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
1. The Office acknowledges the receipt of Applicant’s restriction election filed December 06, 2024. Applicant elects Group IV, claim 2, drawn to a drug comprising the amino acid sequence having SEQ ID NO:1, with traverse.
In the response received on December 06, 2024, Applicant traverses primarily that the inventions of Groups I-V are linked to form a general inventive concept and are in compliance with the unity of invention requirement.
Applicant’s arguments are not found to be persuasive, because the instant application is a national application filed under 35 U.S.C. 111(a). The requirement regarding unity of invention only applies to applications filed under 35 U.S.C. 371. Furthermore, examination of Groups I-V and new claim 5 together would place an undue burden on search and examination as the claims comprise distinct products and processes each requiring unique search queries to identify relevant prior art. Therefore, claims 1 and 3-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.
However, method claims may be rejoined in accordance with In re Ochiai when allowability is indicated.
The requirement is deemed proper and is made FINAL.
Claim Status
2. Claims 1-5 are pending. Claim 2 is examined to the extent of the embodiment comprising SEQ ID NO:1. Claims 1 and 3-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on December 06, 2024.
Priority
3. The Office acknowledges receipt of Applicant’s foreign priority document CN202210763723.1 filed June 29, 2022. No certified translations of priority documents have been received by the Office.
Information Disclosure Statement (IDS)
4. The information disclosure statement (IDS) submitted on June 26, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered only to the extent of the English translations provided. A signed copy is attached.
Specification
5. The disclosure is objected to because of the following:
An acronym should be spelled out in full with the acronym in parentheses at the first recitation of an acronym within the specification. The specification should be amended such that the first recitation of “OsPR6”, “CDS”, and any other acronym is spelled out in full.
The disclosure contains an embedded hyperlink and/or other form of browser-executable code. See p.05, line 2. 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 disclosure appears to be a word-for-word translation into English, contains multiple grammatical and typographical errors, contains unnecessarily complicated syntax, and is difficult to understand. Applicant is recommended to amend the disclosure to comprise more concise and grammatically-correct English.
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. For example, on p. 01, lines 14-15 “A plant disease mainly includes a fungal disease, a bacterial disease, a viral disease, etc.” should be amended to “Plant disease mainly includes a fungal disease, a bacterial disease, a viral disease, etc.” “A” plant disease denotes a singular disease, but the statement results multiple disease sources. An additional example: on p. 08, line 16, “In order to verify that a gene OsPR6 participates” should be amended to “To verify OsPR6 participates”. See below for additional examples excerpted from Applicant’s disclosure.
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From p. 02:
From p. 04:
A close and careful review of the specification is requested.
Appropriate correction is required.
Claim Objections
6. Claim 2 is objected to for the following reasons:
At their first recitation within an independent claim, all acronyms should be spelled out in full with the acronym in parentheses. In line 2, “OsPR6” and “CDS” should be spelled out in full with the acronym in parentheses.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claim 2 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.
In line 3, the metes and bounds of a rice OsPR6 gene with an amino acid sequence shown in SEQ ID NO:1 is unclear, because genes are composed of nucleic acid sequences not amino acid sequences. It is recommended the claim be amended to recite “a protein encoded by the rice OsPR6 gene wherein the protein comprises the amino acid sequence shown in SEQ ID NO. 1”.
The term “drug” in claim 2 is used by the claim to refer to a protein that inhibits growth of M. oryzae, while the accepted meaning generally refers to compositions for the treatment of human and animal diseases. The term is indefinite because the specification does not clearly redefine the term and “drug” is not typically used within the art of plant pathology to refer to antifungal compositions. Given the irregular usage of the term “drug” in claim 2, the metes and bounds of the claim are unclear. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). It is recommended that Applicant amend the claim to recite a “pesticide” or “fungicide” instead of a “drug”.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
9. 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.
Written Description Rejections
10. Claim 2 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 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 has not described portions of OsPR6 that are sufficient for resisting Magnaporthe oryzae.
Claim 2 is drawn to a drug for resisting M. oryzae, comprising a protein with an amino acid sequence show in SEQ ID NO:1, which consists of 100 amino acids. The recitation of “an” amino acid sequence shown in SEQ ID NO:1 does not require the entire sequence of SEQ ID NO:1 and encompasses any sequence comprising at least two tandem amino acids shown in SEQ ID NO:2. As discussed above in the rejection of claim 2 under 35 U.S.C. 112(b), the metes and bounds of the term “drug” are unclear. For the purposes of compact prosecution, the Office interprets a “drug” for resisting M. oryzae to comprise a protein that inhibits the growth or development of M. oryzae in cultures or when expressed in a plant. This interpretation is primarily based on Applicant’s disclosure of the in vivo use of nucleotide sequences encoding SEQ ID NO:1 and in vitro use of SEQ ID NO:1 to inhibit the growth and/or development of M. oryzae (p. 09, second full paragraph; p. 11, second full paragraph). Thus, the claim is broad and encompasses drugs comprising and consisting of proteins with as few as 2 tandem amino acids from SEQ ID NO:1 (2% sequence identity). The limitations encompassing portions and fragments of SEQ ID NO:1 lack adequate written description for the following reasons.
Applicant discloses an increased susceptibility to rice blast in rice comprising an OsPR6 gene knockout (p. 09, second full paragraph), an increased resistance to rice blast in rice overexpressing the full-length OsPR6 CDS (p. 09, second full paragraph), and the in vitro inhibition of appressoria development in M. oryzae cultured with purified a full-length OsPR6-GST fusion protein (p. 11, second full paragraph).
Applicant does not disclose or describe the susceptibility of rice plants expressing only an incomplete portion of OsPR6 to rice blast infection or the ability of an incomplete portion of the OsPR6 protein to inhibit fungal growth or development. While one skilled in the art at the time of filing can express virtually any gene and purify virtually any protein encoded therein, one skilled in the art cannot predict which portions of said protein are sufficient to confer its activity. The state of the art at the time of filing teaches that pathogenesis-related proteins play an important role in disease resistance responses (Hou et al., Plant Cell Reports. 2012; 31:895-904 (U)) and that mutation of as few as 0.006% (7/1173 residues) of the defense-associated protein FLS2 severely impacts normal protein function (Dunning et al., The Plant Cell. 2007; 19(10):3297–3313 (V)). The state of the art at the time of filing does not teach which amino acids in SEQ ID NO:1/OsPR6 are required for its normal protein activity. Thus, Applicant has not disclosed sufficient relevant identifying characteristics to allow one skilled in the art to predictably determine which amino acid sequences shown in SEQ ID NO:1, besides the entirety of SEQ ID NO:1, would be sufficient to confer resistance to or inhibit the development of M. oryzae. Accordingly, there is lack of adequate written 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 2008 online at http://www.uspto.gov/web/menu/written.pdf.
Claim Rejections - 35 USC § 101
11. 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.
12. Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a “drug” comprising a protein having an amino acid sequence shown in SEQ ID NO:1. The Office’s interpretation of claim 2 is as discussed above in the rejections of claim 2 under 35 U.S.C. 112(b) and 35 U.S.C. 112(a). In addition to drugs comprising proteins having the sequence shown in SEQ ID NO:1, claim 2 encompasses drugs consisting of proteins having the sequence shown in SEQ ID NO:1.
In Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.--(June 13, 2013),
the Supreme Court decided that a naturally-occurring nucleic acid or fragment thereof, whether
isolated or not, is not patent-eligible. Therefore, naturally-occurring products, including proteins, are not patentable.
Claim 2 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because neither the claim nor the specification describes additional elements that comprise the “drug” and SEQ ID NO:1 consists of the sequence of a naturally-occurring protein from Oryza sativa (see 01/17/2025 sequence search results, Uniprot, Result 1, Accession ID: A0A8J8XSG7_ORYSJ). The claims and specification recite solely SEQ ID NO:1, the expression of a nucleotide construct encoding SEQ ID NO:1, or SEQ ID NO:3, which comprises SEQ ID NO:1 fused to a GST tag, as the drug inhibiting the growth of M. oryzae without any additional elements.
RESULT 1
A0A8J8XSG7_ORYSJ
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID A0A8J8XSG7_ORYSJ Unreviewed; 100 AA.
AC A0A8J8XSG7;
DT 25-MAY-2022, integrated into UniProtKB/TrEMBL.
DT 25-MAY-2022, sequence version 1.
DT 28-JUN-2023, entry version 3.
DE SubName: Full=Uncharacterized protein {ECO:0000313|EMBL:EEE53143.1};
GN ORFNames=OsJ_35958 {ECO:0000313|EMBL:EEE53143.1};
OS Oryza sativa subsp. japonica (Rice).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; Liliopsida; Poales; Poaceae; BOP clade;
OC Oryzoideae; Oryzeae; Oryzinae; Oryza; Oryza sativa.
OX NCBI_TaxID=39947 {ECO:0000313|EMBL:EEE53143.1};
RN [1] {ECO:0000313|EMBL:EEE53143.1}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RX PubMed=15685292; DOI=10.1371/journal.pbio.0030038;
RA Yu J., Wang J., Lin W., Li S., Li H., Zhou J., Ni P., Dong W., Hu S.,
RA Zeng C., Zhang J., Zhang Y., Li R., Xu Z., Li S., Li X., Zheng H., Cong L.,
RA Lin L., Yin J., Geng J., Li G., Shi J., Liu J., Lv H., Li J., Wang J.,
RA Deng Y., Ran L., Shi X., Wang X., Wu Q., Li C., Ren X., Wang J., Wang X.,
RA Li D., Liu D., Zhang X., Ji Z., Zhao W., Sun Y., Zhang Z., Bao J., Han Y.,
RA Dong L., Ji J., Chen P., Wu S., Liu J., Xiao Y., Bu D., Tan J., Yang L.,
RA Ye C., Zhang J., Xu J., Zhou Y., Yu Y., Zhang B., Zhuang S., Wei H.,
RA Liu B., Lei M., Yu H., Li Y., Xu H., Wei S., He X., Fang L., Zhang Z.,
RA Zhang Y., Huang X., Su Z., Tong W., Li J., Tong Z., Li S., Ye J., Wang L.,
RA Fang L., Lei T., Chen C., Chen H., Xu Z., Li H., Huang H., Zhang F., Xu H.,
RA Li N., Zhao C., Li S., Dong L., Huang Y., Li L., Xi Y., Qi Q., Li W.,
RA Zhang B., Hu W., Zhang Y., Tian X., Jiao Y., Liang X., Jin J., Gao L.,
RA Zheng W., Hao B., Liu S., Wang W., Yuan L., Cao M., McDermott J.,
RA Samudrala R., Wang J., Wong G.K., Yang H.;
RT "The genomes of Oryza sativa: a history of duplications.";
RL PLoS Biol. 3:266-281(2005).
