DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 12/15/2025.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The rejection of claim(s) 1-10 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment.
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.
Claim(s) 1 and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0060409 A1 to Leung et al. (hereinafter “Leung”) in view of US 2009/0210006 A1 to Cohen et al. (hereinafter “Cohen”) (both references previously made of record by the Examiner).
Regarding claim 1, Leung discloses (see abstract; Figs. 1-7B; Examiner’s Diagram of Fig. 7A below; and [0045]-[0178]) a suture structure (80, see Figs. 7A-B and [0135]-[0178]) that enhances lifting effect (see at least [0134]), comprising: a thread (82), which has a thread diameter ("SD") that extends in a lengthwise direction; a plurality of barbs (81), which are arranged on a surface of the thread (see Figs. 7A-B) in the lengthwise direction, the barbs having at least one planar surface; and a plurality of grooves ("CD"), which are formed on the surface of the thread to respectively correspond to the plurality of barbs and are each arranged adjacent to the respective barb of the plurality of barbs at one side of the barb in the lengthwise direction (see Figs. 7A-B), wherein the barbs have a barb height and a barb width, and the grooves have a groove length and a groove depth (see Examiner's Diagram of Fig. 7A below, showing the 4 measurements and referring to X1-X4 as used by applicant in the spec. at Fig. 4), the barb height being between 0.27 times of the thread diameter (see [0172], 0.2-1 times the suture diameter, thus encompassing the claimed value), the barb width being 0.46 times of the thread diameter (see [0172], where it is 0.05-0.6 times the thread diameter, thus encompassing the claimed value), the groove length being 0.55 times of the thread diameter (see [0172], where it is 0.2-2 times the thread diameter, thus encompassing the claimed value), the groove depth being between 0.33 times of the thread diameter (see [0172] where it is 0.05-0.6 times the thread diameter at its maximum depth, note also that the groove depth varies along length "L, thus encompassing the claimed value) (see MPEP 2131.03, when the prior art teaches a range that overlaps the claimed range with sufficient specificity, the claim is anticipated - the ratios of the various measurements to the suture diameter are given with sufficient specificity in Leung for a person of ordinary skill to envisage the claimed range as being specific examples falling within the given range of Leung).
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Leung further discloses (claims 6-7) wherein the plurality of barbs and the plurality of grooves are arranged on the thread in a spiral manner (see Figs. 6A-7B and [0106]/[0135]-[0137]); (claims 8-9) wherein the plurality of barbs and the plurality of grooves are arranged on the thread in an equidistant manner (see [0176]-[0177] and Fig. 7B; at cut distance "P").
With respect to claim 1, Leung fails to specifically disclose wherein for at least one barb of the barbs, the at least one planar surface is formed on a distal end of the at least one barb and distant from the thread and parallel to the lengthwise direction and wherein the groove that corresponds to the at least one barb is defined by at least one planar bottom that is away from the at least one planar surface and parallel to the length wise direction.
Cohen discloses (see abstract; Figs. 1-4A; and [0022]-[0082]), in the same field of endeavor of barbed sutures, a suture structure (Fig. 4A, see [0023]-[0026]) comprising a thread (14), a plurality of barbs (12) arranged on a surface of the thread in the lengthwise direction, the barbs having at least one planar surface (indicated by #12 in Fig. 4A); a plurality of grooves (indicated by #12C in Fig. 4A), which are formed on the surface of the thread to respectively correspond to the plurality of barbs and are each arranged adjacent to the respective barb of the plurality of barbs at one side of the barb in the lengthwise direction (see Fig. 4A), wherein for at least one barb of the barbs, the at least one planar surface is formed on a distal end of the at least one barb and distant from the thread and parallel to the lengthwise direction (see Fig. 4A, the planar surface indicated by #12 extends to the distal end of the barb and is both distant from the thread and parallel to the lengthwise direction indicated by “D-D”) and wherein the groove that corresponds to the at least one barb is defined by at least one planar bottom that is away from the at least one planar surface and parallel to the length wise direction (see Fig. 4A, the portion of the groove formed at portion 12C corresponds to the barb, is defined by a planar bottom that is away from planar surface indicated by #12 of the barb, and is parallel to the lengthwise direction indicated by “D-D”). Cohen deems this type of barb a “compound barb”, and indicates that a suture thread can have any combination of compound barbs and single angle barbs (see Fig. 3 and [0025]). Leung’s device is considered to have single angle barbs. Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of combining prior art elements according to known method to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of a barbed suture such as in Leung having both single angle barbs and at least one compound barb as taught by Cohen since these different types of barbs are useful for providing a gripping effect in tissue into which the suture is inserted to prevent pull-out or migration by providing differing angles of the barb as they are inserted into tissue to provide a variety of gripping forces on the tissue.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 6-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771