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 .
Claims 1-9 have been presented for examination on the merits.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Application No. TW112144620, filed on 11/17/2023; which papers have been made of record in the file.
Claim Objections
Claims 2-3, 5-6 and 8-9 are objected to because a punctuation mark is missing after “of claim …”.
Corrections are required.
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 1-9 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. Claims 1, 4 and 7 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”.
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 1-9 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.
Claims 1-9 are indefinite because claims 1, 4 and 7 recite “a method of using a keratin hydrolysis peptide (KHP) solution to promote …, comprising the steps of a. preparing the KHP solution …. ”. Because “a method of using” is a different statutory class of invention than steps of making the solution, the claims are directed to more than one statutory class of invention. Note: MPEP 2173.05(p)(II). A single claim which claims both an apparatus (or product) and the method steps of using the apparatus (or product) is indefinite because it creates confusion as to when direct infringement occurs. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
Claims 1-9 are rejected as being indefinite because claims 1, 4 and 7 are drawn to a method of using a keratin hydrolysis peptide (KHP) solution to promote the growth of soybean ….., comprising steps a-d. However, steps a-c recite the process of making KHP solution. As such, claims are ambiguous because steps a-c are not directed to a method of using KHP but rather to a method of producing/making a KHP solution. That is, the preamble of the claim is directed to a method of using (applying) while the body of claims are directed to a method of making a KHP solution. Therefore, the claims are rendered indefinite.
Claim 1-9 are rejected as being indefinite because Step a in instant claims 1, 4 and 7 recite “preparing the KHP solution by mixing … kg of feathers whose content is 50% water and 44 Kg of water in a sealed container”. However, it has not been clearly established whether the phrase “50% water” refers to the amount of water present in the sealed container in addition to the feathers or whether the phrase refers to the percentage of water present or retained by the feathers.
Claim 1-9 are rejected as being indefinite because Step a in instant claims 1, 4 and 7 recite “preparing the KHP solution by mixing … kg of feathers whose content is 50% water and 44 Kg of water in a sealed container”. However, it has not clear what the said percentage is based on, is it by mass based on the total mass of the solution, part of it or else, or is it based on volume?
Claim 1-9 are rejected as being indefinite because Step c in instant claims 1, 4 and 7 recite “contain at least 253 peptides”. This is indefinite because the range “at least” encompasses infinity, which is neither possible nor envisioned.
Claim 1-9 are rejected as being indefinite because Step c in instant claims 1, 4 and 7 recite “contain at least 253 peptides… with their molecular masses between 500 and 4000 Dalton”. This is indefinite because it is not clear if the molecular mass is for each peptide or the total number of peptides present.
Claims 1-9 are rejected as being indefinite because Step c in instant claims 1, 4 and 7 recite “the concentration is in the range of 2.0 x105~ 4.5 x105 ppm” (in claims 1 and 4) and “705.9 and 3,194.7 Dalton” (in claim 7). However, it is not clear whether the concentration range is for the presence of at least 253 peptides in the KHP solution or whether each individual peptide has a concentration range of 2.0 x105~ 4.5 x105 ppm or 705.9 and 3,194.7 Dalton.
Remaining claims are rejected for depending on a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juarez et al (WO 2023/001946).
Note: Independent claims 1, 4 and 7 are drawn to a method of using keratin hydrolysis peptide (KHP) solution to promote the growth of soybean …., wherein the recited steps include preparation of the solution and applying the solution to soybean seeds or young seedlings. The claimed method and preamble’s critical step is step d, the step of applying the solution. Thus, not giving the steps of preparing the solution patentable weight, claims are anticipated by Juarez et al as stated below. That is, the method of promoting growth and crop yield can be achieved by a solution made including different steps.
Juarez et al teach 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. 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). Thereby constituting a method of using a KHP solution on wheat plants for the promotion of plant growth and crop yield.
Juarez et al teach that the solutions comprising KHP can be a foliar application (See pg. 3, lines 14-18).
Juarez et al also teach 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).
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 109650946 (Citations from English translation provided).
