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 .
Drawings
The drawings are objected to because the Y-axis values of the graphs in figures 9-13 are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (page 29 line 4). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 lines 1-2 recite “comprising malted germinated dehulled oats according to claim 1 or a leachate of said malted germinated dehulled oats”, and therefore it is unclear which limitation should be followed for claim interpretation. It is unclear if the limitations “malted germinated dehulled oats” and “a leachate of said…oats” should be interpreted as only alternatives (i.e., “or” as recited in line 2), or as either a group or as alternatives (i.e., “and/or” as recited in line 3). The rejection can be overcome by amending “and/or” in line 3 to “or” for consistency with line 2, or vice versa.
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 range 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 the evidence of record does not indicate criticality of 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 naturally occurring in oats. The prior art also recognizes that overall avenanthramide concentration desirably increases during malting and germination, where the increase in total avenanthramide level 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. There is no evidence of record that indicates avenanthramide D content does not increase with total avenanthramides.
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 the evidence of record does not indicate criticality of 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 (claim 3) and 5-15oC (claim 4).
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 the evidence of record does not indicate criticality of the claimed features and 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 be not 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 the evidence of record does not indicate criticality of the claimed features and ranges, 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
The amendment to claim 9 overcomes the rejection under 35 USC 112(b) with respect to “ASP units”. However, amendment removing “and/or” does not address the issue raised in the previous Office Action since the “and/or” referred to in the rejection is that of line 3 (i.e., “said malted germinated dehulled oats and/or the leachate of…”). The rejection of claim 9 and dependent claims 10-12 is maintained.
Applicant's arguments filed 4/29/2026 have been fully considered but they are not persuasive.
Applicant argues on page 7 that a skilled person would not have known which parameters to adjust in order to achieve the desired final content of avenanthramides, and in particular avenanthramide D (hereon “AVD) in dehulled oats, AVD was neither measured nor recognized as being of particular interest prior to the present invention, Examiner states AVD belongs to the avenanthramide group and can therefore be equated to those described by Collins, Examiner acknowledges Collins only describes “pseudo-malting” but still considers it reasonable to conclude that a skilled person reading Collins would be motivated to modify Rege’s process to achieve Collin’s results, and therefore relies on hindsight, and argues Rege does not single out oats or dehulled oats as anything other than an alternative cereal in a long list of possible cereals.
This is not persuasive since Rege teaches germination temperature can be varied based on desired qualities of the final malt, germinating duration, metabolic activation, and enzyme development (paragraph 6), and Collins teaches total avenanthramides increased 150% during a 48-hour germination period, where the increase in total avenanthramide level was time and temperature dependent (column 2 lines 38-40 and 43-45). This suggests to one of ordinary skill in the art that at least germination time and temperature can be optimized for avenanthramide production in oats.
Regarding AVD specifically, Collins teaches AVD is naturally occurring in oats (figure 2; column 8 lines 35-39), where steeping and germinating hulless oats results in a total avenanthramide increase of 530% (column 9 lines 11-15 and 24-30; table 1). While the increase of AVD content is not explicitly disclosed, the cited prior art suggests to one of ordinary skill that AVD content would have increased similarly during germination. Since parameters such as gemmation time and temperature are recognized to facilitate increased total avenanthramide content, one of ordinary skill in the art would have optimized germination conditions to obtain a desired increase in said total avenanthramide content (e.g., by 530% as taught by Collins). Absent evidence to the contrary, it would have been reasonable to expect the concentration of AVD to increase in a similar manner, to an amount that is at least 100% higher than non-malted dehulled oats as claimed.
Regarding Collins describing “pseudo-malting”, Examiner acknowledges the reference is directed to malting without germination. However, the “pseudo-malting” of Collins is not relied on, and the reference is instead cited to show the prior art recognizes known processes that desirably increase total avenanthramide content by more than 100%, said processes including germination with controlled temperature and duration as explained above. One of ordinary skill in the art would have been motivated to modify the process of Rege with the teachings of Collins for the reasons explained in the rejection of claim 1. MPEP 2123 I.-II. recite the following:
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)
“Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Regarding Rege teaching oats as a cereal alternative among a long list of alternatives, the argument is not persuasive for the same reasons stated above. Specifically, the reference nonetheless teaches applying the disclosed process to an embodiment comprising oats (see also claim 5). Further, Collins explicitly teaches oats with respect to avenanthramide content.
Applicant argues on page 7 Rege teaches steeping the cereals in a chlorine dioxide solution, where a skilled artisan would understand that chlorine dioxide is a chemically active component and would not assume that it could be successfully replaced with water, and Rege does not teach malting at 5-20oC and drying at a maximum of 80oC, and malting without a chlorine dioxide containing solution.
This is not persuasive since the claim as currently drafted does not exclude a chlorine dioxide solution. Rege teaches the solution consists essentially of chlorine dioxide and water (paragraph 12). Applicant’s definition of “wet steeping” only requires the oats to be partially or entirely soaked with water (page 17 lines 4-6), and does not exclude chlorine dioxide. Therefore, soaking with the chlorine dioxide solution of Rege reads on the claimed “wet steeping”.
Regarding the argument against the malting and drying temperatures, the term “malting” is construed to refer to the “germinating” of step c in claim 1. Rege teaches germinating and drying at temperature ranges that overlap the respective claimed ranges as stated for claim 1. The reference suggests optimization of germination temperature and duration, as well as drying temperature and duration (paragraphs 6-7). This is particularly in view of the fact that the data provided in the specification does not indicate criticality associated with the claimed ranges.
Applicant argues on page 8 that Rege does not teach measuring or intending to alter the avenanthramide content of the oats, and is instead directed to pre-treatment of cereals with antimicrobial agents before and during malting. Therefore, one of ordinary skill starting with Rege would not be able to achieve the result of Collins, nor the claimed invention, unless using the new process parameters of the presently claimed invention, and the process taught by Rege will not give rise to the enhanced production of avenanthramides in oats or in de-hulled oats.
This is not persuasive since the prior art recognizes avenanthramides are desirable and the total avenanthramide content is increased during germination of oats as taught by Collins. Thus, process of Rege is recognized to increase avenanthramide content in oats regardless of whether or not the avenanthramide content is measured and altered. Further, 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. The process of Rege appears to be the same as that of the claimed process with the exception of Applicant’s lower claimed germination and maximum drying temperatures. However, the claimed ranges are rendered obvious via routine experimentation and optimization for increasing total avenanthramides as taught by Collins. The evidence of record is not sufficient to establish criticality of the claimed ranges since the data of examples 1 and 2 (pages 25-28) and figure 13c (AVD content) are not commensurate in scope with said ranges, see also MPEP 716.02(d) II.
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 BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
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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.
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/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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