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 07/30/2026 have been entered. Applicant amendments overcomes the previous claim objections and 112(b) rejection set forth in the Office Action mailed 06/24/2026, the previous claim objections and 112(b) rejections are withdrawn.
Status of Claims
Claims 1-15, 17-21 remain pending in the application and are currently being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 and 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “a microfluidic device containing a biological sample within the active area of the compressible substrate” on lines 3-4 where it is not seen in the instant specification where there is support for the biological sample being part of the claimed system.
Throughout the instant specification, it describes that “the cell imaging system having a microfluidic device adapted to hold a biological sample within an active area of a compressible substrate” (page 3 lines 22-25). Similar language is used throughout the specification where the microfluidic device is “adapted to hold”, but it is never described that the biological sample is part of the system. Also see page 8 lines 4-7 which describes “a housing (4) in fluid communication with a microfluidic channel (13) positioned in the compressible substrate (32) through one or more input positions (7) and outlet positions (8) forming an open-loop microfluid circuit to facilitate the capillary flow of a biological sample across the active area (14) of the invention.” where while there is a biological fluid sample flowing through, it is still “to facilitate the capillary flow” and therefore the biological sample is not a part of the claimed system.
Claims 2-15 and 17-21 are rejected by virtue of being dependent on a rejected claim.
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) 1-8, 10, 17-19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNeely (US-2004/0037739-A1) in view of Soen (US-2006/0019235-A1) and West (US-2006/0063160-A1).
Regarding claim 1, McNeely teaches a imaging system comprising:
- a compressible substrate (microarray slide 150 and gasket 404) with an active area (microarray 154) ([0083], Figure 2);
- a microfluidic device (main interface layer 617 and base 402) ([0083] cites as base “102”, however this is understood to be a typo as later the base is reference number 402. Herein the base will be 402));
- a compression assembly (clamp mechanism 418 and 420) that applies a compression force to said compressible substrate (150 and 404) ([0083], Figure 2);
- wherein said device (617, 402) is configured to allow an imaging device to image or observe within the active area (154) while said compression force is applied to said compressible substrate (150 and 404) ([0155] see detection may be performed while the interface device is attached to the slide, proving the interface device includes a viewing window to permit visual access to the slide).
Please note that the cell imaging device has not been positively recited and is therefore not a part of the claimed system.
[0086] describes spots 5 on the microarray slide which are formed of biomolecules or other reactant materials immobilized on the surface 7, [0147] describes the microarray slides may include spots of molecules of interest which may be DNA, RNA, oligonucleotides, or proteins. Throughout McNeely, only reference to a “sample” is made where no further details are provided as to what specifically the sample is. Therefore, a sample will be contained within the microarray however it is unclear if the sample is a biological sample.
In the analogous art of cell microarrays, Soen teaches cells that are arrayed on a substrate through binding to immobilized probes (Soen; [0011], [0015]).
Specifically, Soen teaches that the invention finds use in clinical diagnosis for profiling and classification of cell samples, e.g. blood samples, and that cells for use in the assays of the invention include blood (Soen; [0031], [0083]). In the example described in [0134]-[0138], a cellular microarray was assembled using capture, effector, detector and soluble probes where the capture probes are proteins capable of specific binding to molecules present on the cell surface.
McNeely is silent with regards to specific sample to be analyzed using the microarray, therefore, it would have been necessary and thus obvious to look to the prior art for conventional samples that are analyzed using microarrays. Soen provides this conventional teaching showing that it is known in the art to analyze blood using microarrays. Therefore, it would have been obvious to one having ordinary skill in the art for the sample to be analyzed be blood because it is taught by Soen that it is desirable to detect the cells within the blood sample.
The limitation “forming a cell monolayer within said active area” 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 McNeely and the clamp apparatus of McNeely is capable of applying a compression force to form a cell monolayer within the active area. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of McNeely (see MPEP §2114).
[0138] of McNeely describes that the interface device may include various types of sensors that include optical sensors for real-time detection of reactions occurring in the interface device, and [0155] describes that detection-binding molecules from the binding solution to molecules on the microarray slide is typically determined by detecting fluorescence, radioactivity, color change, and so forth occurring at sites where binding occurred where a specific example for the binding molecule in the binding solution is labeled with a fluorescent dye, the sites where binding has occurred fluoresce. However, McNeely does not provide specifics on the optical sensors and therefore does not teach a light source directed to said active area.
