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 .
Applicant’s amendment and response filed March 09, 2026 has been received and entered.
Claim(s) 1 and 3-17 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 04, 2025 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Withdrawn Objections
Applicant’s arguments filed on March 09, 2026 have been fully considered. In regards to the objection of the specification for the terms: “BUCHI”, “Gibco”, “Invitrogen”, “Thermo Fisher Scientific”, “ATCC”, “GE”, “BD” and “Life Technologies”, Applicant has elected to amend the specification to include a proper symbol indicating use in commerce such as TM, SM, or following the term and therefore, the objection of the specification has been withdrawn.
In regards to the claim objection for claim 4, Applicant has elected to amend the claim to include necessary verbiage and therefore the objection of claim 4 has been withdrawn.
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.
Claim(s) 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (U.S. Pub No. 2021/0235727 A1) in view of Zeng et al (Oxidative Medicine and Cellular Longevity (Year: 2020), vol. 2020, article ID 3836172, pp. 1-26) and Sui (CN 114874344 A – English translation provided).
Regarding claim(s) 1 and 3, Jensen teach [a] beverage base is produced by preparing an aqueous extract of unmalted cereal grains (Abstract), unmalted cereal grains are unmalted barley grains (paragraph 0051) [and] the barley may be a hull-less barley variety (paragraph 0053). Jensen goes on to further teach unmalted cereal grains in an aqueous solution in the presence of one or more exogenous enzymes (paragraph 0087), exogenous enzymes may be an amylase (paragraph 0087).
Jensen does not teach the extraction of black hulless barley seed type in an amylase aqueous solution at 80oC to 100oC for 50 min to 70 min to obtain a black hulless barley extract.
Zeng et al teaches anti-inflammatory ingredients in barley are ß-glucans, lignans, vanillic acid, arabinoxylan, and so on (page 8).
Sui's method teaches the preparation of the highland barley leaf alkali extracting polysaccharide (abstract), and high temperature resistant α-amylase method, greatly improving the protein and starch removing rate, improving the yield of highland barley leaf alkali extracting polysaccharide (page 7), adding highland barley leaf powder and water (page 5), extracting time is 3 hours (page 5). Sui teaches extracting temperature is 80 degrees centigrade to 90 degrees centigrade, the extracting time is 3 hours, repeatedly extracting for 3 times (page 4).
It would have been obvious to one of ordinary skill in the art to use the drink as taught by Jensen that contains a hull-less barley variety within an aqueous solution to include Sui's method of extraction of using an aqueous solution that contains barley and conducting a water extraction and then subjecting the solution to an enzyme, like amylase to improve the yield of specific compounds. In addition to Sui’s method of extraction, Sui’s extracting temperature and extracting times could be included. Through acquiring specific compounds through Sui's method using an aqueous solution containing barley and amylase, this would allow the solution to retain specific compounds necessary for promoting anti-inflammatory effects, as taught by Zeng et al. The combination of Jensen, Sui, and Zeng et al references can be made because in the present application, it teaches a method for regulating immunity using an extracted version of black hulless barley (black hulless barley - a type of barley) that was in the presence of amylase; the references combined illustrates the importance of this water extraction method to then include an enzyme, like amylase to obtain a higher yield of desired product(s) through breaking down any complex starches. Moreover, it would have been obvious to one of ordinary skill in the art to combine all of the references above to have found the method used by the Sui reference intrinsic that the purpose of the experimental extraction times and temperatures is to give rise to a better yield of the desired product, thus leading to the desired structure and activity of the retrieved component. It is intrinsic to one of ordinary skill in the art that various extraction times, like 50- 70 mins, as claimed within the present invention, are used to find the optimal time to achieve a maximum yield of the desired product(s). Although the Sui reference uses 3 hours as the extraction time, this is also another method one can use along with repeatedly extracting to get the most effective extract possible.
Before the effective filing date of the claimed invention, one would have been motivated to make such a combination through the use of various extraction times and temperatures to yield extracted products from the barley plant that would create a healthy drink that has anti-inflammatory or immunomodulatory effects, in which the drink would play critical role in regulating immunity in a subject of need thereof.
In regards to claim 4, Sui teaches adding high temperature resistant alpha-amylase into the supernatant (page 5).
