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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/25/2025 and 09/16/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copies of PTO-1449.
Response to Restriction
Applicants' election of Group I (claims 1-14 and 17) without traverse in the reply filed on 04/15/2026 is acknowledged.
The requirement is made FINAL. For examining purpose, Claims 1-14 and 17 of Group I are examined in this office action.
Claim Objections
Claim 6 is objected to because of the following informalities: “poly(lactic-glycolide )”. It should be written as “poly(lactide-glycolide )”.
Appropriate correction is required.
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 non-obviousness.
Claim(s) 1-10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Jeon et al. (KR 102077078 B1) in view of Onda et al. (US 10357573 B2).
Jeon et al. teach a tissue restoration composition comprising a biodegradable copolymer obtained by polymerizing a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer. (Abs). The copolymer is capable of forming nanoparticles. The present invention relates to a tissue repair composition comprising a biodegradable polymer copolymer, and more particularly, the biodegradable polymer copolymer is a copolymer of a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer self-assembled in an aqueous solution. The present invention relates to a tissue repair composition comprising a biodegradable polymer copolymer capable of forming nanoparticles to prevent nodules during intradermal or subcutaneous injection. (pg. 2, 1st par.). The composition of claim 1, wherein the copolymer has a particle diameter of 50 nm to 300 nm. (Claims, pg. 5).
Jeon et al. teach a physiologically active substance - conjugated block copolymer having enhanced efficacy and/or safety is provided by enhancing the property of penetrating into a target diseased tissue and/or enhancing excretability, compared to known physiologically active substance - conjugated block copolymer, and suppressing sensitization of the physiologically
active substance to normal tissues other than a target diseased tissue. Disclosed is a block copolymer including a polyethylene glycol segment connected with a polyamino acid derivative segment conjugated with a physiologically active substance. (Abs). 10 g of monomethoxy polyethylene glycol (molecular weight (MW): 1000 g/mol) and 20 g of ε-caprolactone monomer were polymerized for 12 hours at 120 ° C under 100ul of Stannous octoate catalyst at a weight ratio of 10:20, and then cooled at room temperature to obtain a molecular weight of 3000g/mol A methoxy polyethylene glycol-polycaprolactone copolymer was obtained, (pg. 2, last par.), which provide polycaprolactone MW 2000g/mol (3000g/mol-1000g/mol), so the ratio of MW of hydrophobic polymer over MW hydrophilic polymer is 2.
Jeon et al. do not teach MW ratios of the hydrophilic polymers over the MW of hydrophilic polymer in the copolymer is less than 2.
Onda et al. teach a pharmaceutical composition used as an injectable or a powder. (Col. 54, lines 31-34), comprising a physiologically active substance - conjugated block copolymer having enhanced efficacy and/or safety is provided by enhancing the property of penetrating into a target diseased tissue and/or enhancing excretability, compared to known
physiologically active substance - conjugated block copolymer, and suppressing sensitization of the physiologically active substance to normal tissues other than a target diseased tissue. Disclosed is a block copolymer including a polyethylene glycol segment connected with a polyamino acid derivative segment conjugated with a physiologically active substance, in which the molecular weight (MW) of the block copolymer is from 2 KDas to 15 KDas, and the light scattering intensity of a 1 mg/mL aqueous solution of the physiologically active substance - conjugated block copolymer as measured with a laser light scattering photometer is at least twice or more the light scattering intensity of toluene. (Abs). The block copolymer according to any one of 1-4, wherein the molecular weight of the polyethylene glycol segment is 1 KDas to 10 KDas. (Col. 3, lines 12-46), so the MW of hydrophobic polymers could be 1-14KDas.
With these MW ranges, some of MW ratios of the hydrophilic polymers over the MW of hydrophilic polymer in the copolymer is less than 2. Nanoparticles that are formed by the block copolymer according to the present invention have a smaller volume average particle diameter than known polymeric micelle type DDS preparations , and have enhanced penetration into a target tissues. (Col. 7, lines 12-16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have a tissue restoration composition comprising a biodegradable copolymer obtained from a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer, forming nanoparticles, having a diameter of 50 nm to 300 nm, taught by to Jeon et al., and the composition can be in powder or in injectable formulation, with some of the ratios of MW of hydrophilic polymers over MW of hydrophobic polymers less than 2 taught by Onda et al. since they have proven it would be feasible to do so.
Claim(s) 1 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Jeon et al. (KR 20190076023 A) in view of Onda et al. (US 010357573 B2) and further in view of Crawford et al. (US 20130202659 Al).
The teachings of Jeon et al. and Onda et al. are described in claim 1 above.
Claims 11-13,
Onda et al. teach a polyethylene glycol - polyglutamic acid block copolymer was freeze-dried. (Col. 87, lines 9-10).
Jeon et al. and Onda et al. do not teach the formulation comprising freeze-drying aid lactose, maltose, sucrose, trehalose, mannitol, sorbitol, maltitol, xylitol or lactitol.
