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 statement (IDS) submitted on 01/15/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Paragraph [0076], client computers (131 & 133); electronic display (150 & 151); user inputs (152 & 153); and speakers (154 & 155).
Paragraph [0124], hexagonal link geometry (955)" is not included in Figure 15.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
Figure 13A, reference number (761) should be reference number (761A) given the disclosure of Paragraph [0122], or paragraph [0122] should be amended to recite "inner perimeter (761)" instead of "inner perimeter (761A)" given Figure 13A.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The disclosure is objected to because of the following informalities:
Missing the “CROSS-REFERENCE TO RELATED APPLICATIONS” section which should be under the Title on Page 1 of the specification and prior to the “Field of the Invention” section on the same page.
Paragraph [0099], line 3 of the paragraph, "us" should be "use".
Paragraph [0099], line 8 of the paragraph, missing period at end of sentence, should be "niobium. In this...".
Paragraph [0127], third to last line of the paragraph, "mesh sheet 250" should be "mesh sheet 1250".
Paragraph [0130], line 2 of the paragraph, "the stamp may used" should be "the stamp may be used".
Appropriate correction is required.
Claim Objections
Claims 11 and 15-16 are objected to because of the following informalities:
Claim 11 should be amended to the following, “The implant of claim 2, wherein the mesh sheet includes attachment components extending therefrom.”
Claim 15 should be amended to the following, “An implant system comprising:
a porous mesh sheet having a plurality of segments;
a cable; and
a shell component having a first arm spaced apart from a second arm, wherein the first and second arms are curved such that they can bend around a portion of a bone, and
wherein the porous mesh sheet extends between and is attached to the first and second arms of the shell.”
Claim 16 should be amended to the following, “The implant system of claim 15, further comprising an eyelet link attached to the porous mesh sheet.”
Appropriate correction is required.
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 3, 7, 12, and 15-20 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.
Regarding claim 3, the limitation “wherein the mesh sheet includes chain mail” is indefinite. Independent claim 2 recites “a mesh sheet having a plurality of links that are interlinked and movable with respect to each other.” The specification describes the mesh sheet itself as formed in a chain-mail or chain-link pattern of interlinked links (see, e.g., Paragraphs [0108]-[0116] disclosure of chain-link mesh sheets corresponding to the Figures 9A-9C embodiment). It is unclear whether “includes chain mail” means (i) the mesh sheet is itself a chain-mail structure, (ii) the mesh sheet comprises an additional chain-mail component distinct from the recited plurality of links, or (iii) something else. The claim therefore fails to inform a person of ordinary skill in the art of its scope with reasonable certainty. For examination purposes, “the mesh sheet includes chain mail” is interpreted as the mesh sheet itself being a chain-mail structure formed of the plurality of interlinked links.
The term “large enough” in claims 7 and 12 is a relative term which renders the claims indefinite. The term “large enough” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention (e.g., a minimum dimension, range, or comparative reference). Claim 7 recites “the mesh sheet defines pores large enough to promote tissue ingrowth.” Claim 12 recites in part “the solid eyelet link defining a hole large enough to receive a bone screw or pin.” A person of ordinary skill in the art cannot determine with reasonable certainty when the pores or hole meet the recited functional limitation. See MPEP 2173.05(b). For examination purposes, “large enough to promote tissue ingrowth” is interpreted as pores of a size sufficient, in the view of a person of ordinary skill, to permit tissue ingrowth (consistent with the specification’s discussion of pore sizes preferably greater than approximately 300 μm or in ranges such as 100-1000 μm (Paragraphs [0112] & [0119])). “Large enough to receive a bone screw or pin” is interpreted as a hole sized to accommodate a conventional bone screw or pin of ordinary dimensions used in orthopedic applications.
Regarding claim 15, the limitation “the first and second arms are curved such that they can bend around a portion of a bone” is indefinite. The use of “can” creates ambiguity as to whether the claim requires a structural configuration capable of bending around a bone portion or merely describes a possible result or intended use. Apparatus claims are generally interpreted as requiring structure, not mere capability phrased in contingent language. For examination purposes, “can bend around a portion of a bone” is interpreted as the first and second arms being configured to extend around a portion of a bone.
