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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 13, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 19 are examined here-in.
Rejections of “Use” Claims - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12 – 15 are directed to non-statutory subject matter. The claims does not fall within at least one of the four categories of patent eligible subject matter because "use of the enzymatically hydrolyzed mixture… as a biostimulant" and "use of the thermally hydrolyzed mixture… as a biostimulant" is not a process, machine, manufacture, or composition of matter. According to MPEP 2173.05(q), “use” claims that merely recite a use without any active, positive steps delimiting how this use is actually practiced do not fall into one of the four categories of patent eligible subject matter.
For the purposes of this examination, claims 12 - 15 are interpreted as a method claims.
Rejections of “Use” Claims - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12 – 15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The claims as written recite “use of the enzymatically hydrolyzed mixture… as a biostimulant" or "use of the thermally hydrolyzed mixture… as a biostimulant" which is indefinite because it merely recites a use without any active, positive steps delimiting how the use is practiced. See MPEP 2173.05(q).
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 non-obviousness.
Claims 1 – 5, 7 – 13, and 16 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vanoverschelde (EP 3,262,952 B1) in view of Gade (US 2018/0263259 A1).
Vanoverschelde teaches a method for preparing a hydrolysable mixture of feathers or hair (paragraphs 0001, 0016).
Vanoverschelde teaches the process includes procuring a composition (C) which comprises feathers and/or hair and water, which has a dry matter content less than 60 wt%; then pressing out some portion of the water, wherein the remaining solution (B) has a dry matter content greater than that of the initial composition (C); adding an aqueous liquid (A), such that the solution has a dry matter content less than that of the initial composition (this is a mixture of B and A, which is hydrolysable mixture H); then hydrolyzing the mixture (H) (paragraph 0015).
Vanoverschelde teaches the dry matter content of the initial composition (C) is preferably less than 50 wt. % (paragraph 0025).
Vanoverschelde teaches that pressing out water from the initial composition results in some breakdown of the feathers and hair (paragraphs 0031 – 0033).
Vanoverschelde teaches the aqueous liquid (A) added to the composition is enriched with amino acids and proteins (paragraphs 0042 – 0043).
Vanoverschelde teaches the hydrolysable composition (H) can then be treated according to hydrolysis techniques that are known in the art (paragraph 0048). Vanoverschelde teaches thermal hydrolysis of the mixture for 3 to 15 minutes at a pressure of at least 6 bar and a temperature of at least 175 °C (paragraphs 0052 – 0054).
The hydrolysable composition (H) is known as the hydrolyzed mixture (M) after hydrolysis. Vanoverschelde teaches the hydrolyzed mixture (M) can be separated into liquid (L) and solid (S) phases via any suitable equipment, with centrifugation as an example (paragraphs 0062 – 0063).
Vanoverschelde teaches the liquid fraction (L) is an enriched protein-containing liquid (E) (paragraph 0065). Vanoverschelde teaches that some of the liquid fraction (E) can be used as the aqueous liquid (A) that is added to the composition, wherein the dry matter of the liquid fraction (E) is in an amount such that the dry matter of the hydrolysable composition (H) is less than the dry matter of the initial composition (C) (paragraphs 0065 – 0068).
Vanoverschelde teaches the solid phase (S) is dried in a suitable manner at mild temperatures , resulting in a digestible feather or hair composition (paragraphs 0070 – 0077). Vanoverschelde teaches the dried solid can be enriched by adding the enriched liquid (E) before the drying process (paragraph 0076). The solid phase (S) would necessarily have higher protein content than the (L) phase.
Vanoverschelde teaches that the enriched liquid (E) or the digestible feather or hair composition can be used as a fertilizer or as a foodstuff/feed additive for animals (paragraph 0091).
Vanoverschelde does not teach the mixture is enzymatically hydrolyzed.
Gade teaches the missing element of Vanoverschelde.
Gade teaches enzymatic hydrolysis of keratin, such as that found in feathers (abstract, paragraphs 0003, 0053).