Crawford et al. teach polymer-agent conjugates and particles. (Abs). The polymer has a hydrophilic portion and a hydrophobic portion. In some embodiments, the polymer is a block copolymer. In some embodiments, the polymer comprises two regions, the two regions together being at least about 70% by weight of the polymer (e.g., at least about 80%, at least about 90%, at least about95% ). In some embodiments, the polymer is a block copolymer comprising a hydrophobic polymer and a hydrophilic polymer. In some embodiments, the polymer, e.g., a deblock copolymer, comprises a hydrophobic polymer and a hydrophilic polymer. In some embodiments, the polymer, e.g., a triblock copolymer, comprises a hydrophobic polymer, a hydrophilic polymer and a hydrophobic polymer, e.g., PLAPEG-
PLA, PGA-PEG-PGA, PLGA-PEG-PLGA, PCLPEG- PCL, PDO-PEG-PDO, PEG-PLGA-PEG, PLA-PEGPGA, PGA-PEG-PLA, PLGA-PEG-PLA or PGA-PEGPLGA. (0010).
The particle is associated with a non-particle component, e.g., a carbohydrate component, or a stabilizer or lyoprotectant, e.g., a carbohydrate component, stabilizer or lyoprotectant described herein. While not wishing to be bound be theory the carbohydrate component may act as a stabilizer or lyoprotectant. In some embodiments, the carbohydrate component, stabilizer or lyoprotectant, comprises one or more carbohydrates (e.g., one or more carbohydrates described herein, such as, e.g., Sucrose, cyclodextrin or a derivative of cyclodextrin (e.g. 2-hydrox
ypropyl-f-cyclodextrin, sometimes referred to herein as HP beta -CD)), salt, PEG, PVP or crown ether. In some embodiments, the carbohydrate component, stabilizer or lyoprotectant comprises two or more carbohydrates, e.g., two or more carbohydrates described herein. In one embodiment, the carbohydrate component, stabilizer or lyoprotectant includes a cyclic carbohydrate (e.g., cyclodextrin or a derivative of cyclodextrin, e.g., an O-, 3-, or Y-, cyclodextrin (e.g. 2-hydroxypropyl-3-cyclodextrin)) and a non-cyclic carbohydrate. Exemplary non-cyclic oligosaccharides include those of less than 10, 8, 6 or 4 monosaccharide Subunits (e.g., a monosaccharide or a disaccharide (e.g., sucrose, trehalose, lactose, maltose) or combinations thereof). (0318).
Crawford et al. teach the agent is a compound with pharmaceutical activity. In another embodiment, the agent is a clinically used or investigated drug. In another embodiment, the agent has been approved by the U.S. Food and Drug Administration for use in humans or other animals. In some embodiments, the agent is an antibiotic, anti-viral agent, anesthetic, (1664).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have a tissue restoration composition comprising a biodegradable copolymer obtained from a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer, forming nanoparticles, having a diameter of 50 nm to 300 nm, taught by to Jeon et al., and the composition can be in powder or in injectable formulation, with some of the ratios of MW of hydrophilic polymers over MW of hydrophobic polymers less than 2 taught by Onda et al., and the formulation is freeze-dried, taught by Jeon et al., and lyophilized formulation includes a lyoprotectant comprising polyols trehalose, mannitol, sorbitol, lactose, sucrose, glucose or dextran, and to include an anesthetic taught by Crawford et al. since they have proven it would be feasible to do so.
Claim(s) 1 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Jeon et al. (KR 20190076023 A) in view of Onda et al. (US 010357573 B2) and further in view of Crawford et al. (US 20130202659 Al) and Smith et al. (US 20240016762 A1).
The teachings of Jeon et al. and Onda et al. are described in claim 1 above.
The teachings of Crawford et al. are described in claim 13 above.
Jeon et al. and Onda et al. do not teach an anesthetic and some of anesthetic agents.
Crawford et al. teach anesthetic but do not teach examples of anesthetic agents.
Smith et al. teach micelles, nanoparticles, microparticles, powders or dispersions for delivery. The formulation optionally includes a polymer or series of polymers that facilitate the formation of such micelles, nanoparticles, microparticles, powders or dispersions. In an embodiment, the polymer may be a block co-polymer, such as a polyvinylpyrrolidone-polylactic acid (PVP-PLA) copolymer. An exemplary PVP-PLA copolymer has the structure of Formula III: (0033). The nerve block agent may be procaine, benzocaine, chloroprocaine, cocaine, cyclomethycaine, dimethocaine, piperocaine, propoxycaine, procaine, proparacaine, tetracaine amethocaine, lidocaine, articaine, bupivacaine, cinchocaine, etidocaine, levobupivacaine, lidocaine, mepivacaine, prilocaine, ropivacaine, trimecaine levobupivacaine, prilocaine, tetracaine, lontocaine, septocaine, ropivacaine, bupivacaine, or mepivacaine, (0268), which are a type of local anesthetic.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have a tissue restoration composition comprising a biodegradable copolymer obtained from a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer, forming nanoparticles, having a diameter of 50 nm to 300 nm, taught by to Jeon et al., and the composition can be in powder or in injectable formulation, with some of the ratios of MW of hydrophilic polymers over MW of hydrophobic polymers less than 2 taught by Onda et al., and the formulation is freeze-dried, taught by Jeon et al., and lyophilized formulation includes a lyoprotectant comprising polyols trehalose, mannitol, sorbitol, lactose, sucrose, glucose or dextran, and to include an anesthetic taught by Crawford et al. and nerves block agents, taught by Smith et al. since they have proven it would be feasible to do so.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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