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 (IDSs) submitted on 08/28/2024 and 08/29/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. However, Examiner notes the IDS filed on 08/28/2024 failed to partially comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, foreign references AU 2008271061 A1, KR 101317706 B1, CA 2615708 C, CN 108601659 A, CN 110384573 A, and CN 110612194 A are listed in the IDS but no copies of each of those references was provided; Examiner reviewed earlier filed applications 14/969,695 and 16/781,693 which the current application claims priority to and the later filed application 19/022,694 which claims priority to the current application, no copies (including translations where necessary) of the foreign references listed above were included in any of those applications. The IDS has been annotated such that a strike-out line has been placed over each of the previously listed foreign references.
Claim Objections
Claims 34, 35, 40, 41, 44, 48, 49, and 52 are objected to because of the following informalities:
Claim 34, the phrase “a chain link mesh including a plurality of links, each link of the plurality of links” should read “a chain link mesh including a plurality of links, wherein each link of the plurality of links”.
Claim 35 should read “The implant of claim 34, wherein the at least two link geometries of the set of link geometries extend along a first plane and a second plane, respectively, which are obliquely oriented with respect to a longitudinal axis of the solid structure.” To maintain consistency with how the limitations were initially recited and to avoid ambiguity.
Claim 40 should read, “The implant of claim 39, wherein at least one of the eyelets of the plurality of eyelets is a cable attachment.” To maintain consistency with how the limitations were initially recited and to avoid ambiguity.
Claim 41 should read, “The implant of claim 40, wherein at least one of the eyelets of the plurality of eyelets is a screw attachment.” To maintain consistency with how the limitations were initially recited and to avoid ambiguity.
Claim 44, the phrase “a plurality of links, each link of the plurality of links” should read “a plurality of links, wherein each link of the plurality of links”.
Claim 47 should read, “The implant of claim 44, wherein a majority of the plurality of links are interlocked with four link geometries of the plurality of other link geometries.” To maintain consistency with how the limitations were initially recited and to avoid ambiguity.
Claim 48 should read, “The implant of claim 44, wherein the interlocked plurality of other link geometries are arranged orthogonally to each other.” To maintain consistency with how the limitations were initially recited and to avoid ambiguity.
Claim 49, the phrase “a chain link mesh including a plurality of links, each link of the plurality of links” should read “a chain link mesh including a plurality of links, wherein each link of the plurality of links”. Further, the phrase “a plurality of solid structures integrated into the chain link mesh, each solid structure defining” should read “a plurality of solid structures integrated into the chain link mesh, wherein each solid structure of the plurality of solid structures defining”.
Claim 52 should read, “The implant of claim 49, wherein at least one of the eyelet geometries defines a screw attachment, and wherein at least one of the eyelet geometries defines a cable attachment.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 34-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 34 recites: “a solid structure of the chain link mesh having a set of link geometries extending from a perimeter of the solid structure and interlocked with the plurality of other link geometries.” The specification never describes a solid structure (eyelet, stud, etc.) that itself possesses and extends “link geometries” which then interlock (in the chain-link sense) with the mesh links. The only disclosure of eyelets/studs (Paragraphs [0122] - [0124], FIGS. 13A - 14C) shows mesh links abutting or fused to the outer perimeter of a solid eyelet/stud. No support exists for the solid structure generating “link geometries” that participate in interlocking.
Claims 35-43 are rejected by virtue of their dependency on claim 34.
Claim 44 recites: “a specialized link including a solid structure having a set of link geometries extending from a perimeter of the solid structure and interlocked with the plurality of other link geometries.” Same deficiency as Claim 34. The term “specialized link” is never used; the specification treats eyelets/studs as separate solid features, not specialized links that extend interlocking link geometries.
Claims 45-48 are rejected by virtue of their dependency on claim 44.
