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 .
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 75, 84, 90-92, 104 and 105 are rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476). Sideris discloses the invention substantially as claimed. Sideris discloses, at least in figures 1 and 5 and col. 4, lines 8-58 and col. 5, lines 33-63; a medical implant, comprising an adhesive composition (1), the medical implant comprises two states, wherein the medical implant in its first state can be deployed to the implant site while the adhesive composition is inactive (according to col. 4, lines 40-55), and brought into the second state, by an activation mechanism, the adhesive composition, in said second state, is curable by a curing mechanism (according to col. 4, lines 55-58) wherein the medical implant is a patch (2) adapted to repair or close an opening in a ventricular, atrial, or septal wall (according to col. 1, lines 29-37), the medical implant further comprising at least one retaining element (a portion of the patch, in combination with the adhesive composition, as shown in fig. 5) for retaining a suture (an unlabeled thread at the right-hand side of fig. 5); wherein the adhesive composition is arranged on the medical implant in a pattern (in a band-like structure on the right-hand side of the patch, as shown in fig. 5); wherein the adhesive composition comprises a dried adhesive composition (i.e., a solid composition, according to col. 4, lines 17-20); wherein the dried adhesive composition is activatable by exposure to a liquid (e.g., blood, according to col. 4, lines 55-58); wherein the medical implant comprises a biodegradable material (according to col. 2, lines 53-56; col. 5, lines 47-49; and col. 6, lines 5-6); and wherein the medical implant comprises a spine structure (13, according to col. 5, lines 49-55).
However, for the medical implant shown in fig. 5, Sideris does not explicitly disclose that the at least one retaining element provides a connection to a delivery device, at an outer circumference of the medical implant, wherein the suture is arranged within a loop of the at least one retaining element. Nevertheless, Sideris teaches, in figures 8 and 9 and col. 6, lines 3-28; a medical implant including at least one retaining element (a loop attached to neck 12, as shown in fig. 8) providing a connection to a delivery device (11), at an outer circumference of the medical implant (at patch 9), wherein a suture (10) is arranged within a loop of the at least one retaining element. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of figures 8 and 9, to modify the medical implant shown in fig.5, so that it includes at least one retaining element providing a connection to a delivery device, at an outer circumference of the medical implant, wherein the suture is arranged within a loop of the at least one retaining element. Such modifications would allow a delivery device to advance the medical implant to a physiological opening and precisely implant the medical implant at a surgical site.
Also, Sideris does not explicitly disclose that the biodegradable material is adapted to lose its mechanical strength in a human body within six to 36 months. Nevertheless, Sideris discloses, in col. 5, lines 40-43; that the medical implant may be in a human body “for a long enough period of time in order for the patch to become attached to the cardiac tissue through the normal coagulation/endothelization process.”
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply a biodegradable material in the medical implant, so that it is adapted to lose its mechanical strength in a human body within a time period as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal of workable ranges (e.g., of time periods for a biodegradable material to lose its mechanical strength in a human body) involves only routine skill in the art. In re Aller.
Claims 76-79 are rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476) in view of Lowinger (2013/0030324). Sideris disclose the invention substantially as claimed, wherein the medical implant includes a support structure (13). However, Sideris does not explicitly disclose that the medical implant comprises a radiopaque element, wherein the radiopaque element is arranged within or formed by the adhesive composition, or wherein the radiopaque implant comprises at least one barium sulfate and iodine. Lowinger teaches, in para. [0030] and [0044], a medical implant comprising a radiopaque element (16), wherein the radiopaque element is arranged within or formed by the adhesive composition (16), wherein the radiopaque implant comprises at least one barium sulfate and iodine. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Lowinger, to include a radiopaque element, wherein the radiopaque element is arranged within or formed by the adhesive composition, or wherein the radiopaque implant comprises at least one barium sulfate and iodine. Such a modification would allow locating of the adhesive composition and/or the medical implant relative to its position within target tissue.
Claims 80-82 are rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476) in view of Turkington et al. (10,548,579). Sideris discloses the invention substantially as claimed, wherein the medical implant has a first and a second surface; wherein the first and the second surfaces have substantially opposite orientations, and wherein at least one property of the first surface (formed of mesh) is different from a corresponding property of the second surface (having the adhesive composition); wherein the first surface is adapted to enhance cell ingrowth (via cells of the mesh); and wherein the second surface is adapted to provide adhesion to biological tissue.
However, Sideris does not explicitly disclose that the medical implant has a generally flat shape. Turkington et al. teach, in figure 10, and col. 12, lines 54-66; a medical implant (310) having a generally flat shape with a first and a second surface. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Turkington et al., to modify the medical implant of Sideris, so that has a generally flat shape with a first and a second surface. Such a modification would allow the medical implant to be shaped into a collapsed delivery configuration as well as a deployed configuration wherein the medical implant may be expanded up to the generally flat shape or collapsed to another configuration.
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476) in view of Makower (2007/0250103). Sideris discloses the invention substantially as claimed, but does not explicitly disclose that at least one surface of the implant comprises a velour-like surface. Makower teaches, in figure 22 and para. [0203], a medical implant (10) including at least one surface (152) comprising a velour-like surface. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Makower, to modify the medical implant of Sideris, so that at least one surface of the implant comprises a velour-like surface. Such a modification would promote tissue ingrowth within the medical implant.
Claims 85-88 are rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476) in view of Khademhosseini (2019/0022280). Sideris discloses the invention substantially as claimed, wherein the adhesive composition may be activated with electromagnetic radiation, according to col. 5 lines 6-16. However, Sideris does not explicitly disclose that the adhesive composition comprises GelMA; wherein the GelMA is of animal origin selected from Fish GelMA or porcine GelMA; wherein the GelMA is formed by a mixture of at least two GelMAs of animal origin; or wherein the adhesive composition further comprises a photoinitiator. Khademhosseini teaches, in para. [0061]-[0065], an adhesive composition comprising GelMA; wherein the GelMA is of animal origin selected from Fish GelMA or porcine GelMA; wherein the GelMA is formed by a mixture of at least two GelMAs of animal origin; and wherein the adhesive composition comprises a photoinitiator. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Khademhosseini, so that the adhesive composition comprises GelMA; wherein the GelMA is of animal origin selected from Fish GelMA or porcine GelMA; wherein the GelMA is formed by a mixture of at least two GelMAs of animal origin; and wherein the adhesive composition comprises a photoinitiator. Such a modification would provide a cross-linkable, biocompatible adhesive suitable for adhering the medical implant to tissue.
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Sideris (9,011,476) in view of Khademhosseini (2019/0022280), and further in view of Fathi (2012/000089180). Sideris in view of Khademhosseini discloses the invention substantially as claimed, but does not explicitly disclose that the GeIMA is cross-linkable by X-ray radiation. Fathi teaches, in para. [0108], an adhesive composition that may be cross-linkable by X-ray radiation. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Fathi, to cross-link the adhesive composition of Sideris in view of Khademhosseini by X-ray radiation. Such a modification would allow rapid curing of the adhesive composition.
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.
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771