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 . Claims included in the prosecution are claims 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 18, 19, 29 and 30.
Applicants' arguments, filed 06/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Sequence Requirements
This application contains sequence disclosure that is encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). This application fails to comply with the requirements of 37 C.F.R. §§ 1.821-1.825. Claim 11 contains sequences that are encompassed by the sequence rules and require a sequence identifier, e.g., SEQ ID No. Applicant is reminded to check the entire disclosure to ensure that the application is in sequence compliance.
Any questions regarding compliance with the sequence rules requirements specifically should be directed to the departments listed at the bottom of the Notice to Comply.
APPLICANT IS GIVEN THE TIME ALLOTED IN THIS OFFICE ACTION WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 C.R.F. §§ 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 C.F.R. § 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 C.F.R. § 1.136. In no case may an applicant extend the period for response beyond the six-month statutory period. Direct the response to the undersigned. Applicant is requested to return a copy of the attached Notice to Comply with the response.
Response to Arguments
Applicant has not amended claim 11 to comply with the sequence requirement.
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.
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.
1. Claims 1, 2, 4, 8, 10, 11, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ittah et al. (WO 2017/138002, Aug. 17, 2017) (hereinafter Ittah) in view of Martínez Rovira et al. (US 2021/0401685, Dec. 30, 2021) (hereinafter Martínez Rovira), Radu et al. (Grafting versus Crosslinking of Silk Fibroin-g-PNIPAM via Tyrosine-NIPAM Bridges, Nov. 13, 2019) (hereinafter Radu), Murphy et al. (Modification of silk fibroin using diazonium coupling chemistry and the effects on hMSC proliferation and differentiation, Apr. 15, 2008) (hereinafter Murphy), and Osawa et al. (US 2015/0376247, Dec. 31, 2015) (hereinafter Osawa).
Ittah discloses composite materials based on proteins derived from a MaSp (major ampullate spidroin) protein (¶ [002]). The composite comprises a mixture of proteins in the form of a fiber (claim 3). The fiber is characterized by a porous structure (¶ [190]). Each protein in the mixture comprises repeats of a repetitive region (¶ [010]). The repetitive region has a first moiety and a second moiety (¶ [112]). The second moiety comprises tyrosine (¶ [0115]). Each of the proteins comprise, independently, an amino acid sequence as set forth in SEQ ID NO:1 (X1)ZX2GPGGYGPX3X4X5GPX6GX7GGX8GPGGPGX9X10, wherein X1 is independently, at least instance A or G, Z is an integer between 5 to 30, X2 is S or G, X3 is G or E, X4 is G, S or N, X5 is Q or Y, X6 is G or S, X7 is P or R, X8 is Y or Q, X9 is G or S, and X10 is S or G (¶ [015]). In some embodiments, the mixture of protein is attached to or deposited on at least one surface of a polymer (i.e., claimed functional moiety) via a linker (¶ [271]). The term “linker” refers to a bond, e.g., a covalent bond (¶ [276]). In some embodiments, the linker functionalizes the fibers with other functional groups (¶ [275]). In some embodiments, the polymer is a synthetic polymer, such as a polyamide (¶ [021]). In some embodiments, the mixture of protein is attached to or deposited on at least one surface of an inorganic substrate. Exemplary inorganic substrates include titania (¶ [270]). The fibers may coat the metal (¶ [285]). The term “coat” is used to identify at least 10%, 20%, 30%, 50%, 60%, 70%, 80%, 90% or 100% covering of an outer coated part (substrate) (¶ [285]). The composite may be a cosmetic composition (¶ [304]). The cosmetic composition may be a sun skin-protection product or a face cream (i.e., claimed cosmetic article) (¶ [305]). The composite is characterized by an improved mechanical property as compared to a reference material. In some embodiments, the term "reference material" refers to a same chemical composition as in the composite, being free of the one or more proteins (¶ [203]). The fiber may be used in other forms, such as beadlike particles (¶ [300]).
Ittah differs from the instant claims insofar as not disclosing wherein the fiber has a BET surface area of at least 10 m2/g.
However, Martínez Rovira discloses a graphene nanomaterial such as graphene nanofibers (¶ [0012]) having a BET specific surface area of between 100 and 500 m2/g (¶ [0013]). The graphene nanomaterial is a cosmetic for the treatment of the skin (¶ [0016]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the fiber of Ittah to have a BET specific surface area of between 100 and 500 m2/g since Ittah does not disclose a surface area for the fiber and this is a known and effective surface area for fibers used cosmetically as taught by Martínez Rovira.