Gade teaches that traditional chemical hydrolysis techniques yield incomplete hydrolysis products and contamination with undesirable amino acids and residual salts, however, enzymatic hydrolysis efficiently breaks down peptide bonds in keratin and does not require the use of chemicals, resulting in a food product that is free of undesirable amino acids and residual salts and which has increased palatability and digestibility (paragraphs 0063 – 0066). In Figure 8, Gade shows that the digestibility of hydrolysis product is greater if the hydrolysis product was enzymatically and heat hydrolyzed, rather than with enzymatic hydrolysis alone - Gade reports 89% of the hydrolysis product (enzyme and heat treated) was digestible with Pepsin-HCl in comparison to 74.7% (enzyme treated), (Figure 8, paragraphs 0156, 0161).
Gade teaches thermal hydrolysis can occur prior to, simultaneously, or after enzyme hydrolysis (paragraphs 0005, 0011 – 0013).
Gade teaches that enzymatic hydrolysis may occur at a temperature between 30 and 98 °C and a time period of 30 minutes to 48 hours (paragraphs 0097, 00116 – 0120).
Gade teaches that a sulfite reducing agent may be added to the composition to breakdown the keratin materials (paragraphs 0101, 0115, 0125 – 0126).
Gade teaches that the hydrolyzed product will have 80% of peptides ranging from 0.1 kDa to 1.0 kDa (paragraphs 0038 – 0039).
The combination of Vanoverschelde and Gade’s teachings renders instant claims 1 – 5, 7 – 13, and 16 – 19 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to combine Vanoverschelde and Gade’s teachings for thermal and enzymatic hydrolysis because Gade teaches that the combination of thermal and enzymatic hydrolysis yields more digestible material than with enzymatic hydrolysis alone (Figure 8, paragraphs 0156, 0161). Therefore, the combination of Vanoverschelde and Gade’s teachings is prima facie obvious according to MPEP 2143(i)(a) because each of the elements and techniques were known in the prior art and the combination yields predictable results.
The combination of Vanoverschelde’s teaching for a process to produce a hydrolyzed mixture of feathers and/or hair by procuring a composition (C) which comprises feathers and/or hair and water, which has a dry matter content less than 50 wt%; then pressing out some portion of the water, wherein the remaining solution (B) has a dry matter content greater than that of the initial composition (C); adding an aqueous liquid (A), such that the solution has a dry matter content less than that of the initial composition (this is a mixture of B and A, which is hydrolysable mixture H); thermally hydrolyzing the mixture; separating the hydrolyzed mixture (M) into liquid (L) and solid (S) fractions (paragraphs 0001, 0015 – 0016, 0025, 0031 – 0033, 0042 – 0043, 0053 – 0054, 0065 – 0068 ); in combination with Gade’s teachings for thermal and enzymatic hydrolysis (paragraphs 0005, 0011 – 0013) reads on instant claim 1.
In detail, Vanoverschelde’s teaching for a process to produce a hydrolyzed mixture of feathers and/or hair by procuring a composition (C) which comprises feathers and/or hair and water, which has a dry matter content less than 50 wt% (paragraphs 0001, 0015 – 0016, 0025) reads on the limitation for “providing a composition comprising feathers and/or hair and water, the composition having a dry matter content of less than 50 wt%” recited in instant claim 1. Vanoverschelde’s teaching for dry matter content less than 50 wt% overlaps on the recited 50 wt% recited in the claim. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Vanoverschelde’s teaching for pressing water out of the initial composition (C), resulting in some breakdown of the feathers and hair (paragraphs 0015, 0031 – 0033) reads on the recitation of “pressing at least a part of the water from the composition” in instant claim 1.
Vanoverschelde’s teaching for adding an aqueous liquid (A) creating hydrolysable mixture (H) (paragraph 0015) reads on the recitation of “adding an aqueous liquid to the composition as a result of which a hydrolysable mixture is formed” in claim 1.
Vanoverschelde’s teaching for thermal hydrolysis of the hydrolysable mixture (paragraphs 015, 0053 – 0054) reads on “thermally hydrolyzing the hydrolysable mixture” recited in claim 1.
Vanoverschelde’s teaching that the hydrolyzed mixture (M) can be separated into liquid (L) and solid (S) (paragraphs 0062 – 0063) reads on “at least partially separating solid and liquid phases from the thermally hydrolyzed mixture”. The liquid and solid fractions read on the second and third mixtures recited in the claim. Vanoverschelde’s teaching that the dry matter of the liquid fraction (E) is in an amount such that the dry matter of the hydrolysable composition (H) is less than the dry matter of the initial composition (C) (paragraphs 0065 – 0068), necessarily means that the dry matter of liquid fraction E is ”less than the dry content of the thermally hydrolyzed mixture” as recited in the claim.
Vanoverschelde’s teaching for the solid phase (S), which is dried in a suitable manner at mild temperatures , resulting in a digestible feather or hair composition (paragraphs 0070 – 0077) reads on the limitation of “third mixture with a higher dry matter content” because the solid phase (S) would necessarily have higher protein content than the (L) phase.
Gade’s teachings for thermal and enzymatic hydrolysis (paragraphs 0005, 0011 – 0013) in combination with Vanoverschelde’s teaching that that some of the liquid fraction (E) can be used as the aqueous liquid (A) that is added to the composition, i.e. re-cycled through the hydrolysis process (paragraphs 0065 – 0068) reads on the limitation “the method further comprises enzymatically hydrolyzing the second and/or third mixture” of claim 1.
Gade’s teaching that enzymatic hydrolysis may occur at a temperature between 30 and 98 °C (paragraph 0097) overlaps on the instantly claimed range of 40 to 80°C as recited in claim 2.
Gade’s teaching that enzymatic hydrolysis occurs over a time period of 30 minutes to 48 hours (paragraphs 0116 – 0120) overlaps on the instantly claimed range of 10 minutes to 12 hours recited in claim 3.
Gade’s teaches that a sulfite reducing agent may be added to the composition to breakdown the keratin materials (paragraphs 0101, 0115, 0125 – 0126) reads on disulfide-breaking components of claim 4.
Vanoverschelde’s teaches the solid phase (S) is dried in a suitable manner at mild temperatures, such as by a band or belt dryer, a fluid bed dryer, or a conveyor dryer (paragraph 0071) reads on instant claim 5.
Vanoverschelde’s teaching that thermal hydrolysis may occur for 3 to 15 minutes (paragraph 0052) overlaps on the claimed range of 10 seconds to 4 hours as recited in claim 7.
As discussed above, the dry matter content of the liquid phase (L) after separation from the solid phase (S) would be expected to be less than 50 wt% of the composition because Vanoverschelde teaches that the dry matter of the liquid fraction (L) is in an amount such that the dry matter of the hydrolysable composition (H), which is a combination of (B) and (A), is less than the dry matter of the initial composition (C) (paragraphs 0065 – 0068), necessarily meaning that the dry matter of liquid fraction (L) is less than (C), where (C) was previously specified to be less than 50 wt% (paragraphs 0015 – 0016, 0025). Said differently, because (C) has a dry matter content of less than 50% and (C) is a sum of (B) and (A), (B) is less than 50% and (A) is less than 50%; then, since (L) can be (E) which can be (A), (L) is necessarily less than 50%. Dry matter content of liquid phase (L) less than 50 wt% overlaps on the instantly claimed range of between 5 and 30 wt% as recited in claim 8.
The instant claim 9 recites “An enzymatically hydrolyzed mixture obtained according to the method according to claim 1”. The limitation of obtaining an enzymatically hydrolyzed mixture by a method of claim 1 is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Vanoverschelde and Gade’s combined teachings for methods to obtain hydrolyzed mixtures reads on the claimed enzymatically hydrolyzed mixture. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation for “an enzymatically hydrolyzed mixture obtained according to the method of claim 1” is not patentable, in view of the combination of Vanoverschelde and Gade (MPEP 2113).
Gade’s teaching that the hydrolyzed product will have 80% of peptides ranging from 0.1 kDa to 1.0 kDa (paragraphs 0038 – 0039) overlaps on the instantly claimed ranges of “more than 40 wt% of peptides have a molecular mass below 2500 Dalton”, “more than 20 wt% of peptides have a molecular mass below 1000 Dalton”, and “20 – 80% of the peptides in the enzymatically hydrolyzed mixture have a molecular mass below 1000 Dalton” as recited in claims 10, 11, and 19. Notably, 80% of peptides ranging from 0.1 kDa to 1.0 kDa as taught by Gade (paragraphs 0038 – 0039), could result in “10 – 50 wt% of the peptides… have a molecular mass between 1000 and 5000 Dalton” and “5 – 50 wt% of peptides… have a molecular mass between 5000 and 10000 Dalton”, reading on these recitations of claim 19.
Vanoverschelde’s teaching that the digestible feather or hair composition (i.e. hydrolyzed product) can be used as a fertilizer or as a foodstuff/feed additive for animals (paragraph 0091) reads on claim 12. A fertilizer reads on the definition of biostimulant as “a substance applied to plants to increase nutrient efficiency, increase resistance to stress from biotic or abiotic factors, increase productivity and/or improved product quality” from the instant specification (page 4 lines 4 – 6).
Vanoverschelde teaches that the enriched liquid (E) resulting from thermal hydrolysis can be used as a fertilizer or as a foodstuff/feed additive for animals (paragraph 0091) reads on instant claim 13. Notably, instant claim 13 currently has product-by-process language, which is discussed in detail with regards to claim 9, above.
Vanoverschelde’s teaching that thermal hydrolysis of the mixture at a pressure of at least 6 bar and a temperature of at least 175 °C (paragraphs 0053 – 0054) reads on instant claims 16 – 18.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vanoverschelde (as cited above) in view of Gade (as cited above) and further in view of Raythatha (WO 1997/25076).
The combination of Vanoverschelde and Gade is discussed above.
The combination of Vanoverschelde and Gade does not teach adding sulfur-binding components to the composition (claim 6).
Raythatha teaches the missing component of Vanoverschelde and Gade.
Raythatha teaches agricultural compositions often include sulfur-containing compounds, and suggests that there is a need for odor control that doesn’t compromise the activity of such a composition (page 1 lines 12 – 22, page 1 line 34 to page 2 line 7).
Raythatha teaches that polyvalent transition metal compounds are useful for controlling and reducing odor associated with sulfur-containing organic compounds (page 2 lines 9 – 11). Raythatha teaches the polyvalent transition metal is preferably selected from copper, nickel, iron, or zinc compounds and that copper sulfate and zinc sulfates are preferred salts (page 4 lines 27 – 35).
Raythatha teaches polyvalent transition metals control the odor of sulfur-containing organic compounds by binding sulfur (page 6 lines 15 – 21). Raythatha teaches the sulfur-containing organic compound may be in a liquid composition (page 7 lines 32 – 35).
The combination of Vanoverschelde, Gade, and Raythatha’s teachings render instant claim 6 prima facie obvious according to MPEP 2143(i)(g) because Raythatha’s teaching that polyvalent transition metal compounds are effective for controlling odor for sulfur-containing organic compounds would motivate a person of ordinary skill in the art to modify the combination of Vanoverschelde and Gade. A person of ordinary skill in the art would recognize that the breakdown of disulfide bonds in the protein hydrolysis process would result in odorous sulfur compounds, and thus would be motivated to apply Raythatha’s teaching to add a polyvalent transition metal compound to control these odors.
Raythatha’s teaching to add a transition metal compound such as copper sulfate and zinc to a sulfur-containing organic compound or composition in order to bind sulfur (page 4 lines 27 – 35, page 6 lines 15 – 21, page 7 lines 32 - 35) reads on instant claim 6.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vanoverschelde (as cited above) in view of Gade (as cited above) and further in view of Popko (Popko, M. 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).
The combination of Vanoverschelde and Gade is discussed above.
The combination of Vanoverschelde and Gade does not teach adding sulfur-binding components to the composition (claim 6).
Popko teaches the missing component of Vanoverschelde and Gade.
Popko teaches feather hydrolysates as biostimulants on the growth, yield, and grain quality of winter wheat (page 2 line 48 to page 3 line 1).
Popko teaches feather hydrolysates were applied by foliar spraying at doses of 1 L/ha and 1.25 L/ha (page 9 lines 37 – 47).
The combination of Vanoverschelde, Gade, and Popko’s teachings render instant claims 14 and 15 prima facie obvious according to MPEP 2143(i)(a) as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to use the methods and dose of application as taught by Popko with the feather hydrolysate as taught by Vanoverschelde and Gade because Popko teaches that such methods and dose have a positive effect on the cultivation of winter wheat (page 11 lines 20 – 21). Therefore, the combination of Vanoverschelde Gade, and Popko’s teachings would yield predictable results (i.e. improved cultivation for crops treated with feather hydrolysates).
Popko’s teaching that feather hydrolysates were applied by foliar spraying (page 9 lines 37 – 47) reads on instant claim 14.
Popko’s teaching that feather hydrolysates were applied at doses of 1 L/ha and 1.25 L/ha (page 9 lines 37 – 47) overlap on the instantly claimed range of 0.25 to 25 L/ha as recited in claim 15. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612