DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Disposition of the Claims
Claims 31-45 are pending in the application. Claims 1-30 have been cancelled.
Withdrawn Rejection
The 35 U.S.C. §103 rejection of claims 31-45 over Sander (US PGPUB 2006/0161160) in view of Lendlein et al. (US 2004/0015187 A1), further in view of Shalaby '848 (US PG PUB 2008/0119848), made of record in the office action mailed 6/5/2025, has been withdrawn.
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.
Claims 31-45 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 31 recites the limitations “said absorbable fibers” and “said non-absorbable fibers.” There is insufficient antecedent basis for these limitations in the claim. Claims 32-38 are rejected because they depend on claim 31.
Claim 36 recites the limitation “further comprising an anti-adhesive coating,” although claim 1 recites the limitation “A single-layer porous polymeric sheet mesh consisting of one layer... the one layer consisting of two fiber types co-knit to form the single layer.” Claim 37 is rejected because it depends on claim 36 and because it further includes the limitation “the anti-adhesive coating.” Claim 38 is rejected because it depends on claim 36.
Claim 38 recites the limitation "said absorbable copolyester." There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitations “said absorbable fibers” and “said non-absorbable fibers.” There is insufficient antecedent basis for these limitations in the claim. Claims 40-45 are rejected because they depend on claim 39.
Claim 45 recites the limitation "said absorbable copolyester." There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31-45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sander (US PGPUB 2006/0161160) in view of Lendlein et al. (US 2004/0015187 A1), further in view of Bishop et al. (US 2008/0082113 A1).
Regarding claims 31-34, Sander teaches a tissue repair device comprising a linking member that can be fabricated from the same bioresorbable materials and/or nonresorbable materials used for fabricating anchoring members ([0052] and [0054]). The various fibers or filaments can be woven, braided or knitted together to form the linking member (a single-layer polymeric sheet consisting of one layer, as claimed) (see [0059] and [0061]).
Sander teaches that the bioabsorbable polymers include those derived from polyglycolic acid, glycolide, lactic acid, lactide, dioxanone, e-caprolactone, trimethylene carbonate, polyethylene oxide, etc., and various combinations of these and related monomers (the first fiber type, as claimed) ([0051]-[0052] and [0037]).
Sander also teaches that non-absorbable materials which are especially suitable for fabricating the anchoring member or linking member of the invention device include silk, polyamides, polyesters such as polyethylene terephthalate, polyacrylonitrile, polyethylene, polypropylene, silk, cotton and linen (the second fiber type, as claimed) ([0055]). It is preferred to employ a material which is also elastic, i.e., a polymeric material which in filamentous form exhibits a relatively high degree of reversible extensibility, e.g., an elongation at break of a least about 30 percent, preferably at least about 40 percent and more preferably at least about 50 percent ([0055]-[0056]).
With regard to the claimed limitation “wherein absorbable fibers are interlaced with said non-absorbable fibers and at least partly traverses the non-absorbable fibers such that the absorbable fibers restrict uniaxial and multiaxial movement by said non-absorbable fibers, or wherein said single-layer sheet polymeric mesh has at least two different strength profiles including an initial stiff phase prior to degradation of the absorbable polymeric multifilament fiber and a later extensible phase that results after degradation of the absorbable polymeric multifilament fiber,” Sander teaches that the various fibers or filaments can be woven, braided or knitted together to form the linking member (see [0059] and [0061]). The examiner notes that, when the bioresorbable fibers and the nonresorbable fibers are knitted together, the bioresorbable fibers would be capable of restricting uniaxial and multiaxial movement by said non-absorbable fibers. In addition, as the fibers are knitted together and are made of the materials discussed above, the linking member would have at least two different strength profiles including an initial stiff phase prior to degradation of the absorbable polymeric fiber and a later extensible phase that results after degradation of the absorbable polymeric fiber.