The combined teachings of Ittah and Martínez Rovira do not teach wherein the polymer is bound to the tyrosine of the fiber.
However, Radu discloses polymeric networks based on the crosslinking of Bombyx mori silk fibroin via poly(N-isopropylacrylamide) bridges (abstract). Silk fibroin have amino acids with aromatic side chains such as tyrosine (pages 9-10). NIPAM monomer binds on the tyrosine benzene ring in the orto-position aromatic ring through the generation of PNIPAM bridges (page 4).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the polymer of Ittah covalently bound to the tyrosine of the fiber since binding to tyrosine is a known and effective method of attaching a polymer and a fiber together as taught by Radu.
The combined teachings of Ittah, Martinez Rovira, and Radu do not teach wherein the polymer (i.e. claimed functional moiety) is bound to the tyrosine via a diazo bond and wherein the composite comprises an amine.
However, Murphy discloses a simple chemical modification method using diazonium coupling chemistry to tailor the structure and hydrophilicity of silk fibroin protein (abstract). As illustrated in Scheme 1, diazonium reactions with silk involve an electrophilic aromatic substitution reaction between the tyrosine phenolic side chains and a diazonium salt resulting in an azobenzene derivative.
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422
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While there are many more commercially available derivatives, the anilines shown in Fig.1 are used here to demonstrate the range of functional groups that could be incorporated into silk using this chemistry. These anilines contain carboxylic acid (1), amine (2), ketone (3), sulfonic acid (4), and alkyl (5) functional groups.
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310
394
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(page 2831, 3.1 Diazonium coupling reaction).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have had the polymer bound to the tyrosine via a diazo bond since a diazonium reaction is a known method to attach groups to a silk fiber as taught by Murphy.
Additionally, regarding claims 4 and 10, it would have been prima facie obvious to one of ordinary skill in the art to have attached the amine as shown in Fig. 1 of Murphy onto the fiber of Ittah via a diazonium reaction since Ittah discloses wherein the fiber may comprise other functional groups and the amine is a known and effective functional group for silk fibers as taught by Murphy.
The combined teachings of Ittah, Martinez Rovira, Radu, and Murphy do not teach wherein the fiber is in the form of particles having an average particle size between 0.5 µm and 1.5 µm.
However, Osawa discloses particles of a polypeptide derived from spider silk proteins and having an average particle size of 1000 nm or less (abstract). Since the average particle size of the polypeptide particles is sufficiently small, more particles can adhere to a predetermined substrate surface such as medicament and perfume, as compared with particles having a larger average particle size. Therefore, when the polypeptide particles are attached to the substrate surface such as a medicament and perfume, they can effectively delay an exposure of the substrate surface even if their individual decomposition rate on the substrate surface and the desorption speed from the substrate surface are the same as those of particles having a larger average particle size. As a result, the polypeptide particles can exhibit an excellent property of slowly releasing an effect of the medicament or perfume advantageously (¶ [0009]). The particles may be used in cosmetics (¶ [0010]).
As discussed above, Ittah discloses wherein the fibers may be in the form of beadlike particles and be in a cosmetic composition. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the fiber particle of Ittah to be 1000 nm (1 micron) or less motivated by the desire to have more fiber particle adhere to a predetermined substrate surface as taught by Osawa.
In regards to instant claim 1 reciting wherein the derivatized porous MaSp-based fiber is a water-insoluble protein, Ittah discloses in paragraph [401] wherein the solvent used for fully dissolving the fiber is hexafluoroisopropanol (HFIP). Thus, the fiber is not water soluble.
In regards to instant claim 2 reciting a loading of said functional moiety, Ittah discloses in paragraph [318] that the polymer affects mechanical properties. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on the mechanical properties desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In regards to the formula I of instant claims 4 and 10, formula I comprises a tyrosine residue, an azobenzene, and an amine. As discussed above, the protein has a tyrosine moiety, it would have been obvious to have used diazonium coupling chemistry, which forms an azobenzene, to attach groups to the fiber, and it would have been obvious to have attached the amine shown in Fig. 1 of Murphy to the fiber. The claimed formula would have been obvious from these teachings in the prior art.