CN ‘946 teach a method for producing an amino acid liquid fertilizer by using waste feathers characterized by comprising the following steps: performing enzymolysis on feather powder by using a compound enzyme to obtain an enzymolysis liquid, then adding acid protease into the enzymolysis liquid for enzymolysis, filtering after the enzymolysis is finished, and performing enzyme deactivation on the filtrate to obtain an amino acid liquid fertilizer (See abstract and claim 1).
It is disclosed that the feather waste is a rich natural protein resource, the content of crude protein is as high as 85% -90%, and that the amino acid has the functions of regulating and stimulating the growth and development of crops (promoting the germination and growth of seeds, promoting the growth of root systems, regulating the form of the root systems, promoting the growth of leaves, improving the green content of the leaves and the like), improving the quality of the crops, increasing the yield of the crops, improving the disease resistance and the stress resistance of the crops, and promoting the absorption of the crops to other nutrient components (See 2nd page, 3rd and 4th para).
CN ‘946 teach that the feather powder was obtained by high-temperature cooking (cooking feather at 135 ˚C under 0.4 MPa for 30min) (See 1.3.5).
As for the peptide assay, it is disclosed that the peptide content was determined according to the method in the national Standard for Soybean peptide powder (GB/T22492-2008) (See 1.3.3).
CN ‘946 further teach that the as related technical indexes of the national amino acid-containing water-soluble fertilizer liquid product, the small peptide content is 93.94g/kg, and the feather enzymolysis rate is 80.19%.
The hydrolysis conditions were: the mass concentration of a substrate is 10g/100mL (namely 10g of feather meal is added into 100mL of water), the enzyme adding amount is 4500U/g of the substrate, enzymolysis is carried out for 3d under the conditions of 45 ℃, pH8.0 and 180rpm, the content of free amino acid is taken as a main evaluation index, the feather enzymolysis rate is taken as an auxiliary evaluation index, the optimal protease composition for preparing amino acid related products by screening the enzymolysis feather meal is obtained, and each group is repeated for 3 times (See 1.3.6).
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Juarez et al (WO 2023/001946), in view of Szoeke et al (US 8,617,282), Cheng et al. (Bioresource Technology, Volume 99, Issue 9, June 2008, Pages 3337-3341), and Yin et al (Biomacromolecules, 2007, 8, pp. 800-806).
Regarding claims 1, 4 and 7, Juarez et al teach 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. 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 et al teach 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 et al teach 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). Thereby constituting a method of using a KHP solution on wheat plants for the promotion of plant growth and crop yield.
With respect to step a, Juarez et al teach Example 1 where 10000 g of keratin deriving from milled pig hair was processed (see pg. 12, lines 2-4). The keratin with a humidity between 40-60% was introduced into a solid-state bioreactor (see pg. 12, line 11).
Regarding step b, Juarez et al disclose that the decomposed keratin, i.e., the said decomposed keratin containing material is subsequently treated by steam explosion, which is a process in which biomass is treated with hot steam at a temperature from 110 °C to 160°C, under pressure from 1 to 5 bar, that results in a rupture of the keratin fibrous structure. (See pg. 6, lines 22-27).
Regarding the molecular mass and concentration of the peptides in claims 1 and 5, Juarez et al disclose that the said liquid mixture comprises from 1% to 10% by weight of free amino acids, from 15% to 30% by weight of peptides having a molecular weight >10000 Da, from 25% to 40% by weight of peptides having a molecular weight of 10000 Da to 400 Da, and 35% to 50% by weight of peptides having a molecular weight <400Da (See pg. 3, line 30 to pg. 4, line 4 and pg. 10, lines 15-21).
Regarding claims 2, 5 and 8, Juarez et al teach 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, preferably 20% w/v (reading on diluted in ratios of 1:50-500 and applied to soil).
Regarding claims 1-9 in part, Juarez et al teach that application can be through different methods including foliar application, irrigation, seed treatments, etc, (See pg. 3, lines 14-18).
Juarez et al do not teach or suggest a method comprising mixing 66 kg, 50 Kg or 70 Kg of feathers and water, as recited in instant step a of claims 1, 4 and 7 respectively. This is taught by Szoeke et al. Juarez et al also do not expressly teach or suggest hydrolyzing the mixture in the container with a temperature and pressure setting of 195°C and 16 kg/cm2 (in claim 1) or 185°C and 12 kg/cm2 (in claim 4) or 180°C and 13 kg/cm2 (in claim 7) for a duration of 40 or 80 minutes as recited in instant step b. This is taught by Cheng et al.
