DETAILED ACTION
This action is pursuant to the claims filed on 07/15/2025. Claims 1, 4-7, 9-14, 16, 19, and 28-29 are pending. A final action on the merits of claims 1, 4-7, 9-14, 16, 19, and 28-29 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-7, 9-14, 16, 19, and 28-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a first set of channels … a second set of channels … a plurality of channels…" It is unclear if the first and second sets of channels are the same set of channels of the plurality of channels or if the claims is reciting three distinct sets/pluralities of channels. For examination purposes, these limitations will be interpreted as a plurality of channels comprising a first set of channels and a second set of channels as respectively claimed. Claims 4-7, 9-14, 16, 19, and 28-29 inherit this deficiency.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 9, 13, 19, and 29 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Korvink (DE 102012002663).
Regarding claim 1, Korvink teaches A probe array (see Figs 4a-b) comprising: a substrate having an array of pillar probes, each pillar probe extending in a direction orthogonal to a plane of the substrate and having a first cross-sectional area (Fig 4a-b, substrate 31 with pillar probes 2 having a first cross sectional area), each probe being disposed on a pedestal formed on the substrate wherein each pedestal has a second cross-sectional area greater than the first cross-sectional area and forms a platform from which the pillar probe extends (Figs 4a-b, each probe 2 has a pedestal 31a having a larger cross sectional area), wherein the pedestals and pillar probes are arrayed in a two-dimensional grid area with a first set of channels extending in a first direction along the plane of the substrate between the pedestals and a second set of channels extending in a second direction along the plane of the substrate between the pedestals (Pg 13 of translation and Figs 4a-b “tissue probe 30 can be configured so that the support elements 2 parallel to each other and at the crossing points of an imaginary square grids”; array is formed in a square grid such that a first set of channels extends in a first direction (rows) and a second set of channels extend in a second direction (columns)), a plurality of channels formed between the pedestals configured to provide for a fluid flow to an underside of a sample structure the channels each having a width less than a spacing between the pillar (Fig 4a-b, channels between each pedestal 31a), wherein each pedestal defines an exposed surface substantially parallel to the plane of the substrate at a base of the pillar extending therefrom and the pedestals provide a plurality of said exposed surfaces configured to provide a platform for supporting, in use, the underside of the sample structure when penetrated by the pillar probes to thereby prevent the sample structure from reaching the substrate (see Fig 4b, pedestals prevent tissue from reaching substrate 31 as claimed), and wherein the probe array is configured to receive a flow of fluid into and through the channels from peripheral edges of the probe array which provides a microfluidic channel system to provide for any one or more of oxygenation of the sample, delivery of nutrient to the sample, removal of metabolic waste from the sample structure or homogenous diffusion of compounds to be tested during screening assays (Figs. 4a-b, channel between each pedestal 31a define a microfluid array of channels capable of receiving fluid flow from peripheral edges for any one of the claimed functions; examiner notes this claimed limitation is merely functional).
Regarding claim 9, Korvink teaches in which the pedestals are rectangular in cross-section (Fig 4a-b, pedestals 31a are rectangular in cross cross-sectional view) and the first set of channels are orthogonal to the second set of channels (Fig 4a, first and second set of channels are orthogonal as the array is disclosed as a square grid).
Regarding claim 13, Korvink teaches in which one of:some or all of the probes comprise electrodes (see Fig 4a-b, each probe 2 has a sensor element thereon); and at least some probes comprise an optical sensor or an optical actuator (Bottom of page 8 of translation).
Regarding claim 19, Korvink teaches in which each probe is electrically isolated from other probes (Fig 4a, each probe 2 is electrically isolated from another via pedestals 31a and spatial separation) and electrically connected to a respective connector pad on the substrate or a respective integrated circuit disposed on or in the substrate (each probe 2 is connected to respective connector pad 2c).
Regarding claim 29, Korvink teaches wherein the probe array further includes at least one supply channel configured to direct fluid to the plurality of channels that are disposed between the pedestals (Pg 9 of translation disclosing a microfluidic component for supplying fluid to the device (i.e., the plurality of channels)).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink (DE 102012002663).
Regarding claim 4, Korvink teaches the device of claim 1 as stated above.
Korvink fails to teach is silent to a pedestal height being greater than 10 microns and the channels each have a width greater than 10 microns.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the pedestals of Korvink to incorporate a pedestal height greater than 10 microns and a channel width greater than 10 microns, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Korvink would not operate differently with the claimed >10 micron pedestal height and >10 micron channel width since Korvink discloses a microprobe array with dimensions on the microscale such that minor changes to heights of the pedestal or widths of the channels between pedestals would not change operation or effect of the device. Further, applicant places no criticality on the dimension claimed, indicating simply typical pedestal height may lie in the range 10-30 μm or even 10-50 microns ([0067] of Applicant’s PGPub No. 2021/0310979) and the channels may have a width greater than 10 microns or a width greater than 14 microns ([0014]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink (DE 102012002663) in view of Fu (U.S. PGPub No. 2017/0030892).