Sander does not explicitly disclose wherein the first fiber type is a multifilament fiber and the second fiber type is a monofilament fiber, the absorbable polymeric multifilament fiber providing from 30% to 60% by weight of the single-layer polymeric mesh, or wherein at least one of the absorbable polymeric fiber or the non-absorbable synthetic polymeric fiber comprises a radio-opaque or ultrasound opaque additive as a filler material of the fiber, in an amount effective to render the polymeric warp-knit hernia mesh detectable by a radioscope or ultrasound device.
However, Lendlein et al. (“Lendlein”) teaches wherein a ratio of filaments of biodegradable shape memory material over filaments of non-degradable shape memory material can be in a range from, for example, about 0.5/99.5 to 99.5/0.5, 5/95 to 95/5, 10/90 to 90/10, 20/80 to 80/20, 30/70 to 70/30, 40/60 to 60/40 or 50/50 ([0114], [0107] and claim 11). Lendlein also teaches that braided multifilaments are characterized by a higher flexibility but have a higher roughness than monofilaments ([0107]). Compositions formed of thermoplastic polymers can be blown, extruded into sheets or shaped by injection molding, for example, to form fibers ([0091]). The polymer compositions can be combined with fillers, reinforcement materials, radioimaging materials excipients or other materials as needed for a particular implant application ([0092] and [0097]-[0099]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to have provided the biodegradable and non-degradable filaments in the knitted tissue repair device of Sander in a ratio of from 30/70 to 70/30, 40/60 to 60/40 or 50/50, and to have included radioimaging diagnostic materials in the filaments thereof, wherein the filaments are provided as monofilaments and/or multifilaments, in order to control the degradation, flexibility and roughness of the implants, and in order to provide the implants with x-ray diagnostic properties, as suggested by Lendlein ([0107], [0114]-[0115], [0092], [0097]-[0099], [0103], [0107] and claim 11).
Sander in view of Lendlein does not explicitly disclose wherein the sheet is a mesh, the fibers are warp-knit, wherein the single layer polymeric mesh is porous and defines a plurality of pores extending from a first surface of the single layer to a second surface of the single layer, or wherein said single-layer sheet polymeric mesh does not comprise a bioactive agent.
However, Bishop teaches embodiments of apparatus and methods for tissue lifting, or for correcting a ptosis condition caused by tissue stretching (Abstract). In some embodiments a tissue is supported by a support member (Abstract). The support member comprises an engagement member, effective to limit movement of the support member relative to the engaged portion of the tissue ([0015]). In some embodiments, the engagement member comprises at least one of a barb, a hook, and a suture ([0015], [0101], [0179] and [0182]). Embodiments of support members can be provided as a mesh material with different patterns depending on the loading or stress expected ([0186], [0209] and [0214]). In some embodiments, partially or completely absorbable materials are used, such that a component(s) can be absorbed over a period ranging from about 6 weeks to about 2 years ([0214]). The size of the openings or pores, in support members configured as a mesh, can be adapted to allow tissue in-growth and fixation within surrounding tissue ([0216]). As an example, and not intended to be limiting, the mesh can be woven polypropylene monofilament, knitted with a warp tricot ([0217]). Bishop also teaches that the suture can be coated with another material or can be left uncoated ([0105]). Material can be coated with a therapeutic agent to enhance tissue ingrowth, and in some embodiments the suture material is manufactured to include the therapeutic agent ([0165]). In some embodiments, the therapeutic agent is added just prior to implantation, either by impregnation, by coating, or by a combination of the two processes ([0165]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to have used a warp tricot mesh as the knitted component of the device of Sander in view of Lendlein, and to have coated or not uncoated the as-produced device with a therapeutic agent, in order to obtain a suture-like device that can be adapted to allow tissue in-growth and fixation within surrounding tissue when implanted and can remain securely in place even when subjected to various forces that will be imparted on the tissue of a patient during various activities (Bishop: [0209], [0216]-[0218]; also [0015], [0101] and [0168]). The examiner notes that a warp tricot knit mesh would include pores extending from a first surface to a second surface, as claimed.
