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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/07/2025 has been entered.
Claims 1 and 4 have been amended. Claims 2 and 3 have been cancelled. Claims 1 and 4 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 4, filed 10/07/2025, with respect to the rejection of claim 4 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection has been withdrawn.
Applicant's arguments, see pg. 4-7, filed 10/07/2025, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Gross teaches neither the distance between adjacent barbs nor the protrusion height as claimed in amended claim 1. Applicant further asserts that these features were disclosed as setting forth a distinct advantage over other configurations, citing paragraphs [0033] and [0034] of the Specification.
The Examiner agrees that Gross does not expressly disclose the barbs “a distance between the barbs adjacent in the longitudinal direction of the suture body is 1.0 to 3.0 mm, and a protrusion height of the barbs is 0.2 to 0.6 mm”. However, it is the Examiner’s position, as stated in the Final Rejection mailed 04/07/2025 (see pg. 6), that Gross discloses these features (i.e., the distance between adjacent barbs and protrusion height) as result effective variables in that varying the cut depth and spatial arrangement of the barbs effects the engagement of the barbs with tissue (see Gross [0112]).
Applicant’s disclosure in paragraphs [0033] and [0034] describes a variety of disadvantages and advantages that “may” occur with values outside of the claimed range. However, this disclosure does not amount to a showing of criticality of the range or that the claimed range achieves unexpected results (see MPEP 2144.05). It was already contemplated by Gross that varying cut depth and spatial arrangement of the barbs would negatively or positively affect the engagement of the barbs with tissue. It would therefore have been a matter of routine optimization to have found the optimum or workable ranges for the barb height and barb spacing.
In response to applicant's argument that claim 1 is limited to use in the meniscus, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant’s arguments regarding the rejection of claim 4, rely on the features similarly claimed in claim 1. Therefore, the Examiner’s stated position above with respect to claim 1 also apply to claim 4.
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 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20130238021).
Regarding claim 1, Gross discloses a bidirectional barbed suture (100, see Fig. 1A-1B) comprising: a suture body (120) having a predetermined length, formed in a cylindrical shape, and having a needle (110,112) formed, as a part of the suture body (the needle 110 can be permanently swaged to the suture or the suture itself may have rigid and sharp ends for penetrating tissue, see [0085] and [0099]), at one end or at each of both ends (the needles 110, 112 are at both ends of the suture 120, see Fig. 1A) to be inserted into a cartilage, wherein the cartilage is a meniscus (it is understood that the device can be inserted into a meniscus if desired since it is capable of being inserted into tissue, see [0085]); and a plurality of barbs (130) formed on an outer surface of the suture body (see Fig. 1B) by partially cutting the suture body (see [0110]), along a longitudinal direction of the suture body (see Fig. 1C), disposed symmetrically about a central portion of the suture body (each region 142, 146 containing barbs 130 are disposed symmetrically about the center portion 144 of the suture body 120, see Fig. 1A), protruding outwardly from the suture body (see Fig. 1A), and configured to be inserted into the cartilage to fix the suture body to the cartilage (the suture body would be capable of being inserted and fixed to cartilage since the device includes needles for penetrating tissue and barbs are for retaining the suture within tissue, see [0085]), wherein the suture has a first length from a front end to a rear end of the suture body (the combined length of sections 142, 144, and 146, see Fig. 1A), a third length of the central portion (the central portion 144 has a length, see Fig. 1A), and a second length of the needle (the needles 110 and 112 have a length, see Fig. 1A), and wherein the plurality of barbs are formed to have an angle (alpha, see Fig. 1D) with respect to a center point formed on a cross-section of the suture body, a distance between the barbs (P, see Fig. 1C) adjacent in the longitudinal direction of the suture body, and a protrusion height (EH, see Fig. 1C).
Gross does not expressly disclose the first length from the front end to the rear end of the suture body is about 300 to 950 mm, the third length of the central portion is about 2 to 40 mm. However, Gross discloses (see [0107]) that the length of each region of the suture “may be varied and selected depending upon the application for which the suture is intended to be used”. As such the length of the length from the front end to the rear end of the suture and the length of the central portion are disclosed as result effective variables in that changing the length of the suture portions would make the suture more suitable for use in particular applications. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gross by making the first length from the front end to the rear end of the suture body about 300 to 950 mm and the third length of the central portion about 2 to 40 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Gross does not expressly disclose a second length of the needle is about 200 to 400 mm. However, Gross discloses (see [0108]) that the configuration of each needle can be varied based on the application. As such the configuration of the needle, which is understood to include characteristics like shape and dimension, including length, is disclosed as a result effective variable in that changing the configuration of the needle would make it more suitable for use in particular applications. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gross by a second length of the needle about 200 to 400 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Gross does not expressly disclose wherein the plurality of barbs are formed to have a right angle with respect to a center point formed on a cross-section of the suture body, a distance between the barbs adjacent in the longitudinal direction of the suture body is 1.0 to 3.0 mm, and a protrusion height of the barbs is 0.2 to 0.6 mm. However, Gross discloses (see [0112]) that the geometry and spatial arrangement of the barbs may be varied “to enhance engagement of tissue”. As such the geometry and orientation of the barbs are disclosed as result effective variables in that varying the geometry and spatial arrangement of the bars (which is understood to include the cut angle, protrusion height, and distance between adjacent barbs) affects the amount of tissue engagement by the barbs. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Gross by causing the plurality of barbs to be formed at a right angle with respect to a center point of the suture body, a distance between the barbs adjacent in the longitudinal direction of the suture body to be 1.0 to 3.0 mm, and a protrusion height of the barbs to be 0.2 to 0.6 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20200345344), in view of Gross.
