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
1. Claims 1-3 are pending and under examination on the merits.
Priority
2. The Office acknowledges receipt of Applicant’s foreign priority document CN202310645709.6 filed June 02, 2023. No certified English translation of foreign priority document CN202310645709.6 has been received.
Information Disclosure Statement
3. The Information Disclosure Statement (IDS) submitted on May 16, 2024 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
4. The specification is objected to because of the following:
In paragraph [0003], and all subsequent recitations wherein the term refers to the name of a gene, “ZmARGOS9” should be italicized. It is standard in the biological arts to italicize the formal names of genes to distinguish said genes from the proteins encoded therein.
In paragraph [0003], ln. 2, and all subsequent recitations wherein the term “ZmARGOS9 gene” refers to the name of a gene, the article “the” should be inserted before “ZmARGOS9 gene” for the purpose of grammatical correctness.
Correction and/or clarification is required.
Abstract
5. The abstract of the disclosure is objected to because the abstract contains grammatical errors; in lns. 2 and 3-4, the term “ZmARGOS9 gene” should be amended to “the ZmARGOS9 gene”. The article “the” should be inserted before “ZmARGOS9 gene” for grammatical correctness and it is standard in the biological arts to italicize the names of genes to distinguish said genes from the protein products encoded therein. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
6. Claims 1-3 are objected to for the following reasons:
For grammatical correctness, “ZmARGOS9” should be italicized in every instance wherein “ZmARGOS9” refers to a gene name. It is standard in the biological arts to italicize the formal names of genes to distinguish said genes from the proteins encoded therein.
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.
8. Claims 1-3 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.
The metes and bounds of claims 1-3 are indefinite because it is unclear what methods and/or processes are encompassed by the recitation of “implementing”. Neither the claims nor the specification provides a definition for “implementing”. Thus, it is unclear how one might implement a protein, a nucleotide sequence, a recombinant plasmid, or a recombinant microbial strain to achieve the claimed processes, thereby making the metes and bounds of the claims unclear. For the purpose of compact prosecution, the word “implementing” is herein interpreted broadly to encompass any steps, methods, or means of using the recited sequence in accordance with the definitions provided by the Merriam-Webster dictionary (Merriam-Webster. (n.d.). Implement. In Merriam-Webster.com dictionary; available 02/05/2026, (U)). Applicant is required to clarify the intended recitation; no new matter may be added.
Claim Rejections - 35 USC § 101
9. 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.
10. Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
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 patent-eligible. Similarly, naturally-occurring processes are not patent-eligible.
Claims 1-3 are herein assessed for subject matter eligibility under 35 U.S.C. 101 (see: MPEP 2106(III)).
The claims recite a method of improving drought tolerance (claim 1), improving yield (claim 2), and shortening a growth period (claim 3) of maize by implementing a protein that has an amino acid sequence as shown in SEQ ID NO:3.
Claims 1-3 are each directed to a process.
The processes of claims 1-3 are each directed to a natural phenomenon because maize plants naturally comprise a protein comprising SEQ ID NO:3 (see STIC search results) and neither the claims nor the specification provides a clear definition for “implementing”. As discussed above in the rejection of the claims under 35 U.S.C. 112(b), the word “implementing” is herein interpreted broadly to encompass any steps, methods, or means of using the recited sequence (Merriam-Webster. (n.d.). Implement. In Merriam-Webster.com dictionary; available 02/05/2026, (U)). Accordingly, maize plants that naturally comprise a protein having the sequence of SEQ ID NO:3 inherently implement said sequence to perform the functions and/or activities inherent to the sequence (i.e., improving drought tolerance, improving yield, and shortening a growth period). Thus, the implementation of a protein comprising SEQ ID NO:3 is a natural phenomenon.
The claims place no limitations on how the recited protein must be implemented. There are no additional claim elements that apply the judicial exception (i.e., the natural phenomenon of implementing SEQ ID NO:3) in a practical application. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Because claims 1-3 encompass the naturally-occurring process by which maize plants implement SEQ ID NO:3 to promote various aspects of their growth without further defining how said sequence is implemented to distinguish the claimed implementation from a naturally-occurring process, claims 1-3 are directed to a natural phenomenon without significantly more and are not patent-eligible.
Claim Rejections - 35 USC § 112(a)
11. 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.
Enablement
12. Claims 1-3 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 a method comprising SEQ ID NO:2 and/or SEQ ID NO:3, does not reasonably provide enablement for a method comprising sequences comprising only a portion of SEQ ID NO:2 or SEQ ID NO:3. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
When determining whether a claimed invention complies with the enablement requirement, factors to consider include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant discloses the cloning of complementary DNA (cDNA) comprising the protein-coding region of the ZmARGOS9 gene[0063-0064], the construction of a transgenic expression plasmid comprising said coding region[0089-0095], the creation of maize ZmARGOS9 deletion mutants using CRISPR/Cas9-based gene editing[0096-0097], and the function of ZmARGOS9 in promoting drought resistance[0098-0101],[0108-0110], increasing yield[0102-0104], and shortening plant development time[0105-0107] in maize.
Claims 1-3 are broadly directed to methods of enhancing maize growth via the implementation of a protein that has “an amino acid sequence as shown” in SEQ ID NO:3 or a ZmARGOS9 gene that has “a nucleotide sequence as shown” in SEQ ID NO:2. The recitation of an amino acid sequence shown in SEQ ID NO:3 encompasses sequences comprising as few as two tandem amino acid sequences shown in SEQ ID NO:3. Likewise, the recitation of a nucleotide sequence shown in SEQ ID NO:2 encompasses sequences comprising as few as two tandem nucleotide sequences shown in SEQ ID NO:2.
Applicant provides no guidance with regard to how to identify which fragments of SEQ ID NO:2 and SEQ ID NO:3 are sufficient to encode or form a functional protein.
“An” amino acid sequence “shown in” SEQ ID NO:3 could refer to the entirety of SEQ ID NO:3 or any fragment comprising at least two tandem amino acids therein. Therefore, the recitation of a protein that has “an amino acid sequence as shown in” SEQ ID NO:3 permits the use of any portion of SEQ ID NO:3 and does not require the full sequence.
The recitation of a ZmARGOS9 gene that has “a nucleotide sequence as shown in” SEQ ID NO:2 permits the use of any portion of SEQ ID NO:2 and does not require the full sequence. A nucleotide sequence “shown in” SEQ ID NO:2 could refer to the entirety of SEQ ID NO:2 or any fragment comprising at least two tandem nucleotides therein. As such, “a nucleotide sequence” could refer to the entirety of SEQ ID NO:2 or any fragment comprising at least two tandem nucleotides therein.
An expression construct comprising only a fragment of SEQ ID NO:2 or encoding only a fragment of SEQ ID NO:3 would produce a truncated protein, which would not be expected to yield predictable functions such as the improvement of drought tolerance, yield, or development in maize. The art teaches enzymology as one of the most unpredictable areas of biotechnology. Nonaka (Human Molecular Genetics, 2009; 18(18):3353-3364 (V)) teaches that truncation of TDP-43 to its C-terminal fragments causes abnormally phosphorylated and ubiquitinated inclusions of the protein (Abstract). As such, it is clear that not just any truncation of a gene will yield a functional protein when expressed. As broadly as currently claimed, genes that are truncated and therefore encode truncated proteins are not predictably functional and so are not enabled. The claims encompassing the same or use thereof are therefore not enabled to their full scopes and are rejected here.
In making this determination, the Office has weighed each of the Wands factors. The breadth of the claims is found in claims 1-3 drawn to a method of implementing SEQ ID NOs:2-3. The nature of the invention comprises improving the growth and development of maize. The level of skill of one in this art is high. The specification teaches a functional gene of the instant claims as comprising SEQ ID NO:2/SEQ ID NO:3 in its entirety. The state of the prior art does not teach a functional protein consisting of a fragment of SEQ ID NO:3. Applicant discloses no working examples of truncated versions of SEQ ID NO:3. Weighing all of 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.
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.
14. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo et al. (US-2007/0234443-A1, published 10/04/2007 (Applicant’s IDS)).
Regarding claims 1-3, Guo discloses: (i) a protein, wherein the protein has the amino acid sequence shown in instant SEQ ID NO:3 (Table 1; Guo SEQ ID NO:12; see attached STIC search results); (ii) a ZmARGOS9 gene, wherein the ZmARGOS9 gene comprises the nucleotide sequence shown in SEQ ID NO:2 (Table 1; claims 1 and 13; Guo SEQ ID NO:45; see attached STIC search results); (iii) a recombinant plasmid comprising the ZmARGOS9 gene (claims 2, 4-5, 7-8, 9 and 13) and a drought-inducible promoter[0217]; (iv) a recombinant microbial strain comprising the recombinant plasmid[0097-0105], [0106-0112] (claim 3); and (v) a method for enhancing maize yield comprising introducing into a plant cell a recombinant expression cassette comprising the ZmARGOS9 gene operably linked to a promoter (claims 9-13 and 15-18). The Office notes that Guo’s Table 1 incorrectly lists the ZmARGOS9 polynucleotide as SEQ ID NO:12 and the ZmARGOS9 polypeptide as SEQ ID NO:45.
The function and/or activity of a polypeptide is inherent to its sequence. Therefore, the polypeptide disclosed by Guo (SEQ ID NO:12) has the same function and/or activity of the instant SEQ ID NO:3. Thus, Guo’s SEQ ID NO:12 and SEQ ID NO:45 have the same function of improving drought-tolerance, organ size, and crop yield as the instant SEQ ID NO:2 and SEQ ID NO:3 when expressed in maize.
As discussed in MPEP § 2112, "the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id.
Therefore, in teaching a method for improving maize yield by implementing any one of the following substances: (i) a protein, wherein the protein has the amino acid sequence shown in instant SEQ ID NO:3; (ii) a ZmARGOS9 gene, wherein the ZmARGOS9 gene comprises the nucleotide sequence shown in SEQ ID NO:2; (iii) a recombinant plasmid comprising the ZmARGOS9 gene; (iv) a recombinant microbial strain comprising the recombinant plasmid, Guo inherently teaches a method for improving drought resistance and a method for shortening growth period of maize.
Regarding claim 1, Guo teaches a method for improving drought resistance of maize by implementing any one of the following substances: (i) a protein, wherein the protein has the amino acid sequence shown in instant SEQ ID NO:3 (Table 1; Guo SEQ ID NO:12; see attached STIC search results); (ii) a ZmARGOS9 gene, wherein the ZmARGOS9 gene comprises the nucleotide sequence shown in SEQ ID NO:2 (Table 1; claims 1 and 13; Guo SEQ ID NO:45; see attached STIC search results); (iii) a recombinant plasmid comprising the ZmARGOS9 gene (claims 2, 4-5, 7-8, 9 and 13) and a drought-inducible promoter[0217]; and (iv) a recombinant microbial strain comprising the recombinant plasmid[0097-0105], [0106-0112] (claim 3).
Regarding claim 2, Guo teaches a method for improving maize yield by implementing any one of the following substances: (i) a protein, wherein the protein has the amino acid sequence shown in instant SEQ ID NO:3 (Table 1; Guo SEQ ID NO:12; see attached STIC search results); (ii) a ZmARGOS9 gene, wherein the ZmARGOS9 gene comprises the nucleotide sequence shown in SEQ ID NO:2 (Table 1; claims 1 and 13; Guo SEQ ID NO:45; see attached STIC search results); (iii) a recombinant plasmid comprising the ZmARGOS9 gene (claims 2, 4-5, 7-8, 9 and 13); and (iv) a recombinant microbial strain comprising the recombinant plasmid[0097-0105], [0106-0112] (claim 3).
Regarding claim 3, Guo teaches a method for shortening a growth period of maize by implementing any one of the following substances: (i) a protein, wherein the protein has the amino acid sequence shown in instant SEQ ID NO:3 (Table 1; Guo SEQ ID NO:12; see attached STIC search results); (ii) a ZmARGOS9 gene, wherein the ZmARGOS9 gene comprises the nucleotide sequence shown in SEQ ID NO:2 (Table 1; claims 1 and 13; Guo SEQ ID NO:45; see attached STIC search results); (iii) a recombinant plasmid comprising the ZmARGOS9 gene (claims 2, 4-5, 7-8, 9 and 13); and (iv) a recombinant microbial strain comprising the recombinant plasmid[0097-0105], [0106-0112] (claim 3).
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
13. No claim is allowed.
14. Regarding the rejections of claims 1-3 under the Enablement requirement of 35 U.S.C. 112(a), amending the phrase “an amino acid sequence as shown in SEQ ID NO:3” to “the amino acid sequence shown in SEQ ID NO:3” and the phrase “a nucleotide sequence as shown in SEQ ID NO:2” to “the nucleotide sequence shown in SEQ ID NO:2” would obviate the rejections of record under the Enablement requirement of 35 U.S.C. 112(a).
Examiner’s Contact Information
15. 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.
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.
/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663