In the analogous art of microarray analysis, West teaches a system that includes a manifold, a microfluidic chip comprising a microarray, an illuminator for providing light, and a detector in optical communication with the microarray (West; [0005]).
Specifically, West teaches where suitable signals of the microarray include fluorescence (West; [0022]). [0032] of West describes that illuminators are typically adjacently secured to the microfluidic chip to provide a source of excitation illumination to the analyte molecules situated on the microarray. [0032] further describes that the illuminator is not necessarily fixed to the microfluidic chip and that in preferred embodiments, the illuminator is secured to the edge of the microfluidic chip using a suitable holder such as a compression fitting, holding bar, or screw.
It would have been obvious to one skilled in the art to modify the interface device of McNeely such that it includes a holder and an illuminator as taught by West because West teaches that it is desirable for fluorescent microarrays to include an illuminator that excites the fluorescent probes that are attached to the microarray which is then detected by a detector (West; [0022], [0034]).
Additionally, McNeely is silent with regards to specific optical sensors, therefore, it would have been necessary and thus obvious to look to the prior art for conventional optical sensors. West provides this conventional teaching showing that it is known in the art to use both a detector and an illuminator for microarrays. Therefore, it would have been obvious to one having ordinary skill in the art to include an illuminator as a part of the optical sensor because it is taught by West that illuminators are effective for detection in microarrays.
Regarding claim 2, modified McNeely teaches the system of claim 1. Soen further teaches wherein said biological sample comprises one or more live cells (Soen; [0134]-[0138] describes an example cellular microarray using capture, effector, detector and soluble probes, where [0073] describes effector probes being molecules that elicit a cellular response. Therefore, one skilled in the art would find it obvious that the cells being arrayed are live as they would not have a cellular response if they were not live cells).
Regarding claim 3, modified McNeely teaches the system of claim 1. Soen further teaches wherein said biological sample is selected from: blood (please see claims 1 and 2 supra).
Regarding claim 4, modified McNeely teaches the system of claim 1. McNeely further teaches wherein said microfluidic device (617 and 402) comprises a housing securing the compressible substrate (150 and 404) (McNeely; see Figure 2 where the main interface layer 617 and base 402 are a housing, and Figure 3 which shows the assembled device where the main interface layer 617 and base 402 will secure the microarray slide 150 and gasket 404).
Regarding claim 5, modified McNeely teaches the system of claim 4. McNeely further teaches wherein said compressible substrate (150 and 404) comprises an adhesive membrane positioned between a channel plate (404) and a base plate (150) (McNeely; [0110] describes the gaskets used, where it is effective to provide both clamping and an adhesive layer where the clamping functions to increase the strength of the bond provided by the adhesive, [0123] describes where a gasket may be provided with a sticky or tacky material or adhesive on some or all of its lower surface such that it may be moved for positioning with respect to microarray slide 150 but once in a suitable position it can be secured to the microarray slide 150 by applying pressure).
Regarding claim 6, modified McNeely teaches the system of claim 5. McNeely further teaches wherein said channel plate (404) comprises a first microfluidic channel in fluid communication with a second microfluidic channel on the adhesive membrane forming the active area (154) (McNeely; [0083] describes that the boundaries of a reaction chamber is defined by opening 406 in gasket 404, where this reaction chamber is a channel. Further, as described in [0110] and [0123] that an adhesive may be placed on the underside of the gasket and therefore the adhesive will be in the same shape as the gasket to define a second channel, where both of these channels are in fluid communication with one another).
Regarding claim 7, modified McNeely teaches the system of claim 6. McNeely further teaches wherein said housing (617, 402) comprises an input position (inlet 612) and an output position (outlet 614) in fluid communication with the first and second microfluidic channels (McNeely; [0083], Figure 2).
Regarding claim 8, modified McNeely teaches the system of claim 5. McNeely further teaches wherein the first and second microfluidic channels comprise hydrophilic inner surfaces (McNeely; [0109] describes that the interface device, which includes both the main interface layer 617 and the gasket 404 described in [0083], may be formed of hydrophilic materials. Therefore, when the interface layer 617 is made of a hydrophilic material then the reaction chamber (reaction chamber being the channel as described in claim 6 supra) will have inner surfaces that are hydrophilic).
