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 with traverse of Group II, claims 5-13, in the reply filed on 05/05/2026 is acknowledged. The traversal is on the ground(s) that there is no undue search burden in examining all invention groups. This is not found persuasive because the Restriction Requirement of 03/06/2026 was made under Unity of Invention practice. The Restriction Requirement set forth that that the common technical feature is not a special technical feature as it does not make a contribution over the prior art, and Applicant’s arguments do not dispute this finding. Therefore, the Office maintains that unity of invention is not present.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/06/2026.
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 08/28/2025 and 06/25/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 5-13 are 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 5 includes claim 1 in its entirety. Claim 1 recites the limitation "arranged like a Kenzan (spiky flower frog)” and this limitation renders the claim indefinite because it is unclear if “(spiky flower frog)” is merely a synonym for Kenzan, or whether the limitation specifies a further structural limitation of the Kenzan; if the latter, it is unclear whether the further limitation is required or merely a statement of an example. It is noted that examples and preferences, when included within parentheses, can lead to confusion over the intended scope of the claim. For the purpose of examination on the merits, the Examiner will interpret the needle-shaped parts as having the form of a Kenzan as is well understood in the art, and interpret the “(spiky flower frog)” limitation as being merely a synonym for Kenzan.
Claim 5 includes claim 1 in its entirety. Claim 1 recites the limitation "the outermost needle-shaped part" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 includes claim 1 in its entirety. Claim 1 recites the limitation "the distance” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 includes claim 1 in its entirety. Claim 1 recites the limitation "said needle-shaped part” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 includes claim 1 in its entirety. Claim 1 recites the limitation "the outer edge of the substrate” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the top surface of the substrate” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the substrate” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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)(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.
Claims 5-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lei et al. (US Patent Application Publication 2022/0275342).
Regarding claim 5, Lei et al. discloses a culture system for culturing cell masses (Abstract, para. 31-32), comprising:
a culture tank (called chamber) for housing a culture unit (para. 12) (Figs. 1 and 7, sheets 1 and 8 of 10);
a culture solution container (para. 4) (Fig. 1, sheet 1 of 10); and
a plurality of culture solution supply pipes for supplying a culture solution from the culture solution container to the culture unit (para. 3-4, 24) (Fig. 1, sheet 1 of 10).
As to the limitation of the culture tank being for housing a culture unity comprising cell masses stacked on a plurality of supports according to claim 1, wherein each of the plurality of culture solution pipes is placed between the needle-shaped parts, this is a recitation of intended use and has therefore been given appropriate patentable weight (MPEP 2114). It is noted that the claim does not require that the culture system comprises the culture unit comprising cell masses stacked on a plurality of supports according to claim 1. The noted limitation only limits the claimed system inasmuch as a prior art culture tank must be fully capable of housing a culture unit as claimed. In this case, the culture tank disclosed by Lei et al. is a hollow chamber comprising empty space above, below, and surrounding the culture solution pipes (para. 12) (Figs. 1 and 7, sheets 1 and 8 of 10), and therefore the prior art culture tank is fully capable of achieving the claimed intended use, as an operator could insert an appropriately dimensioned culture unit comprising cell masses stacked on a plurality of supports according to claim 1 in the empty space of the chamber such that each of the pipes is located between needle-shaped parts. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 6, the entirety of the claim is directed to a further limitation of the culture unit; however, neither claim 6 nor claim 5, from which it depends, require that the system comprises the culture unit, as discussed above. Furthermore, the culture tank disclosed by Lei et al. is fully capable of housing supports arranged adjacent to each other, as such supports could be received within empty spaces between pipes within the chamber. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 7, the culture tank disclosed by Lei et al. is fully capable of housing a support according to claim 1 wherein each of the plurality of culture solution pipes is arranged along a top surface of the substrate, as such a support could be received within empty spaces between and below pipes within the chamber. It is noted that the claim does not require that the system comprises any supports, as discussed above. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 8, the culture tank disclosed by Lei et al. is fully capable of housing supports according to claim 1 wherein each of the plurality of culture solution pipes is arranged below the cell masses, as such supports could be received within empty spaces between and below pipes within the chamber. It is noted that the claim does not require that the system comprises any supports, as discussed above. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 9, Lei et al. discloses wherein each of the culture solution supply pipes is provided with an opening through which the culture solution can flow out (para. 24).
Regarding claim 10, Lei et al. discloses wherein the opening is formed to allow the culture solution flow out toward the cell masses (para. 24).
