DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 April 2026 has been entered.
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 Status
Claims 1-2, 5-7, 11-18, 24, 27 & 30-31 are under examination on the merits.
Claims 3-4, 8, 19, 23, 25-26, 28 & 29 are withdrawn from consideration as being drawn to an invention nonelected with traverse in the response filed 04-01-2025.
Claims 9-10, 20-22 are cancelled.
Priority
Claims 1-2, 5-7, 11-18, 24, 27 & 30-31 receive the U.S. effective filing date of 09/08/2020.
Objections to the claims are withdrawn in view of Applicant’s amendments to the claims.
The previous 112(d) rejection of claims 6 & 12 is withdrawn in view of Applicant’s amendment(s) to the claims.
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.
Claims 1-2, 5-7, 15, 27 & 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Rupesh [Insight Into the Prospects for the Improvement of Seed Starch in Legume—A Review. Front. Plant Sci. 10:1213; Published 10-31-2019] in view of Edwards [Food Funct., 2015, 6, 3634–3641; Published 09-02-2015] and Nie [U.S. PG Publication US2006/0193959; Published 31 Aug 2006].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 Dec 2025, as previously applied to claims 1-2, 5-7, 15 & 27. Applicant's arguments filed 16 Apr 2026 have been fully considered but they are not persuasive.
Claims are drawn to methods of generating a SBE1 starch mutant plant and processing it in a manner so as to retain cellular structure and generate food that has digestive properties of reduced increase in postprandial glucose (PPG). Claims are drawn to this method applied in legumes (i.e. pea), cereals (i.e. corn or wheat), and/or root crops (i.e. potato).
Rupesh teaches the relationship between genes and resistant starches in legumes, including Pisum. They teach that the chemical starch composition (i.e. amylose content) and starch granule size impact the digestibility of starches in legumes [p.6, col.1, ¶3]. They also point to the relevant genes including SBE1 specifically and ‘immense increases’ in amylose content associated with its mutant r allele [p.7, col.1, ¶3]. They clearly teach that one can improve resistant starch in peas through use of SBE1 mutants (i.e. rr) with increased amylose content.
Rupesh does not teach the specific details of processing SBE1 mutants, nor do they describe retention of the native cellular structures during processing. This is because their disclosure is focused on genetics, not starch processing per se.
Edwards’ teaches both a cereal (wheat) and a legume (chickpea) wherein different size particles are thermally treated (gelatinized) and assayed for resulting effect on starch structure. They describe the important effects of retaining cellular structure during processing, including modified processing to retain particular physio-chemical properties of edible plant tissues, particularly the plant cell walls [p.3639, col.1, ¶1]. They also use potato as an example of starch crop wherein processing may affect cellular structure or resulting foods [p.3640, col.1, ¶2].
Edwards further teaches that partial gelatinization would retain cellular structures and be expected to have major implications for digestibility and PPG. [p.3635, col.1, ¶2].
This teaches a clear relationship between starch quality and processing wherein retaining cellular or starch granule structure enhances resistant starch profiles in resulting foodstuffs. Edwards clearly teaches that one can improve resistant starches in cereals and legumes through use of modified processing which retains cellular or starch granule structure.
Nie teaches the combination of high amylose starch in combination with specific processing steps that retain the granular structure through processing lead to an increase of resistant starch, reducing susceptibility to enzymatic digestion and increasing dietary fiber [p.2, ¶18].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify starches both genetically, as disclosed by Rupesh, and via processing methods, as disclosed by Edwards and by Nie, to generate foods with improved starch profile or having lower impact on PPG.
One of ordinary skill in the art would have been motivated to do so because combining the elements of genetic improvement of starches with processing improvement of starches would predictably yield improved starches.
One would be motivated to do this because Rupesh directly suggests that starch improvement in legumes is ‘highly desirable’ because it provides ‘immense nutritional and health benefits’ [p.10, col.1, ¶2, l.39—col.2, ¶1, l.4]. Rupesh makes this statement immediately after describing how both the use of SBE1 mutation ‘r’ in pea and the impact of specific processing steps have been shown to lead to improved starch [p.10, col.1, ¶2, l.27-35]. The example cited by Rupesh is that of Edwards.
