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
The claims filed on June 15th, 2026, have been entered. Claims 1-3, 5-12, 18-20, and 22-26 remain pending in the Application. Claims 24-26 have been added by the Applicant.
Response to Arguments
Applicant's arguments filed June 15th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that Lane et al. (Pub. No. 2020/0375590) does not disclose the limitation “the polymer of the absorbable polymeric substrate comprises a copolymer made from…[polydioxanone]; and the at least one adsorbable coating polymer comprises polycaprolactone” because the citation in Lane et al. [0049] provides nine possible materials for the substrate and eleven possible materials for the coating polymer, and it is not enough to establish obviousness by simply showing that a reference discloses each element of a claim, and it is important to identify a reason that would have prompted one of ordinary skill in the art to combine the elements in the manner set forth in the claim. Examiner respectfully disagrees. First, Lane et al. is used to establish lack of novelty for this limitation, not obviousness, and the modification by Olson et al. (Pub. No. 2012/0029561) was just to the separate claim limitation regarding the colorant miscible with the coating polymer. The citations provided by the Applicant all concern the combination of elements from multiple different prior art references. Second, Lane et al. specifically states that an “absorbable” polydioxanone can be coated with a “hydrophilic” polycaprolactone in describing specific combinations of materials for use as sutures ([0049]), which are reasons why one of ordinary skill in the art would be motivated to use them, both independently and together.
Second, Applicant argues that Kim et al. (Pub. No. 2015/0273084) does not disclose the colorant is an ion-exchanged dye or pigment because [0065-0067] states that the sodium stearate was not dissolved in the solvent. Examiner respectfully disagrees. The claim language does not require the full dissolution of sodium stearate into the solvent, and only requires the colorant to be an ion-exchanged dye or pigment having an organic alkanoate exchanged for a dye counteranion. As noted, the present Specification Page 5, lines 6-18, discloses that this process causes the methylene blue to be an ion-exchanged dye or pigment having an organic alkanoate exchanged for a dye counteranion; therefore, the disclosure of the same process using the same materials in Kim et al. satisfies the limitation as claimed.
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.
Claim(s) 1-3, 5-6, 8, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al. (Pub. No. 2020/0375590) in view of Olson (Pub. No. 2012/0029561).
Regarding claim 1, Lane et al. discloses an absorbable suture (220; [0049]) comprising: an absorbable polymeric substrate ([0049] 220 can be comprised of a single strand or braided strands of absorbable polydioxanone), wherein the absorbable polymeric substrate is a monofilament ([0049] 220 can be a single strand) or a multifilament ([0049] 220 can be a braid of multiple strands); and an absorbable composition ([0049] 220 can be coated) disposed on at least a portion of a surface of the absorbable polymeric substrate ([0049] a coating on 220 will cover at least a portion of 220), wherein the absorbable composition comprises at least one absorbable coating polymer ([0049] the coating on 220 can be made of polycaprolactone, which is an absorbable polymer) distinct from the absorbable polymeric substrate ([0049] polydioxanone and polycaprolactone are different polymers), wherein the at least one absorbable coating polymer degrades faster than the absorbable polymeric substrate in vivo (this is a property which is defined by the selections made in the flowing lists in the claims; therefore, since the polymers selected are disclosed in the present Spec as having these properties, the claim language is satisfied); the polymer of the absorbable polymeric substrate comprises poly(p-dioxanone) ([0049] 220 can be made of polydioxanone); and the at least one absorbable coating polymer comprises polycaprolactone ([0049] 220 can be made of polycaprolactone).
Lane et al. does not disclose the absorbable composition further comprises a colorant that is miscible with the at least one absorbable coating polymer.
Olson teaches in the same field of endeavor of absorbable sutures (Abstract), and discloses a suture which has an absorbable composition ([0030]) comprising at least one absorbable coating polymer ([0030] polycaprolactone) and a colorant that is miscible with the at least one absorbable coating polymer ([0030] the coating can be mixed with a concentration of a colorant) for the purpose of improving recognition of suture ends in surgery and providing a means for color coding or marking ([0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the absorbable composition of Lane et al. to include a colorant, as taught by Olson, for the purpose of improving recognition of suture ends in surgery and providing a means for color coding or marking.
Regarding claim 2, Lane et al. as modified by Olson further discloses the suture is initially colored (Olson [0030] the coating has the colorant, and the suture of Lane et al. will therefore be initially colored) and then transitions to translucent within 1 hour to 28 days after in vivo use in a medical procedure on a subject (this is a property which is defined by the selections made in the flowing lists in the claims; therefore, since the polymers selected are disclosed in the present Spec as having these properties, the claim language is satisfied).
Regarding claim 3, Lane et al. as modified by Olson further discloses the absorbable composition forms a layer on at least the portion of the surface of the absorbable polymeric substrate (Lane et al. [0049] the coating is on a portion or all of the surface of the suture).
Regarding claim 5, Lane et al. as modified by Olson further discloses the monofilament or the multifilament has an outer surface (Lane et al. FIG. 1A: 220 has an outer surface), wherein the absorbable composition is disposed only on the outer surface (Lane et al. [0049] the coating is only applied to the outer surface of the suture).
Regarding claim 6, Lane et al. as modified by Olson further discloses the absorbable composition coats all of the outer surface (Lane et al. [0049] the coating can cover the entire outer surface of the suture).
Regarding claim 8, Lane et al. as modified by Olson further discloses the colorant is D&C Violet No. 2, D&C Green No. 6, or D&C Blue No. 6 (Olson [0030]).
Regarding claim 18, Lane et al. as modified by Olson further discloses a method comprising: applying the suture of claim 1 to a subject wherein the suture is colored at the time of applying but then transitions to translucent within 1 hour to 28 days after the time of applying (this is a property which is defined by the selections made in the flowing lists in the claims; therefore, since the polymers selected are disclosed in the present Spec as having these properties, the claim language is satisfied).
Regarding claim 19, Lane et al. as modified by Olson further discloses the at least one absorbable coating polymer comprises polycaprolactone (Lane et al. [0049]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al. in view of Olson, and in further view of Franco (Pub. No. 2005/0165428).
Regarding claim 7, Lane et al. as modified by Olson discloses the invention as claimed in claim 1, as discussed above. Lane et al. does not disclose the absorbable composition forms a layer of 1 nm to 2 mm thickness on the surface of the substrate.
Franco teaches in the same field of endeavor of bioabsorbable sutures (Abstract), and discloses an absorbable composition ([0014]) which forms a layer of 1 nm to 2 mm thickness on the surface of the substrate ([0014] typical coatings, including with colorants, range from 0.1 to 1200 µm, or 100 nm to 1.2 mm) for the purpose of modifying the hydrophilicity and dissolution rate of the suture ([0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the absorbable composition of Lane et al. as modified by Olson to form a layer of 1 nm to 2 mm thickness on the surface of the substrate, as taught by Franco, for the purpose of modifying the hydrophilicity and dissolution rate of the suture.
Claim(s) 9-11 and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al. in view of Olson, and in further view of Kim et al. (Pub. No. 2015/0273084).
Regarding claims 9, 25, and 26, Lane et al. as modified by Olson discloses the invention as claimed in claims 1, 3, and 18, respectively, as discussed above. Olson does not disclose the colorant is an ion-exchanged dye or pigment.
Kim et al. teaches in the same field of endeavor of coloring medical implants (Abstract) and discloses a colorant which is an ion-exchanged dye or pigment ([0065-0067] methylene blue and sodium stearate are prepared by being completely dissolved in solvent; the present Specification, page 5, lines 6-18, discloses that this process prepares the methylene blue to be an ion-exchanged dye or pigment) for the purpose of increasing the hydrophobic properties of the polymer coating (Kim et al. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the colorant of Olson as added to Lane et al. to be an ion-exchanged dye or pigment, as taught by Kim et al., for the purpose of increasing the hydrophobic properties of the polymer coating.
Regarding claims 10 and 24, Lane et al. as modified by Olson discloses the invention as claimed in claims 1 and 2, respectively, as discussed above. Olson does not disclose the colorant is an ion-exchanged dye having an organic alkanoate exchanged for a dye counteranion.
Kim et al. teaches in the same field of endeavor of coloring medical implants (Abstract) and discloses a colorant which is an ion-exchanged dye having an organic alkanoate exchanged for a dye counteranion ([0065-0067] methylene blue and sodium stearate are prepared by being completely dissolved in solvent; the present Specification, page 5, lines 6-18, discloses that this process prepares the methylene blue to be an ion-exchanged dye having an organic alkanoate exchanged for a dye counteranion, and provides stearate as an example organic alkanoate) for the purpose of increasing the hydrophobic properties of the polymer coating ([0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the colorant of Olson as added to Lane et al. to be an ion-exchanged dye having an organic alkanoate exchanged for a dye counteranion, as taught by Kim et al., for the purpose of increasing the hydrophobic properties of the polymer coating.
Regarding claim 11, Lane et al. as modified by Olson discloses the invention as claimed in claim 1, as discussed above. Olson does not disclose the colorant is an ion-exchanged dye having a quaternary phosphonium or ammonium exchanged for a dye counteranion.
Kim et al. teaches in the same field of endeavor of coloring medical implants (Abstract) and discloses a colorant which is an ion-exchanged dye ([0065-0067] methylene blue and sodium stearate are prepared by being completely dissolved in solvent; the present Specification, page 5, lines 6-18, discloses that this process prepares the methylene blue to be an ion-exchanged dye having an organic alkanoate exchanged for a dye counteranion, and provides stearate as an example organic alkanoate) having a quaternary phosphonium or ammonium exchanged for a dye counteranion ([0021] a quaternary ammonium salt can be used in the exchange in place of the sodium stearate) for the purpose of increasing the hydrophobic properties of the polymer coating ([0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the colorant of Olson as added to Lane et al. to be an ion-exchanged dye having a quaternary phosphonium or ammonium exchanged for a dye counteranion, as taught by Kim et al., for the purpose of increasing the hydrophobic properties of the polymer coating.
Regarding claim 22, Lane et al. as modified by Olson and Kim et al. further discloses the alkanoate is stearate (Kim et al. [0066] sodium stearate is used).
Regarding claim 23, Lane et al. as modified by Olson discloses the invention as claimed in claim 2, as discussed above. Olson does not disclose the colorant is an ion-exchanged dye or pigment.
Kim et al. teaches in the same field of endeavor of coloring medical implants (Abstract) and discloses a colorant which is an ion-exchanged dye or pigment ([0065-0067] methylene blue and sodium stearate are prepared by being completely dissolved in solvent; the present Specification, page 5, lines 6-18, discloses that this process prepares the methylene blue to be an ion-exchanged dye or pigment) for the purpose of increasing the hydrophobic properties of the polymer coating ([0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the colorant of Olson as added to Lane et al. to be an ion-exchanged dye or pigment, as taught by Kim et al., for the purpose of increasing the hydrophobic properties of the polymer coating.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al. in view of Olson, and in further view of Day et al. (Pub. No. 2015/0037774).
Regarding claim 12, Lane et al. as modified by Olson discloses the invention as claimed in claim 1, as discussed above. Olson does not disclose the colorant is an ion-exchanged dye having a polyethylene oxide chain exchanged for a dye counteranion.
Day et al. teaches in the same field of endeavor of coloring medical implants (Abstract) and discloses a colorant which is an ion-exchanged dye having a polyethylene oxide chain exchanged for a dye counteranion ([0047] polyethylene oxide chains are added to hydrophobic groups, such as the colorants in Olson [0030] and the coating in Lane et al. [0049]) for the purpose of preventing clumping of the colorant in the polymer coating ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the colorant of Olson as added to Lane et al. to be an ion-exchanged dye having a polyethylene oxide chain exchanged for a dye counteranion, as taught by Day et al., for the purpose of preventing clumping of the colorant in the polymer coating.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al. in view of Olson, and in further view of Mathiowitz et al. (U.S. Patent No. 6,217,908).
Regarding claim 20, Lane et al. as modified by Olson discloses the invention as claimed in claim 1, as discussed above. Lane et al. does not disclose the at least one absorbable coating polymer comprises poly(sebacic anhydride).
Mathiowitz et al. teaches in the same field of endeavor of coated sutures, and discloses coating materials in poly(sebacic anhydride) (C20:L20-32) for the purpose of increasing adhesive bonding (C20:L20-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the at least one absorbable coating polymer of Lane et al. to be poly(sebacic anhydride), as taught by Mathiowitz et al., for the purpose of increasing adhesive bonding.
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.
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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