Claims 16-20 are rejected by virtue of their dependency on claim 15.
Regarding claim 17, the limitation “wherein the eyelet link includes partial segments that are fused to the eyelet link such that the partial links can interlink with some segments of the plurality of segments” is indefinite for multiple reasons. First, it is internally inconsistent and unclear how the eyelet link can both “include” the partial segments and have those same partial segments “fused to” the eyelet link. Second, there is no proper antecedent basis for “the partial links”; the claim previously introduces only “partial segments.” It is unclear whether “partial links” refers to the previously recited partial segments or to some other structure. Third, the use of “can” introduces the same functional ambiguity discussed with respect to claim 15. The claim as a whole fails to particularly point out and distinctly claim the subject matter with reasonable certainty. For examination purposes, the limitation is interpreted as the eyelet link includes partial segments that are fused to its outer perimeter, the partial segments being configured to interlink with some of the plurality of segments of the mesh sheet.
Appropriate correction is required.
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) 2-11, 13-15, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mittelmeier (US 5,397,359).
Regarding claim 2, Mittelmeier discloses, an implant (Figure 5) comprising:
a mesh sheet (Figures 1-2 and 5, mesh knitting (1)) having a plurality of links (Figures 1-2, entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8); Col. 2, line 58-60 and Col. 3, line 56-60) that are interlinked (Col. 2, line 59-60, “entwined and interconnected spiral springs”) and movable with respect to each other (Col. 1, line 65-66, where the structure “yields a relatively high motional elasticity”; Col. 2, line 63-Col. 3, line 2, “relatively high elastic mobility” is conserved after low-temperature sintering/diffusion adhesion at the contact points so that the meshes “may easily follow the elastic deformations of the bone”; The mesh defines open pores sized for bone ingrowth (pore size on the order of 0.2-1.5mm; Col. 2, line 50-52) while remaining elastic); and
a shell component (Figure 5, cylindrical intermediate piece (5)) having two arms (Figure 5, proximal anchorage rod (8) and distal anchorage rod (10)) spaced apart from each other (Figure 5; Col. 4, line 62-Col. 5, line 7; The rods seat in conical bores (6 & 7) at opposite ends of intermediate piece (60) and are therefore spaced apart by the length of piece (5)),
wherein the mesh sheet (mesh knitting (1)) is disposed between and attached to the two arms (proximal anchorage rod (8) and distal anchorage rod (10)) of the shell (cylindrical intermediate piece (5)) (Figure 5; Col. 5, line 3-5; The knitting is applied to and sintered onto the exterior surfaces of intermediate piece (5) and both anchorage rods (8 & 10), so that the mesh/knitting coats and bridges the spaced rods/piece).
Regarding claim 3, as best understood in view of the 112(b) rejection above, Mittelmeier further discloses, wherein the mesh sheet (mesh knitting (1)) includes chain mail (Figures 1-2; The mesh knitting (1) is a sintered hollow mesh knitting of elastic metal wires realized as “entwined and interconnected spiral springs” of the “rete Milanese” type (Col. 2, line 58-60 and Col. 3, line 3-16). This structure of interlocked/entwined closed or open spiral loops that remain movable relative to one another after low-temperature sintering constitutes chain mail).
Regarding claim 4, Mittelmeier further discloses, wherein the plurality of links (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)) include a first set of links defining a first set of apertures and a second set of links defining a second set of apertures, the first set of apertures being oriented in a first direction, and the second set of apertures being oriented in a second direction, wherein the first direction is oblique or perpendicular to the second direction (Figures 1-2; Col. 3, line 56-60; entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8) and the resulting mesh knitting (1) define open pores (apertures) whose orientation follows the alternating spiral directions (e.g., see Figure 4); adjacent sets of loops create apertures that are oblique or transverse to one another. Further, the “rete Milanese” construction inherently produces interwoven sets of apertures (open pores) oriented in crossing directions).
