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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
Priority
This Application claims benefit of priority to People’s Republic of China Application No. CN202110837446.X filed on 07/23/2021. This application is also a 371 of PCT/CN2021/120703 filed on 09/26/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. For the purposes of applying prior art, the effective filing date of the claimed invention is 07/23/2021.
Amendment and Claim Status
In the reply filed on 04/20/2026, Applicant amended claim 1. Claims 3-4 are canceled. Claims 7-14 remain withdrawn as they are not encompassed by the elected group.
Claims 1-2 and 5-14 are currently pending.
Claims 7-14 are withdrawn.
Claims 1-2 and 5-6 are under examination.
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 1-2 and 5-6 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 contains the trademark/trade name DEAE-SepharoseTM Fast Flow. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific type of chromatography and, accordingly, the identification/description is indefinite.
Claim 1 recites “… combining the collected eluate under a third component peak measured by a sulfuric acid-phenol method” in lines 13-14. It is unclear what specifically is being referred to as ‘the collected eluate under a third component peak’ because it is unclear what specifically the third component peak represents. One of ordinary skill in the art would not be reasonably apprised of what the ‘third component peak’ represents based upon the claim or information given within the instant Specification. The phenol-sulfuric acid method can produce multiple peaks based upon the specific carbohydrate(s), polysaccharide(s) in the instant case, present in the solution being analyzed. Thus, it is unclear what is being combined because it is unclear what is in the eluate that is responsible for producing the third component peak. Thus, claim 1 and all claims dependent upon claim 1 are rendered indefinite.
Claim Rejections - 35 USC § 103
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 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being anticipated by Wu et al. (US 20190093067 A1, 03/28/2019) (Of Record) in view of Feng et al. (CN 104450655 A, 03/25/2015) (Of Record).
Regarding claims 1 and 5-6, Wu et al. disclose a method for producing exopolysaccharide by culturing Paenibacillus sp. with deposit number CGMCC NO. 8333 (See entire document, Abstract). Wu et al. further disclose a method for preparing the extracellular polysaccharide with Paenibacillus, wherein Paenibacillus CGMCC No. 8333 is fermented to obtain a fermentation broth (Paragraph [0023]). After fermentation and once the crude product of extracellular polysaccharide is obtained, the crude product is purified by dissolving the crude product in a buffer and chromatographing on a DEAE-Sepharose FF column (Paragraph [0026]). The crude product is loaded onto the DEAE-Sepharose FF column, an elution with Tris-HCl buffer (0.05 mol/L, pH 7.60) is performed and an elution with Tris-HCl buffer (0.05 mol/L, pH 7.60) which contains 0.2-1.2 mol/L NaCl is performed at a flow rate of 3 mL/min (Paragraph [0089]). The liquid is collected in tubes and the sulfuric acid-phenol method is used for tracking and monitoring (Paragraph [0089]). The absorbance is determined at the wavelength of 490 nm which is the characteristic wavelength for polysaccharides (Paragraph [0089]). At this point, a primarily purified product component of polysaccharide is obtained, however, two or more polysaccharide components may be present, so further purification is required (Paragraph [0089]). The aqueous solution obtained through the elution from the tube with the number corresponding to the single peak obtained is collected and dialyzed with a 1000 Da-dialysis bag in deionized water for 72 hours (Paragraph [0089]). Vacuum freeze drying is performed and the purified extracellular polysaccharide is obtained (Paragraph [0089]).
Wu et al. do not disclose fermenting the Paenibacillus sp. with deposit number CGMCC NO. 8333 with wheat bran, an elution speed of 1.5 mL/min or a molecular cut-off of 14,000 Daltons.
However, Feng et al. disclose fermenting Paenibacillus sp. with deposit number CGMCC NO. 8333 (Paragraph [0012]) and wheat bran (Paragraph [0014]). Feng et al. state it is conventional within the field to utilize Paenibacillus sp. with deposit number CGMCC NO. 8333 for producing extracellular polysaccharide (Paragraph [0012]). Additionally, Feng et al. state their culture, comprising wheat bran and Paenibacillus sp. with deposit number CGMCC NO. 8333, produced a high polysaccharide content (Paragraph [0013]).
