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 .
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rizk et al (US 20190062951) in view of Rizk et al (US20190069983) and Gao et al (CN104452107).
Rizk is directed to methods of manufacturing mesh sutures from poly-4-hydroxybutyrate (Title). Rizk is directed to resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required (ABST).
Rizk teaches the mesh is made from P4HB monofilament fibers [0054].
Rizk teaches resorbable multifilament yarns with high tenacity have been developed. The yarns are made using poly-4-hydroxybutyrate homopolymers or copolymers thereof or polymeric blends including poly-4-hydroxybutyrate homopolymers or copolymers thereof. The yarns have excellent drape, pliability, can be knit or woven into meshes with high burst strength, and braided to form, for example, high strength sutures with high knot strength and soft knot bundles [0024].
Rizk teaches the filaments are spun and drawn (ABST), [0097].
Rizk teaches an orientated and/or annealed monofilament of P4HB homopolymer or copolymers thereof, or blends thereof, produced using the methods disclosed herein, has one or more of the following properties (i) an elongation to break of less than 500%, more preferably less than 300%, and even more preferably less than 120%, but greater than 15%; (ii) a tensile strength greater than 500 MPa, more preferably at least 800 MPa or 850 MPa, and even more preferably at least 900 MPa, 1,000 MPa, 1,100 MPa, 1,200 MPa, 1,300 MPa, or 1,400 MPa, but less than 1,600 MPa; and (iii) a Young's modulus less than 2 GPa, more preferably less than 1 GPa, but greater than 70 MPa [0093].
Rizk teaches an elongation to break that overlaps the claimed range.
Rizk teaches a Young’s modulus but differs and does not measure the modulus at an intermediate tension at a strain from 0.25-10% and does not measure the modulus at initial tension strain ranging from 0.05 to 0.25%.
As to claims 1-5, Rizk teaches the same materials, poly-4-hydroxybutyrate and copolymers and structure, monofilaments and mesh for implantable devices, as claimed and teaches substantially the same properties, e.g. elongation at break. When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention the examiner has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP § 2112- 2112.02
It would have been obvious to one of ordinary skill in the art before the effective filing date to produce a fiber of an aliphatic polymer for use as an implantable medical device such as a suture.
Rizk ‘951 does not teach the copolymer include two or more types of hydroxyalkanoate.
Rizk ‘983 is directed to a calendared mesh comprising polyhydroxyalkonoate polymers that have the advantage of a smooth surface (ABST). Rizk ‘983 teaches P4HB and P3HB and that P4HB is strong extensible polymer while PHB is brittle and the polymers have different melting points [0037].
Rizk ‘983 defines copolymers of poly-4-hydroxybutyrate as any polymer of 4-hydroybutyrate with one or more different hydroxyalkanoic acid units [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to employ copolymer of poly-4-hydroxybutyrate motivated to produce a medical mesh with desired strength and smoothness.
Rizk ‘951 in view of Rizk ‘983 differ and do not teach the 4PHB is concentration of 10-30 mol%.
Gao is directed to a high elastic poly-hydroxyl fatty acid ester of porous fibre material (Title). Gao teaches adding poly-hydroxyl fatty acid ester (P3HB4HB with 10-18% 4HB. The preparation process provide simple, controllable, high efficiency, good biodegradability and biocompatibility and the diameter and tensile mechanical properties of bier can be adjusted within a certain range with good elasticity and high breakage stretching rate (ABST).
The purpose of the invention is to provide a more excellent mechanical property especially fiber film stretching rate can reach 500% with high specific surface area porous structure and high elastic poly-hydroxyl fatty acid ester of porous fiber material and a preparation method [0004].
A preparation method of high elastic poly-hydroxyl fatty acid ester of porous fibre material, comprising: [0006]
The polymer is 1) the polymer poly-hydroxyl fatty acid ester under the condition of stirring, adding different mass ratio of mixed solvent of chloroform and acetone, magnetically stirring to obtain the mixed solution, the poly-hydroxyl fatty acid ester is poly (3-hydroxybutyrate-co-4-hydroxyl-butyrate) P3HB4HB, wherein mol content of 4HB is 10 to 18%, abbreviated as P3HB4HB [0007].
It would have been obvious to one of ordinary skill in the art before the effective filing date to employ a poly-hydroxyl fatty acid ester fiber that is P3HB4HB with 10-18% 4HB motivated to provide for high stretching rate, and excellent mechanical properties.
As to claim 6, Rizk is silent with regard to the porosity of the monofilament. As the claimed range is 0% to 50%, Rizk teaches 0% porosity.
As to claim 7, Rizk is silent with regard to the pore size of the fiber. Rizk teaches the pore size of the medical mesh is 5 micron to 5 mm which overlaps the claimed range of less than 100 micron.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rizk et al (US 20190062951) in view of Rizk et al (US20190069983) and Gao et al (CN104452107) in view of Perera (US20090220612).
As to claims 6 and 7, Rizk differs and does not teach the porosity and pore size of the fibers. Rizk teaches the pore size of the mesh.
Gao teaches a porous fiber but differs and is silent with regard to the pore size and porosity.
Perera is directed to a biocompatible drug delivery device in which the mean pore size in one or more layers is less than 100 micron. The device may be a hollow fibre or a membrane comprising a number of hollow fibres or a microsphere. The invention also extends to a method for preparing porous hollow fibres or microspheres, to the apparatus for preparing said fibres and to the use of the fibres as drug delivery devices (ABST).
