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 the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 1/14/26.
Claims 1, 2, 4, 5, 8-10, 12-19, and 28-30 are pending and have been examined on the merits. Claims 3, 6, 7, 11, and 20-27 were previously cancelled. Claim 30 is new.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/14/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 5, 8-10, 12-19, and 28-30 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. There is no support for keratinous protein with reduced malodor. The specification discloses food products having minimal unpleasant odors [00017]; and the food ingredients may not add to any perceived malodors [00053].
The specification does not support the actual keratinous material with reduced malodor.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1, 2, 5, 8-10, 12, 13, 18, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560) in view of Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014.
Regarding Claims 1, 2, 5, 8-10 and 28: Filliéres discloses a method of producing hydrolyzed keratin [abstract; 0070]. Filliéres discloses that the keratin material can be feathers [0003; 0004; 0006]. Filliéres discloses attaining a digestibility of higher than 85% [abstract; 0012; 0016; 0029]. Filliéres discloses that the hydrolysis with steam at a temperature depends on pressure [0038; 0039]. Filliéres discloses steam hydrolysis at a pressure of 2- 15 bar (29-217 psig)[0039]. Filliéres discloses steam hydrolysis at about 4 bar and about 144°C [0039]. Filliéres discloses that the hydrolyzed keratin serves to improve the nutritional value of pet feeds [0019; 0076].
Filliéres does not disclose adding a reducing sugar; wherein the reducing sugar comprises galactose, glucose, glyceraldehyde, fructose, ribose, xylose, cellobiose, lactose, maltose, glucose syrup, maltodextrin, dextrin or glycogen(claim 8); wherein the one or more reducing sugars is xylose (claim 9); wherein the one or more reducing sugars is added in an amount of 5 wt.% or less, based upon the total weight of the mixture (claim 10).
Filliéres does not disclose the cereal bran added at 0.1 to 20%; 0.1 to 10% (claim 5).
Filliéres does not explicitly disclose hydrolyzing the feather, bran, and sugar together.
“Wang 2” discloses a method of making a hydrolyzed keratin product [abstract]. “Wang 2” discloses combining raw material in the form of feather meal, wheat bran and treating with an enzyme separately and then bringing the hydrolyzed feather meal and hydrolyzed wheat bran together [abstract]. “Wang 2” discloses a preparation containing 1-8 parts blood meal, 1-8 parts feather meal, 1-8 parts mycoprotein and 1-8 parts wheat bran [pg. 2]. If wheat bran were present at 1 part, blood meal at 1 part, feather meal at 8 parts and mycoprotein at 8 parts, wheat bran would be present at about 5.5%.
Kim discloses a method for making a liquid amino from keratin that imparts a beef or potato flavor [pg. 2, Advantageous effects]. Kim discloses hydrolyzing a mixture of hair or feathers, reducing sugars including xylose and glucose, maltose, and fructose [pg. 2. Mode for invention; Tech-Solution 1st and 2nd paragraphs]. Kim discloses xylose and glucose [pg. 2. Tech-Solution 1st and 2nd paragraphs]. Kim discloses xylose [pg. 2. Tech-Solution 1st and 2nd paragraphs]. Kim discloses 8 g of xylose in a mixture of at least 1 kg of keratin material [Ex. 1]. Therefore, Kim discloses about .8% xylose which is less than 5% reducing sugar.
Kalinikhin discloses hydrolyzing keratin containing waste (including feather), oats (cereal containing bran), and sugar [abstract; pg. 2 para 6 and 7; claims 1-2]. Kalinikhin discloses that the ingredients are hydrolyzed together [pg. 2, para 7]. Kalinikhin discloses an increase in the digestibility of the feed produced [abstract]. Kalinikhin discloses improving the quality of pet food [pg. 2, para 6].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Filliéres to include cereal bran/wheat bran and at the amounts as in “Wang 2” in order to provide a more complete, balanced, and desirable nutritional composition and to provide other desirable organoleptic properties to the food material.
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of Filliéres to include reducing sugars as in Kim including xylose and glucose and at the amounts in Kim in order to produce a hydrolyzed feather product with reduced poor odor [Kim, pg. 2].
Further it would have been obvious to modify Filliéres to hydrolyze the feather, bran, and sugar together as in Kalinikhin where the ingredients including keratin, oats (bran containing material) and sugar are hydrolyzed together in order to provide an efficient hydrolyzation process and since any order of adding the ingredients is prima facie obvious Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F. 2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in absence of new or unexpected results); In re Gibson, 39 F. 2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.
