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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1- 19, drawn to a suture, classified in A61B17/0401.
II. Claim 20, drawn to a method for treating an eye condition, classified in A61F9/007.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process such as attaching sutures to bone, cartilage or soft tissue during an arthroscopic repair.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the prior art applicable to one invention would not likely be applicable to
another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Grant McNeilly on 9/11/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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) 1- 2, 5, 7- 8, 12- 13 and 17- 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenhalgh et al. (US Pub. No. 2009/0105753 A1).
Regarding claim 1, Greenhalgh discloses a United States Pharmacopeia (USP) Class I nonabsorbable surgical suture comprising:
a synthetic fiber (2) (Figs. 1- 17, 20- 23) having an axial length suitable for tissue ligation or approximation (P. [0057] - - Any or all elements of the suture 2 and/or other devices or apparatuses described herein can be made from, for example … polypropylene, (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g., PEBAX.RTM. from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX.RTM. from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP)), the synthetic fiber (2) further having a non-circular cross-section maintained along at least a portion of the axial length of the synthetic fiber (2) (See Figs. 7, 8, 9) (Ps. [0028], [0031] - - The transverse suture configuration can be … oval, square, rectangular, triangular, hexagonal … The transverse suture configuration can be substantially flat; FIG. 7 illustrates that the transverse suture configuration can form a rectangular shape).
Note: Regarding the preamble reciting “a United States Pharmacopeia (USP) Class I nonabsorbable surgical suture,” it is noted that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951) and Ex parte Masham, 2 USPQ2d 1647 (1987).
It is further noted that according to applicant’s Specification, United States Pharmacopeia (USP) Class I nonabsorbable surgical sutures include nylon, which is disclosed by Greenhalgh (See Greenhalgh P. [0057]; See P. [0005] of applicant’s Specification).
Regarding claim 2, Greenhalgh further discloses wherein the synthetic fiber (2) has a cross-section disposed orthogonally to the length at a portion of the axial length, the cross-section including densified areas surrounding openings disposed between the densified areas, the openings being collapsible when the synthetic fiber (2) is externally compressed in a plane of the cross-section (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
Regarding claim 5, Greenhalgh further discloses wherein the synthetic fiber (2) has a cross-section disposed orthogonally to the length at a portion of the axial length, the cross-section being deformable from a first state to a second state, the first state presenting a first cross-sectional dimension that deforms to a lesser second cross- sectional dimension in the second state, the deforming being due to a reduction of openings disposed within the cross-section (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
Regarding claim 7, Greenhalgh further discloses wherein the synthetic fiber (2) having a variable cross-section disposed along a portion of the axial length, the variable cross-section varying between an uncompressed state presenting a first cross- section defining a first peripheral edge circumscribing the fiber (2) at the first cross-section and a compressed state presenting a second cross-section defining a lesser second peripheral edge circumscribing the fiber (2) at the second cross-section, the compressed state being present in the fiber (2) within a knot (34) (Fig. 20) formed by the fiber (2), the uncompressed state being present in the fiber (2) adjacent to the knot (34) (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
Regarding claim 8, Greenhalgh further discloses wherein the synthetic fiber (2) having a variable cross-section disposed along a portion of the axial length, the variable cross-section varying between an uncompressed state presenting a first cross- section having first openings disposed within the fiber (2) at the first cross-section and a compressed state presenting a second cross-section having second openings disposed within the fiber at the second cross-section, the second openings having a reduced size compared to the first openings, the compressed state being present in the fiber (2) within a knot (34) (Fig. 20) formed by the fiber, the uncompressed state being present in the fiber (2) adjacent to the knot (34) (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
Regarding claim 12, Greenhalgh discloses a surgical suture comprising:
a synthetic fiber (2) (Figs. 1- 17, 20- 23) having an axial length suitable for tissue ligation or approximation, the synthetic fiber (2) further defining a cross-section along at least a portion of the axial length of the synthetic fiber (2) having a major dimension and a minor dimension, wherein the cross-section has a perimeter defined by a porous surface (See Figs. 7, 8, 9) (Ps. [0028], [0031] - - The transverse suture configuration can be … oval, square, rectangular, triangular, hexagonal … The transverse suture configuration can be substantially flat; FIG. 7 illustrates that the transverse suture configuration can form a rectangular shape).
