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 Status
Claims 1-2, 5-7, 11-18, 24 & 27 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Claims 3-4, 8, 19, 23, 25-26, 28 & 29 are withdrawn from consideration as being drawn to an invention nonelected with traverse in the response filed 04-01-2025.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.
The previous 112(b) rejection of claims 11-14, 24 & 27 is withdrawn in view of Applicant’s amendment(s) to the claims.
The previous scope of enablement 112(a) rejection of claims 1-2, 5-7, 11-18, 24 & 27 is withdrawn in view of Applicant’s amendment(s) to the claims.
The previous possession 112(a) rejection of claims 1-2, 5-7, 11-18, 24 & 27 is withdrawn in view of Applicant’s amendment(s) to the claims.
Specification
Objections to the specification are withdrawn in view of Applicant’s amendments to the disclosure.
Claim Objections
Claims 6, 7 & 12 are newly objected to because of the following informalities:
Claims 6, 7 & 12 are not written in proper Markush format. The claims should be in the format “selected from the group consisting of A, B, C and D.” See MPEP § 2173.05(h). Applicant is advised to amend as appropriate if claims are not intended as Markush groups. If they are intended as Markush claims, they should be put in proper format.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 6 & 12 are 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 1 has been amended to limit to “a non-oil seed pulse”. Claim 6 attempts to narrow from claim 1, but recites soybean as an optional plant. Soybean is a globally important oilseed legume outside of the categories presented in claim 1. As such, claim 6 does not narrow or further limit claim 1, but instead includes a broader category of crop germplasm. Because of this failure to narrow limitations, claim 6 is rejected. Similarly, dependent claim 12 includes soy in a list of encompassed crops.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim 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 1-2, 5-7, 15 & 27 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].
Rupesh provides a review of the relationship between genes and resistant starches in legumes, including Pisum. They recite a number of factors impact the digestibility of starches in legumes, including, “…species identity, physicochemical properties…processing and storage conditions…properties of gelatinization, starch granule size, the proportion of amylose and amylopectin content…” [p.6, col.1, par.3]. They also point to the relevant genetic factors, “In pea, the number of mutants that affect various pathways of starch synthesis have been identified through breeding and mutation approaches…Genes present at r (SBE I, SBEII)…loci straightaway affect polymer biosynthesis and degree of starch branching. This alteration leads to an immense increase in amylose content of genotypes with an r [SBE loss-of-function]” [p.7, col.1, par.3]. They go on to suggest the possibility of combining genetic mutations with differential processing techniques that may impact overall starch structure, or encapsulation as occurs in natural pea seeds [p.10, ‘PROSPECT FOR STARCH IMPROVEMENT IN LEGUME SEEDS’].
They do not describe the specific details of processing which are most important to increasing resistant starch in processed products, nor do they describe retention of the native cellular structures.
However, this is remedied by Edwards’ earlier 2015 research report describing 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 as, “…These findings provide new evidence that the effect of particle size on gelatinization behaviour is not simply a result of available surface area per volume, but will also be related to the different physico-chemical properties of edible plant tissues, particularly with regard to the plant cell walls.” [p.3639, col.1, par.1]. Further they state, “…Considering the vast differences in digestion kinetics between native and gelatinised starches, partial gelatinisation [due to intact cellular structures] would be expected to have major implications for digestibility and postprandial glycaemia.” [p.3635, col.1, par.2]. This points to a clear relationship between processing in a manner to retain cellular or starch granule structure, gelatinization characteristics and enhancing resistant starch in resulting foodstuffs.
One would plainly see the advantages of using the specific details relevant to increasing resistant starch in peas genetically, as disclosed by Rupesh, and via processing methods, as disclosed by Edwards. One would be motivated to do this because of the numerous health benefits and potential economic opportunities, pointed to by the references, in generating improved functional foods with higher levels of resistant starch. 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.
Because of this, claims are obvious in view of prior art and claims 1-2, 5-7, 15 & 27 are rejected.
