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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Claim 19 has been amended. Claim 39 is newly added and no claims have been newly canceled.
Claims 19-22, 24, 26-32 and 34-39 are currently pending.
Claims 27-32 and 34-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/14/2022.
Claims 19-22, 24, 26 and 39 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 19-22, 24, 26 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-20, 22-23, 25-29, 40-41 of copending Application No. 15/130780 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method of culturing cells by determining a metabolic shift to lactate consumption prior to transferring the cells to a second cell culture for the production of proteins.
The transfer of a volume of the first culture as a fraction of about 20%-60% of the final volume of the second culture would have been a matter of routine optimization and experimentation in order to maximize the product production in the second culture.
Therefore, the copending claims render obvious the claims of the current application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-22, 24, 26 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,291,563.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of culturing cells by determining a metabolic shift to lactate consumption prior to transferring the cells to a second cell culture for the production of proteins.
The transfer of a volume of the first culture as a fraction of about 20%-60% of the final volume of the second culture would have been a matter of routine optimization and experimentation in order to maximize the product production in the second culture.
Therefore, the patent claims render obvious the claims of the current application.
Claims 19-22, 24, 26 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,390,663.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method of culturing cells by determining a metabolic shift to lactate consumption prior to transferring the cells to a second cell culture for the production of proteins.
The transfer of a volume of the first culture as a fraction of about 20%-60% of the final volume of the second culture would have been a matter of routine optimization and experimentation in order to maximize the product production in the second culture.
Therefore, the patent claims render obvious the claims of the current application.
Claims 19-22, 24, 26 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,545,717.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method of culturing cells by determining a metabolic shift to lactate consumption prior to transferring the cells to a second cell culture for the production of proteins.
The transfer of a volume of the first culture as a fraction of about 20%-60% of the final volume of the second culture would have been a matter of routine optimization and experimentation in order to maximize the product production in the second culture.
Therefore, the patent claims render obvious the claims of the current application.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not fully persuasive.
Applicant's amendments to the claims have overcome the obviousness rejection under 35 USC 103 as the cited prior art does not teach or fairly suggest the new combination of limitations recited in the claims.
However, the double patenting rejections remain and have been expanded to include additional double patenting rejections as recited above.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al., “Correlation of antibody production rate with glucose and lactate metabolism in Chinese hamster ovary cells”, Biotechnol Lett (2012), 34:425–432.
(Chen disclose that a linear relationship was found between the antibody production rate and the glucose and lactate consumption rate in Chinese hamster ovary cells.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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