DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/12/2026 has been entered.
3.. Applicant’s amendment to the claims filed on 02/11/2026 in response to the Final Rejection mailed on 10/24/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
4. Claims 8-11 are cancelled.
5. New claim 22 is added.
6. Claims 1-6 and 12-22 are pending.
7. Applicant’s remarks filed on 02/11/2026 in response to the Final Rejection mailed on 10/24/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 1-6 and 12-22 are newly 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. This new grounds of rejection is necessitated by applicants’ amendment to the claims.
Regarding claim 1 (claims 2-6 and 12-22 dependent therefrom), the recitation of “a polymer having a quaternary ammonium base group or an amino group…” followed by the limitation “wherein the polymer is a water-insoluble polymer having a quaternary ammonium base group” is indefinite because it is unclear whether the polymer is a quaternary base group or an amino group.
Claim Rejections - 35 USC § 103
10. The rejection of claims 1-6, 8, and 14-21 under 35 U.S.C. 103 as being unpatentable over Nakai et al. (WO 2018/159847 A2, published 09/07/2018; cited on IDS filed 09/09/2022 with US Patent Application Publication 2019/0322975 A1 serving as English translation; cited on IDS filed 09/09/2022) in view of Jemaa et al. (US Patent Application Publication 2016/0312317 A1; cited on IDS filed on 09/09/2022), Othman et al. (Frontiers in Microbiology, 2017; cited on PTO-892 mailed on 04/30/2025), and Zakhodyaeva et al. (Theoretical Foundations of Chemical Engineering, 2011; cited on PTO-892 mailed on 04/30/2025) is withdrawn in view of applicants’ amendment to the claims to incorporate the “water-insoluble polymer has a repeating unit represented by General Formular (P1) or (P2)”.
11. The rejection of claims 9-13 under 35 U.S.C. 103 as being unpatentable over Nakai et al. (WO 2018/159847 A2, published 09/07/2018; cited on IDS filed 09/09/2022 with US Patent Application Publication 2019/0322975 A1 serving as English translation; cited on IDS filed 09/09/2022) in view of Jemaa et al. (US Patent Application Publication 2016/0312317 A1; cited on IDS filed on 09/09/2022), Othman et al. (Frontiers in Microbiology, 2017; cited on PTO-892 mailed on 04/30/2025), and Zakhodyaeva et al. (Theoretical Foundations of Chemical Engineering, 2011; cited on PTO-892 mailed on 04/30/2025) as applied to claims 1-6, 8, and 14-21 above and further in view of De Sa et al. (WO 2009/010836 A2; cited on PTO-892 mailed on 04/30/2025) is withdrawn in view of applicants’ cancellation of claims 9-11 and in view of applicants’ persuasive remarks that De Sa et al. does not teach the “water-insoluble polymer has a repeating unit represented by General Formular (P1) or (P2)”.
12. Claims 1-6 and 12-22 are newly rejected under 35 U.S.C. 103 as being unpatentable over Nakai et al. (WO 2018/159847 A2, published 09/07/2018; cited on IDS filed 09/09/2022 with US Patent Application Publication 2019/0322975 A1 serving as English translation; cited on IDS filed 09/09/2022) in view of Jemaa et al. (US Patent Application Publication 2016/0312317 A1; cited on IDS filed on 09/09/2022), Othman et al. (Frontiers in Microbiology, 2017; cited on PTO-892 mailed on 04/30/2025), Zakhodyaeva et al. (Theoretical Foundations of Chemical Engineering, 2011; cited on PTO-892 mailed on 04/30/2025), and Chung et al. (WO 03/028485 A1; examiner cited), and evidenced by DIAION WA30 (Mitsubishi Chemical Corp., p. 1-2). This new grounds of rejection is necessitated upon further consideration of the claims.
13. With respect to claim 1, Nakai et al. a cell culture method comprising: providing a cell culture apparatus and a first and second filter membrane such as an ultrafiltration membrane that separates the culture solution and a metabolic decomposition product removal step of bringing a culture solution containing a metabolic decomposition product into contact with a polymer and removing the metabolic decomposition product from the culture solution to a purified culture solution; and a cell culture step of culturing cells using the purified culture solution [see Abstract; see paragraphs 0070-0079].
With respect to claim 2, Nakai et al. teach the method wherein the culture solution containing the metabolic decomposition product is a culture solution taken out from the culture solution in the culture step [see paragraphs 0070-0079].
With respect to claim 3, Nakai et al. teach the method wherein the culture solution containing the metabolic decomposition product does not contain cells [see paragraphs 0070-0079 and Figure 1].
With respect to claim 4, Nakai et al. teach the method wherein the metabolic decomposition product removal step is a step of passing the filtered culture solution through a purification unit filled with the polymer and removing the metabolic decomposition product from the culture solution to obtain the purified culture solution, the culture step is a step of culturing cells using the purified culture solution in a culture vessel, an inlet side of the purification unit and the culture vessel are connected by a flow channel having a separation membrane in the middle of the flow channel, and the filtered culture solution is a culture solution obtained by filtering, with the separation membrane, the culture solution taken out from the culture solution in the culture step through the flow channel [see Figure 1; paragraphs 0070-0079].
