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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/390752, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant application was filed 07/19/2023 and claims priority under 119(e) to provisional application 63/390,752 filed 07/20/22. Claims 1, 2, 4, 10-17 and newly added claim 20 are not given the benefit of the priority date of the provisional application because the claimed subject matter is not provided in the provisional and does not comply with the requirements of 35 U.S.C. 112(a).
Specifically, the provisional states that the heat shock step may take place in any suitable apparatus in which temperature and humidity may be controlled (page 10) and that the heat shock process comprises subjecting the steeped seeds to a temperature greater than the temperature during the steeping process and lower than about 43C for a period of time ranging from about 0.5 hours to about 12 hours. However, instant claim 1 requires the heat shock step be performed using conductive heating, using conductive heating with a temperature in a range of about 10-30C for a period of about 1-24 hours. The provisional apparatus provides no support for the use of conductive heating. Each of the noted claims include subject matter that is not supported by the provisional application.
Accordingly, claims 1, 2, 4, 10-17 and newly added claim 20 are not entitled to the benefit of the prior application and are considered to have an effective filing date of 07/19/2023.
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.
Claim 2 is 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.
Claim 2 requires the grains are selected from oats, barley, and mixtures thereof. Applicant’s instant specification states that “unless specifically or explicitly noted otherwise, a mention or reference to oat or oats should be understood to likewise refer to other grains, and particularly to barley”. This is cited in [0007] of the instant specification which also states “[w]hen describing grains, it is meant to be inclusive of cereal and other grains, including, but not limited to, oats, barley, rice, sorghum, maize, millet, wheat, rye…”. Thus, based upon applicant’s disclosure, the citation of “oats” is seen to include other grains such as those listed. It is not clear whether claim 2 is limited to oats and barley only or if it is inclusive of other grains as indicated in [0007] of the instant specification.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 essentially repeats the last line of claim 1 as amended. While claim 15 refers to “one or more bio-actives that is at least about 120% greater than the same one or more bio-actives” and claim 1 specifies bioactives as bio-active compounds of GABA and AVA, there are no other bio-active compounds referenced in the claims or the specification such that claim 15 would provide a scope that is further narrow than claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Abernethy, “Thermotolerance Is Developmentally Dependent in Germinating Wheat Seed”, Plant Physiology, 1989 in view of US 2016/0205951 (Christiansen).
Regarding claims 1 and 15, Abernethy discloses imbibing (steeping) wheat seed followed by a heat shock. Specifically, the seeds were imbibed at 25C for various length of time up to 16 hours (page 570). A heat temperature treatment regime is employed after the imbibition time comprising (c) 2hrs at 42C, and 2 hrs at 51C with a 1hr at 25C therebetween (page 571, Table 1, treatment c 42-51C for 3, 6, 9, 12 and 16 hrs imbibing times). Table 1 describes that a treatment of 42C for 2 hours, 1hr at 25C and, and 2 hrs at 51C resulted in thermotolerance when combined with an imbibing time of 12hrs to 16 hours. In other words, when imbibed at 25C for 12-16 hours, a protective effect was observed when the seeds had a combined heat treatment of 4 hours in a range of 42-51C. The instant claims require a heat treatment in a range of about 42C to about 50C which is seen to be met by 42-51C considering that “about” encompasses degrees above and below the claimed precise value. Thus, the disclosure of heating at 42C is within the claimed range and 51C is considered to be “about 50”. Moreover, slight variations in temperature are to be expected and 50C and 51C are considered so close as to not be patentably distinct (MPEP 2144.05).
Abernethy also discloses germination after heat shock by placing the seeds between two layers of germination toweling for 120- or 123-hour growth period at 25C.
Abernethy discloses the steps of loading the grains into a steeping apparatus (the step of imbibing must inherently use an apparatus), steeping (imbibing) the grains within the time and temperature claimed, and removing the grains from the apparatus (see “Germination Temperature Tolerance” on page 570 which described moving the seeds to a chamber for the heat shock), and the step of heat shocking the grains at a temperature of about 42C-about 50C. The disclosure of 51C is considered to meet the “about 50C” and Abernethy also discloses 48 and 50C as noted above. Finally, Abernethy discloses germination at a temperature lower than the heat shock temperature for a period of time to germinate the seeds (growth period).
Abernethy does not specifically teach kilning the grains in order to lower the moisture content after germination.
Christiansen teaches processing grains by steeping and germinating the grains and finally kilning with controlled air circulation at a temperature ranging from at least about 49C to about 93C for less than 20 hours to a moisture content of about 7-16% (abstract). After kilning, the malt (grain) is ready to be sent to a mill for further processing [0006] to produce flour. It would have been obvious to one of ordinary skill to kiln the germinated grain of Abernethy in order to reduce the moisture content thereof as taught by Christiansen and make the grain ready for further processing such as milling. Christiansen also states that knowledge of kiln operation allows the controller to optimize surface moisture removal, moisture content and grain temperature to meet product specification [0029]. Thus, one of ordinary skill in the art is expected to be well appraised of kiln operation for grain processing as well as use of milling to form grains into flour for use.