Perera teaches suitable materials for the production of the biocompatible fibres or microspheres include: Poly(ethylene terephathalate) (which resists fungal and enzymatic degradation) with the addition of 20-25% PLA (which introduces the biodegradation properties); PLA; PGA; a copolymer of PLA and PGA to form PLGA (poly lactic co glycolic acid); Lactide-glycolide copolymers (PLG); Poly-.epsilon.-caprolactone (PCL); Lactide-caprolactone copolymers; [0031] as well as polyhydroxyalkanonate (PHA) class of polymers [0033].
Perera teaches the fibres may have different porosities across the cross section of the fibre with a preferred total porosity in the range 30-55%, in particular 35-45%. Average pore size and effective surface porosity of the hollow fibres can be determined by the Poiseuille flow method. The fibres produced have a pore size in the range 100 nm to 1micron [0024] which is in the range of less than 100 micron as claimed.
Perera teaches the porous fibers implantable devices for are useful for drug delivery [0003], [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date to produce a porous fiber with the claimed porosity and pore size motivated to produce a fiber that can be implanted for drug delivery.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rizk et al (US 20190062951) in view of Rizk et al (US20190069983) and Gao et al (CN104452107) in further view of Dumanian et al (US20160106423).
As to claim 8, Rizk differs and does not teach the dimensions of the filament.
Dumanian is directed to a suture of a microporous hollow tubular wall that facilitates and allows tissue integration into the suture core subsequent to the introduction to the body and improves biocompatibility (ABST).
Dumanian teaches conventional sutures exhibit a cross-sectional profile with radial symmetry or substantially radial symmetry. The present disclosure provides sutures that lack radial symmetry and/or substantial radial symmetry [0035].
The sutures are provided comprising cross-section shapes (e.g. flat, elliptical, etc.) that reduce tension against the tissue at the puncture site and reduce the likelihood of tissue tear. The sutures reduce stress concentration at suture puncture points. The sutures with shaped cross-sectional profiles distribute forces more evenly (e.g., to the inner surface of the suture puncture hole) than traditional suture shapes/confirmation. The cross-sectionally-shaped sutures distribute tension about the suture puncture points [0036].
The cross-sectional dimension of the suture is greater than the orthogonal cross-sectional dimension (e.g., 1.1× greater, 1.2× greater, 1.3× greater, 1.4× greater, 1.5× greater, 1.6× greater, 1.7× greater, 1.8× greater, 1.9× greater, >2× greater, 2.0× greater, 2.1× greater, 2.2× greater, 2.3× greater, 2.4× greater, 2.5× greater, 2.6× greater, 2.7× greater, 2.8× greater, 2.9× greater, 3.0× greater, >3.0× greater up to >10.0× greater) [0036].
The sutures provided are flat or ellipsoidal on cross section, forming a ribbon-like conformation. In some embodiments, sutures are provided that do not present a sharp leading edge to the tissue. In some embodiments, use of the sutures described herein reduces the rates of surgical dehiscence in all tissues (e.g., hernia repairs, etc.). In some embodiments, sutures are provided with cross-sectional profiles that provide optimal levels of strength, flexibility, compliance, macroporosity, and/or durability while decreasing the likelihood of suture pull-through. In some embodiments, sutures are provided with sizes or shapes to enlarge the suture/tissue interface of each suture/tissue contact point, thereby distributing force over a greater area [0036].
Dumanian teaches the sutures have cross-sectional profiles that overlap the range of 1.0 to 3.0.
It would have been obvious to one of ordinary skill in the art before the effective filing date to employ a filament suture that has ribbon like cross-section in the claimed range motivated to improve the strength, flexibility, microporosity and improved suture/tissue interface.
Response to Arguments
Applicant’s amendments and arguments, with respect to the 35 USC 103 rejection over Rizk et al (US 20190062951) have been fully considered and are persuasive. The 35 USC 103 rejection over Rizk ‘951 of claims 1-7, 9 and 10 has been withdrawn.
New grounds of rejection is presented over Rizk 951, Rizk ‘983 and Gao as Gao teaches the composition of 3-PHB and 4-PHB produces a porous fiber with excellent mechanical properties.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kann et al (US 20110256398)
Kann teaches the PHA can be a copolymer (containing two or more different monomer units) in which the different monomers are randomly distributed in the polymer chain. Examples of PHA copolymers poly 3-hydroxybutyrate-co-4-hydroxybutyrate (hereinafter referred to as PHB4HB); poly 3-hydroxybutyrate-co-4-hydroxybutyrate (hereinafter referred to as PHB4HB) [0050]. Type 2 PHB copolymers have a 3HB content of between 80% and 5% by weight of the copolymer, for example: 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5% by weight of the copolymer [0061]. PHB4HB is a Type 2 PHB copolymer where the 4HB content is in the range of 20% to 60% by weight of the copolymer and preferably in the range of 25% to 50% by weight of the copolymer for example: 25% 4HB; 30% 4HB; 35% 4HB; 40% 4HB; 45% 4HB; 50% 4HB by weight of the copolymer [0062].
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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/JENNIFER A STEELE/ Primary Examiner, Art Unit 1789
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