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 .
Applicant’s Response Dated August 20, 2026
In the Response dated August 20, 2026, claims 1-3, 5-14, and 19-20 were amended. Claims 1-20 are pending. An action on the merits of claims 1-20 is contained herein.
The rejection of claims 1-20 under 35 U.S.C. 112(b) has been rendered moot in view of applicant’s amendment(s) dated August 20, 2026.
The rejection of claims 1-2, 5-9, and 13-20 under 35 U.S.C. 103 as being unpatentable over Koivikko et al. EP 3686210 A1 (Koivikko) is maintained for the reasons of record as set forth in the Office Action dated April 21, 2026.
The rejection of claims 3-4 and 10-12 under 35 U.S.C. 103 as being unpatentable over Koivikko et al. EP 3686210 A1 (Koivikko) and Khanzhin et al. WO 2021/064629 A1 (Khanzhin) in combination is maintained for the reasons of record as set forth in the Office Action dated April 21, 2026.
Rejections Set Forth in the Office Action Dated April 21, 2026
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 5-9, and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koivikko et al. EP 3686210 A1 (Koivikko).
Applicant's arguments filed August 20, 2026, have been fully considered but they are not persuasive. Applicant submits that the teaching(s) of Koivikko is generic and such a generic disclosure fails to disclose or suggest the claimed method as presently amended. Applicant submits that a skilled artisan, upon reading Koivikko as a whole, would appreciate that if a loose/open membrane is to be used in a nanofiltration step, the nanofiltration should be conducted (1) on an ultrafiltration product, (2) at a pH around 6.9 - 7.6, and (3) at a temperature ranging from 3 to 7°C (Koivikko, [0217], [0223]) to achieve a high (>97%) yield. Applicant argues that, in contrast, the claimed nanofiltration step d) is conducted (1) on a cation exchange product; (2) at an acidic pH (below 5); and (3) can be performed at room temperature. See also, claim 10, requiring step d) at room temperature. Applicant argues that, with the yields achieved in Koivikko, one skilled in the art would not be motivated to add supplementary measures, such as those described in Koivikko, [0161] as they would unnecessarily complicate the process without providing any notable benefit to yield (i.e., the aim of the method). Applicant further argues that a skilled artisan would not have a reasonable expectation of successfully improving upon yields of 97% or 99%.
Applicant’s arguments have been fully considered but are insufficient to overcome the rejection. The examiner disagrees with applicant’s characterization of Koivikko. Paragraphs [0217] (Example 6) and [0223} (Example 7) are drawn to are drawn to preferred embodiments of Koivikko. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Applicant’s attention is directed to paragraph [0153] wherein Koivikko explicitly teaches that temperature during nanofiltration may be carried out at a temperature from 2 to 18 °C. Applicant’s attention is directed to paragraph [0159] wherein Koivikko explicitly teaches that pH during nanofiltration may be carried out at a pH of 3.0 to 5.5.
Regarding paragraph [0161] of Koivikko, Koivikko explicitly teaches that supplemental measures may be included. Koivikko discloses (emphasis added):
[0161] In some embodiments, the process comprises subjecting the HMO feed solution and/or nanofiltration concentrate to one or more of the following treatments: an enzymatic treatment (e.g., enzymatic hydrolysis of lactose), antifoam removal, electrodialysis, chromatography, cation exchange, anion exchange, mixed bed ion exchange, evaporation, activated carbon, crystallization, evaporation and/or spray-drying.
An improvement upon yields of Koivikko is not required to establish obviousness. Obviousness does not require absolute predictability. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. In the instant case, one would have had a reasonable expectation of success as Koivikko explicitly teaches that supplemental measures may be included. See paragraph [0161].
Regarding applicant’s argument of unexpected results, the cited passage(s) of Khanzhin WO 2021/064629 has been fully considered. Applicant’s unexpected result is that the use of a basic anion exchange resin can be eliminated from the method. Khanzhin reasonably suggests that one ion exchange resin treatment may be sufficient. Khanzhin discloses (emphasis added):
One of the ion exchange resin treatments disclosed above may be sufficient to obtain the neutral HMO in a required purity. If necessary, both cation and anion exchange resin chromatography, in any order, can be applied.
See page 30, lines 12-14. Thus, applicant’s result is not unexpected.
Thus, the rejection of claims 1-2, 5-9, and 13-20 is maintained based upon the preponderance of evidence.
Claim(s) 3-4 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koivikko et al. EP 3686210 A1 (Koivikko) and Khanzhin et al. WO 2021/064629 A1 (Khanzhin) in combination.
Applicant argues that the defects of Koivikko is not remedied by Khanzhin.
Applicant’s argument(s) is not persuasive for the reasons set forth above as applied to claims 1-2, 5-9, and 13-20 above. Thus, the rejection of claims 3-4 and 10-12 is maintained based upon the preponderance of evidence.
Conclusion
Claims 1-20 are pending. Claims 1-20 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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