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
Applicant amendments filed 06/24/2026 have been entered.
Status of Claims
Claims 1-22, 26-28 remain pending in the application, with claims 1-16 and 26-28 being examined and claims 17-25 being withdrawn pursuant to the election filed 02/13/2026.
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28 recites “wherein reagent is selectively” on line 1, where it is suggested to amend line 1 to recite “wherein the reagent is selectively” to add further clarity that the reagent is the same as the one described in claim 1.
However, please note that currently in claim 1 the reagent and reagent reservoir have not been positively recited and are therefore not a part of the claimed apparatus.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mescher (US-2016/0220997-A1).
Regarding claim 1, Mescher teaches an apparatus, comprising:
a reagent reservoir receptacle to receive a reagent reservoir (fluid reservoir 118) containing reagent ([0036], and see Figure 1 where the location where fluid reservoir 118 is placed will be a reagent reservoir receptacle to receive a reagent reservoir (fluid reservoir 118) containing reagent);
a working area comprising a plate receptacle (see Figure 1 where the area of the incubator 104 is a working area and the location where the cell culture platform 102 defines a plate receptacle); and
a non-contact dispenser (pump assembly 1600) fluidly coupled to the reagent reservoir (118), the non-contact dispenser (1600), comprising ([0134], Figures 1, 16, and see [0045] which describes that at least one fluid pump 114 flows liquids into and through the cell culture platform where the pump assembly 1600 seen in Figure 16 is understood to be an example of the fluid pump 114 seen in Figure 1):
a body defining an inlet, an outlet, and a flow path (fluid passage 1624) fluidly coupling the inlet and the outlet ([0136], see Figure 16 where the pump assembly 1600 has a body, where the fluid passage 1624 on the left will define an inlet and the fluid passage 1624 on the right will define an outlet);
a first valve (first valve assembly 1602 (1)) to control flow into a portion of the flow path (1624) ([0134], Figure 16);
a second valve (second valve assembly 1602 (2)) to control flow out of the outlet ([0134], Figure 16); and
a pump (fluid displacement assembly 1630) positioned between the first valve (1602 (1)) and the second valve (1602 (2)) ([0134], Figure 16).
The limitations a working area comprising a plate receptacle “to receive a plate having a well” and “to dispense the reagent from the reagent reservoir into the well of the plate” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Mescher and the incubator is a working area that has a plate receptacle that is capable of receiving a plate having a well, and the pump assembly is capable of dispensing reagent from a reagent reservoir into a well of a plate. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Mescher (see MPEP §2114).
Please note that the reagent reservoir, the reagent, and the plate having a well have not been positively recited in the claim, and are therefore not a part of the claimed apparatus. For convenience the reagent reservoir has been mapped to fluid reservoir 118.
Regarding claim 2, Mescher teaches the apparatus of claim 1. Mescher further teaches wherein the body comprises a nozzle that includes the outlet (see annotated Figure 16 below).
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Regarding claim 3, Mescher teaches the apparatus of claim 1. Mescher further teaches wherein the first valve (1602 (1)) and the second valve (1602 (2)) each comprise diaphragm valves having a diaphragm (valve membrane 1620) ([0135] see where each valve assembly 1602 includes a valve seat 1623 configured for operative engagement with the valve membrane 1620 to block the fluid flow, Figure 16).
Regarding claim 4, Mescher teaches the apparatus of claim 1. Mescher further teaches wherein the first valve (1602 (1)) has a valve seat (valve seat 1623) defined by the body and the second valve (1602 (2)) has a valve seat (valve seat 1623) defined by the body ([0135], Figure 16).
Regarding claim 6, Mescher teaches the apparatus of claim 3. Mescher further teaches wherein the body defines a first aperture to allow a pressure to be applied to the diaphragm (1620) of the first valve (1602 (1)) to actuate the first valve (1602 (1)) and the body defines a second aperture to allow a pressure to be applied to the diaphragm (1620) of the second valve (1602 (2)) to actuate the second valve (1602 (2)) (Figure 16 see where there are two apertures that allows the respective valve heads 1618 to interact with the diaphragm 1620 to push it towards valve seats 1623).
