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 amendments filed on 11/25/2025 have been entered. Claims 2, 4-6, 8-10, 12-17, 23-25, 27-31 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 11/25/2025, with respect to the rejection(s) of claim(s) 2 under 35 USC 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 Therefore, the rejection has been withdrawn.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 Cuevas et al. (US 2009/0099532) in view of Stopek et al. (US 2010/0116694).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 4-6, 10, 15-17, 23-24, and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas et al. (US 2009/0099532) in view of Stopek et al. (US 2010/0116694, hereinafter “Stopek 694”).
Regarding claim 2, Cuevas et al. discloses a system (FIG 1A-1B, [0020-0030]), comprising: elongated flexible medical device (10, [0020]]) having a proximal section (40) and a distal section (30), said medical device co-packaged in a unified package (20) with a wicking medicant transfer sponge (150, FIG 1B, [0022-0023] disclose the distribution media 150 can be a sponge and that the sponge is capable of wicking. “The distribution media may then act as a squeegee. i.e. in the case of a sponge, for transporting liquids to a portion of the medical device”) and a frangible container containing a liquid (160, FIG 1B, [0022]), wherein the frangible container with said liquid is mounted inside the sponge or in contact with the sponge (See contact in FIG 1B), with both the frangible container with said liquid and the sponge mounted on a solid support inside the unified package within a basin formed in the solid support (FIG 1A shows that pouch 20 forms solid support which is hollow, providing a fully enclosed basin. Both the frangible container with the liquid and the sponge are contained within the pouch and therefore are mounted within the basin of the solid support. [0021] discloses the medical device can be held in place within the pouch via a plug or connector integrated within the packaging/pouch).
Cuevas discloses that the elongate medical device “may be any medical device that may be adapted for insertion into a body cavity” [0020] but is silent regarding the elongate flexible medical device being a suture having a connected end attached to a needle and an opposing free end.
However, Stopek 694 teaches in the same field of endeavor a medical device package (10, FIG 1-2B) having an elongated flexible suture (30, [0016, 0026]) having a connecting end attached to a needle (See end of suture attached to needle in FIG 2B) and an opposing free end (See free end at the opposing end of the suture from the needle), wherein the elongate flexible suture is copackaged with a medicant reservoir (40, [0026-0028]) for applying a liquid to the suture as the suture is pulled through the reservoir and removed from the packaging ([0027]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the elongated flexible medical device in the system of Cuevas to be a suture having a needle attached to a connecting end and an opposing free end, as taught by Stopek 694, for the purpose of utilizing the system in a manner which is contemplated by Cuevas (Which states the medical device can be any device adapted for insertion into a body cavity) to perform a desired procedure such as suturing, thereby achieving the predictable result of wicking a liquid on to the medical device upon removal from the package such that it is immediately ready for use in a procedure.
Regarding claim 4, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. The device as modified by Stopek 694 further discloses said suture is absorbable ([0026] discloses the suture 30 can absorb the agent 50, therefore the suture is understood to be absorbable), non-absorbable, monofilament, braid, barbed, or combinations thereof.
Regarding claim 5, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses a medicant (antibacterial or antimicrobial liquid), wherein said medicant is anti-microbial or anti-bacterial agent ([0007, 0025-0029]).
Regarding claim 6, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 5. Cuevas further discloses said medicant comprising chlorhexidine, polyhexamethylene biguanide, octenidine, silver particles, silver salts, triclosan, and combinations thereof ([0029] discloses triclosan, chlorohexidine, charged silver, polyhexamethylene biguanide, and combinations thereof).
Regarding claim 10, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses said suture and said container are configured to be sterilized separately (Because the suture and the container are formed separately and assembled into the packaging, the elements are at least capable of being sterilized separately).
Regarding claim 15, Cuevas/Stopek 694 the invention substantially as claimed, as set forth above for claim 2. The device as modified by Stopek 694 further discloses said suture comprises a coating configured to increase uptake of said medicant in a solution by said suture ([0026] discloses in some embodiments, at least a portion of medical device 30, i.e., a suture, may be in contact or coated with an agent 50 prior to be received and stored within container 20… port 60 can deliver a contact material through port 60 and into area 40 to interact with agent 50. Since at least a portion of medical device 30 is positioned within area 40, the contact material and agent 50 may coat, impregnate, react with, or be absorbed by medical device 30. [0021] discloses a list of agent/coatings, at least one of which is configured to increase uptake of said medicant in a solution by said suture).
Regarding claim 16, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. The device as modified by Stopek 694 further discloses said suture comprises a coating reactive with any of ingredients of said medicant in a solution increasing uptake of said medicant by said suture ([0026] discloses in some embodiments, at least a portion of medical device 30, i.e., a suture, may be in contact or coated with an agent 50 prior to be received and stored within container 20… port 60 can deliver a contact material through port 60 and into area 40 to interact with agent 50. Since at least a portion of medical device 30 is positioned within area 40, the contact material and agent 50 may coat, impregnate, react with, or be absorbed by medical device 30. [0021] discloses a list of agent/coatings, at least one of which is reactive with any of ingredients of said medicant in a solution increasing uptake of said medicant by said suture).
Regarding claim 17, Cuevas/Stopek 694discloses the invention substantially as claimed, as set forth above for claim 2. The device as modified by Stopek 694 further discloses said container contains a first medicant or a first combination of medicants in a solution (The container comprises the liquid solution comprising a medicant within the frangible container 160), and said suture is pre-coated by a second medicant ([0026] of Stopek discloses in some embodiments, at least a portion of medical device 30, i.e., a suture, may be in contact or coated with an agent 50 prior to be received and stored within container 20), said second medicant can be the same or different from said first medicant or said first combination of medicants ([[0021] of Stopek lists the agents of the second medicant coating the suture, which are different than the agents of the liquid in the frangible container of Cuevas).
Regarding claim 23, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses said frangible container is configured to release said liquid into said sponge upon crushing of said container ([0022-0023]) and said sponge is configured to wick and absorb said liquid when released upon crushing of said container ([0023] discloses liquid delivered from the frangible container, by applying pressure to the frangible container through hand, fingers, or other effective means, may flow into the distribution media. The distribution media may then act as a squeegee. i.e. in the case of a sponge, for transporting liquids to a portion of the medical device).
Regarding claim 24, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses said liquid comprises a medicant solution ([0029] the liquid contains an antimicrobial or antibacterial additive i.e. a medicant).
Regarding claim 27, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses said frangible container is located proximal to said sponge (The frangible container is connected to the sponge and therefore is interpreted as being proximal to the sponge depending on the orientation of the system, See FIG 1B).
Regarding claim 28, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. The device as modified further discloses a portion of said suture proximal to the connecting end is pre-positioned inside said sponge (As shown in FIG 1A-1B, a portion of the elongate medical device is prepositioned inside said sponge in the initial position. In the device as modified such that the elongate medical device is a suture, a portion of the suture is therefore prepositioned inside the sponge).
Regarding claims 29-30, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas/Stopek 694 discloses a method of coating the suture of the suturing system of Claim 2, comprising the steps of: Crushing said frangible container (Cuevas [0023] discloses palpation of the frangible container by applying pressure to the frangible container through hand, fingers, or other effective means); releasing said liquid from said container to form a sponge wetted with a medicant solution (Cuevas [0023] discloses the crushing of the frangible container releases the liquid to flow into the distribution media i.e. the sponge); pulling said suture through said sponge wetted with a medicant solution, thus exposing said suture to said medicant solution (Cuevas [0023] disclose the distribution media may then act as a squeegee. i.e. in the case of a sponge, for transporting liquids to a portion of the medical device); removing all suture from said sponge wetted with a medicant solution thus forming suture wetted with said medicant solution and retaining at least some medicant on said suture (Cuevas [0023] discloses upon removal of the medical device from the pouch, a health professional, will grab the proximal end of the device to remove the device from the pouch and the distal portion will be coated further as it is slidably removed from the pouch); and optionally allowing at least a portion of said solution to evaporate (Because this step is “optional”, it is interpreted as not being a necessary step in the method), wherein pulling said suture through said sponge wetted with a medicant solution, results in removing an excess of said medicant solution from said suture (Because the sponge is porous and retains some of the medicant solution. Also the “squeegee mechanism” prevents an excess of liquid on the suture).
Regarding claim 31, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas/Stopek 694 discloses a method of coating the suture of the suturing system of Claim 2, comprising the steps of: Crushing said frangible container (Cuevas [0023] discloses palpation of the frangible container by applying pressure to the frangible container through hand, fingers, or other effective means); releasing said liquid from said container to form a sponge wetted with a medicant solution (Cuevas [0023] discloses the crushing of the frangible container releases the liquid to flow into the distribution media i.e. the sponge); pulling said suture through said sponge wetted with a medicant solution, thus exposing said suture to said medicant solution (Cuevas [0023] disclose the distribution media may then act as a squeegee. i.e. in the case of a sponge, for transporting liquids to a portion of the medical device); removing all suture from said sponge wetted with a medicant solution thus forming suture wetted with said medicant solution and retaining at least some medicant on said suture (Cuevas [0023] discloses upon removal of the medical device from the pouch, a health professional, will grab the proximal end of the device to remove the device from the pouch and the distal portion will be coated further as it is slidably removed from the pouch); and optionally allowing at least a portion of said solution to evaporate (Because this step is “optional”, it is interpreted as not being a necessary step in the method); and using said suture and needle in a suturing surgical procedure within 1 hour after pulling said suture through said sponge wetted with a medicant solution ([Cuevas [0024] discloses the liquid applied to the medical device is “design to provide short term protection, i.e. the time required implantation of the device. This short term protection… desirably between 1 minute and 1 hour”. Therefore, it is understood the surgical procedure occurs within 1 hour after preparing the suture).
Claim(s) 8-9 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas et al. (US 2009/0099532) in view of Stopek et al. (US 2010/0116694, hereinafter “Stopek 694”) further in view of Prajapati (US 2006/0287676).
Regarding claim 8-9, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses the liquid can include diluents or wetting agents, such as water or saline ([0028]) but is silent regarding the liquid comprises a rapidly evaporating solvent/ethanol.
However, Prajapati teaches in the same field of endeavor a means to coat a therapeutic agent onto a suture (abstract) using a sponge which holds a therapeutic agent ([0012]), wherein a medicant in the solution to be applied to a suture (15) for coating said suture and aiding in securing additional agents to said suture, wherein the suture can be treated in a bath of 70% ethanol solution as a part of the process of coating with a medicant ([0148-0149]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the solution of the liquid of Cuevas to comprise ethanol instead of water or another aqueous solution, as taught by Prajapati, because Prajapati teaches that ethanol is an equivalent substitute for achieving the desired function of aiding in adhering a therapeutic agent to the suture ([0149]).
Regarding claim 25, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2. Cuevas further discloses the liquid comprises a solvent (such as water, [0028]).
Cuevas is silent regarding the sponge containing a dry medicant.
However, Prajapati teaches in the same field of endeavor a dry medicant (339, FIG 8A-8D, [0132]) stored within a sponge (329) to be applied to a suture (315) once the sponge is soaked by a liquid comprising a solvent (337, [0138]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the sponge of Cuevas to comprise a dry medicant, as taught by Prajapati, for the purpose of storing the medicant as an inactive ingredient until the sponge is soaked by the liquid, at which point the medicant in the sponge can be transferred to the suture.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cuevas et al. (US 2009/0099532) in view of Stopek et al. (US 2010/0116694, hereinafter “Stopek 694”), further in view of Olson et al. (US 2012/0029561).
Regarding claim 12, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2.
The device as modified is silent regarding the suture being a coreless braid having a hollow core (Claim 12).
However, the use of different suture types in commonly known in the art. For example, Olson teaches a suture (10, FIG 1A-1C) which can be a coreless braid having a hollow core (UHMWPE Force Fiber is a known coreless braided suture, [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the suture as a braided coreless suture, as taught by Oslom, for the purpose of providing a suture commonly known in the art having the desired features for a particular medical application as determined by the user. Coreless braided sutures have the additional benefit that “coreless UHMWPE braid will flatten when it is compressed by the forces of knotting. This phenomenon contributes to its lower knot profile and improved knotting properties” (Olson [0062]).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being Cuevas et al. (US 2009/0099532) in view of Stopek et al. (US 2010/0116694, hereinafter “Stopek 694”) further in view of Stopek et al. (US 2009/0209031, hereinafter “Stopek 031”).
Regarding claim 13-14, Cuevas/Stopek 694 discloses the invention substantially as claimed, as set forth above for claim 2.
The device as modified is silent regarding the suture being a monofilament suture, having surface features configured to increase uptake of said medicant solution by said suture wherein said surface features comprise grooves, apertures, cavities, surface roughening features, and combinations thereof.
However, the use of different suture types in commonly known in the art. For example, Stopek 031 teaches packaging for a medical device (110) which can house a suture (150, FIG 2) attached at one end to a needle (125, [0035]) wherein the suture can be braided or monofilament and can have surface features (barbs are interpreted as surface roughening features) ([0017]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the suture as a monofilament suture having surface roughening features, as taught by Stopek 031, for the purpose of providing a suture commonly known in the art having the desired features for a particular medical application as determined by the user. In the device as modified, the surface features are interpreted as “configured to increase uptake of said medicant solution by said suture” because the roughening of the suture surface by the projections will trap amounts of the medicant solution.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771