It would have been obvious to one of ordinary skill in the art to combine all of the references above to include an amylase (e.g. α-amylase) within a solution in order to have a higher yield of the desired product because amylase is a starch-degrading enzyme. Having the temperature resistant starch-degrading enzyme, as taught by the Sui reference would allow the enzyme to have a higher starch degrading capacity in the presence of the hulless barley aqueous solution, as taught by Jensen in order to yield a hulless barley extract, using Sui's method of extraction that would be comprised of components necessary to achieve the regulation of immunity in a subject.
One would have been motivated to make such a combination, such as a drink that contains the hulless barley extract because one skilled in the art would determine that in order to access particular components within a plant like barley, breaking down starch would allow for easier accessibility of the components of interest necessary for regulating immunity that would otherwise be difficult to retrieve without the amylase.
In regards to claim(s) 5-7, the Sui reference teaches adding highland barley leaf powder and water according to weight of 1: 20 to 1: 30 (under step 3). However, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)" The Sui reference teaches an amylase component that is present within a solution for extracting the polysaccharide from the highland barley leaf and the weight ratios of both the highland barley leaf powder and water. Varying the concentration or weight within or between compositions is not considered to be inventive unless the concentration or weight are deemed as critical. In this particular case, there is no evidence that the claimed concentrations of amylase in solution and the weight ratio of the black hulless seeds versus an aqueous solution produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration and weight ratio would have been obvious before the effective filing date of the applicant's claimed invention.
Claim(s) 1, 8-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (U.S. Pub. No. US 2021/0235727 A1) in view of Sui (CN 114874344 A - English translation provided), Zeng et al (Oxidative Medicine and Cellular Longevity (Year 2020), vol. 2020, article ID 3836172, pp 1-26), and Qiu (CN 111892666 A - English translation provided).
Regarding claims 8-12, Jensen teach [a] beverage base is produced by preparing an aqueous extract of unmalted cereal grains (Abstract), unmalted cereal grains are unmalted barley grains (paragraph 0051) [and] the barley may be a hull-less barley variety (paragraph 0053). Jensen goes on to further teach unmalted cereal grains in an aqueous solution in the presence of one or more exogenous enzymes (paragraph 0087), exogenous enzymes may be an amylase (paragraph 0087).
Jensen does not teach the extraction of black hulless barley seed type in an amylase aqueous solution to obtain a black hulless barley extract.
Sui's method teaches the preparation of the highland barley leaf alkali extracting polysaccharide (abstract), and high temperature resistant α-amylase method, greatly improving the protein and starch removing rate, improving the yield of highland barley leaf alkali extracting polysaccharide (page 7), adding highland barley leaf powder and water (page 5), extracting time is 3 hours (page 5).
Zeng et al teach anti-inflammatory ingredients in barley are ß-glucans, lignans, vanillic acid, arabinoxylan, and so on (page 8).
The Qiu reference teaches that ß-glucan has the function of adjusting human immunity (page 2). Qiu also teaches [that] the research of preparation technique and application of the highland barley and active ingredient β[-glucan] [are] mainly concentrated in the field of food and health care products. The highland barley β-glucan has great development and utilization value in the field of skin care product (page 2). The Qiu reference teaches [that] under the condition of 90 degrees centigrade, the content of the β-glucan is 3.38 mg/mL, the extraction rate is 0.8 % (page 9).
It would have been obvious to one of ordinary skill in the art to use the drink as taught by Jensen that contains a hull-less barley variety within an aqueous solution to include Sui's method of using an aqueous solution that contains barley and conducting a water extraction and then subjecting the solution to an amylase to improve the yield of specific compounds. Through acquiring specific compounds through Sui's method using an aqueous solution containing barley and amylase, this would allow the solution to retain specific compounds necessary for promoting anti-inflammatory effects, as taught by Zeng et al, specifically focusing on ß-glucan, as taught by Zeng et al and Qiu, in which ß-glucan is known for regulating immunity. This combination of Jensen, Sui, Zeng et al, and Qiu can be made because in the present application, claims 8-12 discuss regulating an immune-related gene, IL-B, IL-8, IL-6, IL- 10, IFNG, NK, NO, and immunodeficiency-related symptoms and it is intrinsic that a compound or compound(s) present like ß-glucan, in a aqueous solution after extraction, with amylase combined in the mix after, would have an effect on all molecules involved in the immune system pathway.