Regarding claim 13, Mescher teaches the apparatus of claim 1. Mescher further teaches further comprising a film and wherein the body includes a first portion and a second portion, the film positioned between the first portion and the second portion ([0119] see Figures 12A and B show valve assembly 1200, [0120] see layer stack 1222 that includes a plurality of bonded or laminated layers that form a microfluidic structure defining a path for fluid flow, [0126] see layer stack 1222 seen in Figure 13A includes a load distribution layer 1316, support layer 1318, and valve seat layer 1320, [0134]-[0135] describe Figure 16 where in particular [0135] describes that similar to valve assembly 1200 described in relation to Figure 12A, each valve assembly includes a layer stack 1622. Therefore, the layer stack 1622 seen in Figure 16 will also have a load distribution layer, support layer, and valve seat layer similar to how it is seen in Figure 13A. Please see annotated Figure 16 below for which components are being considered the first portion, second portion, and film).
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Regarding claim 14, Mescher teaches the apparatus of claim 13. Mescher further teaches wherein the film defines apertures and the flow path (1624) passes through the apertures of the film (see annotated Figure 16 above that has the arrow pointing to what is considered the film, where this layer is seen to have apertures that the fluid passage 1624 passes through).
Regarding claim 15, Mescher teaches the apparatus of claim 13. Mescher further teaches further comprising a second film (elastomer layer 1621) and an interposer layer, the film is positioned on a first side of the body, the second film (1621) is positioned on a second side of the body, and the interposer layer is positioned between the film and the second film (1621) (see annotated Figure 16 below which has added an annotation regarding the interposer layer, which is the layer above the annotated film layer).
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Regarding claim 16, Mescher teaches the apparatus of claim 15. Mescher further teaches wherein the interposer layer defines the flow path (see annotated Figure 16 supra with the interposer layer annotated, where this layer is seen to define the fluid passage 1624).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) and as evidenced by Dimas (US-2005/0169575-A1).
Regarding claim 26, Mescher teaches the apparatus of claim 1. While Mescher does describe that the cell culture system 100 includes a microscope such as a fluorescent microscope, where at least a portion of the cell culture platform 102 is configured to allow visual inspection of cells and/or tissues within the cell culture platform, it is unclear if the fluorescent microscope will comprise a light bar.
It is evidenced by Dimas that for a fluorescent microscope, the illumination of the sample of UV light allows for visualization of molecules that are capable of fluorescing (Dimas; [0005]). Therefore, a fluorescent microscope will include a UV light source.
The limitation a light bar “configured to degrade oligonucleotides” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Mescher as evidenced by Dimas, and the fluorescent microscope that will include a UV light source is capable of degrading oligonucleotides. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Mescher (see MPEP §2114).
Please note that the oligonucleotides have not been positively recited in the claim, and are therefore not a part of the claimed apparatus.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) in view of MacMillan (US-2004/0200909-A1).
Regarding claim 5, Mescher teaches the apparatus of claim 4. Meshcer does not teach wherein the body has first internal curved surfaces that define a first space between the valve seat of the first valve and the first internal curved surfaces to allow movement of a diaphragm of the first valve and the body has second internal curved surfaces that define a second space between the valve seat of the second valve and the second internal curved surfaces to allow movement of a diaphragm of the second valve.
In the same problem solving area of sealing valve seats and membranes to prevent flow, MacMillan teaches curved surfaces (MacMillan; [0110], [0111]).
Specifically, MacMillan teaches where a cavity 161 is defined by a first curved surface 162A and a second curved surface 162B that provide two valve seats that are the primary contact area for membrane 63 to seal off flow between channel 158 and 159 (MacMillan; [0111]). Additionally, as better seen in Figure 16B there is a third surface 163 recessed from first and second surfaces 162A and 162B (MacMillan; [0113]).
It would have been obvious to one skilled in the art to modify the valve seats of Mescher such that they are curved with a gap as taught by MacMillan because MacMillan teaches that this arrangement allows the membrane to contact the valve seats rather than the entire surface of the cavity such that maximum pressure is applied to the valve seats to provide a very strong seal with minimal actuator force required (MacMillan; [0113]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) in view of Schmolke (US-2018/0099280-A1).
Regarding claim 7, Mescher teaches the apparatus of claim 6. Mescher does not teach wherein the first aperture and the second aperture are defined on a first side of the body and the pump is positioned on a second side of the body.
In the same problem solving area of cartridges with valves, Schmolke teaches where a first group of valves and a second group of valves are actuated from different sides of the cartridge and/or in different or at least substantially opposing actuation directions (Schmolke; [0016]).
Specifically, Schmolke describes that a cartridge 100 comprises a first group 153 having one or more valves 115 and a second group 154 having one or more valves 115, where the first group 153 and second group 154 are actuated from different sides 100A, 100B of the cartridge seen in Figure 3 (Schmolke; [0110], [0111]).
It would have been obvious to one skilled in the art to modify the first valve assembly and second valve assembly such that they are actuated from the opposite side in comparison to the side the fluid displacement assembly is actuated because it is taught by Schmolke that the load and/or pressure on the cartridge is distributed between the two sides of the cartridge as a result of valves being actuated opposingly and therefore optimized and/or better distribution of forces acting on the cartridge is made possible and the risk of damage to the cartridge and/or the requirements for the mechanical strength of the cartridge is/are reduced (Schmolke; [0016]).
Even though the fluid displacement assembly is not a valve, one skilled in the art would still recognize the benefits of actuating components from opposite sides such as those described by Schmolke because the fluid displacement assembly is similarly actuated by applying force on the valve membrane 1620 seen in Figure 16 of Mescher.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) in view of Maaskant (US-2017/0080422-A1).
Regarding claim 8, Mescher teaches the apparatus of claim 1. Mescher does teach where the fluid displacement assembly 1630 has a pump head 1619 that is driven to generate a relative positive or negative pressure in pump chamber 1632 to move fluid (Mescher; [0136], [0137], [0138]). The fluid displacement assembly is understood to not be a syringe pump.
In the same problem solving area of transferring liquid from chamber to chamber, Maaskant teaches an air displacement device that may be a syringe pump, peristaltic pump, bellows pump, or any other pump or air displacement device which can controllably deliver or remove air from a cartridge via a connected port (Maaskant; [0114]).
Examiner finds that the prior art contained a device/method/product (i.e., valve assembly) which differed from the claimed device by the substitution of component(s) (i.e., the fluid displacement assembly) with other component(s) (i.e., syringe pump), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., fluid displacement assembly for a syringe pump), and the results of the substitution (i.e., applying positive or negative pressure to cause fluid movement) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the fluid displacement assembly of reference Mescher with the syringe pump of reference Maaskant, since the result would have been predictable.
Claim(s) 9-10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) and Maaskant (US-2017/0080422-A1), and as evidenced by Tyrell (US-2006/0207316-A1).
Regarding claim 9, modified Mescher teaches the apparatus of claim 8. Mescher has been modified by Maaskant such that the fluid displacement assembly 1630 seen in Figure 16 is now a syringe pump, where the location is understood to be an aperture in the pump assembly’s body.
Maaskant does not describe the components that make up the syringe pump, however it is evidenced by Tyrell that a syringe pump includes a plunger and a barrel (Tyrell; [0013], Figure 3).
Therefore, it is understood that the barrel of the syringe pump will be received in the aperture of the pump assembly’s body.
Regarding claim 10, modified Mescher teaches the apparatus of claim 9. As described above it is evidenced by Tyrell that a syringe pump includes a plunger and a barrel, where the plunger is an actuator to actuate the barrel.
Regarding claim 12, modified Mescher teaches the apparatus of claim 9. The syringe pump of Maaskant is in the aperture of the pump assembly’s body as seen in Figure 16 of Mescher. One skilled in the art would find it obvious that for the syringe pump to similarly create pressure by interacting with the valve membrane 1620, the barrel would need to be substantially coplanar with a surface of the body defining the flow path.
The layer that holds the valve assemblies and fluid displacement assembly seen in Figure 16 of Mescher is part of the body of the pump assembly that defines the fluid passage 1624.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) and Maaskant (US-2017/0080422-A1), in further view of Lauks (US-2004/0222091-A1).
Regarding claim 11, modified Mescher teaches the apparatus of claim 9. Mescher in view of Maaskant do not teach further comprising adhesive between the barrel and a surface of the body defining the aperture.
In the same problem solving area of engaging a syringe with an entry port, Lauks teaches where the syringe tip forms a seal with an adhesive element surrounding the entry port (Lauks; [0045]).