Regarding claim 13, Greenhalgh further discloses wherein the porous surface is characterized by a plurality of fibers of material separated by spaces (Ps. [0065], [0066] - - changing the porosity of the suture can effect the long-term strength of the suture 2; a softer configuration (e.g., more porous, less dense weave)).
Regarding claim 17, Greenhalgh discloses A suture comprising:
a fiber (2) (Figs. 1- 17, 20- 23) formed of a synthetic, porous material (P. [0057] - - Any or all elements of the suture 2 and/or other devices or apparatuses described herein can be made from, for example … nylon), the fiber (2) having a compressible, non-circular cross-section and defining a fiber axis and having an axial length suitable for tissue ligation or approximation and side surfaces each extending axially along at least a portion of the axial length of the synthetic fiber (2) (See Figs. 7, 8, 9) (Ps. [0028], [0031] - - The transverse suture configuration can be … oval, square, rectangular, triangular, hexagonal … The transverse suture configuration can be substantially flat; FIG. 7 illustrates that the transverse suture configuration can form a rectangular shape), the fiber (2) being in a knotted configuration (Fig. 20) such that the fiber (2) has a first portion defining a first porosity and a second portion defining a second porosity greater than the first porosity, the first portion corresponding to a knotted portion (34) (Fig. 20) and the second portion corresponding to an unknotted portion (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
Regarding claim 18, Greenhalgh further discloses wherein the first porosity is defined by first pore openings, and the second porosity is defined by second pore openings having larger average pore sizes than the first pore openings (Ps. [0066], [0073] - - suture 2 can be configured to deform (e.g., dent) under pressure over the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, for example, to improve knot retention … The suture 2 or elements thereof can be made from softer materials and/or a softer configuration (e.g., more porous, less dense weave) along the length of the suture 2 where the suture 2 is tied in a knot or otherwise frictionally restrained, compared to the materials and/or configuration for the remainder of the suture 2 or elements thereof; the transverse shape of the suture 2 can be adjusted (e.g., round to flat, flat to round). Adjusting the transverse sectional shape can optimize stress distributions, and reduce the maximum stresses on yarns in the suture 2).
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) 3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US Pub. No. 2009/0105753 A1) in view of Bracy (US Pub. No. 2017/0055983 A1).
Regarding claim 3 and claim 6, Greenhalgh discloses the apparatus of claim 1, Greenhalgh further discloses a variety of cross-sectional shapes (See Figs. 7, 8, 9) (Ps. [0028], [0031] - - The transverse suture configuration can be … oval, square, rectangular, triangular, hexagonal … The transverse suture configuration can be substantially flat; FIG. 7 illustrates that the transverse suture configuration can form a rectangular shape), but Greenhalgh does not explicitly disclose
(claim 3) wherein the synthetic fiber having side surfaces each extending axially along at least a portion of the axial length of the synthetic fiber, the axially-extending side surfaces including a flat surface disposed between two curved surfaces, each of the two curved surfaces curving about a fiber axis from 90 degrees to 180 degrees;
(claim 6) wherein the synthetic fiber having a cross-section disposed orthogonally to a fiber axis along a portion of the axial length, the cross-section defining a flat surface of the synthetic fiber extending along the portion of the axial length, the synthetic fiber predisposed to twist about the axis to present the flat surface as an inner surface of a curvature formed when the fiber is deformed to form the curvature.
However, Bracy teaches a suture in the same field of endeavor (P. [0002])
(claim 3) wherein the synthetic fiber having side surfaces each extending axially along at least a portion of the axial length of the synthetic fiber, the axially-extending side surfaces including a flat surface disposed between two curved surfaces, each of the two curved surfaces curving about a fiber axis from 90 degrees to 180 degrees (See Fig. 4E) (P. [0045] - - 4E illustrates a suture portion having an arcuate tape profile where, in various embodiments, the arc will reflect a circular arc, an elliptical arc, or any other arc appropriate to a particular application);
(claim 6) wherein the synthetic fiber having a cross-section disposed orthogonally to a fiber axis along a portion of the axial length, the cross-section defining a flat surface of the synthetic fiber extending along the portion of the axial length, the synthetic fiber predisposed to twist about the axis to present the flat surface as an inner surface of a curvature formed when the fiber is deformed to form the curvature (See Fig. 4E) (P. [0045] - - 4E illustrates a suture portion having an arcuate tape profile where, in various embodiments, the arc will reflect a circular arc, an elliptical arc, or any other arc appropriate to a particular application).
