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
Claims filed on November 17th, 2025 have been entered. Claims 1-4, 6-8, 11, 13- 17, and 19 are pending in the application.
Claim Objections
Claims 1-4, 6-8, 11, 13-17, and 19 are objected to because of the following informalities:
Claim 1, Lines 4-5 states “is barbed or knotless suture”, it is suggested to change this to “is barbed or knotless”.
Claim 2-4, 6- 8, 11, 13- 17, and 19 are objected to for being dependent on or from objected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-2, 7-8, and 13 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claim 3 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Golden et al. (US 4,890,613) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claims 4, 6, 16 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Erneta et al. (CA 2874481) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claim 11 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Gurtner et al. (CA 2735173) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claim 14 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of ‘715 (CN 105288715 English Machine Translation) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claim 15 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Li et al. (CN 108904869) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
The rejection of claims 17 and 19 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Martin et al. (US 2003/0167071) and in further view of Montpetit et al. (US 2005/0250977) has been withdrawn in light of applicant’s amendments; specifically Goldberg does not teach wherein the suture is barbed or knotless.
Examiner’s Note: For purposes of examination, the limitation “free form” recited in claim 1, line 6 is interpreted in view of, applicant’s disclosure, see Paragraph 0045 and Fig. 1A as unattached, not braided, or not wound. The limitation “beneficial filament” is understood as a filament having a medicant as this is commensurate in scope with the claims and disclosure.
Claim(s) 1-2, 7- 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702), and in view of Gross et al. (US 2013/0317545).
Regarding claims 1 and 2, Goldberg teaches a suturing system (Fig. 5) comprising: a needle (36), a metal suture (filament 40)(Column 3, Lines 54- 56), a pliable filament (42, note that a filament is defined as a single thread and thus encompasses a monofilament)(Column 3, Lines 51- 53) with a lower mechanical strength than the suture (Since Goldberg teaches that the filament is soft and pliable, it would be obvious that it would have a lower mechanical strength than the suture, which is taught by Goldberg to be made of metal (Column 3, Lines 50- 53).), wherein the suture has a connecting end attached to the needle and an opposing free end, and wherein the monofilament is attached to the needle and positioned in a free form and unattached alongside said suture anywhere besides attachment at the connecting end (see annotated Fig. 5 below)(Column 3, Lines 45- 48). Goldberg further teaches wherein the beneficial filament is fixed in an opening in said needle together with the suture (Column 3, Lines 48- 52 and 61- 64, see Fig. 5).
Regarding wherein the suture is non-absorbable, Goldberg teaches that the suture (40) is a metallic filament, specifically stainless steel (Column 3, Lines 70- 71). It is well-known in the art that metals, such as stainless steel are non-absorbable.
Regarding wherein the monofilament is absorbable, Goldberg teaches that the monofilament (42) is an animal or synthetic filament, such as a gut filament (Column 2, Lines 35- 37). Gut filament is known in the art to be absorbable by the body.
Regarding the filament (42) having a smaller cross-sectional area than the suture, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to have the beneficial filament have a smaller cross-sectional area than the suture. Goldberg discloses that both the suture and beneficial filament (40,42) have a diameter of one-thousandth to four-thousandths of an inch (Column 3 lines 14-16). Therefore, it would have been obvious to one of ordinary skill in the art to have the beneficial filament have a diameter in the smaller part of the range and have the suture in the higher part of the range given by Goldberg because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp” and Goldberg does not state that the suture and beneficial filament have to be the same size. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
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Goldberg does not teach wherein the elongated flexible suture is made of a biocompatible polymeric material, wherein the filament is a beneficial filament having a medicant or wherein the suture is barbed or knotless.
Regarding the elongated flexible suture as made of a biocompatible polymeric material, Dolphin Sutures teaches a polymer suture that is made of polyester which has a high tensile strength and has elasticity (Page 2). As Dolphin Sutures teaches that the suture are used in “cardiovascular surgeries, General Closure, Orthopedics” (Page 2), the suture is therefore biocompatible.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of suture as taught by Goldberg to be the polyester as taught by Dolphin Sutures, since Dolphin Sutures teaches that polyester is flexible and possesses a high tensile strength , and Goldberg teaches that the material for the suture is required to be hard and flexible. Furthermore, it would have been obvious to modify the material of the suture since Dolphin Sutures teaches that polyester is known to be used within surgical operations (Page 2).
