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 .
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.
Allowable Subject Matter
Claims 17-21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art to the instant application is United States Patent Application Publication US 2019/0270085 to Handique et al. (herein Handique) and “Three Dimensional Microfluidic Cell Arrays for ex Vivo Drug Screening with Mimicked Vascular Flow” to Dereli-Korkut et al. (herein Dereli-Korkut).
Handique discloses a system 100 for capturing and analyzing cells (i.e., biomimetic array device) including, a plurality of inlets 141 (i.e., wells) of a plurality of manifolds 140 configured to receive a fluid from a plurality of reservoirs 120 and/or fluid delivery modules 110 (see [0045]; Figs. 1A & 10A), wherein the fluid is delivered to a tissue biopsy imaging substrate 185 (i.e., tissue sample) (see [0051]; Fig. 10A). The device 100 further comprises a plurality of microchannels 104 fluidically coupled between the plurality of wells 141 and a plurality of microchambers comprising microchannels 106 (see Figs. 1A & 10C), wherein each microchamber shown in Fig. 10C is fluidically isolated from each other microchamber as shown in Fig. 1A, and a set of openings 143 (i.e., plurality of microports) enabling fluid communication between microchannels 106 of the microchamber and a first side of the tissue sample 185, wherein each microport receives fluid from a single microchamber comprising a set of microchannels 106 (see [0051]; Figs. 1A, 6, 10A, & 10C). The device further configured to arrange the tissue sample 185 to extend across and directly contact the plurality of microports 143 (see Figs. 6 & 10A); deposit fluid into the plurality of wells 141 (see [0045]; Figs. 1A & 10A); and allow fluid form the plurality of wells to flow through the plurality of microchannels 104, the plurality of microchambers and the plurality of microports 143 and to the tissue sample 185 (see [0051]; Figs. 1A, 6, 10A, & 10C). Figs. 1A & 10A of Handique discloses tissue samples 185 are supported above the plurality of microchambers.
Dereli-Korkut (see citation below) discloses a tumor microenvironment and 3D microfluidic cell array, wherein the tumor microenvironment comprises cancer cells (see Fig. 1). The 3D microfluidic device comprises an upper layer of microchannels (i.e., fluid reservoir), wherein the bottom of the fluid reservoir (i.e., middle layer) comprises a fluid permeable membrane configured to pass fluid from the fluid reservoir through the fluid permeable membrane to an upper side of a third layer comprising the cancer cells (see Fig. 1). Dereli-Korkut discloses configuring the 3D microfluidic device to comprise intact tissue samples such as biopsy tissues (see Discussion, 7th paragraph).
However, there is no reason nor motivation provided in either reference, alone or in combination, to arrive at the dual sided fluid delivery system of the claimed invention. Therefore, neither Handique nor Dereli-Korkut, alone or in combination, teach nor fairly suggest both “supplying fluid to a first side of a tissue sample … and … delivering fluid from the fluid reservoir to a second side of the tissue sample that is opposite to the first side of the tissue sample” In other words, Handique discloses “supplying fluid to a first side of a tissue sample” and Dereli-Korkut discloses “delivering fluid from the fluid reservoir to a second side of the tissue sample that is opposite to the first side of the tissue sample”, however there is no reason nor motivation provided in either reference to combine the device of Handique and the device of Dereli-Korkut with reasonable expectation of success to arrive at the instant invention. Therefore, claims 17-21 are novel and inventive.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claim Objections
Claims 9-11 and 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 9-11, primary reference Handique discloses the invention of claim 1 and discloses delivering fluid from the plurality of wells 141 to a first side of the tissue sample 185 (see Fig. 10A). In this particular instance, the bottom side of said tissue sample. Secondary reference Dereli-Korkut discloses a tumor microenvironment and 3D microfluidic cell array, wherein the tumor microenvironment comprises cancer cells (see Fig. 1). The 3D microfluidic device comprises an upper layer of microchannels (i.e., fluid reservoir), wherein the bottom of the fluid reservoir (i.e., middle layer) comprises a fluid permeable membrane configured to pass fluid from the fluid reservoir through the fluid permeable membrane to an upper side of a third layer comprising the cancer cells (see Fig. 1). Dereli-Korkut discloses configuring the 3D microfluidic device to comprise intact tissue samples such as biopsy tissues (see Discussion, 7th paragraph). However, there is no reason nor motivation provided in either reference, alone or in combination, to arrive at the dual sided fluid delivery system of the claimed invention. Therefore, neither Handique nor Dereli-Korkut, alone or in combination, teach nor fairly suggest “delivering fluid from the plurality of wells to a first side of the tissue sample and delivering fluid to a second side of the tissue sample that is opposite the first side by covering the second side with a fluid permeable membrane that forms a portion of a fluid reservoir and passing fluid from the fluid reservoir through the fluid permeable membrane” as recited in instant claim 9. In other words, Handique discloses “delivering fluid from the plurality of wells to a first side of the tissue sample” and Dereli-Korkut discloses “delivering fluid to a second side of the tissue sample that is opposite the first side by covering the second side with a fluid permeable membrane that forms a portion of a fluid reservoir and passing fluid from the fluid reservoir through the fluid permeable membrane”, however there is no reason nor motivation provided in either reference to combine the device of Handique and the device of Dereli-Korkut with reasonable expectation of success to arrive at the instant invention. Claims 10 and 11 depend from claim 9.
