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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/2026 has been entered.
Election/Restrictions
Claims 1-8 and 17-23 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 9-1, directed to processes of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 6/2/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
This application is in condition for allowance except for the presence of claim 16 directed to a distinct cultivation system for cultivating non-human metazoan cells non-elected without traverse. Accordingly, claim 16 been cancelled.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/12/2025 (1 IDS), 11/4/2025 (5 IDSs), and 2/23/2026 (7 IDSs) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Response to Arguments
Applicant’s arguments, see pp. 12-14 of , filed 2/23/2026, with respect to independent claim 1 have been fully considered and are persuasive.
Regarding the provisional rejections of claims 1-2 on the ground of nonstatutory double patenting, the Applicant argues that claims 1-2 are patentably distinct from claim 1 of copending Application No. 18/763,199 as claims 1-2 of the instant application have been amended. The examiner agrees that claim 2 does not recite the same subject matter of claim 1 of the copending application, and has withdrawn the nonstatutory double patenting rejection of claim 2 of the instant application. However, claim 1 remains provisionally rejected on the ground of nonstatutory double patenting as claim 1 has not been amended to recite structure which is patentably distinct from claim 1 of the copending application.
Regarding the objection to claim 17 previously set forth in the Final Office Action dated 12/29/2025, the Applicant’s amendments to the claim have overcome the objection. Accordingly, the objection to claim 17 has been withdrawn.
Claim Objections
Claim 5 is objected to because of the following informalities:
It is recommended that “the hydrolysis tank” in line 1 read “the at least one hydrolysis tank” as “at least one hydrolysis tank” is used in claim 1. Appropriate correction is required.
It is recommended that “the proteolytic enzyme” in line 4 read “the at least one proteolytic enzyme” as “at least one proteolytic enzyme” is used in line 3 of the claim. Appropriate correction is required.
It is recommended that “enzyme having phytase activity” in line 4 read “the at least one enzyme having phytase activity” as “at least one enzyme having phytase activity” is used in line 3 of the claim. Appropriate correction is required.
Claim 8 is objected to because of the following informalities:
It is recommended that “a protein source” in line 4 read “the protein source”. Appropriate correction is required.
I. Appropriate correction is required.
It is recommended that “at least one nutritional additive” in line 6 read “the at least one nutritional additive”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities”
It is recommended that “the cultivation system comprises” in line 1 read “the cultivation system further comprises”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities”
It is recommended that “the cultivation system comprises” in line 1 read “the cultivation system further comprises”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities:
It is recommended that "the storage tank" in lines 1 and 3 read "the at least one storage tank" as “at least one storage tank” is used in claim 1. Appropriate correction is required.
It is recommended that “UTH-sterilized” in line 2 read “UHT-sterilized”. Appropriate correction is required.
It is recommended that “the storage tank” in line 3 read “the at least one storage tank” as “at least one storage tank” is used in claim 1. Appropriate correction is required.
It is recommended that “the cultivation device” in line 3 read “the at least one cultivation device” as “at least one cultivation device” is used in claim 1. Appropriate correction is required.
Claim 20 is objected to because of the following informalities:
It is recommended that “culture vessel of the cultivation device” in line 2 read “culture vessel of the at least one cultivation device” as “at least one cultivation device” is used in claim 1. Appropriate correction is required.
Claim 21 is objected to because of the following informalities:
It is recommended that “the cultivation device” in lines 2, 2-3 and 4 (3 occurrences in the claim) read “the at least one cultivation device” as “at least one cultivation device” is used in claim 1. Appropriate correction is required.
Claim 22 is objected to because of the following informalities:
It is recommended that “the hydrolysis tank” in line 1 read “the at least one hydrolysis tank” as “at least one hydrolysis tank” is used in claim 1. Appropriate correction is required.
Claim 25 is objected to because of the following informalities:
It is recommended that “the outer diameter of impeller” read “the outer diameter of the at least one impeller” as “at least one impeller” is used earlier in the claim. Appropriate correction is required.
Claim 29 is objected to because of the following informalities”
It is recommended that “the cultivation system comprises” in line 1 read “the cultivation system further comprises”. 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.
Claims 8, 18, 20 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 8 recites the limitation "a protein source” in line 4. It is unclear as to if this is the same protein source recited in claim 1, line 3. In response to this action, it is suggested that “a protein source” be amended to recite “the protein source”.
Claim 18 recites the limitation "the UHT-sterilized culture medium" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination on the merits, the examiner is interpreting claim 18 as if dependent on claim 17, which provides antecedent basis for UHT sterilization of culture medium. In response to this action, it is suggested that claim 18 be amended to depend on claim 17.
Claim 20 recites the limitation “the culture vessel of the cultivation device” in line 2 and “the inoculum” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 21 recites the limitation “the CO2 in the cultivation device” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the waste medium” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “the food product” in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation “the inner reactor” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation “the temperature” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/763,199 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application recites the same subject matter as claim 1 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1-15, 17, 19, and 22 would be allowable over the prior art of record if the ODP over 18/763,199 is overcome.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, Senaratne et al. (US 2019/0352676) (already of record) provides the closest prior art. As discussed in the prior Office Action, Senaratne et al. discloses a bacterial fermentation system comprising, among other features, a fermentation vessel, a mixing tank, a cell separator, a processing chamber, and a holding tank. However, as Applicant points out in the remarks dated 2/23/2026, Senaratne et al. does not fairly teach the sequential stream/structural orientation of a hydrolysis tank, mixing tank, first filtration unit, second filtration unit, storage tank, and cultivation tank connected as claimed in claim 1 of the instant application. Applicant also points out that Senaratne et al. fails to teach the claimed hydrolysis tank, mixing tank, and cultivation device recited in claim 1 of the instant application. The prior art of record, alone or in combination, does not disclose, teach, or suggest the noted features within the claim environment.
Claims 2-7, 9-15, 17, 19 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 24 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 8, 18, 20-21, 23, and 25-30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 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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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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