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 .
Status of the Claims
Claims 1-4 are pending and under examination.
Priority
Receipt is acknowledged of certified copies of the foreign priority papers required by 37 CFR 1.55. It is noted, that Applicant cannot rely upon the certified copy of the foreign priority application to overcome rejections relying on an intervening reference because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Nucleotide and/or Amino Acid Sequence Disclosures
Applicant’s Sequence Disclosure has been entered.
Oath/Declaration
The submission of the inventor oaths are of record.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Specification (objections)
The disclosure is objected to because of the following informalities: .
a. The specification in paragraph [0017}, line 7 “Recycling or Organic” (should be of)
b. The specification in paragraph [0017], fails to utilize the correct scientific nomenclature for genus/species i.e. Pogostemon cablin and Vigna radiata which should be italicized.
c. The use of the terms Dionex, UltiMate, Orbitrap Fusion Lumos, and Tecan, which
are trade names or marks used in commerce, has been noted in this application. See e.g. in the specification at paragraph [0020], the use of the terms, “Dionex Ultimate 3000 UPLC” ; “Thermal Orbitrap … Tribrid Orbitrap” mass spectrometer which are trade names or trade marks 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.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “Preparing” in step a. should not be capitalized. Appropriate correction is required.
In claim 1, use of the term “infusing the KHP solution to the soil” lacks clarity as to what means are being used and is awkward in the context of the claim. Please consider, revising (consistent with the specification) by substituting “applying” or “mixing into” and indicate support for such language, as appropriate.
In claim 1, step c: the phrase “concentration is in the range of
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38
145
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ppm” is confusing. What does the tilda mean: is it a “dash” or does it correspond to “about”. J With respect to the “ppm” it is unclear as to the intended units. w/w, w/v or a different unitary scheme.
d. In claim 1, the “using” and “confirming” language is awkward.
d. In claim 1,the term “molecular masses are between 500 and 4,000 Daltons lacks clarity regarding whether this limitation refers to each peptide individually.
Correction is required.
Suggested Claim 1 Revision
Regarding revising claim 1 the following suggested modification may be of assistance toward addressing clarity as well as issues raised under 112b discussed below:
SUGGESTED REVISION:
1. A method of using a keratin hydrolysis peptide (KHP) solution to promote the growth of wheat under low temperature condition, comprising the steps of:
preparing the KHP solution by putting 70 kg of feathers whose water content is 46%, in a sealed container without adding any water;
hydrolyzing the feathers in the container with a temperature and pressure setting of 180°C and 13 kg/cm² for 40 minutes to form a KHP solution;
analyzing the KHP solution by mass spectrometry to confirm that the KHP solution contains 253 peptides corresponding to SEQ ID 1-SEQ ID 253, wherein each of the at least 253 peptides has a molecular mass of 500 to 4,000 Daltons, and wherein the total peptide concentration is in the range of 2.0 x10⁵ ppm to 4.5 X 10⁵ ppm; and
infusing the KHP solution to soil containing the wheat seeds.
Note: any claim amendments (including the above suggested language) should indicate where the support can be found in the original specification and claims. Additionally, as emphasized (by italics) in the above suggested claim, relative claim terminology (e.g. “low temperature conditions”) and the term “infusing” should be addressed for the 112b issue discussed below.
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 1-4 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 (and its dependent claims) include the recitation of "at least 253 peptides as listed in the specification". However, the list contains 253 peptides and not more. Therefore, Applicant's Specification does not provide support for "at least 253 peptides" since there is not support for an open upper limit.
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 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.
a. In claim 1: The term “low temperature condition” is a relative term which renders the claim indefinite. The term “low temperature condition” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
b. Claim 1 recites the limitation “the combination of peptides”. There is insufficient antecedent basis for this limitation in the claim.
c. Claim 1 is rejected as indefinite for use of the phrase “as listed in the specification” in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. See MPEP 2173 and 2173.05(r ). The phrase is unclear because it does not specify whether the claim requires peptide identities (e.g. sequences), masses, relative abundance or total count. For purpose of BRI (broadest reasonable interpretation) the limitation will be interpreted to not be limited to a specific peptide or group of peptides. Amending to refer to specifically enumerated peptides by structure (e.g. by SEQ Id.) should be considered to address this issue.