In regards to instant claim 11 reciting wherein said MaSp-based fiber is characterized by a degradation temperature between 280°C and 350°C and a glass transition temperature between 200°C and 250°C, the claim appears to the recite wherein only the MaSp-based fiber has these properties. Therefore, since Ittah discloses substantially the same fiber as claimed, one of ordinary skill in the art would reasonably expect that the fiber of Ittah to have the claimed properties.
2. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ittah et al. (WO 2017/138002, Aug. 17, 2017) (hereinafter Ittah) in view of Martínez Rovira et al. (US 2021/0401685, Dec. 30, 2021) (hereinafter Martínez Rovira), Radu et al. (Grafting versus Crosslinking of Silk Fibroin-g-PNIPAM via Tyrosine-NIPAM Bridges, Nov. 13, 2019) (hereinafter Radu), Murphy et al. (Modification of silk fibroin using diazonium coupling chemistry and the effects on hMSC proliferation and differentiation, Apr. 15, 2008) (hereinafter Murphy), Osawa et al. (US 2015/0376247, Dec. 31, 2015) (hereinafter Osawa), and further in view of Hardy et al. (Composite materials based on silk proteins, Sep. 2010) (hereinafter Hardy) and Chen et al. (TWI290930, Dec. 11, 2007).
The teachings of Ittah, Martinez Rovira, Radu, Murphy, and Osawa are discussed above. Ittah, Martinez Rovira, Radu, Murphy, and Osawa do not teach wherein the composite comprises the fiber, the polymer, and the inorganic substrate together.
However, Hardy discloses man-made composite materials incorporating silk proteins in combination with other polymers (both natural and synthetic) and/or inorganic particles (abstract).
Ittah discloses wherein the fiber may be attached to the surface of a polymer or of an inorganic substrate (e.g., titania). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composite of Ittah to comprise the silk fiber, the polymer, and the inorganic substrate (i.e., titania) together since it was known in the art that silk proteins may be in combination with other polymers and inorganic particles to form a composite as taught by Hardy. Additionally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
The combined teachings of Ittah, Martinez Rovira, Radu, Murphy, Osawa and Hardy do not teach wherein the polymer is covalently bound to a metal oxide chelating group.
However, Chen discloses a method for producing nanoparticles. The method comprises providing a chelating groups-containing polymer template, and producing nanoparticles on the surface of said polymer template by a chelating reaction between the chelating groups and matrix of said nanoparticles (abstract). The material of the nanoparticles may be nanometals (claim 17).
Ittah discloses wherein the composite comprises linkers that provides covalent bonds. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have covalently bound a chelating agent to the polymer of Ittah since the composite of Ittah comprises titania and polymer and one would be able to attach the polymer and titania together through chelating agents as taught by Chen. The chelating agent would be a metal oxide chelating agent since it is attaching titania, which is a metal oxide.
3. Claims 13, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ittah et al. (WO 2017/138002, Aug. 17, 2017) (hereinafter Ittah) in view of Martínez Rovira et al. (US 2021/0401685, Dec. 30, 2021) (hereinafter Martínez Rovira), Radu et al. (Grafting versus Crosslinking of Silk Fibroin-g-PNIPAM via Tyrosine-NIPAM Bridges, Nov. 13, 2019) (hereinafter Radu), Murphy et al. (Modification of silk fibroin using diazonium coupling chemistry and the effects on hMSC proliferation and differentiation, Apr. 15, 2008) (hereinafter Murphy), Osawa et al. (US 2015/0376247, Dec. 31, 2015) (hereinafter Osawa), and further in view of Hardy et al. (Composite materials based on silk proteins, Sep. 2010) (hereinafter Hardy).
The teachings of Ittah, Martinez Rovira, Radu, Murphy, and Osawa are discussed above. Ittah, Martinez Rovira, Radu, Murphy, and Osawa do not teach wherein the composite comprises the fiber, the polymer, and the inorganic substrate together.
However, Hardy discloses man-made composite materials incorporating silk proteins in combination with other polymers (both natural and synthetic) and/or inorganic particles (abstract).
Ittah discloses wherein the fiber may be attached to the surface of a polymer or of an inorganic substrate (e.g., titania). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composite of Ittah to comprise the silk fiber, the polymer, and the inorganic substrate (i.e., titania) together since it was known in the art that silk proteins may be in combination with other polymers and inorganic particles to form a composite as taught by Hardy. Additionally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
In regards to instant claim 18 reciting wherein the metal oxide particle is characterized by a particle size between 10 and 5,000 nm, since size affects amount of adherence as taught by Osawa above, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed particle size depending on the amount fiber desired to be attached to the titania. One of ordinary skill in the art would have optimized the amount since fiber affects mechanical properties as taught by Ittah.
