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 .
Response to Amendment
Applicant's amendment and argument filed 06/23/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3-4, 6, 8-9 are pending of which claims 6, 8-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/05/2026.
Claims 1, 3-4 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Peng Jiang-ning et. al. (CN103382228A), Wang Yingshi et. al. (CN110551230A), A.K.M. Masum et. al. (Influence of drying temperatures and storage parameters on the physiochemical properties of spray-dried infant milk formula powders, International Dairy Journal 105 (2020) 104696), and Quifeng Yan et. al. (Study on the Influencing Factors of the Atomization Rate in a Piezoceramic Vibrating Mesh Atomizer, App. Sci, 2020, 10, 2422). This is a new rejection based on the amendments filed on 06/23/2026.
Jiang-ning teaches of Astragalus polysaccharides; “collect filtrate and the dregs of a decoction, add the water refluxing extraction 1～2h of 6～8 times of amounts in the dregs of a decoction, collect filtrate; (see step 1). Then after enzyme treatment to add ethanol in concentrated solution, transfer alcohol concentration to 5~15% , 4 ℃ standing 2h, suction filtration is collected subsequent filtrate (see step 3). Finally Jiang-ning teaches collecting precipitates and vacuum-drying to obtain polysaccharides of molecular weights less than 1400 (see claim 4). Jiang-ning teaches spray drying (see page 3, para. 3). This would indicate adding heated water to the dregs of Astragalus because refluxing is used with heat and then adding alcohol around a concentration of 20% (~15%), with further filter (to presumably remove insoluble). Also Jiang-ning teaches use of centrifuges (see abstract and claim 2) and this would be a known way to those having ordinary skill in the art of removing insoluble components.
Yingshi is relied upon for selection of specific molecular weight polysaccharides in the instantly claimed range.
Yingshi teaches that the range of molecular weights of the astragalus polysaccharides should be 48000-140000 (see page 18, last para.) and teaches ways to selectively capture specific sized molecular weighted polysaccharides through chromatography and ultrafiltration which can also be used to concentrate specific sized polysaccharides (see table 1, page 8 and page 14, first para.).
Regarding claim 3, regarding adding anhydrous ethanol, Yingshi teaches precipitating until the ethanol content is more than 94% (see page 2, part 2)).
Regarding claim 4, Yingshi teaches using high-speed centrifuge (see at least page 20, step 5), step 3) or page 7 step 5)) and low-temperature centrifugation (see page 8, after table 1).
Masum teaches “the combination of inlet-outlet temperatures affected the moisture content, water activity, particle size and glass transition temperature (Tg) in the freshly spray dried IMF powders, whereas, powder surface composition and morphology were not affected” and teaches “that inlet-outlet temperature combinations used during spray drying affect the stability of powders during storage by affecting their initial moisture content” (see abstract).
Yan teaches “as seen from the above formula, the variation of the micro-tapered aperture volume, driving frequency, and the flow resistances of the micro-tapered apertures all exert some influence on the atomization rate” (see page 4, below figure 2).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to optimize the inlet and outlet air temperatures of the spray drying and to optimize the frequency because each of these has an effect on atomization and the stability of the powders formed as discussed by both Yan and Yingshi. Additionally, optimizing a spray dryer is well within the skill of any artisan and reaching the instantly claimed temperatures and frequencies or vibrations would have been obvious for the same reasons that the applicant has found them to be; for preventing a wall and the bottom of the drying tower from powder deposition and liquefication foaming.
It would have also been obvious control for the percent of solid contents of polysaccharide being in the range of 10-100 kDa at 40% because these are the components that are being extracted and so persons having ordinary skill in the art would optimize this component for matters of concentrating. Jiang-ning and more specifically, Yingshi already teach that the extraction process brings about molecular weight polysaccharides within this range so controlling the amount of those is well within the purview of the skilled artisan. It would have also been obvious to extract the Astragalus membranaceus by water extraction and then alcohol precipitation, removing a solid residue, and adding 3-4 times volume of anhydrous ethanol, because Jiang-ning and Yingshi teaches extracting with water and teaches precipitating with ethanol and Yingshi teaches wherein the ethanol is greater than 94%. Using absolute ethanol would have been obvious given this teaching. Determining volume of that absolute ethanol would have been an optimization well within the purview of the skilled artisan.
Given the relied upon art there would have been a reasonable expectation of success in arriving at the instant invention as the specific method steps have previously been taught in the art to extract astragalus polysaccharides of the specific molecular weights.
Response to Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive. The applicant argues that Yingshi teaches away from the use of spray drying. The applicant argues that Yingshi in Table 25 and paragraphs 0143-0144” teaches that the spray drying was “unqualified”. The Office could not find this in Yingshi’s teaching and so the applicant’s attorney was contacted. She claimed that the Chinese document recited the unqualified terminology and teaching away. It was explained to Daniel Hsieh (the attorney of record) that arguments must be restricted to the English translation that is relied upon and supplied in the Office Action. The Office cannot verify the validity of Mr. Hsieh’s statements and so the argument is not found persuasive.
The applicant argues that none of the recited references teach or suggest the technical features of “a drying tower interlay is cooled to 20 degrees Celsius” and “a bottom of a drying tower is vibrated by a vibrating hammer every 5 minutes”. These operational components are obvious to those having ordinary skill in the art and they do not warrant patentability over the prior art because a PHOSITA would know how to operate a spray drier.
The applicant argues that the recited references further teach away from the concentration levels required by the present invention because although there is overlap of molecular weights if one were to concentrate the higher molecular weight taught by Yingshi 48-140 kDa to 40% concentration required by the present application, the solution would completely lose its fluidity. The applicant argues that since Yingshi teaches concentration of the sugars at 26% then this is a teaching away from the applicant’s claimed 40%. This is not teaching away, rather a matter of judicious selection. Just as the selection of the molecular weight range being merely only at the higher concentration values as what the applicant argues. A PHOSITA would recognize the ability to select within the ranges taught by Yinghsi and would arrive at the instant invention through mere optimizations. Increasing the concentration of 100 kDa polysaccharides to be at 40% would have been an obvious optimization and well within the purview of the skilled artisan especially given the relied upon art.
The applicant argues that the 30-40% percent alcohol concentration used in Yingshi is to precipitate polysaccharides and that the 20% alcohol in the instant invention is to a dissolution stage to ensure the 10-100 kDa polysaccharides. However the precipitation in Yingshi has already happened as can be appreciated from the prior statements of Yingshi wherein it is stated adding ethanol into the precipitate (see step 2).
Examiners note: The applicant needs to direct their arguments to the relied upon English translation, even if they are able to read the Chinese document because the United States Patent and Trademark Office relies on the English language.
Conclusion
Currently no claims are allowed.
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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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