Szoeke teaches a method of preparing a fertilizer by processing feathers (see Abstract). Szoeke describes a production method with a high amount of organic substances with a stimulative and alternative melioration effect, with use of an additive containing keratin and swine dung (see column 2, lines 3-6). The production process itself is a separation of liquid swine dung with help of a phase separation into two parts—a solid part and a liquid part (see column 2, lines 6-7). The solid part of dung is mixed with substances including keratin, hair, or horns (see column 2, lines 7-8). The basic material, originating from Szoeke’s process, contains 5-50% of keratin substance (see column 2, lines 9-11). Szoeke teaches the production process as follows: substances containing keratin (i.e., feathers) are intermixed with hydrate of lime, and during a permanent mixing in an autoclave, the feathers undergo a process of a heat treatment under concomitant pressure change (see column 2, second paragraph). Szoeke adds that feathers pressed out of water, a step standardly done in poultry processing plant, with a humidity in a range from 25% to 29% (see column 3, lines 59-61). Therefore, out of 300 kg of moist feathers delivered from a poultry processing plant it is possible to obtain about 107 kg of dry feathers (300:2.8 ~107), and about 193 liters of water (see column 3, lines 61-65). Szoeke also teaches that water, up to an amount of 1000 liters, is added into a container with a mixture under preparation that is a basis of a fertilizer (see column 5, lines 3-5); and that 1000 liters of keratin fertilizer with an additive of humic acids in a colloid form thus may contain 107 kg of feathers (see column 5, lines 12-13).
Pursuant to MPEP 2144.05 (I), a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metal Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Therefore, the claimed 66 Kg or 50 kg of feathers would have been suggested to one skilled in the art.
From the teachings of the references, the Examiner recognizes that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process for converting keratin into a liquid mixture comprising peptides and/or amino acids as taught by Juarez, with the teachings of Szoeke in order to arrive at the claimed method of using a KHP solution, comprising instant step a.
One of ordinary skill in the art at before the effective filing date of the claimed invention would have been motivated to do so because a method of preparing a fertilizer by processing feathers under permanent mixing conditions, heat treatment and concomitant pressure change was known to contain 5-50% of keratin substance. One of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success given that Juarez’s process for converting keratin into a liquid mixture comprising peptides and/or amino acids is suitable to be used in the agricultural field as a bio-stimulant; given that the liquid mixture improves and/or stimulates germination, rooting, growth, flowering, curdling and maturation of plants and fruits and can be applied to any type of plant and at any stage of plant development. Also, one of ordinary skill in the art would have had a reasonable expectation of success given that Szoeke’s method of preparing a fertilizer by processing feathers yields 1000 liters of keratin fertilizer that may contain 107 kg of processed feathers. Therefore, modifying Juarez’s process for converting keratin into a liquid mixture comprising peptides and/or amino acids by increasing the amount of feathers to be processed to 107 kg as taught by Szoeke would support the claimed method of using a KHP solution, comprising step a; by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention, pursuant to KSR.
Furthermore, one of ordinary skill in the art can prepare a KHP solution from any amounts of feathers as taught by the references. It is the ratio of feather to added water that results in the desired solution, which one of ordinary skill in the art can adjust.
With respect to step b, Juarez’s method includes a steam explosion step, where the decomposed partially soluble keratin is treated in a continuous process, where the mixture reached a pressure of 2 bar and at a temperature of 120°C, and is kept at this pressure and temperature for 20 minutes (see pg. 12, lines 28-31). Juarez’s steam explosion treatment leads to a solubilization of the proteins, and modification of keratin protein structure (see pg. 13, lines 3-4). The solubilization of the protein material is evident, and this process leads to a mixture containing products that are more- bioavailable with respect to keratin (see pg. 13, lines 5-6). Juarez adds that steam explosion is a process in which biomass is treated with hot steam at a temperature from 110 °C to 160°C, under pressure from 1 to 5 bar, that results in a rupture of the keratin fibrous structure (see pg. 6, lines 24-27).
