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 .
Response to Amendment
This office action is in response to the amendments filed on 3/9/2026. Claims 15 is amended. Claims 36-55 are newly added. Claims 1-15 and 35-55 are pending and addressed below.
Response to Arguments
Applicant’s arguments regarding claim 1 for Deister, filed on 3/9/2026, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made with a different interpretation of Deister.
Applicant’s arguments regarding claim 1 for Dann, filed on 3/9/2026, have been fully considered but are not persuasive.
Regarding arguments on page 12, the applicant states that “In addition, modifying Dann's tension element 144 to include barbs would render the gastrointestinal cuff system unsatisfactory for its intended purpose. The cuff 102 is required to be "highly compliant" achieving 150%-200% stretch in a radial direction "without transmitting excessive force or pressure to the tissue" because "a rigid cuff might cause dislodging" (See Dann at paras. [0112]-[0114], [0309]-[0310].) The tension element 144 (also referred to as tension element 184) "extends through the tissue wall." (Dann at para. 0137]). Barbed sutures would reduce compliance by anchoring the suture into the tissue wall and would transmit force directly to the tissue during stretching. Moreover, Dann teaches a tension control system 578 in which the tension element 184 is required to respond to changes in tension by being pulled through a retention element 180 on the cuff and through the tissue wall before returning to its previous position. (See Dann at paras. [0319]-[0322]). Barbed sutures would prevent the tension element 184 from moving in at least one of these directions”. The examiner disagrees with the applicant because nowhere in Dann does it explicitly disclose that adding barbs to the suture would render the gastrointestinal cuff system unsatisfactory for its intended purpose. It appears that the applicant is just making assumptions and also, Dann does not explicitly teach away from adding barbs to the suture resulting in the rejection to be proper. Also, the tension control system 578 is directed towards a different embodiment that is not being used in the current rejection. Therefore, the rejection is proper.
Regarding arguments on page 12, the applicant states that “Biodegradable sutures would be even less reliable for precise tension control because they would break down in the body. Stopek explains that "the term 'biodegradable' includes both bioabsorbable and bioresorbable materials. By biodegradable, it is meant that the materials decompose, or lose structural integrity under body conditions (e.g., enzymatic degradation, hydrolysis) or are broken down (physically or chemically) under physiologic conditions in the body (e.g., dissolution)." (Stopek at para. [0029].) However, a person of ordinary skill would understand that the cuff device disclosed by Dann must remain structurally secured for longer periods of time, and that under ordinary conditions, this is already a challenge”. The examiner disagrees with the applicant because nowhere in Dann does it explicitly disclose that making the suture biodegradable would make the suture less reliable for precise tension control. It appears that the applicant is just making assumptions and also, Dann does not explicitly teach away from making the suture biodegradable. Therefore, the rejection is proper.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation of “wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a circumferential configuration” in claim 37, “wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a net configuration” in claim 38, “wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a spiral configuration” in claim 39 and “wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a serpentine configuration” in claim 40 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
Claims 1-3, 6, 9, 11, 12, 14, 15, 35, 36, 38-43, 46-50 and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hotter (US Pub No. 2011/0125287).
Regarding claim 1, Hotter discloses (Figures 2-3) a tissue connector (Figure 2), comprising: a body (100) formed of a layer of at least one material (Paragraph 0042); and at least one barbed suture (110) attached to the body (Figure 2) (Paragraph 0042) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 3) (Paragraph 0042), wherein the barbed suture is formed of a biodegradable material (Paragraph 0032).
Regarding claim 1 under a second rejection of Hotter, Hotter discloses (Figure 5) a tissue connector (Figure 5), comprising: a body (300) formed of a layer of at least one material (Paragraph 0042); and at least one barbed suture (310, 320) attached to the body (Figure 5) (Paragraphs 0042 and 0045) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 5) (Paragraphs 0042 and 0045), wherein the barbed suture is formed of a biodegradable material (Paragraph 0032).
Regarding claim 1 under a third rejection of Hotter, Hotter discloses (Figure 9) a tissue connector (Figure 9), comprising: a body (600) formed of a layer of at least one material (Paragraph 0042); and at least one barbed suture (610) attached to the body (Figure 9) (Paragraphs 0042 and 0048) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 9) (Paragraphs 0042 and 0048), wherein the barbed suture is formed of a biodegradable material (Paragraph 0032).
Regarding claim 1 under a fourth rejection of Hotter, Hotter discloses (Figure 10) a tissue connector (Figure 10), comprising: a body (700) formed of a layer of at least one material (Paragraph 0042); and at least one barbed suture (710) attached to the body (Figure 10) (Paragraphs 0042 and 0049) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 10) (Paragraphs 0042 and 0049), wherein the barbed suture is formed of a biodegradable material (Paragraph 0032).
