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
Applicant’s preliminary amendment filed on January 29, 2024 is acknowledged. Claims 3-16, 19, 22, 24-26, and 28-29 have been amended. Claims 2 and 32-71 have been canceled. Claims 1 and 3-31 are currently pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 16, 2025; October 23, 2024; and May 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
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.
3. Claim 12 recites the limitation "wherein the biodegradable polymer" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
4. Claim(s) 1 and 3-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mao et al., WO 2019/148147 A1; Published: 08/01/19, and further in view of Dake et al., US 2019/0247293 A1; Published 08/15/19.
Independent claim 1 is drawn to a polyelectrolyte nanocomplex comprising one or more neuromodulators, a carrier molecule, and a counter ion polymer, wherein the counter ion polymer has a charge enabling it to bind electrostatically to the one or more neuromodulators.
Mao et al. teach biodegradable polymeric nanoparticle compositions for encapsulations and sustained release of protein therapeutics. In one embodiment, polyelectrolyte complexes (PEC) of IgG with dextran sulfate were then co-precipitated with block copolymers such as PEG-PLLA or PEG-PCL (see page 5; meets claims 1, 7-8 & 11). One nanoparticle comprises a complex comprising a protein or peptide, and a counter ion polymer wherein the counter ion polymer has a charge enabling it to bind electrostatically to the protein (see page 7, lines 9-11; meets claim 1). Suitable sizes of the nanoparticle is in the range of, for example, 20 to 2000 nm; 20 to 500 nm. The nanoparticles also includes a matrix comprising the complex uniformly distributed throughout a biodegradable polymer(i.e. PEG-b-PLLA; meets claim 13). Examples of suitable counter ion polymers include dextran sulfate, heparin (heparin sulfate), hyaluronic acid, or a combination thereof (meets claim 11; see page 7, lines 15-19). Most proteins may be used in the present invention including polypeptides and antibodies. Suitable copolymer include PLLA, PGA, PLGA, PCL (meets claim 12; see page 7, lines 21-22).
Moreover, the present invention includes a continuous and scalable method to prepare a biodegradable nanoparticle with a uniform distribution of protein PEC throughout the nanoparticle, high payload capacity, and sustained release of protein therapeutics. To regulate protein release and render effective protection and encapsulation, protein therapeutics are complexed into PEC nanoparticles with a polyelectrolyte that carries the opposite charge through a continuous process termed FNC. The protein-loaded nanoparticles exhibit negative surface charge, narrow size distribution and tunable particle sizes by changing the weight ratio of protein to polymer ratio. Most importantly, these nanoparticles enable sustained and prolonged release of proteins. The release rate of these nanoparticles can be tuned via manipulating the weight ratio of protein to polymer. Given the reproducibility and scalability of the nanoparticle production process, as well as the sustained long-term release achieved by these nanoparticles, this platform holds great potential for the preparation of nanoparticles for various of protein therapeutics including many antibody pharmaceutics. In particular embodiments of the disclosure, a subject may be given, or administered, a nanoparticle of the present invention comprising a pharmaceutical agent, such as a protein, peptide, antibody, chemical, nucleic acid, or a combination thereof as would be known to one of ordinary skill in the art (see page 28-29; supports optimization for claim 9, 10 and 14).
Lastly, Mao teaches that the actual dosage amount of a nanoparticles of the present invention can be determined by physical and physiological factors such as body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the patient and on the route of administration. Depending upon the dosage and the route of administration, the number of administrations of a preferred dosage and/or an effective amount may vary according to the response of the subject. The practitioner responsible for administration will, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject (see page 31, lines 12-19).
Mao does not specifically teach that their polyelectrolyte nanocomplex protein is a neuromodulator protein, specifically a Clostridial neurotoxin, as required by claims 1 and 3-6.
Dake teaches compositions comprising a botulinum toxin, more specifically compositions that enable the transport or delivery of a botulinum toxin (see paragraph 0015). One aspect of this invention is to provide a composition containing a botulinum toxin and a carrier. The carrier has a polymeric backbone with attached positively charged branching groups. The association between the carrier and the botulinum toxin is non-covalent (see paragraph 0016). Any of the known types of botulinum toxin, namely botulinum neurotoxin serotypes A, B, C, D, E, F and G can be used. At least two types of botulinum toxin, types A and B, are available commercially in formulations for treatment of certain conditions. Type A, for example, is contained in preparations of Allergan having the trademark BOTOX® and of Ipsen having the trademark DYSPORT®, and type B is contained in preparations of Elan having the trademark MYOBLOC® (see paragraph 0056; meetings claims 3-6).