Regarding the limitation “for increasing the concentration of one or more bio-active compounds selected from GABA and/or AVA” and “at least 120% greater than the same one or more bio-active compounds in raw unprocessed grain seeds”, this limitation is taken as an intended outcome of the method steps. The combination of Abernethy and Christiansen obviate the claimed steps, thus an increase in bioactives is reasonably expected and since the steps performed by Abernathy as modified by Christiansen encompass the limitations and scope of the claims, one of ordinary skill would reasonably expect a similar outcome of increased GABA or ABA. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (MPEP 2145II). As the claimed method steps are obviated and the time and temperatures are disclosed regarding steeping, and heat shock as discussed above, followed by germination at a temperature within the claimed range, one of ordinary skill would reasonably expect the same outcome of increasing the claimed bio-active materials absent a showing otherwise. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 10, as noted above, germination proceeds at 25C.
Regarding claim 14, Christiansen discloses that the grains may be further milled to produce flour [0007]. Depending upon the intended use of the grain, it would have been obvious to one of ordinary skill to further mill the processed grain of Abernethy as disclosed by Christiansen.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Abernethy, “Thermotolerance Is Developmentally Dependent in Germinating Wheat Seed”, Plant Physiology, 1989 in view of US 2016/0205951 (Christiansen) as applied to claim 1 above, and further in view of Pompelli, “Imbibition and Germination of Seeds with Economic and Ecological Interest: Physical and Biochemical Factors Involved”, Sustainability, 03/17/2023.
Abernethy discloses imbibing the seeds as discussed above, which is understood to be with water, but does not specifically disclose the water itself. Pompelli discloses seed imbibition using deionized water (2.2). It would have been obvious to one of ordinary skill to use deionized water as described by Pompelli in the imbibing process of Abernethy with a reasonable expectation of successfully imbibing the seeds prior to heat shock. The pH of deionized water is considered to be “about 7.0” as is widely known.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Abernethy, “Thermotolerance Is Developmentally Dependent in Germinating Wheat Seed”, Plant Physiology, 1989 in view of US 2016/0205951 (Christiansen) as applied to claim 1 above, and further in view of US 2007/0141216 (Kihara).
Abernethy discloses a germination as discussed above but does not disclose a period of time for germination of 18-96 hours. Kihara discloses processing wheat, barley, oats and rye where germination is performed and notes that the amino acid contents vary depending upon the length of time of germination. Kihara states that therefore, it is possible that any targeted free amino acid content in malts can be increased due to the termination of the germination at the appropriate days of germinated seeds [0079]. Kihara gives examples where leucine and glutamine have maximum contents at 2 days and GABA is increased at 1-3 days. Thus, one of ordinary skill would have found it obvious to vary the germination time in Abernethy to obtain a product having an increased amount of any desired amino acid as explained by Kihara.
Regarding claim 2, Abernethy does not disclose oats or barley in addition to wheat. Kihara discloses processing wheat, barley, oats and rye by soaking, heating and germinating in a manner similar to Abernethy. One of ordinary skill would have found it obvious to use other grains such as oats and barley in the process of Abernethy as Kihara discloses beneficial outcomes (increasing GABA and beta-glucan) by a similar treatment. Moreover, Kihara recognizes that a heat treatment at 55C produced the highest GABA, leucine and glutamine contents [0098].
Claims 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Abernethy, “Thermotolerance Is Developmentally Dependent in Germinating Wheat Seed”, Plant Physiology, 1989 in view of US 2016/0205951 (Christiansen) and further in view of Krapf, “Sprouting of oats: A new approach to quantify compositional changes”, Cereals and Grains Association, 2018 (cited on IDS filed 07/19/2023).
Abernethy and Christiansen are relied upon above but do not specifically limit initiating kilning when a size of a radicle (root) is no more than 90% of a size of the seed. Krapf discloses a comparison of sprouted oats and analyzes lengths of radicles as related to grain properties. As shown in Figure 1 and discussed on page 998, Degrees 0-4 fall within the claimed range and Degree 5 falls outside the claimed range (coleoptile is longer than a full grain). Figure 6 shows a relationship between the degree of sprouting and the amounts of beta-glucan, vitamin C, alpha-amylase and reducing sugars. Thus, depending upon the desired amounts of each of these materials, one of ordinary skill can determine the degree of sprouting and when to begin kilning. In other words, since kilning arrests germination, and one of ordinary skill is informed as to the fact that the degree of sprouting is associated with the content of certain bio-actives, the skilled artisan can readily decide at what point to cease germination (i.e. initiate kilning). One of ordinary skill desiring to balance the beta-glucan and other bio-actives, would look to Krapf and reasonably determine that kilning should begin at Degree 3 or 4.
Regarding claim 13, Christiansen teaches kilning with controlled air circulation at a temperature ranging from at least about 49C to about 93C for less than 20 hours to a moisture content of about 7-16%, which overlaps the claimed range renders the claimed range of between about 2-12% prima facie obvious.