Regarding claim 5, Mittelmeier further discloses, wherein at least some of the plurality of links (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)) have a closed perimeter such that the at least some of the plurality of links are inseparable from each other (The spiral-spring loops of the “rete milanese” knitting are entwined and interconnected; after low-temperature sintering (diffusion adhesion) the mesh knitting contact surfaces are permanently joined (Col. 3, line 33-41). Once sintered, individual loops cannot be separated without severing wire or breaking the sintered joints, satisfying the closed-perimeter/inseparable limitation. Further, even in the unsintered state the entwined construction prevents free separation).
Regarding claim 6, Mittelmeier further discloses, wherein the plurality of links (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)) are metallic (Col. 2, line 39-45).
Regarding claim 7, as best understood in view of the 112(b) rejection above, Mittelmeier further discloses, wherein the mesh sheet (mesh knitting (1)) defines pores (Figures 1-2) large enough to promote tissue ingrowth (Col. 2, line 50-52, the open pore size is “in the order of 0.2 to 1.5 mm according to the intended use”. The object of the invention is a structure “whose pore structure allows a good ingrowth of bone tissue” (Col. 1, line 60-68). Thus, these pore sizes are well within the range to promote tissue/bone ingrowth).
Regarding claim 8, Mittelmeier further discloses, wherein the mesh sheet (mesh knitting (1)) defines pores configured to prevent seepage of bone cement therethrough (The pore size is deliberately variable (0.2-1.5mm; Col. 2, line 50-52) and can be selected according to intended use. Thus, a pore size at the lower end of the disclosed range (or further reducing it by adjusting spiral pitch/diameter as expressly permitted (Col. 2, line 60-63)) will indeed retain/ prevent seepage of dough-phase bone cement).
Regarding claim 9, Mittelmeier further discloses, wherein at least some of the plurality of links (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)) are interlinked with four other links of the plurality of links (Figures 1-2; In the “rete Milanese”/entwined-spiral construction, each spiral loop is interconnected with multiple neighboring loops (visible in Figures 1-2 as the alternating wires (D1, D3, D5, D7) set entwined with the wires (D2, D4, D6, D8) set). Further, multi-layer stacking (Figures 14-16; Col. 3, line 61-66) increases the number of interconnections. Thus, connectivity in which interior (within the outer permitter of the mesh knitting (1)) links engage at least four surrounding links is inherently produced).
Regarding claim 10, Mittelmeier further discloses, wherein the two arms of the shell (proximal anchorage rod (8) and distal anchorage rod (10) of cylindrical intermediate piece (5)) and the mesh sheet ((mesh knitting (1)) are configured to extend around a portion of a trochanteric region of a femur (Under the broadest reasonable interpretation (BRI), the phrase "to extend around a portion" does not require the structure to circumferentially encompass or surround the bone, but rather encompasses a configuration that extends adjacent to, alongside, or in the vicinity of a portion of the trochanteric region. Figure 5 and Col. 4, line 62-Col. 5, line 5, disclose/illustrate, a modular femur prosthesis comprising a cylindrical intermediate piece (5) having a proximal anchorage rod (8) and a distal anchorage rod (10), all of which are covered with a mesh knitting (1) and sintered. Thus, the proximal anchorage rod (8) and distal anchorage rod (10) combined with the mesh knitting (1) are positioned in close proximity to and alongside the proximal portion of the femur, thereby extending "around" (i.e., near/adjacent to) a portion of the trochanteric region during implantation).
Regarding claim 11, Mittelmeier further discloses, wherein the mesh sheet (mesh knitting (1)) includes attachment components extending therefrom (Col. 3, line 42-45, discloses, after optional pre-sintering, the knitting may be attached to the prosthesis “by riveting, welding, screwing or clamping,” which necessarily involves fastening elements that engage and effectively extend relative to the mesh for securement. Further, Col. 5, line 5-7, discloses, in the intermediate piece (5) (Figure 5), “the knitting may be fastened by means of single wire loops,” prior to sintering or other fixation, these single wire loops are attachment components associated with and extending relative to the mesh sheet).