Furthermore, Dake teaches that compositions according to this invention may be in the form of controlled-release or sustained-release compositions, wherein the botulinum toxin and the carrier are encapsulated or otherwise contained within a material such that they are released onto the skin in a controlled manner over time. The botulinum toxin and carrier may be contained within matrixes, liposomes, vesicles, microcapsules, microspheres and the like, or within a solid particulate material, all of which is selected and/or constructed to provide release of the botulinum toxin over time (see paragraph 0065).
It would have been obvious before the effective filing date of the presently claimed invention to employ proteins from Clostridial neurotoxin together with a delivery component, a carrier, polymer and polyelectrolyte nanocomplex as suggested by Dake et al. with a reasonable expectation of success. This modification may be viewed as the substitution of particular therapeutic protein which were known and suggested in the art for their treatment of autoimmune conditions, cancer, and ophthalmologic conditions among others generally suggested by the combined teachings of Mao et al. The skilled artisan would have been motivated to make this modification because Mao suggest the use and delivery of any therapeutic protein and Dake suggest delivery formulations of botulinum toxin with a carrier having a polymeric backbone with attached positively charged branching groups. The skilled artisan would have had a reasonable expectation of success because each of the documents teach compositions specifically for the delivery of proteins.
Additionally, the claim would have been obvious because the substitution of one known element or protein for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
Lastly, as it pertains to claims 9, 10 and 14, Mao teaches that the actual dosage amount of a nanoparticles of the present invention can be determined by physical and physiological factors such as body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the patient and on the route of administration. Depending upon the dosage and the route of administration, the number of administrations of a preferred dosage and/or an effective amount may vary according to the response of the subject. The practitioner responsible for administration will, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject. Supporting the fact that it would be obvious to optimize and thus, limitations such as weight ratios, diameters of particle are being viewed as limitations of optimizing experimental parameters.
Accordingly, the subject matter of claims 1 and 3-14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
5. Claim(s) 15, 16, and 19-31 are rejected under 35 U.S.C. 103 as being unpatentable over Mao et al., WO 2019/148147 A1; Published: 08/01/19, in view of Dake et al., US 2019/0247293 A1; Published 08/15/19 as applied to claims 1 and 3-14 above, and further in view of Bromberg et al., US 7,204,997 B2; Published: 04/17/07.
Independent claim 15 is drawn to a microgel comprising: polyelectrolyte nanocomplex, and a crosslinked hydrophilic polymer; wherein the polyelectrolyte nanocomplex comprises one or more neuromodulators, a carrier molecule, and a counter ion polymer, wherein the counter ion polymer has a charge enabling it to bind electrostatically to the one or more neuromodulators; and wherein the polyelectrolyte nanocomplex is distributed throughout the crosslinked hydrophilic polymer.
Mao et al. teach biodegradable polymeric nanoparticle compositions for encapsulations and sustained release of protein therapeutics. In one embodiment, polyelectrolyte complexes (PEC) of IgG with dextran sulfate were then co-precipitated with block copolymers such as PEG-PLLA or PEG-PCL (see page 5; meets claims 1, 7-8 & 11). One nanoparticle comprises a complex comprising a protein or peptide, and a counter ion polymer wherein the counter ion polymer has a charge enabling it to bind electrostatically to the protein (see page 7, lines 9-11; meets claim 1). Suitable sizes of the nanoparticle is in the range of, for example, 20 to 2000 nm; 20 to 500 nm (meets claim 28). The nanoparticles also includes a matrix comprising the complex uniformly distributed throughout a biodegradable polymer(i.e. PEG-b-PLLA; meets claim 13, 15 and 27). Examples of suitable counter ion polymers include dextran sulfate, heparin (heparin sulfate), hyaluronic acid, or a combination thereof (meets claim 11; see page 7, lines 15-19). Most proteins may be used in the present invention including polypeptides and antibodies. Suitable copolymer include PLLA, PGA, PLGA, PCL (meets claim 12 and 26; see page 7, lines 21-22).
Moreover, the present invention includes a continuous and scalable method to prepare a biodegradable nanoparticle with a uniform distribution of protein PEC throughout the nanoparticle, high payload capacity, and sustained release of protein therapeutics. To regulate protein release and render effective protection and encapsulation, protein therapeutics are complexed into PEC nanoparticles with a polyelectrolyte that carries the opposite charge through a continuous process termed FNC. The protein-loaded nanoparticles exhibit negative surface charge, narrow size distribution and tunable particle sizes by changing the weight ratio of protein to polymer ratio. Most importantly, these nanoparticles enable sustained and prolonged release of proteins. The release rate of these nanoparticles can be tuned via manipulating the weight ratio of protein to polymer. Given the reproducibility and scalability of the nanoparticle production process, as well as the sustained long-term release achieved by these nanoparticles, this platform holds great potential for the preparation of nanoparticles for various of protein therapeutics including many antibody pharmaceutics. In particular embodiments of the disclosure, a subject may be given, or administered, a nanoparticle of the present invention comprising a pharmaceutical agent, such as a protein, peptide, antibody, chemical, nucleic acid, or a combination thereof as would be known to one of ordinary skill in the art (see page 28-29; supports optimization for claim 9, 10 and 14).
