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 . 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.
Priority
The instant application claims domestic benefit to US provisional application no. 63/281,869 filed on 11/22/2021 and US provisional application no. 63/192,399 filed on 05/24/2021.
Status of the Claims
The claim amendments and remarks filed on 12/10/2025 is acknowledged. Claims 1, 10, and 12 are amended.
Accordingly, claims 1-17 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(b) rejection for claims 10 and 12-17 are withdrawn in view of claim 10 now reciting an active step of “administering to a subject in need thereof the beta-glucan produced by the method of claim 1”, and the removal of “particulate” before “immunologically active beta-glucan” in claim 12.
The following grounds of rejection are new, maintained, or amended as necessitated by Applicant’s amendments.
Claim Interpretation
Claims 1 and 12 recite “neutralizing … slurry … wherein the method does not include an acid treatment step or an organic solvent extraction step”.
The “wherein the method does not include an acid treatment step or an organic solvent extraction step” is being interpreted as excluding out any acid addition in the claimed process of preparing the particulate beta-glucan from yeast.
It is noted that there is no prior art applicable with the interpretation described above for claims 1-17.
However, Applicant appears to have meant to exclude out an acid extraction step rather than excluding out acid addition entirely for the claimed process.
Applicant states in the remarks filed on 12/10/2025 that “… the claimed method uses a simplified alkaline-only extraction followed by neutralization via water, omitting any acid addition or organic solvent extraction. This distinction is critical, as the specification explains that omitting acid and organic extractions reduced processing time and expense …”.
Here, Applicant is referencing paragraph 0011 in the specification, which states “… omission of the acid and organic extractions and the associated washing steps eliminating approximately wo-thirds of the time and expense”. This exclusion of an acid addition in the specification is referring to exclusion of an acid extraction step and not necessarily exclusion of an acid addition step entirely from the claimed process such as adding acid to neutralize the alkaline solution. Further support for this can be found in the instant specification paragraphs 0026-0027 on page 7, in which the extraction step involved the use of an alkaline extraction base (eg. sodium hydroxide pellets) to bring up the pH and then neutralizing the alkaline solution with a suitable food-grade acid (e.g, citric acid pellets).
Therefore, for purposes of compact prosecution and based on the instant specification as well as remarks filed on 12/10/2025 (page 7), the prior art rejections below are being applied based on a narrower interpretation of excluding out a separate acid extraction step or organic solvent extraction step but not for the use of an acid in the other method steps, for instance, as a means to neutralize the slurry solution in the neutralizing step.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 recite “neutralizing … slurry … wherein the method does not include an acid treatment step or an organic solvent extraction step”.
The excluded “acid treatment step” is being interpreted as excluding any acid treatment to the claimed process as described above. Here, claims 1 and 12 introduce new matter that does not have support in the specification, and one of ordinary skill in the art would not recognize in the Applicant’s disclosure a description of the invention as presently claimed.
MPEP 2173.05(i) recites “Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining.").” and “While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172).”
Here, while the specification discloses that the claimed process does not involve an acid extraction step (paragraph 0011 on page 4), the specification does not provide support for excluding out acid addition in any step of the method. For instance, as disclosed in the instant specification in paragraphs 0026-0027 on page 7, the claimed method involved the use of an alkaline extraction base (eg. sodium hydroxide pellets) to bring up the pH and then neutralizing the alkaline solution with a suitable food-grade acid (e.g, citric acid pellets). The claims require neutralization of the basic slurry, however Applicant has not provided alternatives to neutralizing the alkaline solution without an acid. Therefore, there is no support in the originally filed disclosure for the exclusion of an acid from any step in the claimed method.
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.
Claim(s) 1-3, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection).
