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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the limitation “and/or” in line 3 renders the claim indefinite since line 2 recites “or”, and therefore it is unclear if the consumable product must require only one of the alternatives (i.e., “or”) or can include both (i.e., “and/or”). The rejection can be overcome by amending either limitation to be consistent with the other.
In line 6 the limitation “ASP Units” renders the claim indefinite since it is unclear how the limitation is distinguished from “antisecretory protein and/or fragments thereof” as recited in line 5. Applicant discloses “ASP” refers to “antisecretory protein” (page 12 lines 9-10), but appears to refer to ASP in the body of the specification to be “antisecretory protein and/or fragments thereof” (page 19 lines 14-23). The disclosure appears to indicate that the above limitations refer to the same substance. It is unclear if “antisecretory protein and/or fragments thereof” and “ASP Units” are actually different substances, and thus unclear if both limitations can exist simultaneously as required by the recitation of “and/or” separating the two alternatives.
Claims 10-12 are rejected by virtue of their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over von Rege et al. (US 2014/0227390 A1), hereon referred to as “Rege”, in view of Collins et al. (US 10,334,869 B2). Klose et al. “Fundamental study on protein changes taking place during malting of oats” is relied on as evidence for claim 7.
Regarding claim 1, Rege teaches a method of steeping and malting grains such as oats (abstract), where the oats can be dehulled (paragraph 24), comprising wet steeping of the dehulled oat kernels at a temperature from 5°C to 20°C (paragraphs 32-33), germinating of said dehulled oat kernels at a temperature from 5°C to 30°C (paragraph 52), and subsequently kilning (drying) said dehulled oat kernels (paragraph 47), where kilning is known to be first performed at a temperature of 40-60oC then at 60-105oC (paragraph 7).
Rege does not teach germination at 5-20oC and drying at no more than 80oC.
However, it would have been obvious to one of ordinary skill at the time of the invention to modify the process of Rege to germinate that the claimed temperature and to dry at no more than 80oC since the reference teaches germination temperature can be varied based on desired qualities of the final malt, germinating duration, metabolic activation and enzyme development (paragraph 6) and drying temperature is based on desired final moisture content and duration (paragraph 7), since the prior art recognizes temperature ranges overlapping those of the claimed ranges, since there is no evidence of criticality or unexpected results associated with the claimed ranges, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to the factors stated above, as well as ensuring against unintentional burning and/or destruction of desired components within the germinated oats.
Rege does not teach the malted germinated oats comprise avenanthramide D at a concentration which is at least 100% higher than that in non-malted dehulled oats.
Collins et al. teaches malted oats having increased levels of avenanthramides (abstract), the oats being dehulled or hulless (column 3 lines 48-52). Oats are recognized to synthesize and store avenanthramides, including avenanthramide D (figure 2; column 1 lines 10-17). Avenanthramides have been shown to exhibit anti-oxidant, -irritant, -itch, -inflammatory, and cancer activities (column 1 lines 18-20 and 45-49). It has been shown that the total amount of avenanthramides increased 150% during a 48 hours germination period, and increase in total avenanthramide levels was time and temperature dependent (column 2 lines 38-40 and 43-45). In example 1, non-dormant, hulless oats were steeped and germinated, resulting in a total avenanthramides increase of 530% (column 9 lines 11-15 and 24-30; table 1 “non-dormant” oat type).
Further, Applicant’s specification states that the wet steeping is performed at 5-20oC (page 18 lines 3-4) with alternating dry conditions at temperatures of 5-15oC for 1-3 days and a moisture content between 30-50% (page 16 lines 35-40).
Rege teaches steeping is performed for up to about 24 hours (paragraph 32) at a temperature of e.g., 14.5oC (paragraph 33), where the steeping step is repeated multiple times while aerated between each steeping (paragraph 34). The process hydrates the endosperm mass and activates the metabolic processes of the grain (paragraph 26).
While the increase in avenanthramide D concentration is not explicitly disclosed by the cited references, the substance is recognized to be a naturally occurring substance in oats. The prior art also recognizes that overall avenanthramide concentration desirably increases during malting and germination, where the increase in total avenanthramide levels is time and temperature dependent. Based on said findings, one of ordinary skill would have reasonably expected the concentration of any particular naturally-occurring avenanthramide to increase along with the other avenanthramides during the malting and germination process.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Rege to optimize the malting and germination process for avenanthramide production such that avenanthramide D is increased by at least 100% since avenanthramides as a group of substances are recognized to be beneficial, and therefore maximize the production thereof to similarly maximize the beneficial effects when consumed and/or increase extractable avenanthramide content, since the prior art process used to obtain malted germinated dehulled oats appears to be the same as that of the claimed product-by-process, since there is no evidence of criticality or unexpected results associated with the claimed features and ranges, and since the claimed increase in concentration would have been observed during the course of routine experimentation and optimization procedures due to factors such as temperature and duration of steeping and germinating.
It is noted that the method of Rege is not modified with the “false malting” (i.e., without germination) process of Collins et al. Rather, Collins et al. is relied on to show that the prior art recognizes malting and germination of non-dormant oats causes a desirable increase in avenanthramides, where time and temperature are the result-effective parameters for obtaining a desired increase in avenanthramide concentration.
Regarding claim 2, Rege teaches steeping for about 24 hours at a temperature of e.g., about 14.5oC (paragraphs 32-33) and repeating for a desired number of times (paragraph 34).
Regarding claims 3-4, Rege teaches germinating at 5-30oC for 7 days (paragraph 52), but does not specify 12-15oC for 5-9 days and 5-15oC.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Rege to germinate at the claimed temperatures and durations for the same reasons stated for claim 1, particularly since there is no evidence of criticality or unexpected results associated with the claimed ranges, since germination temperature can be varied based on desired qualities of the final malt, germinating duration, metabolic activation and enzyme development as taught by Rege, and to increase the amount of avenanthramides produced as taught by Collins et al.
