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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 02/05/2026 is acknowledged.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02/05/2026.
Claims 1-5 are being examined on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 3 are 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.
Claim 1, at step 2) recites “removing insoluble thermosensitive macromolecular proteins, polysaccharides and solid residues”, however these terms are relative and there are no definitions that direct one to know what constitutes thermosensitive and macromolecular. For instance what size would constitute macromolecular and what temperature makes the components thermosensitive? The limitation is indefinite.
Claim 1, step 4) recites “low temperature”, however the term is relative and the specifications do not define a range for what the “low temperature” would be.
Claim 3, at lines 3-4, the claim recites “traditional Chinese medicine Astragalus membranaceus pieces” and it is unclear how this is defined and limited. Do the pieces have to be parts or plants from China or is there a specific extraction process for obtaining them? The limitation is indefinite. The claim also recites “hot water” and this phrasing is relative making the limitation unclear.
Claim 5, at line 4, recites “interlayer is cooled by cool air” and this phrasing is indefinite because “cold air” is not defined in the specifications for a range in temperature of what cold air is meant to mean.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wang Yingshi et. al. (CN110551230A).
Regarding claims 1-2, Yingshi teaches a preparation method of astragalus polysaccharide, which comprises the following steps: 1) decocting radix astragali in water, adding ethanol into concentrated solution, and standing at room temperature; (2) filtering to remove supernatant, adding ethanol into the precipitate, filtering to remove supernatant, adding water into the precipitate, and dissolving; 3) adding ethanol into the solution to ensure that the ethanol content is 30-40%, taking supernate and adding ethanol to ensure that the ethanol content is 60-80%, standing, filtering to remove supernate, adding water into the precipitate to fix the volume, filtering, adding water into the filtrate, and ultrafiltering to obtain filtrate with the volume of 25% -30% of the fixed volume. Yingshi also teaches concentrating (see abstract or claim 1); concentrating the supernatant by using a vacuum film concentrator under the conditions that the temperature is between 35 and 45 ℃ (see page 7). Yingshi also teaches spray drying (see page 14, above table 25). Yinghis teaches that the range of molecular weights of the polysaccharides should be 48000-140000 (see page 18, last 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).
Yingshi does not particularly teach the temperature of extraction of part 1) or concentrating the molecular weight polysaccharide contents to be at 40% of solid contents, however it would have been obvious to persons having ordinary skill in the art to optimize the temperature during decoction/extraction to be at 65 degrees Celsius because decocting is known to take place with heat and this is well within the purview of any skilled artisan especially given that this does not appear to be critical to the invention. A person having ordinary skill in the art would want to control temperatures to control temperature sensitive polysaccharides during extraction and to speed up extraction rate/efficiencies. Also the amount of alcohol being controlled at 20% is not far from the 35% of the prior art and appears to being about the same molecular weight polysaccharides unless shown some evidence that this indeed is not the case.
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. Yingshi already teaches 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 the alcohol precipitation, removing a solid residue, and adding 3-4 times volume of anhydrous ethanol, because Yingshi teaches extracting with water and teaches precipitating with ethanol 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wang Yingshi et. al. (CN110551230A) as applied to claims 1-4 above, and further in view of 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).
Yingshi teaches the method for preparing a feeding instant astragalus polysaccharide powder as discussed above but is silent on the parameters for the spray dryer.
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.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655