Regarding the filament as a beneficial filament having a medicant, Goransson (Goransson et al.) teaches a suturing system (Page 1, Lines 4-5)(Figs. 3)(abstract), comprising: a needle (Page 1, Lines 4-5),an elongated flexible suture (element 1)(Page 3, Lines 7- 11) attached to the needle (Page 5, Lines 1- 3) and an opposing free end (On Page 5, Lines 4-6, Goransson teaches that the surgical device comprises two needles, with one needle attached at each end of the surgical thread. Since this current embodiment of Goransson teaches only one needle, the other end of the suture is therefore a free end.); and at least one elongated external beneficial filament (connecting thread 4) that is attached to said needle (Goransson teaches that the thread, of which the connecting thread is taught to be a part of (Page 6, Lines 19- 25), is attached to the needle (Page 5, Lines 1-3), therefore the external beneficial filament is attached to the needle.) and wherein said beneficial filament has a medicant (Page 4, Lines 16- 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the monofilament as taught by the combination of Goldberg and Dolphin Sutures to have a medicant as taught by Goransson, to provide a medicant to a treatment location (Page 4, Lines 16- 18) while the beneficial filament degrades.
The combination of Goldberg, Dolphin Sutures, and Goransson do not teach wherein the suture is barbed or knotless.
Gross (Gross et al.) teaches a suturing system (100)(abstract)(Fig. 1A- 1B) with a needle (110) and a suture (102) with barbs (retainers 130)(Paragraph 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the suture as taught by the combination to be barbed as taught by Gross, since Gross teaches that self-retaining sutures, or sutures with barbs, are superior over plain sutures and prevent slippage over operating (Paragraph 0007).
Regarding claim 7, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
Goldberg, Dolphin Sutures, Goransson, and Gross do not teach wherein said beneficial filament is shorter than said suture.
However, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the beneficial filament to be shorter than the suture, as one of ordinary skill of the art has three options, that of the beneficial filament being shorter than the suture, being the same length as the suture, or being longer than the suture. Thus, the beneficial filament being shorter than the suture would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 8, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
Regarding wherein said suture comprises an indent configured to accept at least a portion of said beneficial filament, Goldberg teaches a surgical noose within the suture which forms an indent which accepts a portion of the beneficial filament (see annotated Fig. 5 below).
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Regarding claim 13, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant and a suture made of a biocompatible polymeric material, as discussed above for claim 1.
Regarding wherein said suturing system has a breaking strength retention (BSR) that is substantially the same as BSR of said suture without the beneficial filament 1-week post- installation, since the combination teaches that the beneficial filament (Goldberg, 42) is soft and pliable, and therefore has weak mechanical properties (Goldberg, Column 3, Line 52) while the suture of the combination is a biocompatible polymer that has a high tensile strength (Dolphin Sutures, Page 2) and therefore able to protect the beneficial filament, it would be obvious to one of ordinary skill that the BSR of the suturing system is substantially the same BSR of the suture without the beneficial filament 1 week post- installation since the beneficial filament would not greatly contribute to the BSR of the suturing system due to its properties.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702), and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of Golden et al. (US 4,890,613).
Regarding claim 3, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
Goldberg teaches wherein the monofilament (filament 42) is absorbable after installation into a tissue of a mammal (As discussed above, Goldberg teaches that the filament can be made of a gut filament (Column 2, Lines 35- 37), and gut filament is known in the art to be absorbable.).
The combination of Goldberg, Dolphin Sutures, Goransson, and Gross do not teach wherein the suture is absorbable.
Golden (Golden et al.) teaches that a biologically acceptable material for a suture that is able to rigid and therefore hard can be an absorbable polymer (Column 5, Line 62- Column 6, Line 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of suture as taught by the combination to be an absorbable polymer as taught by Golden, since the polymer is rigid and therefore hard (Column 6, Lines 5- 11), and Goldberg teaches that the material for the suture is required to be hard and flexible. Furthermore, it would have been obvious to modify the material of the suture since Golden teaches that the absorbable polymer is biologically acceptable and is known to be used as a suture material (Column 5, Lines 62- 65 and Column 6, Lines 1-3).
Claim(s) 4, 6, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702), and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of Erneta et al. (CA 2874481).
Regarding claim 4, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination of Goldberg, Dolphin Sutures, Goransson, and Gross do not make obvious wherein the beneficial filament contains at least 20% by weight of the medicant.
Erneta (Erneta et al.) teaches an absorbable polymer blend (abstract) for a suture (Page 5, Lines 20-23) that has a medicant (Page 17, Lines 7- 10), wherein the suture contains at least 20% by weight of the medicant (Page 17, Lines 11- 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the beneficial filament and the medicant of the combination to have the beneficial filament contain at least 20% by weight of the medicant, since Erneta teaches that the medicant is present in a sufficient amount to “effectively provide for the desired effects or characteristics” (Page 17, Lines 11- 12).
Regarding claim 6, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination of Goldberg, Dolphin Sutures, Goransson, and Gross do not make obvious wherein said suture is a braided filament construct.
