Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-2, 4, 7-13, 15-19, and 25-26 are examined herein.
Response to Arguments
Applicant submits that the wrong Song and Tran references were cited on the PTO-892 accompanying the Non-Final Action mailed on 2/6/2026 (Arguments, page 9). All of the correct documents were submitted with the Non-Final Action mailed on 2/26/2026. However, although Song, Kaili, et al. "Fabrication of a novel functional CNC cross-linked and reinforced adsorbent from feather biomass for efficient metal removal." Carbohydrate Polymers 222 (2019): 115016 was submitted with the Non-Final Action mailed on 2/26/2026, the PTO-892 cited Song, Kaili, et al. "Cellulose nanocrystal-reinforced keratin bioadsorbent for effective removal of dyes from aqueous solution." Bioresource technology 232 (2017): 254-262. Song 2019 is submitted again and cited on the PTO-892 included with this Office action.
With respect to the Tran 2016 and Tran references, both Tran et al. (Carbohydrate Polymers 151 (2016): 1269-1276; referred to in the Non-Final Action mailed on 2/6/2026 as Tran 2016) and Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801; referred to in the Non-Final Action mailed on 2/6/2026 simply as Tran) were correctly submitted with the Non-Final Action mailed on 2/6/2026. However, the PTO-892 cited Tran et al. (ACS Applied Materials & Interfaces 9.49 (2017): 42503-42515) rather than Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801), which was the reference submitted with the Non-Final Action mailed on 2/6/2026. Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) is submitted again with this action and cited on the PTO-892.
In this action, “Tran” refers to Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) and Tran 2016 refers to Tran et al. (Carbohydrate Polymers 151 (2016): 1269-1276), which is consistent with the Non-Final Action mailed on 2/6/2026.
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims under 35 U.S.C. 102(a)(1) as being anticipated by Song on the grounds that Song fails to disclose incorporating any macronutrient into the adsorbent (Arguments, bottom paragraph on page 10).
In response, Song teaches that the adsorbent comprises Ca2+ ions (Song page 3, right column, 3.2. Batch adsorption study, paragraph 2), which are a macronutrient as evidenced by Thor et al. ((2019) Calcium—Nutrient and Messenger. Front. Plant Sci. 10:440).
Applicant argues against the rejection of claims 1-2, 4, 7, 12-13, 15-17, 19, and 25-26 under 35 U.S.C. 103 over Dickerson in view of Tran on the grounds that the person of ordinary skill in the art would not have been motivated to incorporate a micronutrient into the composite (Arguments, paragraphs 1-2 on page 11).
In response, this argument is not persuasive. The metal salt is a micronutrient based upon the broadest reasonable interpretation of the term “micronutrient” in light of the specification. No special definition is provided for the term micronutrient. Applicant’s interpretation of micronutrient to exclude metal salts such as sodium chloride is not consistent with Applicant’s own claims (see dependent claim 19). In addition, Dickerson teaches that several studies have explored the functionalization of wool fabrics via the addition of antimicrobial agents such as nanoparticles (page 5506, left column, top paragraph). Thus, the person of ordinary skill in the art would have had a clear motivation to incorporate Tran’s nanoparticles.
Applicant argues further that there is no disclosure in Tran that a natural biopolymer and keratin derivative are crosslinked by hydrogen bonding (Arguments, paragraph bridging pages 11-12). Applicant argues that Tran’s statement “Furthermore, the difference of the band at ~2870 cm-1 between the spectra of the two composites suggests that there may be some modifications in the hydrogen bonding when the Ag0NP was incorporated into the [CEL+KER] composite” does not teach hydrogen bonding between keratin and cellulose (Arguments, paragraph bridging pages 11-12).
In response, a statement that there is a modification of the hydrogen bonding of a composite is a teaching that there is crosslinking within the composite. Otherwise, there would be no modification by the introduction of the silver nanoparticles. In addition, physical interactions necessarily occur between cellulose and keratin based upon the chemical structure of both cellulose and keratin. Tran teaches that combining cellulose with keratin results in improved mechanical strength relative to keratin by itself (sentence bridging left and right column of page 34792). These improved mechanical properties are necessarily the result of physical interactions between the cellulose and keratin.