Regarding claim 2 under any of the rejections for claim 1 above, wherein the barbed suture is formed of a biodegradable polymer (Paragraph 0032).
Regarding claim 3 under any of the rejections for claim 1 above, wherein the biodegradable polymer is a polyester polymer (Paragraph 0032).
Regarding claim 6 under any of the rejections for claim 1, wherein the barbed suture comprises a plurality of barbs and a main body (clearly shown in Figure 1), wherein the plurality of barbs and the main body are formed of the same material (Figure 1) (Paragraph 0032).
Regarding claim 9 under any of the rejections for claim 1 above, wherein the body is a sheet (Figures 2-3).
Regarding claim 11 under any of the rejections for claim 1 above, wherein the at least one barbed suture is sewn through the one or more layers that form the body so that portions of the at least one barbed suture pass through all of the one or more layers (Paragraph 0042).
Regarding claim 12 under any of the rejections for claim 1 above, wherein the one or more layers includes two or more layers, and wherein the at least one barbed suture is sewn within or between layers, of the two or more layers, so that portions of the at least one barbed suture are entrapped within or between the two or more layers (Paragraph 0042).
Regarding claim 14 under any of the rejections for claim 1 above, wherein the one or more layers includes multiple layers (Paragraph 0042) [Meets the range of 1 layer to about 12 layers].
Regarding claim 15 under any of the rejections for claim 1 above, wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in one of: a longitudinal configuration (Figures 2-3).
Regarding claim 35, Hotter discloses (Figures 2-3) a tissue connector (Figure 2), comprising: a body (100) formed of a layer of at least one material (Paragraph 0042); and at least one barbed suture (110) attached to the body (Figure 2) (Paragraph 0042) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 3) (Paragraph 0042), wherein the barbed suture is formed of a polymer (Paragraph 0032).
Regarding claim 36 under any of the rejections for claim 1 above, wherein the surface is configured to contact tissue during use (Paragraph 0041) [Fully configured in doing this].
Regarding claim 38 under the second rejection for claim 1, wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a net configuration (Figure 5).
Regarding claim 39 under the fourth rejection for claim 1, wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a spiral configuration (Figure 10).
Regarding claim 40 under the third rejection for claim 1, wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a serpentine configuration (Figure 9).
Regarding claim 41, wherein the at least one material and the at least one barbed suture are biodegradable (Paragraphs 0032, 0041 and 0052).
Regarding claim 42, wherein the biodegradable polymer is a polyester polymer (Paragraph 0032).
Regarding claim 43, wherein the barbed suture comprises a plurality of barbs and a main body (clearly shown in Figure 1), wherein the plurality of barbs and the main body are formed of the same material (Figure 1) (Paragraph 0032).
Regarding claim 46, wherein the body is a sheet (Figures 2-3).
Regarding claim 47, Hotter discloses (Figures 2-3) a tissue repair device (Figure 2), comprising: a body (100) formed of a layer of biodegradable material (coating as disclosed Paragraph 0052); and at least one barbed suture (110) attached to the body along a longitudinal axis of the body (Figure 2) (Paragraph 0042) so that at least a portion of the at least one barbed suture is exposed along a surface of the body (Figure 3) (Paragraph 0042), wherein the barbed suture is formed of a biodegradable polymer (Paragraph 0032).
Regarding claim 48, wherein the at least one barbed suture comprises a plurality of barbed sutures (clearly shown in Figures 2-3).
Regarding claim 49, wherein the barbed suture is formed of a biodegradable polymer (Paragraph 0032).
Regarding claim 50, wherein the biodegradable polymer is a polyester polymer (Paragraph 0032).
Regarding claim 55, wherein the surface is configured to contact tissue during use (Paragraph 0041) [Fully configured in doing this].
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 of this title, 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.
Claims 1-6, 8, 10, 35, 45, 47, 51, 52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Deister (US Pub No. 2021/0307753) in view of Stopek (US Pub No. 2010/0198257).
Regarding claim 1, Deister discloses (Figures 1-2) a tissue connector (Figure 1), comprising: a body (50) formed of a layer of at least one material (Paragraph 0044); and at least one suture (20) attached to the body so that at least a portion of the at least one suture is exposed along a surface of the body (along the inner surface of the body as shown in Figure 2).
Deister fails to disclose the suture being a barbed suture and wherein the suture is formed of a biodegradable material.
Stopek, in the analogous art of sutures used in surgery, teaches (Figure 2) a bi-directional suture (110) that is barbed (clearly shown in Figure 2) (Paragraph 0109) and is formed from a biodegradable material (Paragraphs 0029 and 0031-0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Deister to be barbed and be formed of a biodegradable material as taught by Stopek, in order to further secure the suture within tissue without requiring a surgeon to tie a knot, enable the placement of tension in tissue with less slippage of the suture in the tissue (Stopek, Paragraph 0004) and also, have the suture to be excretable or absorbable by the body to reduce risk of long-term complications and infection and promote natural tissue regeneration (Stopek, Paragraphs 0029 and 0031-0033).
Regarding claim 2, Deister modified by Stopek further discloses wherein the barbed suture is formed of a biodegradable polymer (Stopek, Paragraph 0033).
Regarding claim 3, Deister modified by Stopek further discloses wherein the biodegradable polymer includes a polyester polymer (Stopek, Paragraph 0031).
Regarding claims 4 and 5, Deister modified by Stopek further discloses wherein the barbed suture is formed of a biodegradable metal being magnesium (Stopek, Paragraph 0059).
Regarding claim 6, Deister modified by Stopek further discloses wherein the barbed suture comprises a plurality of barbs (Stopek, Figure 2) and a main body (Stopek, Figure 2), wherein the plurality of barbs and the main body are formed of the same material (Stopek, Figure 2) (Paragraph 0118).
Regarding claim 8, Deister modified by Stopek discloses the invention above, Deister further discloses wherein the body is a hollow tube (Paragraph 0048), and wherein the surface is an innermost surface of the hollow tube (clearly shown in Figures 1-2).
Regarding claim 10, Deister modified by Stopek discloses the invention above, Deister further discloses wherein the at least one material is small intestinal submucosa (SIS) (Paragraph 0044).
Regarding claim 35, Deister discloses (Figures 1-2) a tissue connector (Figure 1), comprising: a body (50) formed of a layer of at least one material (Paragraph 0044); and at least one suture (20) attached to the body so that at least a portion of the at least one suture is exposed along a surface of the body (along the inner surface of the body as shown in Figure 2).
Deister fails to disclose the suture being a barbed suture and wherein the suture is formed of a polymer.
Stopek, in the analogous art of sutures used in surgery, teaches (Figure 2) a bi-directional suture (110) that is barbed (clearly shown in Figure 2) (Paragraph 0109) and is formed from a biodegradable polymer (Paragraphs 0029 and 0031-0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Deister to be barbed and be formed of a biodegradable polymer as taught by Stopek, in order to further secure the suture within tissue without requiring a surgeon to tie a knot, enable the placement of tension in tissue with less slippage of the suture in the tissue (Stopek, Paragraph 0004) and also, have the suture to be excretable or absorbable by the body to reduce risk of long-term complications and infection and promote natural tissue regeneration (Stopek, Paragraphs 0029 and 0031-0033).
Regarding claim 45, Deister modified by Stopek discloses the invention above, Deister further discloses wherein the body is a hollow tube (Paragraph 0048), and wherein the surface is an innermost surface of the hollow tube (clearly shown in Figures 1-2).
Regarding claim 47, Deister discloses (Figures 1-2) a tissue repair device (Figure 1), comprising: a body (50) formed of a layer of a biodegradable material (Can be made of a biodegradable material as disclosed in Paragraph 0044); and at least one suture (20) attached to the body along a longitudinal axis of the body (Figure 1) so that at least a portion of the at least one suture is exposed along a surface of the body (along the inner surface of the body as shown in Figure 2).
Deister fails to disclose the suture being a barbed suture and wherein the suture is formed of a biodegradable polymer or metal.
Stopek, in the analogous art of sutures used in surgery, teaches (Figure 2) a bi-directional suture (110) that is barbed (clearly shown in Figure 2) (Paragraph 0109) and is formed from a biodegradable material that can be a polymer (Paragraphs 0029 and 0031-0033) or a metal (Paragraph 0059). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Deister to be barbed and be formed of a biodegradable polymer or metal as taught by Stopek, in order to further secure the suture within tissue without requiring a surgeon to tie a knot, enable the placement of tension in tissue with less slippage of the suture in the tissue (Stopek, Paragraph 0004) and also, have the suture to be excretable or absorbable by the body to reduce risk of long-term complications and infection and promote natural tissue regeneration (Stopek, Paragraphs 0029 and 0031-0033).
Regarding claim 51, Deister modified by Stopek further discloses wherein the barbed suture is formed of a biodegradable metal being magnesium (Stopek, Paragraph 0059).
Regarding claim 52, Deister modified by Stopek discloses the invention above, Deister further discloses wherein the body is formed of small intestinal submucosa (SIS) (Paragraph 0044).
Regarding claim 54, Deister modified by Stopek discloses the invention above, Deister further discloses wherein the body is a hollow tube (Paragraph 0048), and wherein the surface is an innermost surface of the hollow tube (clearly shown in Figures 1-2).
Claims 7 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Deister (US Pub No. 2021/0307753) in view of Stopek (US Pub No. 2010/0198257) as applied to claims 1 and 35 above, and further in view of Bishop (US Pub No. 2008/0082113).
Regarding claims 7 and 44, Deister modified by Stopek discloses the invention above including wherein the barbed suture comprises a plurality of barbs and a main body (clearly shown in Figure 2 of Stopek) but fails to disclose wherein the plurality of barbs and the main body are formed of different materials.
Bishop, in the analogous art of sutures used in surgery, teaches (Figure 1) a suture (10) where the plurality of barbs (20) and the main body (30) are formed of different materials (Paragraph 0103). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Deister modified by Stopek to have the plurality of barbs and the main body to be formed of different materials as taught by Bishop since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 53 is rejected under 35 U.S.C. 103 as being unpatentable over Deister (US Pub No. 2021/0307753) in view of Stopek (US Pub No. 2010/0198257) as applied to claim 47 above, and further in view of Kim (US Pub No. 2020/0046357).
Regarding claim 53, Deister modified by Stopek discloses the invention above except for wherein the body is formed of one or more of polyglycolide, polylactide, poly-caprolactone (PCL), polydioxanone (PDO or PDS), polypropylene, or a polyester polymer.
Kim, in the analogous art of implants in surgery, teaches (Figure 1) an implant (100) formed from a biodegradable polymer being polyglycolide (Paragraph 0049). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of Deister modified by Stopek to be formed from a biodegradable polymer being polyglycolide as taught by Kim since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 1, 12-13, 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Dann (US Pub No. 2007/0198074) in view of Stopek (US Pub No. 2010/0198257).
Regarding claim 1, Dann discloses (Figures 1-3) a tissue connector (134), comprising: a body (102) formed of one or more layers of at least one material (Figure 2); and at least one suture (144) attached to the body so that at least a portion of the at least one suture is exposed along a surface of the body (along the inner surface of the body as shown in Figure 2).
Dann fails to disclose the suture being a barbed suture and wherein the suture is formed of a biodegradable material.
Stopek, in the analogous art of sutures used in surgery, teaches (Figure 2) a bi-directional suture (110) that is barbed (clearly shown in Figure 2) (Paragraph 0109) and is formed from a biodegradable material (Paragraphs 0029 and 0031-0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Dann to be barbed and be formed of a biodegradable material as taught by Stopek, in order to enable the placement of tension in tissue with less slippage of the suture in the tissue (Stopek, Paragraph 0004) and also, have the suture to be excretable or absorbable by the body to reduce risk of long-term complications and infection and promote natural tissue regeneration (Stopek, Paragraphs 0029 and 0031-0033).
Regarding claim 12, Dann modified by Stopek further discloses wherein the one or more layers includes two layers (see annotated figure below), and wherein the at least one barbed suture is sewn within or between layers, of the two layers (clearly shown in Figure 2 of Dann), so that portions of the at least one barbed suture are entrapped within or between the two or more layers (clearly shown in Figure 2 of Dann).
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Regarding claim 13, Dann modified by Stopek further discloses wherein the body is a hollow tube (clearly shown in Figure 2 of Dann), the one or more layers includes two layers (see annotated figure above), and the at least one barbed suture is sewn into the body with portions of the at least one barbed suture being exposed on an innermost surface of the hollow tube (clearly shown in Figure 2 of Dann), and alternating portions of the at least one barbed suture being buried within the two or more layers (clearly shown in Figure 2 of Dann).
Regarding claim 35, Dann discloses (Figures 1-3) a tissue connector (134), comprising: a body (102) formed of one or more layers of at least one material (Figure 2); and at least one suture (144) attached to the body so that at least a portion of the at least one suture is exposed along a surface of the body (along the inner surface of the body as shown in Figure 2).
Dann fails to disclose the suture being a barbed suture and wherein the suture is formed of a polymer.
Stopek, in the analogous art of sutures used in surgery, teaches (Figure 2) a bi-directional suture (110) that is barbed (clearly shown in Figure 2) (Paragraph 0109) and is formed from a biodegradable polymer (Paragraphs 0029 and 0031-0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Dann to be barbed and be formed of a biodegradable polymer as taught by Stopek, in order to enable the placement of tension in tissue with less slippage of the suture in the tissue (Stopek, Paragraph 0004) and also, have the suture to be excretable or absorbable by the body to reduce risk of long-term complications and infection and promote natural tissue regeneration (Stopek, Paragraphs 0029 and 0031-0033).
Regarding claim 37, Dann modified by Stopek further discloses wherein the at least one barbed suture is oriented, relative to the body of the tissue connector, in a circumferential configuration (clearly shown in Figure 2 of Dann).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (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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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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