Regarding claim 10, modified McNeely teaches the system of claim 4. McNeely further teaches wherein said housing (617 and 402) is constructed substantially of a non-compressible material (McNeely; [0083] see lower surface of main interface layer 617 can be formed of a membrane of a thin flexible membrane attached to a more rigid material which forms the bulk of main interface layer 617 or the lower surface may be formed of the same material as the remainder of main interface layer 617).
Additionally, one skilled in the art would find it obvious that since the base 402 and interface layer 617 are clamped via C-channel clamps, the material of the interface layer 617 and base 602 being on the outermost sides would need to be made of a material that is substantially non-compressible.
Regarding claim 17, modified McNeely teaches the system of claim 1. McNeely has been modified with West such that the interface device includes a holder and an illuminator. Based on the location of the clamps 420 and 418 in relation to the interface device, one skilled in the art would find it obvious that the illuminator will be adjacent to the clamps 420 and 418.
Further, the path that the illuminator lights is a light pathway.
Regarding claim 18, modified McNeely teaches the system of claim 17. McNeely has been modified by West such that it includes a holder and illuminator as taught by West.
[0040] of West describes Figure 3 showing a compression backing plate 40 that includes two illuminator notches 54 for positioning a suitable illuminator, the compression backing plate 40 understood to be the holder described in [0032].
Therefore, West teaches where the illuminator (light source) is positioned within a compression backing plate (compression cell), and the interface device along with the base and microarray slide of McNeely will be held by the compression backing plate.
Additionally, because the compression backing plate of West supports the device of McNeely, the compression backing plate will indirectly transmit the compression force to the device of McNeely.
Regarding claim 19, modified McNeely teaches the system of claim 17. McNeely has been modified with West to include the holder (later described to be a compression backing) and illuminator.
[0044] of West describes that the compression backing 40 includes a beveled channel 72 that provides a viewing port 74 for viewing the microfluidic chip, where the beveled channel 72 can hold an optical fiber bundle or other waveguide for transmitting light from the microarray through the transparent backing plate 70 to a suitable detector.
It would have been obvious to one skilled in the art to modify McNeely such that it further includes the optical fiber bundle as taught by West because West teaches that the fiber optic bundles are effective for transmitting light from a microfluidic chip to a detector (West; [0046]).
The compression backing 40 (compression cell) will comprise an optical fiber bundle (guide adaptor) that is positioned along the pathway of light from the illuminator within the viewing port (compression slot) of the compression backing, where the viewing port of the compression backing will be adjacent to the microarray of McNeely.
Regarding claim 21, modified McNeely teaches the system of claim 18.
McNeely has been modified with West such that there is now the compression backing plate with illuminator that supports the device of McNeely, where as seen in Figure 6 that the compression backing plate 40 has parts that overhang the microfluidic chip 30.
The limitation “to prevent extended transit of the compression cell.” 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 modified McNeely and the overhang of compression backing plate of West is capable of preventing extended transit of the compression backing. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified McNeely (see MPEP §2114).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNeely (US-2004/0037739-A1), Soen (US-2006/0019235-A1), and West (US-206/0063160-A1) and in further view of Kurabayashi (US-2022/0387995-A1).
Regarding claim 9, modified McNeely teaches the system of claim 5. McNeely further teaches wherein said channel plate (404) comprises a silicone channel plate (McNeely; [0110] see gasket may be formed of silicone, Figure 2), said adhesive membrane comprises a pressure sensitive adhesive (McNeely; [0123] see pressure sensitive adhesive).
McNeely describes in [0006] that the microarray is normally formed on a planar substrate such as a glass microscope slide, therefore McNeely does not teach that the microarray slide 150 (base plate) comprises a cyclic block copolymer (CBC).
In the analogous art of biomarker detectors, Kurabayashi teaches a microfluidic chip that comprises a plurality of barcode channels (Kurabayashi; [0015]).