Lastly, Mao teaches that the actual dosage amount of a nanoparticles of the present invention can be determined by physical and physiological factors such as body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the patient and on the route of administration. Depending upon the dosage and the route of administration, the number of administrations of a preferred dosage and/or an effective amount may vary according to the response of the subject. The practitioner responsible for administration will, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject (see page 31, lines 12-19).
Dake teaches compositions comprising a botulinum toxin, more specifically compositions that enable the transport or delivery of a botulinum toxin (see paragraph 0015). One aspect of this invention is to provide a composition containing a botulinum toxin and a carrier. The carrier has a polymeric backbone with attached positively charged branching groups. The association between the carrier and the botulinum toxin is non-covalent (see paragraph 0016). Any of the known types of botulinum toxin, namely botulinum neurotoxin serotypes A, B, C, D, E, F and G can be used. At least two types of botulinum toxin, types A and B, are available commercially in formulations for treatment of certain conditions. Type A, for example, is contained in preparations of Allergan having the trademark BOTOX® and of Ipsen having the trademark DYSPORT®, and type B is contained in preparations of Elan having the trademark MYOBLOC® (see paragraph 0056; meetings claims 3-6).
Furthermore, Dake teaches that compositions according to this invention may be in the form of controlled-release or sustained-release compositions, wherein the botulinum toxin and the carrier are encapsulated or otherwise contained within a material such that they are released onto the skin in a controlled manner over time. The botulinum toxin and carrier may be contained within matrixes, liposomes, vesicles, microcapsules, microspheres and the like, or within a solid particulate material, all of which is selected and/or constructed to provide release of the botulinum toxin over time (see paragraph 0065).
The combination of Mao and Dake et al. do not specifically teach a microgel nor does it teach a crosslinked hydrophilic polymer.
Bromberg teaches responsive microgels which are comprised of ionizable networks of covalently cross-linked homopolymeric ionizable monomers. The microgels further comprise at least one therapeutic entity and delivers a substantially linear sustained released of the therapeutic entity under physiological conditions. The invention relates to stable chemically cross-linked networks (gels) of a polyelectrolyte (see abstract; column 6, lines 5-61; and column 7, lines 43-66; meets claim 15 and 29). Moreover, the polyelectrolyte network are comprised of a monomer selected from poly(acrylic acid). The ionizable network also includes dextran sulfate, heparin, hyaluronic acid, polyvinyl alcohol as well as natural hydrogels such as basic gelatins and chitosan (see column 9, lines 5-17, 25, 30, 59-61; meets claims 20-21). Additionally, responsive microgels include poly(2-hydroxyethyl methacrylate) (see column 11&12, lines 40-44 &45-46, respectively; meets claim 19). Bromberg teaches that the hydrophilic blocks (hydrophilic monomers and polymers) can also be used in the compositions as an element of the ionizable network (polyelectrolyte) (see column 10, lines 53-56). The therapeutic entity includes proteins such as neurotoxins (see column 39, line 11). Lastly, the microgel particles are spherical in shape and have a median diameter of 13 µm (see column 43, lines 61, 65-66; meets claims 22-23).
Further, as it pertains to claim 24, Bromberg teaches that swelling of the microgels corresponds to the swelling of other super absorbents and is governed by elasticity of the permanent cross-links and osmotic term corresponding to the electrostatic repulsion of the chains. The elasticity of the microgel becomes higher due to the appearance of additional cross-links (see column 49, lines 47-55). The Office takes the position that the microgel has a shear storage modulus from about 10 Pa to about 10,000 Pa, absent evidence to the contrary.
It would have been obvious before the effective filing date of the presently claimed invention to employ the microgel of Bromberg having a crosslinked hydrophilic polymer as a benefit for the delivery of therapeutics with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification because microgels offer enhanced drug delivery and absorption and they are customizable in nature allowing for controlled release making them valuable in medicine as carriers. The microgels have the ability to deliver a substantially linear and sustained release of the therapeutic entity under physiological conditions. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Regarding the specific concentrations listed in the instant claims in terms of ratio (claim 16); nanocomplex size (claim 25); nanoparticle size (claim 28); and fraction amount of protein to nanoparticle/nanocomplex and polymer range (claim 30-31), MPEP 2144.05 states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).”
Limitations such as weight ratios, diameters of particle are being viewed as limitations of optimizing experimental parameters.
Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
6. Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mao et al., WO 2019/148147 A1; Published: 08/01/19, in view of Dake et al., US 2019/0247293 A1; Published 08/15/19, in view of Bromberg et al., US 7,204,997 B2; Published: 04/17/07 as applied to claims 1 and 3-16 and 19-31 above, and further in view of Azimi et al., Journal of Engineered Fibers and Fabrics, 2014; 9(3): 74-84.
Independent claim 15 is drawn to a microgel comprising: polyelectrolyte nanocomplex, and a crosslinked hydrophilic polymer; wherein the polyelectrolyte nanocomplex comprises one or more neuromodulators, a carrier molecule, and a counter ion polymer, wherein the counter ion polymer has a charge enabling it to bind electrostatically to the one or more neuromodulators; and wherein the polyelectrolyte nanocomplex is distributed throughout the crosslinked hydrophilic polymer.
Dependent claim 17 is drawn to the microgel of claim 15, wherein the microgel comprises a composite of the crosslinked hydrophilic polymer and a nanofiber.
Dependent claim 18 is drawn to the microgel of claim 17, wherein the composite comprises a plurality of polycaprolactone fibers having a mean length of less than about 200 micrometers, which are covalently linked to the crosslinked hydrophilic polymer.
The teachings of Mao are set forth supra.
The teachings of Dake are set forth supra.
The teachings of Bromberg are set forth supra.
The combination of Mao, Dake, and Bromberg do not specifically teach that their microgel composite comprising crosslinked hydrophilic polymer has a nanofiber and that said composite comprises a plurality of polycaprolactone fibers having a mean length of less than about 200 micrometer, which are covalently linked to the crosslinked hydrophilic polymer.
Azimi et al. teach that poly (ε-caprolactone), (PCL) or simply polycaprolactone as it is usually referred to, is a synthetic biodegradable aliphatic polyester which has attracted considerable attention in recent years, notably in the biomedical areas of controlled-release drug delivery systems, absorbable surgical sutures, nerve guides, and three-dimensional (3-D) scaffolds, for use in tissue engineering. Various polymeric devices like microspheres, microcapsules, nanoparticles, pellets, implants, and films have been fabricated using this polymer. It can be transformed by spinning into filaments for subsequent fabrication of desirable textile structures. Spinning may be accomplished by various approaches. The fibers may be fabricated into various forms and can be used for implants and other surgical applications such as sutures. (see abstract). As it pertains to medical application of PCL fiber-biodegradability, biocompatibility, pliability, good solubility, low melting point and exceptional blend compatibility of PCL have stimulated extensive research into its potential application in the biomedical field (page 77; Medical Application of PCL Fiber).
Furthermore, the drug delivery system was developed for the purpose of bringing, up taking, retaining, releasing, activating, localizing and targeting the drugs at the right timing, period, dose and place. The biodegradable polymer can contribute largely to this technology by adding its own characters to the drugs. Several drug delivery vehicles composed of PCL, such as microspheres, microcapsules, nanospheres and micro and nanofibers have been developed for the controlled release of drugs or protein (see page 79; pharmaceutical). The fiber of the diameter is determined by the extrusion rate and the speed(s) of the winder(s) with a constant drawing rate paramount for attaining uniform diameter, continuous fibers. Electrospinning is of great interest as a scaffold fabrication technique, since the resulting fiber diameters are in the size range (submicron to nanometer) of the extracellular matrix (ECM) microstructures, particularly the higher-ordered collagen microfibrils [115]. The flexibility of the electro spun fibers, due to the very high aspect ratio (length/diameter), is also beneficial, allowing seeded cells to remodel their surroundings (see page 82). Lastly, the nanofibers features excellent characteristics, such as biodegradability, biocompatibility, mild undesirable host reactions, three-dimensional and directional porous structures, PCL fiber is broadly studied and used in different biomaterials (see page 84; conclusion).
It would have been obvious before the effective filing date of the presently claimed invention to incorporate nanofibers, specifically polycaprolactone fibers to the microgel composite having the crosslinked hydrophilic polymer as suggested by Azimi with a reasonable expectation of success. This modification may be viewed as the combining of elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396). One would be motivated to combine because doing so allows for seeded cells to remodel their surroundings as well as allows the nanofibers to exhibit their known characteristics of biodegradability, biocompatibility, having mild undesirable host reactions, having three-dimensional and directional porous structures, with an expectation of success.
Accordingly, the subject matter of claims 17 and 18 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 September 29, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645