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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 23-31, in the reply filed 6/1/2026 is acknowledged.
Claims 32-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
In claim 23, line 2, the limitation “receptacle” will be interpreted under the broadest reasonable interpretation (BRI) as any element capable of containing liquid.
In claim 25, line 2, the limitation “reservoir” will be interpreted under the BRI as any element capable of containing liquid.
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.
Claims 23-25, 28, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Huh et al. (WO 2017/019796 A1) (hereinafter referred to as Huh, see PTO-892) in view of Hatch et al. (US Patent 10,988,723 B1) (hereinafter referred to as Hatch, see PTO-892).
Regarding claim 23, Huh discloses a cartridge for culturing organ-on a chip (Fig. 2A, biomimetic five-layer fibrosis model 200 – see figure below; pg. 2, lines 6-10, prior art cartridge can model organs), comprising:
a. a receptacle (Fig. 2A, second channel slab 220) configured to contain fluids (pg. 12, lines 24-26, second channel slab includes a second microchannel; pg. 5, lines 20-24, prior art receptacle can hold cell media via second microchannel), the receptacle comprises at least one receptacle inlet configured to deliver a first fluid into the receptacle, and at least one receptacle outlet configured to withdraw fluids from the receptable (Fig. 2A, ports 222 and 223; pg. 31, lines 4-6 and 13-15, prior art receptacle inlet and receptacle can achieve intended uses);
b. at least one organ chip (Fig. 2A, first channel slab 210) having a bottom face (Fig. 2A, first channel slab has a bottom face) configured to be in fluid communication with the fluids within the receptacle (pg. 19, lines 3-11, bottom face of prior art organ chip in fluid communication with fluids in receptacle via first microchannel 211 and gel layer), the organ chip comprising
i. a membrane located at the bottom face of the at least one organ chip (Fig. 2A, first membrane 240) the membrane having an upper side and a lower side each configured for cell, tissue or organoid culture (pg. 21, lines 6-9 discloses a layer of cells can be attached to both sides of a membrane), wherein the membrane is permeable to fluids (pg. 19, lines 3-11 implicitly discloses fluid permeability) and wherein the upper side of the membrane is facing the top face of the organ chip (Fig. 2A);
ii. an inlet conduit having an external inlet protruding through the top face of the organ chip (pg. 31, lines 9-12 discloses access through the top; Fig. 2A), wherein the inlet conduit is configured to deliver a second fluid into the organ chip (pg. 31, lines 9-12);
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iii. an outlet conduit having an external outlet protruding through the top face of the organ chip (pg. 31, lines 9-12; Fig. 2A), wherein the outlet conduit is configured to withdraw fluids from the organ chip (pg. 31, lines 9-12).
Huh is silent to a cover layer comprising at least one slot.
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However, Hatch in the art of on-chip cell culturing teaches it is known to use a cover layer to hold an organ chip, the cover layer comprising at least one slot (Fig. 11C – see annotated figure below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of Huh to incorporate a cover layer, as it would predictably hold the organ chip, as taught by Hatch.
The limitation “configured to cover the receptacle” is directed toward the intended manner of operating the claimed cover layer and does not differentiate the claimed cover layer from the prior art cover layer because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination cover layer would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I). Examiner suggests amending the claim of note to positively recite the structural relationship between the cover layer and the receptacle.
Similarly, the limitation “configured to hold at least one organ chip such that the bottom face of the organ chip and the lower side of the membrane are immersed in the fluid in the receptacle” is directed toward the intended manner of operating the claimed at least one slot and does not differentiate the claimed at least one slot from the prior art at least one slot because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination at least one slot would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I). Examiner suggests amending the claim of note to positively recite the structural relationship between the at least one slot, at least one organ chip, the bottom face of the organ chip, and the lower side of the membrane.
The prior art combination is silent to the external outlet and inlet being open to or protruding outside the cartridge, through the cover layer.
Nonetheless, modifying the prior art combination such that the external outlet and inlet are open to or protrude outside the cartridge, through the cover layer would amount to merely rearrangement of parts, as such a modification would predictably result in the prior art combination facilitating fluid flow through the cover layer. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
Regarding claim 24, the claim is directed towards structure not positively recited, e.g., the first fluid and second fluid. Claim 23, which claim 24 depends upon, recites the first fluid and second fluid in the intended use of the at least one receptacle inlet and inlet conduit, respectively. In the absence of further positively recited structure, the prior art applied to claim 23 above applies to claim 24.
Regarding claim 25, the prior art combination teaches the cartridge of claim 23.
Huh of the prior art combination discloses wherein the receptacle further comprises at least one reservoir (Fig. 2A, second microchannel 221).
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Hatch of the prior art combination discloses wherein the cover layer further comprises at least one reservoir opening (Fig. 11C shows openings with slot – see annotated figure below).
The limitation “in fluid communication with the fluids within the receptacle” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115). The fluids within the receptacle is drawn to the intended use of the receptacle (see claim 23, line 2). Therefore, the claimed fluids within the receptacle is not positively recited.
