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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 5/27/26 is acknowledged.
Claims 53-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/27/26.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 28, 30 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti US 5718717.
Regarding claims 28 and 30, Bonutti discloses an implantable bone anchor comprising: a first portion for immediate fixation of the bone anchor to a bone upon implantation of the bone anchor (figure 8, ribs or 138 for engagement with tissue), and a second portion including a swelling material that expands to provide long-term fixation to the bone (figure 8, column 10, lines 2-6; portion 116c absorbs body liquid and expands radially and axially outward to enhance the mechanical interlock with the body tissue), wherein the first portion is made of a swelling material that may be the same or different swelling material as included in the second portion (Examiner notes any two portions of the anchor may be considered, for example, as shown in annotated figure 8 below, the same swelling material 116c is in the first portion and the second portion (shaded)).
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Regarding claim 32, Bonutti discloses where in the implantable bone anchor is cylindrical (figure 8).
Claim(s) 28, 30, 31 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aeschlimann et al. US 2007/0265622.
Regarding claim 28, Aeschlimann et al. discloses implantable bone anchor comprising: a first portion for immediate fixation of the bone anchor to a bone upon implantation of the bone anchor (barbs on exterior of anchor, figure 22), and a second portion including a swelling material (liquefiable or material 44 may further comprise in situ swelling constituents, paragraphs 0066, 0091) that expands to provide long-term fixation to the bone (material is liquefied or swellable and pressed through porous sleeve material 13 into the surrounding bone to anchor into tissue, paragraph 0092).
Regarding claims 30, 31 and 32, Aeschlimann et al. discloses wherein the first portion is made of a swelling material 44 that may be the same or different swelling material as included in the second portion (figure 22, once material moves through the porous sleeve to the exterior, material 44 may considered a second portion within opening 43, and part of the first portion when covering barbs), wherein the second portion is an outer sleeve surrounding at least part of the first portion (figure 22, once swells and extends through the exterior of sleeve 13), where in the implantable bone anchor is cylindrical (figure 22).
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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti US 5718717 in view of Huebner US 5868789.
Regarding claim 29, Bonutti discloses an implantable bone anchor essentially as claimed including a plurality of ribs or projections 138 on an outer surface (figure 8) which may comprise barbs or other projections to interlock with the body tissue (column 10, lines 13-18), but fails to explicitly disclose the projections being threads.
Heubner teaches a suture anchor comprising barbs, threads, or other means to resist pullout force applied to the anchor (column 1, lines 14-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bonutti to have protrusions such as threads, as a known substitute in the art for providing a suture anchor with a means to resist pullout force applied to the anchor.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aeschlimann et al. US 2007/0265622 in view of Huebner US 5868789.
Regarding claim 29, Aeschlimann et al. discloses an implantable bone anchor essentially as claimed including a plurality of cylindrical projections on an outer surface (figure 22), but fails to explicitly disclose the projections being threads.
Heubner teaches a suture anchor comprising barbs, threads, or other means to resist pullout force applied to the anchor (column 1, lines 14-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bonutti to have protrusions such as threads, as a known substitute in the art for providing a suture anchor with a means to resist pullout force applied to the anchor.
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti US 5718717.
Regarding claims 33 and 34, Bonutti discloses the swelling material of the second portion and the first portion being a porous swelling polymer (column 9, lines 36-38, formed of a hydrophilic polymeric material which absorbs body liquid), the swelling materials in a similar embodiment being a porous polymer or copolymer (column 3, lines 34-41, column 3, lines 50-52; anchor 20 formed of a polymer material which absorbs body liquid, the polymeric material may be a copolymer, porous material forming the anchor 20, or other known material which absorb body liquid). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a porous swelling copolymer as taught in similar embodiments, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 31, 35-37, 39 and 45-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti US 5718717 as discussed above, and further in view of Kerr et al. US 2013/0211541.
Regarding claim 31, Bonutti discloses an implantable bone anchor, but fails to disclose wherein the second portion is an outer sleeve surrounding at least part of the first portion.
Kerr teaches material layers formed around to form the swellable material, the layers may be considered a sleeve (paragraph 0057), the layers forming the desired porosity throughout the body or porosity gradient as desired (paragraph 0057).
Therefore, it would have been obvious to modify Bonutti with a first and second layer or sleeve surrounding the implant, as taught by Kerr et al. to allow for the desired porosity or gradient porosity of the implant.