Regarding claim 13, Mittelmeier further discloses, wherein the mesh sheet (mesh knitting (1)) includes a spike link connected to the plurality of links (Col. 3, line 42-45, discloses, after optional pre-sintering, the knitting may be attached to the prosthesis “by riveting, welding, screwing or clamping;” Col. 5, line 8-14, discusses the securement of the mesh knitting (1)/double-layered knitting to the bone using screws (15) (spike) (Figures 7-8); As such any of the entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8) is capable of acting as the “spike link” where screws (15) pass and secure into the bone).
Regarding claim 14, Mittelmeier further discloses, wherein the spike link includes a through hole (Figures 1-2; the pores of/formed by the entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8) that would allow for screws (15) to pass through as seen in Figures 6-7).
Regarding claim 15, as best understood in view of the 112(b) rejection above, Mittelmeier discloses, an implant system (Figure 5) comprising:
a porous mesh sheet (Figures 1-2 and 5, mesh knitting (1); Col. 2, line 39-Col. 3, line 23) having a plurality of segments (Figures 1-2, entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8); Col. 2, line 58-60 and Col. 3, line 56-60);
a cable (Col. 5, line 5-7, “the knitting may be fastened by means of single wire loops.” The single wire loops constitute “a cable”); and
a shell component (Figure 5, cylindrical intermediate piece (5)) having a first arm (Figure 5, proximal anchorage rod (8)) spaced apart from a second arm (Figure 5, distal anchorage rod (10)) (Figure 5; Col. 4, line 62-Col. 5, line 7; The rods seat in conical bores (6 & 7) at opposite ends of intermediate piece (60) and are therefore spaced apart by the length of piece (5)), wherein the first and second arms (proximal anchorage rod (8) and distal anchorage rod (10)) are curved such that they are configured to bend around a portion of a bone (Under the broadest reasonable interpretation (BRI), the limitation, “curved such that they are configured to bend around a portion of a bone” requires only that the first and second arms possess a non-linear geometry capable of conforming to or engaging the contours of a bone segment. Figure 5 and Col. 4, line 64-Col. 5, line 1, disclose/illustrate the proximal anchorage rod (8) and the distal anchorage rod (10) as having cones (9 & 11) respectively, which constitute curvature in the rods (8 & 10). Thus, once the rods are inserted into the bone, the tapered surfaces imparted by the cones adapt to and wrap about the curved wall of the bone, thereby satisfying the functional requirement of bending around a portion of a bone), and
wherein the porous mesh sheet (mesh knitting (1)) extends between and is attached to the first and second arms of the shell (proximal anchorage rod (8) and distal anchorage rod (10) of cylindrical intermediate piece (5)) (Figure 5; Col. 5, line 3-5; The knitting is applied to and sintered onto the exterior surfaces of intermediate piece (5) and both anchorage rods (8 & 10), so that the mesh/knitting coats and bridges (“extends between and is attached”) the spaced rods/piece).
Regarding claim 18, Mittelmeier further discloses, wherein the plurality of segments (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)) are arranged in a chain link structure (Figures 1-2; The mesh knitting (1) is a sintered hollow mesh knitting of elastic metal wires realized as “entwined and interconnected spiral springs” of the “rete Milanese” type (Col. 2, line 58-60 and Col. 3, line 3-16). This structure of interlocked/entwined closed or open spiral loops that remain movable relative to one another after low-temperature sintering constitutes an arrangement in a chain link structure).
Regarding claim 19, Mittelmeier further discloses, wherein the porous mesh sheet (mesh knitting (1)) is a woven mesh (Figure 1; Col. 2, line 39-Col. 3, line 10, describing the manufacturing/formation of mesh (1) as a knitted of the “rete Milanese” type mesh through the entwining and interconnection of spiral springs, supporting that mesh (1) is a woven mesh).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12, 16-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mittelmeier, in view of Weiss (US 2016/0199201 A1).
Regarding claim 12, as best understood in view of the 112(b) rejection above, Mittelmeier teaches, the mesh sheet (mesh knitting (1)) having the plurality of links (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)).
Mittelmeier fails to teach, wherein the mesh sheet includes a solid eyelet link surrounded by the plurality of links, the solid eyelet link defining a hole large enough to receive a bone screw or pin.