One would have been motivated to make such a combination to create a healthy drink directed towards regulating immune system molecules including but not limited to those molecules stated within the present invention.
In regards to claim(s) 16-17, the Zeng et al and Qiu reference teaches that barley contains specific components (e.g. ß-glucan) that would have been obvious to one of ordinary skill in the art to find it intrinsic that if immune function is being regulated as a result of a component from barley (e.g. ß-glucan) within a drink, as taught by Jensen using Sui's method of extraction using water and subjecting the water-extracted solution that contains a hull-less barley variety to an amylase, that it would affect total T cells, helper T cells, and CD4/CD8 within a subject because those cells are naturally part of the immune system. This combination of Jensen, Sui, Zeng et al, and Qiu can be made because a person of ordinary skill in the art knows that CD4 and CD8 are both memory T cells that serve functions that includes but not limited to regulating immune responses and targeting and ameliorating infected cells.
One would have been motivated to make such a combination to create a healthy drink geared towards regulating immunity, such as molecules like T cells, helper T cells, and CD4/CD8 types, that are pivotal to immunity and life-saving functions in a subject in need thereof.
Claim(s) 1, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (U.S. Pub. No. US 2021/0235727 A1) in view of Sui (CN 114874344 A - English translation provided), Zeng et al (Oxidative Medicine and Cellular Longevity (Year 2020), vol. 2020, article ID 3836172, pp 1-26), Qiu (CN 111892666 A - English translation provided), and Kanauchi (U.S. Pub. No. US 2011/0262571 A1). Regarding claims 12-13, Jensen teach [a] beverage base is produced by preparing an aqueous extract of unmalted cereal grains (Abstract), unmalted cereal grains are unmalted barley grains (paragraph 0051) [and] the barley may be a hull-less barley variety (paragraph 0053). Jensen goes on to further teach unmalted cereal grains in an aqueous solution in the presence of one or more exogenous enzymes (paragraph 0087), exogenous enzymes may be an amylase (paragraph 0087).
Jensen does not teach the extraction of black hulless barley seed type in an amylase aqueous solution to obtain a black hulless barley extract.
Sui's method teaches the preparation of the highland barley leaf alkali extracting polysaccharide (abstract), and high temperature resistant α-amylase method, greatly improving the protein and starch removing rate, improving the yield of highland barley leaf alkali extracting polysaccharide (page 7), adding highland barley leaf powder and water (page 5), extracting time is 3 hours (page 5).
Zeng et al teaches anti-inflammatory ingredients in barley are ß-glucans, lignans, vanillic acid, arabinoxylan, and so on (page 8).
The Qiu reference teaches that ß-glucan has the function of adjusting human immunity (page 2).
Kanauchi teaches to provide a food or drink for inhibiting IBS (paragraph 0006) and the substance according to (1) above, wherein the grain plant is a Gramineae plant. (3) The substance according to (2) above, wherein the Gramineae plant is rice, barley, rye, or wheat (paragraph 0007).
It would have been obvious to one of ordinary skill in the art to use the drink as taught by Jensen that contains a hull-less barley variety within an aqueous solution to include Sui's method of using an aqueous solution that contains barley (barley is also taught by Kanauchi) and conducting a water extraction and then subjecting the solution to an amylase to improve the yield of specific compounds. Through acquiring specific compounds through Sui's method using an aqueous solution containing barley and amylase, this would allow amylase to breakdown any complex starches, leaving behind specific compounds necessary for promoting anti-inflammatory effects, as taught by Zeng et al, specifically focusing on ß-glucan, as taught by Zeng et al and Qiu, in which ß-glucan is known for regulating immunity.
This combination of Jensen, Sui, Zeng et al, Qiu, and Kanauchi can be made because in the present application, claim(s) 12-13 discuss reducing immunodeficiency-related symptoms and that those symptoms can be listlessness, gastrointestinal discomfort, split lip, cough, headache, or any combination thereof; and the combination of these references makes a drink that retains particular compounds necessary to treat IBS (e.g. irritable bowel syndrome) that falls under gastrointestinal discomfort, which is part of immunodeficiency-related. symptoms that are equally treated when regulating immunity on a broad scale.
One would have been motivated to make such a combination to create a healthy drink that helps a subject in need thereof that is suffering from IBS, as a result of immunodeficiency-related symptoms.