Regarding claims 13-15, Handique discloses the invention of claim 12. However, dependent claim 13 recites similar limitations to that of claim 9 and thus contains allowable subject matter for the same reason as cited above in regards to claim 9. Claims 14 and 15 depend from claim 13.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0270085 to Handique et al. (herein Handique).
Regarding claim 1, Handique discloses a method comprising: providing a system 100 for capturing and analyzing cells (i.e., biomimetic array device) including, a plurality of inlets 141 (i.e., wells) of a plurality of manifolds 140 configured to receive a fluid from a plurality of reservoirs 120 and/or fluid delivery modules 110 (see [0045]; Figs. 1A & 10A), wherein the fluid is delivered to a tissue biopsy imaging substrate 185 (i.e., tissue sample) (see [0051]; Fig. 10A). The device 100 further comprises a plurality of microchannels 104 fluidically coupled between the plurality of wells 141 and a plurality of microchambers comprising microchannels 106 (see Figs. 1A & 10C), wherein each microchamber shown in Fig. 10C is fluidically isolated from each other microchamber as shown in Fig. 1A, and a set of openings 143 (i.e., plurality of microports) enabling fluid communication between microchannels 106 of the microchamber and the surface of the tissue sample 185, wherein each microport receives fluid from a single microchamber comprising a set of microchannels 106 (see [0051]; Figs. 1A, 6, 10A, & 10C). The method further comprises: arranging the tissue sample 185 to extend across and directly contact the plurality of microports 143 (see Figs. 6 & 10A); depositing fluid into the plurality of wells 141 (see [0045]; Figs. 1A & 10A); and allowing fluid form the plurality of wells to flow through the plurality of microchannels 104, the plurality of microchambers and the plurality of microports 143 and to the tissue sample 185 (see [0051]; Figs. 1A, 6, 10A, & 10C).
Regarding claim 2, Handique discloses the invention of claim 1 and discloses delivering the fluid to spatially distinct regions of the tissue sample (see Figs.6 & 10A) wherein each microport 143, including 144/145, are located in spatially distinct regions of the tissue sample 185 (see [0051)).
Regarding claim 3, Handique discloses the invention of claim 2 and discloses wherein each microport distinct region (see Fig. 6) receives fluid from a single microchamber (see Figs. 10A & 10C).
Regarding claim 4, Handique discloses the invention of claim 1 and discloses wherein each microport 143 (see Fig. 6) interfaces with the tissue sample 185 (see Figs. 10A & 10C), wherein each interface corresponds to the single microchamber comprising microchannels 106 (see [0051]; Figs. 10A & 10C).
Regarding claim 5, Handique discloses the invention of claim 1 and discloses wherein the plurality of microports 143 form a microport bank configured for supporting the tissue sample 185 (see [0051]; Fig. 6 & 10A).
Regarding claim 12, Handique discloses a system 100 for capturing and analyzing cells (i.e., biomimetic array device) including, a plurality of inlets 141 (i.e., wells) of a plurality of manifolds 140 configured to receive a fluid from a plurality of reservoirs 120 and/or fluid delivery modules 110 (see [0045]; Figs. 1A & 10A), wherein the fluid is delivered to a tissue biopsy imaging substrate 185 (i.e., tissue sample) (see [0051]; Fig. 10A). The device 100 further comprises a plurality of microchannels 104 fluidically coupled between the plurality of wells 141 and a plurality of microchambers comprising microchannels 106 (see Figs. 1A & 10C), wherein each microchamber shown in Fig. 10C is fluidically isolated from each other microchamber as shown in Fig. 1A, and a set of openings 143 (i.e., plurality of microports) enabling fluid communication between microchannels 106 of the microchamber and the surface of the tissue sample 185, wherein each microport receives fluid from a single microchamber comprising a set of microchannels 106 (see [0051]; Figs. 1A, 6, 10A, & 10C). The device is configured to arrange the tissue sample 185 to extend across and directly contact the plurality of microports 143 (see Figs. 6 & 10A); deposit fluid into the plurality of wells 141 (see [0045]; Figs. 1A & 10A); and allow fluid form the plurality of wells to flow through the plurality of microchannels 104, the plurality of microchambers and the plurality of microports 143 and to the tissue sample 185 (see [0051]; Figs. 1A, 6, 10A, & 10C). Handique discloses wherein the plurality of microports 143 form a microport bank configured for supporting the tissue sample 185 (see [0051]; Fig. 6 & 10A). Handique discloses delivering the fluid to spatially distinct regions of the tissue sample (see Figs.6 & 10A) wherein each microport 143, including 144/145, are located in spatially distinct regions of the tissue sample 185 (see [0051)).