Bracy further disclosing that an arcuate tape profile (Fig. 4E) is a structurally equivalent cross-sectional shape as an oval (Fig. 4C), square (Fig. 4H), rectangular (Fig. 4G), triangular (4N), hexagonal (Fig. 4L) (Ps. [0041], [0042], [0048] - - It should be recognized that along with other benefits, a particular cross-sectional profile will aid in the identification of a particular portion of a suture to a user; different embodiments and aspects of the invention will include different cross-sectional profiles associated with one or more portions of a suture. FIGS. 4A-4P illustrate, in schematic form and purely for exemplary purposes, various cross-sectional profile that will be beneficially applied in respective embodiments of the invention; these various geometrical configurations disclosed here are not intended to form an extensive list, but are merely exemplary of the wide variety of cross-sectional profile that will be beneficially employed and readily apparent to one of ordinary skill in the art who considers the matter in light of the foregoing disclosure).
Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (an arcuate tape profile (Fig. 4E) taught by Bracy) for another (a variety of cross-sectional shapes (See Figs. 7, 8, 9) associated with Greenhalgh) since the substitution would have yielded predictable results, namely, along with other benefits, aiding in the identification of a particular portion of a suture to a user (Bracy - - Ps. [0041], [0042], [0048]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 4, 9- 11 and 14- 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US Pub. No. 2009/0105753 A1) in view of Bogart et al. (US Pub. No. 2011/0015653 A1).
Regarding claim 4, Greenhalgh discloses the apparatus of claim 1, but Greenhalgh does not disclose
(claims 4, 9- 11 and 14- 16) microfilament ends that engage each other end-to-end along a portion of the axial length of the synthetic fiber as claimed.
However, Bogart teaches ferrule (20) (Figs. 1- 2E) for joining similar or dissimilar sutures (10, 12) wherein the ends (12, 32) of the first and second lengths of sutures (10, 12) are welded within continuous respective first and second cavities such that the end of the first length of suture (12) may abut the end of the second length of suture (32) within the cylindrical body (See Fig. 2D) (P. [0029] - - as seen in FIG. 2D, first and second cavities 24, 26 are continuous and do not include a divider therebetween. Depending on the configuration of ferrule 20, ends 12, 32 of respective first and second lengths of suture 10, 30 may abut or overlap one another within ferrule 20).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the synthetic fiber having a variety of cross-sectional shapes associated with Greenhalgh to use ferrule 20 to combine two or more synthetic fibers having different cross-sectional shapes since the ferrule 20 would lessen the transition between the first suture length and the second suture lengths in order to be more easily received through tissue (Bogart - - P. [0028]). Since Greenhalgh discloses a multi-filament suture (P. [0007]), Greenhalgh in view of Bogart would encompass or make obvious
(claim 4) wherein the synthetic fiber has a plurality of microfilaments (10, 30) (Figs. 1- 3) each having microfilament ends (12, 32) that engage each other end-to-end along a portion of the axial length of the synthetic fiber (See Fig. 2D);
(claim 9) wherein the synthetic fiber associated with Greenhalgh includes a plurality of microfilaments with each microfilament having opposing microfilament ends, a portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a monofilament composed of engaged microfilaments extending at least a portion of the axial length (See Fig. 2D);
(claim 10) wherein the synthetic fiber associated with Greenhalgh includes a plurality of microfilaments with each microfilament having opposing microfilament ends, a first portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a first monofilament composed of engaged microfilaments, a second portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end- to-end to define a second monofilament composed of engaged microfilaments, the first and second monofilaments twisted about each other for at least a portion of the axial length (See Fig. 2D) (Ps. [0027], [0029] - - Either or both of suture lengths 10, 30 may be drawn, oriented, crinkled, twisted, commingled or air entangled to form yarns as part of the suture forming process; as seen in FIG. 2D, first and second cavities 24, 26 are continuous and do not include a divider therebetween. Depending on the configuration of ferrule 20, ends 12, 32 of respective first and second lengths of suture 10, 30 may abut or overlap one another within ferrule 20; it is noted that abutting the respective twisted ends of the first and second length of suture within ferrule 20 would have been within the purview of one of ordinary skill);