Regarding claim 5, Korvink teaches the device of claim 1 as stated above.
Korvink fails to teach in which the pedestals define said channels to each have a cross-sectional area of at least 100 square microns for flow of fluids therethrough when a sample structure is penetrated by the pillar probes and supported on the platform defined by the pedestal.
In related prior art, Fu teaches a similar probe array comprising microfluidic channels each have a cross-sectional area of at least 100 square microns for flow of fluids therethrough when a sample structure is penetrated by the pillar probes and supported on the platform defined by the pedestal ([0066] channel size is 7 mm x 5 mm, thus a cross-sectional area is greater than 100 square microns). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluid channels of Korvink in view of Fu to incorporate the channels each having a cross-sectional area of at least 100 square microns to arrive at the device of claim 5. Doing so would be obvious to one of ordinary skill in the art as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 6, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink (DE 102012002663) in view of Byun (KR 20130091917).
Regarding claim 6, Korvink teaches the device of claim 1 as stated above.
Korvink fails to teach a plurality of pedestals each having no pillar probes disposed thereon.
In related prior art, Byun teaches a similar probe device wherein a plurality of pedestals each having no pillar probes disposed thereon (Fig 1 multiple pedestals have no pillar probe thereon). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe array of Korvink in view of Byun to incorporate the pedestals with no pillar probe thereon to arrive at the device of claim 6. Doing so would advantageously allow for the use of return terminals for the electrodes formed on the pillar probes (Page 6 of translation, second full paragraph from bottom).
Regarding claim 14, Korvink teaches the device of claim 1 as stated above. Korvink further teaches wherein some or all of the probes comprise electrodes (see Fig 4a-b, each probe 2 has a sensor element thereon) and wherein the probes comprise pillar electrodes (see Fig 4a-b, each probe 2 with a sensor element thereon is interpreted as a pillar electrode)
Korvink fails to teach further comprising an electrically insulating material extending over a major portion of the surfaces of the pedestals and pillar electrodes.
In related prior art, Byun teaches a similar probe device wherein an electrically insulating material extending over a major portion of the surfaces of the pedestals and pillar electrodes (Figs 1-2, probe and pedestal comprise insulating coating 800 on majority of portions thereof). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe pillars of Korvink in view of Byun to incorporate the probe pillar and pedestals covered by an insulating material over a major portion thereof to arrive at the device of claim 14. Doing so would be a simple substitution of one well-known probe pillar configuration (Korvink, probe pillars with conductive electrodes thereon) for another well-known probe pillar configuration (Byun, Figs 1-2, probe electrode pillar with insulating coating) to yield the predictable result of a pillar probe with a conductive tip for sensing and/or stimulating tissue.
Regarding claim 16, Korvink teaches the device of claim 1 as stated above.
Korvink fails to teach in which one of: the pedestals and pillars are both formed of the same electrically conductive material; and the pedestals and pillars are both formed of the same electrically conductive material and at least a lower portion of each pillar are coated with an electrically insulating material.
In related prior art, Byun teaches a similar probe device wherein one of: the pedestals and pillars are both formed of the same electrically conductive material (Figs 1-2, probe and pedestal are formed from same material); and the pedestals and pillars are both formed of the same electrically conductive material and at least a lower portion of each pillar are coated with an electrically insulating material (Figs 1-2, probe and pedestal are formed of same conductive material and comprise insulating coating 800 on lower surfaces of each). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe pillars of Korvink in view of Byun to incorporate the probe pillar and pedestals made of the same conductive material and covered by an insulating material at a lower portion to arrive at the device of claim 16. Doing so would be a simple substitution of one well-known probe pillar configuration (Korvink, probe pillars with conductive electrodes thereon) for another well-known probe pillar configuration (Byun, Figs 1-2, probe electrode pillar with insulating coating) to yield the predictable result of a pillar probe with a conductive tip for sensing and/or stimulating tissue.
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink in view of Schouenborg (U.S. PGPub No. 2006/0085056).
Regarding claims 7 and 10, Korvink teaches the device of claim 1 as stated above.
Korvink fails to teach in which at least some pedestals each have a plurality of pillars disposed thereon; in which the pillars are arrayed in a two- dimensional grid area and the pedestals form a one-dimensional array with channels therebetween extending across the two-dimensional grid area in one direction, each pedestal supporting a plurality of pillars.