In regards to instant claim 18 reciting wherein a w/w ratio of said derivatized porous MaSp-based fiber to said metal oxide particle is between 0.01 and 100, since Ittah discloses wherein the fiber may coat 10%-100% of the substrate, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratio depending on the level of coating desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
4. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ittah et al. (WO 2017/138002, Aug. 17, 2017) (hereinafter Ittah) in view of Martínez Rovira et al. (US 2021/0401685, Dec. 30, 2021) (hereinafter Martínez Rovira), Radu et al. (Grafting versus Crosslinking of Silk Fibroin-g-PNIPAM via Tyrosine-NIPAM Bridges, Nov. 13, 2019) (hereinafter Radu), Murphy et al. (Modification of silk fibroin using diazonium coupling chemistry and the effects on hMSC proliferation and differentiation, Apr. 15, 2008) (hereinafter Murphy), Osawa et al. (US 2015/0376247, Dec. 31, 2015) (hereinafter Osawa), Hardy et al. (Composite materials based on silk proteins, Sep. 2010) (hereinafter Hardy), and further in view of Chen et al. (TWI290930, Dec. 11, 2007).
The teachings of Ittah, Martinez Rovira, Radu, Murphy, Osawa, and Hardy are discussed above. Ittah, Martinez Rovira, Radu, Murphy, Osawa, and Hardy do not teach wherein the titania is covalently bound to the polymer (i.e., functional moiety) via a metal oxide chelating agent.
However, Chen discloses a method for producing nanoparticles. The method comprises providing a chelating groups-containing polymer template, and producing nanoparticles on the surface of said polymer template by a chelating reaction between the chelating groups and matrix of said nanoparticles (abstract). The material of the nanoparticles may be nanometals (claim 17).
Ittah discloses wherein the composite comprises linkers that provides covalent bonds. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have covalently bound a chelating agent to the polymer of Ittah since the composite of Ittah comprises titania and polymer and one would be able to attach the polymer and titania together through chelating agents as taught by Chen. The chelating agent would be a metal oxide chelating agent since it is attaching titania, which is a metal oxide.
In regards to instant claim 15 reciting wherein a molar ratio of said chelating agent to the derivatized porous MaSp-based fiber is between 0.01 and 1, since the fiber, which comprises mixtures of proteins, provides improved mechanical property compared to a reference material, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ratio depending on the mechanical property desired since amount of fiber attached to titania would affect the amount of chelating agent present.
5. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ittah et al. (WO 2017/138002, Aug. 17, 2017) (hereinafter Ittah) in view of Martínez Rovira et al. (US 2021/0401685, Dec. 30, 2021) (hereinafter Martínez Rovira), Radu et al. (Grafting versus Crosslinking of Silk Fibroin-g-PNIPAM via Tyrosine-NIPAM Bridges, Nov. 13, 2019) (hereinafter Radu), Murphy et al. (Modification of silk fibroin using diazonium coupling chemistry and the effects on hMSC proliferation and differentiation, Apr. 15, 2008) (hereinafter Murphy), Osawa et al. (US 2015/0376247, Dec. 31, 2015) (hereinafter Osawa), Hardy et al. (Composite materials based on silk proteins, Sep. 2010) (hereinafter Hardy), Chen et al. (TWI290930, Dec. 11, 2007), and further in view of Tennican (US 2022/0062335, Priority Date: Jan. 28, 2019).
The teachings of Ittah, Martinez Rovira, Radu, Murphy, Osawa, Hardy, and Chen are discussed above. Ittah, Martinez Rovira, Radu, Murphy, Osawa, Hardy, and Chen do not teach wherein the chelating agent is salicylic acid.
However, Tennican discloses an antimicrobial agent including one or more compounds that are chelating agents. Examples of chelating agents include salicylic acid (¶ [0057]). Chelators are primarily known to act to form strong bonds to a wide variety of inorganic or organic ions (¶ [0058]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated salicylic acid to the composite since it is a known and effective chelating agent for forming bonds as taught by Tennican.