Claim 49 recites: “a plurality of solid structures integrated into the chain link mesh, each solid structure defining an eyelet geometry and having a set of link geometries extending from a perimeter of the solid structure and interlocked with the plurality of other link geometries.” Identical lack of support as above.
Claims 50-52 are rejected by virtue of their dependency on claim 44.
Claims 34-53 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.
In claim 34:
1. “a solid structure of the chain link mesh” is unclear: is the solid structure part of the mesh or merely attached to it?
2. “a set of link geometries extending from a perimeter of the solid structure and interlocked with the plurality of other link geometries” – “link geometries” is a CAD-model term only (Paragraphs [0086]–[0094]); its meaning in the finished physical implant is unclear.
3. “at least two of the link geometries of the set of link geometries are oriented in parallel to each other” – unclear whether this refers to longitudinal axes, planes, or some other reference.
Claims 35-43 are rejected by virtue of their dependency on claim 34.
Claim 39 recites: “further comprising a plurality of eyelets integrated into the chain link mesh.” This is indefinite because claim 34 recites “a solid structure of the chain link mesh having a set of link geometries extending from a perimeter of the solid structure and interlocked with the plurality of other link geometries.” Dependent claim 36 expressly states that “the solid structure defines an eyelet geometry.” Thus, claim 34’s solid structure is an eyelet. It is unclear whether the “plurality of eyelets” in claim 39 (i) refers to additional eyelets beyond the solid structure/eyelet already required by claims 34 and 36, or (ii) redefines the single solid structure as multiple eyelets. The phrase “integrated into the chain link mesh” adds further ambiguity because the solid structure is already described as of the chain link mesh (claim 34).
Claims 40 and 41 are rejected by virtue of their dependency on claim 39.
In claim 44: Same “link geometries … oriented in parallel” ambiguity as Claim 34.
Claims 45-48 are rejected by virtue of their dependency on claim 44.
Claim 46 recites, “wherein the plurality of links are spaced apart a slight distance from each other and have the same size.”
The terms “slight distance” and “the same size” are relative terms that render the claim indefinite. The specification uses nearly identical language (“spaced apart a slight distance from each other and have the same size” - see specification of link geometries (455A/455B) in Paragraphs [0109]-[0115] and FIG. 9C), but provides no objective standard, numerical range, or reference point for ascertaining what constitutes “slight” or which dimension(s) must be “the same size” (overall diameter? strut thickness? pore opening? planar width?). No specific values, tolerances, or measurement context are given. A POSITA would not know, with reasonable certainty, whether a 0.05 mm gap is “slight” or whether links differing by 5% in one dimension but identical in another satisfy “the same size.”
Claim 47 recites, “wherein a majority of the plurality of links are interlocked with four link geometries of the other link geometries.”
The term “a majority” is indefinite in this context. Claim 44 is open-ended (“comprising”) and recites only “a plurality of links” with no fixed total number. “Majority” is a relative term whose scope depends on the total number of links present, yet the claim provides no baseline or objective criterion (e.g., “at least 51%,” “more than half of all links,” or a specific numerical threshold). The specification does not define “majority” or provide examples that would allow a POSITA to determine the outer bounds.
In claim 49:
1. Same “link geometries” and “oriented in parallel” ambiguities.
2. “each solid structure defining an eyelet geometry and having a set of link geometries” - unclear whether the eyelet is the solid structure or a separate feature.
Claims 50-52 are rejected by virtue of their dependency on claim 44.
Claim 50 recites “each link geometry of the set of link geometries are angled with respect to a central axis of each eyelet geometry” - unclear what “angled” means relative to the already-recited “parallel” orientation in claim 49 which claim 50 depends upon.
Claims 51 is rejected by virtue of its dependency on claim 50.
Claim 51 recites “at least three link geometries of the set of link geometries are aligned with each other” - unclear relative to what.
Claim 52, the two “wherein” clauses create ambiguity: are the screw-attachment and cable-attachment eyelets required to be distinct structures?