Regarding claim 35-37, 39 and 45-47, Bonutti discloses an implantable bone anchor comprising a porous swelling copolymer, but fails to explicitly disclose wherein the porous swelling copolymer has an average pore size of from about 50 microns to about 750 microns, wherein the porous swelling copolymer has an average pore size of from about 250 microns to about 700 microns, wherein the porous swelling copolymer has an average pore size of from about 400 microns to about 600 microns, wherein the porous swelling copolymer has a porosity from about 30% to about 70%, wherein the porous swelling copolymer has a varying porosity with a porosity distribution that decreases from an outer portion of the porous swelling copolymer to an inner portion of the porous swelling copolymer, wherein the outer portion of the porous swelling copolymer has a pore size of from about 50 microns to about 600 microns, and the inner portion of the porous swelling copolymer has a pore size of from about 400 microns to about 750 microns, wherein the outer portion of the porous swelling copolymer has a porosity of from about 40% to about 70%, and the inner portion of the porous swelling copolymer has a porosity in the range of from about 30% to about 60%.
Kerr et al. discloses an implant comprising a porous swelling copolymer (paragraph 0030), the porous swelling copolymer has an average pore size of from about 50 microns to about 750 microns, wherein the porous swelling copolymer has an average pore size of from about 250 microns to about 700 microns, wherein the porous swelling copolymer has an average pore size of from about 400 microns to about 600 microns (paragraph 0058, 50 micrometers to about 1000 micrometers, or in the range of from about 100 micrometers to about 500 micrometers, or even in the range of from about 200 micrometers to about 300 micrometers), wherein the porous swelling copolymer has a porosity from about 30% to about 70% (paragraph 0058, porosity in the range of about 10% to 70%), wherein the porous swelling copolymer has a varying porosity with a porosity distribution that decreases from an outer portion of the porous swelling copolymer to an inner portion of the porous swelling copolymer (paragraph 0057, graded porosity having outer portion having a more open porosity to a non-porous inner surface), wherein the outer portion of the porous swelling copolymer has a pore size of from about 50 microns to about 600 microns, and the inner portion of the porous swelling copolymer has a pore size of from about 400 microns to about 750 microns (paragraphs 0057, 0058, graded densities, pores 50 micrometers to about 1000 micrometers, or in the range of from about 100 micrometers to about 500 micrometers, or even in the range of from about 200 micrometers to about 300 micrometers), wherein the outer portion of the porous swelling copolymer has a porosity of from about 40% to about 70%, and the inner portion of the porous swelling copolymer has a porosity in the range of from about 30% to about 60% (paragraph 0058, sheets or layers for materials, material porosity in the range of about 10% to 70%).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the material porosity, or graded porosity, with the desired pore range for a particular use, since it has been held that where the general conditions of a claim are disclosed in the prior art, as taught by Kerr et al., discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 48 and 49, Bonutti discloses wherein the bone anchor comprises a porous swelling material, but fails to explicitly disclose wherein porosity is introduced to the porous swelling copolymer by preparing the copolymer with inclusions of one or more dissolvable materials and subsequently leaching at least some of the one or more dissolvable materials out of the porous swelling copolymer, wherein porosity is introduced to the porous swelling copolymer by use of 3D stereolithographic digital light processing.
Kerr et al. teaches contacting a plurality of polymer constituents with at least one solvent capable of dissolving the polymer constituents, applying pressure to the polymer constituents to form an implant having a porous body of bonded polymer constituents, or removing at least a portion of the constituents (paragraph 0073), the implant formed by various means (paragraph 0060).
Although the combination of references does not disclose “porosity is introduced to the porous swelling copolymer by preparing the copolymer with inclusions of one or more dissolvable materials and subsequently leaching at least some of the one or more dissolvable materials out of the porous swelling copolymer, wherein porosity is introduced to the porous swelling copolymer by use of 3D stereolithographic digital light processing”, it is noted that this is being treated as a product by process limitation. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Claim(s) 38 and 40-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti US 5718717 in view of Kerr et al. US 2013/0211541 in view of Siegler et al. US 5824079.
Regarding claims 38 and 40-44, Bonutti discloses the implantable bone anchor essentially as claimed, but fails to expclitily disclose wherein the second portion comprises a solid swelling copolymer and a porous swelling copolymer, the solid swelling copolymer and the porous swelling copolymer each comprise a crosslinked copolymer of a hydrophobic monomer and a hydrophilic monomer, wherein the hydrophobic monomer is selected from the group consisting of methyl methacrylate, styrene, vinyl toluene, carvacryl (meth)acrylate, menthyl (meth)acrylate, thymyl (meth)acrylate, cyclohexyl (meth)acrylate, butyl (meth)acrylate and hexyl (meth)acrylate, wherein the hydrophilic monomer is selected from the group consisting of 2-hydroxy ethyl (meth)acrylate (HEMA or HEA), N,N-dimethyl acrylamide, N-Isopropylacrylamide (NiPAM), 2-dimethylaminoethyl (meth)acrylate (DMAEMA), dimethylaminoethyl acrylate DMAEA), acrylic acid (AA), polyethylene glycol (meth)acrylate (PEG-MA or PEG-A) and glyceryl mono(meth)acrylate, wherein the hydrophobic monomer is methyl methacrylate and the hydrophilic monomer is acrylic acid, wherein one or both of the copolymer(s) are crosslinked using a cross-linking agent selected from the group consisting of allyl methacrylate, hexane diol di(meth)acrylate, butane diol di(meth)acrylate, bisphenol A-glycidyl methacrylate (BisGMA), ethylene glycol di(meth)acrylate and polyethylene glycol di(meth)acrylate.
Kerr et al. discloses layers of material, may be a solid swelling material or a porous swelling material (paragraph 0057, body may be formed of a swellable material that is one or more layers having various porosity or a solid nonporous material).
Siegler et al. teaches anchoring soft tissue to bone having an implant with immediate fixation and long term fixation (column 5, lines 32-45), comprising a mixture of a hydrophobic monomer and a hydrophilic monomer and a cross linking agent to form a swellable copolymer (column 2, lines 40-44), wherein the hydrophobic monomer is methyl methacrylate (column 2, lines 54-55) and the hydrophilic monomer is acrylic acid (column 2, lines 54-55) wherein one or both of the copolymer(s) are crosslinked using a cross-linking agent selected from the group consisting of allyl methacrylate, hexane diol di(meth)acrylate, (column 2, lines 61-64).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bonutti with a swellable material comprising a a hydrophobic monomer and a hydrophilic monomer and a cross linking agent to form a swellable copolymer, wherein the hydrophobic monomer is methyl methacrylate and the hydrophilic monomer is acrylic acid wherein one or both of the copolymer(s) are crosslinked using a cross-linking agent selected from the group consisting of allyl methacrylate, hexane diol di(meth)acrylate, as taught by Siegler et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouduban et al. US 9259216 in view of Burki et al. US 2014/0277127.
Regarding claim 50, Bouduban et al. discloses a bone anchor 1 comprising: a tip 10; an anchoring element including: a distal portion 3 configured for connection to the tip (figure 2), a proximal portion (portions 4, 5), and a central portion between the distal and proximal portions including an additional suture tunnel adapted for receiving the suture (suture 6 within transverse hole 7, figure 2), but fails to disclose a proximal portion including two suture tunnels therein which are adapted for receiving a suture, wherein the proximal portion is provided with circumferential threads on an outer surface thereof.
Burki et al. teaches a suture anchor 34 comprising a proximal portion including two suture tunnels 34 therein which are adapted for receiving a suture 28 (figures 4A-4B) the tunnels may extend along the entire length of the body or a portion of the body (paragraph 0033), the anchor may include any number of channels to receive a suture within the perimeter of the body (paragraph 0033).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a proximal portion including two suture tunnels, as taught by Burki et al. as known in the art to provide a space within the anchor body for receiving a suture, and with proximal threads, as taught by West et al. to provide an additional means for engaging bone tissue and anchoring the suture anchor therein.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouduban et al. US 9259216 in view of Burki et al. US 2014/0277127 and in view of Kerr et al. US 2013/0211541.
Regarding claim 51, Bouduban et al. discloses further comprising a ring-like swelling body 12, but fails to explicitly disclose a hollow swelling sleeve including: a tube of a solid swelling copolymer configured for surrounding the central portion of the anchoring element, and an outer layer of a porous swelling copolymer surrounding the tube.
Kerr et al. teaches an implant body comprising a swelling body comprising any number or layers laminated onto a surface (paragraph 0057), comprising swelling copolymers (paragraphs 0067, 0072) to employ layers having a consistent porosity or a graded porosity providing a surface having a greater porosity and an inner central portion being a solid swelling copolymer (paragraphs 0057, 0070, body may be formed of a swellable material that is one or more layers having various porosity or a solid nonporous material), resulting in the layers of the implant body may be considered the tube of a solid swelling copolymer, and an outer layer of a porous swelling copolymer surrounding the tube.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the swellable material of Bouduban et al. with hollow swelling sleeve including: a tube of a solid swelling copolymer configured, and an outer layer of a porous swelling copolymer surrounding the tube, as taught by Kerr et al. as known in the art to provide layered tubular members to form an inner and outer portion of an anchor body. In combination with the swelling material 12 of Bouduban et al. the layers would be positioned for surrounding the central portion of the anchoring element as necessary to further secure the anchor within the tissue.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouduban et al. US 9259216 in view of Burki et al. US 2014/0277127 and in view of West, Jr. US 2013/0013064.
Regarding claim 52, Bouduban et al. in combination discloses a bone anchor essentially as claimed, but fails to disclose wherein the proximal portion is provided with circumferential threads on an outer surface thereof.
West et al. teaches a similar suture anchor comprising proximal threads 20 for further engaging bone tissue (paragraph 0033).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a proximal portion with proximal threads, as taught by West et al. to provide an additional means for engaging bone tissue and anchoring the suture anchor therein.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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