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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
This office action is responsive to the amendment filed on 12/08/2025. As directed by the amendment: claims 11, 13, 27-39 have been amended and claims 1-10, 12 and 15-26 have been cancelled. Thus, claims 11, 13, 14, 27-39 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11, 27, and 36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites “the first coupling element and the second coupling element are not engaged” and independent claim 11 recites “the first coupling element comprises an aperture configured to engage and retain the second coupling element” rendering the scope of claim 35 unclear as these limitations are in opposition to one another. The claim will be interpreted such that prior to engagement of the coupling members they are not engaged. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 11, 13, 30, 33, 35, 36, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Riskin et al. (US 20090036922 A1).
Regarding claim 11 Riskin discloses (fig. 1-2) a surgical closure device comprising: a first coupling element 2; and a second coupling element 3 (see fig. 1 and [0122]); wherein the first coupling element 2 comprises an aperture 4 configured to engage and retain the second coupling element 3 (see fig. 1-2 and [0122]).
Riskin (fig. 1-2) is silent regarding the first coupling element protruding a first panel and the second coupling element protruding from a second panel.
However Riskin in a variant embodiment (fig. 9A-11) teaches a first coupling element 21 protruding a first panel 17a and a second coupling element 22 protruding from a second panel 18a (see fig. 9aA-9B and [0131]).
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 Riskin (fig. 1-2) to have first and second panels positioned between the respective coupling elements and adhesive layer such that the first coupling element protruding the first panel and the second coupling element protruding from the second panel as taught by Riskin (fig. 9A-11), for the purpose of being able to have a larger surface area of adhesive to improve adhesion of the device to the wound edge (see Riskin fig. 1-2 and 9A-11).
Regarding claim 13, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin further discloses (fig. 1-2) the perimeter of the aperture 4 is the same shape as the perimeter of the second coupling element 3 (see fig. 1-2).
Regarding claim 30, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin as modified further teaches the first and the second panel are elastic (see [0131]).
Regarding claim 33, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin as modified further teaches the first and the second panel are deformable (see [0131], elastomeric material is deformable).
Regarding claim 35, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin further discloses (fig. 1-2) the first coupling element and the second coupling element are not engaged (prior to deployment the first coupling element and the second coupling element are not engaged, see fig. 1).
Regarding claim 36 Riskin discloses (fig. 1-2) a surgical closure device comprising: a first coupling element 2; and a second coupling element 3 (see fig. 1 and [0122]); wherein the first coupling element 2 comprises an aperture 4 configured to engage and retain the second coupling element 3 (see fig. 1-2 and [0122]); the perimeter of the aperture 4 is the same shape as the perimeter of the second coupling element 3 (see fig. 1-2).
Riskin (fig. 1-2) is silent regarding the first coupling element protruding a first panel and the second coupling element protruding from a second panel, the first panel detached from the second panel.
However Riskin in a variant embodiment (fig. 9A-11) teaches a first coupling element 21 protruding a first panel 17a and a second coupling element 22 protruding from a second panel 18a (see fig. 9A-9B and [0131]); the first panel 17a detached from the second panel 18a (see fig. 9A-9B and [0131]).
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 Riskin (fig. 1-2) to have first and second panels positioned between the respective coupling elements and adhesive layer such that the first coupling element protruding the first panel and the second coupling element protruding from the second panel, the first panel detached from the second panel as taught by Riskin (fig. 9A-11), for the purpose of being able to have a larger surface area of adhesive to improve adhesion of the device to the wound edge (see Riskin fig. 1-2 and 9A-11).
Riskin as modified teaches the first coupling element is configured to extend over the second panel. Riskin (fig. 1-2) is modified to have the panels of fig. 9A-11. As can be seen in fig. 9A-11 each of the panels extends slightly past the distal edge of the coupling elements, thus when the elements come together as in fig. 2, the aperture, which is at the very edge, will be slightly over the second panel.
Regarding claim 38, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 36. Riskin as modified further teaches the first coupling element integrally protrudes from the first panel (integral is defined by dictioinary.com as “of, relating to, or belonging as a part of the whole” and the first coupling element and first panel are part of the whole device with the first coupling element protruding from the first panel, see fig. 9A-11).
Regarding claim 39, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 36. Riskin as modified further teaches the second coupling element integrally protrudes from the second panel (integral is defined by dictioinary.com as “of, relating to, or belonging as a part of the whole” and the second coupling element and second panel are part of the whole device with the second coupling element protruding from the second panel, see fig. 9A-11).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Natarajan et al. (US 20130172927 A1).
Regarding claim 14, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 13. Riskin as modified is silent regarding the right panel and the left panel each comprise Poly (glycerol sebacate) (PGS), are each biocompatible, are each degradable.
However Natarajan, in the same field of endeavor, teaches that Poly (glycerol sebacate) (PGS) is a suitable material to form a panel of a wound closure device out of (see [0034]), wherein the PGS material is biocompatible (it degrades in the body thus is biocompatible) and degradable (see [0033]-[0034]).
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 Riskin to have the right panel and the left panel each comprise Poly (glycerol sebacate) (PGS) as taught by Natarajan, for the purpose of being able to have the panels be resorbable to resorb after wound closure (see Natarajan [0033]-[0034]).
