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 .
Claim(s) 1, 3-4, 6-13 and 16-17 are currently pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 07, 2026 has been entered.
Pending Rejections:
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, 3-4, 6-11 and 16-17 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), Sui (CN 114874344 A – English translation provided), Zhang (CN 102919648 A – English translation provided), Qiu (CN 111892666 A - English translation provided) and Xie (CN 111096404 A – English translation provided).
Jensen teaches [a] beverage base [that] 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 hulless 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 teaches [that the invention] may also comprise mashing in the presence of one or more starch degrading enzymes [such as] alpha-amylase ([an exogenous enzyme]) (paragraph 0091). Jensen teaches[that] mashing may be done at one or more predetermined temperatures selected in order to ensure activity of said one or more exogenous enzymes (paragraph 0074). Jensen teaches [that] the mashing temperature(s) are typically temperature(s) in the range of 30 to 90° C (paragraph 0073). Jensen teaches [that] the time for incubation in the aqueous solution may, e.g., be for in the range of 60 to 300 min (paragraph 0076).
Jensen does not teach the extraction of black hulless barley seed type in an amylase aqueous solution at 80°C to 100°C for 50 min to 70 min to obtain a black hulless barley extract (as stated within claim 1 of the present invention). Jensen does not teach a concentration of amylase in the amylase aqueous solution is 0.3% (w/v) to 0.7% (w/v); and wherein the black hulless barley extract relieves allergic reactions in the subject, and the allergic reactions are at least one of the following: allergic asthma, food allergy, and skin allergy (also stated within claim 1 of the present invention). Jensen does not teach a weight ratio of the amylase aqueous solution to the seeds of the black hulless barley is 5-10:1 and a specific weight ratio of 10:1 (as stated within claim(s) 6-7 of the present invention). Jensen does not teach that the black hulless barley extract regulates an expression level of an immune-related gene in the subject where the immune related gene is an interleukin-1ß (IL-1β) gene, an interleukin-8 (IL-8) gene, an interleukin-6 (IL-6) gene, an interleukin-10 (IL-10) gene, an interferon-y (IFNG) gene, or any combination thereof (as stated within claim(s) 8-9 of the present invention). Jensen does not teach that the black hulless barley extract enhances a cell killing ability of natural killer cells (NK cells) in the subject, and that the extract reduces a content of nitric oxide (NO) caused by inflammation in the subject (as stated across claim(s) 10-11 of the present invention). Jensen does not teach that the black hulless barley extract increases contents of total T cells and helper T cells in blood of the subject and that the extract increases a CD4/CD8 ratio in blood of the subject (as stated within claim(s) 16-17 of the present invention).
Zeng et al teaches anti-inflammatory ingredients in barley are ß-glucans, lignans, vanillic acid, arabinoxylan, and so on (page 8).
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). 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). The Sui reference teaches adding high temperature resistant α-amylase into the supernatant (page 5).
Zhang teach that [barley] has the function of treatment and assistant treatment of skin allergy (paragraph 0005). Zhang 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).
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 ß-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 ß-glucan is 3.38 mg/mL, the extraction rate is 0.8 % (page 9). Qiu teaches [that] α amount of the high temperature amylase is 0.02 to 0.05wt % (page 4).
Xie teaches a method for [preparing a drink that contains barley and the steps include] adding amount of α-amylase [that] is 0.3%, keeping the temperature for 30min at 80 degrees centigrade (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 hulless 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 also subjecting the solution to an enzyme, like α-amylase to improve the yield of specific compounds within the hulless barley extract. 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 hulless 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 the aforementioned references can be made because in the present application, it teaches a method for regulating immunity using an extracted version of black hulless barley (a type of barley) that was in the presence of α-amylase. It would have been obvious to one of ordinary skill in the art to have modified the α-amylase amount used in Qiu to be 0.3% of α-amylase as taught by Xie in order to create Jensen's 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 hulless barley, breaking down starch using particular concentrations of α-amylase, namely 0.3%, would allow for easier accessibility of the components of interest for regulating immunity that would otherwise be difficult to retrieve without that specific concentration of amylase. Moreover, through acquiring specific compounds through Sui's method using an aqueous solution containing hulless 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. In addition, by including α-amylase within the solution to degrade complex starches, this would allow the retrieval of specific compounds (e.g. ß-glucan) 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 (also taught by Zhang) in a subject in need thereof. This combination of the aforementioned references can also be made because in the present application, claim(s) 8-12 discuss regulating an immune-related gene, IL-β, IL-8, IL-6, IL- 10, IFNG, NK, NO (nitric oxide), and immunodeficiency-related symptoms and although the references doesn’t not specifically teach the regulation of each explicitly mentioned immune-related gene, it is intrinsic that a compound or compound(s) present like ß-glucan, in an aqueous solution after extraction, with α-amylase combined in the mix, would have an effect on all molecules involved in the immune system pathway. Furthermore, the combination of references would render one skilled in the art to reasonably expect that Jensen’s drink would too affect total T cells, helper T cells, and CD4/CD8 within a subject because those cells are naturally part of the immune system. 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. The references combined illustrates the importance of this water extraction method to then include an enzyme, like α-amylase in order 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 and the Jensen references discusses an incubation range of 60-300 mins, these are other time ranges one can adopt along with conducting repeated extractions in order to get the most effective extract possible in a reasonable amount of time.
