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 55-75, are pending. Claims 1-54, are canceled. Claims 62-67, are withdrawn. Claims 55-61 and 68-75, are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendments
Objections withdrawn from action:
Claim objection are added.
The specification objections are amended.
The drawing objections are withdrawn.
Status of Rejections from action:
The rejection for Claims 61, 70 and 73 under 112(b) is added in view of amendment.
The rejection for Claims 55-58, 60, 61 and 73-75 under 101 is modified in view of amendment.
The rejection for Claims 55-61 and 68-74 under 112(a) written description is modified in view of amendment. Because the Applicant amended claims and removed “biologically active fragments” and limited the claims to 95% sequence identity.
The rejection for Claims 55-61 and 68-75 under 112(a) enablement is modified in view of amendment. Because the Applicant amended claims and removed “biologically active fragments” and limited the claims to 95% sequence identity.
The rejection for Claims 55-58, 60, 61, 68-71 and 73-75 under 102(a)(1) is added.
The rejection for Claim 59 under 103 is modified in view of amendment.
Specification
The disclosure is objected to because of the following:
In the specification dated 05/05/2023 (clean copy) the symbols in Table 4 are unclear, because McIntosh et al. 1995 does not address what “12=” denotes. Applicant is advised to reproduce the legend in the Specification.
In the specification dated 05/05/2023 (clean copy), example 2 recites multiple “Ptg” and seems to be a grammatical error. Applicant is advised to amend to “Pgt”
In the specification dated 05/05/2023 (clean copy) on page 41, the disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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.
www.softberry.com
www.edi.ac.uk/Tools/sequence.html
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the Abstract contains grammatical errors such as:
“res is tance”
“gram in is r. sp. tTitici”
Applicant is also reminded that scientific names should be italicized.
Appropriate correction is required.
Claim Objections:
Claims 55-61 and 68-75, are objected to because of the following informalities:
In claims 55-58 and 75, “a sequence as provided in SEQ ID NO:1” should be amended to “the sequence as provided in SEQ ID NO:1” because only one sequence is recited.
In claim 59, “comprises one or more further exogenous polynucleotides” should be amended to “further comprises one or more exogenous polynucleotides” because no exogenous polynucleotide is recited in claim 55.
In claim 75, line 2, “or” should be inserted before “an amino acid sequence”.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 55-61 and 68-75 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.
In claim 55, it is unclear what target population the polypeptide confers resistance to—a particular plant? Is the polynucleotide expressed to confer resistance?
In claim 60, it is unclear whether “one, more or all” means that the claim requires only one of the three recited domains, or the claim requires at least portions of all three domains. For examination purpose, the Office interprets the claim to require only one of the three recited domains.
In claim 60, the metes and bounds of the coiled coil (CC) domain, the nucleotide binding (NB) domain and the leucine rich repeat (LRR) domain are unclear. The claim does not identify the regions of a sequence having 95% sequence identity to SEQ ID NO:1 that constitute these domains.
In claim 61, “the leucine rich repeat (LRR) domain” and “the coiled coil (CC) domain” lack antecedence.
In claim 61, “the leucine rich repeat (LRR) domain or the coiled coil (CC) domain of the polypeptide having a sequence as provided in SEQ ID NO:1” implies that SEQ ID NO:1 is the LRR domain or the CC domain. As these are two structurally different domains, they cannot be the same sequence. Additionally, it would appear that SEQ ID NO:1 is an Sr50 polypeptide that contains the LRR domain and the CC domain. However, the claim indicates that SEQ ID NO:1 is only a domain.
In claim 70(a), “a chimeric vector” should be amended to “the chimeric vector” for proper antecedence.
In regard to claim 73, the recitation of “use of” is unclear. Applicant fails to specify how to use the plant comprising the chimeric vector.
In claim 73, the recitation of “Use” is unclear because it is not known whether Applicant is claiming a method or a product. For examination purpose, the Office interprets the “Use” claim to be a product claim.
Correction and/or clarification is required.
Claim Rejections - 35 USC § 101
Claim 73 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a “Use”. However, no step is recited for said “Use”. It is unclear whether Applicant is claiming a method or a product.