Specifically, Kurabayashi teaches where a sensor 200 includes a microfluidic chip 202 disposed between an illumination source 204 and a photodetector array 206 (Kurabayashi; [0055], Figure 3). As further described in [0056], the microfluidic chip has a plurality of nanoplasmonic barcode detectors that are each configured through antibody conjugation to capture a different biomarker. [0057] describes that the microfluidic chip may be formed of a substrate made of polymethyl methacrylate, polycarbonate, polystyrene, polyvinyl chloride, polyimide, and the family of cyclic olefin polymers including cyclic block copolymer, and glass.
Examiner further finds that the prior art contained a device/method/product (i.e., reaction device including a microarray slide) which differed from the claimed device by the substitution of component(s) (i.e., microarray slide being a glass microscope slide) with other component(s) (i.e., microarray slide comprising a cyclic block copolymer), 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., the glass for cyclic block copolymer), and the results of the substitution (i.e., creation of a microarray on the surface and subsequent detection) 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 glass material for the microarray slide of reference McNeely with a cyclic block copolymer of reference Kurabayashi, since the result would have been predictable.
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNeely (US-2004/0037739-A1) Soen (US-2006/0019235-A1) and West (US-2006/0063160-A1), and in further view of Hajipouran (US-2020/0055054-A1).
Regarding claim 11, modified McNeely teaches the system of claim 1. While McNeely teaches that the interface device and slide 150 are clamped together with a clamp mechanism such as C-channel clamps 418 and 420 (McNeely; [0083]), McNeely does not teach wherein said compression assembly comprises a spring-actuated compression assembly.
In the same problem solving area of clamping systems for microfluidic devices, Hajipouran teaches where the clamping system includes a base 370, vertical posts 330 and 340, a top cover 360, compression plate 314, and springs 317 and 318 (Hajipouran; [0009], [0068]).
Specifically, Hajipouran describes where the compression plate 314 under the action of the springs 317 and 318 applies a substantially uniform pressure to a top surface of a microfluidic device that is placed between the compression plate 317 and base 370 (Hajipouran; [0068]). [0064] of Hajipouran further describes that a transparent window can be integrated into the clamp device that enables good optical access for macroscopic, visual, or microscopic imaging that may be desirable through viewing portions of the clamp system.
Examiner further finds that the prior art contained a device/method/product (i.e., reaction device) which differed from the claimed device by the substitution of component(s) (i.e., clamping mechanism such as C-channel clamps) with other component(s) (i.e., a spring-actuated compression assembly), 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., the C-channel clamps for the clamping system with compression plate, base, vertical posts, top cover, and springs), and the results of the substitution (i.e., compression of the interface device and the slide) 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 C-channel clamps of reference McNeely with the clamping system seen in Figure 3A of reference Hajipouran, since the result would have been predictable.
Regarding claim 12, modified McNeely teaches the system of claim 11. Hajipouran further teaches wherein said spring-actuated compression assembly comprises a bottom compression panel (compression plate 314) coupled with a top compression panel (top cover 360) by one or more calibrated springs (springs 317, 318) (Hajipouran; [0068], Figure 3A).
Regarding claim 13, modified McNeely teaches the system of claim 12. Hajipouran further teaches wherein a force applied to said top compression panel (360) is transmitted to said bottom compression panel (314) through said one or more calibrated spring (317, 318) (Hajipouran; [0068] see Figures 3A-C, [0090] describing where the compression plate is urged upward as seen in Figure 7B. One skilled in the art would understand that an upward force is applied to the cover that is then transferred through the springs into a downward force on the compression plate).
Regarding claim 14, modified McNeely teaches the system of claim 13. Hajipouran further teaches wherein said spring-actuated compression assembly comprises one or more cylinders (posts 330 and 340), wherein each cylinder (330, 340) is responsive to one of said one or more calibrated springs (317, 318) and secured by a lower and upper support post (Hajipouran; [0071] see springs 317 and 318 can extend around an outer boundary of their respective vertical posts 330, 340, Figure 3A).
Further, [0053] of Hajipouran describes that the design of the posts illustrated are illustrated with a square or rectangular cross-section, the shape of the post itself can be that of any geometric entity that allows a compression device, such as a spring, to apply the needed force to the compression plate. Therefore, one skilled in the art would find it obvious that the posts 330 and 340 may be cylindrical in shape.