Regarding claim 28, although Filliéres does not explicitly disclose 140°C one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Filliéres overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Regarding Claim 12: Filliéres as modified discloses as discussed above in claim 1. Filliéres does not disclose a pretreated feather and therefore discloses a raw feather material.
Regarding Claim 13: Filliéres as modified discloses as discussed above in claim 1. Filliéres discloses steam hydrolysis for about 5 to 180 minutes under pressure of 2 to 15 bar (from about 29 psig to about 217 psig) [0039].
Although Filliéres does not explicitly disclose from about 15 to about 240 minutes one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Filliéres overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Filliéres does not explicitly disclose at least 38 psig one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Filliéres overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Regarding Claim 18: Filliéres as modified discloses as discussed above in claim 1. Filliéres discloses wherein the hydrolyzed keratinous protein-containing material is further processed by, drying [0050; 0051].
Regarding Claim 30: Filliéres as modified discloses as discussed above in claim 1. Filliéres discloses steam hydrolysis for about 5 to 180 minutes and preferably 10 minutes to 1 hour [0039].
Although Filliéres does not explicitly disclose from 15 to 60 minutes one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Filliéres overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560), Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014 as applied to claim 1 above and in further view of CZ 2014395.
Regarding Claim 28: Filleres does not disclose the claimed temperature. CZ2014395 discloses treating keratin at 140°C.
At the effective filing date of the invention it would have bene obvious to modify the temperature to exactly 140 C as it is able to effectively hydrolyze keratin at the temperature disclosed in CZ 2014395.
Claims 4 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560), Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014 as applied to claim 1 above and in further view of Janse et al. (WO 2014/064024).
Regarding Claims 4 and 29: Filliéres as modified discloses as discussed above in claim 1. Filliéres does not disclose wherein the wheat bran is defatted (claim 4). Filliéres does not disclose rice bran fiber (claim 29).
Janse discloses defatted rice bran subjected to hydrolysis to produce hydrolyzed rice bran [abstract; pg. 5, paragraphs 1-3]. Janse discloses that defatted rice bran is typically used for feed compositions [pg. 3, Background of the invention].
At the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the method of Filliéres to include wheat bran in defatted form as in Janse or to use defatted rice bran in place of the wheat bran of modified Filliéres as in Janse in order to utilize bran in a form that is appropriate for incorporation into feed.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560), Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014 as applied to claim 1 above and in further view of Papadopoulos et al. “Effect of Different Processing Conditions on Amino Acid…” Poultry Science 1985 col. 64 pages 1729-1741.
Regarding Claim 14: Filliéres as modified discloses as discussed above in claim 1. Filliéres discloses that known methods for hydrolyzing keratin include steam, enzymatic hydrolysis, and chemical hydrolysis [0006]. Filliéres does not disclose that the method further includes an enzyme hydrolysis step.
Papadopoulos discloses steam treating feathers followed by enzymatic hydrolysis to ensure complete digestion [abstract; Table 1]. Papadopoulos discloses treating at a temperature of 146°C and under pressure and that this is followed by chemical or enzymatic hydrolysis by a proteolytic enzyme [pg. 1730 “Materials and Method”].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to further modify the method of Filliéres to further include the step of hydrolyzing via enzymatic hydrolysis as in Papadopoulos in order to further or more completely hydrolyze the feather or keratin material.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560), Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014 and Papadopoulos et al. “Effect of Different Processing Conditions on Amino Acid…” Poultry Science 1985 col. 64 pages 1729-1741 as applied to claim 14 above and in further view of Xia (WO 2103/070798).
Regarding Claim 15: Filliéres as modified discloses as discussed above in claim 14. Filliéres does not disclose adding a proteolytic enzyme slurry comprising a quantity of at least one proteolytic enzyme in an aqueous environment to the mixture to produce a protein slurry; incubating the protein slurry for a time sufficient to produce the food protein ingredient.
Xia discloses mixing an enzyme in an aqueous solution to produce an enzyme solution and adding the enzyme solution to a proteinaceous mixture [00025; 00069].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of Filliéres to include enzymes in an enzyme solution and incubating them in order to hydrolyze the keratin as in Xia in order to efficiently break down the keratin thereby making it highly digestible [0007].
Regarding Claims 16 and 17: Filliéres as modified discloses as discussed above in claim 15. Filliéres does not disclose wherein the proteolytic enzyme is selected from the group consisting of endoproteases, exoproteases, endogenous enzymes, and combinations thereof (claim 16); wherein the endoproteases include enzymes selected from the group consisting of keratinase, papain, and combinations thereof (claim 17).
“Wang 2” discloses the endoprotease and specifically papain [abstract; pg. 4].
Xia discloses endoproteases, exoproteases, endogenous enzymes and combinations and specifically discloses keratinase, papain, and combinations [00016].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to further modify the method of Filliéres to include the enzymes of “Wang 2” and Xia in order to better digest the keratin and other protein sources in the mixture.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Filliéres et al (US 2016/0183560), Wang et al. (CN 105494886) “Wang 2”, Kim (WO 2014/126313), and Kalinikhin et al. RU 2505993 Machine Translation 2014 as applied to claim 1 above and in further view of Fado et al. (JP 2004283033) Oct 2004.
Regarding Claim 19: Filliéres as modified discloses as discussed above in claim 1. Filliéres does not disclose further comprising adding an amount of one or more antioxidants to the keratinous protein-containing material before, during or after hydrolysis.
Fado discloses adding an antioxidant to animal feed with improved digestibility [0015].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the method of Filliéres to include further including antioxidants as in Fado in order to help better preserve the hydrolyzed keratin product.
Response to Arguments o
The Applicants assert that Sorensen relates to bread odor and recites that malodor may be achieved. The Examiner notes that the instant specification also speaks in optional language [00053]. The Examiner maintains that Sorensen discloses bread products with improved flavor and odor [0231]. Sorensen’s disclosure of improved flavor and decreased odor is sufficient to support knowledge in the art.
Applicants assert that Sorensen does not support that the reduced odor is caused by the treated bran. The Examiner notes that Applicants application does not support the assertion either. Applicants specification is drawn to the ingredients together having reduced malodor. Applicants ask Examiner to prove Sorensen achieves reduced malodor by their methods. The Examiner maintains that the disclosure in Sorensen is sufficient to render the so called unexpected results expected. The Office is not equipped to manufacture prior art products and compare them for patentability. Applicant is reminded that 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Further, every patent is presumed valid and that presumption includes the presumption of operability. MPEP 716.07
The Applicants assert unexpected results in maximizing free amino acids.
The Examiner maintains the rejection because it is not so unexpected that hydrolyzing keratin would increase free amino acid content. Nickerson et al. (US 2,988,487) Nickerson discloses steam treating keratin/feathers followed by enzymatic hydrolysis via keratinase to ensure complete digestion including amino acid formation [col. 1, lines 28-42; col. 2, lines 5-15; 50-62; col.4, lines 55-74; col. 5, lines 51-58]. Villa et al. BMC Biotechnology discloses free amino acids from hydrolyzed keratin [abstract; pg. 2, 1st column 1st paragraph; ].
12. Regarding Claims 1 and 5, the Applicants assert the reasons against the references separately.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
14. Regarding Claims 4 and 29, the Applicant assert Janse does not correct the deficiencies of Filliéres, Wang 2, Kim and Kalinikhin but it does not disclose hydrolyzing a mixture of keratin and rice bran fiber. The Examiner disagrees because the limitations of hydrolyzing keratin in the presence of bran was covered by Filliéres and Wang 2. Janse was relevant for its teaching of defatted rice bran that is subjected to hydrolysis.
Applicants further assert the degree of hydrolysis was partial in Janse and therefore teaches away from the invention.
A prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness; however, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
In this case the level of hydrolysis was met by the primary and secondary refences. Janse was included for it teaching of hydrolysis treatment on defatted rice bran with the hydrolysis disclosed to show relevance to the fact that the rice bran is exposed to enzymes, but the major emphasis was on the pre-enzymatic treatment state of the bran being defatted.
15. Regarding Claim 14, the Applicants assert that Papadopoulos does not remedy the deficiencies of the previous references.
The Examiner maintains the reference for the reasons provided above and that the references were not deficient.
16. Regarding Claims 15-17, the Applicants assert that Xia does not cure the deficiencies of Filliéres, Wang 2, Kim and Kalinikhin. The Applicants assert that Xia merely discloses processing food with an enzyme.
The Examiner disagrees and notes that Xia discloses why one would mix an enzyme in an aqueous solution which would be to more efficiently break down the keratin thereby making it highly digestible.
17. Regarding Claim 19, the Applicants assert that Fado does not remedy the deficiencies of the previous claims.
The Examiner maintains that the previous claims are not deficient for the reasons discussed above and that Fado was relevant and met the limitation for which it was included.
For the reasons above the rejections have been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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.
/Felicia C Turner/Primary Examiner, Art Unit 1793