Prior art clearly demonstrates it was known that both starch type/composition of grains or seeds and food structure have an impact on resistant starch levels, digestibility and postprandial glucose levels. Prior art demonstrates it was known that SBE1 mutants, notably the r mutant from pea, improve resistant starch characteristics. Prior art demonstrates it was known that purified starches are more susceptible to α-amylase hydrolysis as compared to less processed starches or those with alternate processing that retains native structure. One seeking to improve methods of making improved starch-based food products would be motivated to combine known methods of improving starches previously reported in the research literature, such as use of particular types of raw materials (i.e. SBE1 mutants from grains, legumes or roots) with particular processing (i.e. retaining cellular & starch structures) to achieve the ‘immense nutritional and health benefits’ stated by Rupesh.
Regarding claims 1-2, 15 & 27; Rupesh describes use of SBE1 mutants [p.6, col.1, ¶3; p.7, col.1, ¶3] and Edwards describes processing to retain the cellular structure of plant parts [p.3639, col.1, ¶1] and that this would impact PPG [p.3635, col.1, ¶2].
Regarding claims 5-7; Rupesh describes modification of starches in legumes [p.6, col.1, ¶3], as does Edwards [p.3635, col.2, ¶2-3]. Edwards describes modification of starch structure in wheat [p.3635, col.2, ¶2-3] and potato [p.3640, col.1, ¶2].
Regarding claims 30 & 31; Edwards describes processing mutant starch plants into flour [p.3638, col.1, ¶2].
For these reasons claims are obvious in view of prior art and claims 1-2, 5-7, 15, 27 & 30-31 are rejected.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rupesh, Edwards & Nie as applied to claim 1 above, and further in view of Burton [The Plant Journal (1995) 7(1), 3-15; Published 1995] and Abad [WO2007044043A2; Published 04-19-2007].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 Dec 2025, as previously applied to claims 1-2, 5-7, 15 & 27. Applicant's arguments filed 16 Apr 2026 have been fully considered but they are not persuasive.
Claims are drawn to a method utilizing both genetic mutants of SBE1 and processing methods to improve starch quality. Claims are drawn to the specific gene and polypeptide sequences of SBE1 and mutations thereof.
Rupesh, Edwards & Nie teach the use of high amylose SBE1 mutant pea and specific processing methods to increase resistant starch, as discussed above [see p.3-6].
Rupesh, Edwards & Nie do not teach the genetic or polypeptide sequence of the SBE1 gene.
Burton teaches the identification and molecular characterization of the nucleotide and polypeptide sequences of SBE1 [p.4, col.2, ¶3, p.6, col.1, ¶3; see NPL_STIC_SeqID1_Burton]. Burton teaches that mutations lead to differences in alleles of SBE1 and attendant differences in the encoded enzyme cause alterations in starch types [p.9, col.1, ¶1 – col.2, ¶2].
Abad teaches the sequence of SEQ ID NO.2, which is SBE1 [see NPL_STIC_SeqID2_Abad]. Search of patent databases reveals their WIPO application discloses numerous sequences relevant to crop plants, one of which corresponds to the polypeptide product of SBE1 [WO2007044043A2, SEQ ID NO.7999], previously reported by Burton in 1995.
Prior art clearly discloses the SBE1 gene sequence and its polypeptide product, claimed as SEQ ID NO.2 in the instant application. Mutant alleles of SBE1 with resulting modifications to starch profile were clearly described and known.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the use of SBE1 taught by Rupesh to methods using specific genetic sequences, taught by Burton, along with its protein sequence taught by Abad.
One of ordinary skill in the art would have been motivated to do so because applying disclosed sequence data to a known genetic device, such as the SBE1 gene, would predictably yield improved methods of detecting, breeding with, or otherwise manipulating SBE1 via the now routine tools of molecular biology. One would be motivated to combine sequence information into methods of genetically manipulating SBE1 or breeding plants with modified starch profiles because it is known that sequence information is both necessary and useful in modern molecular approaches to plant breeding. This would be obvious to a plant breeder.
Regarding claims 16 & 17; Burton discloses the genetic and polypeptide sequences of SBE1 [p.4, col.2, ¶3, p.6, col.1, ¶3]. Abad discloses the protein sequence of SBE1, which is included as SEQ ID NO.7999 of their 2008 patent filing [WO2007044043A2].
Regarding claim 18; Burton describes a mutation in SBE1 resulting in altered function between alleles [p.9, col.1, ¶1 – col.2, ¶2].
For these reasons, claim to methods using SEQ ID NO. 1 & 2, and mutants thereof, associated with SBE1 are obvious in view of prior art. As such, claims 16-18 are rejected.
