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 .
Status of the Claims
The amendment filed 5/15/2026 has been entered. Claims 1-11 and 13-15 remain pending in the application; claims 11 and 13-15 remain withdrawn; and claim 12 has been cancelled. Applicant’s amendments to the claims have overcome each objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 2/13/2026.
Specification
The abstract of the disclosure was objected to because “Disclosed is” is a phrase which can be implied and should therefore be deleted. Amendments to the abstract were received 5/15/2026, and accordingly, the objection to the abstract has been withdrawn.
The specification was objected to due to the use of the terms AutoCAD (para. 0062); Matrigel (para. 0063); mTESR medium (para. 0063); ReLeSR (para. 0063); Aggrewell (para. 0064); SYBR Green real-time PCR master mix (para. 0072); Duolink (para. 0075). Amendments to the specification were received 5/15/2026, and accordingly, the objection to the specification has been withdrawn.
Response to Arguments
Applicant’s arguments filed 5/15/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Claim Objections
Claim objected to because of the following informalities: it is recommended that "is . Appropriate correction is required.
Claim 7 is objected to because of the following informalities: it is recommended that "The device of claim 3, the fluid agent comprising" read "The device of claim 3, wherein the fluid agent comprises". Appropriate correction is required.
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 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gottardi et al. (US 2019/0076840 A1) in view of Oakley et al. (US 2019/0002809 A1).
Regarding claim 1, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid (para. 0009), the device comprising: a support structure having a wall and a lumen extending from a first end to a second end (inner body 302), wherein the wall comprises a plurality of openings extending therethrough (upper porous screen 316, lower porous screen 316; para. 0103 “both of which include a plurality of pores, or small openings”); an enclosure configured to extend at least partially around and support the support structure (shell 300; para. 0103 “The shell 300 also includes a hollow, generally cylindrical inner space 314 within which the inner body 302, upper ring 304, and cellular material can be situated.”) and configured to support a plurality of cells disposed between the enclosure and the support structure (para. 0105 “the inner body 302 has a cylindrical inner open space 330 which spans through the entire body 302 to accommodate the positioning of cellular material therein”); and a first reservoir fluidly coupled to the first end of the support structure (para. 0106 “upper and lower fluid flow chambers”; Fig. 5E inlet 384, outlet 388) and a second reservoir fluidly coupled to the second end of the support structure (para. 0106 “upper and lower fluid flow chambers”; Fig. 5E inlet 386, outlet 390), the first and second reservoirs facilitating storing therein a fluid agent (para. 0106 “fluid”), wherein a flow direction of the fluid agent (a) is from the first reservoir to the second reservoir (para. 0106) or (b) from the second reservoir to the first reservoir.
Gottardi et al. does not teach that the fluid flow is adjusted by rocking or tilting the enclosure with respect to a perpendicular axis that is to a longitudinal axis extending from the first end to the second end of the support structure. However, Oakley et al. teaches a rocker apparatus (para. 0022) which promotes media exchange between chambers and pores of a culture insert membrane which aids oxygenation and removal of toxic metabolites to increase viability and function of the tissue (para. 0146). It would have been obvious to a person of ordinary skill in the art to use the Oakley et al. configuration of a rocker apparatus in Gottardi et al.’s device with a reasonable expectation that it would promote media exchange between chambers and pores of a culture insert membrane which aids oxygenation and removal of toxic metabolites to increase viability and function of the tissue. This method for improving Gottardi et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Oakley et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gottardi et al. and Oakley et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the enclosure is configured to be removed from extending at least partially around the support structure (abstract “the cover and base can be attached and detached from the main body”).
Regarding claim 3, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the plurality of openings comprise at least one of holes, pores, slots, mesh, or semi-permeable membranes (upper porous screen 316, lower porous screen 316; para. 0103 “both of which include a plurality of pores, or small openings”).
Regarding claim 4, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the plurality of openings have a cross-sectional distance of from about 1 micron to about 1 cm (para. 0123 “20 μm pores”).
Regarding claim 6, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the support structure is formed from an additive manufacturing process, or wherein the support structure is composed of a biocompatible polymer (para. 0105 “biocompatible plastic-polymer”).
Regarding claim 7, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the fluid agent comprises at least one of a medium, cells, and therapeutic agents (para. 0010 “liquid cell growth medium”); and wherein the fluid agent is configured to contact at least a portion of the 3D tubular organoid through the semi-permeable membranes (para. 0015 “pores through which fluids can flow”).
Regarding claim 8, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the system is configured to be positioned within a standard well plate (para. 0014).
Regarding claim 9, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid wherein the plurality of cells comprise a group selected from a cell mass, an embryonic body, a tissue fragment, and a cell culture (para. 0012 “osteogenic and chondrogenic tissue components can be produced using adult human mesenchymal stem cells (MSCs”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gottardi et al. (US 2019/0076840 A1) in view of Oakley et al. (US 2019/0002809 A1) as applied to claim 1 above, and further in view of Nuber et al. (WO 2020/089178 A1) (already of record) (machine translated).
Regarding claim 5, Gottardi et al. discloses a device for supporting growth of a three dimensional (3D) tubular organoid, but does not explicitly disclose wherein the wall has a thickness from about 0.5 microns to about 2 millimeters. However, Nuber et al. teaches a chamber extending from several hundred micrometers to at least one millimeter which influences growth, maturation, and maintenance of cells (p. 2). It would have been obvious to a person of ordinary skill in the art to use the Nuber et al. configuration of a chamber extending from several hundred micrometers to one millimeter in modified Gottardi et al.’s device with a reasonable expectation that it would influence growth, maturation, and maintenance of cells. This method for improving modified Gottardi et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Nuber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Gottardi et al. and Nuber et al. to obtain the invention as specified in claim 5.
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 ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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