Applicant argues that claims 9-13 and 15-19 are non-obvious as they each depend from nonobvious independent claim 1 (Arguments, paragraph 2 on page 13).
In response, this argument is unpersuasive. Claims 9-13 and 15-19 incorporate all of the limitations of independent claim 1. Thus, the rejection of claims 9-13 and 15-19 under 35 U.S.C. 103 satisfies all limitations required by the dependent claims.
With respect to the nonstatutory double patenting rejections over U.S. Patent No. 11,505,587 and 11,549,198, Applicant argues that there is no disclosure, teaching or suggestion in any of the cited references to incorporate a macronutrient or micronutrient into a substrate comprising a keratin derivative and a natural biopolymer (Arguments, page 13, Non-Statutory Double Patenting).
However, as discussed above with respect to the rejection under 35 U.S.C. 103, the broadest reasonable interpretation of the claim limitation “micronutrient” in light of the specification includes both metal oxides and metal salts (see for example, the instant dependent claim 19).
Claim Objections
Claim 26 is objected to because of the following informalities: the hyphen marks are superfluous and should be removed.
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.
(New Rejection Necessitated by Amendment) Claims 4 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites wherein the natural biopolymer is a modified biopolymer; and/or the natural biopolymer or modified natural biopolymer comprises hydroxyl, amine, carboxyl, thiol, aldehyde, and/or methacrylate groups; and/or the natural biopolymer is selected from the group consisting of cellulose, modified cellulose, nanocellulose, modified nanocellulose, chitosan, modified chitosan, chitin, modified chitin, collagen, modified collagen, fibrinogen, modified fibrinogen, polysaccharide, modified polysaccharide, starch, modified starch, alginate, modified alginate, silk fibroin, modified silk fibroin, sericin, modified sericin, pullulan, modified pullulan, and any combination thereof. The claim recites that the natural biopolymer is a modified biopolymer but the claim also recites “a natural biopolymer or a modified natural biopolymer.” Thus, it is unclear whether the requirement is that the natural biopolymer is a modified natural biopolymer or whether the biopolymer is alternatively a natural biopolymer or a modified natural biopolymer. It is further unclear whether the modifications are the hydroxyl, amine, carboxyl, thiol, aldehyde, and/or methacrylate groups or whether the claim scope is a biopolymer modified with these groups and subject to further modifications. It is further unclear whether the modifications to the natural biopolymers in the Markush group are the hydroxyl, amine, carboxyl, thiol, aldehyde, and/or methacrylate groups or other modifications. Furthermore, the claim term, natural biopolymer, is selected from a Markush group that includes modified biopolymers (not natural), which are in disagreement with the requirement of a natural biopolymer, leading to further ambiguity in the claim scope.
Claim 7 is rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(New Rejection Necessitated by the Amendment) Claims 1-2, 4, 7, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Carbohydrate Polymers 222 (2019): 115016) as evidenced by Thor et al. ((2019) Calcium—Nutrient and Messenger. Front. Plant Sci. 10:440).
This rejection applies to the embodiment in which the substrate comprises modified cellulose nanocrystals (modified nanocellulose), a keratin protein derived from feathers, and calcium (the bioactive). Keratin derivative is interpreted as any component of keratin (e.g. keratin intermediate filament protein, kerateine, or keratose).
Claim 1 is interpreted as requiring that the keratin derivative and natural biopolymer are crosslinked to each other. “Crosslinked” is interpreted according to the definition in the specification: a connection between keratin derivative and natural biopolymer, which encompasses chemical crosslinks (bonds) or physical crosslinks, such as hydrogen bonding and electrostatic interactions (specification lines 12-19 on page 4).