Additionally it has been held that changing the shape of a component is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape of the claimed component was significant, please see MPEP 2144.04 IV. B.
The posts 330 and 340 seen in Figure 3A are seen to connect to support structures 332 and 342, where support structure 332 is a lower support post and 342 is an upper support post.
Regarding claim 15, modified McNeely teaches the system of claim 13.
The limitation “wherein said spring-actuated compression assembly can be calibrated to adjust the orientation or morphology of the cells in the monolayer.” 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 modified McNeely and the clamping system of Hajipouran is capable of being calibrated to adjust the orientation or morphology of the cells in the monolayer. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified McNeely (see MPEP §2114).
Further, the sample, and thus the cells and monolayer, have not been positively recited in the claim, and are therefore not a part of the claimed system.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNeely (US-2004/0037739-A1), Soen (US-2006/0019235-A1) and West (US-2006/0063160-A1), and in further view of Yoder (US-2006/0074108-A1).
Regarding claim 20, modified McNeely teaches the system of claim 1. McNeely has been modified with West to include the holder and illuminator, where [0032] of West describes that the illuminators typically include light emitting diodes. However, McNeely nor West describe an optical diffuser positioned between said light source and a viewing surface.
In the same problem solving area of illuminating a microfluidic array through the use of one or more light emitting diodes, Yoder teaches that a light shaping diffuser may be placed on the output end of a light emitting diode to shape the light and provide better illumination uniformity (Yoder; [0139], [0140]).
It would have been obvious to one skilled in the art to modify the illuminator of modified McNeely such that it further includes a light shaping diffuser on its output end as taught by Yoder because Yoder teaches that the diffuser allows for better illumination uniformity (Yoder; [0140]).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
UNIV BAYREUTH (EP-2023119-A1) teaches where the invention provides a method for providing a cell sample to be tested, forming the cells to a cell monolayer, applying shear stress and/or shear deformation to the cell monolayer, and measuring the mechanical response of the cell monolayer ([0023]). It is seen in Figure 1 that the device comprises two parallel horizontal plates 2, 3 having a gap between them and held by support 6, 7, where plate 2 is connected to a shaft 4 to an actuator 5 where the actuator moves the plate 2 downward to form cells 14a into cell monolayer 14 ([0050], [0051], [0054]). Additionally, there is a camera 21 coupled to an objective 17 ([0056]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 6, filed 07/30/2026, with respect to the 103 rejection in view of Hajipouran Benam (US-2020/0055054-A1) in view of West (US-2006/063160-A1) have been fully considered and are persuasive. The 103 rejection of claims 1-15, 17-19, and 21 in view of Hajipouran Benam in view of West has been withdrawn.
Applicant’s amendments to the claims and arguments, see page 6, filed 07/30/2026, with respect to the 103 rejection of claim 1 in view of McNeely and West 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 McNeely (US-2004/0037739-A1), Soen (US-2006/0019235-A1) and West (US-2006/0063160-A1).
In response to applicant's argument on page 7 that McNeely’s gasket is not a compressible substrate that is compressed to form a cell monolayer, 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.
It is further respectfully noted that “the compressible substrate” is being mapped to both the microarray slide 150 and gasket 404.
Applicant further argues that the compression assembly applies a compression force to the compressible substrate, which is opposite to McNeely which recites once the gasket deforms the assembly is “sealed and held together but no longer under significant pressure” described in [0089].
Examiner does agree that [0089] recites this, however this passage is not saying that the assembly is under no pressure at all, just that it is no longer under “significant” pressure. Therefore, a pressure is still present and would be capable of creating the cell monolayer.
In response to applicant's argument on page 7 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., spreading a fluid-borne cell population into an imaging monolayer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is respectfully noted that currently, while the claim does recite “a microfluidic device containing a biological sample”, there is no connection between the biological sample and the formed cell monolayer.
Applicant argues on page 7 that because McNeely affirmatively teaches that the assembly is “no longer under significant pressure” after sealing, reliance on MPEP 2114 is inapplicable. Please see supra regarding “significant pressure” and intended use when “forming a cell monolayer”. Further, applicant argues that the device “containing a biological sample” and a compression assembly “that applies a compression force… forming a cell monolayer” please see supra regarding the biological sample and cell monolayer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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