Erneta (Erneta et al.) teaches an absorbable polymer blend (abstract) for a suture (Page 5, Lines 20-23) that has a medicant (Page 17, Lines 7- 10), wherein a bioabsorbable suture is a braided filament construct (Page 32, Lines 5- 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the suture as taught by the combination to be a braided filament construct as taught by Erneta, because both sutures are disclosed as equivalent structures for suturing tissue (Goldberg, Column 1, Lines 9-12; Erneta, Page 2, Lines 6- 17) and to substitute one known equivalent for another would have been obvious to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 16, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination of Goldberg, Dolphin Sutures, Goransson, and Gross is silent to the medicant comprising chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof.
Erneta teaches an absorbable polymer blend (abstract) for a suture (Page 5, Lines 20-23) that has a medicant (Page 17, Lines 7- 10), wherein the medicant is triclosan (Page 17, Lines 16- 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the medicant of the combination be triclosan as taught by Erneta, since Goransson teaches that the medicant can be “additives and/or bioactive additives, such as drugs” and Erneta teaches that triclosan is an antimicrobial agent (Page 17, Lines 16- 19) and is an additive, as it is taught by Erneta to be added to the polymer blend (Page 17, Lines 7-10).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine) in view of Goransson et al. (WO 2006/024702) and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of Gurtner et al. (CA 2735173).
Regarding claim 11, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination of Goldberg, Dolphin Sutures, Goransson, and Gross does not teach wherein said beneficial filament is swellable in the cross- section after installation into a tissue of a mammal by at least 25% within 60 minutes.
Gurtner (Gurtner et al.) teaches a suture (Page 1, Line 5) for use in surgery that has a therapeutic agent (Page 6, Lines 32- 33) and that is swellable in the cross-section after installation into a tissue of a mammal by at least 25% (Page 8, Lines 33- 34) within 60 minutes (On Page 8, Lines 33- 34, Gurtner teaches that the cross-sectional area of the thread fully hydrated swells between 0% to 10,000%, since 25% is within that range, it is therefore taught by Gurtner. Gurtner then teaches on Page 9, Lines 10- 11, that full hydration occurs in between 1 second to 24 hours, and 60 minutes is within that range. Therefore, Gurtner teaches that the suture swells in the cross- section after installation by at least 25% within 60 minutes.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of the beneficial filament of the combination to be the material and therefore have the properties of the material as taught by Gurtner, since Gurtner teaches that a hyaluronic acid, of which the suture is made of, is “highly biocompatible” (Page 1, Lines 7- 14).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702) and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of ‘715 (CN 105288715 English Machine Translation).
Regarding claim 14, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant and a suture made of a biocompatible polymeric material, as discussed above for claim 1.
The combination does not teach wherein said beneficial filament is configured to fully dissolve or fully resorb within about 168 hours after installation into a tissue or a tissue model.
‘715 teaches that it is well known within the art that certain gut filaments used as sutures can be fully absorbed within the range of 6 to 20 days (Paragraph 0002).
As Goldberg teaches that the beneficial filament can be made of gut, and ‘715 teaches that certain gut filaments can be fully absorbed within 6 to 7 days and therefore within about 168 hours after installation, it would have been obvious to one of ordinary skill in the art to modify the beneficial filament to be a gut filament that absorbs within 6 to 7 days.
Alternatively, ‘715 sets forth that the time to fully absorb a suture is a result effective variable, wherein the time depends upon “the thickness of the gut and the condition of the tissue” (Paragraph 0002). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the time to fully absorb the beneficial filament of the combination to be within about 168 hours, for the purpose of treating tissue trauma, 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. (MPEP 2144.05)(In re Aller, 105 USPQ 233).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702) and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of Li et al. (CN 108904869 English Machine Translation).
Regarding claim 15, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant and a suture made of a biocompatible polymeric material, as discussed above for claim 1.
The combination does not teach wherein said beneficial filament is configured to release at least 10% of the medicant within 24 hours after installation into a tissue or a tissue model.
Li (Li et al.) teaches a beneficial filament for being placed within tissue that is configured to release at least 10% of the medicant within 24 hours after installation into a tissue (see annotated Fig. 3 below)(Paragraphs 0034 and 0066).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the beneficial filament to be configured to release at least 10% of the medicant within 24 hours after installation as taught by Li, since Goldberg teaches that the beneficial filament can be silk (Column 3, Lines 48- 53) and Li teaches that the beneficial filament has silk (Paragraphs 0034 and 0066) and as Goldberg and Li both teach beneficial filaments for insertion into a patient (Goldberg, abstract; Li, Paragraph 0034).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), in view of Goransson et al. (WO 2006/024702) and in view of Gross et al. (US 2013/0317545), as applied to claim 1 above, in further view of Martin et al. (U.S. 2003/0167071) and in further view of Montpetit et al. (US 2005/0250977).
Regarding claim 17, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination is silent to wherein the beneficial filament is sterilized separately and differently from said suture and said needle.
Martin (Martin et al.) teaches a kit (700)(Fig. 25) containing a loading tool (200), two separate suture strands (104, 106), and that the kit can have a needle (Paragraph 0074). Martin further teaches wherein the needle and both sutures are sterilized separately (In Paragraph 0074, Martin teaches that the components are sterilized and maintained within the kit, and that the kit can comprises separate pouches or packaging. Therefore, it would be obvious to one of ordinary skill in the art that the components can be sterilized separately.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device to have the beneficial filament, needle, and suture as taught by the combination to be sterilized separately but in the same manner as taught by Martin, in order to “separately maintain the components in a sterile fashion” (Paragraph 0074).
The combination does not teach wherein the beneficial filament is sterilized differently from the suture and the needle.
Montpetit (Montpetit et al.) teaches a kit that contains separate packaging according to what sterilization is required for the individual element (Paragraph 0082).
As the beneficial filament, the suture, and the needle of the combination are taught to be made of different materials (Goldberg, beneficial filament (42)(Column 3, Lines 51- 53) and needle (36); and Golden (Column 5, Line 62- Column 6, Line 3)), it would be obvious to one of ordinary skill in the art to sterilize each element separately and package them separately, as Montpetit teaches that different elements have different sterilization requirements (Paragraph 0082).
Regarding claim 19, Goldberg, Dolphin Sutures, Goransson, and Gross make obvious the device with a beneficial filament with a medicant, as discussed above for claim 1.
The combination is silent to a kit for assembling the suturing system of claim 1 comprising: the elongated flexible suture attached to the needle, separate from the suture and needle, at least one elongated external beneficial filament, configured for attaching to said needle or to said suture at the connecting end, said external beneficial filament subjected to a sterilization treatment separately from said suture attached to the needle and by a different sterilization technique.
Martin (Martin et al.) teaches a kit (700)(Fig. 25) containing a loading tool (200), two separate suture strands (104, 106), and that the kit can have a needle (Paragraph 0074). Martin further teaches wherein the needle and both sutures are sterilized separately (In Paragraph 0074, Martin teaches that the components are sterilized and maintained within the kit, and that the kit can comprises separate pouches or packaging. Therefore, it would be obvious to one of ordinary skill in the art that the components can be sterilized separately.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination to have a kit as taught by Martin and to have the beneficial filament, needle, and suture as taught by Goldberg be sterilized separately but in the same manner as taught by Martin, in order to “separately maintain the components in a sterile fashion” (Paragraph 0074).
The combination does not teach wherein the beneficial filament is sterilized differently from the suture and the needle.
Montpetit (Montpetit et al.) teaches a kit that contains separate packaging according to what sterilization is required for the individual element (Paragraph 0082).
As the beneficial filament, the suture, and the needle of the combination are taught to be made of different materials (Goldberg, beneficial filament (42)(Column 3, Lines 51- 53) and needle (36); and Golden (Column 5, Line 62- Column 6, Line 3)), it would be obvious to one of ordinary skill in the art to sterilize each element separately and package them separately, as Montpetit teaches that different elements have different sterilization requirements (Paragraph 0082).
Response to Arguments
Applicant's arguments filed November 17th, 2025, regarding the rejection of claims 1-2, 7-8, and 13 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702), claim 3 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Golden et al. (US 4,890,613), claims 4, 6, 16 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Erneta et al. (CA 2874481), claim 11 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Gurtner et al. (CA 2735173), claim 14 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of ‘715 (CN 105288715 English Machine Translation), claim 15 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Li et al. (CN 108904869), and claims 17 and 19 under 35 U.S.C. 103 over Goldberg (U.S. 2,591,063) in view of Dolphin Sutures (pages 1-2 http://www.dolphinsutures.com/resources/information-on-polyester, Date November 29, 2018 obtained from Wayback Machine), and in view of Goransson et al. (WO 2006/024702) in further view of Martin et al. (US 2003/0167071) and in further view of Montpetit et al. (US 2005/0250977) have been fully considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments.
Applicant’s arguments, see Page 6, regarding that there is no motivation to modify the teachings in Goldberg is not persuasive, as discussed above Gross (US 2013/0317545) teaches that self-retaining sutures, or sutures with barbs, are superior over plain sutures and prevent slippage over operating (Paragraph 0007).
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 LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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/L.R.R./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771