Regarding claims 1-2, 4, and 7, Song teaches an adsorbent (“substrate”) comprising dialdehyde cellulose nanocrystals crosslinked to keratin (page 2, left column, top paragraph and 2.2 Preparation of DCNC reinforced keratin adsorbent, paragraph 1). The keratin is derived from feathers (page 2, left column, top paragraph and 2.2 Preparation of DCNC reinforced keratin adsorbent, paragraph 1). Song also teaches that Pb2+ and Cd2+ form a monolayer on the surface of the keratin adsorbent (page 4, left column, lines 1-2). Song teaches that Ca2+ exchanges with Cd2+ at the adsorption site (page 3, right column, 3.2. Batch adsorption study, paragraph 2), so Song also teaches DCNC reinforced keratin adsorbent comprising calcium ions. Calcium ions are an essential macronutrient for plant growth as evidenced by Thor (page 1, Abstract and Introduction line 1).
Regarding claims 12, Song also teaches that Pb2+ and Cd2+ form a monolayer on the surface of the keratin adsorbent (page 4, left column, lines 1-2). Song teaches that Ca2+ exchanges with Cd2+ at the adsorption site (page 3, right column, 3.2. Batch adsorption study, paragraph 2), so Song also teaches DCNC reinforced keratin adsorbent comprising calcium. Calcium is both a micronutrient and a bioactive.
(New Rejection Necessitated by Amendment) Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Bioresource technology 232 (2017): 254-262) as evidenced by Thor et al. ((2019) Calcium—Nutrient and Messenger. Front. Plant Sci. 10:440) and by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
See discussion of Song and Thor above, which is incorporated into this rejection.
Regarding claim 8, the proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph), which overlaps with the claimed range.
(New Rejection Necessitated by Amendment) Claims 1-2, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801).
“Crosslinked” is interpreted according to the definition in the specification: a connection between keratin derivative and natural biopolymer, which encompasses chemical crosslinks (bonds) or physical crosslinks, such as hydrogen bonding and electrostatic interactions (specification lines 12-19 on page 4).
This rejection applies to the embodiment in which the substrate comprises keratin derived from wool, cellulose, and a metal salt (micronutrient) or antimicrobial (bioactive).
Regarding claims 1-2, 12-13 and 15, Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1). The keratin and cellulose are crosslinked by hydrogen bonding (lines bridging left and right column of page 34795). Although Tran does not specify that the keratin is crosslinked to the cellulose, Tran teaches that combining cellulose with keratin results in improved mechanical strength relative to keratin by itself (sentence bridging left and right column of page 34792). These improved mechanical properties are necessarily the result of physical interactions between the cellulose and keratin. The silver chloride nanoparticles are antimicrobial agents (Tran Abstract), so the composite (“substrate”) comprises both metal salts (“micronutrient”) and a bioactive (the antimicrobial agent, which is the silver chloride nanoparticles).
Regarding claim 16, the silver chloride nanoparticles are particulates with an average size of 27 nm (Abstract), which is within the claimed range of 1 nm to about 500 nm. The particulates are roughly spherical in size (Figure 3), so the average size is the average diameter.
(Maintained Rejection) Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) as evidenced by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
See discussion of Tran above, which is incorporated into this rejection as well.
Regarding claim 8, the proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph), which overlaps with the claimed range.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following rejections are necessitated by the amendment.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (Carbohydrate Polymers 222 (2019): 115016) as evidenced by Thor et al. ((2019) Calcium—Nutrient and Messenger. Front. Plant Sci. 10:440).
See discussion of Song and Thor above, which is incorporated into this rejection as well.
Regarding claim 11, “about” is interpreted according to the definition in the specification (line 6 on page 5): plus or minus 5%.
Song teaches an adsorbent comprising 20% DCNC/keratin, which is a weight ratio of 4:1 keratin to cellulose, which is less than the claimed weight ratio of 5:1 for the keratin to cellulose (page 2, left column, 2.2. Preparation of DCNC reinforced keratin adsorbent, paragraph 2). Song teaches that the ratio of cellulose to keratin changes the mechanical properties of the composite (Figure 3(A)).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the ratio of keratin to cellulose in the composite of Song. The person of ordinary skill in the art would have been motivated to tune the desired material properties of the composite. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the ratio between the two components of the composite.