Regarding claim 11, the culture tank disclosed by Lei et al. is fully capable of housing a support according to claim 1 wherein each of the plurality of culture solution pipes extends over the substrate parallel to at least one side of the substrate, as such a support could be received within empty spaces between and below pipes within the chamber such that the culture pipes extend over the substrate thereof parallel to at least one side. It is noted that the claim does not require that the system comprises any supports, as discussed above. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 12, Lei et al. discloses wherein the plurality of culture solution supply pipes are arranged parallel to each other (para. 19) (Fig. 1, sheet 1 of 10).
Regarding claim 13, Lei et al. discloses wherein the culture tank comprises a frame or hollowed part of housing the culture unit (para. 11-12) (Figs. 6-7, sheets 7-8 of 10).
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 5-6, 8-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (FABRICA: A Bioreactor Platform for Printing, Perfusing, Observing, & Stimulating 3D Tissues) in view of Lei et al. (US Patent Application Publication 2022/0275342).
Regarding claim 5, Smith et al. discloses a culture system for culturing cell masses (Abstract, p. 3), comprising:
a culture tank (called chamber) for housing a culture unit comprising cell masses (pp. 2-3) (Fig. 1, p. 2) stacked on a support, the support comprising needle-shaped parts arranged like a Kenzan on a substrate (p. 2) (Fig. 1, p. 2); and
a culture solution supply pipe (see conduit terminating in “opening for perfusion”) for supplying a culture solution to the culture unit (pp. 2-4) (Fig. 1, p. 2),
wherein the culture solution supply pipe is placed between the needle-shaped parts (the cross-section of the culture supply pipe is bounded within the needle-shaped parts, see Fig. 1).
As to the limitation of wherein the supports are according to claim 1, that is, wherein the outermost needle-shaped part on the substrate is arranged such that the distance from the needle-shaped part to the outer edge of the substrate is shorter than the distance between adjacent needle-shaped parts, this does not introduce a patentable distinction as claim 5 does not require that the system comprises a culture unit comprising cell masses stacked on a plurality of supports according to claim 1. Rather, the limitation is a recitation of intended use and has therefore been given appropriate patentable weight (MPEP 2114). The culture tank disclosed by Smith et al. would be capable of housing various supports, including supports having relative dimensions as set forth in claim 1.
Smith et al. is silent as to the culture tank being for housing a plurality of the supports, a culture solution container, and a plurality of culture solution supply pipes.
As to the claimed plurality of supports and plurality of culture solution pipes, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04). Modifying the culture tank disclosed by Smith et al. so as to comprise multiple supports, and accordingly multiple culture solution supply pipes for supplying each support, would require mere duplication of the configuration already disclosed by Smith et al., and such a modification would yield the predictable result of increasing cell culture throughput.
As to the claimed culture solution container, Smith et al. discloses circulating culture medium through a circulation loop including the culture tank and a pump (Fig. 1, p. 2) without the use of a culture solution container.
However, Lei et al. discloses that it was known in the art to circulate culture medium through a circulation loop from a culture medium container to a culture tank by means of a pump (para. 3) (Fig. 1, sheet 1 of 10).
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 modify the system disclosed by Smith et al. to comprise a culture solution container, as Lei et al. discloses that it was known in the art to use such a configuration, and the skilled artisan would have been motivated to provide a culture solution container to allow for changes in a type and/or amount of culture medium without directly accessing the culture tank.
Regarding claim 6, modified Smith et al. teaches wherein the culture unit comprises a plurality of supports, as set forth above. As to the limitation of the supports being arranged adjacent to each other, it has been held that rearrangement of parts is a prima facie obvious modification (MPEP 2144.04), and therefore the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 8, Smith et al. discloses wherein the culture solution supply pipe is arranged below the cell masses (Fig. 1, p. 2), and modified Smith et al. teaches a plurality of such culture solution supply pipes, as set forth above.
Regarding claim 9, Smith et al. discloses wherein each culture solution supply pipe is provided with an opening through which the culture solution can flow out (Fig. 1, p. 2).
Regarding claim 10, Smith et al. discloses wherein the opening is formed to allow the culture solution to flow out toward the cell masses (pp. 2-4) (Fig. 1, p. 2).
Regarding claim 12, modified Smith et al. teaches a plurality of culture solution supply pipes, as set forth above. As to the limitation of the plurality of culture solution supply pipes being arranged parallel to each other, it has been held that rearrangement of parts is a prima facie obvious modification (MPEP 2144.04), and therefore the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 13, Smith et al. discloses wherein the culture tank comprises a frame or hollowed part for housing the culture unit (Fig. 1, p. 2).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moldovan et al. (US Patent Application Publication 2020/0095557) is directed to a Kenzan device comprising a plurality of needle-shaped parts for supporting stacks of cell masses.
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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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.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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