Claims 11-14 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rupesh, Edwards & Nie as applied to claim 1 above, and further in view of Chen [Crop Science. Vol.53 Mar-Apr 2013 p.482-490; Published 02-06-2013].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 Dec 2025, as previously applied to claims 1-2, 5-7, 15 & 27. Applicant's arguments filed 16 Apr 2026 have been fully considered but they are not persuasive.
Claims are drawn to a method utilizing both genetic mutants of SBE1 and processing methods to improve starch quality. Claims are drawn to ‘identifying and selecting’ a plant carrying a specific polymorphism in the SBE1 gene causing loss-of-function or partial loss-of-function.
Rupesh, Edwards & Nie teach the use of high amylose SBE1 mutant pea plants and specific processing methods to increase resistant starch, discussed above [see p.3-6].
Rupesh, Edwards & Nie do not teach the use of molecular markers, marker assisted selection, or DNA-based methods of diagnosing or identifying mutant SBE1 plants with reduced function or loss-of-function.
Chen teaches that loss of function mutations in SBE1 can be detected using genetic polymorphisms in Development of Functional Molecular Markers of SbeI and SbeIIb for the High Amylose Maize Germplasm Line GEMS-0067. They teach the use of an effective loss-of-function to increase amylose content of grain, and its selection [p.484, col.1, ¶2]. Chen teaches such polymorphism in starch biosynthesis genes can be used to track and introgress desirable SBE1 alleles via DNA markers.
Chen teaches development of functional molecular markers for SBE1 starch mutants, their manipulation in breeding practice, and provides that use of such markers can help breeders maintain recessive SBE1 mutations and pyramid them for high amylose content [p.484, col.1, ¶2; col.2, ¶2]. They specifically teach backcrossing or introgression using markers [p.484, col.1, ¶2¶, l.12-16]. They explicitly state that the SBE1 mutant they describe is predicted to not be functional (i.e. loss-of-function) [p.489, col.1, ¶1].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine use of SBE1 for improved starch qualities, as taught by Rupesh & Edwards, with use of selection of a loss-of-function mutant to achieve the beneficial mutant starch phenotype, as described in maize by Chen.
One of ordinary skill in the art would have been motivated to do so because the use of the same technique described in maize, utilizing a major gene of qualitative effect with orthologs in other plant species, would predictably generate the same type of valuable starch mutant phenotype in other crops.
One seeking to improve or modify starch qualities would be motivated to use the marker assisted selection techniques described by Chen in maize to alter peas or other plants in the same way, using loss-of-function mutants, to generate valuable starch producing plants described by both Rupesh and Edwards. Such plants would have ‘immense nutritional and health benefits’ (i.e. be valuable) as stated by Rupesh.
Regarding claims 11, 13-14 & 24; Chen describes the identification of SBE mutant alleles and indicates they likely represent a loss-of-function in SBE1 [p.489, col.1, ¶1]. Additionally, they describe the introgression process for such mutant alleles in plant parts or food in the form of grain (i.e. maize seed) [p.484, col.1, ¶2¶, l.12-16].
Regarding claim 12; this narrows to two groups of starch-producing crops where the harvested portion is a seed (i.e. cereals and/or legumes) or a group of plants where the harvested portion is a root (i.e. potato). Rupesh, Edwards, and Chen all describe cereals or legumes [Rupesh, p.6, col.1, ¶3; Edwards, p.3635, col.2, ¶2-3; Chen, p.484, col.1, ¶3] and Edwards describes potato as a starch crop [p.3640, col.1, ¶2].
Response to Arguments
Applicant urges that previous 103 rejection of claims 1-2, 5-7, 11-18, 24 & 27 is improper because (a) the Office uses hindsight reasoning to combine genetic and processing approaches of using high-amylose starch, in which the necessary motivation comes only from Applicant’s disclosure [Remarks, p.9, ¶3]. Applicant argues that (b) without guidance from the Applicant’s disclosure, one of skill in the art would not consider combining SBE1 mutants and the specialized processing described [p.10, l.1-2].
Applicant further argues (c) unexpected results [p.10, ¶3], that it was not possible to predict how high amylose starches would behave during processing [p.12, ¶2], surprising results of in vivo tests because health benefits of such food could not be predicted in humans [p.13, ¶2], and a synergistic effect (i.e. not additive) between Genotype X Processing effects [p.14, ¶1]. Applicant yet further argues (d) that non-obviousness is evidenced by praise, publications, and commercial interest [p.14, ¶3-4].
