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 1-11 in the reply filed on 12/3/25 is acknowledged.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (method), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/3/25.
Claim Status
Claims 1-11 are pending and are examined. Claims 12-15 are withdrawn and are not examined.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vacanti (US Pub 2011/0091930).
Regarding Claim 1, Vacanti teaches a sample carrier, comprising:
a reservoir with a bottom; and two channels, each having an opening into the reservoir, wherein the two openings are arranged above the bottom (Figs. 4 and 5 [0042] A plurality of drain conduits 66 extend through drain ledge 58 to a drain channel 68 that is in fluid communication with outlet 42. Drain conduits 66 are tubular and each have an axis that is parallel to central axis 38. Drain conduits 66 are spaced equally around the drain ledge 58. In an embodiment, well 30 includes eight drain conduits. Drain channel 68 starts at a channel end 70 then wraps around the perimeter of base section 34 and terminates at a channel end 72. Drain channel is formed in the layer of base section 34 in which inlet conduit 46 is formed. Channel ends 70,72 are positioned on opposite sides of inlet conduit 46. Hence, well 32 provides a flow path for introducing and draining medium. Medium can flow into inlet 40, through inlet conduit, through discharge conduit 48, out discharge mouth 50, through flow chamber 56, through drain conduits 66, through drain channel 68, and through outlet 42.)
wherein an underside of the sample carrier is formed flat (the underside appears flat in Figs. 5 and 6), and
wherein each of the two openings faces in a direction that is not parallel to the underside (the inlet and the outlet each has an opening in an opposite direction than the underside).
Regarding Claim 2, Vacanti teaches the sample carrier according to claim 1, wherein the reservoir has a side wall comprising a surface region that is not perpendicular to the underside, wherein one opening or both openings are arranged in the surface region (Figs. 4-6, [0042] A flow chamber wall 52 extends from discharge mouth 50. Flow chamber wall 52 is frusto-conical and centered around central axis 38. Flow chamber wall 52 opens away from discharge mouth 50, with its widest point defined by an annular flow chamber edge 54.).
Regarding Claim 3, Vacanti teaches the sample carrier according to claim 2, wherein the surface region is configured in the form of a step, and wherein the surface region is provided parallel to the underside ([0044] Referring to FIGS. 6-8, well 30 provides for radial flow of medium. Medium enters flow chamber 56 at discharge mouth 50, which is at the center and bottom of flow chamber 56. The surface region is capable of being in the form of a step.).
Regarding Claim 4, Vacanti teaches the sample carrier according to claim 1, wherein a second end of one of the two channels is configured in the form of a hole on an upper surface of the sample carrier, which is arranged opposite to the underside (a second end of one of the two channels is capable of being configured in the form of a hole on an upper an upper surface of the sample carrier, which is arranged opposite to the underside).
Regarding Claim 5, Vacanti teaches the sample carrier according to claim 1, further comprising: a cover element, and a bottom element, wherein the cover element and the bottom element are connected to each other over the complete area, wherein the underside of the sample carrier is configured on the bottom element, wherein at least one of the channels is at least partially configured in the form of a trench on one side of the cover element, and wherein the trench is covered by the bottom element ([0041] Reference is now made to FIGS. 1-3 which show a multi-well cell culture plate 10 including a flow system according to an embodiment of the present invention. Plate 10 includes a body 12, in which are formed a plurality of bioreactor wells 14, a plurality of supply lines 16, and a plurality outlet lines 18. As discussed below, wells 14 are configured to hold cell culture inserts that include a structure for seeding cells and other biological materials. Supply lines 16 supply medium to wells 14 and outlet lines 18 drain medium from wells 14. Plate 10 is shown with 24 bioreactor wells but can be scaled to include any number of wells, such as 1, 6, 8, or 96 wells.).
Regarding Claim 6, Vacanti teaches the sample carrier according to claim 1, wherein one channel or both channels extend from the openings at least partially perpendicularly to the underside through the sample carrier ([0042] Referring now to FIGS. 4-6, a well 30 provides medium to a cell culture insert 32. Well 30 includes a base section 34 and an insert section 36. Base section 34 is cylindrical about a central axis 38. Base section 34 includes an inlet 40 for introducing medium to well 30 and an outlet 42 for draining medium from well 30.).