Regarding claim 18, although Song does not explicitly state the pore size, Figure 3(f) illustrates the porous structure of the adsorbent and the pores are on the order of 50 µm (see scale bar), with some pores almost double the size of the scale bar (see vertical height of leftmost pore in figure 3(f)). Therefore, Song’s pore size approaches the claimed range of about 100 µm to about 200 µm.
Claims 1-2, 4, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (Carbohydrate Polymers 151 (2016): 1269-1276; hereafter Tran 2016) in view of Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) as evidenced by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
This rejection applies to the embodiment in which the substrate comprises cellulose and keratin derived from wool, keratin derived from hair, or keratin derived from feather.
Tran 2016 teaches seven different composites with different compositions and concentrations of keratin-containing substances and cellulose: 40:60 Hair:CEL (1:1.5) ; 40:60 Feather:CEL (1:1.5), 65:35 Hair:CEL (approximately 2:1), 65:35 Feather:CEL (approximately 2:1), 80:20 Hair:CEL (4:1), 75:25 Feather:CEL (3:1), and 90:10 Hair:CEL (9:1): see 2.3. In vitro antibacterial assays. The composites have antimicrobial properties (Title). Tran 2016 produces the composite by mixing keratin from wool, hair, or feather with cellulose in solution (Scheme 1).
Tran 2016 does not explicitly teach that physical crosslinking occurs between the keratin-containing substances and cellulose. However, Tran 2016 notes that interactions occur between the keratin-containing substances and cellulose (page 1273, right column, paragraph 1). Tran 2016 also teaches that combining cellulose with keratin improves the mechanical strength of the composite (page 1276, 4. Conclusions, middle of paragraph 1). Therefore, there are necessarily physical interactions between cellulose and the keratin within the composite resulting in these improved mechanical properties.
Tran 2016 does not teach that the composite further comprises a micronutrient.
However, Tran 2016 teaches that keratin can encapsulate and control release of drugs (page 1272, right column, bottom paragraph, 3.4. Mechanical properties).
Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Tran’s silver chloride nanoparticles with the composite of Tran 2016 in order to further enhance the antimicrobial property of the composite. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tran also teaches a keratin/cellulose composite. Tran teaches mixing the silver chloride nanoparticles into a cellulose/keratin solution (page 34793, left column, Synthesis paragraph) and Tran 2016 also teaches blended solutions of keratin and cellulose (Scheme 1), thus the person of ordinary skill in the art would have had a reasonable expectation of success in mixing the silver chloride nanoparticles into Tran 2016’s cellulose/keratin solution in order to create the composite.
Regarding claim 2, Tran 2016 teaches that the keratin is derived from wool, feather, or hair (page 1270, left column, paragraph 3).
Regarding claim 4, the claim is interpreted as requiring either a modified natural biopolymer comprising hydroxyl, amine, carboxyl, thiol, aldehyde, and/or methacrylate groups or requiring a natural biopolymer selected from the group consisting of cellulose, modified cellulose, nanocellulose, modified nanocellulose, chitosan, modified chitosan, chitin, modified chitin, collagen, modified collagen, fibrinogen, modified fibrinogen, polysaccharide, modified polysaccharide, starch, modified starch, alginate, modified alginate, silk fibroin, modified silk fibroin, sericin, modified sericin, pullulan, modified pullulan, and combinations thereof.
Regarding claims 4 and 7, Tran 2016 teaches that the composite comprises microcrystalline cellulose (page 1270, left column, bottom paragraph, 2.1 Chemicals).
Regarding claim 8, Tran 2016 teaches a composite that contains keratin from wool, hair or feather (Scheme 1). The proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph), which overlaps with the claimed range.
Regarding claims 9-11, Tran 2016 does not teach that the composite comprises about 0.5 wt% to about 2.0 wt% keratin derivative (claim 9), the composite comprises about 0.25 wt% to about 1.0 wt% of natural biopolymer (claim 10), or that the weight percentage ratio is about 5:1 to about 5:3 of keratin derivative to natural biopolymer (claim 11),
Tran 2016 teaches that adding cellulose into keratin substantially improves mechanical strength of keratin-cellulose composites (page 1276, 4. Conclusions, middle of paragraph 1). Tran 2016 teaches that the composite’s antimicrobial activity is due to keratin, not cellulose (page 1276, 4. Conclusions, middle of paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of keratin and cellulose in the composite of Tran 2016 modified by Tran. The person of ordinary skill in the art would have been motivated to tune the desired material properties of the composite. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the amounts of the two components of the composite. The person of ordinary skill in the art would have recognized a tradeoff between mechanical strength based on the amount of cellulose in the composite and antibacterial activity based on the amount of keratin.
