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 Arguments
Applicant’s arguments, filed 02/19/26, with respect to the rejection of claims under 35 U.S.C. 102(a)(1) as being anticipated by Buchs (US 2009/0170183) have been fully considered and are persuasive. Applicant has amended claims 1 and 21 to recite “a bottom plate operable to be secured to the top plate, the bottom plate having a plurality of trough sets, each of the plurality of trough sets including a linear array of troughs; and a plurality of micro-channel sets formed when the bottom plate is secured to the top plate, each micro-channel set associated with a corresponding trough set and including a plurality of micro-channels, each micro-channel defined by a portion of a corresponding divisional wall of a corresponding well and middle portions of a corresponding trough, each micro-channel enabling communication between the first reservoir and the second reservoir of the corresponding well when the bottom plate is secured to the top plate” and then argued that the cited prior art Buchs does not tach the combination of features now recited in the amended claims. See pages 6-7 of Applicant’s Remarks. The Examiner agrees that Buchs does not teach the combination of elements that includes the highlighted features in the claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Applicant’s arguments, filed 02/19/26, with respect to the rejection(s) of claims under 35 U.S.C. 102(a)(1) as being anticipated by Schulte et al. (US 2003/0034306) have been fully considered and are persuasive. Applicant has amended claims 1 and 21 to recite a bottom plate operable to be secured to the top plate, the bottom plate having a plurality of trough sets, each of the plurality of trough sets including a linear array of troughs; and a plurality of micro-channel sets formed when the bottom plate is secured to the top plate, each micro-channel set associated with a corresponding trough set and including a plurality of micro-channels, each micro-channel defined by a portion of a corresponding divisional wall of a corresponding well and middle portions of a corresponding trough, each micro-channel enabling communication between the first reservoir and the second reservoir of the corresponding well when the bottom plate is secured to the top plate” and then argued that the cited prior art Schulte does not tach the combination of features now recited in the amended claims. See pages 6-7 of Applicant’s Remarks. The Examiner agrees that Schulte does not teach the combination of elements that includes the highlighted features in the claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 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 1-4, 6-11 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schulte et al. (US 2003/0034306) in view of Vulto et al. (US 2020/0063081). Schulte teaches an assay plate assembly.
Regarding claims 1, 2, 3, 18, 19 and 20 - As shown in Figures 5A and 5B, Schulte teaches an assay plate assembly comprising: a top plate (substrate 103) having a plurality of wells (the Examiner considers unit cell having connected microchannels to be a well comprised of four reservoirs), each of the plurality of wells (unit cells) defined at least in part by a first reservoir (first well 106), a second reservoir (second well 106), and a divisional wall (portion of substrate 103 between the wells 106) extending between the first reservoir (wells 106) and the second reservoir (well 106), a bottom plate (plate 102) operable to be secured to the top plate (substrate 103), the bottom plate having a plurality of troughs (microfluidic structure 300); and a plurality of micro-channels (channels 306) formed when the bottom plate (plate 102) is secured to the top plate (substrate 103), each of the plurality of micro-channels (channels 306) defined by a portion of the divisional wall of each of the plurality of wells and middle portions of the plurality of troughs, the plurality of micro-channels (channels 306) enabling communication between the first reservoir (first well 106) and the second reservoir (second well 106) when the bottom plate (plate 102) is secured to the top plate (substrate 103). Schulte does not teach each of the plurality of trough sets including a linear array of connecting troughs.
Vulto teaches a cell culture device. The embodiment(s) of the device most relevant to the instant claims are shown in Figures 1-15, 19-24, and 34-35, especially Figure 19. As shown in Figure 1, Vulto teaches a general device having a plurality of micro channel sets comprised of a central organoid compartment (103) flanked by two reservoirs (101) and a micro fluidic channel (102) in a microfluidic layer connecting the reservoirs with the organoid compartment. Figures 19 and 34 show embodiments where each of the plurality of micro channel sets are connected by the micro fluidic channel (102). The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the array of connecting microchannels from Vulto with the device of Schulte. One of ordinary skill in the art would add the array of connecting micro channels to Schulte in order to process samples in series as taught by Vulto.
Regarding claim 4 - Figure 5A shows a plurality of trough sets that includes a first linear array of troughs (channels) and second linear array of roughs extending between the wells.