Cheng et al teach hydrolysis of biomass waste (such as feathers) to produce amino acids in sub- critical water (i.e., high-temperature and high-pressure water) with reaction temperatures from 180 to 320°C (see pg. 3337, Abstract). Cheng’s results show that the controlling of reaction atmosphere, pressure, temperature and time of hydrolysis is very important to obtain high yield of amino acid (see pg. 3337, Abstract). Cheng also reports amino acid yield in dependency on reaction temperature and time; in particular that the effect of reaction temperature and time was investigated for reaction time ranging from 1-50 min at a temperature range from 180 to 320°C (see pg. 3338, right column, second to last paragraph). Cheng adds that at first the yield of amino acids increases with extension of reaction time, then decreases with continued extension of reaction time when time is extended to a certain value and suggests operation of the system at short reaction time and mild temperature condition (see pg. 3339, left column, paragraph 1). Moreover, the amino acid yield in dependency on reaction pressure was also investigated at a range of 3-30MPa, and it was determined that the reaction pressure can be adjusted by the relationship between reaction pressure and V/Vo, where V is the volume of feed injected into vessel and Vo is the volume of vessel (see pg. 3339, left column, last paragraph).
It would have been obvious to one of ordinary skill in the art to optimize the hydrolyzation parameters (i.e., temperature, pressure and duration) as recited in instant step b. because as taught by Cheng et al, controlling of reaction atmosphere, pressure, temperature and time is very important to obtain high yield of amino acids during the hydrolysis of biomass waste such as feathers. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. Therefore, it would have been customary for an artisan of ordinary skill to determine the optimal temperature, pressure and time needed to achieve the desired KHP solution. Thus, an ordinary skilled artisan would have been motivated to modify the temperature, pressure and time taught by Juarez to solubilize the proteins, and modify the keratin protein structure thereby resulting in a liquid mixture comprising peptides and/or amino acids. An ordinary skilled artisan would have been able to utilize the teachings of Cheng to obtain various hydrolysis parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters (i.e., 180°, 13kg/cm2, and a duration of 40 minutes), the optimization of the hydrolysis step as recited in instant step b would have been obvious before the effective filing date of Applicant's invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because it was well-known that hydrolysis of biomass waste, such as feathers in high-temperature and high-pressure water (i.e., sub-critical water) breaks down keratin and produces amino acids. One of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success given that hydrolysis parameters such as temperature, pressure and time/duration of the reaction were known to influence the yield of the target products (i.e., amino acids) as taught by Cheng et al. Also, one of ordinary skill in the art would have had a reasonable expectation of success given that Juarez’s method includes a steam explosion step, which leads to solubilization of the proteins and modification of the keratin protein structure. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because the combined teachings of the prior art are fairly suggestive of the claimed invention, by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention, pursuant to KSR.
With respect to step c. Juarez teaches that the liquid fraction of the keratin hydrolysate comprises peptides having a molecular weight comprised between 150 Da and 10.000 Da and/or free amino acids (see pg. 3, lines 29-31). MPEP 2144.05(1) states that "[i]n the case where the claimed ranges “overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. /n re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Therefore, the claimed molecular mass range would have been obvious to one of ordinary skill in the art since the prior art range (i.e., 150 Da and 10.000 Da) lies within the claimed range (i.e., 500 and 4000 Da). However, Juarez does not expressly teach or suggest using a mass spectrometer to confirm the combination of peptides in the solution, as recited in instant step c.
Yin et al explore the hydrolysis of keratin in water under specific pressure-temperature conditions where the hydrolysis through scission of the protein chain yields oligopeptides (see pg. 800, abstract). Yin shows Fig. 1, depicting MALDI-ToF analysis of the solutions which indicates the presence of peptide sequences (see pg. 803, left column, bottom paragraph). Thereby constituting using a mass spectrometer to confirm the combination of peptides in the solution as recited in step c. Assuming an average of molecular weight of 100 for each amino acid, the obtained peptides are between a sequence of 10 to 18 amino acids in length, suggesting that on hydrolysis a considerable proportion of the amino acid sequence is conserved (see pg. 803, left column, bottom paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Juarez by incorporating MALDI-ToF analysis of Yin, in order to arrive at the instantly claimed method, comprising step c.