The limitation “configured to be positioned above the at least one reservoir thereby enabling withdrawal of fluids from the receptacle through the at least one reservoir opening” is directed toward the intended manner of operating the claimed reservoir opening and does not differentiate the claimed reservoir opening from the prior art reservoir opening because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art reservoir opening would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I). Examiner suggests amending the claim to positively recite the structural relationship between the reservoir opening and the reservoir.
Regarding claim 28, the prior art combination teaches the cartridge of claim 23.
The prior art combination is silent to the cartridge comprising a plurality of organ chips, wherein the cover layer comprises a plurality of slots.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination cartridge to comprise a plurality of organ chips as such a modification represents mere duplication of the prior art at least one organ chip discussed above (see claim 1 rejection under 35 U.S.C. 103). It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). Such a modification would predictably allow for culturing of multiple different tissues on the same device.
Further, modification of the prior art combination cover layer such that it comprises a plurality of slots represents a mere duplication of the prior art at least one slot discussed above (claim 1 rejection under 35 U.S.C. 103). Such a modification would predictably facilitate the plurality of organ chips.
The limitation “each configured to hold one organ chip from the plurality of organ chips” is directed toward the intended manner of operating the claimed plurality of slots and does not differentiate the claimed plurality of slots from the prior art plurality of slots because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination plurality of slots would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 29, the prior art combination the cartridge of claim 25.
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Hatch of the prior art combination discloses wherein the cover layer comprises a plurality of reservoir openings (Fig. 11C – see annotated figure below).
The prior art combination is silent to a plurality of reservoirs.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination cartridge to comprise a plurality of reservoirs as such a modification represents mere duplication of the reservoir. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). Such a modification would predictably provide space for more liquid or different types of liquid.
The limitation “each configured to be positioned above one reservoir from the plurality of reservoirs” is directed toward the intended manner of operating the claimed plurality of reservoirs and does not differentiate the claimed plurality of reservoirs from the prior art plurality of reservoirs because all structural limitations are taught in the prior art (MPEP § 2114 II). Each of the plurality of reservoirs would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 31, the prior art combination teaches the cartridge of claim 23.
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Huh of the prior art combination discloses wherein the receptacle comprises a plurality of receptacle inlets and a plurality of receptacle outlets (Fig. 2A – see annotated figure below).
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Huh and Hatch as applied to claim 23 above, and further in view of Ingber et al. (US 2016/0313306 A1) (hereinafter referred to as Ingber, see PTO-892).
Regarding claim 26, the prior art combination teaches the cartridge of claim 23.
The prior art combination is silent to the receptacle further comprising at least one fluid impermeable partitioning unit creating a barrier that prevents flow of the fluids out of the receptacle.
However, Ingber teaches it is known in the art of organ-on-chip devices to incorporate a partition wall, i.e., a partitioning unit, to create a fluidic seal, i.e., prevent flow of fluids ([0155]). Ingber implicitly discloses that the partition wall is fluid impermeable ([0155], “The partition walls can form a fluidic seal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination receptacle to further comprise at least one fluid impermeable partitioning unit, as Ingber teaches that such a modification was known in the art.
The limitation “creating a barrier that prevents flow of the fluids out of the receptacle” is directed toward the intended manner of operating the claimed partitioning unit and does not differentiate the claimed partitioning unit from the prior art partitioning unit because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination partitioning unit would be fully capable of achieving every claimed intended use because the prior art combination partitioning unit can form a fluidic seal, as discussed above.
Regarding claim 27, the prior art combination teaches the cartridge of claim 26.
Ingber of the prior art combination discloses wherein the partitioning unit comprises flexible, semi-flexible or rigid members ([0405] discloses PDMS used to form the device, which is flexible; [0154] and Figs. 22A-22B show that the partition wall is formed integral with the device).
The limitation “wherein the partitioning unit comprises rigid members which are held in place by partitioning holders” is phrased in the alternative. Because at least one of the limitations, e.g., wherein the partitioning unit comprises flexible, semi-flexible or rigid members, is rejected above, no further rejections are required at this time.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Huh and Hatch as applied to claim 23 above, and further in view of Varone et al. (US 2018/0346859 A1) (hereinafter referred to as Varone, see PTO-892).
Regarding claim 30, the prior art combination teaches the cartridge of claim 23.
The prior art combination is silent to top face of the organ chip comprising an opening.
However, Varone in the art of organ-on-chip models teaches it is known in the art to form an organ chip with an opening on the top face of an organ chip (Fig. 5F – see figure below).
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Varone teaches that open-top devices allows users to interface with parts of the device or cells contained therein ([0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination cartridge such that there is an opening on the top face of an organ chip as such a modification was known in the art, as shown by Varone, and such a modification would allow a user to interface with cells cultured in the device.
The limitation “configured to enable view of the cells or organelles cultured on the top side of the membrane” is directed toward the intended manner of operating the claimed opening and does not differentiate the claimed opening from the prior art opening because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art opening would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zheng et al. (CN 105754855 A) (English machine translation provided, see PTO-892) discloses a culture organ chip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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