Zapata et al. discloses a method for producing yeast beta-glucan by autolysis of Saccharomyces
cerevisia yeast cells (see Abstract). Zapata discloses that purification of yeast beta-glucans and other microorganisms has been extensively investigated (see first paragraph under section “Summary” on page 3). Zapata discloses that beta glucan extraction with hot alkali followed by the extraction with acid at high temperatures and extraction with enzymatic treatment to modify the purity of the Glucan when the intact yeast cells are used, makes the processes expensive by requiring long processing times with significant waste production and high cost (see first paragraph under section “Summary” on page 3). Therefore, Zapata discloses that their process takes advantage of the cellular remains obtained from the autolysis process, which is treated with hot alkali by introducing only alkaline retention without the need to supplement the alkali (see first paragraph under section “Summary” on page 3). Zapata discloses that they do not perform acid treatment for the extraction of the beta-glucan and instead introduce a process of bleaching the material to obtain a beta-glucan with white and unique characteristics that is not obtained in the processes known in the art (see first paragraph under section “Summary” on page 3).
Zapata et al. discloses that the obtained beta-glucans from their process have a glucose concentration of 60-90% dry product with a solid material particle size of ~0.2-10 microns (see Abstract). Zapata et al. discloses that a harvested yeast biomass was washed several times with water (see page 4, second paragraph). Zapata et al. discloses their method includes autolysis of yeast cells and separating the cell debris from the soluble fraction by centrifugation and subsequent washing of the cell debris (see claim 1 of Zapata on page 1). Zapata et al. discloses that the autolyzed cell debris can also be subject to direct steam heating in a handling tank at a temperature of 40-95 degree Celsius (see page 4). Here, the step of “direct steam heating in a handling tank”, “washed several times with water”, “subsequent washing” is being interpreting as “hydrating the autolyzed yeast material with water in a vat processor” as well as “draining and replacing the water” as recited in instant claim 1. Zapata et al. demonstrates in Example 1 that the autolyzed cell debris material was subjected to alkali treatment in a pH range between 5-15 using sodium hydroxide for 2-6 hours at 40-95 degrees Celsius (see page 4). Zapata et al. discloses that the alkali treated cell debris was then washed with hot water in successive stages at 40-95 degree Celsius and centrifuged to recover the treated material (see page 4). Here, the “successive stages of washing with hot water” is being interpreted the same as “washing the extracted solid material in the vat processor with another fill of water” as recited in instant claim 2. Zapata et al. demonstrates in Example 2 that the extracted alkali treated material is further pH adjusted using sulfuric acid to a final pH range between 5.5-7.0 (see page 5), which is being interpreted the same as “neutralizing the slurry and extracted solid material” as recited in instant claim 1. Zapata et al. demonstrates in Example 3 of further sterilizing and drying the recovered material using a NIRO dryer, in which the final dried yeast beta-glucan product was analyzed by HPLC and had a total carbohydrate of 71-85% based on dry matter weight (see page 5).
The difference between Zapata et al. and the claimed invention is that Zapata et al. does not expressly disclose a step of extracting the solid material by adding an alkaline base to bring the pH up between 10-14 for a period of 5 mins to 2 hours and performing this step a temperature of up to 80 degrees Celsius.
It would have been prima facie obvious to perform the alkali treatment of Zapata et al. at a pH of 10-14 for 2 hours at a temperature of up to 80 degrees Celsius because Zapata et al. discloses an overlapping range of the alkali treatment in a pH range between 5-15 using sodium hydroxide for 2-6 hours at 40-95 degrees Celsius. See MPEP 2144.05 section I.
Furthermore, even though Zapata involves a step of adding an acid in their process, the acid addition is involved in the step of neutralizing the alkaline extraction method, and is not a separate acid extraction step. Furthermore, Zapata explicitly discloses that they do not perform acid treatment for the extraction of the beta-glucan and instead introduce a process of bleaching the material to obtain a beta-glucan with white and unique characteristics that is not obtained in the processes known in the art (see first paragraph under section “Summary” on page 3). Here, the additional bleaching step uses sodium hypochlorite (claim 11 of Zapata) which is not an organic solvent, and since the recited method uses the transitional phrase “comprising”, additional unrecited method steps such as the bleaching step of Zapata are still within scope of the instant claims. See MPEP 2111.03 I. Therefore, the method of Zapata meets the limitation of “does not include an acid treatment step or an organic solvent extraction step”.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection), as applied to claims 1-3, 5, and 8 above, and further in view of Varelas et al. (E-Journal of Science & Technology, 2016 in PTO-892 dated 06/10/2025)
The teachings of Zapata et al. are as described above.