With respect to step d. Juarez teaches that the liquid mixture including peptides and/or amino acids obtained, can be applied through different methods such as: foliar application (see pg. 3, lines 10- 12 and 15); thereby constituting the claim limitations recited in instant step d. applying the solution to the leaf surface of the soybean plant.
Regarding claims 2-9 in part, Juarez teaches the liquid mixture including peptides and/or amino acids obtained through the process that can be applied in its different variants to any type of plant, at any stage of plant development and by different methods including foliar application (see pg. 3, lines 10-13).
Thereby constituting where the solution is applied to the leaf surface of the soybean plant at the growth stage of early budding, as recited in instant claims 1-9. Additionally, the liquid mixture is advantageously effective in promoting germination, rooting, growth, flowering, fruit setting and maturation of plants and their fruits (see pg. 3, lines 8-10); thereby constituting where the solution is applied to the leaf surface of the soybean plant at the growth stage of fruiting.
Regarding claims 2, 5 and 8, Juarez et al disclose diluting the mixture with water in a proportion of 15 to 40% by volume. Additionally, Szoeke et al teach adding water, up to an amount of 1000 liters, into a container with a mixture under preparation that is a basis of a fertilizer (see column 5, lines 3-5); and that 1000 liters of keratin fertilizer with an additive of humic acids in a colloid form thus may contain 107 kg of feathers (see column 5, lines 12-13). As such, the combined teachings of Juarez et al and Szoeke et al suggest the claim limitations as recited in instant claims 3-4 and 7-8, where the solution is diluted with water by volume at the ratio of 1:100-1000 or 1:50-500.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references discussed above.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12,527,269. This is a statutory double patenting rejection.
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 2-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5 of U.S. Patent No. 12,527,269. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been anticipated or rendered obvious by the reference claims.
Instant claim 1 is drawn to a method of using a keratin hydrolysis peptide (KHP) solution to promote the growth of soybean under low light conditions, comprising the steps of:
a. Preparing the KHP solution by mixing 66 kg of feathers whose content is 50% water and 44 kg of water in a sealed container;
b. hydrolyzing the mixture in the container with a temperature and pressure setting of 195° C. and 16 kg/cm2 for a duration of 40 minutes;
c. 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; and
d. applying the KHP solution to soybean seeds or the young seedlings.
Instant claim 4 is drawn to the same method wherein the amount of feathers is 50 Kg, added to 40Kg of water and the temperature and pressure settings are 185° C. and 12 kg/cm2, and in claim 7, the amount of feathers is 70 Kg. Instant claims 2-3, 5-6 and 8-9 are drawn to different limitations including the dilution ratio or the application to soil or leaves.
Reference claim 1 is drawn to a method of using a keratin hydrolysis peptide (KHP) solution to increase the fertilizer use efficiency for soybean plants, comprising the steps of:
a. Preparing the KHP solution by mixing 66 kg of feathers whose content is 50% water and 44 kg of water in a sealed container;
b. hydrolyzing the mixture in the container with a temperature and pressure setting of 195° C. and 16 kg/cm2 for a duration of 40 minutes;
c. 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; and
d. applying the solution to the fertilized soil in which the soybean seeds are planted.
Reference claims 2-5 are drawn to limitations of dilution ratios.
Examined claims 2-9 are anticipated by reference claims because the claimed ratio of 1:50-500 and an application to seeds or young seedlings (leaves) is well within the scope of the reference ratios of :100-500.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/408,257 (US 20250145678) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by the reference claims.
Instant claims are delineated above and incorporated herein.
Reference claim 1 is drawn to a method of using a keratin hydrolysis peptide (KHP) solution to enhance the drought tolerance for wheat plants, comprising the steps of:
a. Preparing the KHP solution by mixing 50 kg of feathers whose content is 50% water and 40 kg of water in a sealed container;
b. hydrolyzing the mixture in the container with a temperature and pressure setting of 195° C. and 16 kg/cm2 for a duration of 40 minutes;
c. 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; and
d. applying the solution to soil in which the wheat seeds are planted.
The difference between the instant claims and the reference claim 1 is in the amount of feathers or temperature and pressure degrees. However, the differences are close enough that they would be anticipated and/or are well within the capabilities of the person of ordinary skill in the art to adjust. It is also noted that instant claims and reference claims share the temperature and pressure values and the amount of feathers.
In other words, the recited claims of the instant application are so close to the reference claims that they are not mutually exclusive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/671,837 (US 20250206677) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the reference claims.
Instant claims have been delineated above.
Reference claim 1 is drawn to a method of using a keratin hydrolysis peptide (KHP) solution to enhance the drought tolerance for wheat plants, comprising the steps of:
a. Preparing the KHP solution by putting 70 kg of feathers whose water content is 46% without mixing any water in a sealed container;
b. 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;
c. 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; and
d. applying the solution to the soil containing the wheat seeds.
The difference between the instant claims and the reference claims is in the amount of feathers or temperature and pressure degrees. However, the differences are close enough that they would be anticipated and/or are well within the capabilities of the person of ordinary skill in the art to adjust. The other difference is that instant claims require addition of water in step a, while reference claims do not mix water with feathers.
One of ordinary skill in the art is more than capable of adjusting the amounts of feathers in the process with a reasonable expectation of success. Additionally, it would have been obvious to one of ordinary skill in the art add or not add water to the feathers in step a, as the feathers include an amount of water already and can result in the same hydrolysis process.
In other words, the recited claims of the instant application are so close to the reference claims that they are not mutually exclusive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/536,214 (US 20250081964) in view of Juarez et al (WO 2023/001946) and Minkiewicz et al., Int J Mol Sci. 2019, 20(23):5978, pp. 1-23.
Instant claims have been delineated above.
Reference claim 1 is a method of using a keratin hydrolysis peptide (KHP) solution to promote the ripening, increase the reducing sugars, and decrease the chlorogenic acid of the coffee plant, comprising the steps of:
a. Preparing the KHP solution by preparing and putting 70 kg of feathers whose content is 46% water in a sealed container;
b. 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;
c. using the BIOPEP-UWM database 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; and
d. applying the solution to the leaf surface of the coffee plant.
The differences between the instant claims and reference claims are in the plant type being treated, the amount of feathers and water and the temperature and pressure values. These differences would have been obvious to one of ordinary skill in the art especially in view of Juarez et al and Minkewicz. Juarez et al teach that similar solutions can be applied to any plant and one of ordinary skill in the art is more than capable of adjusting the amount of feathers, water and temperature and pressure to achieve the desired outcome with a reasonable expectation of success. Additionally, it is well known in the art to determine the peptide content of the solution by either mass spectrometer or BIOPEP-UWM™ database, as taught by Minkiewicz. Minkiewicz teaches that BIOPEP-UWM™ database of bioactive peptides has become a popular tool in the research on bioactive peptides because the database is continuously updated and offers the possibility to characterize the presence of bioactive fragments in protein sequences (see pg. 1, abstract). Minkiewicz adds that the BIOPEP-UWM plays the role of a metaserver, enabling access to databases and software useful in research concerning peptides and proteins; for instance, tools supporting proteomics research including mass spectrometry (see pg. 15, last paragraph and pg. 16, Table 6).
Although the claims at issue are not identical, they are not patentably distinct from each other because an ordinary skilled artisan would have been motivated with reasonable expectation of success after reading Juarez and Minkiewicz to combine claims 1-6 of the copending Application 18/536,214 in order to arrive at the claimed method.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/428,193 (US 20250143323) in view of Juarez et al (WO 2023/001946).
Instant claims are delineated above.
Reference claims are drawn to a method of using a keratin hydrolysis peptide (KHP) solution to enhance the production yield of tomato fruits under hot weather condition, comprising the steps of:
a. Preparing the KHP solution by mixing 66 kg of feathers whose content is 50% water and 44 kg of water in a sealed container;
b. hydrolyzing the mixture in the container with a temperature and pressure setting of 195° C. and 16 kg/cm2 for a duration of 40 minutes;
c. 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; and
d. infusing the solution to the soil in which the tomato seedlings are planted.
The differences between the instant claims and reference claims are in the plant type being treated, the amount of feathers and water and the temperature and pressure values. These differences would have been obvious to one of ordinary skill in the art especially in view of Juarez et al. Juarez et al teach that similar solutions can be applied to any plant and one of ordinary skill in the art is more than capable of adjusting the amount of feathers, water and temperature and pressure to achieve the desired outcome with a reasonable expectation of success.
Although the claims at issue are not identical, they are not patentably distinct from each other because an ordinary skilled artisan would have been motivated with reasonable expectation of success after reading Juarez to combine claims 1-8 of the copending Application 18/428,193 in order to arrive at the claimed method. As such, copending application 18/428,193 claims a species of the instantly claimed method. This is a provisional nonstatutory double patenting rejection.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/533,181 (US 20250101072) in view of Juarez et al (W0 2023/001946).
Instant claims are delineated above.
Reference claim 1 is directed to a method of using a keratin hydrolysis peptide (KHP) solution to a tea plant for the enhancement of the tea leaves' flavors, comprising the steps of:
a. Preparing the KHP solution by mixing 50 kg of feathers whose content is 50% water and 40 kg of water in a sealed container;
b. hydrolyzing the mixture in the container with a temperature and pressure setting of 185° C. and 12 kg/cm2 for a duration of 80 minutes;
c. 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; and
d. applying the solution to tea plants at leaf sprouting stage.
The differences between the instant claims and reference claims are in the plant type being treated, the amount of feathers and water and the temperature and pressure values. These differences would have been obvious to one of ordinary skill in the art especially in view of Juarez et al. Juarez et al teach that similar solutions can be applied to any plant and one of ordinary skill in the art is more than capable of adjusting the amount of feathers, water and temperature and pressure to achieve the desired outcome with a reasonable expectation of success.
Although the claims at issue are not identical, they are not patentably distinct from each other because an ordinary skilled artisan would have been motivated with reasonable expectation of success after reading Juarez to combine claims 1-8 of the copending Application 18/533,181 in order to arrive at the claimed method. As such, copending application 18/533,181 claims a species of the instantly claimed method. This is a provisional nonstatutory double patenting rejection.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/643,738 (US 20250169507); 18/531,687 (US 20250081965); 18/409,790 (US 20250113828); 18/409,792 (US 20250136523); 18/537,395 (US 20250081910); 18/656,153 (US 20250187995); 18/758,140 (US 20250212892), 18/643,756 (US 20250176560); 18/758,198 (US 20250212893); 18/642,487 (US 20250324978); 18/748,493 (US 20250214906); 18/418,259 (US 20250128995); 18/534,628 (US 20250084010); 18/412,611 (US 20250128994); 18/412,615 (US 20250136524); 18/642,007 (US 20250160325); 18/645,293 (US 20250160337); 18/645,307 (US 20250160338); 18/658,824 (US 20250194606); 18/389,780 (US 20250081972); 18/403,246 (US 20250113794), 18/536,211 (US 20250107532), 18/645,354 (US 20250331517), and 18/527,787 (US 20250084134) in view of Juarez et al (W0 2023/001946).
Instant claims are delineated above.
Reference claims are directed to similar methods of using a keratin hydrolysis peptide (KHP) solution to a plant for the ….. , comprising the same or similar steps as in instant claims.
The differences between the instant claims and reference claims are in the plant type being treated, the amount of feathers and water and the temperature and pressure values. These differences would have been obvious to one of ordinary skill in the art especially in view of Juarez et al. Juarez et al teach that similar solutions can be applied to any plant and one of ordinary skill in the art is more than capable of adjusting the amount of feathers, water and temperature and pressure to achieve the desired outcome with a reasonable expectation of success.
Although the claims at issue are not identical, they are not patentably distinct from each other because an ordinary skilled artisan would have been motivated with reasonable expectation of success after reading Juarez to combine claims of the listed copending Applications in order to arrive at the claimed method. As such, copending applications claim a species of the instantly claimed method.
These are provisional nonstatutory double patenting rejections. Due to the huge number of co-pending application, the rejections had to be grouped together.
Claims 1-9 are rejected.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights