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.
Response to Amendment
The Response filed July 25, 2025 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 5, 8, 9, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Palese (U.S. Patent Application Publication No. 20120316594) in view of Ford et al. (U.S. Patent No. 7101381; hereinafter “Ford”) and Ory et al. (U.S. Patent No. 6443964; hereinafter “Ory”).
Regarding claim 1, Palese discloses a patch for sealing an amniotic membrane (“patch” (para. [0165]) is capable of sealing an amniotic membrane because it is configured to seal against tissue adjacent a trocar entry site in a patient (paras. [0165]-[0166]) and no structure prevents such function), characterized in that the patch comprises a support (“body of the patch”; para. [0165]) and an adhesive being activated in presence of amniotic liquid or a wet environment (“sugar-based adhesive material” (para. [0165]) is activated, i.e., “enables a stronger bond” (para. [0165]), when in contact with a wet surface), wherein the support comprises a mesh-like material (para. [0164]) whereby the patch unfolds for placement via the mesh-like material (e.g., the patch unfolds from the delivery instrument when deployed through a small hole; paras. [0165]-[0166]; see also Figs. 5-8 and paras. [0014], [00017], and [0083]-[0087] describing how the patch unfolds for placement within a patient).
Palese discloses the invention substantially as claimed, except for the support including an elastomeric material.
Ford, a reference in the wound closure field of endeavor, teaches providing patch (22) with an elastomer layer (104) to prevent undesired adhesions with the patch after a wound is closed (Figs. 1-8; col. 15, ln. 1 – col. 16, ln. 53).
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 body of the patch of Palese with an elastomer layer such that the support includes an elastomeric material, in view of Ford, in order to prevent undesired tissue adhesions with the patch after it closes a wound.
As explained above, Palese discloses wherein the support comprises a mesh-like material whereby the patch unfolds for placement via the mesh-like material within a patient. Thus, Palese discloses the mesh-like material having flexible properties so that the a patch unfolds for placement via the mesh-like material within a patient (paras. [0165]-[0166]).
However, Palese does not explicitly disclose the mesh-like material being a flexible mesh that acts as an internal skeleton.
Ory, a reference in the surgical fabric field of endeavor, teaches configuring a mesh material as a flexible mesh (Fig. 2) that acts as an internal skeleton to improve mechanical properties and anchoring of the fabric (col. 3, ln. 59 – col. 4, ln. 15). Ory also discloses the flexible mesh being configured for positioning and placement on tissue within the confines of a patient (col. 1, ll. 4-9).
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 support to include a flexible mesh that acts as an internal skeleton whereby the patch unfolds for placement via the flexible mesh, in view of Ory and Palese, to facilitate placement of the mesh within a patient and to provide the patch with improved mechanical properties and improve anchoring of the patch within a patient.
Regarding claim 4, the modified device discloses the invention substantially a claimed, except for the support including an outer layer and an inner layer. Ford, a reference in the wound closure field of endeavor, teaches providing a patch (22) with an outer layer (104) to prevent undesired adhesions with the patch after a wound is closed (Figs. 1-8; col. 15, ln. 1 – col. 16, ln. 53). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add an outer layer to the modified patch such that the support includes an outer layer, as taught by Ford, and an inner layer (formed by the “body of the patch” of Palese), in order to prevent undesired tissue adhesions with the patch after it closes a wound.
Regarding claim 5, the modified device discloses wherein the outer layer is made from silicone (Ford col. 15, ll. 28-33) and the inner layer is made from a thermoplastic material (polyglycolic acid; Palese para. [0064]).
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 9, the modified device discloses Palese discloses wherein the support also comprises a micropattern (“patterned interface” formed by “nanoscale hills and valleys”; Palese para. [0165]), which is in contact with said adhesive (Palese para. [0165]).
Regarding claim 12, the modified device discloses wherein the patch has a semi-lentil shape (e.g., the patch assumes a semi-lentil or domed shape (shown in phantom in Palese Fig. 7) as the patch expands from a folded state (Palese Fig. 6) to a deployed state (Fig. 7); Palese paras. [0085]-[0086]).
Regarding claim 14, the modified device based on the patch embodiment disclosed by para. [0165] of Palese discloses the invention substantially as claimed, except for the body being provided with a plurality of harpoons. However, Palese teaches another embodiment of a patch (110) including 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 adjacent to a trocar entry site (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 harpoons 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]).
Regarding claim 17, the modified device discloses a system for sealing an amniotic membrane, comprising the modified patch (e.g., as presented with respect to claim 1 above) and a device (“delivery instrument” Palese para. [0165]) for placing said patch on an amniotic membrane, characterized in that the device comprises:
- a cannula (101) for inserting said patch in a rolled-up position ( Palese Figs. 4-6; para. [0084]), said cannula being provided with a handle (proximal end of trocar (101) outside the patient; Palese Figs. 4-6); and
- a dipstick (150) provided with a pusher (155), said dipstick being inserted inside the cannula in the use position (Palese Figs. 4-6; paras. [0083]-[0085]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Palese in view of Ford and Ory, as applied to claim 1 above, and further in view of Stopek et al. (U.S. Patent Application Publication No. 20100087854; hereinafter “Stopek”).