Regarding Claim 7, Vacanti teaches the sample carrier according to claim 1, further comprising a supply channel, wherein one end of the supply channel opens into the reservoir in a supply opening, and wherein the supply opening is arranged at a level of one of the two openings or above both openings ([0049] When arranged in a multi-well plate such as plate 10 of FIGS. 1-3, the inlet of a well is in fluid communication with one of supply lines 16 and outlet conduit of the well is in fluid communication with one of outlet lines 18. In this embodiment, each well has its own medium supply and outlet, which allows for separate experiments on one plate. Each wells' supply and outlet medium are segregated from the other wells on the plate, which allows for investigation of the contents and condition of each wells' medium both before and after passage through the culture system. Other embodiments can provide different supply and outlet line configurations. For example, a network of supply and outlet lines can be configured to connect a number of wells in serial.).
Regarding Claim 8, Vacanti teaches the sample carrier according to claim 7, wherein the supply opening is arranged at a point in the side wall of the reservoir at which an edge is present and/or at which a radius of curvature of the side wall has a local minimum ([0049] When arranged in a multi-well plate such as plate 10 of FIGS. 1-3, the inlet of a well is in fluid communication with one of supply lines 16 and outlet conduit of the well is in fluid communication with one of outlet lines 18. In this embodiment, each well has its own medium supply and outlet, which allows for separate experiments on one plate. Each wells' supply and outlet medium are segregated from the other wells on the plate, which allows for investigation of the contents and condition of each wells' medium both before and after passage through the culture system. Other embodiments can provide different supply and outlet line configurations. For example, a network of supply and outlet lines can be configured to connect a number of wells in serial.).
Regarding Claim 9, Vacanti teaches the sample carrier according to claim 1, further comprising a closing element that closes the reservoir to the outside ([0043] Well 30 includes a pair of annular sealing protrusions 74 that extend inwardly from well wall 62. A sealing member 76 is seated between sealing protrusions 74 and seals against cell culture insert 32 when cell culture insert 32 is positioned in insert cavity 64.).
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.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vacanti (US Pub 2011/0091930), in view of Bertassoni (“Hydrogel bioprinted microchannel networks for vascularization of tissue engineering constructs.” Lab On a Chip. 14. 2014. P.2202).
Regarding Claims 10 and 11, Vacanti teaches the sample carrier according to claim 1.
Vacanti is silent to the reservoir is filled with a hydrogel, and wherein the openings are not covered with the hydrogel, wherein a channel structure is formed in the hydrogel, and wherein the channel structure connects the openings.
Bertassoni teaches in 1. Introduction a recent strategy for fabrication of well defined microchannels within engineered tissues has been based on bioprinting techniques to position sacrificial template materials, such as carbohydrate glass and ‘fugitive inks’ of Pluronic F127 enclosed inside a hydrogel matrix. In paragraph 3 of 1. Introduction In this paper, we report a bioprinting-based strategy in which agarose, a naturally derived polysaccharide, is used as a permissive template material for vascularization of engineered hydrogel constructs. In the proposed strategy, agarose fibers are bioprinted with a well-defined and controlled three dimensional (3D) architecture. Then, a hydrogel precursor is casted over the bioprinted templates and subsequently photopolymerized. After gelation, the bioprinted agarose fibers do not adhere to the surrounding photocrosslinked hydrogels. Hence the bioprinted templates can be easily removed to form fully perfusable networks without any requirement for template dissolution (Fig. 1). Herein, we demonstrate the effectiveness of the proposed strategy in fabricating microchannel networks and microfluidics constructs in a wide variety of photocrosslinkable hydrogels commonly used for tissue engineering applications.
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 filled the reservoir with a hydrogel, and wherein the openings are not covered with the hydrogel, wherein a channel structure is formed in the hydrogel, and wherein the channel structure connects the openings, as taught by Bertassoni, in the device of Vacanti, to allow for an effective technique for vascularization of hydrogel constructs with useful applications in tissue engineering and organs on a chip, as taught by Bertassoni, in the Abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798