Claims 27, 28, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Luchetti et al. (US 20190357908 A1).
Regarding claim 27 Riskin discloses (fig. 1-2) a method for internal wound closure comprising:
providing a surgical closure device comprising a first coupling element 2 and a second coupling element 3 wherein the first coupling 2 element comprises an aperture 4 configured to engage and retain the second coupling element 3 (see fig. 1-2 and [0122])
adhering the first panel to a first side of a tissue wound (see [0122] and [0128])
adhering the second panel on an opposite side of the tissue wound (see [0122] and [0128])
abutting the first side of the tissue wound with the opposite side (see [0126] and [0129]); and
inserting the second coupling element through the aperture 4, thereby interlocking the first and second coupling elements to hold the tissue wound together (see [0126] and [0129]).
Riskin (fig. 1-2) is silent regarding the first coupling element protruding a first panel and the second coupling element protruding from a second panel.
However Riskin in a variant embodiment (fig. 9A-11) teaches a first coupling element 21 protruding a first panel 17a and a second coupling element 22 protruding from a second panel 18a (see fig. 9aA-9B and [0131]).
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 Riskin (fig. 1-2) to have first and second panels positioned between the respective coupling elements and adhesive layer such that the first coupling element protruding the first panel and the second coupling element protruding from the second panel as taught by Riskin (fig. 9A-11), for the purpose of being able to have a larger surface area of adhesive to improve adhesion of the device to the wound edge (see Riskin fig. 1-2 and 9A-11).
Riskin further discloses (fig. 1-2) the first and second coupling mechanism can be a variety of locking mechanisms (see [0123]) but fails to expressly disclose a snap fit.
However Luchetti, in the same filed of endeavor, teaches (fig. 5) locking mechanisms 14 for first and second coupling members including snap fit (see [0019]).
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 Riskin as modified to have first and second coupling elements engage via snap fit as taught by Luchetti, for the purpose of being able to securely engage the two coupling elements to prevent unwanted/early separation (see Luchetti [0006]).
Regarding claim 28, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Riskin further discloses (fig. 1-2) the first coupling element extends over the tissue wound (see fig. 2, 6, and [0129]).
Regarding claim 37, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 36. Riskin further discloses (fig. 1-2) the first and second coupling mechanism can be a variety of locking mechanisms (see [0123]) but fails to expressly disclose a snap fit.
However Luchetti, in the same filed of endeavor, teaches (fig. 5) locking mechanisms 14 for first and second coupling members including snap fit (see [0019]).
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 Riskin as modified to have first and second coupling elements engage via snap fit as taught by Luchetti, for the purpose of being able to securely engage the two coupling elements to prevent unwanted/early separation (see Luchetti [0006]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Luchetti as applied to claim 27 above, and further in view of Wilk (US 20060241691 A1).
Regarding claim 29, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Riskin as modified is silent regarding the tissue wound is a wound in urinary tract tissue.
However Wilk, in the same filed of endeavor, teaches wound closure devices for closing a wounds (see [0011]) including of the urinary tract (see [0077]).
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 Riskin as modified to have the device used to close a wound of the urinary tract as taught by Wilk, for the purpose of being able to close the wound of a urinary tract minimally invasively (see Wilk [0011]-[0012]).
Claims 31 is rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Leung (US 20170333039 A1).
Regarding claim 31, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin as modified is silent regarding the right panel and the left panel are transparent.
However Leung, in the same field of endeavor, teaches of a similar wound closure device with panels that can be transparent (see [0040]).
Therefore, the substitution of one known material characteristic (transparent as taught in Leung) for another (opaque as taught in Riskin as modified) would have been obvious to one of ordinary skill in the art at the time of the invention since Leung teaches that a transparent material is a suitable alternative and the substitution of the elastic as taught in Leung would have yielded predictable results, namely, a wound closure device that would close a wound and allow visibility of the wound while healing. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Moustafa (US 20180168653 A1).
Regarding claim 32, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin as modified is silent regarding the right panel and the left panel are magnetic.
However Moustafa, in the same field of endeavor, teaches (fig. 4) of a right panel 12a and a left panel 12b that are magnetic (see [0043]-[0044]).
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 Riskin as modified to have the right panel and the left panel be magnetic as taught by Moustafa, for the purpose of having an extra force that draws the wound edges together (see Moustafa Abstract).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Riskin in view of Lebner (US 20050020956 A1).
Regarding claim 34, Riskin as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Riskin as modified is silent regarding the right panel and the left panel have a thickness between 10 µm to 1 cm.
However Lebner, in the same field of endeavor, teaches (fig. 1-2) a surgical closure device comprising: a right panel 17; a left panel 16 (see fig. 1 and [0046]); and a closure member (18+19), the right panel and the left panel have a thickness between 10 µm to 1 cm (see [0004]).
Therefore, the substitution of one thickness (10 µm to 1 cm as taught in Lebner) for another (as taught in Riskin as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Lebner teaches that 10 µm to 1 cm is a suitable thickness for a wound closure device and the substitution of the thickness as taught in Lebner would have yielded predictable results, namely, a closure device of Riskin as modified that would close a wound. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771