Regarding claim 6, the claim recites alternatives (i)-(v). For the sake of examination, alternative (i) “avenanthramide A” is chosen. Thus, the remaining alternatives are construed to not be required.
Collins et al. teaches avenanthramide A concentration increases during malting (tables 5-6). Therefore, absent persuasive evidence to the contrary, one of ordinary skill in the art would have expected the malted dehulled oats of Rege to similarly comprise increased avenanthramide A concentration as compared to non-malted dehulled oats.
Regarding claim 7, the claim recites alternatives, where “L-tryptophan” is chosen for examination. Thus, the remaining alternatives are construed to not be required.
Klose et al. is relied on as evidence to show that malting oat causes storage proteins to be degraded into small peptides and amino acids (abstract). All free amino acids in oats and total amino acids are increased after the malting process (page 86 sections 3.4.1. and 3.4.2.; page 89 tables 1-2).
Collins et al. also recognizes that malting leads to breakdown of protein and increased availability of amino acids (column 2 lines 32-35). Therefore, absent persuasive evidence to the contrary, one of ordinary skill in the art would have expected the malted dehulled oats of Rege to similarly comprise increased L-tryptophan concentration as compared to non-malted dehulled oats.
Regarding claim 8, the alternative “L-tryptophan” was chosen for examination as stated in claim 7. Since the limitation “guaiacol or a derivative thereof” is construed to not be required by the claim, the limitation of claim 8 is similarly interpreted to not be required.
Regarding claim 20, Rege teaches a method of malting dehulled oats to obtain germinated dehulled oats. Collins et al. teaches avenanthramides provide desirable benefits, where malting and germinating dehulled oats increases total avenanthramide content by more than 100%, and the increase in total avenanthramide content during malting is time and temperature dependent. The prior art combination applied to claim 1 teaches Applicant’s method for obtaining the claimed product, and modification of the malting process to maximize total avenanthramide concentration (including avenanthramide D) would have been obvious for the same reasons stated for claim 1
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rege in view of Collins et al. as applied to claim 1 above, and further in view of Chu et al. (US 2016/0095335 A1).
Regarding claim 9, Rege teaches the treated cereal grain (malted dehulled oats) can be used in any contemporary food and beverage applications (paragraph 47), but does not teach the consumable product comprises malted dehulled oats in an amount sufficient to increase antisecretory protein and/or fragments thereof in a subject’s blood to at least about 1 unit/ml. It is noted that the specification appears to indicate the increased endogenous production of AF protein and/or fragments thereof is related to avenanthramide D concentration (page 8 lines 9-12), where one ASP unit corresponds “approximately to 1.5 nM AF protein per liter plasma” (page 12 lines 17-19).
Chu et al. teaches that avenanthramides are known to have antioxidant, anti-inflammatory and anti-atherosclerotic properties (paragraph 4), and a sufficient amount of avenanthramide must be taken in order to benefit human health, where it has been shown that oral ingestion of 60-120 mg avenanthramides results in maximum total plasma avenanthramide concentrations of 168-560 nM (paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to form a consumable product including the malted dehulled oats of Rege in sufficient amounts to increase antisecretory protein and/or fragments thereof in a subject’s blood to at least about 1 unit/ml since avenanthramides are understood to provide health benefits in sufficient quantities, and therefore to provide enough avenanthramides to affect the consuming individual’s health, since there is no evidence of criticality or unexpected results associated with the claimed features, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as flavor, texture, nutritional profile, characteristics of the consumer, avenanthramide potency and desired effect.
Regarding claim 10, the claim is interpreted to recite alternative forms of the consumable product. For the sake of examination, the alternative “a food” is chosen. Rege teaches using the malted germinated dehulled oats is used in foods as stated for claim 9.
Regarding claim 11, Rege teaches the malted germinated dehulled oats is used in a food product as stated for claim 9, and the food would have necessarily been a liquid, a solid, or a combination thereof.
Regarding claim 12, the claim recites alternatives. For the sake of examination, the alternative “anti-inflammatory properties” is chosen.
Chu et al. teaches avenanthramides are known to have anti-inflammatory properties as stated for claim 9. The same combination is applied to claim 12 and would have been obvious for the same reasons.
Response to Arguments
Applicant’s arguments, see page 9, filed 9/2/2025, with respect to the rejection of claim 1 under 35 USC 102(a)(1) have been fully considered and are persuasive since Collins et al. teaches away from germination. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Rege.
Rege teaches malting and germination of cereal grains, where the grains include oats, and the process comprises steeping, germinating, and drying the dehulled oats at temperatures within, overlapping, and/or encompassing the claimed ranges. Collins et al. is no longer relied on to teach the process applied to the oats. While Examiner acknowledges that Collins et al. teaches away from germination with respect to the inventive feature of “false malting”, the reference still teaches that malted germinated dehulled oats exhibit total avenanthramide increase greater than 100% as compared to non-malted oats, where increase in total avenanthramide levels was time and temperature dependent (column 2 lines 38-40 and 43-45; column 9 lines 11-15 and 24-30; table 1 “non-dormant” oat type). Absent persuasive evidence to the contrary, one of ordinary skill would have expected a similar increase of total avenanthramides (including avenanthramide D) in the malted germinated dehulled oats of Rege.
Applicant’s argument against Chu and the dependent claims have been considered but the instant combination applied to claim 1 teaches the features as explained above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
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, Erik Kashnikow can be reached on (571)-270-3475. 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.
/BRYAN KIM/Examiner, Art Unit 1792