Response to Arguments
Applicant argues that current claim 1 specifies that the derivatized MaSp-based fiber is in a form of distinct particles having an average particle size between 0.5 µm and 1.5 µm, which is completely different from Radu’s complex polymeric network -i.e., a bulk macroscopic material.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Ittah teaches a derivatized MaSp-based fiber is in a form of beadlike particles and Osawa provided motivation to formulate the particles to be 1000 nm or less. As such, Applicant’s argument is unpersuasive.
Applicant argues that Radu is completely silent regarding instantly claimed functional moiety covalently bound to a tyrosine of the derivatized porous MaSp-based fiber via a diazo bond or a silyl group.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Murphy provides motivation to have the polymer bound to the tyrosine via a diazo bond. As such, Applicant’s argument is unpersuasive.
Applicant argues that Martinez Rovira is directed to graphene, which is a 2-dimensional carbon sheet, and which is completely irrelevant to the claimed protein (MaSp).
The Examiner does not find Applicant’s argument to be persuasive. Ittah discloses MaSp fibers for a cosmetic composition, but does not disclose the BET surface area of the fibers. Therefore, one of ordinary skill in the art would have looked towards the teachings of Martinez Rovira which teaches a known and effective surface area for fibers used cosmetically. As such, Applicant’s argument is unpersuasive.
Applicant argues that Murphy is directed to a process of chemical modification of water-solubilized silk protein. In sharp contrast, the instantly claimed derivatized porous MaSp-based fiber is insoluble in an aqueous solution. A skilled artisan would question the possibility of diazo-coupling of the instantly claimed water insoluble protein particulates by method of Murphy.
The Examiner does not find Applicant’s argument to be persuasive. Murphy discloses that for a diazonium coupling reaction with silk, a silk solution in borate buffer was combined with 0–500 µL of a stock diazonium salt solution (page 3, 2.2 Diazonium Coupling Reaction with Silk). Murphy also discloses wherein the silk solution in a borate buffer was formed from a purified silk fibroin solubilized in a LiBr solution, which was then filtered, then dialyzed against distilled water, and then against borate buffer (pages 2-3, Preparation of Aqueous Silk Solutions). Ittah discloses wherein the mixture of proteins is dissolved in a water-miscible solvent prior to contacting the plurality of peptides with the polymer (i.e., claimed functional moiety) (¶ [315]). Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success of using Murphy’s method since Murphy discloses use of a silk solution, wherein the silk is dissolved in a LiBr solution (i.e., water-miscible solvent), for the diazonium coupling reaction and Ittah discloses a silk solution wherein the silk is dissolved in a water-miscible solvent prior to any functional moiety being bonded. As such, Applicant’s argument is unpersuasive.
Applicant argues that Murphy recites that chemical modification was found to influence the fibroin protein structure. Such influence on the protein structure is highly undesirable since a skilled artisan apparently wouldn’t be interested in disrupting the highly intricate porous structure of the claimed MaSp particles, which is not only responsible for a high surface area but is also contributing to dispersibility and encapsulation properties of the claimed MaSp.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s argument is merely speculative since Applicant has not provided any objective evidence supporting their allegation. Applicant has not shown wherein influence on fibroin protein structure would be undesirable to one of ordinary skill in the art and Applicant has not shown wherein the porous structure of the claimed MaSp particles is responsible for a high surface area and also contributes to dispersibility and encapsulation properties. As such, Applicant’s argument is unpersuasive.
Applicant argues that Hardy and Ittah never teach nor suggest using a derivatived MaSp-based fiber, modified by a polymer including numerous chelating groups suitable for binding TiO2 nanoparticles, as recited by instant claim 1.
The Examiner does not find Applicant’s argument to be persuasive. Instant claim 1 does not require the fiber to have numerous chelating groups. Instant claim 1 recites wherein the fiber comprises at least one functional moiety bound to a tyrosine. As such, Applicant’s argument is unpersuasive.
Applicant argues that based on the teaching of Hardy and Ittah, a skilled artisan would be solely motivated using a non-modified MaSp-based fiber.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown Hardy teaches that a non-modified MaSp-based fiber is advantageous over a modified MaSp-based fiber. Therefore, Applicant’s argument that one would be solely motivated to using a non-modified MaSp-based fiber is unpersuasive.
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.
Claims 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 18, 19, 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,453,688. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite specific use and additional limitations) and thus read on the instant claims.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 18, 19, 29 and 30 are rejected.
No claims are allowed.
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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/TRACY LIU/Primary Examiner, Art Unit 1614
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