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 1-3 were previously pending.
A non-final rejection office action was mailed 16 March 2026.
In response to that 16 March 2026 office action, Applicant filed an amendment/request for reconsideration received 29 May 2026 whereby claims 1-3 were amended. No claims were added or cancelled.
Therefore, claims 1-3 remain pending and under examination.
Affidavit/Declaration under 37 CFR 1.132
Examiner acknowledges the Affidavit by Affiant Ya-Wen Huang (listed inventor) was received on 29 May 2026. Examiner has fully considered the Affiant’s statement and addresses its contents below.
Terminal Disclaimer
The Terminal Disclaimer filed on 29 May 2026 for the following co-pending applications in Table 1 has been reviewed and is accepted/recorded:
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(Table 1)
Information Disclosure Statement
There are no IDSs currently filed in this application.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes
a duty to disclose to the Office all information known to that individual to be material to
patentability as defined in this section.”
Withdrawn Claim Objections
Applicant’s claim amendments were sufficient to overcome the previous claim objections of claims 1-3. Therefore, the objection of claims 1-3 is hereby withdrawn.
Withdrawn Claim Rejections
Claims 1-3 were previously rejected on the grounds of nonstatutory double patenting over the co-pending applications listed in Table 1. Applicant has filed a Terminal Disclaimer for each co-pending application listed in Table 1. Therefore, the rejection of claims 1-3 on the grounds of nonstatutory double patenting is withdrawn.
Maintained Claim Rejections
The following claim rejections are maintained, amended only to reflect Applicant’s claim amendments.
Claim Rejections - 35 USC § 112(a)
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 1-3 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.
Claim 1 contains the limitation of “at least 253 peptides as listed in the specification.” The ‘list’ referred to in claim 1 is the sequence listing ([0002]) incorporated by reference as part of the disclosure and specification ([0003]). Applicant’s sequence listing contains 253 entries, SEQ ID NOs: 1-253, so without any further guidance, it is assumed claim 1 is directed toward SEQ ID NOs: 1-253. However, this gives rise to the rejection of claims 1-3 under 35 USC 112(a) as failing to comply with the written description requirement because the sequence listing is only comprised of 253 peptides. Yet claim 1 recites the solution contains “at least 253 peptides as listed in the specification…” The specification is otherwise silent regarding the specificity of the peptides (e.g., genus of structure, specific amino acid sequences, etc.), so one of ordinary skill is required to rely only on the sequence disclosure. Therefore, claim 1 lacks proper written description as the disclosure fails to demonstrate Applicant had possession of more than 253 peptides as recited in claim 1.
Claims 2 and 3 are rejected here since they depend from and therefore require all limitations of a rejected base claim.
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 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.
Claim 1, step a recites, “…Preparing the KHP solution my mixing 50 kg of feathers whose content is 50% by water and 40 kg of water in a sealed container…” This limitation is unclear because the lack of proper grammar creates ambiguity: does the 50% water refer to a) the solution or b) the feathers?
Claim 1, step c recites, “…using a mass spectrometer to confirm the combination of peptides in the solution to contain at least 253 peptides as listed in the specification where their molecular masses are between 500 and 4,000 Daltons, and the concentration is in the range of 2.0×105 ~ 4.5×105 ppm…” This limitation is unclear for four reasons. First, are the molecular masses ‘between 500 and 4,000 Daltons’ a limitation to a) the sum of the peptides or b) the range for each of the individual peptides in the mixture? Second, it is not clear if the concentration of 2.0×105 ~ 4.5×105 ppm is limiting the peptides in solution as a whole or the concentration of individual peptides within the mixture (or something else altogether). Third, the term “as listed in the specification” can be interpreted as exemplary language (i.e., such as). Therefore, it is unclear if the 253 peptides are necessarily those listed in the sequence disclosure, especially since claim 1 includes an amount of peptides greater than 253. In addition, as set forth in MPEP § 2173.05(s), where possible, claims are to be complete in themselves and incorporation by reference to a section of the specification such as a Figure or a Table is permitted only in exceptional circumstances where there is no practical way to define the invention. If the intended peptides have a sequence identifier provided in the sequence listing, it is suggested the claim be amended to refer to specific sequence identifiers associated with the desired peptides. For examination purposes, no patentable weight will be given to the term “using a mass spectrometer …molecular masses are between… Daltons.”