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 hulless barley seed that could be incorporated into 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. Furthermore, it is known in the art that hulless barley refers to the seed of that of the barley plant and although the claims of the present invention discuss black hulless barley and the combined aforementioned references discuss hulless barley, that would not take away from the fact that both types of hulless barley would produce the same intended results.
In regard to claim(s) 6-7, the Sui reference teaches adding highland barley leaf powder and water according to weight of 1: 20 to 1: 30 (under step 3) and the combined aforementioned references does not teach the amounts claimed by the applicant. 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)". 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 and 12-13 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), Sui (CN 114874344 A – English translation provided), Zhang (CN 102919648 A – English translation provided), Qiu (CN 111892666 A - English translation provided), Xie (CN 111096404 A – English translation provided) as applied to claim(s) 1, 3-4, 6-11 and 16-17 above, and further in view of Kanauchi (U.S. Pub. No. US 2011/0262571 A1).
The teachings of Jensen, Zeng et al, Sui, Zhang, Qiu and Xie are above.
Jensen does not teach that the immunodeficiency-related symptoms comprise listlessness, gastrointestinal discomfort, split lip, cough, headache, or any combination thereof (as stated within claim(s) 12-13 of the present invention).
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).
One of ordinary skill in the art would have made the combination of the aforementioned references 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) which falls under gastrointestinal discomfort, which is part of immunodeficiency-related symptoms that are equally treated when regulating immunity on a broader 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.
Response to Arguments
Applicants’ arguments filed August 07, 2026 have been fully considered and the arguments regarding the rejection under 35 USC § 103 for obviousness are found to be non-persuasive.
Regarding applicants’ remarks for the rejection under 35 USC § 103 wherein the combination of references used does not teach “the amylase concentration of 0.3% (w/v) to 0.7% (w/v) in the amylase aqueous solution” (as stated on page 6 of applicants’ arguments). A newly added reference, namely Xie, does teach 0.3% of α-amylase (which is within the range provided within claim 1 of the present invention) in combination with the remainder of the aforementioned references in order to meet the claim limitations of the present invention. In addition, the Jensen reference does teach an aqueous extract using hulless barley and Jensen combined with the remaining aforementioned references, namely Sui, Zeng et al, Zhang, Qiu, Kanauchi and Xie incorporated various methods of extraction that can be incorporated into Jensen that can meet the claim limitations of the present invention. Moving towards page 7 of applicant arguments, applicant states: “As clearly analyzed above, all the cited references significantly differ from the present application in terms of the process sequence (e.g., Qiu and Sui perform extraction first before adding amylase) or enzyme type (e.g., Qiu uses lipase and pectinase for extraction). More importantly, among the cited references that do mention amylase, the disclosed concentrations are either far too low (e.g., 0.02-0.05% in Qiu), far too high (e.g., 2.0% in Kanauchi), or defined by entirely different units of measurement (e.g., 200 U/g in Zhang, 2-3 g/kg in Jensen). That is to say, there is no teaching or suggestion in any single reference, or in any combination thereof, to use an amylase aqueous solution specifically having a concentration of "0.3% (w/v) to 0.7% (w/v)" for the direct high-temperature extraction of seeds. This specific process parameter is a critical distinguishing feature that enables the claimed invention to achieve the unexpected and superior immune-regulating efficacies demonstrated in Examples 3-5 of the original disclosure.” In addition, applicant goes from page 7 into page 8 of applicant arguments discussing examples from the disclosure of the present invention namely, examples 1-5, discussing the superiority of the black hulless barley versus the white hulless barley and the associated differences in efficacy of the black hulless barley extract when discussing immune-related functions. Moreover, going towards the bottom of page 8 and into page 9 of applicant arguments, applicant discusses Qiu, more specifically discussing Qiu’s extraction temperatures of 70oC and 90oC and β-glucan yielding rates. In addition, on page 9 of applicant arguments, applicant states: “For one skilled in the art, there would have been no motivation or scientific logic to reasonably deduce that decreasing the temperature to 80°C-89°C would result in a significant increase in ß-glucan extraction rate. Even if one were to hypothesize that "lowering the temperature to 80°C-89°C can increase ß-glucan," such an assumption must be supported by experimental data or objective literature. In other words, the Examiner's assertion constitutes a "Speculation / Unsupported Assertion." A rejection must be based on specific teachings of the prior art or objective literature, rather than the Examiner's subjective speculation or hindsight derived from the present application. Without the addition of specific enzymes, one skilled in the art would have reasonably expected that at temperatures between 70°C and 90°C (including the 80°C-89°C range speculated in the Final Action), the extraction rate of ß-glucan would remain at a very low level of about 0.7% to 0.8% due to severe starch gelatinization, and would never have baselessly speculated that the ß- glucan extraction rate would exhibit a "reputable increase and be far above 0.8%." The ß-glucan extraction rate