Claim Rejections - 35 USC § 101(amended)
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 55-58, 60, 61 and 73-75 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature. The claims encompass a naturally-occurring gene. Page 25 defines “chimeric vector” as a nucleic acid molecule. The “preferably” embodiments are examples and do not limit or define the “chimeric vector”. The claims state that the chimeric vector comprises a polynucleotide encoding SEQ ID NO:1, operably linked to a promoter. SEQ ID NO:1 is an unmodified sequence from Secale cereale. Thus, the claimed chimeric vector is indistinguishable from a naturally-occurring gene. Naturally-occurring nucleic acid or fragment thereof, whether isolated or not, is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.--(June 13, 2013).
With regard to the embodiments in claims 60 and 61, these are inherent properties of SEQ ID NO:1.
Claim 73 is interpreted by the Office to be a product claim. Wholemeal (claim 74) is an inherent property of the S. cereale seed.
Response to Applicant's Remarks:
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are addressed below.
To the extent Applicant’s traversals apply to the above rejection, Applicant traverses primarily that "A chimeric vector ... ". Chimeric vectors are recognized as manmade constructs to a person having ordinary skill in the art, as they include polynucleotides from two or more sources. If a vector comprised polynucleotides originating from a single source, by definition, it would not be chimeric”.
(Remarks, December 12, 2025, page 10).
This argument has been fully considered but not found persuasive.
In regard to Applicants argument about chimeric vectors are manmade. However, the specification defines a chimeric vector as a nucleic acid. As mentioned above SEQ ID NO:1 is an unmodified sequence from Secale cereale. Applicant may be their own lexicographer. When a definition is given for a particular term in the specification, that definition controls and overrides the art-recognized definition. Here, the definition given for “chimeric vector” does not require “manmade” elements from different sources.
At least for these reasons, the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 55-61 and 68-75, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,566,258 (hereafter ‘258). Although the claims at issue are not identical, they are not patentably distinct from each other because the novelty of both the claims of the instant application and the claims of the ‘258 patent is SEQ ID NO:1. A plant comprising SEQ ID NO:1 of ‘258 renders obvious a chimeric vector comprising SEQ ID NO:1 (claims 55-58 and 75) and plant comprising the chimeric vector (claim 73). Claim 5 of ‘258 recites the exogenous polynucleotide present in claim 59 of the instant application. Claim 12 of ‘258 recites the domains present in claims 60-61 of the instant application. Method claims 68-72 of the instant application are included because these method claims are not restricted in the instant application. It would have been obvious to produce a progeny plant comprising the chimeric vector for propagation purposes (claim 68), identify a plant comprising the chimeric vector (claim 69), produce a plant part such as a seed (claim 70), produce a consumer product such as flour or wholemeal from a seed (claims 71 and 74), and mix the flour or wholemeal with another food ingredient to produce a food product such as bread (claim 72). The species (plant comprising a gene encoding SEQ ID NO:1 of ‘258) renders obvious the genus (a chimeric vector comprising SEQ ID NO:1 operably linked to a promoter) of the instant application.
Claim Rejections - 35 USC § 112(a)(Written Description)
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.
Claims 55-61 and 68-74, 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.
Applicant’s disclosure is as follows.
Applicant transforms susceptible wheat plants with pVecBarSr50 (SEQ ID NO: 12), contained a 7.9 kb PCR-amplified genomic sequence of ScRGA1-A including the native promoter and terminator (2.4 and 1.4 kbp, respectively) and pVecNeoSr50 (SEQ ID NO: 11), contained a 9.7 kb Not1 genomic fragment from BAC p2D7 with larger 5' and 3' regions, within the T-DNA. Both constructs contained ScRGA1-A (SEQ ID NO: 1) including all of its introns as well as the native promoter, but linked to heterologous sequences within a chimeric T-DNA construct, (see page 47 example 5). Transformed plants resulted in Sr50-mediated stem rust resistance against Puccinia graminis Pers. f. sp. tritici (Pgt), strains Ug99 (TTKSK) its derivative TTKST and 98-1,2,3,5,6 (#781219). Any gene with at least 95% sequence identity to SEQ ID NO: 1 having resistance to all P. graminis strains.
The claimed invention lacks adequate written description for the following reasons. Claims 55-61 and 68-74, are directed to a construct comprising SEQ ID NO: 1 which these construct are pVecNeoSr50 (SEQ ID NO: 11) and pVecBarSr50 (SEQ ID NO: 12) containing the nucleic acid sequence, including the non-coding regulatory regions, that was isolated from the natural occurring Secale cereale plant having any structure. Additionally, these polypeptide sequences having at least 95-99% sequence identity to SEQ ID NO: 1, the 95-99% scope encompasses resistance genes obtained from sources other than Secale cereale, whereby their structures and identities are not disclosed, so long as they share at least 95-99% sequence identity to SEQ ID NO: 1. From the disclosure of SEQ ID NO: 1 one skilled in the art cannot predict the structures of other resistance genes from other sources and their allelic variants and sequence having at least 95% sequence identity to SEQ ID NO:1 and having resistance to one or more races of P. graminis. Applicant does not disclose a common structure or motif for resistance genes having 95% sequence identity that would allow one skilled in the art to predict their structures of resistance genes from other sources, including monocots and dicots.
SEQ ID NO:1 was isolated from S. cereale (rye), however, the 95-99% sequence identity encompasses sequences obtained from sources other than S. cereale, whereby their structure and identity are not disclosed, so long as they share at least 95-99% sequence identity to SEQ ID NO:1. The claims encompass mutants and allelic variants of SEQ ID NO:1 and thus imply that structural variants exist in nature, yet no structural variant has been disclosed. The implication is that there is a gene and a protein other than that disclosed which exists in nature, but the structure thereof is not known. The disclosure of SEQ ID NO:1 isolated from S. cereale is not representative of other sequences from other sources having the disease resistance. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine such mutants and allelic variants of other sequences, from another S. cereale or a source other than S. cereale, absent further guidance.
Moreover, while one skilled in the art can generate a population of sequences having at least 95-99% sequence identity to SEQ ID NO:1, one skilled in the art cannot predictably determine which sequence(s) within said population would confer resistance. Applicant failed to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Meaning SEQ ID NO:1 could have between 10-48 different substitutions, deletions, insertions, or additions in any of the remaining position, respectively. There are virtually an ad infinitum number of possible mutations to the recited sequences having at least 95% sequence identity to SEQ ID NO: 1. It is highly unpredictable from an ad infinitum number of possible mutations to predict which mutation or combination of mutations would produce the claimed phenotype. The failure to do so for a representative number of species or common structural features necessary to support the claimed genus. Therefore, the scope of the claimed invention does not allow one skilled in the art to predictably determine other variants for producing the claimed phenotype.
Additionally, since Applicant did not disclose any sequence alignments or conserved regions it would be unpredictable which of these different combination would result in said phenotype without mutating important regions. It is unpredictable which species within the population would also have resistance activity in all plants.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111
Claim Rejections - 35 USC § 112
Claims 55-61 and 68-75, 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 enablement requirement. The claim(s) 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
(A) The breadth of the claims;
The breadth of the claims encompass a vector comprising a polynucleotide encoding a polypeptide which has at least 95% sequence identity to SEQ ID NO: 1 resulting in resistance to all strains of Puccinia graminis, wherein the polynucleotide is operably linked to any homozygous (i.e. native) or heterozygous promoter.
(B) The nature of the invention;
The nature of the claimed invention is directed a chimeric vector comprising SEQ ID NO: 1 (Sr50). Applicant has only enabled transforming Secale cereale using either pVecBarSr50 (SEQ ID NO: 12) and pVecNeoSr50 (SEQ ID NO: 11). Both constructs therefore contained the genomic form of ScRGA1-A (SEQ ID NO: 1) including all of its introns as well as the native promoter, but linked to heterologous sequences within a chimeric T-DNA construct. Applicant is not enabled sequences with at least 95-99% sequence identity to SEQ ID NO: 1 in all plants and having resistance to all Pgt strains.
(C) The state of the prior art;
The state of the art does not identify sequences with at least 95% sequence identity to SEQ ID NO: 1 having resistance of Puccinia graminis or resistance to the entire genus of Pgt strains.
(D) The level of one of ordinary skill;
The level of one ordinary skill in the art is high.
(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based
As stated in the written description rejection above, Applicant has provided enabling guidance for transforming wheat plants with SEQ ID NO: 1 resulting in stem rust resistance.
The claimed invention lacks adequate enabling experimentation for the following reasons. Claims 55-61 and 68-75, are directed to a chimeric vector comprising SEQ ID NO: 1 conferring stem rust resistance to Puccinia graminis.
While one skilled in the art can generate a population of sequences having at least 95-99% sequence identity to SEQ ID NO: 1, it is unpredictable which species within the population would also have Pgt resistance activity. The claims encompass nucleotide insertions, deletions, substitutions, and any combination thereof anywhere within a sequence encoding SEQ ID NO:1. The state of the prior art does not teach a structure and function relationship for sequences that can confer resistance to P. graminis. The disclosure of SEQ ID NO: 1 is not representative of sequences having 95-99% sequence identity to SEQ ID NO: 1 and having Pgt resistance. No common structure or motif is disclosed. Meaning SEQ ID NO:1 could have between 10-48 different substitutions, deletions, insertions, or additions in any of the remaining position, respectively, to confer resistance. No guidance or working examples are provided to allow one skilled in the art predict which region(s) of SEQ ID NO: 1 can be altered, and which region(s) must be conserved to confer resistance. The state of the art teaches that some mutations will retain sequence functional activity while others do not. Thus, for these reasons, one skilled in the art cannot make and use a sequence having 95-99% sequence identity to SEQ ID NO: 1 as commensurate in scope with the claims without undue experimentation.
In regard to claim 75, the specification does not recite a function of how to use sequence within the 90% sequence identity population that have no known function. The claim does not indicate whether the sequence(s) having the 95% sequence identity is required to have a particular functional activity or produce a plant having a particular phenotype. There is no guidance provided for one skilled in the art to predictably determine sequences with at least 95% sequence identity that have an unknown use or function without resorting to random trial and error requiring undue experimentation.
Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
There is insufficient written description and guidance. An unnecessary amount of undue experimentation would be needed to use a chimeric vector or nucleic acid construct to produce plants within the 95-99% sequence identity scope of SEQ ID NO: 1 without enabling a representative number of variant species.
Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Response to Applicant's Remarks:
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are responded below:
To the extent Applicant’s traversals apply to the above rejection, Applicant traverses primarily that because they have provided that CC-NB-LRR” domains are well known in the art and adequately described. (Remarks, 12/22/2025, pages 11-16)
These arguments has been fully considered but not found persuasive.
Regarding the first argument that CC-NB-LRR domains are well understood in the art and described in the specification is unpersuasive. Applicant is arguing limitations not present in the claims. None of the claims requires the CC domain, the NB domain and the LRR domain. While a 95% sequence identity threshold significantly narrows the scope compared to the broader functional claims, a 5% variation in a protein having 956 amino acids which permits 48 amino acid substitutions, additions, and deletions anywhere within SEQ ID NO:1. The Applicant’s reliance on the general CC-NB-LRR domains being well known ignores that these motifs are very sensitive, where a single misses mutation can render the protein inactive despite having 99% sequence identity. The LRR domain acts like a sensor that binds to pathogen associated molecular patterns (PAMPs) or effectors that detect the presence of pathogens. Mutations in such region would render the sensor ineffective and unable to respond to P. graminis, thereby failing to provide the claimed resistance phenotype. This uncertainty undermines the “rational design” assumption, as current tools still struggle to predict functional proteins without undue experimentation. Consequently, the predictability remains low because the specification lacks a representative map of mutable residues within that 5% margin, forcing a person skilled in the art requiring undue experimentation to identify functional resistance genes with the vast scope of the claims.
At least for these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 55-58, 60, 61, 68-71 and 73-75, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mago et al. (Resistance genes for rye stem rust (SrR) and barley powdery mildew (Mla) are located in syntenic regions on short arm of chromosome. 2004 Genome vol. 47,1: 112-21.(previously cited))
The specification states that SrR, Sr50 and SEQ ID NO:1 are the same (p. 1 of the specification of 05/05/2023; p. 8 “KEY TO THE SEQUENCE LISTING).
With regard to claims 55-58 and 75, Mago teaches the rye SrR gene confers resistance to P. graminis (Title). The SrR gene inherently has an operably linked promoter. Thus, the SrR gene of Mago is identical to Applicant’s claimed chimeric vector comprising SEQ ID NO:1.
With regard to claims 60 and 61, the SrR gene of Mago inherently has the coiled coil (CC) domain, a nucleotide binding (NB) domain and a leucine rich repeat (LRR) domain.
With regard to claims 68-71, in the “Materials and methods” section, Mago teaches crossing two parents, wherein one plant comprises the SrR gene, and screening progeny plants for the presence / absence of the SrR gene; obtaining nucleic acid from a plant and screening for the presence / absence of the SrR gene; growing a plant comprising the SrR gene and harvesting the plant part (leaves); and obtaining seed comprising the SrR gene and extracting DNA.
With regard to claim 73, the “Use” claim is interpreted by the Office to be a product claim, and the intended use of said product holds little patentable weight.
With regard to claim 74, the rye seed of Mago inherently contains wholemeal.
Accordingly, the claimed invention is anticipated by the prior art.
Claim 72 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (US 7901725 B2 (A)).
In regard to claim 72, The claim does not require that the flour, wholemeal and starch from the seed contain the chimeric vector. Accordingly, the claim encompass flour, wholemeal and starch from any seed source. Johnson et al. discloses “A food product for human consumption, wherein the food product comprises flour obtained from Phleum spp. seeds” (claim 1). Additionally, example 6 of Johnson et al. discloses combining flour obtained from Timothy seed with another food ingredient.
Therefore, the prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 59, is rejected under 35 U.S.C. 103 as being unpatentable over Mago et al. (Resistance genes for rye stem rust (SrR) and barley powdery mildew (Mla) are located in syntenic regions on short arm of chromosome. 2004 Genome vol. 47,1: 112-21.(previously cited)) and further in view of Lagudah et al., (WO 2010022443 A1 (previously cited)).
a. Regarding claim 59, and the teachings of Mago have been discussed above.
b. Mago does not teach one or more exogenous polynucleotides encoding another plant pathogen resistance polypeptide.
c. Regarding claim 59, Lagudah teaches a chimeric vector comprising one or more exogenous polynucleotides encoding another plant pathogen resistance polypeptide (p. 3, lns. 15-18; p. 30, lns. 7-13).
d. Therefore, prior to the effective filing date, It would have been prima facie obvious for one skilled in the art at the time of filing to include an exogenous polynucleotide encoding another plant pathogen resistance polypeptide with the SrR gene of Mago, such as the polynucleotides of Lagudah, for the purpose of conferring or increasing resistance to a pathogen(s) in a plant. One skilled in the art would have been motivated to do so with a reasonable expectation of success.
Response to Applicant's Remarks:
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are responded below:
To the extent Applicant’s traversals apply to the above rejection, Applicant traverses primarily that “erroneous conclusion that RGA and RGH are synonymous terms. As shown above, RGH1a is from barley, not rye. Any conclusion that these genes are the same or structurally identical is thus erroneous.” Secondly, that Mago only identifies the markers for a large chromosomal segment not the specific gene. Thirdly, it took a lot of work of “more than 10 years passed between the teachings of Mago 2004 and the cloning described by the present specification. Applicant thus submits that any assumption or conclusion that the Sr50 phenotype was known to be caused by a single gene is erroneous.” (Remarks, 12/22/2025, pages 17-19).
This argument has been fully considered but not found persuasive.
MPEP says, "the Board stated that when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 402-03, 82 USPQ2d at 1390” (MPEP, 2143/section E).
In response to applicant's 1st and 2nd argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the technical distinctions between RGA/RGH and barley versus rye) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Since the current claim language remains broad enough to encompass the structures and sources taught in the Mago reference, the Applicants focus on nomenclature and origin represents a distinction without legal difference.
Mago establishes RGH1a as a specific class of RGA (pg. 118, col.1) and utilizes the “RGA39 probe, derived from the NBS region of one of the Mia1 gene members (RGH1a),” to detect the 3 DNA fragments carrying the resistance gene in the Gabo 1BL.1RS line (i.e. same plant source as the instant application). The study demonstrates that these sequences are specialized members within the broader genus of RGA’s. Specifically, the RGA39 probe leverages the (MIa1) resistance gene in barley to identify and map the corresponding resistance gene in rye (figs. 2 and 4). This clearly identifies the location of the SrR (Sr50) gene in rye, stating that “RGA39 indicates the presence of barley Mia orthologs on 1RS in the region carrying SrR” (pg.118, col.2 last para.). Therefore, it is technically sound to treat these terms as functionally “synonymous” in this context, as Mago relies on their structural homology to successfully identify the resistance gene in rye. Applicant is advised to amend claims appropriately.
In regard to the third argument regarding complexity and length to develop said construct. The Office agrees and we see the Applicants argument and it was clearly a lot of work. However, the work was done at the time of the prior art was identifying the resistance genes within the Gabo 1BL.1RS line was a known objective at the time of the prior art. Because this is the same source material as disclosed by Mago (see page 113 right column “plant material”), it inherently comprises SEQ ID NO: 1. Unfortunately, the effort was not in making a transgenic plant the reference cited as prior art already captures the very difficult and significant step is identifying the sequence of interest. The subsequent step of testing it out to ensure the efficacy of it being a transgene is of routine in the art and something that could be done by anybody in the lab, as demonstrated in the Lagudah reference.
At least for these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
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