Claim 53 is rejected by virtue of its dependency on claim 52.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 34-39 and 44-51is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Weiss (US 2016/0199201 A1).
Regarding claim 34, as best understood in view of the 112(a) & 112(b) rejections above, Weiss discloses, a porous implant for tissue ingrowth (Figure 1, direct skeletal attachment (DSA) device (10); Paragraphs [0024] & [0029]) comprising:
a chain link mesh (Figures 1-5, interface (40); Paragraphs [0024]-[0025]) including a plurality of links (Figures 4A-4C, series of interconnected links (41); Paragraph [0025]), wherein each link of the plurality of links having a plurality of connected segments which are interlocked with a plurality of other links of the plurality of links to form the chain link mesh (Figures 4B & 10, walls (47) of links (41); Paragraph [0032]; walls (47) comprise the claimed segments of individual links (41) that interlock with other links (41)); and
a solid structure (Figure 5, through-hole features (48); Paragraph [0035]) of the chain link mesh having a plurality of segments of links of the plurality of links extending from a perimeter of the solid structure and interlocked with the plurality of other links of the plurality of links (Figure 5 and Paragraph [0035] describe/show features (48) as clearly being comprised of a hollow cylindrical solid structure embedded within the scaffold/chainmail (42) formed from the interconnected links (41), as such walls (47) (segments) of links (41) in the vicinity where features (48) are embedded are indeed extending from the perimeter of features (48) and interlocking with other links (41)),
wherein at least two of the segments of links of the plurality of segments of the plurality of links are oriented in parallel to each other (As seen in Figures 4A-4C and described in Paragraph [0034], rows of links (41) are oriented differently from other adjacent and interlinked rows of links (41), any of those links in the same row will be oriented in parallel to each other, including their walls (47) in the vicinity of features (48)).
Regarding claim 35, Weiss further discloses, wherein the at least two of the segments of links of the plurality of segments of the plurality of links (walls (47) of links (41)) extend along a first plane and a second plane, respectively, which are obliquely oriented with respect to a longitudinal axis of the solid structure (As best seen in Figure 4C, links (41) are oriented in different planes and given that paragraph [0026] describes the interface (40) is in a dome shape, they’re indeed obliquely/slanted with respect to a longitudinal axis of features (48)).
Regarding claim 36, Weiss further discloses, wherein the solid structure defines an eyelet geometry (as seen in Figure 5 and described in paragraph [0035], through-hole feature (48) are indeed eyelets).
Regarding claim 37, Weiss further discloses, wherein at least one of the links of the plurality of links (links (41)) defines a closed loop (Figures 4A-4C; Paragraphs [0025]-[0027]).
Regarding claim 38, Weiss further discloses, wherein at least one of the links of the plurality of links (links (41)) is metallic (Paragraph [0025]).
Regarding claim 39, Weiss further discloses, further comprising a plurality of eyelets (through-hole features (48)) integrated into the chain link mesh (Figure 5; Paragraph [0035]).
Regarding claim 44, as best understood in view of the 112(a) & 112(b) rejections above, Weiss discloses, a porous implant for tissue ingrowth (Figure 1, direct skeletal attachment (DSA) device (10); Paragraphs [0024] & [0029]) defining a chain link mesh (Figures 1-5, interface (40); Paragraphs [0024]-[0025]) comprising:
a plurality of links (Figures 4A-4C, series of interconnected links (41); Paragraph [0025]), wherein each link of the plurality of links having a plurality of connected segments which are interlocked with a plurality of other links of the plurality of links to form the chain link mesh (Figures 4B & 10, walls (47) of links (41); Paragraph [0032]; walls (47) comprise the claimed segments of individual links (41) that interlock with other links (41)); and
a specialized link including a solid structure (Figure 5, through-hole features (48); Paragraph [0035]) having a plurality of segments of links of the plurality of links extending from a perimeter of the solid structure and interlocked with the plurality of other links of the plurality of links such that the specialized link is connected to the plurality of links (Figure 5 and Paragraph [0035] describe/show features (48) as clearly being comprised of a hollow cylindrical solid structure embedded within the scaffold/chainmail (42) formed from the interconnected links (41), as such walls (47) (segments) of links (41) in the vicinity where features (48) are embedded are indeed extending from the perimeter of features (48) and interlocking with other links (41) such that features (48) are connected to the links (41)),
wherein at least two of the segments of links of the plurality of segments of the plurality of links are oriented in parallel to each other (As seen in Figures 4A-4C and described in Paragraph [0034], rows of links (41) are oriented differently from other adjacent and interlinked rows of links (41), any of those links in the same row will be oriented in parallel to each other, including their walls (47) in the vicinity of features (48)).