This is not found persuasive with respect to (a) because motivation is clearly provided by Rupesh as described above [see p.5, ¶4]. Applicant argues that Rupesh does not suggest combining genetics with food processing to improve starch [Remarks, p.11, lines 12-14]. Rupesh does not describe the exact combination of genetics and processing being claimed by Applicant – if they did, it would be anticipatory rather than obvious. Rather, Rupesh makes the case that improving resistant starch in key food ingredients, including legumes, would have great benefits to health and nutrition. They focus on genetic aspects of this while pointing to use of SBE1 for such improvements, but also telling the reader that differential processing, as previously disclosed by Edwards, is important and can be used to improve starch.
Regarding the lack of processing details in Rupesh; Applicant is arguing individual references rather than considering that one skilled in the art would reasonably consider both the known genetic and processing approaches, presented by different research groups, to improve resistant starch content. Rupesh does not need to indicate the exact details of processing, because the teaching of processing with respect to the structure of starches as occurs in natural pea seeds is provided by Edwards. Obviousness is based on reasonable consideration of these references, taken together.
Applicant further argues that because Rupesh presents more than one potential enzyme in addition to SBE, one skilled in the art would not consider SBE1.
As referenced in Applicant’s response, Rupesh points to three potential targets, one of which are SBE enzymes [Remarks, p.10, lines 4-7]. Applicant admits that the SBE1 mutant is one of the most widely studied starch mutant phenotypes, and that sbe mutant peas have been commercially cultivated for several decades [Specification, p.40, lines 19-28]. Rupesh states use of SBE1 mutant r produces ‘immense increases’ in amylose, after making the case that increased amylose is beneficial.
It is unconvincing that one skilled in the art, concerned with variable starch phenotypes and presented only three options including SBE genes, would not obviously consider modifying SBE1 or its orthologs and also combining it with an improved processing method as disclosed by Edwards prior to Applicant’s filing. It is unconvincing that SBE1 would not be an obvious candidate, because it is a well-characterized and long-established starch mutant phenotype; it is not an unknown gene or previously uncharacterized QTL. It is predictable or obvious to try to combine known, improved genetics with known, improved processing methods that are both directed to improving the same outcome.
Applicant’s argument that preliminary in-vitro tests of digestibility from Edwards argue against obviousness or such motivation to combine are not persuasive. This is because preliminary in-vitro tests are routinely used to present initial evidence before in-vivo testing in biological research.
It would be highly unusual for a research study to proceed directly to in-vivo, human, testing without preliminary in-vitro studies. It would also be unusual for in-vitro studies to be performed without doing so under the express expectation that they are providing preliminary data (hopefully favorable) to make a decision on whether to proceed to more elaborate and expensive in-vivo studies using animal or human subjects. In addition to the scientific reasons for this, there are frequently regulatory reasons or requirements surrounding testing procedures for food products which are intended to be marketed using specific health claim language on packaging [see FDA ‘Label Claims for Food and Dietary Supplements’, available online www. fda.gov/food/nutrition-food-labeling-and-critical-foods/label-claims-food-dietary-supplements; Accessed 5 June 2026, and, attached ‘NPL_FDA_Authorized health claims that meet the SSA standard.pdf’].
Moreover, the key teaching of Edwards relevant to the instant application is that processing, specifically gelatinization or cooking, impacts cellular and starch structures with resultant improvements to digestibility and/or resistant starch content. Their research report is teaching that gelatinization and the ‘food matrix’ structure being intact improves resistant starch content [Edwards, p.3639, col.2, ¶2], which is the relevant inventive component being combined with the SBE1 teachings of Rupesh, to predictably arrive at the claimed instant invention.
It is unclear how a seemingly logical and routine study directed to starch digestion, and which presents convincing preliminary in-vitro evidence of the role of intact cellular structures / processing, would not obviously indicate reasonable progression from the preliminary in-vitro study to in-vivo applications (i.e. human foodstuffs). This argument is particularly unconvincing when considering the in-vitro study appears to support the same results/conclusion that both genotype and processing can be beneficial to starch quality, and there is no evidence that the in-vitro data would teach away from or otherwise indicate the in-vivo results are particularly surprising or unexpected.
With respect to (b); arguments of hindsight bias are not persuasive because prior art clearly demonstrates that it was known prior to filing that one can use both high-amylose SBE1 mutant starch sources, and, processing methods which retain cellular structures to increase resistant starch content, and thus potential health benefits. The prior art explicitly points to combining genetics and processing to improve starch, as evidenced by Edward’s 2015 paper, which publicly disclosed the use of both mutant SBE1 alleles and differential processing procedures to improve starch.
