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 .
Receipt is acknowledged of Amendments, Remarks (including a Declaration) and a Terminal Disclaimer filed on 03/16/26. Examined claims 1-8 have been canceled and new claims 9-16 have been added. Accordingly, claims 9-16 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 03/16/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of listed Applications has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Application No. TW112137541, filed on 09/28/2023; which papers have been made of record in the file.
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 9-16 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 9, 11, 13 and 15 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 9-16 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 9-16 are rejected as being indefinite because claims 9, 11, 13 and 15 are drawn to a method of using a keratin hydrolysis peptide (KHP) solution on wheat plants to promote the growth and the eventual crop yield, comprising steps a-d. However, steps a-c recite the process of making KHP. Because “preparing and hydrolyzing” is a method of making which is a different statutory class of claims than “a method of using and applying”, the claim is 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). As such, claims 9, 11, 13 and 15 are indefinite because steps a-c are not directed to a method of using KHP but rather to a method of producing/making a KHP solution.
Claim 9-16 are rejected as being indefinite because Step c in instant claims 9, 11, 13 and 15 recite “contain at least 253 peptides”. This is indefinite because the range “at least” encompasses infinity, which is neither possible nor envisioned.
Claim 9-16 are rejected as being indefinite because Step c in instant claims 9, 11, 13 and 15 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 9-16 are rejected as being indefinite because Step c in instant claims 9, 11, 13 and 15 recite “the concentration is in the range of 2.0 x105~ 4.5 x105 ppm” (in claims 9 and 11) and “3.0 x105~ 4.5 x105 ppm” (in claims 13 and 15). 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 3.0 x105~ 4.5 x105 ppm.
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 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juarez et al (WO 2023/001946).
Note: Independent claims 9, 11, 13 and 15 are drawn to a method of using keratin hydrolysis peptide (KHP) solution on wheat plants, wherein the recited steps include preparation of the solution and applying the solution to the soil. 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 including seed, 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).
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 9-16 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 9, 11, 13 and 15, 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 including seed, 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 step d, Juarez et al teach that application can be through different methods including foliar application, irrigation, seed treatments, etc, (See pg. 3, lines 14-18).
Regarding claims 10, 12, 14 and 16, 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).
Juarez et al do not teach or suggest a method comprising mixing 66 kg or 50 Kg of feathers and water, as recited in instant step a of claims 9, 11, 13 and 15. 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 or 185°C and 12 kg/cm2 for a duration of 40 minutes 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).
Juarez does not expressly teach or suggest hydrolyzing the mixture in the container with a temperature and pressure setting of 195°C and 16 kg/cm2 or 185°C and 12 kg/cm2 for a duration of 40 or 80 minutes as recited in instant step b.
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 wheat plant.
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 wheat plant at the growth stage of early budding, as recited in instant claims. 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 wheat plant at the growth stage of fruiting.
Regarding dilution limitation, 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, 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.
Response to Arguments
Applicant's arguments filed 03/16/26 have been fully considered but they are not persuasive.
First argument is regarding the rejection of the term “at least 253 peptides” in independent claims. Applicant argues that “at least…” is commonly used and understood by a POSITA. Applicant relies on examples such as "I need to study for at least two hours", or "The repairs will cost at least $100" as consistent with 2 hours or $100. Applicants also argue this point in a Declaration included in the reply (See Remarks, pages 2-3).
The argument is not persuasive. A claim is required to be directed to a specific and distinct subject matter and fully supported by the Speciation. MPEP states:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Thus, a limitation of “at least 253” is interpreted as from 253 to infinity, not 253, just as anyone receiving an estimate would interpret “at least $100”, as from $100 and above. It is also noted that a Declaration is not for redefining the claim language. Also, it is not permissible for an Applicant to define a term inconstant with its general meaning in the art. Furthermore, the Specification neither supports the presence of more than 253 peptides nor defines the term “at least”.
Next argument is regarding the rejection of claims as being indefinite for reciting the stapes of making the solution in a claim to a method of using the solution. Applicant argues that “This invention does NOT encompass any KHP solutions which can be made from many different keratin-based materials, via different processes, with addition of different chemicals. As such, the claim scope (of each claim) is definite because it is narrowly drawn to the specific KHP solution prepared and the specific steps (including the steps in the dependent claims)” (See Remarks, page 3).
This argument is also not persuasive. The claims are directed to a method of using a KHP solution, but the majority of steps are directed to a method of making the solution. Thus, the claims are directed to more than one statutory class of invention. See MPEP 2173.05(p)(II) and In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
Applicant further argues that the claim recitation of a molecular mass and the concentration range refers to the total number of peptides, “as attested to by the Declaration of the Inventor” (See Remarks, pages 3-4).
This argument is similarly found unpersuasive. The claim language is given its broadest reasonable interpretation and should be clear and complete on its own. A Declaration cannot define, change or determine the scope.
Regarding the rejection of claims under USC 102, as being anticipated by Juarez et al, Applicant argues that Juarez et al do not teach the claimed temperature range and disclose using an enzyme which is “completely NOT intended by, and not relevant to, the teachings in present application” (See Remarks, page 4).
The above argument is neither persuasive nor commensurate with the scope of claims. The rejection has clearly stated a claim interpretation for the rejection of claims under anticipation. The claims are directed to a method of using a KHP solution to a wheat plant by applying the solution to the soil around the wheat plant or seedlings.
Juarez et al clearly anticipate this. They disclose applying a KHP solution to any plant or soil at any stage of development. The solution is also diluted before application. Thus, Juarez et al anticipated all claims and all relevant limitations.
Regarding the argument that Juarez et al teach using enzymes, it is noted that the enzyme is a step in the method of making the solution and is irrelevant to the claimed method of applying the solution to a wheat plant.
Regarding the rejection of claims under USC 103, as being unpatentable over Juarez et al in view of Szoeke, Cheng et al and Yin, Applicant argues that “The first problem related to the citation of these 5 prior arts is that the Examiner did not explain the rationales for the reason to combine them. In other words, other than the fact that some of these prior arts are related to keratin or peptides in general (and the system to catalog the peptides), there is no factual basis to show any teaching, suggestion, or motivation that these prior arts can be combined or viewed together in the same context as the inventive substance introduced in the present application. Apparently, the Examiner's selection of the prior arts is exactly what is not allowed: to "pick and choose from a reference only so much of it as will support a conclusion of obviousness to the exclusion of other parts necessary to a full appreciation of what the reference fairly suggest to" ….. The Examiner simply failed to consider each of the prior arts as a whole” (See Remarks, pages 5-7).
The above argument is not found convincing. Firstly, contrary to Applicant’s opinion of the rejection, the rejection has very clearly and in detail discussed every claim step and every claim limitation and provided more than adequate rational for combining the references.
Secondly, as explained in the rejection and repeated above, the claims are directed to a method of using a KHP solution on a wheat plant by applying the solution to the wheat plant or its soil. Juarez et al alone teaches all of the recited limitations. Thirdly, in the event that one was to consider the method of making the said solution pertinent to the examined claims, the method steps are disclosed in the art and known to one of ordinary skill in the art, and it would have been obvious to one of ordinary skill in the art to incorporate the teachings of the different references into the method sand solutions of Juarez et al with a reasonable expectation of success. For example, Juarez et al teach that keratin can be obtained from feathers, animal hair, nails, hoofs, etc, but discloses using pig hair in the disclosed methods. Szoeke teach that keratin may come from feathers or hair and teaches a method of making a fertilizer from keratin including feathers. It also teaches the amount of feathers used in the said method.
Juarez et al teach a method of making a KHP solution by exposing the keratin and water to a temperature of up to 160 ˚C under pressure. Cheng et al also teach a method of hydrolysing biomass waste such as feathers and teaches incorporating high temperatures including from 180 to 320 ˚C, high pressures and process time. Thus, one of ordinary skill in the art would have been motivated to have incorporated the specific temperature, pressure and times as taught by Cheng et al into the process of Juarez et al to obtain the same or better solution. That is, optimization of parameters is a routine practice and well within the capabilities of one of ordinary skill in the art. Additionally, 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, constituting using a mass spectrometer to confirm the combination of peptides in the solution as recited in step c.
Next argument is that “For Juarez, the use of proteolytic enzyme to conduct the hydrolysis process is NOT taught in present application” (See Remarks, page 7).
Regarding the argument that Juarez et al teach using enzymes, it is noted that the instant claimed method uses the open transitional phrase of “comprising” which allows for the inclusion of unrecited components or steps. Thus, the instant claims encompass including an enzyme in the process. That is the claims do not exclude an enzyme.
Next argument is that “For Szoeke, it explicitly distinguished itself from using "heat treatment under concomitant pressure" while mixing in various chemical compounds (KOH, H3P04, MgSO4, FeSO4, H3B03, ….. to make keratin fertilizer. All of these teachings are the OPPOSITE of present invention's teaching” (See Remarks, page 7).
Regarding the argument that Szoeke teach mixing in various chemical compounds, it is noted that the instant claimed method uses the open transitional phrase of “comprising” which allows for the inclusion of unrecited components or steps. Thus, the instant claims encompass including other components in the process. That is the claims do not exclude the said components. Additionally, the rejection relied upon the process steps as taught by Szoeke, not the entire composition. In this regard the courts have held that “the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant also argues that “For Cheng, the general discussion of biomass waste to produce amino acids has no relevance to the keratin peptide breakdown process and use application taught in the present application. The temperature ranges also are separate and distinct” (See Remarks, page 7).
This argument is also not convincing. The biomass of Cheng et al includes feathers which are broken down by a method of hydrolysis to usable amino acids, i.e building blocks of peptides.
Next Applicant argues that “For Yin, it is a research paper that discussed the OPPOSITE of what is intended by present invention. Yin described that "sell-assemble" process of oligopeptides, under appropriate condition, to form a hierarchical architecture, whereas the present invention aims to break down, aka disassemble, keratin peptides” (See Remarks, page 7).
This argument is similarly not found convincing. Yin et al teach a method of hydrolysis of keratin in water by heating chicken feathers in water to obtain oligopeptides. They disclose and tabulate the influence of different temperatures and time on the dissolution of feathers in distilled water.
Applicant also argues against the teachings of Minkiewicz (See Remarks, page 7), however this reference was not part of the rejection under 103.
In conclusion, the claims are rejected because from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 9-16 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights