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
Claim 7 is under examination on the merits.
Claims 1-5 are withdrawn from examination.
Claims 6 & 8 are canceled.
Priority
Claim 7 receives the U.S. effective filing date of 09/16/2022
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.
Previous rejection of claims 7 & 8 under 35 U.S.C. 112(b) is withdrawn, with respect to indefiniteness for lack of specifying the amounts and types of oligosaccharides which are modified, due to Applicant’s amendment to the claims.
Claim 7 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.
The claim is drawn to detecting a genetic polymorphism associated with altered oligosaccharide content in soybean, utilizing three primers to amplify DNA via PCR.
Claims are indefinite because it is unclear what is intended by the genotyping step(s) as currently written; use of a ‘primer pair’ in standard genetic screening via PCR involves two flanking primers, an upstream and a downstream primer. These two primers are designed to amplify the DNA sequence between them.
Applicant indicates there are three primers involved in their genotyping process, comprising two upstream primers F1 and F2, and a single downstream primer R. It is unclear what is intended by the non-standard inclusion of a third primer in describing a ‘primer pair’ and if such inclusion indicates an additional method beyond that of standard PCR genotyping. It is unclear if this indicates a multi-step genotyping method.
As such, claims as currently written fail to point out and distinctly define the metes and bounds of the claims, and one would not be able to ascertain what limits the claimed genotyping process, potentially involving three primers, or how to avoid infringement. Because of this, claim 7 is rejected as indefinite.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Previous rejection of claims 7 & 8 under 35 U.S.C. 112(a) is withdrawn, with respect to failing scope of enablement due to breadth of oligosaccharides claimed, due to Applicant’s amendment to the claims.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claim is broadly drawn to ‘retaining a soybean’ with elevated raffinose and/or stachyose content based on a specific allele. In order to achieve such a retaining step, one would need to have starting material (i.e. a breeding line or cultivar) carrying the claimed allele to be selected. Practicing the step of retaining a soybean plant with the claimed allele(s), via selection, requires one has access to a soybean plant with said allele(s).
The guidance in the specification is directed to methods of diagnosing or selecting a soybean plant possessing a particular naturally occurring allele using markers detected with primers of SEQ ID NO.2-6.
The specification fails to provide guidance on the starting material required for ‘retaining a soybean’ that possesses the allele to be selected. The specification is absent working examples of specific source germplasm and only indicates that such alleles exist in soybean germplasm from two regions in China without indicating their names, line identifiers, and/or public availability [p.6, par.42]. Applicant merely states that 284 soybean samples were used to detect said alleles, comprising both cultivated and wild accessions [id]. No information is provided regarding how one would identify or obtain seed of the material used in their analysis, nor which particular materials carry the claimed alleles (i.e. required starting material).
The specification does not tell the reader where to find the necessary source germplasm in order to predictably be able to obtain & retain such a plant in a breeding program, which is a critical step of the claimed method. Applicant depicts this soybean material as a phylogenetic tree in Fig 1A but provides no identifying information as to the germplasm depicted or where it may be obtained from:
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Without indicating a source of the allele required of the method, one would essentially be tasked with re-discovering the critical breeding material claimed in the instant application through blindly screening global soybean germplasm. The quantity of experimentation necessary to do this excessive and without indication of what source germplasm carries the allele(s) necessary to the claimed method, one would have no way of knowing whether such blind screening of soybean material, generally, would even uncover relevant source material with such alleles.
Even with marker data, application of such markers within specific breeding materials in order to retain specific functional alleles is required. Targeted selection and modification of the genomes of plants remains limited by the natural diversity found in the germplasm resources utilized [Dwivedi et al. (2017) Front. Plant Sci. 8:1461; Published 29 Aug 2017; p.2, col.2, par.2]. Thus, even with molecular marker data, clear guidance on source germplasm required to retain plants with specific functional alleles is still required.
It is reasonable to consider one attempting to apply the method, absent clear indication of starting material, may undertake a large or involved screening only to uncover none of the material they included in attempting to apply the method of the instant application carries said allele(s), and thus although they apply genetic screening of the disclosed markers, they are unable to retain a soybean with the genotype recited in claim 7.
Thus, the instant specification fails to teach any plant with the claimed alleles. Such a plant is required to use the claimed inventive method. Because of this, the instant invention is not enabled, and therefore claim 7 is rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to detection of a naturally occurring phenomenon (an allele or genetic variant) without significantly more.
This rejection is modified from the rejection set forth in the Office Action dated 23 Sep 2025. Applicant’s arguments filed 23 Dec 2025 have been fully considered but they are not persuasive.
Claim 7 recites a method of detecting genetic polymorphisms associated with particular oligosaccharide phenotype(s) in collections of existing germplasm. Applicant’s specification describes mapping/detecting the polymorphism and attendant oligosaccharide phenotype(s) in, “264 representative soybeans from all over China” including, “natural populations” of material [0042] & [0045].
This judicial exception is not integrated into a practical application because while applicants specifically describe unique PCR primers for detection of the existing genetic polymorphism, claims are only directed to ‘screening’ (i.e. detection or diagnosis) for presence or absence of a gene. While the specific sequences claimed were not known in the prior art, their discover and discovery of the naturally occurring alleles relationship to oligosaccharide phenotypes is merely the discovery of a natural phenomenon.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no additional step involved in the claims. For example, if a breeding step, or similar from the specification, followed the detection of said genotype, that may potentially qualify as inventive subject matter. However, lacking that, the claimed genetic diagnosis alone is not integrated into a practical application.
Because of this, claim 7 is rejected.
Response to Arguments
Applicant urges that 101 rejection of claim 7 is improper due to the characteristic of their invention as being directed to accelerated breeding workflow(s) rather than the natural correlation of raffinose and stachyose with genetic markers [Remarks, p.5, par.4].
This is not found persuasive because Applicant has not claimed any additional breeding steps (i.e. workflows) beyond that of molecular diagnosis of markers associated with naturally occurring phenotypes. Applicant has merely amended claim language from ‘screening a soybean’ (i.e. selecting an individual) to now recite ‘retaining a soybean’ (i.e. selecting an individual) based on genotyping with molecular markers (i.e. diagnosis). They have also included language reciting the phenotypic characteristics correlated with those genetic markers [claim 7, l.16-19].
As amended, claim 7 remains drawn to genetic diagnosis and identification or selection (i.e. ‘retaining’) of naturally occurring genetic variation, without any additional breeding steps or workflow processes beyond that of genetic diagnosis. While such descriptions of naturally occurring correlations and genetic markers are informative to the research community, they are not inventive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663
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