Response to Arguments
Applicant’s arguments have been fully considered but are unpersuasive. Applicant argues that the prior art of Rupesh and Edwards address fundamentally different problems, Rupesh directed to SBE1 effect on amylose content and, separately, Edwards directed to cell wall effect on gelatinization [Applicant Response; p.15, par.2].
However, both documents are clearly research reports directed to increasing resistant starch in natural grains or seeds for digestibility / health benefits. In Rupesh, this is covered in several dedicated sections including ‘Significance of Legume and Starch in Human Diet’ [p.3], ‘Factors Influencing Starch Digestibility and Content in Legumes’ [p.6], ‘Prospect for Starch Improvement in Legume Seeds’ [p.10] & ‘Approaches for Starch Improvement in Legume Seeds’ [p.10]. It is notable that in several of these sections, gelatinization is also discussed, presenting explicit functional connections between genetics and gelatinization – this is the gelatinization process which Edwards goes on to describe the role of cell walls in.
In Edwards, the opening Title and Abstract state their research report has implications for digestibility, and a primary goal or problem is to "investigate the role of the plant food matrix…during hydrothermal processing, and its implications for starch digestibility" [Abstract, first sentence]. Their conclusion reinforces the larger research problem being studied, that of manipulation of resistant starch for healthy foods, as “we envisage that this work is highly relevant to the development of a range of novel ingredients and functional foods, with potential applications in obesity management, colonic health, and the management and prevention of cardiometabolic diseases” [p.5, Conclusions, final summary sentence].
Both references are clearly addressing the same challenging problem of how to functionally increase resistant starch, modify digestibility of foodstuffs, and potentially reduce glycemic reaction to starch-based foods, as is Applicant’s invention.
It is reasonable, and would be expected, that one skilled in the art would recognize a known variable able to be manipulated to achieve a desired effect (i.e. genetic background), and a separate known variable that could be independently manipulated to achieve a desired effect (i.e. processing/gelatinization). It is also reasonable that one would rationally consider that applying both manipulations simultaneously could have an improved (additive) outcome, barring specific evidence to the contrary. Such logical combination of prior research is one the most foundational forms of scientific or technological progress over time, and routine to any researcher.
Applicant argues that statements from both prior art references directed to the general need for, and challenges of, further research indicates “the skilled person would not be incentivized to combine these documents” [Applicant Response; p.15, par.2]. This is unconvincing, as to the contrary, such statements directly indicate a need or motivation (i.e. incentive) to look for, and combine, insights from related research. There is no indication from either reference that they have tried Applicant’s claimed combination(s) and failed, or otherwise would teach away from an obvious combination of the two known beneficial improvement methods. Generic statements that ‘more work/understanding is needed’ are an almost universal feature of any research publication coming from a public-facing lab that is active and planning to continue working. Such statements are not the same as evidence of experimental failure or negative results.
Further, Applicant argues the following problems posed by the prior art as weighing against reasonable expectation of success, or obviousness:
1. The unpredictability of functional properties of starch from genetically altered
plants; and
2. The lack of a thorough understanding of the importance of cellular structures in
relation to starch digestibility. [Applicant Response, p.16, par.3]
This indicates Applicant is of the position one would not be expected to be able to cross-apply insights regarding SBE1, generally, nor be able to cross-apply insights regarding starch processing and resulting functionality, generally [Applicant Response; p.16, par.2].
However, regarding (1.) unpredictability of starch from genetically altered plants; Applicant has not presented evidence of unpredictability of starch behavior in SBE1 mutants. Further, Applicant contradicts their own argument in a separate section of their response to the Office. They argue an obvious, reasonable expectation of success of their invention’s starch properties that rely on SBE1, which is highly conserved and broadly applicable, as:
“the molecular basis for this phenotype is conserved…it has been shown in the literature that the effects of modifying SBEs can be applied across different plants…as such, the concept that introducing a SBE1 loss of function mutation increases resistant starch [i.e. functional properties] can plausibly be applied to other plants” [Applicant Response, p.11, par.3 – p.12, par.2]
In support of the predictability associated with SBE1 mutation relative to function, they provide additional references from different crop species using at least three modes of genetically modifying SBE/starch and achieving similar functional results [id.p.12, par.2]. Thus, applicant admits, and argues directly, that the genetic methods described by Rupesh (and others) drawn to SBE starch mutants would be reasonably predictable and cross-applicable.
Further, regarding (2.) the role of cellular structures and starch digestibility; Applicant once again argues a case of obviousness in a separate section, as:
“any minor modification to processing methods to account for differences in cellular structure between plant species would be considered routine optimization performed using common general knowledge, not undue experimentation…[disclosure] sets out that processing must retain cellular or starch granule structure…it would be clear to the skilled person that processing other starch containing plants in this way would also increase levels of resistant starch…the applicability of this concept to diverse plant types is supported by the literature…preservation of an intact cell wall is protective across plants and thus the principle that processing a plant in a way that retains cellular, or starch structure is not restricted” [id.p.13, par.1-2].
Thus, they are also taking the position that the relevant features of processing would be reasonable, or routine, to consider as broadly cross-applicable or obvious to one skilled in the art once initially disclosed. Such a disclosure of processing requirements to maintain cell wall structure and associated functional characteristics is made by Edwards in 2015, and from the position of Applicant’s argument above, provides a public disclosure of a principle that “is not restricted” and would be obvious as broadly applicable.
For these reasons, arguments of non-obviousness are not persuasive, and previous 103 rejections are maintained.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rupesh & Edwards 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].
As previously described in Rupesh, & Edwards, the use of high amylose SBE1 mutant pea plants and specific processing methods are known to increases resistant starch. They do not specifically describe the genetic or polypeptide sequence of the SBE1 gene.
However, Burton discloses the associated nucleotide sequence of SBE1 and Abad discloses the claimed polypeptide SEQ ID NO.2 [See attached, NPL_STIC_SeqID2_Abad & NPL_STIC_SeqID1_Burton]. Abad’s WIPO application discloses numerous sequences relevant to crop plants, one of which corresponds to the polypeptide product of SBE1, whose nucleotide sequence was 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. They also disclose mutant alleles of SBE1 with resulting modifications to starch profile.
Because of these previous sequence disclosures, claim to SEQ ID NO.2 or other native sequences 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 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].
Rupesh & Edwards disclose the use of high amylose SBE1 mutant pea plants to increase resistant starches and describe methods of processing to retain native cellular or starch granule structure. They do not specifically describe the use of molecular markers, marker assisted selection, or DNA-based methods of diagnosing or identifying mutant SBE1 plants.
However, this is remedied by Chen in their disclosure Development of Functional Molecular Markers of SbeI and SbeIIb for the High Amylose Maize Germplasm Line GEMS-0067, which teaches that loss of function mutations in SBE1 can be detected using molecular markers based on sequence polymorphisms, and that such polymorphism in starch biosynthesis genes can then be used to rapidly introgress a gene to affect a desired starch phenotype.
In the instant case, the major SBE1 loss of function mutation is visible as wrinkled seed, but can be detected prior to flowering or seed set using such DNA-based markers. Chen teaches the identification of SBE mutant alleles described in claim 11 as well as the introgression process of claim 13. Claims 12, 14 & 24 simply narrow to specific plant species or products of claims 11 & 13. Chen discloses development of functional molecular markers for SBE1 starch mutants, their manipulation in breeding practice, and provides motivation in teaching that they can “help breeders to better use…high amylose germplasm in maintaining recessive alleles in backcrossing…and in pyramiding SbeI and SbeIIb for high amylose content” [p.484, col.1, par.2].
Marker assisted backcrossing is now well established as a general plant breeding procedure. It would be obvious to one skilled in the art of plant breeding that methods drawn to use of molecular markers for SBE1 alleles during selection could be used as in claims 11-14 & 24, and as previously outlined for the specific modification of starch content taught by Chen.
Because of this, claims 11-14 & 24 are rejected.
Conclusion
No claims are allowed.
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.
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
/Anne Kubelik/Primary Examiner, Art Unit 1662