The difference between Zapata et al. and the claimed invention is that Zapata et al. does not disclose hydrating the autolyzed yeast material at a ratio sufficient to produce a slurry having a hydration level up to 10.6%.
Varelas et al. discloses different methods for the extraction of yeast beta glucans from Vin 13, a S. cerevisiae strain (see Abstract). Varelas et al. discloses that the starting material were divided in three equal portions and then diluted using deionized water leading to yeast cell slurry of 10% rehydration (w/v) (see page 76 section “2.2.1.1”). Varelas et al. discloses that the yeast cell rehydration is important during autolysis and that the maximum cell rehydration is achieved with 10% w/v (see first paragraph on page 84). Varelas et al. discloses that the rehydration triggers the cell’s enzyme systems properly via the water efflux through the lipid bilayer, which leads to cellular reprogramming and results in a higher autolysis ratio at 10% w/v hydration (see first paragraph on page 84). Varelas et al. discloses that their method 3 involving 10% w/v yeast cell rehydration, 24h yeast autolysis, and 0.5 M hot NaOH treatment resulted in the highest concentration of beta-glucans in the final yeast powder (see Abstract).
It would have been prima facie obvious to combine Zapata and Varelas before the effective filing date of the claimed invention by modifying the water washing of the yeast material disclosed in Zapata to include a 10% w/v rehydration level as disclosed by Varelas to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Varelas provides guidance that 10% w/v hydration of yeast material allows for the yeast cells to achieve maximum cell hydration and results in the highest yield of beta-glucans.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection), as applied to claims 1-3, 5, and 8 above, and further in view of Grossman et al. (US10092646B2 in PTO-892 dated 06/10/2025) and as evidenced by GEA (website for NIRO dryer in PTO-892 dated 06/10/2025)
The teachings of Zapata et al. are as described above. Furthermore, as evidenced by GEA, a NIRO dryer is a spray dryer.
The difference between Zapata et al. and the claimed invention is that Zapata et al. does not disclose cold-storing the extracted solid material at 4 degrees Celsius.
Grossman et al. discloses a composition that includes a β-glucan component and an antibody component that specifically binds to the β-glucan (see Abstract). Grossman et al. demonstrates in Example 1 that their beta-glucan formulation was stored at 4-8 degree Celsius until use.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have stored the extracted beta-glucans of Zapata at 4 degrees Celsius until further use as disclosed by Grossman to arrive at the claimed invention because Grossman provides guidance that storing beta-glucans at this temperature is suitable until further use.
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection), as applied to claims 1-3, 5, and 8 above, and further in view of Smet et al. (Human Vaccines & Immunotherapeutics, 2014 in PTO-892)
The teachings of Zapata et al. are as described above.
The difference between Zapata et al. and the claimed invention is that Zapata et al. does not expressly disclose a method of administering vaccinations using the beta glucans as an adjuvant and as an adjuvant for general immune enhancement, anti-viral, or anti-cancer treatments.
Smet et al. discloses oral vaccine development using yeast-derived β-glucan particles (see Abstract). Smet et al. discloses that particulate β-glucans may serve as a suitable vaccine delivery
platform, and that beta-glucans exert intrinsic adjuvanticity and are potent activators of the innate immune system suitable for both immunocompetent and immunocompromised subjects (see page 1315, right column).
It would have been prima facie obvious before the effective filing date of the claimed invention to administer the beta glucans of Zapata et al. as an adjuvant in vaccinations for general immune enhancement as disclosed by Smet et al. to arrive at the claimed invention because Smet et al. provides guidance that the produced beta-glucans exert intrinsic adjuvanticity and are potent activators of the innate immune system as well as being suitable as a vaccine delivery platform.
Claim(s) 9, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection), as applied to claims 1-3, 5, and 8 above, and further in view of Javmen et al. (Biologia, 2017 in PTO-892 dated 06/10/2025)
The teachings of Zapata et al. are as described above.
The difference between Zapata et al. and the claimed invention is that Zapata et al. does not expressly disclose that a method of increasing the expression of interferon-producing genes by human macrophages by administering the claimed beta-glucans.
