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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 13, 2026 has been entered. Claims 1-2, 4-6, and 8-18 are pending in the application. Response to applicant's arguments can be found at the end of this office action.
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 1-2, 4-5, 8, 12, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yannick et al. (EP3300669A1; hereinafter “Yannick”) in view of O’Brien et al. (U.S. Patent No. 8408212; hereinafter “O’Brien”) and Ory et al. (U.S. Patent No. 6443964; hereinafter “Ory”).
Regarding claim 1, Yannick discloses a patch (120) for sealing a perforation in an amniotic membrane (Fig. 1), the patch (1) comprising:
a support (121) comprising an elastomeric material (paras. [0023], [0029]) such that the support adapts to movements of the amniotic membrane without causing damage thereto (structural characteristics (e.g., flexibility, strength) of the silicone-based membrane enable sheet (121) to adapt to movement of an amniotic membrane without causing damage thereto);
an adhesive (para. [0030]) on only one side of the support (Fig. 1); and
a flexible support structure (123) embedded within the support (para. [0043]) that acts as an internal skeleton whereby the patch unfolds for placement (para. [0042]),
whereby the patch is adapted to adhere only to a fetal side of the amniotic membrane to seal the perforation (Fig. 1) without blocking a natural sliding movement between chorio-amniotic membranes (as patch (120) is only present on one side of the amniotic membrane (Fig. 1), the patch does not interfere/block sliding movement between the amnion and chorion membranes of the amniotic membrane at the puncture site and/or at locations away from the puncture site).
The device of Yannic is not explicitly disclosed with the adhesive being specifically formulated to be activated upon contact with amniotic liquid.
O’Brien, a reference in the puncture closure field of endeavor, teaches providing to a patch device an adhesive that is specifically formulated to be activated upon contact with amniotic liquid (e.g., the water-activated adhesive activates upon contact with water in amniotic liquid) to promote sealing a puncture in an amniotic membrane (col. 8, ll. 23-26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the adhesive to be specifically formulated to be activated upon contact with amniotic liquid, in view of O’Brien, in order to promote sealing of the puncture in the amniotic membrane covered by the patch.
The modified device is not explicitly disclosed with the flexible support structure being a flexible mesh.
Ory, a reference int e surgical fabric field of endeavor, teaches configuring a flexible mesh (Fig. 2) that act as an internal skeleton to improve mechanical properties and anchoring of a device (col. 3, ln. 59 – col. 4, ln. 15).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the flexible support structure of Yannick as a flexible mesh embedded within the support that acts as an internal skeleton whereby the patch unfolds for placement, in view of Ory, to facilitate placement of the patch within a patient and to provide the patch with improved mechanical properties and improved anchoring of the patch within a patient.
Regarding claim 2, Yannick discloses wherein the patch (120) also comprises an attachment thread (retention element (117A) or (117B); Figs. 2C-2D; para. [0036]).
Regarding claim 4, Yannick discloses wherein the support (11) comprises an outer layer (silicone-based membrane) and an inner layer (structure coupled to the silicone-based membrane; para. [0029]).
Regarding claim 5, Yannick discloses wherein the outer layer is made from silicone (silicone-based membrane) and the inner layer is made from a thermoplastic material (suitable synthetic polymer material PTFE; para. [0029]).
Regarding claim 8, the modified device discloses wherein said mesh is a hexagonal mesh (Ory Fig. 2; col. 3, ln. 59 – col. 4, ln. 15).
Regarding claim 12, Yannick discloses wherein the patch (120) has a semi- lentil shape (Fig. 1).
Regarding claim 17, the modified device discloses a system for sealing an amniotic membrane, comprising a patch according to claim 1 (in view of the teachings of Yannick, O’Brien, and Ory, as explained above) and a device for placing said patch on an amniotic membrane (Yannick Figs. 2A-2D), characterized in that the device (110) comprises:
- a cannula (111) for inserting said patch in a rolled-up position (tube-shaped body (111) is sized and shaped to be capable of inserting the patch in a rolled-up position because the body inserts the patch in a folded configuration; Fig. 2B; para. [0042]), said cannula being provided with a handle (at the proximal end of tube-shaped body which includes actuation mechanism (116); Figs. 2A, 2C; paras. [0034]-[0035]); and
- a dipstick (114) provided with a pusher (115), said dipstick being inserted inside the cannula in the use position (Fig. 2A; para. [0034]).
