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 .
Prosecution Reopened
In view of the appeal brief filed on December 8th, 2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed December 8th, 2025, with respect to the rejection(s) of claim(s) 1-3, 5-12, 18-20, and 22-23 under 102(a)(1) and 103 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 Therefore, the rejection has been withdrawn.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 in view of Lane et al. (Pub. No. 2020/0375590) in view of Olson (Pub. No. 2012/0029561).
The rejection of claims 1-3, 5-12, 18-20, and 22-23 under 102(a)(1) and 103 over McDaniel et al. (Pub. No. 2012/0097194) has been withdrawn in light of Applicant’s arguments made in the Appeal Brief filed on December 8th, 2025; Applicant argued that McDaniel et al. (Pub. No. 2012/0097194) did not disclose a combination of a polycaprolactone coating and a colorant on a polyglactin suture because while McDaniel et al. may have disclosed all three of those elements, McDaniel et al. did not disclose or suggest that the three elements should be combined together in one medical device. Upon further review of McDaniel et al., Examiner agrees with these arguments.
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 22-23 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 claim 9, 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 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 claim 10, 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 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
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771