Javmen et al. discloses that S. cerevisiae β-glucans affect proliferation, phagocytosis and cytokine production of murine macrophages and dendritic cells (see Abstract). Javmen et al. discloses that macrophages and dendritic cells (DCs) are one of the first cells, which encounter potential pathogens and their structures, and that these cells play a crucial role in innate immunity and help to initiate specific defense mechanisms of the adaptive immunity by secreting cytokines (see left column page 562). Javmen et al. demonstrates that S. cerevisiae beta-glucans stimulated interferon-gamma (INF-gamma) synthesis in murine macrophages (see Fig 6C and page 565 right column).
It would have been prima facie obvious before the effective filing date of the claimed invention to have used the produced beta-glucans of Zapata et al. for increasing expression of IFN-producing genes by human macrophages as disclosed by Javmen et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Javmen et al. provides guidance that S. cerevisiae β-glucans, the same beta-glucan type produced in Zapata et al., is effective at increasing expression of IFN-gamma in murine macrophages, which is a vital mechanism for innate immunity.
Furthermore, even though the combined teachings of Zapata and Javmen described above involves a step of adding an acid in their process, the acid addition is involved in the step of neutralizing the alkaline extraction method, and is not a separate acid extraction step. Additionally, Zapata explicitly discloses that they do not perform acid treatment for the extraction of the beta-glucan and instead introduce a process of bleaching the material to obtain a beta-glucan with white and unique characteristics that is not obtained in the processes known in the art (see first paragraph under section “Summary” on page 3). Here, the additional bleaching step uses sodium hypochlorite (claim 11 of Zapata) which is not an organic solvent, and since the recited method uses the transitional phrase “comprising”, additional unrecited method steps such as the bleaching step of Zapata are still within scope of the instant claims. See MPEP 2111.03 I. Therefore, the method of Zapata meets the limitation of “does not include an acid treatment step or an organic solvent extraction step”.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zapata et al. (WO2008032134A1 in PTO-892 dated 06/10/2025, an English translation is also provided in PTO-892 dated 06/10/2025 and used as the basis for this rejection) in view of Javmen et al. (Biologia, 2017 in PTO-892 dated 06/10/2025), as applied to claim 12 above, and further in view of Varelas et al. (E-Journal of Science & Technology, 2016 in PTO-892 dated 06/10/2025).
The combined teachings of Zapata et al. and Javmen et al. are as described above.
The difference between combined teachings of Zapata et al. and Javmen et al. and the claimed invention is that combined teachings of Zapata et al. and Javmen et al. do not disclose hydrating the autolyzed yeast material at a ratio sufficient to produce a slurry having a hydration level up to 10.6%.
Varelas et al. discloses different methods for the extraction of yeast beta glucans from Vin 13, a S. cerevisiae strain (see Abstract). Varelas et al. discloses that the starting material were divided in three equal portions and then diluted using deionized water leading to yeast cell slurry of 10% rehydration (w/v) (see page 76 section “2.2.1.1”). Varelas et al. discloses that the yeast cell rehydration is important during autolysis and that the maximum cell rehydration is achieved with 10% w/v (see first paragraph on page 84). Varelas et al. discloses that the rehydration triggers the cell’s enzyme systems properly via the water efflux through the lipid bilayer, which leads to cellular reprogramming and results in a higher autolysis ratio at 10% w/v hydration (see first paragraph on page 84). Varelas et al. discloses that their method 3 involving 10% w/v yeast cell rehydration, 24h yeast autolysis, and 0.5 M hot NaOH treatment resulted in the highest concentration of beta-glucans in the final yeast powder (see Abstract).
It would have been prima facie obvious to have combined the teachings of Zapata and Jaymen with Varelas before the effective filing date of the claimed invention by modifying the water washing of the yeast material disclosed in the combined teachings of Zapata and Jaymen to include a 10% w/v rehydration level as disclosed by Varelas to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Varelas provides guidance that 10% w/v hydration of yeast material allows for the yeast cells to achieve maximum cell hydration and results in the highest yield of beta-glucans.