Claim 1, in its entirety, is drawn to a method of using a keratin hydrolysis peptide (KHP) solution on corn or seedlings to improve the drought tolerance of corn plants, comprising steps a-d. However, steps a-c recite the process by which the KHP solution is made. As such, claim 1 is ambiguous because steps a-c are not directed to a method of using a KHP solution but rather to a method of producing/making a KHP solution. As such, the preamble of the claim creates confusion because in order to use the solution on soil via infusion (i.e., step d), the solution must first be made as recited in steps a-c. Therefore, the body of claim 1 is directed to a method of making a KHP solution (steps a-c) and a method of using a KHP solution (step d), while the preamble of the claim is directed to a method of using a KHP solution.
Because of the inconsistencies and ambiguousness of claim 1, one of ordinary skill in the art could not define the metes and bounds of the claim to determine infringement. Appropriate clarification is required. Claims 2 and 3 are rejected here since they depend from and therefore require all limitations of a rejected base claim.
Response to Arguments
Applicant's arguments filed 29 May 2026 have been fully considered but they are not persuasive.
35 USC 112(a)
First argument is regarding the rejection of the term "at least 253 peptides" in independent claim 1 under 35 USC 112(a). Applicant argues that the phrase ‘at least’ means “equal to” or “more than” in common English usage and “is commonly acceptable in the relevant field and is sufficient to enable a POSITA to practice the claimed invention” (see remarks, p. 2). Applicants also argue this point in the Declaration included in the reply (See Remarks, page 2).
The argument is not persuasive for the following reasons:
Applicant argues enablement when the claims were rejected under the written description requirement. Furthermore, the claims are required to be directed to a specific and distinct subject matter and fully supported by the Speciation. MPEP states:
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 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.
A limitation of "at least 253" is interpreted as from 253 to infinity, not 253, just as anyone receiving an estimate would interpret “at least $100” as from $100 and above. It is also noted that a Declaration cannot redefine the claim language and opinion evidence is only considered when it is not on the ultimate legal conclusion at issue (see MPEP 716.01(c)). Furthermore, the Specification neither supports the presence of more than 253 peptides nor defines the term “at least.”
Applicant has claimed a method of use with functional language, claiming any combination of 253 peptides to infinity is used to improve the drought tolerance of corn plants. As previously stated, Applicant’s sequence listing discloses 253 sequences of peptides identified by SEQ ID NOs: 1-253. However, Applicant does not claim these sequences with particularity but merely states a solution containing at least 253 peptides is capable of improving drought tolerance in corn plants. Furthermore, Applicant’s disclosure does not identify combinations of peptides or the specificity of peptides used in this method (e.g., genus of structure, specific amino acid sequences), and simply changes the ratio of feathers to water in the working examples (Specification, [0027]).
35 USC 112(b)
Applicant’s next argument is regarding the rejection of claims 1-3 under 35 USC 112(b). First, regarding the rejection of claims as being indefinite for reciting the steps of making the solution in a claim to a method of using the solution, Applicant argues that “Examiner is mistaken about the statement that the body of claim 1 is directed to a method of making a KHP solution” (Remarks, p. 4). Applicant further argues that “nowhere in the submitted application claimed a ‘method of making a KHP solution’…ONLY claimed a method of using a specific KHP solution, which is made pursuant to steps a-c” (Remarks, p. 4). This argument is also not persuasive. As the rejection clearly states and Applicant agrees, the claims are directed to a method of using a KHP solution (the preamble), but the majority of steps are directed to a method of making the solution (aka 3 of the 4 steps by Applicant’s own admission). Thus, the claims are directed to more than one statutory class of invention. See MPEP 2173.05(p)(II) and In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
Applicant is encouraged to review USPTO’s claim drafting guidance found here:
https://www.uspto.gov/sites/default/files/documents/Claim%20drafting.pdf
Applicant next argues that the claim recitation of a molecular mass and the concentration range refers to all the peptides in the KHP solution. Applicant further argues the grammatically incorrect recitation of ‘preparing the KHP solution by mixing 50 kg of feathers whose content is 50% water and 40 kg of water in a sealed container’ simply means “50% of the 50 kg of feathers is water” (Remarks, p. 3). This argument is similarly found unpersuasive. Applicant’s argument is not sufficient to overcome the rejection because 1-The claim language is given its broadest reasonable interpretation and should be clear and complete on its own. A Declaration cannot define, change or determine the scope of claims. 2- The claim reads “their molecular masses are”… which can be interpreted as each of the peptides having a molecular mass between 500 and 4,000 Daltons or a total molecular mass of at least 253 peptides is between 500 and 4,000 Daltons. Therefore, the claim language is unclear and one of ordinary skill in the art could not reasonably ascertain the metes and bounds of the claim.
Conclusion
Claims 1-3 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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