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Abernethy, “Thermotolerance Is Developmentally Dependent in Germinating Wheat Seed”, Plant Physiology, 1989 in view of US 2016/0205951 (Christiansen) and US 2007/0141216 (Kihara) and further in view of Krapf, “Sprouting of oats: A new approach to quantify compositional changes”, Cereals and Grains Association, 2018 (cited on IDS filed 07/19/2023) and of Pompelli, “Imbibition and Germination of Seeds with Economic and Ecological Interest: Physical and Biochemical Factors Involved”, Sustainability, 03/17/2023.
As noted above, the time period for germination is obviated by Abernethy, Christiansen and Kihara and the pH of the aqueous solution for steeping is obviated by Pompelli. However, these references do not limit initiating kilning when a size of a radicle (root) is no more than 90% of a size of the seed. Krapf discloses a comparison of sprouted oats and analyzes lengths of radicles as related to grain properties. As shown in Figure 1 and discussed on page 998, Degrees 0-4 fall within the claimed range and Degree 5 falls outside the claimed range (coleoptile is longer than a full grain). Figure 6 shows a relationship between the degree of sprouting and the amounts of beta-glucan, vitamin C, alpha-amylase and reducing sugars. Thus, depending upon the desired amounts of each of these materials, one of ordinary skill can determine the degree of sprouting and when to begin kilning. In other words, since kilning arrests germination, and one of ordinary skill is informed as to the fact that the degree of sprouting is associated with the content of certain bio-actives, the skilled artisan can readily decide at what point to cease germination (i.e. initiate kilning). One of ordinary skill desiring to balance the beta-glucan and other bio-actives, would look to Krapf and reasonably determine that kilning should begin at Degree 3 or 4.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant argues that while Abernathy discloses that even at 2 hours of heat shock (HS) at 51C which can be addressed by providing a pre-treatment at 38-42C for 2 hours, this contradicts the assertion that it would have been obvious to perform the heating for a period of 2 hours. Applicant states that Abernathy’s teaching that at 2 hours HS at 51C a variation in seed survival occurs, thus extending the time to 4 hours would lead to a greater variation in seed survival. Applicant states that Abernathy’s further testing of HS at 52C for 2 hours led to a germination rate of only 16%, thus it would not have been obvious to increase the time of heating at 51C from 2 to 4 hours. Finally, applicant argues there is nothing in Abernathy that informs the skilled artisan that the described imbibition and HS would have any effect on GABA and/or AVA.
As explained above and in applicant’s remarks, Abernathy observes that the combination of 2 hrs of HS at 51C and pretreatment at 38-42C for 2 hrs (with 42C exemplified in Table 1), and imbibing at 12-16 hours (ie. Steeping from 9-16 hrs), resulted in thermotolerance defined as an increase in germination percentage of treatment (c) over that of treatment (b) (Table 1). The cumulative treatment of 4 hours at a range of 42-51C is seen to obviate the claimed step of “subjecting the steeped grain seeds to a heat shock step by subjecting the steeped seeds to conductive heating at a temperature in a range of about 42C to about 50C for a period of time between about 4 hours and 9 hours to provide heat-shocked seeds. The claims do not require a single step for the heating and the provision of 1 hr at 25C is not seen to negate the disclosure of 4 hours heating in the claimed range. The outcome of increased GABA and/or AVA would be reasonably expected due to the elevated temperatures for the prescribed time.
Regarding applicant’s argument that Abernathy does not disclose any effect on GABA and/or AVA is not persuasive as "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (MPEP 2145II).
Regarding Kihara, applicant argues that Abernathy and Kihara only share the step of imbibing of seeds and does not hint at the HS step. Applicant further argues that Kihara’s imbibition step differs from Abernathy and cannot be concluded that these processes are similar. It is acknowledged that there are some differences in the specific times and temperatures. Kihara is relied upon to show that oats are treated in a similar manner such that wheat, barley, oats and rye are known to be processed in a similar manner to target GABA or other free amino acids and that the treatment requires soaking, and germinating which are the same steps carried out by Abernathy on wheat. One of ordinary skill would reasonably consider treating oats in the manner disclosed by Abernathy as Kihara discloses that wheat, barley, oats and rye are subjected to treatments and are collectively recited in the treatment of grains. Moroever, Kihara discloses that controlling the germination of wheat, barley, oats and rye, functional ingredient contents such as GABA can be controlled. Thus, indicating that control of germination can control the content of GABA in wheat, barley, oats and rye. Still further, applicant’s instant specification states that “unless specifically or explicitly noted otherwise, a mention or reference to oat or oats should be understood to likewise refer to other grains, and particularly to barley”. This is cited in [0007] of the instant specification which also states “[w]hen describing grains, it is meant to be inclusive of cereal and other grains, including, but not limited to, oats, barley, rice, sorghum, maize, millet, wheat, rye…”. Thus, based upon applicant’s disclosure, the citation of “oats” is seen to include other grains such as those listed. Alternatively, it is not clear whether claim 2 is limited to oats and barley only and not to other grains.
Regarding Krapf, applicant’s arguments are cumulative.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
Prosecution Insights