d. In claims 2-4 the limitation: “the solution” lacks clear antecedent basis for this limitation in the claim since there is more than one solution in claim 1 to which this term can be referring back to e.g. ambiguous antecedence
d. In claim 1, the term “infusing the KHP solution to the soil” is indefinite since it is not a “term of art”, it is not defined in the specification; and it is unclear as to the mode, timing, and frequency of application encompassed by use of the term “infusing”. For purposes of BRI, this term will be interpreted broadly as to encompass “applying” and art-recognized means (e.g. mixing into the soil; spraying etc.) for contacting the KHP solution to the soil containing the wheat seeds.
e. In claims 2-4: the ratio e.g. “wherein the solution is diluted with water by volume at the ratio of 1:30-300” is confusing as to the ratio of water as it related to a 2nd component; since the 2nd component is not stated in the claim. Is 1-part KHP solution to 30-300 parts water? Or 1 part solution: total 30-300 parts final mixture? Is the ratio inclusive? Is the unit strictly by volume for both components?
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popko et al. “Effect of the New Plant Growth Biostimulants Based on Amino Acids on Yield and Grain Quality of Winter Wheat”, Molecules 2018, 23, 470: pages 1-13 (herein: Popko) and/or Gezgincioğlu et al. “Chicken feather protein hydrolysate improves cold resistance by upregulating physiologic and biochemical responses of wheat (Triticum aestivum L.)”, Environ Sci Pollut Res Int . 2023 Jan;30(2):3593-3605. doi: 10.1007/s11356-022-22013-z. Epub 2022 Aug 10 (hereinafter: Gezgincioğlu)
in view of
Nurdiawati et al. Liquid feather protein hydrolysate as a potential fertilizer to increase growth and yield of patchouli (Pogostemon cablin Benth) and mung bean (Vigna radiata)" International Journal of Recycling of Organic Waste in Agriculture Vol. 8 No. 3: 221-232 (2019) (herein: Nurdiawati)
Vineis et al. Extraction and Characterization of Keratin from Different Biomasses. In Keratin as a Protein Biopolymer: Extraction from Waste Biomass and Applications (Chapter 3: pages 35-76). Springer (Sharma and Kumar: editors) (hereinafter: Vineis)
Stieger et al. Optimized Fragmentation Improves the Identification of Peptides Cross-Linked by MS-Cleavable Reagents J. Proteome Res. 18 (3): 1363–1370. (2019) (hereinafter: Stieger)
taken separately, or in combination.
Popko teaches the use of “plant growth stimulants” to maximize crop yield and quality, especially under unfavorable for plant growth and development environmental conditions. The role of bio stimulants is to control and accelerate the life processes of plants, increase the resistance to stress and stimulate their development (roots and leaves). Bio stimulants contribute to better seed germination and induce biological activity of plants. One type of bio stimulants is preparations based on amino acids. In the reference method feathers were used as a keratin material for the production of bio stimulants comprising amino acids.
Popko tested the effect of new products based on amino acids produced by chemical hydrolysis of feathers—AminoPrim (at a dose 1.0 L/ha) and AminoHort (at doses 1.0 and 1.25 L/ha) —on the growth, yield and the grain quality of winter wheat. See Abstract. AminoPrim and AminoHort, contain 15% and 20% amino acids, respectively, and 0.27% and 2.1% microelements, respectively. The basic component of both formulations is a liquid containing a highly concentrated mixture of amino acids and short peptides, obtained in the hydrolysis (H2SO4/H3PO4; POCh S.A., Gliwice, Poland) of keratin material (feathers) and then enriched with selected nutrients.
The field experiment was carried out during 2012–2013 (planting day of wheat was 20 October 2012; harvest was on 12 August 2013) on winter wheat (Triticum aestivum L.) variety Tacitus. The field experiments showed that the application of products based on amino acids influenced the increase of wheat grain yield of winter wheat (5.4% and 11%, respectively, for the application of AminoPrim at a dose 1.0 L/ha and AminoHort at dose 1.25 L/ha) when compared to the control group without bio stimulant.