Regarding claim 35, Lendlein teaches that the term "biodegradable" refers to materials that are bioresorbable and/or degrade and/or break down by mechanical degradation upon interaction with a physiological environment into components that are metabolizable or excretable, over a period of time from minutes to three years, preferably less than one year, while maintaining the requisite structural integrity ([0031]). Bishop teaches that, in some embodiments, partially or completely absorbable materials are used, such that a component(s) can be absorbed over a period ranging from about 6 weeks to about 2 years ([0214]). In the addition, with regard to the claimed property, the examiner notes that the structure of modified Sander discussed above (as applied to claim 31) is either the same as or is substantially similar to that disclosed by applicant. Thus, it is the position of the Office that the composition of modified Sander would have the claimed property as the same compound necessarily has the same properties. In the alternative, it would have been obvious to one having ordinary skill in the art at the time of the invention to expect that the claimed properties would be so provided, as the references teach similar materials as the claimed structure, and as the properties cannot be separated from the materials. Thus, absent an objective showing to the contrary, the examiner expects the absorbable fiber taught by modified Sander to have the claimed properties.
Regarding claims 36-37 and 39-44, modified Sander remains as applied above, teaching the claimed limitations. In addition, with regard to the claimed anti-adhesive coating, Bishop teaches that, in some embodiments, an elastomeric material can be used to cover device components ([0117]). Conveniently, in some embodiments, the elastomer can comprise without limitation, silicone, thermoset polyurethane, glycolide-co-caprolactone, copolymers of lactic acid and sebacic acid, and the like, as well as combinations of more than one elastomeric material ([0117]). All embodiments described in Bishop can be fashioned from bioabsorbable materials ([0126]). A variety of polymers can be used to produce bioabsorbable sutures including, without limitation, poly(glycolic acid), poly(glactin), poly(para-dioxanone), poly(trimethylenecarbonate), or poly(caprolactone) ([0126] and [0214]). The examiner notes that a coating of these copolyesters would meet the claimed anti-adhesive coating limitation.
Regarding claims 38 and 45, modified Sander is applied in the same manner applied above to claims 36-37, 39 and 44, wherein Bishop teaches copolymers of poly(glycolic acid), poly(glactin), poly(para-dioxanone), poly(trimethylenecarbonate), or poly(caprolactone) ([0126]). In addition, with respect to the claimed tri-axial copolymer limitation, Lendlein teaches that the polymers can be in the form of linear diblock-, triblock-, tetrablock, or multiblock copolymers, branch or graft polymers, thermoplastic elastomers, which contain dendritic structures, and blends thereof ([0071]).
Modified Sander does not explicitly disclose a glycolide:trimethylene carbonate:Ɛ-caprolactone molar ratio of 55:25:20.
However, Bishop further teaches that different combinations of materials can be used to produce sutures that display different rates of absorption in vivo ([0126]). Therefore, Bishop implies that the proportions of the combination of materials is a result effective variable.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have varied the ratio of the disclosed copolymers in order to achieve different rates of absorption in vivo, as suggested by Bishop ([0126]). "[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).
Response to Arguments
Applicant’s arguments with respect to claim(s) 31-45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2007/0250147 A1 (Walther) teaches a surgical implants comprising an areal base and at least one projection that may each be partially absorbable and may comprise polymers such as polyester, as well as polylactides, polyglycolides, polycaprolactones, polydioxanones and copolymers and mixtures of such substance (Abstract and [0017]-[0019]). The base structure preferably contains a knitted mesh ([0012]). Walther teaches examples of forming knits on a double-bar Raschel knitting machine ([0031]-[0032]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached on Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marla McConnell can be reached on 571-270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kevin Worrell/Examiner, Art Unit 1789 /MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789