Regarding claim 45, Weiss further discloses, wherein the plurality of links (links (41)) and the specialized link (through-hole features (48)) are additively manufactured (Figure 6; Paragraphs [0036]-[0044]).
Regarding claim 46, Weiss further discloses, wherein the plurality of links (links (41)) are spaced apart a slight distance from each other (Paragraph [0033], discloses in part, “…the center-to-center link spacing as the interface is being manufactured is 230 microns.”) and have the same size (Paragraph [0033], also discloses in part, “…the size of each link 41 start at 350 micron inside diameter×420 micron outside diameter×35 micron thickness at the second end 44 (furthest from the stem 20 and post 30) of the interface 40. The inside diameter of the links 41 progressively decreases and the thickness of the links 41 progressively increase, each by 12.5 microns, until the links 41 become solid discs at the first end 43 of the interface 40 next to the stem 20 and post 30.” Although, the thickness and inner diameter of links (41) is changing, the outside diameter is maintained, satisfying the limitation “the same size”).
Regarding claim 47, Weiss further discloses, wherein a majority of the plurality of links (links (41)) are interlocked with four link segments of the other links of the plurality of links (As seen in Figure 4B best, it is clear that walls (47) of links (41) are interlocking with four other adjacent links (41) and their walls (47)).
Regarding claim 48, Weiss further discloses, wherein the interlocked plurality of link segments (walls (47)) are arranged orthogonally to each other (Paragraph [0032], discloses, “…walls 47 of adjacent links 41 intersect and join…”; Figures 4A-4C).
Regarding claim 49, as best understood in view of the 112(a) & 112(b) rejections above, Weiss discloses, a porous implant for tissue ingrowth (Figure 1, direct skeletal attachment (DSA) device (10); Paragraphs [0024] & [0029]) comprising:
a chain link mesh (Figures 1-5, interface (40); Paragraphs [0024]-[0025]) including a plurality of links (Figures 4A-4C, series of interconnected links (41); Paragraph [0025]), wherein each link of the plurality of links having a plurality of connected segments which are interlocked with a plurality of other links of the plurality of links to form the chain link mesh (Figures 4B & 10, walls (47) of links (41); Paragraph [0032]; walls (47) comprise the claimed segments of individual links (41) that interlock with other links (41)); and
a plurality of solid structures (Figure 5, through-hole features (48)) integrated into the chain link mesh (Paragraph [0035]), wherein each solid structure of the plurality of solid structures defining an eyelet geometry (Figure 5; Paragraph [0035]) and having a plurality of segments of links of the plurality of links extending from a perimeter of the solid structure and interlocked with the with the plurality of other links of the plurality of links (Figure 5 and Paragraph [0035] describe/show features (48) as clearly being comprised of a hollow cylindrical solid structure embedded within the scaffold/chainmail (42) formed from the interconnected links (41), as such walls (47) (segments) of links (41) in the vicinity where features (48) are embedded are indeed extending from the perimeter of features (48) and interlocking with other links (41)),
wherein at least two of the segments of links of the plurality of segments of the plurality of links are oriented in parallel to each other (As seen in Figures 4A-4C and described in Paragraph [0034], rows of links (41) are oriented differently from other adjacent and interlinked rows of links (41), any of those links in the same row will be oriented in parallel to each other, including their walls (47) in the vicinity of features (48)).