Claims 1-2, 4, 7, 12-13, 15-17, 19, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Dickerson et al. (Journal of Materials Chemistry B 1.40 (2013): 5505-5514) in view of Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) as evidenced by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
This rejection applies to the embodiment in which the substrate comprises keratin protein derived from wool.
Dickerson teaches extracting keratin proteins from delipidated wool (page 5506, right column, bottom paragraph, 2.1 Preparation of regenerated keratin-based films and fibers). The proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph). Dickerson then uses the regenerated keratin comprising intermediate filament protein to produce regenerated cellulose/keratin composites (page 5507, left column, paragraph 2). The cellulose is in the form of nanofibers (Supplementary Figure 5 caption “cellulose nanofibers”), which is a synonym for nanofibrils.
Dickerson does not explicitly teach that the cellulose and keratin physically interact by hydrogen bonding or electrostatic interactions (i.e. physical crosslinking). However, Dickerson teaches that the composite is more chemically stable (page 5509, right column, bottom of top paragraph), less brittle, and more tough (page 5510, left column, bottom paragraph). These material properties are necessarily the result of physical crosslinking interactions between the cellulose and keratin.
Dickerson does not teach that the composite further comprises particulate micronutrients.
However, Dickerson teaches that several studies have explored the functionalization of wool fabrics via the addition of antimicrobial agents such as nanoparticles (page 5506, left column, top paragraph).
Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1). The keratin and cellulose are crosslinked by hydrogen bonding (lines bridging left and right column of page 34795). Tran’s silver chloride nanoparticles are metal salts, so Tran teaches a micronutrient.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Tran’s silver chloride nanoparticles with the composite of Dickerson in order to further enhance the antimicrobial property of the composite. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tran also teaches a keratin/cellulose composite. Tran teaches mixing the silver chloride nanoparticles into a cellulose/keratin solution (page 34793, left column, Synthesis paragraph) and Dickerson also teaches blended solutions of keratin and cellulose (page 5507, left column, paragraph 2), thus the person of ordinary skill in the art would have had a reasonable expectation of success in mixing the silver chloride nanoparticles into Dickerson’s cellulose/keratin solution in order to create the composite.
Regarding claim 2, Dickerson’s keratin protein is derived from wool (page 5506, right column, bottom paragraph, 2.1 Preparation of regenerated keratin-based films and fibers).
Regarding claims 4 and 7, Dickerson’s cellulose is in the form of cellulose nanofibers (Supplementary Figure S5), so Dickerson’s cellulose is cellulose nanofibrils (a type of nanocellulose).
Regarding claims 12-13 and 15, Tran’s silver chloride nanoparticles are antimicrobial agents (Tran Abstract), so the composite (“substrate) comprises both metal salts (“micronutrient”) and a bioactive (the antimicrobial agent, which is the silver chloride nanoparticles).
Regarding claim 16, the silver nanoparticles are particulates with an average size of 27 nm (Tran Abstract), which is within the claimed range of 1 nm to about 500 nm. The particulates are roughly spherical in size (Figure 3), so the average size is the average diameter.
Regarding claims 17 and 25-26, Dickerson does not teach that the composite comprises 0.005 mg/ml to about 1.0 mg/ml silver chloride nanoparticles (“bioactive” and “antimicrobial agent”).
Tran teaches composites comprising 3.5, 0.72 and 0.48 mmol silver chloride NP (page 34797, left column, Antibacterial Assay, paragraph 1). The composites are 3×20 mm (right column, paragraph 2, In Vitro Antibacterial Assays) and can be molded to the desired thickness (page 34793, left column, bottom paragraph).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of silver chloride nanoparticles within the composite of Dickerson modified by Tran in order to maximize the antibacterial activity of the composite. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tran teaches that the silver chloride nanoparticles exhibit antibacterial activity even at low concentrations (3.5, 0.72 and 0.48 mmol).
