DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
The claim amendments filed 08 December 2025 have been entered. Claims 12-16 and 18-23 are pending. Claims 1-11 and 17 have been cancelled. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 102 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, delete either “free tyrosine in a content ranging from 2.50 to 3.50% by weight relative to the total weight of the free amino acids of the hydrolysate (lines 4-5) or “tyrosine in a content ranging from 2.50 to 3.50% by weight” (line 19).
Appropriate correction is required.
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.
Claims 12-13, 15-16 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sergheraert (WO 2019/043128 A1, published: 07 March 2019) in view of Bryndina (L BRYNDINA ET AL: "Comparative evaluation of biostimulator efficiency on corn seeds germination: keratin protein and preparation Ribav Extra", IOP CONFERENCE SERIES: EARTH AND ENVIRONMENT AL SCIENCE, vol. 392, 1 November 2019 (2019-11-01), page 012068, XP055768276, ISSN: 1755-1307,DOI: 10.1088/1755-1315/392/l/012068).
Note: all citations to Sergheraert are to the English equivalent document (US 2020/0206119 A1).
Regarding claims 12, 22 and 23; Sergheraert discloses a dietary supplement comprising keratin hydrolysate [0001]. Sergheraert discloses the hydrolysate comprises at least 88% by weight free amino acids relative to the total weight of the amino acids of the hydrolysate [0010]. Sergheraert discloses feeding the hydrolysate to roosters, which meets the claim 22 limitation of foodstuff for pets (Example 2, p6).
Sergheraert discloses in [0034]:
aspartic acid from 6-9%, which overlaps with the claim 17 range and encompasses the claim 23 range.
threonine from 4-6%, which falls within the claim 17 and claim 23 ranges.
serine from 10-15%, which overlaps with the claim 17 and 23 ranges.
glutamic acid from 9-14%, which overlaps or encompasses the claim 17 and 23 ranges
glycine from 7-10%, which falls within the claim 17 and 23 ranges
alanine from 4-6%, which falls within the claim 17 and 23 ranges
valine from 6-10%, which overlaps with the claim 17 and 23 ranges
L-cystine from 4-6%, which falls within or overlaps with the claim 17 and 23 ranges.
methionine from 0.1-0.4%, which overlaps with the claim 17 and 23 ranges
isoleucine from 4-6%, which overlaps with the claim 17 and 23 ranges
leucine from 6-9%, which falls within or overlaps with the claim 17 and 23 ranges
phenylalanine from 2-3%, which overlaps with the claim 17 range and falls outside the claim 23 range
lysine from 1-3%, which falls within or overlaps with the claim 17 and 23 ranges
histidine from 0.4-1%, which falls within the claim 17 and 23 ranges
arginine from 5-8%, which falls within or overlaps with the claim 17 and 23 ranges
proline from 9-14%, which overlaps with or encompasses the claim 17 and 23 ranges
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Sergheraert does not disclose the claimed quantity of tyrosine (claims 17 and 23) nor the claimed quantity of phenylalanine in claim 23.
Bryndina, in the field of keratin hydrolysate, discloses a hydrolysate of feather waste where ground feathers are the source of keratin (p2, Materials and Methods paras 1 and 4). Bryndina discloses the hydrolysis of the keratin reaches a maximum of free amino acids of 89% after 4-6 hrs of hydrolysis (p7, Table 3).
Bryndina discloses the end products of the keratin hydrolysis are free amino acids and the amino acid composition of the resulting product is shown in Figure 1 on page 5 (p7, para 1). Figure 1 of Bryndina discloses the tyrosine is approximately 3% of the total amino acids in the hydrolysate, which falls within the claim 17 and 23 ranges. Figure 1 of Bryndina discloses approximately 5% phenylalanine, which falls within the claim 17 and 23 ranges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the keratin hydrolysate product of Sergheraert comprising free amino acids with the keratin hydrolysate product of Bryndina since both are drawn to preferred amino acid contents of keratin hydrolysates.
Regarding claim 13, Sergheraert discloses the hydrolysate comprises L-cystine and 16 other amino acids, ([0044] and Table 1, p2). Sergheraert discloses the hydrolysate comprises at least 88% by weight free amino acids [0010].
