claim 27, modified Kambez et al. teaches the apparatus of claim 26, but fails to teach that a joint between the pliable material and removable barrier component is configured to be substantially impermeable to live cells. Peters’ teaching of a removable barrier component further teaches that wall section (element 1) is sealed in a liquid-tight manner on the underside by baseplate, with the plurality of chambers 2 being formed (Col. 2, Detailed Description of Invention paragraph, Col. 3, First paragraph). Structurally, the wall member forms a joint with the plate by forming a liquid tight seal with base plate (element 3), specifically when pressed (Col. 1, 3rd paragraph of Summary of Invention). This seal isolate cell cultures into specific areas (Col. 1, 2nd paragraph – Background).
It would have been obvious to a person of ordinary skill in the art to use Peters’ teaching of a liquid tight seal in modified Kambez et al.’s clamping device with a pliable material because the liquid tight seal would isolate cell cultures. Furthermore, a person of ordinary skill in the art would recognize that a liquid tight seal or joint would prevent liquid media from entering regions with cells to be cultured. This method of improving modified Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Peters. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of modified Kambez et al. and Peters to obtain the invention as specified in claim 27.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kambez et al. (already referenced) in view of Stroup et al. (already referenced), Peters (already referenced), and Zhou et al. (already referenced).
Regarding claim 28, Kambez et al. teaches a base (FIG. 6, element 670) configured to support a plate (FIG. 6, glass slide – element 616) and a removable barrier component (microfluidic device – element 612) that cooperate to define a region for receiving cells (FIG. 2 – where microfluidic device defines a first region formed from an upper microchannel 34 and lower microchannel 36 (para. [0035])), where the plate is located between the base and the removable barrier component (See FIG. 6); a press (movable compression plate – element 614) configured to apply pressure to the removable barrier component, with the removable barrier component being between the press and the plate (See FIG. 6).
Kambez et al. fails to teach the following limitations:
A joint between the plate and the removable barrier component is substantially impermeable to live cells.
A toggle down clamp.
A removable cover defining an interior region, the removable cover configured to engage the base to enclose the press, the plate and the removable barrier component within the interior region.
Regarding Limitation I, Peters teaches a removable barrier component, where the base plate (FIG. 2a, element 3) and wall section (FIG. 2a, element 1) define chambers for cell culturing, with the wall section being pressed (compression) to produce adhesion (Col. 1, 5th paragraph), which allow the holes to be sealed in a liquid tight manner on their underside by the base plate (Col. 2, Detailed Description of Invention paragraph). Structurally, wall member forming a joint with the plate by forming a liquid tight seal causes cells to be unable to grown there (impermeable to live cells to be grown on).
It would have been obvious to a person of ordinary skill in the art to use Peters’ teaching of barrier component in Kambez et al.’s clamping device because the barrier component creates a liquid-tight seal to base, which defines regions for receiving cells (cell culture chambers) with the base. This method of improving Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Peters. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Peters to obtain the invention as specified in claim 28.
Regarding limitation II, Stroup et al. teaches a press for injection molding machines (FIG. 1). Stroup et al. specifically teaches using a toggle press mechanism in the apparatus, where the “toggle mechanisms provide a mechanical advantage allowing the use of a hydraulic system having a smaller capacity pump than the hydraulic systems used in a press which is closed directly by a hydraulic cylinder. Toggle mechanisms also provide positive lock capabilities” (Col. 1, lines 20-32).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Stroup et al.’s teaching of a toggle press mechanism in Kambez et al.’s clamping device because the toggle press mechanism provides i) a mechanical advantage allowing the use of a hydraulic system having a smaller capacity pump than the hydraulic systems used in a press which is closed directly by a hydraulic cylinder and ii) positive lock capabilities. This method of improving Kambez et al.’s clamping device was within the ability of one ordinary skill in the art based on the teachings of Stroup et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kambez et al. and Stroup et al. to obtain the invention specified in claim 28.
Regarding Limitation III, Zhou et al. teaches a cell culture device, where bottom plate (element 42 - structurally the base), cell culture pore plate (element 43 – structurally the barrier component), and press (element 44 – cover plate) are enclosed by antibacterial cover (element 41) (para. [0041] of MT), specifically when applying compressive force stimulus to the culture (para. [0039]). Furthermore, antibacterial cover defines an interior region that engages with a base to enclose the press, plate and removable barrier component of their system.
It would have been obvious to a person of ordinary skill in the art to use Zhou et al.’s teaching of a cover plate in Kambez et al.’s clamping device because the cover plate provides an antibacterial enclosure, or sealed environment, when applying compressive force stimulus to the culture. This method of improving Kambez et al.’s clamping device was within the ability of one of ordinary skill in the art based on the teachings of Zhou et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Kambez et al. and Zhou et al. to obtain the invention as specified in claim 28.
Response to Arguments
Applicant’s arguments, see p. 11, filed 08/05/2026, with respect to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see p. 11, filed 08/05/2026, with respect to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see p. 12, filed 08/05/2026, with respect to the 35 U.S.C. § 112(b) have been fully considered and are persuasive. The rejection of claim 10 has been withdrawn.
Applicant’s arguments, see p. 12-16, filed 08/05/2026, with respect to the rejection of claims 1-28 under 35 U.S.C. §§ 102 & 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kambez et al. (US 20200055054 A1) and Stroup (US 4297901 A).
Conclusion
Applicant's amendment necessitated the new ground 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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/J.F.Y./ Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799
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