DETAILED ACTION
Claims 1-10 are pending and being examined on the merits in this office action. Claims filed 6/11/2025 are the claims of record being examined.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed 10/18/2022 is a duplicate of the IDS filed 6/10/2022.
Claim Objections
Claims 1 and 5-10 are objected to because of the following informalities:
Claim 1 recites the acronyms IDL6 and MS which should be written out in full name in first order of appearance in the claims. The claim should be amended to recite “An IDL6 mature polypeptide plant aging promoter, wherein is [[as]] a main functional component, and the IDL6 mature polypeptide comprises [[has]] the (SEQ ID NO:1); the IDL6 mature polypeptide plant aging promoter includes… an MS liquid culture medium; and a concentration of the IDL6 mature polypeptide in the IDL6 mature polypeptide plant aging promoter…”.
The term “MS liquid culture medium” is not expressly defined in the claim or specification. Claim 1 should be amended to more clearly define what is encompassed by the claim term.
Claim 5 should be amended to recite: A preparation method for the IDL6 mature polypeptide plant aging promoter according to claim 1, comprising
i) dissolving IDL6 mature polypeptide power in water to prepare an IDL6 mature polypeptide mother solution with a concentration of 10-13 mmol/L;
ii) adding 2-(N-morpholino)ethanesulfonic acid monohydrate to a prepared MS liquid culture medium to prepare 2-(N-morpholino)ethanesulfonic acid solution, wherein a concentration of 2-(N-morpholino)ethanesulfonic acid in the 2-(N-morpholino)ethanesulfonic acid solution is 2.8-3 mmol/L; adjusting a pH value of the 2-(N-morpholino)ethanesulfonic acid solution to [[be]] 5.8-5.9, and mixing fully and dissolving evenly to obtain the 2-(N-morpholino)ethanesulfonic acid solution; and
iii) adding the to
Clarification is required for the claim term “IDL6 mature polypeptide power”.
Claim 6 should be amended to recite: The preparation method according to claim 5, further comprising iv) [[of]] adding 1-2 v/v%0 of Tween-20.
Claim 7 should be amended to recite: “wherein ;[[,]] or a cotton ball is immersed”.
Claim 8 should be amended to recite: “wherein a concentration of the IDL6 mature polypeptide plant aging promoter
Claim 9 should be amended to remove redundant claim language.
Claim 10 should be amended to recite: “wherein a concentration of the IDL6 mature polypeptide plant aging promoter .
Appropriate correction is required.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
The use of the term Tween-20, which is a trade name or a mark used in commerce, has been noted in this application. 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. See specification at pp. 3 and 5.
Sequence Compliance
This application is objected to because the peptide sequence in the abstract is not associated with a sequence identifier (a SEQ ID NO). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422. Applicant must amend the specification in response to this office action and must confirm that all peptide sequences of the specification are included in the sequence listing. Examiner requests that the Applicants review the specification to confirm that all of the peptides, as required, comply with MPEP § 2421-2422.
Claim Rejections - 35 USC § 112
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 1-8 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 an IDL6 mature polypeptide tobacco or A. thaliana plant aging promoter, does not reasonably provide enablement for an ILD6 mature polypeptide plant aging promoter for any and all plants. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They 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 unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, 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 without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to a mixture of a polypeptide of SEQ ID NO: 1 with a 2-(N-morpholine) ethanesulfonic acid solution at a concentration of 10-13 µmol/L peptide, 2.8-3 mmol/L of the 2-(N-morpholine) ethanesulfonic acid, and a pH of 5.8-5.9. The mixture is an IDL6 mature polypeptide plant aging promoter. The mixture is applied to a plant leaf surface [encompassing any and all plants] to promote plant aging.
Breadth of the Claims
The claims are narrow with respect to the mixture, but broad with respect to the generically claimed “plant aging promoter”. This broadest reasonable interpretation of this language commensurate in scope with the specification is that it encompasses aging promoter/acceleration in any plant.
State of the Prior Art
The claimed peptide is a fragment of a larger polypeptide found in A. thaliana, for instance see UniProt Accession No. A0A178UHG8 (accessed 2/26/2026 at URL rest.uniprot.org/uniprotkb/A0A178UHG8.txt), showing the sequence of SEQ ID NO: 1 occurs in residues 75-95 of the A. thaliana protein. However, the protein sequence is not specifically annotated or discussed elsewhere as promoting plant aging in Arabidopsis or tobacco, nor any other plant species. The art does not suggest that the specific residues of SEQ ID NO: 1 should be utilized alone with the 2-(N-morpholine) ethanesulfonic acid to prepare a mixture that acts as a general plant senescence accelerator across all plant species. Vie et al. (J. Exp. Bot. 68:3557-3571, 2017- cited in IDS filed 6/10/2022) discusses SEQ ID NO: 1 as being a negative modulator of stress response in A. thaliana, but provides no suggestion that it would serve as a plant aging promoter when combined with 2-(N-morpholine) ethanesulfonic acid (abstract, Table 1, pp. 3564-3569). Instead Vie SEQ ID NO:1 combines with Silwet L-77, a surfactant containing a modified trisiloxane (p. 3559).
