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/Restrictions
Applicant’s election without traverse of Invention I (claims 1-12), Species III (Fig. 3a-h), and Subspecies ii (Fig. 8b) in the reply filed on 11/6/25 is acknowledged.
Claims 7, 9, and 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/6/25.
Specification
The disclosure is objected to because of the following informalities: in paragraph [0001] the corresponding patent number for the parent application must be added.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-12 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.
Claim 11 recites the limitation "the barb" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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) 1-5, 8, 10, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maiorino et al. (2008/0132943).
Maiorino discloses the following claimed limitations:
Claim 1: A self-retaining suture comprising: an elongated barbed suture filament (20) (Fig. 1 and [0015]) affixed to a needle (22) (Fig. 1 and [0015]) and a plurality of visually identifiable apertures (16) (Fig. 1-2d and [0015-16]) arrayed at fixed intervals along a longitudinal axis of the elongated barbed suture filament (Fig. 1-2d and [0015-16]), wherein the apertures are formed with opposing aperture walls (a wall at the top opening of the aperture and the other one on the bottom opening of the aperture seen in Fig. 1-2d) having a thickness substantially similar to that of the suture filament (where the aperture goes through the suture filament so the thickness between the wall at the top aperture opening and the bottom aperture opening would be similar to that of the filament (Fig. 1-2d and [0015-16])), and wherein the apertures are dimensioned to admit one-way passage of the suture laterally through the apertures while barbs (14) on the suture filament resist backwards movement of the suture filament in a direction substantially opposite a direction of deployment of the suture (Fig. 4-7, [0015], and [0022]).
Claim 2: wherein the opposing aperture walls are pliable and able to stretch (the suture is made of a flexible material ([0014]) and with tension causes the aperture to wedge ([0019]).
Claim 3: wherein the opposing aperture walls are pliable and flatten under tension (the suture is made of a flexible material ([0014]) and with tension causes the aperture to wedge/flatten ([0019]).
Claim 4: wherein the self-retaining suture is formed of a bioresorbable material ([0025-26]).
Claim 5: wherein the self-retaining suture is formed of a non- bioresorbable material ([0025-26]).
Claim 8: wherein the suture filament is circular or generally circular in cross section (Fig. 3d and [0017]).
Claim 10: wherein the barbs (14) are disposed on the body of the suture filament in a disposition selected from: unidirectional or bidirectional, evenly spaced down the length of the suture filament in symmetrical pairs, helically placed along a longitudinal axis of the suture filament, in a staggered disposition along the longitudinal axis of the suture filament, in a twist cut multiple spiral disposition along the longitudinal axis of the suture filament, in an overlapping disposition along the longitudinal axis of the suture filament, in a random disposition along the longitudinal axis of the suture filament, and combinations thereof (Fig. 1 and [0015]).
Claim 11: A self-retaining suture comprising: a plurality of visually identifiable apertures (16) (Fig. 1-2d and [0015-16]) interconnected by barbed suture filament (20) (Fig. 1 and [0015]), wherein the apertures are formed with opposing aperture walls (a wall at the top opening of the aperture and the other one on the bottom opening of the aperture seen in Fig. 1-2d) having a thickness substantially similar to that of the suture filament (where the aperture goes through the suture filament so the thickness between the wall at the top aperture opening and the bottom aperture opening would be similar to that of the filament (Fig. 1-2d and [0015-16])), and wherein the apertures are dimensioned to admit one-way passage of the barbed suture filament laterally through the apertures while the barbs (14) on the suture filament resist backwards movement of the suture filament through the apertures in a direction substantially opposite a direction of deployment of the suture between opposing tissue surfaces of a wound (Fig. 4-7, [0015], and [0022]) thus permitting a succession of one-way self-retaining loops to be formed across the wound without use of knots (Fig. 1 and [0015] where the needle can be threaded again through any of the apertures and would form multiple one-way loops).
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.
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maiorino et al. (2008/0132943) in view of Avelar et al. (2011/0319932)
Maiorino teaches all the claimed limitations discussed above however; Maiorino does not disclose locator bands as claimed.
Avelar discloses a suture with markers wherein the markers can be locator bands having a visually identifiable distinctive coloring ([0067]) or is located one of a plurality of locator bands having visually identifiable distinctive coloring ([0067]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Maiorino with locator bands/markers in view of the teachings of Avelar, in order to identify the location of the of portions of the suture, the depth of the suture, or to indicate suture stress ([0067]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations when considered alone or in combination.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771