Claim(s) 1 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (U.S. Pub. No. US 2021/0235727 A1) in view of Sui (CN 114874344 A - English translation provided), Zeng et al (Oxidative Medicine and Cellular Longevity (Year 2020), vol. 2020, article ID 3836172, pp 1-26), and Zhang (CN 102919648 A - English translation provided).
Regarding claim(s) 14-15, Jensen teach [a] beverage base is produced by preparing an aqueous extract of unmalted cereal grains (Abstract), unmalted cereal grains are unmalted barley grains (paragraph 0051) [and] the barley may be a hull-less barley variety (paragraph 0053). Jensen goes on to further teach unmalted cereal grains in an aqueous solution in the presence of one or more exogenous enzymes (paragraph 0087), exogenous enzymes may be an amylase (paragraph 0087).
Jensen does not teach the extraction of black hulless barley seed type in an amylase aqueous solution to obtain a black hulless barley extract.
Sui’s method teaches the preparation of the highland barley leaf alkali extracting polysaccharide (abstract), and high temperature resistant α-amylase method, greatly improving the protein and starch removing rate, improving the yield of highland barley leaf alkali extracting polysaccharide (page 7).
Zeng et al teaches anti-inflammatory ingredients in barley are ß-glucans, lignans, vanillic acid, arabinoxylan, and so on (page 8).
Zhang teach that [barley] has the function of treatment and assistant treatment of skin allergy (paragraph 0005). Zang teaches the other important nutrient content of highland barley is barley. Barley is full natural food rich in mineral nutrition, enzymes, vitamins and chlorophyll (paragraph 0005). Zhang teaches a method for producing the functional barley jelly (paragraph 0009). Zhang teaches [that] barley contains a polysaccharide and beta-glucan of important nutritional value and healthcare effect (paragraph 0004).
It would have been obvious to one of ordinary skill in the art to use the drink as taught by Jensen that contains a hull-less barley variety within an aqueous solution to include Sui’s method of using an aqueous solution that contains barley and conducting a water extraction and then subjecting the solution to an amylase to improve the yield of specific compounds. Through acquiring specific compounds through Sui’s method using an aqueous solution containing barley and amylase, this would allow the solution to retain specific compounds necessary for promoting anti-inflammatory effects, as taught by Zeng et al, and for treating allergies, more specifically, a skin allergy, as taught by Zhang. This combination of Jensen, Sui, Zeng et al, and Zhang can be made because it combines all of the teachings similar to that of the present application, where it teaches the method of using a black hulless barley extract (black hulless barley – a type of barley) that was subjected to an enzyme, like amylase in solution to degrade complex starches to retrieve specific compounds necessary for relieving allergic reactions in a subject, where the allergic reactions can comprise allergic asthma, food allergy, and skin allergy.
One would have been motivated to make such a combination to create a healthy drink geared towards exhibiting immunomodulatory effects which includes but is not limited to relieving allergic reactions, such as skin allergies in a subject in need thereof.
Response to Arguments
Applicant’s arguments filed March 09, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. 103 are found to be non-persuasive.
Regarding applicant’s remarks for the 35 U.S.C. 103 rejection wherein obviousness with the Jensen, Zeng et al, Sui, Qiu, Kanauchi and Zhang references fails to disclose or teach that the claimed black hulless barley extract obtained by extracting seeds of Hordeum vulgare L. var. nudum Hook. F. has the ability of regulating immunity. Below, examiner has re-stated each cited reference and applicant’s point of view: Beginning on page 9, Jensen neither specifies the use the use of “black” varieties as Hordeum vulgare L. var. nudum Hook. f., nor provides any teaching related to “regulating immunity”. In addition, Jensen fails to teach to the scientific name of “black” variety of Hordeum vulgare L. var. nudum Hook f. Jensen also fails to teach the black hulless barley extract obtained from the seeds of Hordeum vulgare L. var. nudum Hook f. having the functional ability of regulating immunity. Zeng et al fails to motivate one skilled in the art to combine the “black seed” source with an “immune regulating” function and doesn’t teach the “black” variety of Hordeum vulgare L. var. nudum Hook f. and does not teach that the black hulless barley extract obtained from the seeds of Hordeum vulgare L. var. nudum Hook f. having the functional ability of regulating immunity. Sui fails to teach to the scientific name of “black” variety of Hordeum vulgare L. var. nudum Hook f. and does not teach that the black hulless barley extract obtained from the seeds of Hordeum vulgare L. var. nudum Hook f. having the functional ability of regulating immunity. Qiu fails to provide any suggestion for internal immune system regulation because Qiu’s reference teaches that β-glucan’s proven effects are limited to radical scavenging and UV protection in cosmetics and the reference pertains to general β-glucan for “topical skin care” applications. Kanauchi’s teachings targets “Irritable Bowel Syndrome (IBS)” using insoluble dietary fibers and involves a mechanism that involves gastrointestinal motility and serotonin levels, which is pathogenically unrelated to the claimed immune-regulating function. Zhang fails to disclose an extract derived solely from “black” barley seeds [that] provides the claimed immune benefit, in addition, Zhang fails to teach the “black” variety of Hordeum vulgare L. var. nudum Hook f. and does not teach that the black hulless barley extract obtained from the seeds of Hordeum vulgare L. var. nudum Hook f. having the functional ability of regulating immunity.
Regarding Jensen, Zeng et al and Sui for the 35 U.S.C. 103 rejection for claim(s) 1 and 3-7, the combination of references is sufficient to conclude that the black hulless barley (e.g. Hordeum vulgare L. var. nudum Hook f.) is one of many varieties under barley in general. In addition, barley is known to possess specific compounds (e.g. β-glucan) that is known for having immunomodulatory effects, thus, one skilled in the art would know that one variety of barley, like black hulless barley as claimed within the present invention would possess more or less compounds dedicated towards modulating immunity. Moreover, although the Sui reference teaches a method of extraction using the leaves of barley, the method is similar to the present invention in the sense that Sui’s leaf extract was subjected to an enzyme, like α-amylase in order to improve the yield of particular compounds from the extract. Using Sui’s methodology combined with Jensen and Zeng et al, one skilled within the field of analytical chemistry and molecular biology would reasonably expect that a barley variety, like black hulless barley would be subjected to a extraction method combined with a high temperature amylase that would comprise optimized temperatures, an optimized concentration of the amylase enzyme and an optimized weight ratio of amylase solution to the hulless barley that would aid in compound yield efficiency such that the compound obtained can be used within a drink that would promote anti-inflammatory effects within an individual.
Thus, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)" The Sui reference teaches an amylase component that is present within a solution for extracting the polysaccharide from the highland barley leaf and the weight ratios of both the highland barley leaf powder and water. Varying the concentration or weight within or between compositions is not considered to be inventive unless the concentration or weight are deemed as critical. In this particular case, there is no evidence that the claimed concentrations of amylase in solution and the weight ratio of the black hulless seeds versus an amylase aqueous solution produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration and weight ratio would have been obvious before the effective filing date of the applicant's claimed invention.
Lastly, although the references combined does not teach the seeds of black hulless barley, one skilled in the art knows that hulless barley does include the seed and that in general, the difference between hulless barley and barley is that hulless barley requires much less processing and is easier to digest which allows hulless barley to be easily distinguished from regular barley based on those properties alone.
Regarding Jensen, Sui, Zeng et al and Qiu for the 35 U.S.C. 103 rejection for claim(s) 1, 8-12, and 16-17, the combination of references is sufficient to conclude that black hulless barley (e.g. Hordeum vulgare L. var. nudum Hook f.) is one of many varieties under barley in general. In addition, within the Qiu references above, the text provided clearly illustrates that β-glucan are known within food and healthcare products (as mentioned within the Qiu reference above) and can also be used within a “topical skin care” context (as mentioned in applicant arguments and within the Qiu reference above); therefore, β-glucan from barley is versatile in how it can be used. Therefore, one would reasonably expect that the combination of the references mentioned is enough to prove that β-glucan is not only limited to modulating the immune system internally, it also possesses external benefits; therefore, Jensen’s drink would carry a multitude of benefits as a health drink all because the health drink possesses an abundant compound: β-glucan.
Regarding Jensen, Sui, Zeng et al, Qiu and Kanauchi for the 35 U.S.C. 103 rejection for claim(s) 1 and 12-13 wherein the combination of references is sufficient to conclude that black hulless barley (e.g. Hordeum vulgare L. var. nudum Hook f.) is one of many varieties under barley in general. In addition, based on the provided information in the reference above by Kanauchi, applicant suggests that Kanauchi only targets “Irritable Bowel Syndrome (IBS)” using insoluble dietary fibers, in which, the mechanism involves gastrointestinal motility and serotonin levels, which is pathologically unrelated to the claimed immune-regulating function. One of ordinary skill in the art would know that barley is considered to be abundant in β-glucan (which is a soluble fiber), therefore, the combination of all of the aforementioned references is enough to motivate one skilled in the art to create a drink that would effectively treat a condition under gastrointestinal discomfort, like IBS due to immunomodulatory symptoms.
Regarding Jensen, Sui, Zeng et al and Zhang for the 35 U.S.C. 103 rejection for claim(s) 1 and 14-15 wherein the combination of references is sufficient to conclude that outside of being used as a health drink, as taught by Jensen, the important nutritional content of barley is that it contains a polysaccharide and β-glucan as mentioned within the Zhang reference above in the 35 U.S.C. 103 rejection. Despite the fact that Zhang discusses the creation of a barley jelly, Zhang also discusses a method of extraction from the highland barley powder using barley flour and highland barley grass (also mentioned in the Zhang reference above). With Zhang’s creation, one of ordinary skill in the art would reasonably expect that the combination of all of the references for the specified claims are sufficient enough to prove that Jensen’s health drink possesses compounds from barley that would also assist with allergies, such as a skin allergy.
Moving forward, applicant’s arguments on page 10 states that Qiu discloses that conducting the extraction at a temperature of 90oC yields a β-glucan concentration of merely 0.8%. Therefore, applicant states it would not have been reasonable to conclude that the extract has the function of regulating immunity based on β-glucan. In this situation, the applicant’s arguments are disputable. Given that Qiu discloses the information provided just above, one could also argue that an extraction temperature of less than 90oC and in-between 80oC to 89oC could see a reputable increase in the concentration of a compound like β-glucan that would be far above 0.8% (since the temperature is lower than 90oC) which would still be deemed as reasonable such that the extract would have just enough β-glucan to exhibit immune-regulating capabilities. Plus, based on the information provided in the Qiu reference, Qiu has successfully demonstrated enough that β-glucan yield in general is still possible at higher temperatures (e.g. 90oC) in combination with experimental extraction times that would allow the yield of certain compounds in order to achieve the present’s invention’s purpose – to regulate immunity. All of the aforementioned references within the FAOM issued December 18, 2025 in which Jensen is the baseline reference and the supporting references (Zeng et al, Sui, Qiu, Kanauchi and Zhang) were used to remedy the deficiencies in Jensen is enough to prove that with the present inventions temperature and extraction times, β-glucan yield would be sufficient to help with the immune system with the general knowledge that β-glucan along with lignans, vanillic acid and arabinoxylan are known to have its presence within barley that works to modulate immune function with greater emphasis on two references (Zeng et al and Qiu) that explain that the compound, β-glucan has greater immunomodulatory effects.
Lastly, applicant arguments beginning on page 10 suggests that examples 3, 4 and 5 of the present invention show evidence of the black hulless barley having a superior effect on multiple pathways [and pathway molecules] such as improving the expression levels of IL-1β, IL-8, IL-6 and IL-10 within the experimental group in example 3, reducing the expression level of the IFNG gene in the experimental group in example 4 and enhancing the killing ability of NK cells within the experimental group in example 5. In addition, applicant also points out within figures 1-2 how the black hulless barley enhances the gene expression levels of IL-1β, IL-8, IL-6 and IL-10. To further add, applicant believes that the “cited references lacks comparative teachings that would have possibly led to one having ordinary skill in the art to select the black variety (i.e. Hordeum vulgare L. var. nudum Hook. f.) specifically for achieving the superior immunological outcomes of the claimed invention”. The examiner refutes this judgement; regardless of the barley variety (e.g. white hulless barley extracts or black hulless barley extracts) as mentioned within applicant arguments, generally, hulless barley will possess immunomodulatory compounds like β-glucan that are capable of enhancing immune function. In addition, hulless barley is known to one skilled in the art for requiring far less processing, meaning that irrespective of the barley type, the hulless barley will always carry immunomodulatory functions given that hulless barley comes from barley; thus rendering applicant’s arguments wholly ineffective.
Conclusion
THIS ACTION IS MADE FINAL. 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.Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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, Anand U Desai can be reached at (571)272-0947. 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.
NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights