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 Arguments
Applicant’s amendment filed 12/10/2025 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant alleges that Kornerup does not have a cannula configured to be inserted within the cannula housing such that the at least one aperture located within the cannula housing provides fluid communication between the suction source and the wound after formation of the microbial barrier. However, this is not persuasive. The cannula of Kornerup is fully capable of being placed in the cannula housing such that at least one of the apertures is located within the cannula housing, for example by only inserting the cannula so far under the patient’s skin.
Applicant did not specifically address the dependent claims.
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 (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 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.
Claim(s) 1-5 and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kornerup (US 5685859).
Regarding Claim 1, Kornerup discloses an apparatus, comprising:
a cannula (drainage tube 5, Figs. 14-15) defining a lumen, wherein the cannula (5, Figs. 14-15) is configured to operatively couple with a suction source to thereby establish fluid communication between the suction source and the lumen (Col. 1 lines 9-15), wherein the cannula (5, Figs. 14-15) further comprises a distal portion (portion of cannula that sits within the recess 465 and the portion that passes through the membrane 479 and into the patient, Figs. 14-15) defining at least one aperture (as seen in Fig. 2, the drainage tube has multiple apertures), wherein the at least one aperture is in fluid communication with the lumen and an exterior surface of the distal portion (as seen in Figs. 2, 14-15); and
a wound closure device (400, Figs. 14-15) dimensioned to cover a wound in skin (Col. 1 lines 4-8), wherein the wound closure device (400, Figs. 14-15) is configured to receive a layer of topical adhesive to thereby adhere to the skin and form a microbial barrier over the wound (Col. 4 lines 49-56, Col. 10 lines 39-43; the adhesive can be considered a microbial barrier as it will impede the penetration of bacteria into the wound compared to no adhesive being present), wherein the wound closure device (400, Figs. 14-15) comprises a cannula housing (combination of support component 450 and elongated securing strip 443, Figs. 14-15) defining a channel (recess 465, Figs. 14-15) dimensioned to receive the distal portion of the cannula (portion of cannula that sits within the recess 465 and the portion that passes through the membrane 479 and into the patient, Figs. 14-15) such that the at least one aperture is housed within the cannula housing (Figs. 14-15; the channel is fully capable of housing a portion of the distal end of the catheter with at least one aperture), wherein the cannula (5, Figs. 14-15) is configured to be inserted within the cannula housing (combination of 450 and 443, Figs. 14-15) such that the at least one aperture located within the cannula housing (combination of 450 and 443, Figs. 14-15) provides fluid communication between the suction source and the wound after formation of the microbial barrier (Col. 1 lines 9-15; the catheter is fully capable of being placed such that at least one aperture is located within the cannula housing).
Regarding Claims 2 and 3, Kornerup discloses the wound closure device (400, Figs. 14-15) further comprises a textile mesh (441 and 443, Figs. 14-15; Col. 5 lines 43-46, Col. 6 lines 25-29, Col. 11 lines 26-28), wherein the textile mesh comprises the cannula housing (combination of 450 and 443, Figs. 14-15; Col. 5 lines 43-46, Col. 6 lines 25-29, Col. 11 lines 26-28; the plaster component 441 can be made of nonwoven polyamide, and the securing strip 443 is made integrally with the plaster component and therefore is also made of a nonwoven polyamide).
Regarding Claim 4, Kornerup discloses the wound closure device (400, Figs. 14-15) further comprises a pressure sensitive adhesive configured to temporarily attach the textile mesh (441 and 443, Figs. 14-15) to the wound (Col. 10 lines 34-59; the adhesive on strip 443 can be considered to temporarily attach the strip 443 to the wound when the cannula is in place; medical adhesives are well known in the art to be pressure sensitive adhesives to allow for removal of the dressing after use).
Regarding Claim 5, Kornerup discloses the wound closure device (400, Figs. 14-15) further comprises a backing removably covering the pressure sensitive adhesive (Col. 10 lines 34-59; the adhesive on strip 443 is covered by a removable cover layer).
Regarding Claim 10, Kornerup discloses the wound closure device (400, Figs. 14-15) comprises a first textile mesh (441, Figs. 14-15; Col. 5 lines 43-46, Col. 6 lines 25-29, Col. 11 lines 26-28; the plaster component 441 can be made of nonwoven polyamide) and a second textile mesh (443, Figs. 14-15; Col. 5 lines 43-46, Col. 6 lines 25-29, Col. 11 lines 26-28; the plaster component 441 can be made of nonwoven polyamide, and the securing strip 443 is made integrally with the plaster component and therefore is also made of a nonwoven polyamide), wherein the distal portion of the cannula (portion of cannula that sits within the recess 465 and the portion that passes through the membrane 479 and into the patient, Figs. 14-15) is interposed between the first textile mesh (441, Figs. 14-15) and the second textile mesh (443, Figs. 14-15).
Regarding Claim 11, Kornerup discloses the second textile mesh (443, Figs. 14-15) comprises a pressure sensitive adhesive (Col. 10 lines 34-59; the adhesive on strip 443 can be considered to temporarily attach the strip 443 to the wound when the cannula is in place; medical adhesives are well known in the art to be pressure sensitive adhesives to allow for removal of the dressing after use), wherein the cannula (5, Figs. 14-15) is attached to the pressure sensitive adhesive (Col. 10 lines 34-59; the adhesive on strip 443 can be considered to temporarily attach the strip 443 to the wound when the cannula is in place via the adhesive attaching to the cannula; medical adhesives are well known in the art to be pressure sensitive adhesives to allow for removal of the dressing after use).
Regarding Claim 12, Kornerup discloses the wound closure device (400, Figs. 14-15) comprises a substantially rectangular shape (as seen in Figs. 14-15).
Regarding Claim 13, Kornerup discloses the cannula housing (combination of support component 450 and elongated securing strip 443, Figs. 14-15) comprising an open proximal end (where the securing strip 443 is attached to top of plaster 441, Figs. 14-15) and a closed distal end (where securing strip 443 extends through slit 442 and adheres to the bottom of plaster 441, Figs. 14-15).
Regarding Claim 14, Kornerup discloses the open proximal end (where the securing strip 443 is attached to top of plaster 441, Figs. 14-15) is located at a first peripheral location of the wound closure device (400, Figs. 14-15).
Regarding Claim 15, Kornerup discloses the distal end (where securing strip 443 extends through slit 442 and adheres to the bottom of plaster 441, Figs. 14-15) is located at a second peripheral location of the wound closure device (400, Figs. 14-15).
Regarding Claim 16, Kornerup discloses an apparatus, comprising:
a cannula (drainage tube 5, Figs. 14-15) defining a lumen, wherein the cannula (5, Figs. 14-15) further comprises a distal portion (portion of cannula that sits within the recess 465 and the portion that passes through the membrane 479 and into the patient, Figs. 14-15) defining at least one aperture (as seen in Fig. 2, the drainage tube has multiple apertures), wherein the at least one aperture is in fluid communication with the lumen and an exterior surface of the distal portion (as seen in Figs. 2, 14-15); and
a wound closure device (400, Figs. 14-15) configured to temporarily secure relative to and cover a wound (Col. 1 lines 4-8), wherein the wound closure device (400, Figs. 14-15) comprises a longitudinally extending cannula housing (combination of support component 450 and elongated securing strip 443, Figs. 14-15) defining a channel (recess 465, Figs. 14-15) dimensioned to receive the distal portion of the cannula (portion of cannula that sits within the recess 465 and the portion that passes through the membrane 479 and into the patient, Figs. 14-15) such that the at least one aperture is located within the channel of the cannula housing (Figs. 14-15; the channel is fully capable of housing a portion of the distal end of the catheter with at least one aperture), wherein the wound closure device (400, Figs. 14-15) is configured to receive a topical adhesive to form a microbial barrier over the wound (Col. 4 lines 49-56, Col. 10 lines 39-43; the adhesive can be considered a microbial barrier as it will impede the penetration of bacteria into the wound compared to no adhesive being present) and the longitudinally extending cannula housing such that the at least one aperture is located within the microbial barrier (Col. 1 lines 9-15; the catheter is fully capable of being placed such that at least one aperture is located within the cannula housing, and therefore within the microbial barrier), wherein the cannula (5, Figs. 14-15) is configured to be inserted within the longitudinally extending cannula housing (combination of 450 and 443, Figs. 14-15) to thereby provide fluid communication between a suction source and the wound after formation of the microbial barrier (Col. 1 lines 9-15).
Claim(s) 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lockwood et al (US 6855135).
Regarding Claim 21, Lockwood discloses an apparatus (Fig. 17), comprising:
a cannula (tube 13, Fig. 17) defining a lumen (interior of tube 13, Fig. 17), wherein the cannula (13, Fig. 17) is configured to operatively couple with a suction source (12, Fig. 1) to thereby establish fluid communication between the suction source (12, Fig. 1) and the lumen (interior of tube 13, Fig. 17; Col. 13 lines 16-19), wherein the cannula (13, Fig. 17) further comprises a distal portion (end that fits inside connector 23, Fig. 17) defining at least one aperture (outlet of the tube 13, Fig. 17), wherein the at least one aperture (outlet of the tube 13, Fig. 17) is in fluid communication with the lumen (interior of tube 13, Fig. 17) and an exterior surface of the distal portion (end that fits inside connector 23, Fig. 17); and
a wound closure device (wound dressing member 19, Fig. 17) dimensioned to cover a wound in skin (Col. 12 lines 17-31), wherein the wound closure device (19, Fig. 17) is configured to receive a layer of topical adhesive to thereby adhere to the skin and form a microbial barrier over both the wound and an entirety of the wound closure device (19, Fig. 17; Col. 11 lines 17-39, Col. 14 lines 45-48), wherein the wound closure device (19, Fig. 17) comprises a cannula housing (connector 23, Fig. 17) defining a channel (horizontal portion 27, Fig. 17) dimensioned to receive the distal portion (end that fits inside connector 23, Fig. 17) of the cannula (13, Fig. 17), wherein the cannula (13, Fig. 17) is configured to be inserted within the cannula housing (23, Fig. 17) to thereby provide fluid communication between the suction source (12, Fig. 17) and the wound after formation of the microbial barrier (Col. 11 lines 17-39, Col. 13 lines 38-54, Col. 14 lines 45-48).
Regarding Claim 22, Lockwood discloses the at least one aperture (outlet of the tube 13, Fig. 17) is located within the cannula housing (23, Fig. 17) such that the at least one aperture (outlet of the tube 13, Fig. 17) is located within the microbial barrier (Col. 11 lines 17-39, Col. 13 lines 38-54, Col. 14 lines 45-48).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornerup (US 5685859) in view of Wells et al (US 2017/0304509).
Regarding Claim 6, Kornerup is silent whether the distal portion of the cannula further comprises a closed distal tip.
Wells teaches an aspiration system, thus being in the same field of endeavor, where the distal end tip is a closed distal tip (¶ [0053]) so that the tip does not disturb or destroy the tissue it comes into contact with (¶ [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal portion of the cannula to comprise a closed distal tip, as taught by Wells, to ensure that the tip does not disturb or destroy the tissue that it comes in contact with (as motivated by Wells ¶ [0053]).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornerup (US 5685859) in view of Murphy et al (US 2022/0249823).
Regarding Claims 7-9, Kornerup is silent whether the distal portion of the cannula further comprises at least one barb, wherein the at least one barb comprises a longitudinal array of barbs, wherein the longitudinal array of barbs extends away from the at least one aperture of the distal portion of the cannula.
Murphy teaches a cannula, thus being in the same field of endeavor, with a distal portion that comprises a longitudinal array of barbs (16, Fig. 5) to hold the cannula in the desired position (¶ [0142]).
Therefore, it would have been obvious to modify the distal portion of the cannula of Kornerup to comprise a longitudinal array of barbs, as taught by Murphy, to allow the cannula to be held in the desired position (as motivated by Murphy ¶ [0142]). The combination of Kornerup/Murphy would have the longitudinal array of barbs extending away from the at least one aperture of the distal portion of the cannula, as the barbs would extend outward from the cannula and the apertures are located in the cannula side walls.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornerup (US 5685859) in view of Ryan (US 2024/0335328).
Regarding Claim 17, Kornerup further discloses the cannula housing (combination of 450 and 443, Figs. 14-15) comprises a proximal end (end with 482, Figs. 14-15) and distal end (end adjacent to 479, as seen in Figs. 14-15).
Kornerup is silent whether the cannula housing is tapered such that the proximal end is wider than the distal end.
Ryan teaches a wound dressing, thus being in the same field of endeavor, with a cannula housing (tunnel 132, Fig. 10) that is tapered such that the proximal end is wider than the distal end (as seen in Fig. 10).
Therefore, it would have been obvious to modify the cannula housing of Kornerup to be tapered such that the proximal end is wider than the distal end, as taught by Ryan, as Ryan shows that tapered cannula housings were well known in the art as of the effective filing date of the invention.
Regarding Claim 18, the combination of Kornerup/Ryan discloses the claimed invention substantially as claimed as set forth above for Claim 17.
Kornerup/Ryan further discloses the proximal end (Kornerup end with 482, Figs. 14-15) and the distal end (Kornerup end adjacent to 479, as seen in Figs. 14-15) are both located within the peripheral edges of the wound closure device (400, Figs. 14-15; the peripheral edges of 400 are the peripheral edges of 441).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781