Laboratory tests showed that the use of the tested preparations at different doses also contributed to the increase of the nutrients content in grains, in particular copper (ranging 31–50%), as well as sodium (35–43%), calcium (4.3–7.9%) and molybdenum (3.9–16%).
Popko concluded that biostimulants based on amino acids, tested in the present study, which can be enriched with nutrient supplements is recommended for efficient agricultural production of plants. The study demonstrated a positive effect of the use of preparations with amino acids in the cultivation of winter wheat which was shown to have improved plant vigor and optimum wheant leaf color.
Thus, Popko would render obvious the use of feather keratin hydrolysis peptide (KHP) solution to promote the growth of wheat under low temperature conditions, since the winter wheat is made more hardy to environmental conditions when applied to wheat seeds as demonstrated by their field and laboratory analysis data.
Similarly, Gezgincioğlu teach that chicken feather protein hydrolysate improves cold resistance by upregulating physiologic and biochemical responses of wheat (Triticum aestivum L.).
Gezgincioğlu’s study produced a chicken feather protein hydrolysate (CFPH) by an alkaline process and investigated its effect on the low-temperature response of two wheat cultivars (Triticum aestivum L., cvs. Altındane and Bezostaja). The CFPH contained 19 proteinogenic and 3 non-proteinogenic amino acids, as well as beneficial salts for plant growth. The aqueous solution of CFPH (0.1%, w/v) was applied to seedling leaves before cold stress and then the seedlings (treated and untreated) were transferred to cold conditions (5/2 °C, day/night) for 3 days. The CFPH application increased the expression of Rubisco protein and the contents of photosynthetic pigment, soluble sugar, and free proline while decreasing phenolic content in the leaves of both cultivars under cold stress. The cold application alone increased the levels of reactive oxygen species (ROS) and lipid peroxidation (as malondialdehyde), while CFPH decreased their levels. Compared to cold alone, CFPH stimulated antioxidant enzyme activities in both cultivars. This finding was supported by the changes in isoenzyme profiles of the same enzymes on native PAGE. In addition, CFPH application raised reduced ascorbate and glutathione levels, while decreasing the levels of their oxidized forms. Thus, the results of Gezgincioğlu’s study showed that the application of waste CF-derived CFPH to leaves as a bio stimulant alleviated physiological and antioxidative responses in the wheat seedlings under cold stress, thus having the potential to increase cold-stress tolerance in wheat. See e.g. Abstract; and experimental protocol.
Accordingly, both the Popko and Gezgincioğlu references teach the use a feather keratin hydrolysis peptide (KHP) solution to promote the growth of wheat under low temperature conditions, since the winter wheat is made more hardy to environmental conditions upon application of the keratin hydrolysate to wheat seeds/seedling as demonstrated by their field and laboratory analysis data.
Although both the Popko and Gezgincioğlu references, although teaching steps a. and d. of the instantly claimed method (the application of feather hydrosylate to wheat seeds to improve wheat resistance to low temperatures), the reference teachings differ by failing to teach the high pressure/temperature method (Hydrothermal treatment or HTT) of using feather waste for making the feather keratin hydrolysis peptide (KHP) solution in steps b. and c. as claimed.
However, Nurdiawati, came up with a Hydrothermal treatment (HTT) process utilizing a mixture of α-amylase and protease to hydrolyze feather waste, resulting in a mixture of amino acids, fatty acids, and sugars.
Nurdiawati prepared the liquid product with using 10 kg of feathers and 30 kg of water (biomass: water ratio = 1:3) and the pilot-scale productions, and HTT was conducted at two different operating conditions ( 160 °C, 0.6 MPa and 180 °C, 0.9 MPa) for 30 minutes to convert feathers into a liquid feather-derived protein hydrolysate (FPH) containing nitrogen and amino acids. (see page 223: right column and Fig. 1).
To evaluate the bio stimulant effect of FPH produced from the HTT process on plant growth, FPH (0.5–5 mL/L) and its combination with 50% recommended dose of chemical fertilizers were applied to patchouli and mung bean plants. More particularly, the 0.5–5 mL/L dilution range, as applied as a soil drench or foliar spray led to a conclusion that combining this range with a 50% reduced dose of conventional chemical fertilizers significantly enhances crop yield and fertilizer use efficiency. The reference teaching of 0.5 to 5 mL/L corresponds to an optimal dilution ration of 1:200 to 1:2000 that prevents plant toxicity and maximizes bio-stimulant efficiency.
The following table compares the claim 1 and Nurdiawati Hydrothermal treatment or HTT parameters
Claim 1
Feathers: 70kg
180 celsius
13Kg/cm2
40 min.
Nurdiawati (ref)
Feathers: 10kg
180 celsius
.9MPa (9.18 Kg/cm2)
30 min.
Nurdiawati (ref)
Feathers: 10kg
160 celsius
.6MPa
30 min.
Nurdiawati differs from the instant claim HTT feather hydrolysate method as follows:
1. Reaction parameters: (starting product amount/water content: HTT pressure/time)
A. “waste feather”: ref: 10 Kg/> %H2O vs. 70Kg %H2O (claim 1) ;
B. HTT pressure: ref: 9.18 Kg/cm2 vs. 13 Kg/cm2 (claim 1).
c. HTT time ( ref: 30 min. vs. 40 min. (claim 1). AND
Characterization of the hydrolysate peptide composition by mass spectrometric evaluation
However, the prior art recognizes that the above different reaction parameters are result-effective variables that are subject to design choice depending upon the experimental design criteria.
In this respect, Vineis teaches green methods that obtain sustainable conversion of low-cost keratinous biomasses into proteins or polypeptides, based on the treatment of keratinous biomasses under strong chemical–physical conditions (e.g. high pressures or high temperatures), including keratin extraction assisted by steam explosion and superheated water which are promising. See Vineis: Other Green Methods: bottom of page 64.
Vineis ( 5.4.1 Steam Explosion: pages 65-66) is directed to Steam Explosion (SE) which is a hydrothermal treatment that consists in the use of high pressure saturated steam to rapidly heat the biomass in a continuous or discontinuous reactor at desired temperatures (180–230 °C) for a short time (1–10 min), during which steam enters the material, dissolving it. At the end of treatment, the pressure is rapidly brought back to atmospheric value, obtaining an explosive decompression that further weakens the biomass.
The flash steam explosion was proposed as sustainable and practical pretreatment
to increase the solubility of feathers in deionized water and other buffers or solvents,
such as potassium phosphate (PBS) 0.01 M, pH 7.5, also with 2% urea and
0.2%NaOH (Zhao et al. 2012; Zhang et al. 2015). During the pretreatment step, feathers
were put into the chamber of the steam explosion plant, treated at different steam
pressure (1.4–2 MPa) for a desired time (0.5–5 min) and then exploded within 0.1 s.
The protein extraction yield in different media was found to be correlated to process parameters of the steam explosion. As shown in Fig. 9, the extraction yield increased with increasing the pressure of SFE treatment in all considered media. However, the effect of pressure increase was enhanced for the PBS+Urea (2%) buffer and NaOH (0.05 M). See e.g. Vineis Fig. 9: which compares yield % in different media with feathers treated with SFE (feather steam explosion) at different pressures.
Vineis Section 5.4.3 further describes Superheated Water (page 680 treatment that was applied to keratin extraction from feathers, which were sealed in a pressure cell with water at a concentration of 20 mg/mL and placed in a pre-heated oven. The pressure in the cell increased due to the partial pressure of water (22 bar at 220 °C). As expected, it was found that the dissolution degree depended on the temperature and time of treatment (Fig. 10). An extraction yield of about 98%, was found for 1 h treatment under these conditions and the majority of oligopeptides dissolved in the liquid fraction had a molar mass between 1 and 1.8 kDa (Yin et al. 2007).
Accordingly, Vineis , in different HTT methods, demonstrates that temperature, pressure and time of treatment are “result-effective” variables which are reaction dependent.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). …. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See e.g. MPEP 2144.05
Thus, differences in reaction conditions represent the optimization of result-effective variables by the skill artisan, as supported by the prior art and the caselaw. For example, utilizing 7x more feather (albeit less water) could alter the reference HTT method by performance at the same temperature but utilizing increased pressure for 10 additional minutes to optimize hydrosylation efficiency. Accordingly, the different in the selection of the amount and water content of the starting product as compared to the reference would render obvious modifications of the HTT method (180 degrees) by increasing the pressure for a slightly increased duration (10minuts).