Regarding claim 19, the composite of Dickerson modified by Tran comprises keratin comprising keratin intermediate filament protein: Dickerson teaches extracting keratin proteins from delipidated wool (page 5506, right column, bottom paragraph, 2.1 Preparation of regenerated keratin-based films and fibers). The proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph). The composite also contains cellulose nanofibrils (Dickerson Supplementary Figure 5 caption “cellulose nanofibers”) and silver chloride nanoparticles (Tran Abstract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The following rejections are necessitated by the amendment.
Claims 1-2, 4, 8, 12-13, 15-17, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,505,587 (‘587) in view of Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) as evidenced by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
Claim 1 of ‘587 is drawn to a method of preparing a microporous keratin-based biomaterial, the method comprising: a) reacting keratin with a polymer having at least one of an amine and carboxylic functional group in the presence of a carbodiimide cross-linking agent to form an amide cross-linked keratin-polymer material, wherein the keratin being used to react with the polymer comprises cleaved disulfide bonds after having been extracted from a keratin-containing material by incubating the keratin-containing material with a reducing agent or an oxidizing agent, wherein the polymer having at least one of the amine and carboxylic functional group comprises an alginate, and wherein the keratin is present in a proportion greater than the alginate prior to the reacting; and b) freeze-drying the amide cross-linked keratin-polymer material to form the microporous keratin-based biomaterial.
Claim 6 of ‘587 requires that the polymer having at least one of an amine and carboxylic functional group further comprises chitosan, gelatin, collagen, hyaluronic acid, fibrin, polyaminomethacrylate derivative, polylactic acid, polyglycolic acid, polyacrylamide, mixtures thereof, or copolymers thereof.
Regarding instant claim 1, claims 1 and 6 of ‘587 do not recite that the material comprises a micronutrient.
Regarding instant claim 2, although claim 1 of ‘587 recites extracting keratin from a keratin-containing material, claim 1 of ’587 does not recite that the keratin derivative is keratin intermediate filament protein derived from wool.
Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1). The silver chloride nanoparticles are antibacterial (Abstract). Tran’s silver chloride is a micronutrient because silver chloride is a metal salt.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to extract the keratin from wool because Tian teaches that wool is a keratin-containing material. It would have been further obvious to combine Tran’s silver chloride nanoparticles with the keratin-based biomaterial of claims 1 and 6 of ‘587. The person of ordinary skill in the art would have been motivated to confer antibacterial properties to the material. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination of silver chloride nanoparticles with the keratin-containing biomaterial of claims 1 and 6 of ‘587.
Instant claim 1 is obvious over claim 1 of ‘587 in view of Tran.
Instant claim 1 is also obvious by claim 6 of ‘587 in view of Tran because chitosan, gelatin, and collagen are natural polymers.
Instant claim 4 is obvious over claim 1 of ‘587 (the natural biopolymer is alginate) in view of Tran.
Instant claim 4 is also obvious over claim 6 of ‘587 in view of Tran for the embodiment in which the polymer is chitosan or collagen.
Regarding instant claim 8, the proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph), which overlaps with the claimed range.
Regarding instant claims 12-13 and 15, the silver chloride nanoparticles are antimicrobial agents (Tran Abstract), so the material of claims 1 and 6 of ‘587 modified by Tran comprises both metal salts (“micronutrient”) and a bioactive (the antimicrobial agent, which is the silver chloride nanoparticles).
Regarding claim 16, Tran’s silver chloride nanoparticles are particulates with an average size of 27 nm (Abstract), which is within the claimed range of 1 nm to about 500 nm. The particulates are roughly spherical in size (Figure 3), so the average size is the average diameter.
Regarding instant claim 17 and 25-26, Tran teaches composites comprising 3.5, 0.72 and 0.48 mmol silver chloride NP (page 34797, left column, Antibacterial Assay, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of silver chloride nanoparticles within the material of claims 1 and 6 of ‘587 modified by Tran in order to maximize the antibacterial activity of the material. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tran teaches that the silver chloride nanoparticles exhibit antibacterial activity even at low concentrations (3.5, 0.72 and 0.48 mmol).