Weiss discloses, a skin-to-direct skeletal attachment (DSA) interface. Weiss teaches, a mesh sheet (Figures 1-5, interface (40)/chainmail scaffolding (42); Paragraph [0025]) having a plurality of links (Figures 4A-4C, series of interconnected links (41)) that are interlinked and movable with respect to each other (Paragraphs [0025] and [0027]; Further, paragraph [0026], discloses, “…the interface 40 is not limited to a dome shape… a person having skill in the art will appreciate that the interface 40 can have a variety of shapes, which can be achieved by varying the spacing and size of the links 41.”), and wherein the mesh sheet includes a solid eyelet link (Figure 5, through-hole features (48)) surrounded by the plurality of links (Figure 5; Paragraph [0035]), the solid eyelet link defining a hole large enough to receive a bone screw or pin (As clearly stated in paragraph [0035] and shown in Figure 5, features (48) are defined as “through-hole features” and “provide another feature for skin and underlying tissue to interconnect and lock into the interface 40.” As such, they are indeed capable of receiving a screw or pin).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to substitute the mesh sheet of Mittelmeier for the mesh sheet taught by Weiss, which includes a solid eyelet link surrounded by the plurality of links, and the solid eyelet link defines a hole large enough to receive a bone screw or pin, as both references and the claimed invention are directed to implants. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, to provide another feature for interconnection and locking between the mesh sheet and the tissue/bone at the treatment site (Paragraph [0035] of Weiss).
Regarding claim 16, Mittelmeier teaches, the porous mesh sheet (mesh knitting (1)) having the plurality of segments (entwined and interconnected spiral-spring loops formed by wires (D1, D2, D3, D4, D5, D6, D7, D8)).
Mittelmeier fails to teach, further comprising an eyelet link attached to the porous mesh sheet.
Weiss teaches, a porous mesh sheet (Figures 1-5, interface (40)/chainmail scaffolding (42); Paragraph [0025]) having a plurality of segments (Figures 4A-4C, series of interconnected links (41); Paragraphs [0025] and [0027]; Further, paragraph [0026], discloses, “…the interface 40 is not limited to a dome shape… a person having skill in the art will appreciate that the interface 40 can have a variety of shapes, which can be achieved by varying the spacing and size of the links 41.”), and further comprising an eyelet link (Figure 5, through-hole features (48)) attached to the porous mesh sheet (Figure 5; Paragraph [0035]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to substitute the mesh sheet of Mittelmeier for the mesh sheet taught by Weiss, which includes an eyelet link, as both references and the claimed invention are directed to implants. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, to provide another feature for interconnection and locking between the porous mesh sheet and the tissue/bone at the treatment site (Paragraph [0035] of Weiss).
Regarding claim 17, as best understood in view of the 112(b) rejection above, modified Mittelmeier teaches, wherein the eyelet link (through-hole features (48)) includes partial segments that are fused to an outer permitter of the eyelet link (Under the broadest reasonable interpretation (BRI), Figure 5 of Weiss, the portions of the surrounding links (41) (partial segments) that are attached/in-contact at the outer surface/permitter of each through-hole feature (48)) such that the partial segments can interlink with some segments of the plurality of segments (Figure 5 and Paragraph [0035] of Weiss, the surrounding links (41) that include portions attaching/in-contact (fused) with the outer of each through-hole feature (48) are continuing to interlock with neighboring links (41) of the interface (40)/chainmail scaffolding (42)).
Regarding claim 20, Mittelmeier further teaches, further comprising an attachment component attached to and extending away from the porous mesh sheet (Col. 3, line 42-45, discloses, after optional pre-sintering, the knitting may be attached to the prosthesis “by riveting, welding, screwing or clamping,” which necessarily involves fastening elements that engage and effectively extend relative to the mesh for securement. Further, Col. 5, line 5-7, discloses, in the intermediate piece (5) (Figure 5), “the knitting may be fastened by means of single wire loops,” prior to sintering or other fixation, these single wire loops are attachment components associated with and extending relative to the mesh sheet).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 2006/0058795 A1), in view of Weiss.