Regarding the failure of the Nurdiawati reference to further isolate and identify the peptide composition of its hydrolysate, the means for performing such a characterization of the peptide composition of such a hydrolysate was well known in the art.
For example, the Stieger reference teaches improved identification of peptides cross-linked in a high-complexity sample by use of high energy C-Trap dissociation (HCD) equipped Mass Spectroscopy (MS). The reference employs an Orbitrap Fusion Lumos Tribrid instrument. Digested peptides were separated using a Dionex UltiMate 3000 high-performance liquid chromatography (HPLC)RSLC nano System prior to MS analysis.
Accordingly, it would be an obvious design choice to one of ordinary skill in the art before the effective filing date to utilize the Stieger mass spectroscopy/HPLC protocol to further identify the (modified) Nurdiawati hydrolysate peptide compositions with a reasonable expectation of success.
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Popko and Gezgincioğlu in view of Nurdiawati, Vinei and Stieger as applied to claim 1 above, and further in view of
--Huang: US2025/0081910 (effectively filed: 9/8/23) (herein: Huang), and
Xia et al. US202501: effectively filed: 12/1/23 (herein: Xia)
(NOTE: the Huang and Xia references share common ownership and common inventorship; and although available under 102(a)(2) are subject to a (b) exception if put forth)
---Juarez et al (WO 2023/001946) (hereinafter Juarez); and
---Malhotra: Water soluble fertilizers in horticultural crops— An appraisal, Indian Journal of Agricultural Sciences 86 (10): 1245–56, October 2016 (hereinafter: Malhotra).
The combined teaching of the Popko and Gezgincioğlu in view of Nurdiawati, Vinei and Stieger references as applied against claim 1 is hereby incorporated by reference in its entirety.
The combined teaching differs from instant claims 2-4 by failing to explicitly teach the “infusion” of a diluted claim 1 hydrolysate in the following hydrolysate/water ratios:
1:30-300 (claim 2); 1:50 (claim 3); and 1:100 (claim 4).
Initially is noted that Nuriwati when evaluating the bio stimulant effect of FPH produced from the HTT process on plant growth, FPH (0.5–5 mL/L) and its combination with 50% recommended dose of chemical fertilizers were applied to patchouli and mung bean plants. More particularly, the 0.5–5 mL/L dilution range, as applied as a soil drench or foliar spray led to a conclusion that combining this range with a 50% reduced dose of conventional chemical fertilizers significantly enhances crop yield and fertilizer use efficiency. The reference teaching of 0.5 to 5 mL/L corresponds to an optimal dilution ration of 1:200 to 1:2000.
Huang discloses a method for using/applying a cotton keratin hydrolysis peptide solution prepared by the steps of: preparing the KHP solution by putting 70 kg of feathers whose content is 46% water in a sealed container, and hydrolyzing the mixture in the container with a temperature and pressure setting of 180 c and 13 kg/cm2 for a duration of 40 minutes (see e.g. claim 5) . Huang teaches the method of using a keratin hydrolysis peptide (“KHP”) solution to enhance the drought-tolerance of the cotton plant.
By selectively choosing specific weights of feathers and water, and treating the mixture, though one embodiment does not have water mixed in, to a high-temperature high-pressure hydrolysis process, the resulting solution was confirmed by Huang to contain at least 253 peptides and then applied to the cotton seeds and the soil around the cotton plants. Optionally, the KHP solution can be diluted by water, as taught in the specification, before applying to the seeds and the soil. Dilution ratios include: 1.25:1-2.5:1; and 1:50-100 and the hydrolysate can be directly applied to the plant seed. See e.g. abstract; claims and examples; particularly [0044-0049].
Accordingly, applying Huang’s keratin hydrolysate HTT method protocol and fertilization use (dilution and direct seed application) to cotton, to a different plant e.g. winter wheat, would render obvious claims 1-4.