Regarding claim 2, the modified device discloses the invention substantially as claimed, except for the patch also comprising an attachment thread. However, Palese discloses that a tissue opening may be closed by suturing closed (para. [0090]).
Stopek, a reference in the wound closure field of endeavor, teaches providing a closure device (80) with an attachment thread (74) for suturing a tissue opening to be closed (Figs. 7A-7B; paras. [0039]-[0042]).
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 an attachment thread, in view of Stopek, in order to facilitate suturing a tissue opening closed after a surgical procedure.
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Palese in view of Ford 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 of the patch of Palese 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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Palese in view of Ford and Ory, as applied to claim 9 above, and further in view of Kovac et al. (U.S. Patent No. 5921979; hereinafter “Kovac”).
Regarding claim 10, the modified device discloses the invention substantially as claimed, except for the micropattern being formed by hills and valleys to grip tissue (para. [0165]) instead of concave hemispheres. Kovac, a reference in the tissue stabilizing field of endeavor, teaches providing a patch (35) with concave hemispheres (37) to grip tissue (Fig. 8; col. 7, ll. 1-10).
Thus, a person having ordinary skill in the art would recognize hills and valleys and concave hemispheres as equivalent structures in the art for gripping tissue. Therefore, a person having ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to substitute concave hemispheres taught by Kovac for the hills and valleys of Palese to achieve the predictable result of gripping tissue and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Palese in view of Ford 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 a trocar wound.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Palese in view of Ford and Ory, as applied to claim 17 above, and further in view of Stopek.
Regarding claim 18, the modified device discloses the invention substantially as claimed, except for the pusher including a hole for placing a fastening thread. However, Palese discloses that a tissue opening may be closed by suturing closed (para. [0090]).
Stopek, a reference in the wound closure field of endeavor, teaches providing a pusher (52; fig. 5) with a hole (lumen of sleeve (52)) for placing a fastening thread (74) for suturing a tissue opening to be closed (Figs. 7A-7B; paras. [0039]-[0043]).
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 pusher with a hole for placing a fastening thread, in view of Stopek, to allow a fastening thread to delivered with the patch to facilitate suturing a tissue opening closed after a surgical procedure.
Response to Arguments
Applicant's arguments filed July 25, 2025 have been fully considered but they are not persuasive.
On page 6 of the Response, Applicant argues that the claimed invention provides the “once the claimed patch is placed in position and released from the placement tool, the internal mesh permits the support to unfold into its use position in a homogenous way, i.e., with no folds.” (Response pg. 6). This argument is not persuasive.
The fact that the inventor has recognized an alleged benefit which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Furthermore, Applicant's arguments concerning the alleged benefit of the invention of the instant application is not commensurate with the scope of the claims. For example, the conditions for placement and positioning of the patch, the placement tool, the “internal” positioning of the mesh, and the “homogenous” unfolding are not recited in the claims. As such, these arguments concerning merits of the instant application are not given patentable weight until they are commensurate with the scope of the claims.
On page 6 of the Response, Applicant argues that Ory alone does not disclose “a mesh that would act as an internal skeleton with flexible properties that would aid in unfolding a patch.” (Response pg. 6). This argument is not persuasive.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Here, the combined teachings of Palese and Ory provide sufficient teaching and motivation for a person having ordinary skill in the art to have found obvious a “flexible mesh that acts as an internal skeleton whereby the patch unfolds for placement via the flexible mesh,” as claimed.
Palese discloses a mesh-like material with flexible properties so that the a patch unfolds for placement via the mesh-like material within a patient (paras. [0165]-[0166]).
Ory teaches configuring a mesh material as a flexible mesh (Fig. 2) that acts as an internal skeleton to improve mechanical properties and anchoring of the fabric (col. 3, ln. 59 – col. 4, ln. 15) after positioning and placement of the mesh on tissue within the confines of a patient (col. 1, ll. 4-9).
As the mesh-like material of Palese and the flexible mesh of Ory are configured for positioning and placement within the confines of a patient, a person having ordinary skill in the art would have found it obvious to provide the flexible mesh with properties sufficient for folding and unfolding, to facilitate placement of the mesh within a patient and to provide the patch with improved mechanical properties and improve anchoring of the patch within a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thomas et al. (U.S. Patent Application Publication No. 20100189764) disclosing a surgical mesh woven in a diamond or hexagonal pattern (Figs. 7A-7B).
Applicant's amendment necessitated any 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.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771