Similar art by Guo et al., CN 106234415 A- cited in IDS filed 6/10/2022, discusses an IDA mature polypeptide of sequence PIPPSAPSKRHN as being mixed with 2-(N-morpholine) ethanesulfonic to act as a plant senescence accelerator. The Gao reference does not discuss or suggest a IDL6 mature polypeptide as being useful for the same purpose.
Relative Skill of those in the Art
The relative skill of those in the art: MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” /d. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the level of skill in the art (scientists) would be high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Amount of Direction or Guidance Given
The guidance does not establish how the single IDL6 mature polypeptide serves as a generic plant aging promoter across all plant species. The guidance from the specification primarily concerns tobacco rather than all plant species. Plant hormones are discussed regarding plant senescence, for instance auxin and cytokinin as potential inhibitors while ethylene and abscisic acid as potential promoters (p. 1).
Presence/Absence of Working Examples
There are two working examples present, which concern application to A. thaliana leaves or tobacco variety K326 leaves to promote plant aging/senescence. No other plants are discussed or utilized in the working examples.
Quantity of Experimentation Necessary
Given that the claims encompass promotion of senescence of any plant the skilled artisan is faced with an extremely broad genus to test the polypeptide formulation against. The specification offers no indication that the IDL6 mature polypeptide is a universal planting aging/senescence promoter, nor that the pathway is found in a representative number of plant species. The only information concerns A. thaliana and tobacco, from which there is no reasonable nexus to extend to all plant species. The burden is left on the skilled artisan to test against a representative number of species, or determine on their own if there is a common pathway that can be utilized through the IDL6 mature polypeptide application. Such a burden is not routine, but places an undue level of experimentation on the skilled artisan to determine where the scope of the mixture activity ends.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
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 1-4 and 6-10 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.
Claim 1, lines 2-3, 5, and 9 recites the limitation "the plant aging promoter". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 1 should be amended to recite “the IDL6 mature polypeptide plant aging promoter”.
The metes and bounds of claim 1 are deemed to be indefinite. Claim 1 is deemed to be indefinite due to alternative and conflicting claim interpretations. Claim 1 recites an ILD6 mature polypeptide plant aging promoter comprising an IDL6 mature polypeptide (SEQ ID NO:1) and 2-(N-morpholino)ethanesulfonic acid solution. [Referred to hereinafter as “MES” for purposes of discussion].
Under a first claim interpretation, the IDL6 mature polypeptide and MES are in the same composition, e.g. a mixture of the two compounds. Under a second claim interpretation, the IDL6 mature polypeptide and MES are physically separate compounds, not in a mixture together.
The final clause of claim 1 recites [separate for claim clarity]:
a concentration of the IDL6 mature polypeptide in the plant aging promoter is 10-13 pmol/L,
a concentration of 2-(N-morpholino)ethanesulfonic acid in the 2-(N- morpholino)ethanesulfonic acid solution is 2.8-3 mmol/L, and
a pH of the 2-(N-morpholino)ethanesulfonic acid solution is 5.8-5.9.
Examiner expressly notes that the pH and concentration of the solution relate back to MES, not a pH relating to the IDL6 mature polypeptide plant aging promoter. This claim language is consistent with two separate compounds that are not in a mixture, e.g., the 2nd claim interpretation.
However, such an interpretation conflicts with the claimed preparation method. Instant claim 5, last clause recites that the IDL6 mature polypeptide mother solution is added to the 2-(N- morpholino)ethanesulfonic acid solution. The preparation method of claim 5 is consistent with the first claim interpretation; e.g., a mixture of the polypeptide and MES.
Claim 1 should be amended to clarify the physical/structural interactions [e.g., mixture vs separate compounds] between the claimed polypeptide and MES.
Because claims 2-4 and 6-10 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Claims 2-4 each recite the limitation "the plant aging promoter” twice in the respective claims. There is insufficient antecedent basis for this limitation in the claims. To overcome this rejection, the claims should be amended to recite “the IDL6 mature polypeptide plant aging promoter”.
Claims 3, 4, and 6 contain the trademark/trade name Tween-20®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an assistant in the form of a surfactant and, accordingly, the identification/description is indefinite. This indefiniteness applies to all dependent and linked claims.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vie et al. (J. Experimental Botany 68:3557-3571 (2017)- cited in IDS filed 6/10/2022), Vie et al. (J. Experimental Botany 66:5351-5365 (2015), hereinafter referred to as Vie 2) and CN106234415 (published 2016, hereinafter referred to as “‘415”- cited in IDS filed 6/10/2022; English Machine Translation, pp. 1-15).
Inventor Guo is a named inventor of the ‘415 application.
