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 .
Election/Restrictions
Applicant’s election without traverse of group II, consisting of claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57, in the reply filed on 19 May 2026 is acknowledged. Applicant has elected the species of SEQ ID NO.1 for examination.
Claim Status
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57
are under examination on the merits.
Claims 1-4, 10-13, 16, 32-33, 35-36, 39-40, 58-60 & 63
are withdrawn as non-elected subject matter.
Claims 5-9, 14-15, 21, 23-26, 29-30, 34, 37-38, 43-45, 48-49, 55-56 & 61-62
are canceled.
Priority
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57
receive the U.S. effective filing date 26 May 2022.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [p.53, ¶.1 & 3]. 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.
The use of the term ‘Terragreen’, which is a trade name or a mark used in commerce, has been noted in this application [p.45, ¶.1; p.46, ¶.2 & 7; p.47, ¶.7; p.50, ¶.2]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 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 claims 22 & 42, the phrase "for example" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 28, 31, 47, 50, 54 & 57 recite the broad recitation ‘rice’, and the claims also recite ‘Oryza sativa’ which is the narrower statement of the range/limitation. The term ‘rice’ can refer to several different species of Oryza which are domesticated and cultivated for grain.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Because of this, claims 28, 31, 47, 50, 54 & 57 are rejected.
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 include the limitation of the protein ‘GBP1’, its orthologs, and/or corresponding encoding gene(s). Claims recite GBP1 is any ortholog of SEQ ID NO.1, including variants with as little as 70% sequence identity. There is no art recognized meaning for GBP1. It is unclear how one would determine whether they have GBP1 vs other GBP family of genes.
Turning to the specification to determine what specific sequence defines ‘GBP1’, Applicant states that glucan binding protein (GBP) are encoded by a gene family [i.e. plural, multiple forms], thus indicating ‘GBP’ is not any one particular molecule or protein sequence, instead potentially having several dozens of variant forms even within a single plant species [Specification, p.1, ¶.3-4]. Applicant then goes on to further state, “…that GBP1 [i.e. singular] is a negative regulator…with a loss of function mutation in GBP1 [i.e. singular] …” [p.1, ¶.5]. Applicant subsequently describes ‘GBP1 genes’ as a family [i.e. plural] of genes with orthologs in several leguminous species [p.1, ¶.6—p.2, ¶.1].
Further, Applicant defines gene orthologs of GBP1 as any sequences having as little as 25% sequence similarity to GBP1 nucleic acid sequences [p.17, ¶.3].
Applicant then defines ‘GBP1 nucleic acid sequence’ or ‘GBP1 gene’ as any nucleic acid encoding a GBP1 protein [p.16, ¶.3]. Applicant does not define the polypeptide sequence of said GBP1 protein. Thus, it is unclear if Applicant’s use of the name designation GBP1 is claiming a singular polypeptide/protein or if the term encompasses the entire family of GBP orthologs and their diverse proteins.
No specific sequence is indicated as unambiguously defining the specific ‘GBP1’ protein referenced in claims. Presented numerous orthologs referenced in the specification, there is no apparent species-specific identifier or other guidance from Applicant defining the allele to be used as reference sequence for ‘GBP1’. Further, there is no specific sequence referenced to define what constitutes a wild type allele (e.g. claim 52) for comparative purposes.
As such, it is unclear which polypeptide sequence or ortholog is specifically being referenced or claimed by Applicant’s reference to the ‘GBP1’ protein. Within the specification ‘GBP1’ is used to refer to different protein variants (i.e. orthologs) of different plant species [p.11, Figure 11 & 12 captions]. These various, optional, orthologs of GBP proteins and their encoding sequences appear as an extensive list [p.53-99].
Because the scope of the claims varies depending on which sequence is chosen from among the GBP gene family as the recited ‘GBP1 protein’, claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 are indefinite, and rejected.
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 27-28, 31, 46-47, 50, 53-54 & 57 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.
Claims 27, 46 & 53 attempt to narrow from their corresponding independent method claims by reciting limitations of a plant being (1) a legume plant or (2) a non-legume plant. However, a plant is either a legume or it is not, and therefore such claim language merely limits to ‘a plant’ of some sort being involved. This does not narrow scope of the invention, as independent claims 17, 41 & 51 already specify claimed methods limited to ‘a plant’. Because of this, claims 27, 46 & 53, and their dependent claims 28, 31, 47, 50, 54 & 57 are rejected.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for sequences of 100% identity to SEQ ID NO.1 in Medicago and other nitrogen-fixing legumes, does not reasonably provide enablement for sequences of <100% identity to it, nor in plants which do not naturally fix nitrogen, nor for increases in biomass not caused by differences in nitrogen fixation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
It is unclear how one would even find or determine the identity of the specifically claimed ‘GBP1’ in other plants absent further information on required conserved domain(s) required.
Regarding use in any plant; Claims 17, 41 & 51, from which all other claims depend, encompass methods of modulating nitrogen fixation via reducing or abolishing the function of the protein GBP1 or its encoding sequence (i.e. SEQ ID NO.1) in any and all plants.
Turning to the specification for support to such broad claim, Applicant only describes the genetic manipulation of GBP1 and description of accompanying effects on nitrogen fixation in closely related leguminous species which naturally fix nitrogen, including Medicago, Vicia faba (broad bean) & Pisum sativum (pea) [Specification, p.49, ¶.6; p.50, ¶.5].
Because of this, claims 17, 41 & 51 are rejected as not having been fully enabled, as modulation of nitrogen fixation via modification of GBP1 in any and all plant species is not described by Applicant. Further, prior art does not appear to show any use of GBP1, to confer or modulate nitrogen fixation qualities in plants other than leguminous species which already naturally fix nitrogen.
Therefore, without guidance from the specification as to the methods of making such plants across a diverse and broad range encompassing any and all plants, it would require undue experimentation to make and use methods of modifying GBP1 to induce, increase or modulate nitrogen fixation in such plants, if it is even possible to do so. As such, claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 are rejected.
Regarding any GBP1 gene; Claims 19, 42 & 52 encompass alleles of GBP1 which encode proteins modulating nitrogen fixation in plants, and having as little as 70% encoding sequence identity to SEQ ID NO.1.
Claims recite a nucleotide with only 70% identity to the 1,992 bp long SEQ ID NO.1 encoding allelic variants of the protein GBP1. This encompasses nucleic acids with ~597 variable nucleotide substitutions, of which a representative number of substitution variants were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of requiring only 70% identity to the encoding nucleotide SEQ ID NO.1. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the GBP1 protein. Making random changes in proteins is unpredictable and therefore one would not be enabled to isolate or derive such proteins as GBP1 effectively modulating nitrogen fixation, having less than 100% identity to SEQ ID NO.1, with any reasonable certainty that it would function properly.
Therefore, without guidance from the specification as to which sequences of 70% identity to SEQ ID NO.1 effectively modulate nitrogen fixation, it would require undue experimentation to find these functional variant sequences, if even possible to do so.
Regarding phenotypic effects; Claim 17 and its dependents 18-20, 22, 27-28 & 31 include a limitation that abolishing expression of GBP1 increases biomass. This is presented in the alternative (‘or’) indicating that altering GBP1 increases biomass independent of altering to nitrogen fixation properties.
Applicant’s specification describes an increase in biomass as a result of increased available nitrogen, or the presence of nitrogen-fixing microbes [p.1, ¶.1]. They go on to repeatedly describe that biomass is increased a consequence of the modulated (i.e. improved) symbiosis between mutant plants and nitrogen-fixing microbes [p.1, ¶.5; p.11, Figure 8; p.47, Example 5; p.48, ¶6—p.49, ¶.4; p.50, ¶.5; p.52, ¶.3].
Applicant does not describe any effect of altering GBP1 on biomass per se, absent alteration of nitrogen fixation characteristics. It appears the reported increases in biomass are correlated to, or an inherent result of, improved nitrogen fixation.
Therefore, without guidance from the specification as to how one would increase or improve biomass via GBP1 modification independent of nitrogen fixation characteristics, it would require undue experimentation to determine methods that would have the achieved effect via manipulation of GBP1, separate from impacting nitrogen fixation characteristics, if even possible to do so.
Claims 17-20, 22, 27-28, 31, 41-42, 46-47, 50-54 & 57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It is unclear how one would even find or determine the identity of Applicant’s specifically claimed ‘GBP1’ in other plants absent further information on required conserved domain(s) required.
Regarding description in any plant; Claims 17, 41 & 51, from which all other claims depend, encompass methods of modulating nitrogen fixation via reducing or abolishing the function of the protein GBP1 or its encoding sequence (i.e. SEQ ID NO.1) in any and all plants.
Turning to the specification for support to such broad claim, Applicant only describes the genetic manipulation of GBP1 and description of accompanying effects on nitrogen fixation in closely related leguminous species which naturally fix nitrogen, including Medicago, Vicia faba (broad bean) & Pisum sativum (pea) [Specification, p.49, ¶.6; p.50, ¶.5].
Because of this, claims 17, 41 & 51 are rejected as not having been in possession of the inventor, as modulation of nitrogen fixation via modification of GBP1 in any and all plant species is not described by Applicant. Further, prior art does not appear to show any use of GBP1, to confer or modulate nitrogen fixation qualities in plants other than leguminous species which already naturally fix nitrogen.
Therefore, without guidance from the specification as to the methods of making such plants across a diverse and broad range encompassing any and all plants, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Regarding any GBP1 gene; Claims 19, 42 & 52 encompass alleles of GBP1 which encode proteins modulating nitrogen fixation in plants, and having as little as 70% encoding sequence identity to SEQ ID NO.1.
Claims recite a nucleotide with only 70% identity to the 1,992 bp long SEQ ID NO.1 encoding allelic variants of the protein GBP1. This encompasses nucleic acids with ~597 variable nucleotide substitutions, of which a representative number of substitution variants were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of requiring only 70% identity to the encoding nucleotide SEQ ID NO.1. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the GBP1 protein. Making random changes in proteins is unpredictable and therefore Applicant does not appear to be in possession of such proteins as GBP1 having less than 100% identity to SEQ ID NO.1, with any reasonable certainty that they would function properly.
Therefore, without guidance from the specification as to which sequences of 70% identity to SEQ ID NO.1 effectively modulate nitrogen fixation, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
For these reasons, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Their disclosure does not support that they were in possession of functional analogs of FUS1 within Fragaria having as little as 90% identity to SEQ ID NO.2 or with as little as 75% identity to SEQ ID NO.1 & 28.
Regarding phenotypic effects; Claim 17 and its dependents 18-20, 22, 27-28 & 31 include a limitation that abolishing expression of GBP1 increases biomass. This is presented in the alternative (‘or’) indicating that altering GBP1 increases biomass independent of altering to nitrogen fixation properties.
Applicant’s specification describes an increase in biomass as a result of increased available nitrogen, or the presence of nitrogen-fixing microbes [p.1, ¶.1]. They go on to repeatedly describe that biomass is increased a consequence of the modulated (i.e. improved) symbiosis between mutant plants and nitrogen-fixing microbes [p.1, ¶.5; p.11, Figure 8; p.47, Example 5; p.48, ¶6—p.49, ¶.4; p.50, ¶.5; p.52, ¶.3].
Applicant does not describe any effect of altering GBP1 on biomass per se, absent alteration of nitrogen fixation characteristics. It appears the reported increases in biomass are correlated to, or an inherent result of, improved nitrogen fixation.
Therefore, without guidance from the specification as to how one would increase or improve biomass via GBP1 modification independent of nitrogen fixation characteristics, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
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.
Claims 51-54 & 57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for detecting plants with mutant (i.e. not wild-type) alleles of GBP1 genes. This judicial exception is not integrated into a practical application because the claim is to the abstract idea of identifying different alleles in a naturally occurring, polymorphic gene family with only reciting additional elements drawn to of particular optional plant species the method is to be used with.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because Applicant merely presents lists of the various plants that naturally occurring GBP1 orthologs can be detected in. Applicant does not provide any steps in addition to ‘identifying a plant’ having polymorphism or mutation in one of the naturally occurring GBP gene family orthologs, among which there would reasonably be considered to be differences of at least one or more nucleic acids (i.e. polymorphisms) absent evidence to the contrary.
The research literature indicates the GBP family of genes naturally occurs as a series of orthologs in various plant species, and said orthologs vary slightly in sequence (i.e. have polymorphisms) [see p.1134, col.2, ¶.2 in Fliegmann, Journal of Biological Chemistry, Vol. 279, No. 2, Issue of January 9, pp. 1132–1140, 2004; Published 24 Oct 2003]. Detection of differences in natural allelic variants based on sequence polymorphisms (i.e. identifying) is well-understood, routine, and conventional to one skilled in the art of plant breeding. The identification or association of plants with their naturally occurring variants of the widely present GBP alleles in question, and generic comparison of such naturally occurring sequences among plants does not add a meaningful limitation, as it is merely a description of what is essentially a product of nature (i.e. orthologous GBP alleles).
Because of this claims 51-54 & 57 are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Prosecution Insights