In related prior art, Shouenborg teaches a similar probe device wherein at least some pedestals each have a plurality of pillars disposed thereon (Fig 6, columns I, II, III, and IV define pedestals having multiple pillars each); in which the pillars are arrayed in a two- dimensional grid area and the pedestals form a one-dimensional array with channels therebetween extending across the two-dimensional grid area in one direction, each pedestal supporting a plurality of pillars (see Fig 6 disclosing this claimed structure). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pedestals of Korvink in view of Schouenborg to incorporate the long pedestals defining an entire column such that each pedestal form a one-dimensional array with channels therebetween to arrive at the device of claims 7 and 10. Doing so would be a simple substitution of one well-known probe-pedestal configuration (Korvink, unique pedestal for each probe) for another well-known probe-pedestal configuration (Schouenborg, Fig 6, column pedestal with multiple pillar electrodes thereon) to yield the predictable result of an array of pillar probes with a conductive tip for sensing and/or stimulating tissue and channels located between the pedestals capable of functioning as a microfluidic channel.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink in view of Du (U.S. PGPub No. 2017/0253915).
Regarding claims 11 and 12, Korvink teaches teh device of claim 8 as stated above.
Korvink fails to teach a first plurality of supply channels each extending parallel to the substrate outside the two-dimensional grid area in the first direction and communicating with at least one of the first set of channels; and a second plurality of supply channels each extending parallel to the substrate outside the two-dimensional grid area in the second direction and communicating with at least one of the second set of channels.
In related prior art, Du teaches a device comprising a microfluidic array defining five microchannels comprising five inlet openings connected to five external supply channels ([0155] inlet openings are connected to Teflon tubes which are connected to syringes controlled by a pump). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channels of Korvink to incorporate a first and second plurality of supply channels extending parallel to the substrate outside of the grid respectively corresponding to the first and second set of channels to arrive at the device of claims 11-12. Providing microfluid supply channels to the channels between pedestals such that the channels are configured as microfluidic channels would be obvious to one of ordinary skill in the art as Korvink contemplates the use of a microfluidic component to the system for advantageously delivering active substances to the tissue (Korvink bottom pg 10). Providing the supply channels as claimed would have been obvious to one of ordinary skill in the art as the use of supply channels is well-known in the art to yield the predictable result of supplying a liquid to a channel configured to receive liquid.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korvink in view of Ionescu (U.S. PGPub No. 2018/0070869).
Regarding claim 28, Korvink teaches wherein the plurality of channels comprise an inlet end and an outlet end (Pg 9 of translation disclosing a microfluidic component for supplying fluid to the device (i.e., the plurality of channels) such that the opposing end of the microfluidic component is the outlet end and the end containing the microfluidic component is the inlet end).
Korvink fails to explicitly teach wherein the flow of fluid is provided to flow from the inlet end, into and through the plurality of channels and out from the outlet end.
In related prior art, Ionescu teaches a similar device comprising a plurality of channels comprise an inlet end and an outlet end (Fig 1A [0040], inlet 007 and outlet 008 with fluidic channels 006 therebetween), wherein the flow of fluid is provided to flow from the inlet end, into and through the plurality of channels and out from the outlet end ([0043] fluid flows from inlet through channels and through outlet). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic component of Korvink in view of Ionescu to incorporate the defined inlet and outlet ends such that fluid flows from the inlet end, through the channels, and out from the outlet end to arrive at claim 28. Doing so would be obvious to one of ordinary skill in the art as the use of an inlet and outlet end to supply and remove fluid from a plurality of channels therebetween is well-known in the art to yield the predictable result of providing a complete fluid pathway in a device to supply and remove said fluid (Fig 1a [0040] [0043]).
Response to Arguments
Applicant's arguments filed 07/15/2025 have been fully considered but they are not persuasive. Applicant argues that the Korvink reference does not disclose an “array is formed in a square 2D grid … instead Korvink explicitly states “The tissue probe 30 [shown in Fig 4A] has a plate-like base element 31, on which a plurality, in this case eight, of needle-like carrier elements is arranged.” In summary, applicant argues that Fig 4A of Korvink discloses only 8 needle like carrier elements disposed in a single vertical column, and does not disclose a square grid of carrier elements.
The Examiner respectfully disagrees. Fig 4A of Korvink clearly depicts a 2D square grid of carrier elements indicated by the dashed lines forming a cube and the circles indicating a depth of additional vertical columns of carrier elements. This interpretation is explicitly supported by the translation of Korvink. Stating plainly, on page 13, “4a shows the tissue probe which is formed with a 3-D array of micro LEDS and microelectrodes” and “As in 4a indicated by dashed lines and black dots, the tissue probe can 30 be configured so that the support elements 2 parallel to each other and at the crossing points of an imaginary square grids are arranged or aligned on the base element” (emphasis added). As such, these arguments are unpersuasive.
In response to applicant's argument that Korvink does not teach a microfluidic channel system, 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. In the instant case, the claims merely recite functional, “configured to”, language regarding the flow of fluid to provide a microfluidic channel. Korvink discloses a plurality of channels as claimed that are capable of receiving fluid therein to form a microfluidic channel system as claimed. As such, these arguments are unpersuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794