With respect to claims 5 and 6, Nakai et al. teach the method of adding a nutritional component to the purified culture solution, wherein the nutritional component is energy sources and growth supporting factors [see paragraphs 0008]. Given the breadth of the terms “energy sources” and “growth supporting factors”, it is the examiners position that the culture medium containing nutrient components as taught by Nakai et al. would inherently contain these components, given that it is known by one of ordinary skill in the art that these components are necessary for cell culturing.
With respect to claims 14-19, Nakai et al. teach the method wherein the cell is a floating, animal cell such as CHO cell that produces an antibody [see paragraphs 0007-0010; 0053; 0070-0079].
With respect to claim 20, Nakai et al. a cell culture method comprising: a metabolic decomposition product removal step of bringing a culture solution containing a metabolic decomposition product into contact with a polymer and removing the metabolic decomposition product from the culture solution to a purified culture solution; and a cell culture step of culturing CHO cells using the purified culture solution [see Abstract; see 0007-0010; 0053; paragraphs 0070-0079].
With respect to claim 21, Nakai et al. teach the method wherein the separation membrane capable of separating cell is a ultrafiltration membrane [see Abstract; see paragraphs 0070-0079].
However, Nakai et al. does not teach the method of claim 1, wherein the polymer has a quaternary ammonium base group or an amino group, wherein the metabolic decomposition product is at least one organic acid selected from isovaleric acid, butyric acid, and citric acid and the specific quaternary ammonium structures set forth in claims 1 and 12-13; the method of claim 20, wherein the polymer has a quaternary ammonium base group or an amino group and removing an organic acid selected from the group consisting of isovaleric acid, butyric acid, and citric acid; and the method of claim 22, wherein the metabolic decomposition product is at least one organic acid selected from isovaleric acid and citric acid.
Jemaa et al. teach the efficient separation of acids such as sulfuric acid and lactic acid from acid hydrolysis of biomass to provide sugars for downstream fermentation into biofuels using quaternary ammonium resin that allows for 98.5% recovery of the acid that allows for recycle of the acid [see Abstract; paragraphs 0002, 0017-0021].
Othman et al. teach that lactic acid bacteria are industrially important microorganisms that are recognized for their fermentative ability for the production of lactic acid for various applications; however, lactic acid fermentation often suffers from end product inhibition which decreases the cell growth rate [see Abstract]. Othman et al. teach that the restriction imposed by lactic acid on its fermentation can be avoided by extractive fermentation using quaternary ammonium base resins to absorb lactic acid via acid-base interaction [see p. 4-5].
Zakhodyaeva et al. teach that many foodstuffs and beverages are fermentation products and contain a wide variety of organic acids, whose recovery, separation and determination is an important technological and analytical problem [see p. 739, column 1]. Zakhodyaeva et al. teach that quaternary ammonium base and amines are effective in extracting organic acids such as butyric acids [see Abstract; p. 741; Tables 2 and 3].
Chung et al. teach processes for deacidifying juice by removing citric acid from said juice using ion-exchange columns loaded with polystyrene based quaternary ammonium resin such as Amberlite IRA-67, Amberlite IRA-95, Dowex 67, Dowex 77 and Diaion WA 30 [see Abstract; paragraphs 0013-0015; 0022-0025]. Polystyrene contains the general formular of (P1) and evidentiary reference Diaion WA 30 demonstrate the primary functional group is a tertiary amine.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the teachings of Nakai et al., Jemaa et al., Othman et al., Zakhodyaeva et al., and Chung et al. according to the teachings of Jemaa et al., Othman et al., Zakhodyaeva et al. and Chung et al. to include a quaternary ammonium resin in the separation unit of Nakai et al. because Nakai et al. teach a cell culture method comprising: a metabolic decomposition product removal step of bringing a culture solution containing a metabolic decomposition product into contact with a polymer and removing the metabolic decomposition product from the culture solution to a purified culture solution; and a cell culture step of culturing cells using the purified culture solution. Both Jemaa et al. and Othman et al. teach the inhibition on cell culture growth in the downstream fermentation processes by organic acids such as lactic acid and teach that quaternary ammonium base resins offer an efficient way to remove said acids from downstream fermentation processes and recycling. Zakhodyaeva et al. teach that quaternary ammonium base and amines are effective in extracting organic acids such as butyric acids useful for food and pharmaceuticals. Chung et al. acknowledges the benefit of polystyrene based quaternary ammonium compound resins in the removal of organic acids from substances. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Nakai et al., Jemaa et al., Othman et al., and Zakhodyaeva et al. because both Jemaa et al. and Othman et al. acknowledge that quaternary ammonium base resins offer an efficient way to remove acids from downstream fermentation processes and recycling, and both Zakhodyaeva et al. and Chung et al. acknowledge that quaternary ammonium base and amines are effective in extracting organic acids useful for food and pharmaceuticals. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Remarks Regarding Prior Art Rejections
14. Applicants’ remarks filed on 02/11/2026 have been fully considered by the examiner and rendered moot in view of the new rejections set forth above.
Conclusion
15. Status of the claims:
Claims 1-6 and 12-22 are pending.
Claims 1-6 and 12-22 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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