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 .
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)(w) as being anticipated by Adriani et al. (US 2024/0018483)
Regarding claim 1 Adriani 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 Adriani Abstract Figs. 1A-1F wherein an open culture chamber 110 has at least one fluid inlet 116/106 and at least one fluid outlet 120/104 through which fluid may flow in a non-tangential manner.)
The chamber comprises a hydrogel on a bottom surface and wherein the flow of fluid from the inlet to the outlet comprises interstitial flow through the hydrogel. (See Adriani Figs. 1A-1F, [0036]-[0042] wherein the hydrogel includes vasculature through which materials flow from the inlet to the outlet.)
Furthermore it is noted that limitations directed to the fluid and flow thereof both non-tangentially as well as through the hydrogel from the inlet to the outlet are considered intended uses of the claimed device which do not define structural elements which differentiate the claimed invention from the cited art as the cited art is fully capable of being provided with such fluids and flow thereof. See MPEP 2114 and 2115.
Regarding claim 4 Adriani discloses all the claim limitations as set forth above as well as the device wherein the chamber does not comprise a sacrificial material. (See Adriani Abstract and Figs. wherein the formed device has no sacrificial material)
Regarding claim 5 Adriani discloses all the claim limitations as set forth above as well as the device wherein the chamber does not comprise a membrane. (See Adriani Abstract and Figs. wherein the formed device has no membrane in the chamber 110.)
Regarding claim 6 Adriani discloses all the claim limitations as set forth above as well as the device wherein the inlet and/or outlet is a channel. (See Adriani Abstract and Figs. 1A-2F wherein the inlet 106 and outlet 108 are fluid channels.)
Regarding claim 11 Adriani 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 Adriani Abstract and Figs. 1A-1F wherein there are two inlets 116 and 118 and two outlets 120 and 122.)
Regarding claim 14 Adriani 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 Adriani Abstract and Figs. And [0105] wherein fluid flows at least unidirectionally from the inlet to the outlet)
Regarding claims 15-16 Adriani discloses all the claim limitations as set forth above as well as the device further comprising a mixture of hydrogel cand cells 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 Adriani Fig. 1E, [0036], and [0104] wherein cells and hydrogel are mixed are cultured on the bottom surface of the open chamber in a scaffold material, i.e. wherein the scaffold is a fibrin or matrigel.)
Regarding claim 17 Adriani discloses all the claim limitations as set forth above as well as the device, further comprising cells seeded into the open chamber. (See Adriani Abstract, Figs. 1A-1F and [[0076]-[0079[] and [0104] wherein cells are grown in the open chamber 110 and are seeded therein trough opening 112.)
Regarding claim 18 Adriani 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 Rejection of Claim 1 Above and Adriani Figs 1A-1F wherein there is an array comprising the open chamber 110 an, inlet chamber 106, and an outlet chamber 108.)
Regarding claim 19 Adriani discloses all the claim limitations as set forth above as well as a multi-well plate comprising the array of claim 18. (See Adriani [0058] and Fig. 1A-1F wherein the array is formed in/on a multiwell plate 10 as shown in Fig 1A and 1F.)
Regarding claim 20 Adriani discloses all the claim limitations as set forth above as well as the device comprising a plurality of arrays. ((See Adriani [0058] and Fig. 1A-1Fwherein wherein the multiwell plate has a plurality of arrays.)
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 Adriani et al. (US 2024/0018483) as applied to claims above.
Regarding claims 7-8 Adriani discloses all the claim limitations as set forth above as well as the device wherein the channel size is known to be modified according to use (See Adriani [0107]) 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 Adriani 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).
Claims 12 -13 are rejected under 35 U.S.C. 103 as being unpatentable over Adriani et al. (US 2024/0018483) as applied to claims above, and further in view of Sandoz et al. (US 2020/0318048).
Regarding claims 12 and 13 Adriani discloses all the claim limitations as set forth above but does not specifically disclose a patterned base.
Sandoz 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 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.)The open chamber comprises a patterned base. (See Sandoz Figs. 1-2 and [0101] wherein the open chamber has a patterned base 16). 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.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a patterned base as described by Sandoz in the device of Adriani because such a patterned base allows the culture of a plurality of spheroids and cell types embedded in a matrix while preventing unwanted agglomeration and movement thereof as would be desirable in the device of Adriani which requires exact spheroid placement and one would have a reasonable expectation of success in using such a patterned base to prevent movement in the device of Adriani.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In response the applicant’s claim amendments new a new reference and/or rational have been provided to teach all features and as such applicant’s arguments are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
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