With respect to (c); arguments of synergy are not found persuasive because Applicant does not in fact provide evidence of a synergistic response.
Applicant argues that their disclosure describes a synergistic (i.e. non-additive) response that renders their claimed invention non-obvious. A synergistic response is one in which the use of two methods in combination produces results greater than additive effect of the combined individual treatments.
Referring to Applicant’s specification for evidence of an unexpected synergistic response, none is found. Applicant’s embodiments show differences between rr and RR (i.e. SBE1 mutant or wild type) starches that are processed [Specification, p.62, Table S11]. ‘Processing’ as described by Applicant consisted of milling, grinding or generally disrupting the cell wall, as would typically occur in generating flour from a legume or any other grain [p.3, l.6-9]. They also cook (i.e. gelatinize) samples to determine processing effect(s). There is not a controlled comparison of the gelatinized vs. non-gelatinized processing treatments using both genotypes that would be needed to make a determination of more-than-additive effects.
The individual components of variation attributable to either genotype alone (i.e. rr or RR treatment), attributable to processing method alone (i.e. process A vs process B), or attributable to genotype-by-processing interactions (i.e. rr + process A, vs, rr + process B, vs, RR + process A, vs, RR + process B) are not described. Lacking comparative treatment combinations, the impact of interactive effects remain unclear. Applicant describes that results of their experiment relate largely to whether peas are RR or rr genotype, but does not discuss or quantify synergistic results of SBE1 in the context of other variables.
In the in-vivo trials describing the effect of variable starches on humans (i.e. the argued ‘synergistic’ response), in trials 1 & 2 only cooked samples from RR and rr were administered [p.28, l.4-6]. In both, separate, trials Applicant admits the primary differentiator between groups was due to rr versus RR genotype [p.27, line 36—p.28, lines 1-2]. A trial testing the effect of raw vs. cooked peas is not described, and because of this the reader has no way to determine if anything other than additive effects are reported. There is insufficient information to ascertain ‘synergy’ in view of such results.
It is not debated that Applicant describes both starch genotype and food structure have an impact on PPG. However, Applicant does not describe synergistic, non-additive effects between genetic and processing treatments. Nor do they report the effect of raw samples in their in-vivo studies, in a manner which can be objectively assessed for ‘synergy’ with respect to resulting data. While a trial may have positive results, or be subjectively interesting or surprising to a researcher, objective claim to a synergistic response would require one to have evidence that observed results of combined treatments are significantly more than additive. Applicant has not provided such supporting information.
Lacking sufficient data to assess non-additive variation in trial results, Applicant’s argument of such ‘synergistic results’ are unsupported. Applicant has merely demonstrated that both factors of starch composition and milling into flour, individually, impact glycemic response and may have some level of additive effect(s). It is highly predictable that a major starch mutation (i.e. SBE1 / rr) and the type of processing (i.e. disruption of cellular / starch structure) would both individually impact digestion of a starch or flour based on what is taught in the prior art.
Finally, and with respect to (d), arguments are not found persuasive regarding secondary indicators of non-obviousness. Praise and/or publication of research alone does not make it inventive or non-obvious, and does not overcome the other issues described above. Clearly there was a large amount of work involved in the study described, which has contributed to the scientific understanding of starch and foods; however, such extensive work associated with detailed study of any biological phenomenon is routine in research science. The mere act of ‘extensive work’ or ‘expensive work’ is not inventive per se. Research work can be informative and valuable to the public, as evidenced by publication in peer-reviewed journals, but this does not mean something is inherently patentable or non-obvious.
Further argument that the claimed invention is not obvious because Applicant’s research has attracted grant funding and commercial interest is also not persuasive. Grant funding is common and often required in the sciences, particularly public institutions where the majority of academic laboratories are ‘grant funded’ – it is not reasonable to argue that a research project supported by grants therefore indicates or involves patentable invention(s) by virtue of the researcher having obtained grant funding to do the work.
It is reasonable to consider that commercial interest would be expected in the case of the instant invention. This is because there is an established commercial market for SBE1 mutant starches in maize. Again, funding or commercial interest does not in and of itself indicate presence of a patentable invention, as many commercially valuable products and methods are obvious or otherwise in the public storehouse of knowledge and therefore unpatentable.
For these reasons, arguments of non-obviousness are not persuasive, and previous 103 rejections are maintained.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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