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 1 (Claims 1,4-8, and 11-20) in the reply filed on 11/26/2025 is acknowledged.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1,4-6,11,14, and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mohapatra et al. (US 11,685,885).
Regarding claim 1 Mohapatra discloses an open chamber for cell culture, the chamber comprising an inlet and an outlet for non-tangential flow of fluid from the inlet to the outlet. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein an open culture chamber 21 has at least one fluid inlet 24 and at least one fluid outlet 26 through which fluid may flow in a non-tangential manner.)
Regarding claim 4 Mohapatra discloses all the claim limitations as set forth above as well as the device wherein the chamber does not comprise a sacrificial material. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein the formed device has no sacrificial material)
Regarding claim 5 Mohapatra discloses all the claim limitations as set forth above as well as the device wherein the chamber does not comprise a membrane. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein there is no membrane in the chamber.)
Regarding claim 6 Mohapatra discloses all the claim limitations as set forth above as well as the device wherein the inlet and/or outlet is a channel. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein the inlet 24 and outlet 26 are fluid channels.)
Regarding claim 11 Mohapatra discloses all the claim limitations as set forth above as well as the device comprising at least two inlets and/or at least two outlets. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 5A, and 6 wherein there are more than two inlets 24 and more than two outlets 26.)
Regarding claim 14 Mohapatra discloses all the claim limitations as set forth above as well as the device configured for unidirectional or bidirectional fluid flow from the inlet to the outlet. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein fluid flows at least unidirectionally from the inlet to the outlet)
Regarding claim 17 Mohapatra discloses all the claim limitations as set forth above as well as the device, further comprising cells seeded into the open chamber. . (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6-7 wherein cells are grown in the open chamber 21 and thus must be seeded therein.)
Regarding claim 18 Mohapatra discloses all the claim limitations as set forth above as well as an array comprising the open chamber of claim 1 and at least one inlet chamber and at least one outlet chamber. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein there is an array comprising the open chamber 21 an, inlet chamber 20, and an outlet chamber 22.)
Regarding claim 19 Mohapatra discloses all the claim limitations as set forth above as well as a multi-well plate comprising the array of claim 18. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein the array is formed in/on a multiwell plate 10 as shown in Fig 1A.)
Regarding claim 20 Mohapatra discloses all the claim limitations as set forth above as well as the device comprising a plurality of arrays. (See Mohapatra Abstract Col. 6 Lines 37-56 and Figs. 1A-1EE, 5A, and 6 wherein the multiwell plate 10 has a plurality of arrays.)
Claim 1, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sandoz et al. (US 2020/0318048)
Regarding claim 1 Sandoz discloses a open chamber for cell culture, the chamber comprising an inlet and an outlet for non-tangential flow of fluid from the inlet to the outlet. (See Sandoz Abstract [0109]-[0112] and Figs. 4-8 wherein an open chamber for cell culture 22 comprises an inlet and outlet via microfluidic channel 28 such that flow may be non-tangential from the inlet to the outlet.)
Regarding claim 12 Sandoz discloses all the claim limitations as set forth above as well as the device wherein the open chamber comprises a patterned base. (See Sandoz Figs. 1-2 and [0101] wherein the open chamber has a patterned base 16)
Regarding claim 13 Sandoz discloses all the claim limitations as set forth above as well as the device wherein the patterned base comprises connected grooves for guiding self-assembly of cultured cells. (See Sandoz Figs. 1-2 and [0101] wherein the open chamber has a patterned base formed from connected grooves 16 for guiding cells.)
Regarding claims 15-16 Sandoz discloses all the claim limitations as set forth above as well as the device further comprising a hydrogel on a bottom surface of the open chamber and the hydrogel comprises a fibrin matrix, fibrin, Matrigel, collagen I, a decellularized matrix, or a combination thereof. (See Sandoz [0126]-[0127] wherein cells are cultured on the bottom surface of the open chamber in a scaffold material, i.e. the scaffold is one the bottom surface and [0135] wherein the scaffold is a collagen type I hydrogel.)
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mohapatra et al. (US 11,685,885) as applied to claims above.
Regarding claims 7-8 Mohapatra discloses all the claim limitations as set forth above as well as the device wherein the channel size is known to be modified to adjust flow properties but does not specifically disclose wherein the channel is about 200 microns wide and about 100 to about 200 microns tall.
It is noted that such a modification would have required a mere change in size of the channel of Mohapatra which would have been obvious to one of ordinary skill in the art at the time of filing to optimize flow into and out of the chamber and because a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799