Regarding claim 16, Handique discloses the invention of claim 12 and Figs. 1A and 9 disclose wherein the plurality of microchambers form a microchamber array contained within an enclosure having a top wall that extends over each microchamber of the microchamber array.
Claim Rejections - 35 USC § 103
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0270085 to Handique et al. (herein Handique).
Regarding claim 6, Handique discloses the invention of claim 1, however, fails to explicitly disclose “wherein an equal volume of fluid is deposited in each well of the plurality of wells” as recited in the instant claim. Handique does disclose transmitting a volume of fluid into each well of the plurality of wells (see claim 1 and Fig. 1A), wherein the fluid delivery module 110 is configured to control delivery of specific fluid to the reservoir 130 and thus to the plurality of wells 141 (see [0035]; Fig. 1A & 2A) and wherein the reservoir comprises a level sensor and processor configured to receive a signal and generate a command to control fluid delivery into the plurality of wells in any suitable manner to facilitate cell capture and analysis (see [0042]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Handique as desired, including distribution of equal volume into plurality of wells, for the benefit of facilitating desired analysis across the plurality of manifolds (see [0042]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0270085 to Handique et al. (herein Handique) in view of “Three Dimensional Microfluidic Cell Arrays for ex Vivo Drug Screening with Mimicked Vascular Flow” to Dereli-Korkut et al. (herein Dereli-Korkut).
Regarding claim 7, Handique discloses the invention of claim 1 and discloses the set of fluids delivered to the tissue sample can be any suitable fluid for analysis (see [0032]). However, Handique fails to disclose “wherein the fluid deposited in any well of the plurality of wells is selected from the group consisting of culture media, a therapeutic agent and a pharmaceutical compound” as recited in the instant claim.
Dereli-Korkut (see citation below) discloses a tumor microenvironment and 3D microfluidic cell array, wherein the tumor microenvironment comprises cancer cells (see Fig. 1). The 3D microfluidic device comprises an upper layer of microchannels (i.e., fluid reservoir), wherein the bottom of the fluid reservoir (i.e., middle layer) comprises a fluid permeable membrane configured to pass fluid from the fluid reservoir through the fluid permeable membrane to an upper side of a third layer comprising the cancer cells (see Fig. 1). Dereli-Korkut discloses configuring the 3D microfluidic device to comprise intact tissue samples such as biopsy tissues (see Discussion, 7th paragraph). Dereli-Korkut discloses delivering fluids consisting of cell culture media (see Experimental section, 3rd paragraph), therapeutic agent (see Discussion, last paragraph), and pharmaceutical compound (see abstract).
Dereli-Korkut and Handique are analogous in the field of microfluidic devices for fluid delivery and analysis of tissue samples. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the fluids of Handique to be the culture media, therapeutic agent, and pharmaceutical compound of Dereli-Korkut for the benefit of providing a system that provides better predictions of drug responses and identification of a suitable treatment for a specific patient (see abstract of Dereli-Korku).
Regarding claim 8, Handique discloses the invention of claim 1 and discloses the device 100 can be used to capture and analyze circulating tumor cells (see [0031]). However, Handique fails to disclose “wherein, when the tissue sample is intact tumor tissue from a patient, characterizing the viability of cells within the intact tumor tissue after exposure to fluid, such that fluids that result in cell death are identified as therapeutic candidates for the patient” as recited in the instant claim.
Dereli-Korkut (see citation below) discloses a tumor microenvironment and 3D microfluidic cell array, wherein the tumor microenvironment comprises cancer cells (see Fig. 1). The 3D microfluidic device comprises an upper layer of microchannels (i.e., fluid reservoir), wherein the bottom of the fluid reservoir (i.e., middle layer) comprises a fluid permeable membrane configured to pass fluid from the fluid reservoir through the fluid permeable membrane to an upper side of a third layer comprising the cancer cells (see Fig. 1). Dereli-Korkut discloses configuring the 3D microfluidic device to comprise intact tissue samples such as biopsy tissues (see Discussion, 7th paragraph). Dereli-Korkut discloses applying potential cancer drugs to said microfluidic device to measure the dynamic responses of apoptotic activities (i.e., cell death) to identify the potential of anticancer drugs for treatment (see 5th paragraph of document).
Dereli-Korkut and Handique are analogous in the field of microfluidic devices for fluid delivery and analysis of tissue samples. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the tissue sample of Handique to be an intact tumor tissue sample and to characterize the viability of cells after exposure to a fluid comprising a potential therapeutic candidate for a patient for the benefit of identifying a potential drug to be used as treatment (see 5th paragraph of document of Dereli-Korkut).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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