Regarding claim 4, Johnson discloses a treatment method (a method of repairing damaged tissue, see Abstract and Fig. 10-16) using a barbed suture (suture 64 may be barbed, see paragraph [0058]), the method comprising: inserting a suture body into a cartilage in a damaged area through any one of needles at both ends of the suture body wherein the cartilage is a meniscus (Fig. 13 shows a needle 68 of suture 64 being inserted into meniscus 78, which is cartilage tissue); exposing the needles to an outside of a human body while keeping the central portion supported in the cartilage after the needles pass through the cartilage using an endoscope (Fig. 16 shows the central portion of the suture supported within the meniscus after the needles have passed through using the arthroscopic device 10); and pulling a pair of portions of the suture body exposed to the outside of the human body and thereby suturing the damaged area once both needles are passed through, the surgeon tensions both ends of the suture to close the tear 76, see paragraph [0062]).
Johnson fails to expressly the teach that the barbed suture is specifically a bidirectional barbed suture, with needles formed as part of the suture body, wherein barbs formed on the outer surface of the suture body by partially cutting the suture body are fixed to the cartilage, and removing the needles from the suture body.
Gross, in the same field of art, discloses a bidirectional barbed suture (100, see Fig. 1A-1B), with barbs (130) formed on the outer surface of the suture body (120) by partially cutting the suture body (see [0110]), needles (110, 112) formed as a part of the suture body a both ends of the suture body and removing the needles from the suture body (which has been interpreted as the needles are formed at each end of the suture body based and removed from the suture body on the specification see [11] and [35]) (the needles 110, 112 are formed at both ends of the suture body 120, see Fig. 1A, and are removed from the suture body using a sharp tug, see [0099]).
The substitution of one known element (bidirectional barbed suture as shown in Gross) for another (suture as shown in Johnson) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the suture in Gross would have yielded predictable results, namely, suturing tissue. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Regarding the limitation “fixed to the cartilage without a knot”, it is understood that this is an inherent property of bidirectional barbed sutures which allow the suture to pass through tissue in one direction while opposing movement in the opposite direction, thus allowing the suture to be retained or fixed within tissue without the need for a knot or anchor (see Gross [0085]).
Gross further teaches wherein the suture has a first length from a front end to a rear end of the suture body (the combined length of sections 142, 144, and 146, see Fig. 1A), a third length of the central portion (the central portion 144 has a length, see Fig. 1A), and a second length of the needle (the needles 110 and 112 have a length, see Fig. 1A), and wherein the plurality of barbs are formed to have an angle (alpha, see Fig. 1D) with respect to a center point formed on a cross-section of the suture body, a distance between the barbs (P, see Fig. 1C) adjacent in the longitudinal direction of the suture body, and a protrusion height (EH, see Fig. 1C).
Gross does not expressly disclose the first length from the front end to the rear end of the suture body is about 300 to 950 mm, the third length of the central portion is about 2 to 40 mm. However, Gross discloses (see [0107]) that the length of each region of the suture “may be varied and selected depending upon the application for which the suture is intended to be used”. As such the length of the length from the front end to the rear end of the suture and the length of the central portion are disclosed as result effective variables in that changing the length of the suture portions would make the suture more suitable for use in particular applications. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Johnson and Gross by making the first length from the front end to the rear end of the suture body about 300 to 950 mm and the third length of the central portion about 2 to 40 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Gross does not expressly disclose a second length of the needle is about 200 to 400 mm. However, Gross discloses (see [0108]) that the configuration of each needle can be varied based on the application. As such the configuration of the needle, which is understood to include characteristics like shape and dimension, including length, is disclosed as a result effective variable in that changing the configuration of the needle would make it more suitable for use in particular applications. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Johnson and Gross by a second length of the needle about 200 to 400 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Gross does not expressly disclose wherein the plurality of barbs are formed to have a right angle with respect to a center point formed on a cross-section of the suture body, a distance between the barbs adjacent in the longitudinal direction of the suture body is 1.0 to 3.0 mm, and a protrusion height of the barbs is 0.2 to 0.6 mm. However, Gross discloses (see [0112]) that the geometry and spatial arrangement of the barbs may be varied “to enhance engagement of tissue”. As such the geometry and orientation of the barbs are disclosed as result effective variables in that varying the geometry and spatial arrangement of the bars (which is understood to include the cut angle, protrusion height, and distance between adjacent barbs) affects the amount of tissue engagement by the barbs. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Johnson and Gross by causing the plurality of barbs to be formed at a right angle with respect to a center point of the suture body, a distance between the barbs adjacent in the longitudinal direction of the suture body to be 1.0 to 3.0 mm, and a protrusion height of the barbs to be 0.2 to 0.6 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Foumenteze et al. (US 2020/0281588) discloses a bidirectional barbed suture (1, see Fig. 4) where a distance between adjacent barbs in the longitudinal direction of the suture body is 1.0 to 3.0 mm ([0077]-[0079]) and a protrusion height of the barbs is 0.2 to 0.6 mm ([0058]).
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/SERENITY A MILLER/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771