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 .
This office action is in response to applicant’s amendments filed on May 18, 2026.
Claims 1-9,13,14 and 25-43 are pending. Claims 25-43 are new. Claims 1-4,6-9,13 and 14 have been amended. Claims 10-12 and 15-24 have been cancelled.
The objection to claim 14 is maintained for the reasons set forth below.
All prior 112 second paragraph rejections are withdrawn in view of applicant’s amendments to the claims.
Claims 1-7 and 9 stand rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Muench (US 1,967,679) for the reasons set forth below.
Claims 1-9 stand rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536) for the reasons set forth below.
Claims 1-9 and 14 stand rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536) and further in view of Muench (US 1,967,679) for the reasons set forth below.
Claim 13 stands rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Fenyes (WO 2006/096159) and Biyu (CN 101235421A) for the reasons set forth below.
Claim Objections
Claim 14 is objected to because of the following informalities: in lines 3-4, the claim recites “including comprising” which is redundant. Only one term “including” or “comprising” should be recited. Appropriate correction is required.
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 8,32-35,37,38 and 40-43 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 8 and 43 recite “non-denaturing solution” which lacks literal basis in the original specification or claims. Claim 33 depends from claim 8 and inherits the same deficiency.
Claims 32 and 43 recite a “pH of between 3.0 and 4.5” which lacks literal basis in the original specification or claims.
Claim 33 recites “0.1-2.0% by weight relative to the skin mass” which lacks literal basis in the original specification or claims.
Claims 34 and 43 recite “non-ionic”, “0.1%-1% by volume” and “0.1%-0.5% by weight” which lack literal basis in the original specification or claims.
Claim 35 recites “marine” which lacks literal basis in the original specification or claims.
Claims 37,38 and 43 recite purity values of ≥99% by weight or ≥99.5% by weight, respectively, which lack literal basis in the original specification or claims.
Claim 40 recites “per [Symbol font/0x61]-chain” which lacks literal basis in the original specification or claims.
Claims 41 and 43 recite “≥3-log reduction in total aerobic viable count and ≥4-log reduction in endotoxin” which lacks literal basis in the original specification or claims.
Claim 42 recites “synergistically loosens attached wool or hair while preserving the native triple-helical structure of said collagen” which lacks literal basis in the original specification or claims.
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 26,27,34 and 43 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 26 and 27 do not further limit claim 14 as the limitations of claim 26 are already present in claim 14. Claim 14 does not recite “organic acid” or “metal fluoride” so the “said organic acid” and “said metal fluoride” lack antecedent basis. Claim 27 depends from claim 26 and inherits the same deficiency.
Claim 34 recites “detergent solution” which lacks antecedent basis as claim 14 does not recite a detergent solution.
Claim 42 recites “boric acid and sodium fluoride” which lack antecedent basis as claim 1 does not recite these species.
Claim 43 recites “non-ionic detergent (0.1-1.0% v/v)”, “sodium metabisulphite (0.1-0.5% w/w) and acetic acid: sodium acetate: water (1:1:0.5)” which renders the claim indefinite as it is unclear of the values in the parenthesis are required or optional preferred values.
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 1-7,9,25,28-33,35-38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Muench (US 1,967,679).
Snowden teaches a method for producing collagen from bovine, porcine or ovine animal skin (abstract, paragraphs 0012,0023,0090) by applying an organic acid buffer solution containing acetic acid or citric acid (paragraph 0013), anhydrous sodium acetate and water (paragraph 0036) to the animal skin and incubating the treated skin for a sufficient time to allow the wool and hair to be loosened or removed (paragraph 0014). Snowden teaches the incubation temperature is between 20-40°C and the incubation time is between 8-27 hours (paragraph 0037). Snowden teaches a pH from 3-5 (paragraph 0013). Snowden exemplifies using a composition of 40% (w/w) glacial acetic acid in water and adding 20% anhydrous sodium acetate (paragraph 0036). Snowden teaches applying the solution by spraying, painting or dipping and diluting the solution 10 fold with water if dipping (paragraph 0037). Snowden teaches extracting collagen from the treated skin by applying a protease containing solution wherein the concentration of protease is 1:10 to 1:1000 (w/w) by weight of the hide, particularly 1:100 (1%) (paragraphs 0039,0046-0050). Snowden teaches type I and Type III collagen of native collagen with the [Symbol font/0x61]-chains forming a triple-stranded helical structure which has a low antigenicity and resistance to enzymatic digestion (paragraph 0006,0027-0028) with purity of ≥99% or ≥99.5% by weight (claims 29-39) as non-collagenous protein, phospholipids and neutral lipids and glycolipids are less than 0.1%, 0.0001% and 0.001 percent by weight of the collagen and the type I and type III collagen can be mixed and add up to 100%.
Snowden does not teach adding inorganic acid to the chemical solution, the predefined ratio of organic acid, water and sodium acetate of 1:1:0.5, the salt additive concentration of 1.4-2% and the log reduction in TAVC or endotoxin..
Muench teaches that applying a solution of weak acids such as boric acid to raw hides substantially assist in loosening the epidermal layer and the hairs (page 1, lines 98-102; page 3, lines 55-57). Muench teaches the acid treatment is especially useful for removing wool from sheepskins because the wool is protected (page 2, line 9-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Snowden by adding boric acid as an inorganic acid additive because Muench teaches that applying a solution of weak acids such as boric acid to raw hides substantially assist in loosening the epidermal layer and the hairs and the acid treatment is especially useful for removing wool from sheepskins because the wool is protected. Selecting the concentration of boric acid to be the claimed 1.4-2% of the chemical solution or the ratio of organic acid, water and sodium acetate to 1:1:0.5 could be achieved through routine experimentation as the amounts of each chemical compounds would directly impact the loosening of the hair to ease in removal of animal hair or wool. It would be expected that similar treated by similar methods would produce collagens with similar log reduction values in TAVC and endotoxin as this would be an expected property of applying similar chemical components in similar concentrations to similar hides using similar methods.
Regarding claims 6 and 25, if claims 6 and 25 were written in independent form, sodium fluoride would still be an optional component of the claims as metal fluoride is an alternative embodiment in claim 1.
Claims 1-9,25,28-33,35-38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536).
Snowden teaches a method for producing collagen from bovine, porcine or ovine animal skin (abstract, paragraphs 0012,0023,0090) by applying an organic acid buffer solution containing acetic acid or citric acid (paragraph 0013), anhydrous sodium acetate and water (paragraph 0036) to the animal skin and incubating the treated skin for a sufficient time to allow the wool and hair to be loosened or removed (paragraph 0014). Snowden teaches the incubation temperature is between 20-40°C and the incubation time is between 8-27 hours (paragraph 0037). Snowden teaches a pH from 3-5 (paragraph 0013). Snowden exemplifies using a composition of 40% (w/w) glacial acetic acid in water and adding 20% anhydrous sodium acetate (paragraph 0036). Snowden teaches applying the solution by spraying, painting or dipping and diluting the solution 10 fold with water if dipping (paragraph 0037). Snowden teaches extracting collagen from the treated skin by applying a protease containing solution wherein the concentration of protease is 1:10 to 1:1000 (w/w) by weight of the hide, particularly 1:100 (1%) (paragraphs 0039,0046-0050). Snowden teaches type I and Type III collagen of native collagen with the [Symbol font/0x61]-chains forming a triple-stranded helical structure which has a low antigenicity and resistance to enzymatic digestion (paragraph 0006,0027-0028) with purity of ≥99% or ≥99.5% by weight (claims 29-39) as non-collagenous protein, phospholipids and neutral lipids and glycolipids are less than 0.1%, 0.0001% and 0.001 percent by weight of the collagen and the type I and type III collagen can be mixed and add up to 100%.
Snowden does not teach adding metal fluorides to the chemical solution, the predefined ratio of organic acid, water and sodium acetate of 1:1:0.5, the salt additive concentration of 1.4-2% and the log reduction in TAVC or endotoxin.
Michel teaches dehairing animal hides and skins is effectively accomplished by using acid fungal protease enzymes such as Aspergillus orzae proteases (page 1, lines 13-21) wherein 0.1-5% sodium fluoride is added as a preservative to the dehairing composition (page 2, lines 3-9).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Snowden by adding sodium fluoride as a metal fluoride and Aspergillus orzae protease as an acid fungal proteases to a dehairing treatment for animal hides and skins because Michel teaches that applying a solution of acid fungal proteases and a 0.1-5% sodium fluoride preservative allows for the efficient hair removal from animal hides. Using known effective dehairing agents in art recognized effective concentrations in methods also directed to removing hair from animal hides is obvious to try. It would be expected that similar hides treated by similar methods would produce collagens with similar log reduction values in TAVC and endotoxin as this would be an expected property of applying similar chemical components in similar concentrations to similar hides using similar methods.
Regarding claim 5, is claim 5 was written in independent form, boric acid would still be an optional component of the claims as inorganic acid is an alternative embodiment in claim 1.
Claims 1-9,14,25-33,35-38,41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536) and further in view of Muench (US 1,967,679).
Snowden and Michel are relied upon as set forth above.
Snowden and Michel do not teach adding boric acid.
Muench teaches that applying a solution of weak acids such as boric acid to raw hides substantially assist in loosening the epidermal layer and the hairs (page 1, lines 98-102; page 3, lines 55-57). Muench teaches the acid treatment is especially useful for removing wool from sheepskins because the wool is protected (page 2, line 9-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Snowden and Michel by adding boric acid as an inorganic acid additive because Muench teaches that applying a solution of weak acids such as boric acid to raw hides substantially assist in loosening the epidermal layer and the hairs and the acid treatment is especially useful for removing wool from sheepskins because the wool is protected. Selecting the combined concentration of boric acid and sodium fluoride to be the claimed 1.4-2% of the chemical solution, the ratio of organic acid, water and sodium acetate to 1:1:0.5 and the ratio by weight of the sodium fluoride to boric acid to be 1:3 to 3:1 could be achieved through routine experimentation as the amounts of each chemical compounds would directly impact the loosening of the hair to ease in removal of animal hair or wool. Muench exemplifies 0.3% boric acid in example 9 (M/20 boric acid = 1M/20= 0.05M boric acid *61.83 g/mol= 3.09g boric acid /1000g water*100%=0.3% boric acid). Michel teaches 0.1-5% sodium fluoride. Selecting from these concentrations would permit a total amount of salt additives of boric acid and sodium fluoride to be between 1.4-2% as applicant claims and the ratio of sodium fluoride to boric acid to be between 1:3 and 3:1. Selection of boric acid and sodium fluoride at the claimed concentrations and ratios would be expected to provide the same synergism claimed and Snowden emphasizes the importance of the native triple strand-helical structure of the collagen produced and maintaining this through the collagen production process would be important to provide collagen produced with low antigenicity and resistance to enzymatic digestion.
Regarding claim 14, Muench teaches dewooling sheepskin and Snowden teaches painting the solution onto the skin for unhairing. Since the unhairing components taught by Snowden, Michel and Muench in combination are applied to the hide as a solution and also are known to be applied as a paint, the paint application meets the dewooling and applying steps of claim 14.
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536) and further in view of Qazi (WO 2013/015674).
Snowden and Michel are relied upon as set forth above.
Snowden and Michel do not teach the particle size, purity and molecular weight of the collagen.
Qazi teaches that collagens used in veterinary, medical and medicinal skincare applications preferably has a nanoparticle structure of diameters less than 250nm, particularly less than 100 nm (page 3, lines 1-16; page 4, line 10; page 5, lines 1-3; page 10, lines 17-28) to enhance permeation into the skin surface (page 5, lines 27-28; page 10, lines 30-35). Qazi teaches it is known to use collagen of 300,000 daltons (300kDa) in medical and veterinary applications (page 2, -15).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Snowden and Michel by preparing collagens of the claimed particle sizes and molecular weight as Qazi teaches in medicinal and medical applications collagens of 300kDa are conventionally used and nano-collagens of less than 100 nm are effective at penetrating the skin in medicines. Snowden invites the inclusion of collagens produced for biomedical or veterinary uses.
Claims 13,34 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Snowden (US 2006/0149040) in view of Michel (US 1,767,536) and further in view of Muench (US 1,967,679) and further in view of Speight (WO 2019/068133).
Snowden, Michel and Muench are relied upon as set forth above.
Snowden, Michel and Muench do not teach washing in 0.1%-1.0% by volume non-ionic detergent and 0.1-0.5% sodium metabisulphite.
Speight teaches cattle, pig or sheep hides are conventionally washed in a composition comprising 0.25% to about 10% sodium metabisulphite reducing agent and about 1-20% non-ionic surfactant to remove waste from the hide prior to enzymatic treatment such as protease which loosens hair (page 2, page 10 -page 12, page 15).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Snowden, Michel and Muench by first washing animal hides in a detergent solution comprising the claimed amounts of sodium metabisulphite and non-ionic surfactant as Speight teaches this is advantageous to remove waster which is stuck like glue to the hides and further adding enzymes to loosen and remove hair from the hides. Speight emphasizes the surfactant acts as a detergent and allows dispersal and removal of fatty/way materials on the hide in water solutions and the sodium metabisulphite stimulates or promotes keratin (hair) degradation via breaking down disulphide bonds in the hair and opening the structure to hydrolysis by enzymes. This pretreatment wash of Speight starts the hair loosening process.
Response to Arguments
Applicant's arguments filed regarding Snowden, Muench and Michel have been fully considered but they are not persuasive. The examiner argues that the teachings of Muench and Michel are reasonable pertinent to the process of Snowden as all three references are directed towards treating animal hides for the common purpose of unhairing or hair loosening. IN this aspect the references are directed to a similar problem to be solved in the unhairing of animal hides. Biyu is no longer relied upon. Adding chemicals known to be useful in the unhairing of hides to the methods of Snowden are obvious and Snowden teaches the claimed pH values. Applicant’s arguments regarding tanning-art teachings leading to enzyme inactivation are conclusory and the references of Michel and Muench are simply relied upon for addition chemicals to the unhairing and hide treatment of Snowden. Snowden teaches the triple-helical structure must be maintained and teaches using the same pH ranges claimed which would protect the collagen product. Snowden emphasizes the importance of the native triple strand-helical structure of the collagen produced and maintaining this through the collagen production process would be important to provide collagen produced with low antigenicity and resistance to enzymatic digestion and therefore this property is not unexpected by Snowden but rather a desired outcome an integral to the invention.
Applicant’s Declaration under 1.132 shows new chemical paint with 37.2% water, 40% acetic acid, 20% anhydrous sodium acetate, 1.4% boric acid, 1.4% sodium fluoride. This ratio does not match the 1:1:0.5 amounts of organic acid: anhydrous sodium aetate and water. Claims 1 and 13 can have any organic acid, any sodium acetate, and any inorganic acid or any metal fluoride, wherein the data are only for acetic acid, and require both boric acid and sodium fluoride. Claim 14 requires the same 1:1:0.5 amounts of acetic acid: sodium aetate and water but this is not what is tested. Claims 13 and 14 have a maximum concentration of 2% for the combined boric acid and sodium fluoride but the tested value is 2.8% total and outside the claimed range. The treatment time and temperatures are not in claim 1,13 and 14, therefore the methods of these claims are much broader than what is tested as the times could be infinite and applicant has only tested a single temperature of 36°C and 18-22 hours. Accordingly the data are not sufficient to provide unexpected results.
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 AMINA S KHAN whose telephone number is (571)272-5573. The examiner can normally be reached Monday-Friday, 9am-5:30pm EST.
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/AMINA S KHAN/Primary Examiner, Art Unit 1761
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