Regarding claim 18, Yannick discloses wherein the pusher (115) comprises a hole for placing a fastening thread (117A) for fastening said patch (Fig. 2D; para. [0036]).
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yannick in view of O’Brien and Ory, as applied to claim 1 above, and further in view of Ericson et al. (U.S. Patent Application Publication No. 20140222067; hereinafter “Ericson”).
Regarding claim 6, the modified device discloses the invention substantially as claimed, except for the adhesive being based in a formulation of hydroxypropyl methylcellulose (HPMC) and hydroxyethyl cellulose (HEC). Ericson, a reference in the wound closure field of endeavor, teaches basing a water-activated adhesive (212; paras. [0063]-[0070]) for a patch (200) in a formulation of hydroxypropyl methylcellulose (HPMC) and hydroxyethyl cellulose (HEC; para. [0070]) in order to control viscosity of the adhesive to immobilize a patch within a patient (para. [0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to base the adhesive in a formulation of hydroxypropyl methylcellulose (HPMC) and hydroxyethyl cellulose (HEC), in view of Ericson, in order to provide the adhesive with an appropriate viscosity to hold the patch in place to close a wound.
Regarding claim 11, the modified device discloses the invention substantially as claimed, except for the adhesive being formed by several adhesive coatings. Ericson teaches providing a patch (200) with several adhesive coatings (212A, 212B) to improve adhesion of the patch to tissue within a patient (para. [0094]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the adhesive by several adhesive coatings, in view of Ericson, in order to allow more tissue to adhere with the patch to close a wound.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yannick in view of O’Brien and Ory, as applied to claim1 above, and further in view of Kovac et al. (U.S. Patent No. 5921979; hereinafter “Kovac”).
Regarding claim 9, the modified device discloses the invention substantially as claimed, except for the support including a micropattern.
Kovac, a reference in the tissue stabilizing field of endeavor, teaches providing a patch (35) with a micropattern of concave hemispheres (37; Fig. 8), in contact with an adhesive to facilitate gripping tissue (col. 7, ll. 1-10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the support with a micropattern, which is in contact with said adhesive, in view of Kovac, in order to provide a strong bond between the patch and the amniotic membrane.
Regarding claim 10, Kovac teaches wherein said micropattern is formed by concave hemispheres (37; Fig. 8).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yannick in view of O’Brien and Ory, as applied to claim 1 above, and further in view of Odermatt et al. (U.S. Patent Application Publication No. 20140148827; hereinafter “Odermatt”).
Regarding claim 13, the modified device discloses the invention substantially as claimed, except for the adhesive including a polyvinyl alcohol (PVA) layer. Odermatt, a reference in the surgical mesh field of endeavor, teaches that a polyvinyl alcohol layer is especially useful for adhering a mesh to tissue (paras. [0095]-[0097]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the adhesive to include a polyvinyl alcohol (PVA) layer, in view of Odermatt, in order to effectively secure the patch to tissue to close an amniotic puncture.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yannick in view of O’Brien and Ory, as applied to claim1 above, and further in view of Palese (U.S. Patent Application Publication No. 20120316594).
Regarding claim 14, the modified device discloses the invention substantially as claimed, except for a body provided with a plurality of harpoons. Palese, a reference in the wound closure field of endeavor, teaches providing a patch (110) with a body (annular portion of first face (114) including barbs (120); Figs. 1-3) provided with a plurality of harpoons (120; Figs. 1-3) along different portions of the patch (para. [0069]) in order to secure the patch to tissue (paras. [0068]-[0069]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the patch with a body provided with harpoons, in view of Palese, in order to improve securement of the patch with tissue.
Regarding claim 15, the modified device discloses the wherein said body is made from a plurality of segments (e.g., each distinct barb (120) constitutes a segment of the body; Palese Figs. 1-3).
Regarding claim 16, the modified device discloses wherein said harpoons protrude from the support (Palese Figs. 1-3; paras. [0068]-[0069]).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-6, and 8-18 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wilk (U.S. Patent No. 7753934) disclosing a medical closure patch (Figs. 1-5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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