Regarding claim 50, Weiss further discloses, wherein each link segment of the plurality of link segments of the plurality of links (walls (47) of links (41)) are angled with respect to a central axis of each eyelet geometry of each solid structure of the plurality of solid structures (As best seen in Figure 4C, links (41) are oriented in different planes and given that paragraph [0026] describes the interface (40) is in a dome shape, they’re indeed angled with respect to a central axis of features (48)).
Regarding claim 51, Weiss further discloses, wherein at least three link segments of the plurality of link segments of the plurality of links (walls (47) of links (41)) are aligned with each other (As seen in Figures 4A-4C, a number of links (41), including three, are aligned with each other, including their walls (47)).
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) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss, in view of Pease (US 2671444 A).
Regarding claim 40, Weiss teaches, the plurality of eyelets (features (48)) which provide another feature for skin and underlying tissue to interconnect and lock into the chain link mesh (interface (40); Paragraph [0035]).
Weiss fails to teach, wherein at least one of the eyelets of the plurality of eyelets is a cable attachment.
Pease discloses, a surgical mesh. Pease teaches, an eyelet (Figures 1 and 3-4, opening (16)) is a cable (Figure 4, cord (22)) attachment (Col. 3, line 55-Col. 4, line 8).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a cable attachment as taught by Pease, as both references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a cable attachment as taught by Pease, since doing so allows for suturing (secure attachment) of the implant to the body tissue (Col. 4, line 5-8 of Pease).
Claim(s) 41 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss, in view of Shipp (US 2011/0022065 A1).
Regarding claim 41, Weiss teaches, the plurality of eyelets (features (48)) which provide another feature for skin and underlying tissue to interconnect and lock into the chain link mesh (interface (40); Paragraph [0035])
Weiss fails to teach, wherein at least one of the eyelets of the plurality of eyelets is a screw attachment.
Shipp discloses, an anchor for a surgical mesh. Shipp teaches, an eyelet (Paragraph [0071], discloses, “Unlike the embodiment of anchor 10 with no mesh retention section 12, either the conical or cylindrical configuration mesh retention section 12 locks mesh 52 on to anchor 10 when mesh 52 is screwed past the proximal-most tissue-snaring thread 18 since there is no thread located in mesh retention section 12 that would allow mesh 52 to be unscrewed from anchor 10. Mesh retention section 12 is generally cylindrical or conical shaped with a dimension transverse to its longitudinal axis that is smaller than the transverse dimension of head 11 and the transverse dimension of proximal most tissue-snaring thread 18.” The requirement for the mesh to be screwed past the tissue-snaring threads into a non-threaded locking section directly indicates the presence of an eyelet in the mesh) is a screw (Figures 1-3, anchor (10)) attachment (Paragraphs [0070]-[0072]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a screw attachment as taught by Shipp, as both references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a screw attachment as taught by Shipp, since doing so allows for securement of the implant at the implant/treatment site (Abstract of Shipp).
Regarding claim 42, Weiss teaches, the solid structure (through-hole features (48)).
Weiss fails to teach, further comprising a spike extending from the solid structure.
Shipp teaches, a spike extending from the eyelet (Figures 8-10, 16-18 or Figures 19-22, penetration shaft section (112) or tissue snaring section (223); Paragraph [0085] or Paragraph [0092]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to allow the anchor of Shipp to be attached to/pass through the solid structure of Weiss such that a spike extends from the solid structure, as both references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow the anchor of Shipp to be attached to/pass through the solid structure of Weiss such that a spike extends from the solid structure, since doing so allows for securement of the implant at the implant/treatment site (Abstract of Shipp).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss, in view of Pacey (US 2002/0103494 A1).