Regarding claim 21, Boyd discloses, one plates that utilize cerclage wire to fix the plate, at least in part to bone, where such devices have been used to reattach trochanteric bone to the femur. Boyd teaches, a trochanteric gripper device (Figures 1-5, bone plate (10); Paragraph [0020]), comprising:
a mesh (In the background discussion (Paragraphs [0002]-[0004]), Boyd references bone grafts in procedures taken from the Dall paper and U.S. patent No. 4,269180 where: an internal bone graft (14) is placed in the bone cavity during reconstructive surgery involving osteotomy of the greater trochanter; and elongate medial and lateral bone grafts (22) are applied to a femoral fracture ad bound in place by multiple cerclage cables (25) that are tensioned and locked with crimp sleeves. These are conventional bone grafts (meshes) held by cerclage wiring);
a pair of hooks (Figures 1-5, hooked-shaped arm portions (12 & 14)) configured to bend around a portion of a femur (Figure 1A, femur (11)) and hold the mesh against the femur (Paragraph [0020]; hooked-shaped arm portions (12 & 14) are indeed capable of holding a mesh against the femur); and
a cable (Figure 1A, cerclage wire (11a)) configured to wrap around the mesh and the pair of hooks (hooked-shaped arm portions (12 & 14)) when placed against the femur (femur (11)) (Figure 1A; Paragraph [0020]; cerclage wire (11a) is indeed capable of wrapping around a mesh and the hooked-shaped arm portions (12 & 14) when placed against the femur (11)).
Boyd fails to teach, the mesh as a chain mail mesh having a plurality of individual links interlinked with each other, the chain mail mesh defining a porous surface configured to promote tissue ingrowth; and eyelet attachments disposed within the chain mail mesh, each of the eyelet attachments having partial links fused to a perimeter thereof, the partial links interlinked with the plurality of individual links.
Weiss teaches, a chain mail mesh (Figures 1-5, interface (40)/chainmail scaffolding (42); Paragraph [0025]) having a plurality of individual links interlinked with each other (Figures 4A-4C, series of interconnected links (41); Paragraphs [0025] and [0027]; Further, paragraph [0026], discloses, “…the interface 40 is not limited to a dome shape… a person having skill in the art will appreciate that the interface 40 can have a variety of shapes, which can be achieved by varying the spacing and size of the links 41.”), the chain mail mesh (interface (40)/chainmail scaffolding (42)) defining a porous surface configured to promote tissue ingrowth (Paragraph [0029]); and eyelet attachments (Figure 5, through-hole features (48)) disposed within the chain mail mesh (Figure 5; Paragraph [0035]), each of the eyelet attachments having partial links fused to a perimeter thereof (Under the broadest reasonable interpretation (BRI), Figure 5 of Weiss, the portions of the surrounding links (41) (partial links) that are attached/in-contact (fused) at the outer surface/permitter of each through-hole feature (48)), the partial links interlinked with the plurality of individual links (Figure 5 and Paragraph [0035] of Weiss, the surrounding links (41) that include portions attaching/in-contact (fused) with the outer of each through-hole feature (48) are continuing to interlinked with neighboring links (41) of the interface (40)/chainmail scaffolding (42)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the trochanteric gripper device of Boys by substituting or incorporating the chain-mail mesh (including the through-hole features as eyelet attachments) of Weiss for the bone graft referenced in Boyd, as both references and the claimed invention are directed to devices for fixation, reattachment, and tissue integration in/at the treatment site/region. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, providing a flexible, porous chain-mail structure that promotes tissue ingrowth and improves mechanical compliance between the implant and surrounding tissue while remaining securable by the existing pair of hooks and cerclage cable (Paragraphs [0025]-[0029] and [0035] of Weiss).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2002/0151909 A1 is relevant because it teaches a surgical mesh that includes an eyelet/link that receives in its through hole a spike. US 3,824,995 is relevant because it teaches a trochanteric gripper device comprising a pair of hooks configured to bend around a portion of a femur. US 5,549,610 is relevant because it teaches a shell component (equivalent to the cylindrical intermediate piece (5) of Mittelmeier above) having two arms spaced apart from each other and configured to extend around a portion of a trochanteric region of a femur.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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