Sergheraert does not explicitly disclose the amount of free cystine relative to the total weight of the cystine in the hydrolysate, however given that cystine is present in the hydrolysate and that the hydrolysate comprises at least 88% free amino acids it naturally flows that the hydrolysate comprises at least 88% free cystine relative to the total weight of cystine in the hydrolysate, which falls within the claimed range of at least 90% free cystine.
Regarding claim 15, Sergheraert discloses aspartic acid, threonine, serine, glutamic acid, glycine, alanine, phenylalanine and proline in the hydrolysate (Table 1, p2). Sergheraert discloses the hydrolysate of the keratin comprises at least 88% by weight of free amino acids [0010].
Sergheraert does not explicitly disclose the amount of free aspartic acid, threonine, serine, glutamic acid, glycine, alanine, phenylalanine and proline relative to the total weight of the same amino acid in the hydrolysate. However, given that aspartic acid, threonine, serine, glutamic acid, glycine, alanine, phenylalanine and proline are present in the hydrolysate and that the hydrolysate comprises at least 88% free amino acids it naturally flows that the hydrolysate comprises at least 88% free aspartic acid, threonine, serine, glutamic acid, glycine, alanine, phenylalanine and proline relative to the total weight of the same amino acid in the hydrolysate, which overlaps with the ranges of claim 15.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Regarding claim 16, Sergheraert discloses the hydrolysate comprises L-cystine and 16 other amino acids, and thus the keratin starting material also contains these 17 amino acids ([0044] and Table 1, p2). Sergheraert discloses the hydrolysate comprises at least 88% by weight free amino acids [0010].
Sergheraert does not disclose the hydrolysis rate of each individual amino acid. However, given that the free amino acids in general are present in the hydrolysate and the hydrolysate comprises at least 88% free amino acids it naturally flows that the hydrolysate comprises at least 88% of each free amino acid in the hydrolysate compared to the amount of the same amino acid in the starting keratin material, which corresponds to the percentage variation between the weight of a free amino acid in the hydrolysate and the weight of this amino acid in the starting keratin material is less than 12% in absolute value. This falls within the claimed range of less than 20% in absolute value.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sergheraert in view of Bryndina as applied to claim 12 above, and further in view of Kolbeck (US 5,049,397).
Regarding claim 14, Sergheraert in view of Bryndina discloses the keratin hydrolysate of claim 12 as discussed above. Sergheraert does not disclose the salt content of the hydrolysate.
Kolbeck, in the field of mineral salt free total protein degradation products, discloses a obtaining a protein material by mineral acid hydrolysis from keratin (Abstract). Kolbeck discloses the product comprises 1-99% by weight of amino acids (col 2, lines 25-30). Kolbeck discloses the products are completely free of inorganic salts (col 3, lines 25-30). Kolbeck discloses high content of inorganic salts is a drawback which prohibits further use of the hydrolysate (col 1, lines 55-62). Kolbeck’s disclosure that the product is completely free of inorganic salts meets the claim limitation of wherein the hydrolysate comprises less than 11%, by weight of salts relative to the weight total of the hydrolysate, the salts being chosen from sodium chloride, sodium sulphate, sodium phosphate, potassium chloride, potassium sulphate and potassium phosphate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the keratin hydrolysate of Sergheraert with the low salt content of Kolbeck in order to achieve a protein hydrolysate which is free of inorganic salts and avoids the high salt content prohibiting further use of the hydrolysate.
The claim limitation “wherein the hydrolysate is desalinated” is a product by process claim limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113 I. Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I. In the instant case Sergheraert in view of Bryndina and Kolbeck discloses the keratin hydrolysate with the claimed salt content.
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sergheraert (WO 2019/043128 A1, published: 07 March 2019) in view of Kolbeck (US 5,049,397) and Bryndina (L BRYNDINA ET AL: "Comparative evaluation of biostimulator efficiency on corn seeds germination: keratin protein and preparation Ribav Extra", IOP CONFERENCE SERIES: EARTH AND ENVIRONMENT AL SCIENCE, vol. 392, 1 November 2019 (2019-11-01), page 012068, XP055768276, ISSN: 1755-1307,DOI: 10.1088/1755-1315/392/l/012068).
Note: all citations to Sergheraert are to the English equivalent document (US 2020/0206119 A1)
Regarding claim 18, Sergheraert discloses a method for preparing a keratin hydrolysate from a poultry keratin raw material [0016].
As to: subjecting the keratin material to at least one chemical hydrolysis by means of an acid under conditions capable of obtaining a hydrolysate comprising at least 88% by weight of free amino acids relative to the total weight of the amino acids of the hydrolysate, the rest of the amino acids of the hydrolysate being in the form of peptides having a molecular mass less than or equal to 800 Dalton
Sergheraert discloses subjecting the raw material to at least one chemical hydrolysis by means of an acid under conditions suitable for obtaining a hydrolysate comprising at least 88% by weight of free amino acids relative to the total weight of the amino acids of the hydrolysate, the remainder of the amino acids of the hydrolysate being in the form of peptides having a molecular mass less than or equal to 800 Dalton [0017].
As to: subjecting the hydrolysate to a step of adjusting the pH to a value ranging from 3 to 5
Sergheraert does not disclose adjusting the pH to a value ranging from 3-5.
Kolbeck, in the field of mineral salt free total protein degradation products, discloses a obtaining a protein material by mineral acid hydrolysis from keratin (Abstract). Kolbeck discloses the product comprises 1-99 by weight of amino acids (col 2, lines 25-30). Kolbeck discloses the hydrolysate has a pH of 4.5 (Example 1, col 6, line 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the pH of the hydrolysate to 4.5 since Kolbeck discloses that as an appropriate pH for the hydrolysate.
As to: recovering the precipitate and the liquid phase; separating the precipitate and the liquid phase;
Kolbeck discloses filtering the hydrolysate and obtaining a solution as filtrate (col 6, Example 1).
As to: subjecting the precipitate to at least one washing with water until a desalted precipitate is obtained comprising less than 1% of salts by weight relative to the total weight of the precipitate, and recovering the desalted precipitate, on the one hand, and washing waters, on the other one, combining the washing waters and the liquid phase to obtain a solution and proceed with desalinating this solution by electrodialysis to obtain a desalinated solution, adding the desalted precipitate to the desalted solution, and recovering the desalted obtained suspension.
Kolbeck discloses the products are free of inorganic salts (less than 1%) (col 3, lines 25-30). Kolbeck discloses after hydrolysis, the excess HCl is evaporated and the residue is again absorbed with water and subsequently filtered (washed) (col 6, Example 1). Kolbeck discloses filtering the hydrolysate and obtaining a solution as filtrate (col 6, Example 1). Kolbeck discloses the products of the invention are suited to purification steps, including electrodialysis and molecular filtration (col 4, lines 15-20).
Sergheraert discloses drying the product [0067].
Sergheraert does not disclose recombining the filtrate, washing liquid and the precipitate to form a suspension, however it would have been obvious to one of ordinary skill in the art to recombine the filtrate, washing liquid and precipitate after salt removal since Kolbeck teaches salt removal is advantageous and recombining the filtrate, wash water and precipitate retains as much of the hydrolysate amino acids as possible.
Regarding the order of method steps, Sergheraert in view of Kolbeck does not disclose the same order of method steps. However, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP 2144.04 IV C). Given that PRIOR ART provides the method steps as claimed, the claimed order of steps is not considered to provide unexpected results.
Regarding the composition produced by the method of claim 18, Sergheraert discloses a dietary supplement comprising keratin hydrolysate [0001]. Sergheraert discloses the hydrolysate comprises at least 88% by weight free amino acids relative to the total weight of the amino acids of the hydrolysate [0010]. Sergheraert discloses feeding the hydrolysate to roosters, which meets the claim 22 limitation of foodstuff for pets (Example 2, p6).
Sergheraert discloses in [0034]:
aspartic acid from 6-9%, which overlaps with the claim 17 range and encompasses the claim 23 range.
threonine from 4-6%, which falls within the claim 17 and claim 23 ranges.
serine from 10-15%, which overlaps with the claim 17 and 23 ranges.
glutamic acid from 9-14%, which overlaps or encompasses the claim 17 and 23 ranges
glycine from 7-10%, which falls within the claim 17 and 23 ranges
alanine from 4-6%, which falls within the claim 17 and 23 ranges
valine from 6-10%, which overlaps with the claim 17 and 23 ranges
L-cystine from 4-6%, which falls within or overlaps with the claim 17 and 23 ranges.
methionine from 0.1-0.4%, which overlaps with the claim 17 and 23 ranges
isoleucine from 4-6%, which overlaps with the claim 17 and 23 ranges
leucine from 6-9%, which falls within or overlaps with the claim 17 and 23 ranges
phenylalanine from 2-3%, which overlaps with the claim 17 range and falls outside the claim 23 range
lysine from 1-3%, which falls within or overlaps with the claim 17 and 23 ranges
histidine from 0.4-1%, which falls within the claim 17 and 23 ranges
arginine from 5-8%, which falls within or overlaps with the claim 17 and 23 ranges
proline from 9-14%, which overlaps with or encompasses the claim 17 and 23 ranges
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Sergheraert does not disclose the claimed quantity of tyrosine (claims 17 and 23) nor the claimed quantity of phenylalanine in claim 23.
Bryndina, in the field of keratin hydrolysate, discloses a hydrolysate of feather waste where ground feathers are the source of keratin (p2, Materials and Methods paras 1 and 4). Bryndina discloses the hydrolysis of the keratin reaches a maximum of free amino acids of 89% after 4-6 hrs of hydrolysis (p7, Table 3).
Bryndina discloses the end products of the keratin hydrolysis are free amino acids and the amino acid composition of the resulting product is shown in Figure 1 on page 5 (p7, para 1). Figure 1 of Bryndina discloses the tyrosine is approximately 3% of the total amino acids in the hydrolysate, which falls within the claim 17 and 23 ranges. Figure 1 of Bryndina discloses approximately 5% phenylalanine, which falls within the claim 17 and 23 ranges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the keratin hydrolysate product of Sergheraert comprising free amino acids with the keratin hydrolysate product of Bryndina since both are drawn to preferred amino acid contents of keratin hydrolysates.
Regarding claim 19, Sergheraert discloses the chemical hydrolysis is generally carried out for a time ranging from 1 hour to 8 hours, preferably ranging from 6 to 7 hours at a temperature ranging from 110° C to 115° C [0056], which falls within the claimed time and temperature ranges.
Regarding claim 20, Sergheraert discloses according to a particular variant, the chemical hydrolysis is carried out in two steps: a first chemical hydrolysis carried out at a temperature ranging from 60° C. to 80° C. for a period ranging from 4 to 5 hours, then a second chemical hydrolysis carried out at a temperature ranging from 100° C. to 115° C. for a period ranging from 5 to 7 hours [0057-0059].
Regarding claim 21, Sergheraert discloses advantageously, the keratin hydrolysate obtained is spray-dried in order to obtain the hydrolysate in solid form [0068].
Response to Arguments
Applicant's arguments filed 08 December 2025 have been fully considered. To the extent they apply to the above rejections, they are not persuasive.
Applicant argues Bryndina does not consistently report values for the levels of free amino acids. Applicant argues the method of measuring the free amino acids of Bryndina is actually measuring larger residues due to the concentration of TCA that the same is dissolved in before analysis. Remarks p9-10.
This argument is not persuasive. In the above rejection Sergheraert is relied upon to disclose the free amino acid content of the hydrolysate is at least 88%. Additionally, in the procedure disclosed by Bryndina, there are additional steps taken to isolate the amino acids after combining the hydrolysate with TCA. The hydrolysate is combined with TCA and non-hydrolyzed proteins are precipitated. Sulfuric acid and phosphoric acid are subsequently added to the filtrate to precipitate the peptides. After the peptides have been filtered out then the quantity of amino acids was determined (p3, paras 6-8).
Applicant argues the quantity of tyrosine disclosed by Bryndina in Figure 1 is the total amino acid content of either the hydrolysate or the native feather, not the free amino acid content. Applicant argues hydrolysates obtained by enzymatic means are inherently specific to the enzyme employed and therefore the resulting levels of individual amino acids are dependent on the enzyme selected. Remarks p11.
This argument is not persuasive. While the selection of the enzyme for hydrolysis may determine the quantity of certain free amino acids in the hydrolysate, applicant has presented no evidence that the hydrolysis of Bryndina would not produce at least 88% free tyrosine in the hydrolysate.
Applicant argues the addition of sodium tetraborate by Bryndina converts cystine to cysteine. Remarks p12.
This argument is not persuasive. Bryndina is not relied upon to disclose the quantity of cystine in the hydrolysate.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARRIE GLIMM whose telephone number is (571)272-2839. The examiner can normally be reached Monday-Thursday 10:30-6:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michele L Jacobson/Primary Examiner, Art Unit 1793
/C.L.G./Examiner, Art Unit 1793