Regarding claim 43, Weiss teaches, the plurality of links (links (41)).
Weiss fails to teach, further comprising a hook extending from a link of the plurality of links.
Pacey discloses, a porous prosthesis. Pacey teaches, hooks (Figure 3, hooks (13 & 14)) protruding from structural elements (arms/struts) of a mesh/scaffold/patch (Figure 3, ePTFE patch (11); Paragraphs [0028]-[0030]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify a link of the plurality of links of Weiss such that it comprises hook as taught by Pacey, as both references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a link of the plurality of links of Weiss such that it comprises hook as taught by Pacey, as such a modification would have been predictable, namely, to anchor and prevent prosthesis movement (Paragraph [0006] of Pacey).
Claim(s) 52 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss, in view of Shipp, and further in view of Pease.
Regarding claim 52, Weiss teaches, the plurality of eyelets (features (48)) which provide another feature for skin and underlying tissue to interconnect and lock into the chain link mesh (interface (40); Paragraph [0035]).
Weiss fails to teach, wherein at least one of the eyelet geometries defines a screw attachment, and wherein at least one of the eyelet geometries defines a cable attachment.
Shipp teaches, an eyelet (Paragraph [0071], discloses, “Unlike the embodiment of anchor 10 with no mesh retention section 12, either the conical or cylindrical configuration mesh retention section 12 locks mesh 52 on to anchor 10 when mesh 52 is screwed past the proximal-most tissue-snaring thread 18 since there is no thread located in mesh retention section 12 that would allow mesh 52 to be unscrewed from anchor 10. Mesh retention section 12 is generally cylindrical or conical shaped with a dimension transverse to its longitudinal axis that is smaller than the transverse dimension of head 11 and the transverse dimension of proximal most tissue-snaring thread 18.” The requirement for the mesh to be screwed past the tissue-snaring threads into a non-threaded locking section directly indicates the presence of an eyelet in the mesh) is a screw (Figures 1-3, anchor (10)) attachment (Paragraphs [0070]-[0072]).
Pease teaches, an eyelet (Figures 1 and 3-4, opening (16)) is a cable (Figure 4, cord (22)) attachment (Col. 3, line 55-Col. 4, line 8).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a screw attachment as taught by Shipp, and at least one of the eyelets of the plurality of eyelets of Weiss to be a cable attachment as taught by Pease, as all the references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow at least one of the eyelets of the plurality of eyelets of Weiss to be a screw attachment as taught by Shipp, and at least one of the eyelets of the plurality of eyelets of Weiss to be a cable attachment as taught by Pease, since doing so allows for securement of the implant at the implant/treatment site (Abstract of Shipp and Col. 4, line 5-8 of Pease).
Regarding claim 53, Weiss teaches, the implant of claim 52 (See above rejection of claim 52).
Weiss fails to teach, an implant kit, comprising: at least one cable; and at least one screw.
Shipp teaches, an implant kit (Figures 1-7, delivery device/applier (20), anchor (10), & mesh (52); Paragraphs [0070]-[0073]), comprising: an implant (Figure 3, mesh (52)); and at least one screw (anchor (10)).
Pease teaches, at least one cable (cord (22)) that passes through an eyelet of an implant (Col. 3, line 55-Col. 4, line 8).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to use an implant kit as taught by Shipp that comprises the implant of Weiss, the at least one cable of Pease, and the at least one screw of Shipp, as all the references and the claimed invention are directed to porous surgical implant meshes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an implant kit as taught by Shipp that comprises the implant of Weiss, the at least one cable of Pease, and the at least one screw of Shipp, as such a modification would have been predictable, namely, deliver/implant the porous implant and secure it to the body tissue at the site (Abstract and Paragraph [0073] of Shipp and Col. 4, line 5-8 of Pease).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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