obtained under the 90°C process conditions in Qiu is practically negligible. Without further concentration or purification, it is hard for a subject to reach an "effective dose" from a reasonable intake volume. In other words, for one skilled in the art, directly equating the mere "presence" of trace components with "immune efficacy" is an inference lacking objective scientific evidence. When conducting experiments to achieve a specific efficacy, one skilled in the art would not have adopted such high temperatures, but would instead been directed to choose a lower temperature, such as the 50°C used in Comparative Example 1 of Qiu. Taking a step back, even if the Examiner were to insist that "the presence of trace ß-glucan provides a baseline immune efficacy," the NK cell killing experimental data of the original disclosure would clearly overcome such assertion. Referring to Example 5 and FIG. 4 of the original disclosure of the present application (as reproduced below), the regular hulless barley extract, which also contains ß-glucan, only increased the NK cell killing ability to 87.20% as compared to the control group; however, the black hulless barley extract of the claimed invention significantly boosted the killing ability to 111.82% (page 9 of applicant arguments) …. As discussed above, none of the cited references, individually or in combination, disclose or teach the specific technical features of the claimed black hulless barley extract, which is obtained from seeds of black hulless barley extracted at 80°C to 100°C for 50 min to 70 min with an amylase aqueous solution having a concentration of amylase being 0.3% (w/v) to 0.7% (w/v), and that the claimed black hulless barley extract possesses the functional ability of relieving allergic reactions, such as allergic asthma, food allergy, and skin allergy (page 10 of applicant arguments).” From pages 10-13 of applicant arguments, applicant discusses each of the references used by examiner namely, Jensen, Zeng et al, Sui, Qiu, Kanauchi and Zhang and why the arts presented are insufficient when used to reject the amended claims of the present invention. Furthermore, pages 14-15 of applicants’ arguments goes into detail of the examples from the present disclosure regarding the enhanced gene effects from black hulless barley extract along with improved cytotoxic activity of natural killer (NK) cells and discusses the allergy effects of the extract. Addressing all of applicants’ remarks, based on the new 35 USC § 103 rejection above, a newly added reference, Xie, was added in order to address prior teaching deficiencies from the other prior arts used and to address the claim amendments. Given that the independent claim, claim 1 of the present invention uses the word “comprising”, the term “comprising” is an open-ended term and therefore any other additional ingredients or method steps used to obtain the extract can vary, as long as what is taught in the references can render the claims of the present invention obvious by one skilled in the art. Moreover, hulless barley is the actual seed and therefore, any teachings that only discusses “hulless barley” is no different than “seeds of hulless barley”; and also, although the combination of the aforementioned references teach a different color of hulless barley, the hulless barley as a whole, regardless of color will naturally possess immune-regulating effects as long as the hulless barley is subject to the appropriate extraction and uses the exogenous enzyme, α-amylase that is present within the solution at a specified concentration in order to help break down complex starches to achieve components necessary to get the intended effects (at the gene level first which would affect other areas of the body afterwards) within a subject in need. Finally, based on what applicant argues in regard to the differences between black hulless barley and white hulless barley on the cell killing ability of NK cells percentage wise (page 8 of applicant arguments), what is being argued is not commensurate in scope; in other words, what is being argued is more specific than what is claimed within the amended claims of the present invention. Therefore, based on the synonymous terms applicant provided within the specification namely “hulless barley, naked barley, highland barley, pearl barley, Hordeum vulgare L. var. nudum Hook f.” (pgs. 1-2 of the specification of the present invention) combined with other search terms examiner found and searched, the extract of hulless barley, has been shown and proven to have immune-modulating effects when combined with an exogenous enzyme like α-amylase. Furthermore, it is also important to note that although some of the cited references or each of the cited references may teach a different intended use or objective of that specific invention, that does not mean that the composition that contains barley or hulless barley would have that one or specific isolated effects; what it means is that the inventor of that invention decided to focus on particular intended effect(s) but that does not mean that barley or hulless barley cannot have additional effects outside what has been stated by the applicant of that invention. Lastly, it is well-known in the art that barley, in general, possess a number of compounds, especially compounds dedicated towards immune regulating capabilities that would also be present within hulless barley; the difference between barley and hulless barley is how they are both processed and therefore would allow both types to maintain their superior function in helping to regulate immunity.
Thus, based on applicants’ claim amendments and examiners’ additional art, the combination of the aforementioned references effectively overcome the presented amended claims of the present invention and therefore, the 35 USC § 103 rejection for obviousness is proper.
No claim(s) are allowed.
Conclusion
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.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
