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 .
Response to Arguments
Applicant's arguments filed 08/18/2026 have been fully considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
The claim amendments dated 08/18/2026 have overcome the previously presented claim objections, 35 U.S.C. 112(b) rejections, and non-statutory double patenting rejections.
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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Frey et al. (WO 2019008189 A1; US equivalent document Patent Application Publication 2020/0208088 will be cited herein).
Regarding claim 1, Frey et al. discloses a cell aggregate culture device (Abstract, para. 1, 10), comprising:
a cell culture chamber (microtissue wells 4 and spaces 13 collectively form a cell culture chamber, see para. 1, 160-162) including a plurality of wells (spaces 13 read on wells, see para. 162 and Fig. 1A, sheet 1 of 11);
one or more reservoirs storing a culture medium (para. 169);
one or more first conduits respectively connecting the culture chamber and the one or more reservoirs (para. 61-62, 169); and
a plurality of second conduits (22) each connecting adjacent wells of the plurality of wells (13) (para. 163, 173) (Figs. 1A and 4A, sheets 1 and 4 of 11),
wherein each of the plurality of wells (13) is open at a top and a bottom thereof (para. 163, 173) (Figs. 1A-4A and 10A, sheets 1-4 and 11 of 11), and
wherein each of the plurality of second microchannels is connected to upper portions of the adjacent wells (Figs. 1A and 4A, sheets 1 and 4 of 11).
Frey et al. does not expressly teach wherein the first conduits are first microchannels and wherein the second conduits are second microchannels.
Nonetheless, it has been held that changes in size are not sufficient to introduce a patentable distinction over the prior art (MPEP 2144.04). Therefore, the claim limitation of microchannels does not introduce a patentable distinction over Frey et al., as Frey et al. discloses channels (conduits).
Furthermore, Frey et al. discloses that the device is a “microfluidic system” (para. 183) and further discloses that other fluid conduits within the device are microchannels (para. 73-74).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to form each of the first conduits and second conduits disclosed by Frey et al. as microchannels, in order to fabricate the device using a known conduit configuration already disclosed by Frey et al.
Regarding claim 3, Frey et al. discloses wherein a distance between the adjacent wells (13) is 4.5 mm or 2.25 mm (either falls within the claim range) (Frey et al. discloses that distance between wells 4 is 4.5 mm or 2.25 mm, see para. 76-77, and this would also apply to the wells 13 as they are coaxial with the wells 4, see para. 162).
Frey et al. does not expressly teach a diameter of each of the plurality of wells (13).
However, the skilled artisan would clearly recognize that each of the plurality of wells (13) has a diameter on the order of millimeters based on the dimensions of the device as a whole (see para. 72-78 and Figs. 1A-2A, sheets 1-2 of 11). Furthermore, Frey et al. discloses that the wells (13) serve to exchange gas with a cell culture (para. 57).
Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to discover an optimum or workable range for the diameter, as it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, when the particular parameter is recognized as a result-effective variable (MPEP 2144.05).
Regarding claim 4, Frey et al. discloses wherein the one or more reservoirs are located at both ends of the device (para. 169) (Fig. 4A, sheet 4 of 11).
Regarding claim 5, Frey et al. discloses wherein the cell aggregate is a spheroid or organoid derived from cardiac cells (para. 10, 98).
Regarding claim 6, Frey et al. discloses wherein the cell aggregate is derived from heart organoids (para. 10, 98).
Regarding claim 7, Frey et al. discloses a cell aggregate culture system (Abstract, para. 1, 10, 68), comprising:
a cell aggregate culture device (Abstract, para. 1, 10), comprising:
a cell culture chamber (microtissue wells 4 and spaces 13 collectively form a cell culture chamber, see para. 1, 160-162) including a plurality of wells (spaces 13 read on wells, see para. 162 and Fig. 1A, sheet 1 of 11);
one or more reservoirs storing a culture medium (para. 169);
one or more first conduits respectively connecting the culture chamber and the one or more reservoirs (para. 61-62, 169); and
a plurality of second conduits (22) each connecting adjacent wells of the plurality of wells (13) (para. 163, 173) (Figs. 1A and 4A, sheets 1 and 4 of 11),
wherein each of the plurality of wells (13) is open at a top and a bottom thereof (para. 163, 173) (Figs. 1A-4A and 10A, sheets 1-4 and 11 of 11), and
wherein each of the plurality of second microchannels is connected to upper portions of the adjacent wells (Figs. 1A and 4A, sheets 1 and 4 of 11);
a rocker (para. 68); and
culture medium shared through a microchannel (para. 68-74).
Frey et al. does not expressly teach wherein the first conduits are first microchannels and wherein the second conduits are second microchannels.
Nonetheless, it has been held that changes in size are not sufficient to introduce a patentable distinction over the prior art (MPEP 2144.04). Therefore, the claim limitation of microchannels does not introduce a patentable distinction over Frey et al., as Frey et al. discloses channels (conduits).
Furthermore, Frey et al. discloses that the device is a “microfluidic system” (para. 183) and further discloses that other fluid conduits within the device are microchannels (para. 73-74).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to form each of the first conduits and second conduits disclosed by Frey et al. as microchannels, in order to fabricate the device using a known conduit configuration already disclosed by Frey et al.
Regarding claim 8, Frey et al. discloses wherein the rocker may cause the device to make a swing motion (para. 68).
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 HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
Prosecution Insights