Claims 1-2, 4, 7-8, 12-13, 15, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 11,549,198 (‘198) in view of Tran et al. (ACS Applied Materials & Interfaces 8.50 (2016): 34791-34801) as evidenced by Jacob et al. (Cold Spring Harbor perspectives in biology 10.4 (2018): a018275).
Claim 1 of ]198 recites a method of producing non-woven protein fibers comprising protein and at least one additional non-protein material. In one embodiment, the additional non-protein material is a nanofiber.
Claim 2 of ‘198 recites that the at least one additional non-protein material is at least one of (a) a metal oxide and (d) a natural polymer selected from the group consisting of cellulose, chitin, and starch. Therefore, in one embodiment the fibers comprise both the metal oxide and cellulose, the metal oxide and chitin, or the metal oxide and starch. The metal oxide is a micronutrient.
Claim 4 of ‘198 recites that the protein is derived from at least one natural source. In one embodiment, the natural source is keratin.
Although the protein keratin is claimed separately from the natural polymers cellulose or chitin (claims 4 and 2, respectively), both claims 2 and 4 depend from claim 1, which recites a generic protein and additional non-protein material.
Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1). Tran teaches that combining cellulose with keratin results in improved mechanical strength relative to keratin by itself (sentence bridging left and right column of page 34792). The keratin and cellulose are crosslinked by hydrogen bonding (lines bridging left and right column of page 34795).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to construct a non-woven protein material comprising keratin and cellulose with a metal oxide. The person of ordinary skill in the art would have been motivated to improve the mechanical strength of the non-woven protein fibers by incorporating cellulose, as suggested by Tran. Although claims 1-2 and 4 of ‘198 do not recite crosslinking the protein to the non-protein material, the combination of cellulose with keratin necessarily results in physical crosslinking interactions (such as hydrogen bonding) between the two molecules resulting in the improved mechanical properties of the combination.
Regarding instant claim 2, claims 1-2 and 4 of ‘198 do not recite that the keratin is derived from wool.
Regarding instant claim 4, claim 2 of ‘198 recites that the additional non-protein material is cellulose.
Regarding instant claims 7 and 19, claim 2 of ‘198 recites that the additional non-protein material is cellulose. Claim 2 of ‘198 depends from claim 1, which recites that the additional non-protein fiber is a nanofiber. Therefore, in one embodiment, the additional non-protein material is a cellulose nanofiber (synonym for cellulose nanofibril).
Regarding instant claim 8, claims 1-2 and 4 of ‘198 do not recite that the molecular weight of the keratin derivative is about 40 kDa to about 60 kDa.
Regarding instant claims 12-13, claim 2 of ‘198 recites that the additional non-protein material is a metal oxide.
Regarding instant claims 15 and 19, the metal oxides recited in claim 2 of ‘198 include TiO2, CuO, ZnO, FeO, MnO, NiO, and Fe2O3.
Further regarding instant claim 19, claims 1-2 and 4 of ‘198 do not recite that the keratin protein is intermediate filament protein.
Tran teaches a composite (substrate) comprising keratin derived from wool, microcrystalline cellulose (“natural biopolymer”), and silver chloride (AgCl) nanoparticles (Abstract, page 34793, left column, Experimental Section, Chemicals, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to derive the keratin from wool, per the teaching of Tran. The person of ordinary skill in the art would have been motivated to use any readily available source of keratin in the protein fibers of claims 1-2 and 4 of ‘198. The person of ordinary skill in the art would have had a reasonable expectation of success in applying Tian’s method to obtain keratin to the protein fibers of claims 1-2 and 4 of ‘198. The proteins in keratin comprise intermediate filament proteins having a molecular weight of 40-70 kDa as evidenced by Jacob (2 Introduction to keratin IF genes and proteins page 2, left column, bottom paragraph), which overlaps with the claimed range.
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.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
CANDICE LEE SWIFT/Examiner, Art Unit 1657