Vie describes IDA-like polypeptides from A. thaliana, including IDL6 (see e.g. Abstract). Vie discloses that the IDA family includes nine genes, including those with roles in plant development (see e.g. p.3558 Col.2). IDL6 is described as being a member of the family and are induced by stress (see e.g. p.3558 Col.2). Specifically, IDL7 residues 75-98 are utilized, which are identical to SEQ ID NO: 1, and demonstrate down-regulation of a large number of genes (see e.g., Table 1, methods, pp.3562-3563, 3566-3569).
The difference between Vie and the claimed invention is that Vie does not disclose use of 2-(N-morpholine) ethanesulfonic acid or that the IDL6 mature polypeptide composition serves to promote plant aging.
The ‘415 application discloses an IDA mature polypeptide plant senescence promoter containing an IDA polypeptide PIPPSAPSKRHN and 2-(N-morpholine) ethanesulfonic acid, where the peptide is at a concentration of 10-13 µM/L, the 2-(N-morpholine) ethanesulfonic acid is at 2.8-3 mmol/L, and the pH is 5.8-5.9 (see e.g. claims 1-3). The ‘415 application further discloses application to tobacco leaves (see e.g. Figures 3 and 4, Example 1).
Vie 2 discloses an examination of IDA family members in Arabidopsis development (see e.g. Abstract). Vie 2 identifies the same IDL6 and IDL7 peptides as found in Vie (see e.g. Table 1, Figure 1). IDL6 and IDL7 are identified as being closest to one another (see e.g. Figure 2B). Vie 2 indicates that gene expression analyses during plant growth demonstrate that high transcript levels of IDL6 and IDL7 are found in later plant development states, suggesting their involvement in plant aging (see e.g., pp.5356-5357; Figure 4). IDL6 and IDL7 are generally expressed upon a variety of stress exposures (see e.g., pp. 5359-5360, Figures 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that since Vie discloses the IDL6 peptide as being a member of the IDA family, Vie 2 discloses that IDL6 is a IDA member involved in plant senescence level, and ‘415 discloses IDA peptides for application to tobacco for plant aging/ senescence, one of ordinary skill could have utilized the Vie IDL6 for the IDA polypeptide of ‘415 and had a reasonable expectation it would be a tobacco plant aging promoter. Since Vie discloses it as being a member of the same family as ‘415 and Vie 2 specifically highlights IDL6 and IDL7 as being IDA-like peptides involved in plant aging/senescence based upon transcriptional assays in Arabidopsis, one of ordinary skill in the art would have expected it to have similar properties as the other IDA peptide of ‘415, including plant aging/senescence activity. Furthermore, since Vie 2 specifically discusses IDL6 and IDL7 as being involved in plant aging, one of ordinary skill in the art has a rationale to utilize those peptides and assess their functionality as compared to IDA as in ‘415. The rationale to utilize IDL6 comes from Vie specifically identifying IDL6 as being from the same family of polypeptides as the ‘415 IDA peptides, and more specifically from Vie 2 identifying IDL6 and IDL7 as being involved in plant aging/senescence. There would have been a reasonable expectation of success because of the Vie 2 disclosure of the plant aging/senescence activity, as well as the Vie art already disclosing that IDL6 had impacts on a large number of stress-related genes. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Accordingly, claim 1 is rendered obvious.
With respect to claim 2, as set forth above the ‘415 application claims ranges encompassing those in claim 2. The ‘415 application also claims these specific amounts (see e.g. claim 4).
With respect to claims 3 and 4, the ‘415 application claims inclusion of 1-2% Tween-20® (e.g., claims 5-6).
With respect to claim 5, the ‘415 application claims a method of preparing the plant aging promoter/ senescence accelerator (see e.g. claim 7).
With respect to claim 6, the ‘415 application claims inclusion of 1-2% Tween-20® in the preparation method (see e.g. claim 8).
With respect to claims 7-10, the ‘415 application also discloses application to tobacco in the amounts claimed (see e.g. Test Treatments 1-3, pp. 13-15, claims 9-10).
Relevant Art Not Relied Upon
CN106614586 (published 2017-cited in IDS filed 6/10/2022) teaches IDL4 mature polypeptide plant senescence accelerator, preparation methods and application (abstract). IDL4 mature polypeptide is PVPASAPSRKHN (claim 1). See English Machine Translation, attached. The IDL4 mature polypeptide plant senescence accelerator comprises a polypeptide, and 2-(N-morpholine) ethanesulfonic acid, where the peptide is at a concentration of 8-10 µM/L, the 2-(N-morpholine) ethanesulfonic acid is at 2.8-3 mmol/L, and the pH is 5.8-6 (see e.g. claims 1-3, paras [0030]-[0032]). The reference further discloses application to tobacco leaves (see e.g. Treatments 1-3).
Conclusion
No claims are allowed.
Claims 1-10 are pending and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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, LIANKO GARYU can be reached at 571-270-7367. 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.
/KRISTINA M HELLMAN/Examiner, Art Unit 1654