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 .
CONTINUING DATA
This application is a 371 of PCT/EP2020/081920 11/12/2020
FOREIGN APPLICATIONS
EP 19209604.8 11/15/2019
This office action is in response to Applicant’s amendment submitted September 10, 2025. Claims 1-2, 4, 6-9, 11, 13-19, and 21-22 are pending.
The following new rejections were necessitated by Applicant’s amendment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4, 6-9 and 13-19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra (WO2019063757A1, 2019) in view of EP2885977 A1 (2015, cited on IDS), Salvado (EP 1988096 A1, 2008), Karthik (“Drum Drying,” Handbook of Drying for Dairy Products, 2017, cited on IDS) and Food Safety Foundation, an article provided with the IDS submitted August 1, 2024 (previously cited by the examiner).
Dijsktra teaches a mixture of HMOs having 90-95% purity (paragraph bridging pages 2-3). An aqueous solution is dried using spray-cooling, spray drying, or lyophilization. Page 12, fourth paragraph. The HMOs include 2’-FL, 3’-FL, LnT, 6’-galactosyllactose, and 3’-galactosyllactose. Page 4, lines 11-15. The solution comprising HMO has an HMO content of 25-35 wt. % (page 2, lines 29-33).
Dihsktra does not teach that drying is done using a vacuum drum dryer or a vacuum roller dryer.
EP2885977 teaches that any suitable drying technique, including drum drying, may be used for drying oligosaccharides including sialyloligosaccharides [0016]. A 20% solution of oligosaccharides was freeze dried [0034].
Salvado teaches drying galactooligosaccharides using a drum dryer. See abstract. Spray-dried products still contain a high percentage of water, leading to handling problems. Page 2, lines [0008]-[0012]. Drum drying aqueous products containing galactooligosaccharides yields highly beneficial powders [0016].
Karthik teaches that preconcentrated milk can be dried by single-drum or double-drum dryers. End of page 44. Skim milk was dried at 85°C. End of page 45. Vacuum dryers are used for heat-sensitive foods such as milk products and operate at a lower pressure compared to standard atmospheric drying (which means less than 1013 mbar, which is standard pressure). Page 48. The gap between drums is 0.1-1 mm (page 52). For drying non-fat milk, the drum rotates for two to three revolutions per minute. In another example, milk was dried at 55-65°C. Page 53.
Food Safety Foundation teaches that roller drying is applicable to foods such as skim milk. A double-roller dryer features two rollers, where the thickness of the material layer on its surface can be controlled by adjusting the distance between the rollers. The thickness ranges from 0.3 to 5 mm. Roller speeds for general feeds liquids is 5 rpm or 1-3 rpm for liquids with higher viscosity. The pressure is 0.2 Mpa or 0.3-0.4 MPa, which corresponds to 200-400 mbar.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to dry the Dijsktra composition by drum drying because EP2885977 teaches that drum drying may be used as an alternative to freeze drying, and Salvado teaches that drum drying is superior to spray drying for oligosaccharides. It would have been further obvious to utilize vacuum drum drying because vacuum drying is used for heat-sensitive foods such as milk products. Karthik and Food Safety Foundation teach conditions for drum drying milk products.
Response to Arguments
Applicant’s arguments have been considered to the extent that they are pertinent to the new ground of rejection. Applicant’s arguments regarding the purity in EP28885977 are moot in view of the new ground of rejection necessitated by the addition of a purity limitation to claim 1. Applicant argues that the skilled artisan would have likely turned to freeze-drying and spray drying due to the exemplification provided in EP28885977. This argument is not persuasive because EP28885977 teaches a finite number of drying techniques, and drum drying is one. Furthermore, Salvado teaches that drum drying is superior to spray drying for GOS, so the skilled artisan would have chosen drum drying.
Conclusion
Claim(s) 1-2, 4, 6-9 and 13-19, and 22 is/are rejected. Claims 11 and 21 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. The cited references do not teach drying of an aqueous solution containing 1.0-50% v/v ethanol. The art of record does state that ethanol may be used in purification of oligosaccharides, but does not suggest that a particular amount of ethanol should be present in the aqueous solution to be dried.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693