It would have been obvious to one skilled in the art to modify the aperture that will hold the syringe pump of Mescher to include an adhesive element as taught by Lauks because Lauks teaches that the adhesive gasket permits a reliable fluid-tight seal between the syringe and card (Lauks; [0018]).
One skilled in the art would find it obvious that the adhesive gasket would allow a seal such that no pressure is lost when actuating the syringe pump to interact with the valve membrane.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mescher (US-2016/0220997-A1) in view of Tsuruta (US-2006/0194193-A1).
Regarding claim 27, Mescher teaches the apparatus of claim 1. Mescher does describe in [0046] that pumps flow a fluid through the cell culture platform, where fluids include growth medium, test agents, toxins, medicaments, or any combination thereof. As described by [0134], Figure 16 shows a pump assembly 1600 where the pump assembly 1600 is therefore understood to deliver these various fluids to the cell culture platform.
However, Mescher does not show a configuration as seen in Figure 1 when there are multiple fluid reservoirs 118 holding the various fluids described in [0046].
In the same problem solving area of supplying various solutions to a culture vessel, Tsuruta teaches a flow path switching valve (Tsuruta; [0120]).
Specifically, Tsuruta teaches where one end of respective culture solution supply tubes 56 that are used to supply culture solution, reagent, or buffer solution to culture vessel 100 is connected to each of the vessels 44, 45, 46, and 48 and the other end of these tubes 56 is connected to flow path switching valve 57 (Tsuruta; [0120], Figure 1). From the flow path switching valve 57, there is a common culture solution supply tube 58 that delivers the respective supplies to the culturing vessel 100, where there is also a culture solution supply pump 59 seen between the flow path switching valve 57 and the culturing vessel 100 ([0122], [0123], Figure 1).
It would have been obvious to one skilled in the art to modify the system seen in Figure 1 of Mescher, when there are multiple fluids being supplied to the culture platform as described by [0046], to include the culture solution supply tubes, the flow path switching valve, and the common culture supply tube as taught by Tsuruta because Tsuruta teaches that these components are effective for supplying multiple solutions to a culture vessel.
The culture solution supply tubes are reagent sippers that are disposed within respective fluid reservoirs that connect to ports of the flow path switching valve, where the common culture supply tube is a fluidic line that will couple the culture solution supply tubes and ports of the flow path switching valve with the pump assembly 1600 of Mescher (similar to how the common culture supply tube is connected to pump 59 seen in Figure 1 of Tsuruta).
Please note that the reagent reservoir has not been positively recited, and is therefore not a part of the claimed apparatus.
Regarding claim 28, modified Mescher teaches the apparatus of claim 27. Modified Mescher further teaches wherein reagent is to selectively flow from the reagent reservoir, through the reagent sipper, through the fluidic line, and out of the non-contact dispenser (please see claim 27 supra).
Please note that the reagent reservoir has not been positively recited in the claim, and is therefore not a part of the claimed apparatus.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dykstra (US-5594138-A) teaches where sample slides are analyzed using a fluorescent microscope and the sample is viewed using a photomicroscope with a ultraviolet source such as a mercury or xenon lamp (column 9 lines 19-28).
Vodyanoy (US-2007/0139764-A1) teaches where a fluorescent microscope has a light source that provides a short-wavelength light such as UV and/or blueviolet light (Vodyanoy; [0012]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 7, filed 06/24/2026, with respect to the rejection(s) of claim(s) 1-4, 6, 13-16 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mescher (US-2016/0220997-A1), previously used in the Office Action mailed 04/01/2026.
Please note that with regards to applicant arguments beginning on page 7 that Mescher does not disclose a reagent reservoir receptacle to receive a reagent reservoir containing reagent, nor a working area comprising a plate receptacle to receive a plate having a well, as currently written the reagent reservoir, reagent, and plate having a well have not been positively recited and are therefore not a part of the claimed apparatus.
In response to applicant's argument on page 8 that Mescher does not disclose a non-contact dispenser fluidly coupled to a reagent reservoir to dispense reagent from the reagent reservoir into wells of a plate, and rather Mescher’s system is designed for cell culture applications not for dispensing reagent from a reagent reservoir into wells of a plate, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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