In addition, as discussed above, Wu et al. disclose an elution speed of 3.0 mL/min and a molecular cutoff of 1000 Daltons.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized wheat bran in the fermentation of Wu et al., which already comprises Paenibacillus sp. with deposit number CGMCC NO. 8333, because fermenting wheat bran with Paenibacillus sp. with deposit number CGMCC NO. 8333 was a known and effective means of producing extracellular polysaccharides as taught by Wu et al. Therefore, it would have been obvious to ferment wheat bran with Paenibacillus sp. with deposit number CGMCC NO. 8333 to produce high amounts of extracellular polysaccharide with a reasonable expectation of success because Wu et al. teach Paenibacillus sp. with deposit number CGMCC NO. 8333 is conventional for use in producing polysaccharides and Wu et al. ferment wheat bran with Paenibacillus sp. with deposit number CGMCC NO. 8333 and successfully produce a fermentation medium with a high extracellular polysaccharide content.
Additionally, it is noted that all experimentation steps after the fermentation process, as instantly-disclosed, are steps to isolate the extracellular polysaccharides from the fermentation process and data extrapolation steps, there are no additional steps to produce the claimed polysaccharides. Therefore, absent evidence to the contrary, it appears the fermentation of Wu et al. with the addition of wheat bran would necessarily produce the same extracellular polysaccharides as the claimed polysaccharides in instant claims 1 and 5-6 because the production of the polysaccharides utilizes the same process as instantly claimed, being fermenting wheat bran with Paenibacillus sp. with deposit number CGMCC NO. 8333.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized an elution speed closed to an elution speed disclosed in the prior art with a reasonable expectation of success, with 1.5 mL/min being close to 3.0 mL/min. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). Thus, it would have been obvious to utilize an elution speed close to the elution speed disclosed by the prior art because it would be expected similar elution speeds would provide similar results.
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a dialysis bag with a specific molecular cutoff to obtain a purified specific size extracellular polysaccharide as utilizing a dialysis bag with a specific molecular cutoff was a known and effective means of obtaining a purified extracellular polysaccharide from a solution containing two or more polysaccharide components as taught by Wu et al. Therefore, it would have been obvious to select any size molecular cutoff motivated by the desire to purify the solution containing multiple polysaccharide components so that only the desired polysaccharide would remain.
Overall, it would have been obvious to utilize a fermentation medium comprising wheat bran and Paenibacillus sp. with deposit number CGMCC NO. 8333 to produce extracellular polysaccharides and utilize a DEAE-Sepharose FF column with the discussed parameters, a sulfuric acid-phenol method and a dialysis bag with a specific molecular cutoff to purify the extracellular polysaccharides produced from the fermentation based upon the teachings of Wu et al. and Feng et al. for the reasons discussed above.
Regarding claim 2, as the strain in the instant claim is the same as the strain disclosed by the prior art and the prior art utilizes the strain for fermenting wheat bran, the strain is capable of fermenting wheat bran to synthesize the extracellular polysaccharide.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
Applicant argued Wu et al. do not disclose the same extracellular polysaccharide as is instantly claimed.
The Examiner agrees that Wu et al. do not disclose the same extracellular polysaccharide as is instantly claimed. However, as discussed above, the combination of Wu et al. and Feng et al. would necessarily produce the same extracellular polysaccharides as instantly claimed because the combination of Wu et al. and Feng et al. utilizes the same fermentation steps, being fermenting Paenibacillus sp. CGMCC NO. 8333 with wheat bran.
Applicant argued on Page 9 that Wu et al. do not disclose the claimed molecular weight cutoff of 14,000 Da.
While Wu et al. do not explicitly disclose a molecular weight cutoff of 14,000 Da, they do disclose a molecular weight cutoff of 1,000 Da and it would be obvious to utilize a specific weight cutoff geared toward isolating a specific weight of polysaccharide as discussed above on Page 8.
Applicant argued on Pages 10-11 that the claims are not obvious in view of the cited prior art because substantial reconstruction is necessary to combine the prior art elements.
A modified rejection has been set forth above which does not require substantial reconstruction.
Applicant argued on Pages 11-12 that the proposed combination would be not have been predictable.
It is the Examiner’s position that the modified rejection set forth above shows predictability and obviousness of the instant claims.
Applicant argued on Page 13 that the instant claims are not obvious over the prior art because a problem was discovered and a solution was put forth by Applicant.
It is the Examiner’s position that the instant claims are obvious over the cited prior art for the reasons set forth above.
Conclusion
Claims 1-2 and 5-6 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights