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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 May 2026 has been entered.
Status of the Claims
11-20 have been cancelled.
Claims 1-10 and 21-30 are presented for examination on the merits.
Claim Objections
Claim 1 objected to because of the following informalities: the amendment made to the claim “isoldated from human hair” would appear to be a misspelling. Appropriate correction is required.
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.
Claim 2 is 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 2 is rendered vague and indefinite by the phrase “wherein the keratin protein extract is isolated from human hair” in light of the amendments made to claim 1. It is unclear how claim 2 is meant to further limit claim 1, does the phrase mean that the keratin protein extract is exclusively isolated from human hair or is only one of many extracts isolated from human hair?
Appropriate clarification is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-10 and 21-30 stand rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (2022) and Mohanapriya et al. (2023) in view of McCrory et al. (US 8,281,516)
Li (2022) beneficially teaches that organic fertilizers and biofertilizers are important for sustainable agriculture by providing nutrients to enhance the growth speed of the plant and production. Keratin-containing wastes, therefore, will be an important resource to produce organic fertilizers. Many microorganisms exhibit capabilities to degrade keratins making them attractive to convert keratin-containing wastes into valuable products. With proper treatment, feather wastes which are rich in keratin can be converted into high-value fertilizers to serve as nutrients for plants, reduce environmental pressure and improve the quality of the soil for sustainable agriculture. Keratin-containing wastes play a role in sustainable agriculture by providing value-added products. The keratin hydrolysate influences the plant growth because of the peptides and amino acids which play versatile roles in plants. These products have been shown to have an impact on the stimulation of carbon and nitrogen metabolism, which may result in the difference in seeds germination, seedling growth, and activation of the plant proton pump. Peptides in the keratin hydrolysate may exhibit hormonal activities. These products can also play a role in stimulating plant growth through their indirect effect on nutrient update and usage. The amino acids in keratin hydrolysate will have an impact on the rhizospheric microbes by serving as a nitrogen source, which in turn will affect the action of the microorganism on the root of the plant. Therefore, hydrolysate derived from keratin wastes is a promising biofertilizer. Studies have shown that microbial keratin hydrolysate can serve as a biofertilizer to promote plant growth (Table 2). Addition of hydrolysate such as 5 g feather in 250 g soil and 1 kg in 10 kg soil enhanced plant growth.
Mohanapriya et al. beneficially teach the optimal parameters for the keratin extraction from human hair with production of biofertilizer. These results provide new insight into the extraction of keratin from human hair with implications for its use as an organic fertilizer. Further disclosed is that keratin can be extracted using several methods such as chemical hydrolysis, enzymatic and microbial treatment, dissolution in ionic liquids, microwave technique, steam explosion technique, and thermal hydrolysis or superheated process. Keratin was extracted from human hair using agents namely, sodium sulfide, peracetic acid, urea, and thioglycolic acid. Keratin is an organic nitrogen
fertilizer suitable for the nutrition of vegetables, flowers, and aquatic plants. As a major source of nitrogen, it is suitable for all crops with and increasingly demand nitrogen. In addition to nitrogen, it contains a small amount of other nutrients. The polyproteins in keratin can be converted into amino acids to serve as nitrogen sources for plant growth and then the microorganisms used in waste treatment will be another source of nutrients for plant growth. The keratin material is useful as a soil amendment providing organic and inorganic nutrients. The keratin material is also useful as a nutrient
source in the bioremediation of toxic contaminants in soils and liquids. To convert keratin containing waste into biofertilizers
As stated by Applicant in the instant Specification at paragraph [0059], the device employed in the claims is disclosed in U.S. Patent No. 8,281,516.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to employ a keratin extracted from human hair in agricultural biofertilizer as taught by the prior art and to disperse in with known devices.
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, 1254-1255, 195 U.S.P.Q. (BNA) 430, 432-33 (C.C.P.A. 1977).
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant's amendments/arguments have been fully considered but they are not persuasive.
Applicant has made amendments to the claimed composition including that the keratin extract:
(a) is from human hair,
(b) contains keratoses, kerateines, or combinations produced by oxidative or reductive treatment of a keratin source, and
(c) has a peak average molecular weight in the range of from about 60 Da to about 6.2 MDa.
Applicant asserts that:
The amended claims now recite "keratoses, kerateines, or combinations thereof produced by oxidative or reductive treatment of a keratin source." As explained in the specification, "[i]f an oxidative treatment is used, the resulting keratin proteins are referred to as 'keratoses.' If a reductive treatment is used, the resulting keratin proteins are referred to as 'kerateines."' See pending application, paragraph [0018]. Li's microbial/enzymatic degradation and Mohanapriya's alkaline hydrolysis process do not produce keratoses or kerateines as defined by these specific oxidative or reductive treatments.
However, conclusory statements by the Applicant are not a substitute for evidence, particularly surprising or unexpected results. This is unpersuasive, since the vague terms of “oxidative treatment” and “reductive treatment” are not as specific as Applicant assets and are so broad as to include myriad methods known in the art. That is – oxidative and/or reductive treatment can include acidic or alkaline treatment. Indeed, the very paragraph cited by Applicant states “[s]oluble keratin proteins can be extracted from keratin protein sources by oxidation or reduction using methods known in the art”.
Furthermore, as Applicant point out in the specification
[0036] According to one embodiment, the method of producing an agricultural composition includes the step of extracting or lifting the keratin source cuticle thereby enabling release of one or more keratin proteins. The step of extracting or lifting the keratin protein may be accomplished by oxidation or reduction reactions of the keratin protein source by which the crosslinked structure of keratin source is broken down. According to one embodiment, the disulfide bonds in cystine amino acid residues are cleaved, rendering one or more keratin proteins within the keratin protein source soluble.
[0037] According to one embodiment, the one or more keratin proteins trapped in the keratin source (e.g., inside the cuticle's protective structure of hair) may be released by oxidatively reacting a denaturing solution with the rinsed keratin protein source to form an acid mixture. Suitable denaturing solutions include urea, transition metal hydroxides, surfactant solutions, and combinations thereof. Common methods utilize aqueous solutions of tris base (2- Amino-2-(hydroxymethyl)-1,3-propanediol) in concentrations between 0.1 and 1.0 M, and urea solutions between 0.1 and 10M. According to one embodiment, the denaturing solution may be peracetic acid that is present at a concentration of from about 0.1 M to about 0.15M.
[0038] According to one embodiment, the method of producing an agricultural composition includes the step of heating the acid mixture to about 40OC-45°C to form a heated acid mixture. According to one embodiment, the method of producing an agricultural composition includes the step of incubating the heated acid mixture for about 15 hours to about 18 hours to form an incubated acid mixture. According to one embodiment, the method of producing an agricultural composition includes the step of removing the peracetic acid from the incubated acid mixture to form an oxidized keratin protein source. The peracetic acid may be removed by rising the keratin protein source with water.
This it is known from the cited prior art that keratin preparations from human hair can be useful biofertilizers and that common methods of extraction include employing peracetic acid.
As for the limitation of the peak average molecular weight in the range of from about 60 Da to about 6.2 MDa. While the prior art does not explicitly disclose it, any keratin extract will have an average molecular weight, such is an inherent property of the extract, particularly given the enormous range of 60 to 6,200,000 Da. It is noted that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004)(“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”); Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348-49 (Fed. Cir. 1999) (“Because sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention…. An inherent structure, composition, or function is not necessarily known.”)>; SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound “inherently” anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound “inherently results in at least trace amounts of” the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate) (See MPEP 2112).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the claim is so broad as to cover the concept of employing keratin extracts in bioagriculture, as the prior art clearly shows this is well known. Furthermore, the extracts of the instant Application appear to be obtained by commonly-employed methods of extraction. In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Indeed, Applicant argument against the McCrory reference is unpersuasive given the instant Application specification states that “The multi-function horticultural device includes the device as set forth in U.S. Patent No. 8,281,516”.
It would appear that the keratin extract of the claims is prepared by the same methods of that of the prior art. As stated previously, 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, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant asserts that the specification demonstrates that the claimed agricultural compositions achieve quantified, unexpected improvements. Example 2 demonstrates that plants treated with the agricultural composition showed a 16% increase in height, a 52% increase in stem diameter, and a 58% increase in three plant weight compared to plants treated with chicken manure. As-Filed Specification, paragraphs [0074]- [0076]. Additionally, treatment with the claimed agricultural composition provided a 15% pod increase, a 17% increase in pod weight, and a 16% increase in average plant weight compared to the chicken manure treatment. See paragraph [0080]. These quantified improvements constitute objective evidence of unexpected results that the prior art does not teach or suggest.
However, contrary to Applicant’s assertion these results were obtained by a particular embodiment, not the claimed composition. With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). In order to accord substantial weight to secondary considerations in an obviousness analysis, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). “The patentee bears the burden of showing that a nexus exists.” WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). “To determine whether the patentee has met that burden, we consider the correspondence between the objective evidence and the claim scope.” Henny Penny, 938 F.3d at 1332.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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