Similarly, : Xia is drawn to the same starting product (amount/water feather content); the same Hydrothermal treatment (HTT) process parameter (temp/pressure/time: peptide content) and differs from instant claim 1 (and its dependents) only in not teaching “infusing” wheat seeds (the Xia reference application addresses corn seeds and the means of administration (e.g reference is “foliar” i.e. leaves; while instant claim is “infusion”).
However, the Juarez reference cures the Xia deficiency, by rendering obvious the Xia reference protocol to be applied to different plants includes winter wheat, via both direct (infusion) and indirect (foliar) seed application.
IN this respect, Juarez teaches a process for converting keratin into a liquid mixture comprising peptides and/or amino acids (see Abstract); thereby constituting a keratin hydrolysis peptide (KHP) solution. Although pig hair is the preferred keratin source, the reference contemplates the use of other keratin sources including “animal feathers”. See Background. Juarez's invention is suitable to be used in several technical fields such as, e.g., agriculture, for example as a bio-stimulant (see pg. 1, lines 4-5). Juarez teaches that the liquid mixture may be used to improve and/or stimulate one or more of germination, rooting, growth, flowering, curdling and maturation of plants and fruits (see pg. 11, lines 6-10). Furthermore, Juarez teaches that advantageously, the liquid mixture including peptides and/or amino acids obtained through the process of the invention, can be applied in its different variants to any type of plant, at any stage of plant development, on any soil and form of cultivation, and is also potentially usable in organic farming (see pg. 3, lines 10-14). According, this reference suggests a method of using a KHP solution on wheat plants for the promotion of plant growth and crop yield. Juarez teaches that the KHP solutions can not only be applied to the leaves ( foliar application) but also by irrigation (drench, drip irrigation systems, furrows, etc,). (See pg. 3, lines 14-18). Juarez also teaches that the decomposed keratin containing material is milled into small pieces (microns) that are then diluted into water in a proportion of 15%-40% w/v (reading on diluted in ratios of 1:50-500 and applied to soil).
Finally, Malhotra addresses plant application of liquid e.g. water-soluble fertilizers including “fertigation” and foliar application. It views liquid fertilizers as a special class of fertilizers, that hold very strong promise in protected cultivation, hydroponic/aeroponic or even open field hydroponic for perennial fruit crops. Liquid fertilizers as a means of tailoring nutrient use across critical growth stages, a pre-requisite for better nutrient-use-efficiency. Customized fertilization/fertigation is another potential reality, besides its suitability in site specific nutrient management. See Abstract
Accordingly, the N rich (amino acids/peptides) feather hydrolysate application and water dilution proportions would be dependent upon various factors including soil conditions (temperatures), plant root length; application protocol and nutrient supplementation. Generally, application techniques for closer root applications (e.g. fertigation/ hydroponic mixing directly) would in all likelihood lead to modification (e.g. less water dilution) than other indirect application techniques.
It is noted that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). …. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See e.g. MPEP 2144.05
Thus, it would represent routine optimization to determine the most efficacious (root uptake) hydrolysate dilution given the experiment/agricultural application technique and plant selection. Thus, the instant claim 2-4 proportions are obvious design parameters’ amenable to routine optimization and thus would be obvious to one of ordinary skill in the art before the effective filing date of the instant application.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/643,756 (US202501) in view of Juarez et al. WO2023001946 .
‘756 reference claims 1-4 are drawn to the same starting product (amount/water feather content); the same Hydrothermal treatment (HTT) process parameter (temp/pressure/time: peptide content) and
differs only in not teaching “infusing” wheat seeds e.g. the reference application addresses corn seeds and “foliar” i.e. leaf application.
These differences would have been obvious to one of ordinary skill in the art especially in view of Juarez that teaches that similar seed application techniques can be applied to any plant and one of ordinary skill in the art is more than capable of adjusting the means of application as suggested by Juarez to include “infusion” (direct) seed application.