(claim 11) wherein the synthetic fiber associated with Greenhalgh includes a plurality of microfilaments with each microfilament having opposing microfilament ends, a first portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a first monofilament composed of engaged microfilaments, a second portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end- to-end to define a second monofilament composed of engaged microfilaments, the first and second monofilaments each defining pathways along the axial length to define a braided structure formed by the first and second monofilaments extending along at least a portion of the axial length (See Fig. 2D);
(claim 14) wherein the plurality of fibers associated with Greenhalgh include a plurality of microfilaments with each microfilament having opposing microfilament ends, a portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a monofilament composed of engaged microfilaments extending at least a portion of the axial length (See Fig. 2D);
(claim 15) wherein the plurality of fibers associated with Greenhalgh include a plurality of microfilaments with each microfilament having opposing microfilament ends, a first portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a first monofilament composed of engaged microfilaments, a second portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a second monofilament composed of engaged microfilaments, the first and second monofilaments twisted about each other for at least a portion of the axial length (See Fig. 2D) (Ps. [0027], [0029] - - Either or both of suture lengths 10, 30 may be drawn, oriented, crinkled, twisted, commingled or air entangled to form yarns as part of the suture forming process; as seen in FIG. 2D, first and second cavities 24, 26 are continuous and do not include a divider therebetween. Depending on the configuration of ferrule 20, ends 12, 32 of respective first and second lengths of suture 10, 30 may abut or overlap one another within ferrule 20; it is noted that abutting the respective twisted ends of the first and second length of suture within ferrule 20 would have been within the purview of one of ordinary skill);
(claim 16) wherein the plurality of fibers associated with Greenhalgh include a plurality of microfilaments with each microfilament having opposing microfilament ends, a first portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a first monofilament composed of engaged microfilaments, a second portion of the plurality of microfilaments disposed so that opposing microfilament ends engage each other end-to-end to define a second monofilament composed of engaged microfilaments, the first and second monofilaments each defining pathways along the axial length to define a braided structure formed by the first and second monofilaments extending along at least a portion of the axial length (See Fig. 2D).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US Pub. No. 2009/0105753 A1) in view of Fortson (US Pub. No. 2021/0052270 A1).
Regarding claim 19, Greenhalgh discloses the apparatus of claim 17, but Greenhalgh does not disclose
(claim 19) wherein the knotted portion has a knot size of from 25 μm to 100 μm.
However, Fortson teaches a suture (10) including one or more knotted portions (14a- j) (Figs. 1- 6E, 13D- 14E)
(claim 19) Fortson discloses suture (10) knotted portions (14a- j) having knot sized from approximately 280 microns to approximately 1,320 microns (P. [0030]).
However, Fortson also sets forth that the knotted portions’ knot size is a result effective variable, wherein the specific diameter(s) of knots can be selected based on, among other things, the relative diameter of the needles used to pierce the walls of the vessel to be closed, the cross-sectional diameter of suture and the degree of elasticity of the vessel walls (P. [0025]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the knotted portion associated with Greenhalgh to have a knotted portion knot sized from 25 μm to 100 μm for the purpose of being large enough that it will not readily pass through the tissue of the needle penetrations without the application of a predetermined amount of force that is sufficient to cause the needle penetrations to elastically deform to a diameter sufficient to allow the knot to pass therethrough and, once passed through a needle penetration, the elasticity of the vessel wall causes the tissue surrounding the needle penetration to retract to a diameter less than the diameter of knot, thereby preventing suture pull-through (Fortson - - P. [0025]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771