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 I, claims 1-8, in the reply filed on 05/10/2026 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/10/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/03/2023, 05/02/2024, 01/03/2025, and 07/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 3-4 are objected to because of the following informalities:
Claim 1: it is recommended to change “the reservoir” (line 4) to “the one or more reservoirs” to match the style of the prior line(s) of the claim.
Claim 3: it is recommended to change “the well” (line 2) to “the one or more wells” to match the style of claim 1.
Claim 4: it is recommended to change “the reservoir” (line 2) to “the one or more reservoirs” to match the style of claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the wells connected through the microchannel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 1-2 and 4-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho et al. (US Patent Application Publication 20190390149) (already of record) (already of record).
Regarding claim 1, Cho et al. discloses a cell aggregate culture device (Abstract, para. 49-53), comprising:
a culture chamber including one or more wells (102) (para. 42, 49, 80) (Figs. 1 and 17, sheets 1 and 16 of 18);
one or more reservoirs (101) storing a culture medium (para. 49) (Figs. 1-2, sheets 1-2 of 18); and
a microchannel (103) connecting the culture chamber and the reservoir (para. 8, 49, 83) (Figs. 1-2, sheets 1-2 of 18).
Regarding claim 2, Cho et al. discloses wherein the culture chamber further includes a microchannel connecting a plurality of wells (para. 8, 49, 83) (Figs. 1-2, sheets 1-2 of 18).
Regarding claim 4, Cho et al. discloses wherein the reservoir is located at both ends of the device (para. 49) (Figs. 1-2, sheets 1-2 of 18).
Regarding claim 5, Cho et al. discloses wherein the cell aggregate is an organoid derived from induced pluripotent stem cells (para. 121).
Regarding claim 6, Cho et al. discloses wherein the cell aggregate is derived from the group consisting of brain, optic cup, kidney, liver, pancreas, neural tube, stomach, large intestine, prostate, breast, heart, salivary gland, endometrium, mammary gland, thyroid, tongue, lung, tumor, small intestine, and olfactory organoids (para. 18).
Regarding claim 7, Cho et al. discloses a cell aggregate culture system (Abstract, para. 49-53), comprising:
a cell aggregate culture device (Abstract, para. 49-53), comprising:
a culture chamber including one or more wells (102) (para. 42, 49, 80) (Figs. 1 and 17, sheets 1 and 16 of 18);
one or more reservoirs (101) storing a culture medium (para. 49) (Figs. 1-2, sheets 1-2 of 18); and
a microchannel (103) connecting the culture chamber and the reservoir (para. 8, 49, 83) (Figs. 1-2, sheets 1-2 of 18);
a rocker (para. 85-89) (Fig. 3, sheet 3 of 18); and
a culture medium shared through a microchannel (para. 8, 56, 83).
Regarding claim 8, Cho et al. discloses wherein the rocker may cause the device to make a swing motion (para. 20, 85-89) (Fig. 3, sheet 3 of 18).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US Patent Application Publication 20190390149) (already of record) (already of record).
Regarding claim 3, Cho et al. discloses wherein a diameter of each of the one or more wells is 5.0 to 15.0 mm, and further discloses a distance between wells connected through a microchannel (para. 8, 49, 83) (Figs. 1-2, sheets 1-2 of 18).
Cho et al. does not expressly teach wherein a diameter of the well is 1.5 mm to 4 mm, and a distance between the wells connected through the microchannel is 1.5 mm to 5 mm.
As to the claimed diameter of 1.5 mm to 4 mm, it has been held that in the case where the claimed range approaches the prior art range, a prima facie case of obviousness exists. In this case, the claim range (1.5 mm to 4 mm) approaches the prior art range (5.0 mm to 15.0 mm) so closely that the skilled artisan would not expect any noticeable difference between the claimed well and the prior art well. Therefore, this limitation does not introduce a patentable distinction over the prior art.
As to the claimed distance of 1.5 mm to 5 mm, Cho et al. discloses a distance between wells connected through a microchannel, as discussed above, and the skilled artisan would clearly recognize that the distance is on the order of millimeters based on the other disclosed dimensions of the device and the disclosure that the device is a “microfluidic” device (para. 8, 80-83) (Figs. 1-2, sheets 1-2 of 18). Furthermore, Cho et al. discloses flowing culture medium through the microchannels to be distributed to the wells (para. 55, 73-74, 85-88). 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). Cho et al. discloses general conditions for the distance between the wells and the distance is clearly a result-effective variable as it impacts the flow of medium to wells. 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 distance through routine experimentation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-10 of U.S. Patent No. 11,725,173. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, claim 1 of the reference patent recites a cell aggregate culture device (called organoid culture device; an organoid reads on a cell aggregate), comprising a culture chamber (called at least one second chamber); one or more reservoirs storing a culture medium (called at least two first chambers for storing a culture medium); and a channel connecting the culture chamber and the reservoir.
The reference patent claim does not expressly teach one or more wells; however, modifying the culture chamber recited by the reference claim to comprise one or more well would require mere modification to the size and/or shape of the at least one second chamber recited by the reference claim. It is well established that changes in size and/or shape represent a prima facie obvious modification (MPEP §2144.04). Therefore, the limitation does not introduce a patentable distinction over the reference claim.
The reference patent claim does not expressly teach wherein the channel is a microchannel; however, modifying the channel recited by the reference claim to comprise microchannel would require mere modification to the size of the channel recited by the reference claim. It is well established that changes in size represent a prima facie obvious modification (MPEP §2144.04). Therefore, the limitation does not introduce a patentable distinction over the reference claim.
Regarding claim 2, claim 1 of the reference patent recites a channel connecting a plurality of chambers, and forming the channel as a microchannel and the chambers as wells would have been prima facie obvious to the skilled artisan, as discussed in the rejection of claim 1, above.
Regarding claim 3, the claim amounts to a recitation of the size of a well and the size of a distance between wells connected by the microchannel, and it has been held that changes in size represent a prima facie obvious modification (MPEP §2144.04). Therefore, the limitation does not introduce a patentable distinction over the reference claim as claim 1 of the reference patent recites a well and wells connected through a microchannel, as set forth above.
Regarding claim 5, claim 8 of the reference patent recites an organoid derived from cardiac cells (called heart cells).
Regarding claim 6, claim 8 of the reference patent recites a organoid derived from the group consisting of brain, optic cup, kidney, liver, pancreas, neural tube, stomach, large intestine, prostate, breast, heart, salivary gland, endometrium, mammary gland, thyroid, tongue, lung, tumor, small intestine, and olfactory organoids.
Regarding claim 7, claim 9 of the reference patent recites a cell aggregate culture system (called organoid culture system; an organoid reads on a cell aggregate) comprising the device according to claim 1 (reads on the device of claim 1 of the instant application as discussed above); a shaker (reads on a rocker); and a culture medium shared through a channel.
The reference patent claim does not expressly teach wherein the channel is a microchannel; however, modifying the channel recited by the reference claim to comprise microchannel would require mere modification to the size of the channel recited by the reference claim. It is well established that changes in size represent a prima facie obvious modification (MPEP §2144.04). Therefore, the limitation does not introduce a patentable distinction over the reference claim.
Regarding claim 8, claim 10 of the reference patent recites wherein the shaker (reads on a rocker) may cause the device to make a swing motion.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Eilenberger et al. (A Microfluidic Multisize Spheroid Array for Multiparametric Screening of Anticancer Drugs and Blood–Brain Barrier Transport Properties) is directed to a microfluidic hanging drop culture device for generating a spheroid, the device comprising wells interconnected by a microchannel and medium reservoirs.
Conclusion
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.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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