Response to Arguments
Applicant’s arguments filed on 12/10/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that Zapata discloses a method for producing beta-glucan that includes an alkaline treatment followed by an explicit acid treatment step using sulfuric acid to adjust the pH to 1.0-5.0, and then successive washes to reach a neutral pH of 5.5-7.0. Applicant states that this acid treatment is integral to Zapata’s process for purification and recovery of the cell debris. Applicant states in contrast, their method uses a simplified alkaline-only extraction followed by neutralization via water, omitting any acid addition or organic solvent extraction. Applicant states this distinction is critical because omitting acid and organic extractions reduces processing time and expense while yield a beta-glucan with superior immune-modulating properties. Applicant states that the Office Action dated 06/10/2025 interprets Zapata’s acid adjustment as equivalent to the claimed “neutralizing” step, and that the new amendments now explicitly excludes acid addition, distinguishing claim 1 from Zapata’s required acid treatment.
Applicant’s arguments described above was not found persuasive because while Applicant has disclosed a process that does not involve an acid extraction process (paragraph 0011 on page 4 in instant specification), Applicant has not provided support for excluding out acid addition entirely from the claimed process as described above in the 35 USC 112(a) new matter rejection. In paragraph 0026 on page 7 of the instant specification, Applicant discloses their method involves neutralizing the recited alkaline extraction process with a suitable food-grade acid (e.g citric acid pellets). Since Applicant’s claimed process involves a neutralization step, and Applicant has not provided alternatives to neutralizing the alkaline solution without an acid, there is no support in the originally filed disclosure for the exclusion of an acid from any step in the claimed method.
Furthermore, as noted in the claim interpretation section above, there is no prior art applicable for claims 1-17 with the interpretation of excluding out any acid-addition in the claimed process. However, Applicant appears to have meant to exclude out an acid extraction step rather than excluding out acid addition entirely for the claimed process as described above in the claim interpretation section. Therefore, for purposes of compact prosecution, the prior art rejections were applied based on a narrower interpretation of excluding out a separate acid extraction step or organic solvent extraction step but not for the use of an acid in the other method steps, for instance, as a means to neutralize the slurry solution in the neutralizing step.
While Zapata discloses the use of an acid, the addition of the acid in Zapata is performed in order to neutralize the alkaline extraction process in Zapata and is not a separate acid extraction step. Additionally, Zapata explicitly discloses that they do not perform acid treatment for the extraction of the beta-glucan and instead introduce a process of bleaching the material to obtain a beta-glucan with white and unique characteristics that is not obtained in the processes known in the art (see first paragraph under section “Summary” on page 3). Here, the additional bleaching step uses sodium hypochlorite (claim 11 of Zapata) which is not an organic solvent, and since the recited method uses the transitional phrase “comprising”, additional unrecited method steps such as the bleaching step of Zapata are still within scope of the instant claims. See MPEP 2111.03 I. Therefore, the method of Zapata meets the limitation of “does not include an acid treatment step or an organic solvent extraction step”.
Applicant states that the process recited in claim 1 provides an unexpected advantage in efficiency and biological activity, as evidenced by the specification’s description of enhanced interferon gene expression and reduced inflammatory response compared to prior art beta-glucans.
In response to Applicant’s statement of an unexpected advantage, Applicant must provide a comparison to the closest prior art according to MPEP 716.02(e). Here, the closest prior art is Zapata. Table 1 and 2 from the instant specification are shown below:
PNG
media_image1.png
155
591
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Greyscale
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354
579
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Greyscale
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416
607
media_image3.png
Greyscale
Here, Applicant provides comparisons of beta-glucan sourced from S. cerevisiae yeast and produced by their method (alkali only) to beta glucan sourced from baker’s yeast and produced according to standard production methods, LPS, or Poly-IC.
While Applicant has provided an extensive comparison to various produced beta-glucans, Applicant has not provided a comparison to the beta-glucans produced by Zapata. Applicant also has not provided the steps or conditions involved in the “standard production method” beta glucans that are being compared to, therefore it could not be determined if these beta glucans are comparable to the beta-glucans produced by Zapata. Furthermore, Zapata discloses that their production method involved an alkali extraction process without an acid extraction step and discloses using an additional bleaching step, which are within scope of the instant claims. Therefore, Applicant has not demonstrated a sufficient showing of an unexpected result over the closest prior art because a comparison to the process disclosed in Zapata has not been presented, which is needed in order to determine if the alleged unexpected advantages also apply over the beta-glucans produced in Zapata.
Conclusion
No claim is found allowable.
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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693