This is a provisional non-statutory double patenting rejection.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
a. 18748493: claims 1-10
b. 18898195: claims 1-9
c. 18656153: claims 1-8
d. 18408257: claims 1-4-
e. 18412615:claims 1-4
f. 18412611: claims 1-4
g. 18418259 : claims 1-5
h. 18902317: claims 1-4:
in view of Juarez et al. WO2023001946, Popko et al. “Effect of the New Plant Growth Biostimulants Based on Amino Acids on Yield and Grain Quality of Winter Wheat”, Molecules 2018, 23, 470: pages 1-13 (herein: Popko) and/or Gezgincioğlu et al. “Chicken feather protein hydrolysate improves cold resistance by upregulating physiologic and biochemical responses of wheat (Triticum aestivum L.)”, Environ Sci Pollut Res Int . 2023 Jan;30(2):3593-3605. doi: 10.1007/s11356-022-22013-z. Epub 2022 Aug 10 (hereinafter: Gezgincioğlu)
All of the above application claims are drawn to obtaining keratin hydrolysates comprising the same peptide profile from hydrothermal treatment (HTT) utilizing feather waste (65-70 kg:40-50% with/without added water and applying the peptide hydrolysate to crop (wheat/rice/corn) seeds for its bio stimulant plant growth effect under normal or stress (dry/cold etc.) growth conditions:
--Here’s a brief outline of the related applications:
18408257: 1-4: wheat: dilute higher temp/press. (same time1:100-
18412615: 1-4: wheat: dilute higher temp/press. (same time1:100-
18412611: 1-4: corn: dilute 50% 66 kgfeathers: higher temp/press. (same time1:100-500;1:125)
18418259 1-5: corn: dilute 50% (-66 kg) feathers: higher temp/press. (same time1:100-500;1:125)
18902317: 1-4: farming plants/acidity stress:
18748493: 1-10: corn/stress: 70kg/46% (no water): identical t/p/time
18898195: 1-9: rice: identical t/p/time: leaf-spray rice
18656153: 1-8 : tomato (lo light): identical: applying seeds
The above application claims differ in the following respects:
--Method result: growth/in light of various stresses (e.g. lack of light/temperature etc.)
--Type of crop addressed: wheat/rice/corn
--HTT parameters: temperature/pressure (when not identical): temp/pressure elevated
---manner of application of hydrolysate to seed (when different): infusion vs. “apply” to leaf/soil/et.
As discussed in the 103 rejections provided above (incorporated by reference), the bio stimulatory effect of utilizing waste feather keratin protein/peptide hydrolysate when applied (spray/hydroponic/soil mixing etc.) to plants/crops (seed/seed let/leaves) was taught by the Popko and Gezgincioğlu references.
Additionally, Juarez teaches utilizing plant waste (including feathers) with/without additional water in a hydrothermal process to obtain protein/peptide hydrolysate. Juarez further teaches that similar seed application techniques can be applied to any plant seed and one of ordinary skill in the art is more than capable of adjusting the means of application as suggested by Juarez to include “infusion” (direct) seed application.
Further, optimization of result-effective variables (temperature/pressure/concentration amounts) is an obvious design choice to one of ordinary skill in the art.
Thus, the teaching of the claims of the above application, when combined with the teaching of the prior art of record (e.g. Popko/ Gezgincioğlu Juarez) would have rendered obvious instant claims 1-4 to one of ordinary skill in the art prior to the effective filing date.
Relevant Prior Art
-----Paul et al. Waste to Value Aided Fertilizer: An Alternative Cleaning Technique for Poultry Feathers Waste Disposal Annals of Microbiology and Immunology 1(2)1006: pages 1-10. 2018:
The Paul reference recognized the advantages of feather waste for obtaining protein hydrolysates as a means to elevate protein (0.78± 0.001 mg/g of dry wt), total carbohydrate (0.3±0.002 mg/g of dry wt), total chlorophyll (1.52±0.08 mg/g of dry wt), and proline (0.106±0.001 mg/g of dry wt) as valuable plant fertilizer including improving wheat seed germination and growth.
In the Paul study commercially usable feather fertilizer was developed by mixing the feather waste with fly ash, which increased its effectiveness and storage ability and resulted in significantly improved crop yields. Consequently, feather hydrolysates created through the microbial conversion of feather keratin could be a potential bioactive agricultural nitrogen source. See Paul Abstract.
Conclusion
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/BENNETT M CELSA/Primary Examiner , Art Unit 1600
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