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 .
DETAILED ACTION
Claims 1-10, 13-17, and 20 are pending. Claims 11-12 and 18-19 are cancelled.
Election/Restrictions
Applicant’s election without traverse of the species of animal manure and thermal hydrolysis in the reply filed on 5/19/2026 is acknowledged.
Claims 14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026.
Claims 1-10, 13, and 15-17 are examined herein.
Claim Objections
Claims 2, 5, and 7-8 are objected to because of the following informalities:
In claim 2 and 8, the claims recite “the said,” which is redundant and grammatically incorrect. Applicant may draft the claim using “the” or “said” but not both.
In claim 5, AFUF should be spelled out as anti-membrane fouling ultrafiltration (AFUF) in the first appearance in the claims.
In claim 7, “higher than or equal to” should be ordered as “equal to or higher than.”
Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [0027]-[0028]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 1-10, 13, and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for i=1~5. It is unclear whether the “~” symbol is used to designate a range or an approximation. It is further unclear whether the steps refer to the temperature, pressure, or reaction time and whether “i” is the number of steps.
Claim 1 is also indefinite for step (5) “adjusting the pH of the reverse osmosis concentrate to render reverse osmosis concentrate into a final powder that is water soluble.” It is unclear whether step (b) includes drying, since adjusting the pH does not render a concentrate into water-soluble particle or powder without drying.
Claim 2 recites the limitation "the said concentrated solution" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 is further indefinite for “wherein the pH of the said concentrate solution is adjusted so that the pH shifts away from the protein’s isoelectric point by adding either base or acid before drying the solution.” Claim 2 is indefinite because the metes and bounds of the claim are unclear with respect to what constitutes a sufficient “shift” away from the protein’s isoelectric point.
Claim 4 is indefinite because the claim recites “wherein the reverse osmosis concentrate is dried by a drying process to make water-soluble protein powders,” thus it is unclear whether the method produces a single soluble protein powder (see claim 1 preamble and step (b) of claim 1) or two or more protein powders.
Claim 7 recites adding an alkali to the solution before drying the solution by a drying process “for powder preparation.” It is unclear whether the drying process produces the final powder that is water soluble or whether there are additional steps of powder preparation to produce the final powder.
Claim 8 recites the limitation "the said keratin below 5,000 Da" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In addition, claim 8 recites that the keratin below 5,000 Da is recovered by nanofiltration through adjusting the membrane pore size. It is unclear whether the method further comprises an additional nanofiltration step or whether claim 8 is further limiting the pore size in either step (2) or step (3).
Claim 9 recites “wherein the THP is performed at the temperature equal to or higher than 160 °C, but lower than or equal to 200 °C for 2 hrs.” However, it is unclear whether this limitation applies to only one step or all steps, since claim 1 recites controlling the temperature over several steps.
Claim 10 is likewise indefinite because it is unclear whether the temperature range applies to a particular step or all steps.
Claims 2-10, 13, and 15-17 are rejected for depending from a rejected base claim and not rectifying the sources of indefiniteness discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 15-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 fails to include all the limitations of the claim upon which it depends because claim 3 depends from claim 1, which requires rendering the reverse osmosis concentrate into a final powder.
Claims 15-17 fail to further limit the method of claim 1, as they recite intended uses of the product of the method rather than further limiting any method steps.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-10, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tasaki (Bioresources and Bioprocessing 8.1 (2021): 60; hereafter Tasaki 2021) in view of Haque et al. (Handbook of industrial drying 33.10 (2015): 971-985) as evidenced by Tasaki (Waste Management 104 (2020): 33-41; hereafter Tasaki).
Tasaki 2021 teaches the thermal hydrolysis process (THP) of manure digestate solid (“organic waste”) by heating at 100 °C for 1 h followed by 130 °C for 1 h (page 3, THP process, left column, bottom paragraph) to extract crude protein. In other words, Tasaki 2021 teaches controlling the temperature over 2 steps (i=2). During thermal hydrolysis, the pressure in the reactor is the vapor pressure at the given temperature as evidenced by Tasaki (page 34, right column, 2.4 Thermal hydrolysis).
Tasaki 2021 then filters the reaction solution after the THP process by a 90 mm mesh screen, followed by a shear wave-induced membrane ultrafiltration (SWIMU) with a 150 kDa membrane (page 3, right column, Protein filtration by ultrafiltration). Tasaki 2021 teaches that SWIMU generates a vortex flow by rotating the membrane disk, effectively preventing membrane fouling (page 3, right column, Protein filtration by ultrafiltration). Tasaki 2021 increases the concentration of the protein hydrolysate by reverse osmosis (page 4, left column, paragraph 1). After reverse osmosis (RO), Tasaki 2021 produces a powder by vacuum evaporation (page 4, right column, Powder preparation).
Tasaki does not teach adjusting the pH of the reverse osmosis concentrate to render the reverse osmosis concentrate into a final powder that is water soluble.
Haque teaches that solvent conditions such as pH affect denaturation of proteins, which is relevant to protein drying: when the pH of the solution approaches the isoelectric point of the protein, due to insufficient repulsion forces, association occurs among protein assemblages (page 975, left column, 49.4.1 Causes and Implications of Protein Denaturation). Longer time duration in association state leads to irreversible aggregation (page 975, left column, 49.4.1 Causes and Implications of Protein Denaturation).
Regarding claims 1-2, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to improve the method of Tasaki 2021 by adjusting the pH of the RO-concentrated protein hydrolysate solution away from the isoelectric point by adding either acid or base, thus minimizing protein aggregation during drying. The person of ordinary skill in the art would have had a reasonable expectation of success in adjusting the pH of the solution before the final drying step.
Regarding the solubility of the powder in claims 1 and 4, decreasing the formation of aggregation of the protein hydrolysate would have necessarily improved the water-solubility of the protein.
Regarding claim 3, Tasaki 2021 teaches removing water from the protein hydrolysate by reverse osmosis (page 4, left column, paragraph 1). However, Tasaki 2021 dries the hydrolysate into a powder by vacuum evaporation (page 4, right column, Powder preparation), rather than producing a concentrated protein solution.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to eliminate the final step of vacuum evaporation in order to produce a concentrated protein hydrolysate solution rather than a powder. The person of ordinary skill in the art would have been motivated to save energy by eliminating vacuum evaporation and also to reduce the number of steps of the method. The person of ordinary skill in the art would have had a reasonable expectation of success in producing a concentrated protein solution rather than a powder.
Regarding claim 5, Tasaki 2021 teaches that the shear wave-induced membrane ultrafiltration (SWIMU) generates a vortex flow by rotating the membrane disk, effectively preventing membrane fouling (page 3, right column, Protein filtration by ultrafiltration), thus the SWIMU is a type of anti-membrane fouling ultrafiltration (AFUF).
Regarding claim 6, Tasaki 2021 teaches filtering the reaction solution after the THP process by a 90 mm mesh screen, followed by SWIMU (ultrafiltration) with a 150 kDa membrane (page 3, right column, Protein filtration by ultrafiltration).
Regarding claim 8, the claim is interpreted as requiring that the first filtration step is nanofiltration in order to recover protein.
Tasaki 2021 does not teach that the method further comprises nanofiltration.
However, Tasaki 2021 teaches both filtration of the reaction solution after the THP process by a 90 mm mesh screen an ultrafiltration with a 150 kDa membrane (page 3, right column, Protein filtration by ultrafiltration). Tasaki 2021 also teaches controlling the molecular weight of the hydrolysate by adjusting the THP reaction temperatures (page 3, left column, THP process, paragraph 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the size of the filter based upon the desired molecular weight of the hydrolysate obtained by the THP process. The person of ordinary skill in the art would have had a reasonable expectation of success in optimizing the filtration size.
Regarding claims 9-10, Tasaki 2021 teaches the thermal hydrolysis of manure digestible solids by heating at 100 °C for 1 h followed by 130 °C or 160 °C for 1 h (page 3, THP process, left column, bottom paragraph). Tasaki 2021 also teaches the temperature and the reaction time can control the extraction yield and the degree of hydrolysis of the protein (page 3, left column, THP process, paragraph 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the reaction time and temperature in order to control the extraction yield and degree of hydrolysis of the protein. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization because Tasaki 2021 teaches that reaction temperature controls how much crude protein can be extracted from manure solid and how low the MW of the hydrolysate is (page 3, left column, THP process, paragraph 2).
Regarding claim 13, Tasaki 2021 teaches performing THP hydrolysis on manure digestate solid, which is animal manure (Abstract and page 2, right column, Materials and Methods, Materials).
Regarding claim 15, Tasaki 2021 teaches that the protein hydrolysate has antioxidant activity (Abstract).
Regarding claims 16-17, Tasaki 2021’s protein hydrolysate is capable of being used as a feed additive and is thus also a biostimulant because protein is a nutrient that stimulates growth.
Claim 7 is are rejected under 35 U.S.C. 103 as being unpatentable over Tasaki (Bioresources and Bioprocessing 8.1 (2021): 60; hereafter Tasaki 2021) in view of Haque et al. (Handbook of industrial drying 33.10 (2015): 971-985) as evidenced by Tasaki (Waste Management 104 (2020): 33-41; hereafter Tasaki), as applied to claims 1-6, 8-10, 13, and 15-17 above, further in view of Sathe et al. (Journal of the American Oil Chemists' Society 95.8 (2018): 883-901) and Macovescu et al. (Revista de Pielarie incaltaminte 18.1 (2018): 53).
See discussion of Tasaki 2021 and Haque above, which is incorporated into this rejection as well.
Tasaki 2021 does not teach adjusting the pH of the reverse osmosis concentrate to greater than or equal to 8 but lower than 10 by adding an alkali to the solution before drying the solution.
Tasaki 2021 suggests that the protein hydrolysate may be used as a feed additive and compares the amino acid composition of the protein hydrolysate to that of soybean meal (page 8, AA composition, paragraph bridging left and right columns).
Sathe teaches that at the isoelectric pH, the net charge on the protein is zero and protein solubility reaches a minimum (page 890, left column, Extrinsic Factors, pH). Sathe teaches that solubility increases with increased magnitude of net charge at pH < pI and pH > pI (page 890, left column, Extrinsic Factors, pH). Sathe teaches that alkali solvents at pH values > 10.5 are undesirable due to the destruction of essential amino acids, such as lysine, present in the solubilized proteins (page 890, left column, Extrinsic Factors, pH). Sathe teaches that a large number of food proteins have acidic pI values and that solvents at alkaline pH are often used to solubilize food proteins (page 890, left column, Extrinsic Factors, pH). Sathe teaches that the desired pH range may be achieved using alkali (page 890, left column, Extrinsic Factors, pH).
Macovescu teaches a method for determining the isoelectric point of various protein solutions, including protein hydrolysates (Abstract). Macovescu teaches that the concentration of hydrogen ions at which the isoelectric point is achieved is a protein-specific value that varies between the pH range of 4.1 to 6.7 (page 56, right column, paragraph 2).
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add alkali to the protein hydrolysate of Tasaki 2021 in order to reach a pH above the isoelectric point but less than 10.5, per the teaching of Sathe. Although Tasaki 2021 does not teach the isoelectric point of the protein hydrolysate, Macovescu estimates an isoelectric point between 4.1 to 6.7, thus the person of ordinary skill in the art would have aimed at a pH greater than 6.7 but less than 10.5. The person of ordinary skill in the art would have been motivated to minimize protein aggregate formation during drying, per the teaching of Haque, but also to minimize the destruction of essential amino acids, such as lysine, by keeping the pH less than 10.5, per Sathe’s teaching.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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