RN [2] {ECO:0000313|EMBL:EEE53143.1}
RP NUCLEOTIDE SEQUENCE.
RA Wang J., Li R., Fan W., Huang Q., Zhang J., Zhou Y., Hu Y., Zi S., Li J.,
RA Ni P., Zheng H., Zhang Y., Zhao M., Hao Q., McDermott J., Samudrala R.,
RA Kristiansen K., Wong G.K.-S.;
RT "Improved gene annotation of the rice (Oryza sativa) genomes.";
RL Submitted (DEC-2008) to the EMBL/GenBank/DDBJ databases.
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DR EMBL; CM000149; EEE53143.1; -; Genomic_DNA.
DR Proteomes; UP000007752; Chromosome 12.
PE 4: Predicted;
FT REGION 37..58
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 100 AA; 11159 MW; 430378F1D77511D8 CRC64;
Query Match 100.0%; Score 533; Length 100;
Best Local Similarity 100.0%;
Matches 100; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MNSTSHFVAISFFHHQLDQTAETREDELVGEDVVAGGGWAEHRGGQEGDSQGQARRRHRR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNSTSHFVAISFFHHQLDQTAETREDELVGEDVVAGGGWAEHRGGQEGDSQGQARRRHRR 60
Qy 61 AAIRHGGARGFSLQPCPNLRRHRRRDASCGLASRIYIALN 100
||||||||||||||||||||||||||||||||||||||||
Db 61 AAIRHGGARGFSLQPCPNLRRHRRRDASCGLASRIYIALN 100
Because claim 2 does not include additional elements that distinguish the claimed drug from the naturally-occurring O. sativa protein, claim 2 encompasses a naturally-occurring product and is not patent-eligible.
Claim Rejections - 35 USC § 102
13. 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.
14. Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Chinese Bulletin of Botany. 2021; 56(6):687-698 (W)).
As discussed above in the rejection of claim 2 under 35 U.S.C. 112(a), “an” amino acid encompasses proteins comprising as little as 2% sequence identity to SEQ ID NO:1 and a “drug” for resisting M. oryzae to comprise a protein that inhibits growth or development of M. oryzae in cultures or when expressed in a plant. As discussed above in the rejection of claim 2 under 25 U.S.C. 112(b), the phrase “encoded by a rice OsPR6 gene” is not given patentable weight, because genes are not comprised of amino acids and the metes and bounds of the phrase is unclear as described in the rejection of claim 2 under 25 U.S.C. 112(b).
Therefore, claim 2 is broad and encompasses a drug for resisting M. oryzae, wherein the drug comprises a protein comprising at least 2% sequence identity to SEQ ID NO:1.
Wang (2021) discloses an O. sativa plant, its pathogen resistance gene OsPR6, and the OsPR6 protein encoded therein (p. 687, Abstract; p. 698, Abstract).
Regarding claim 2, Wang (2021) teaches OsPR6, a protein with an amino acid sequence shown in SEQ ID NO:1 and O. sativa, which inherently comprises said protein (p. 687, Abstract; p. 698, Abstract). Because the function of resisting M. oryzae is inherent to OsPR6 and Wang (2021) teaches both OsPR6 and a species comprising OsPR6, Wang teaches a drug for resisting M. oryzae, wherein an active component of the drug comprises a protein with an amino acid sequence shown in SEQ ID NO:1.
15. Claim 2 is rejected 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Theoretical and Applied Genetics. Jan 2022; 135:173-183 (X), published online 10/04/2021).
The Office’s interpretation of claim 2 is as discussed above.
Wang (2022) discloses the M. oryzae resistance gene Pi65, which encodes a leucine-rich repeat receptor-like kinase (LRR-RLK) from O. sativa japonica, enhanced resistance to M. oryzae in rice overexpressing Pi65, and increased susceptibility to M. oryzae in rice lacking Pi65 due to gene knockouts (Abstract).
Regarding claim 2, Wang (2022) teaches the expression of Pi65 which encodes a protein that has more than 2% sequence identity to SEQ ID NO:1 and confers resistance to M. oryzae (pp. 175-177, “Molecular cloning and functional analysis of Pi65”). Therefore, Wang (2022) teaches a drug for resisting M. oryzae, wherein an active component comprises a protein with an amino acid sequence shown in SEQ ID NO:1.
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
16. No claim is allowed.
Examiner’s Contact Information
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663