Regarding claim 6 - Schulte discloses changing the wettability of a channel by plasma treatment in Paragraph 0036. The Examiner submits changing the wettability would provide one-way communication in the channel by preventing the flow of chosen materials.
Regarding claim 7 - Figure 5B of Schulte teaches a 96 well card having 24 unit cells. See Paragraphs 0028-0033.
Regarding claims 8 and 17 - Schulte teaches a plate having 1536 or more wells in Paragraph 0021. The Examiner submits a plate with that many wells would have more than 24 channels.
Regarding claim 9 - Figure 5A shows channels of different length. See middle connecting channel in Figure 5A.
Regarding claims 10, 11, 16 and 18 - Schulte teaches channel dimensions of 100-3000 um in width and 400-500 in depth in Paragraph 0038. The Examiner submits a width of 100-300 um would require a wall thickness of 100-3000 um in order to form the channel.
Regarding claims 21, 22, and 23 - Schulte teaches forming the device (500) by providing the top plate with wells (substrate 103) and connecting it to a bottom plate (plate 1092) having the troughs (channels 306) to form the assembly in Paragraph 0028. Schulte teaches various techniques for forming the layers including using hot embossing or injection molding in Paragraphs 0039. See also Paragraph 0022.
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schulte et al. (US 2003/0034306) in view of Vulto et al. (US 2020/0063081), and further in view of Buchs (US 2009/0170183). Schulte and Vulto as combined above in Paragraphs 8-17 teach every element of claims 12-16 except for the changing dimensions of the microchannels. Bucks teaches a microtiter plate assembly. As shown in the Figures, Buchs teaches an microtiter plate assembly comprising: a top plate (microtiter plate 1) having a plurality of wells (connected cavities 2 and 3), each of the plurality of wells defined at least in part by a first reservoir (cavity 2), a second reservoir (cavity 3), and a divisional wall (unlabeled area between wells over recess 11 shown in Figures 1A, 2A, 3A and 5A) extending between the first reservoir (cavity 2) and the second reservoir (cavity 3), a bottom plate (plate 5) operable to be secured to the top plate (microtiter plate 1), the bottom plate (plate 5) having a plurality of troughs (recesses 11); and a plurality of micro-channels (recesses 11) formed when the bottom plate (plate 5) is secured to the top plate (plate 1), each of the plurality of micro-channels (recesses 11) defined by a portion of the divisional wall of each of the plurality of wells and middle portions of the plurality of troughs, the plurality of micro-channels (recesses 11) enabling communication between the first reservoir (cavity 2) and the second reservoir (cavity 3) when the bottom plate (plate 5) is secured to the top plate (microtiter plate 1). In Figures 5, 5A, and 5B and Paragraph 0062, Buchs teaches that the recesses (11) or channels (19) connecting the cavities (2, 3) may have a variable cross section which expands or decreases which allows for easier filling of the channel with material such as a hydrogel during production. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the recess or channel shape from Buchs with the combined teachings of Schulte and Vulto. One of ordinary skill in the art would add the recess or channel shape to the combined teachings of Schulte and Vulto to provide an improved channel shape for the depositing of materials into the channel during production as taught by Buchs.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Schulte et al. (US 2003/0034306) in view of Vulto et al. (US 2020/0063081), and further in view of Coassin et al. (US 6,517,781). Schulte and Vulto as described in Paragraphs 8-17 above teach every element of claims 24 and 25 except for the use of cycloolefin polymer. Coassin teaches a multiwell plate. The basic embodiment of the plate is shown in Figures 1A-1B and includes a top layer comprised of a frame (10) having a plurality of wells connected to a bottom layer (1). In column 14, Coassin teaches that one of the advantages of their multiwell platform is a low intrinsic fluorescence provided by the use of cycloolefin polymers. The multiwell platform of Coassin comprised of cycloolefin polymer produces about 100 to 200 percent or less of the fluorescence compared to glass of comparable thickness. The Examiner submits it would have been obvious to one of ordinary skill in the art to combine the cycloolefin polymer from Coassin with the combined device of Schulte and Vulto. Schulte teaches the use of glass layers. One of ordinary skill in the art at the time of the effective date of the invention would add the cycloolefin polymer to Schulte in order to take advantage of the low intrinsic fluorescence as taught by Coassin.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 June 19, 2026
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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