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 . Claims 1-20 are pending and examined below.
Response to Arguments
Applicant’s arguments, filed 01/29/2026, with respect to the rejection(s) of claim(s) 1-20under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hirata. Please see the rejection below.
Claim Objections
Claims 2 & 5 objected to because of the following informalities:
Claim 2 recites the limitation “ ‘the’ first, second, third, and fourth arms” in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “The medical device according to claim 43”. It is unclear what claim, claim 5 is dependent from. For the purpose of examination, it is being regarded as depending from claim 4.
Appropriate correction is required.
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.
Claim(s) 1, & 3-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 5501700 A) in view of Seid (US 5254133 A) and further in view of Kugel (US 5634931 A).
Regarding claim 1, Hirata teaches a medical device (Fig. 1, Hirata) for repairing a defect in a tissue of an animal (tympanic membrane, abstract, Hirata), said medical device comprising:
an overlay member (3, Fig. 5, Hirata) comprising an overlay member body (body of 3, Fig. 5, Hirata) having a first overlay member surface (one side of 3, Fig. 5, Hirata), a second, opposing overlay member surface (another side of 3, Fig. 5, Hirata),
the overlay member body (body of 3, Fig. 5, Hirata) defining a first overlay member passageway (see annotate Fig. 3 below, Hirata) extending through the overlay member body from the first overlay member surface (one side of 3, Fig. 5, Hirata) to the second overlay member surface (another side of 3, Fig. 5, Hirata);
an underlay member (1, Fig. 3, Hirata) comprising an underlay member body (body of 1, Fig. 3, Hirata) having a first underlay member surface (one side of 1, Fig. 5, Hirata) and a second, opposing underlay member surface (another side of 1, Fig. 5, Hirata),
the underlay member body defining a peripheral edge (peripheral edge at 1, Fig. 4, Hirata), and
a first underlay member passageway (see annotate Fig. 3 below, Hirata) extending through the underlay member body from the first underlay member surface to the second underlay member surface (see annotate Fig. 3 below, Hirata); and
a securement member (2, Fig. 3, Hirata) extending through the first overlay member passageway and the first underlay member passageway (see annotate Fig. 3 below, Hirata).
Hirata does not teach at least one arm. However, Seid teaches a surgical implantation device to be placed within a patient's body (abstract, Seid)
and at least one arm (96, Fig. 15, Seid).
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 teachings of Hirata by incorporating the at least one arm as taught by Seid in order to better reinforce the implantation site (col. 9, lines 49-50, Seid).
Hirata in view of Seid does not teach at least one slit extending inwardly from the peripheral edge. However, Kugel teaches surgically implantable hernia mesh patches (abstract, Kugel) wherein
at least one slit (58, Fig. 5, Kugel) extending inwardly from the peripheral edge.
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 teachings of Hirata and Seid by incorporating at least one slit extending inwardly from the peripheral edge as taught by Kugel in order to create scalloped or fringed edges to fill uneven voids in the patient's tissue surface (col. 5 lines 3-5, Kugel).
Regarding claim 3, Hirata teaches
wherein the underlay member comprises a bioremodelable material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 4, Hirata teaches
wherein the underlay member comprises a synthetic material (artificial material, col. 4 lines 31-32, Hirata).
Regarding claim 5, Hirata teaches
wherein the underlay member comprises a natural material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 6, Hirata teaches
wherein the underlay member comprises a collagenous material (collagen fiber membrane, col. 4, line 33, Hirata).
Regarding claim 7, Hirata teaches
wherein the underlay member comprises extracellular matrix (collagen fiber membrane, col. 1 lines 43, Hirata).
Regarding claim 8, Hirata teaches
wherein the overlay member comprises a bioremodelable material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 9, Hirata teaches
wherein the overlay member comprises a synthetic material (artificial material, col. 4 lines 31-32, Hirata).
Regarding claim 10, Hirata teaches
wherein the overlay member comprises a foam artificial material, col. 4 lines 31-32, Hirata).
Regarding claim 11, Hirata teaches
wherein the securement member comprises a bioremodelable material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 12, Hirata teaches
wherein the underlay member and the overlay member are formed of the same material (same material, col. 4 lines 34-35, Hirata).
Regarding claim 13, Hirata teaches
wherein the overlay member (3, Fig. 3, Hirata) defines a second overlay member passageway (see annotated Fig. 3 below, Hirata) extending through the overlay member body from the first overlay member surface (left surface of 3, Fig. 3, Hirata) to the second overlay member surface (right surface of 3, Fig. 2, Hirata); wherein
the underlay member (1, Fig. 3, Hirata) defines a second underlay member passageway (see annotated Fig. 3 below Hirata) extending through the underlay member body from the first underlay member surface (left surface of 1, Fig. 3, Hirata) to the second underlay member surface (right surface of 1, Fig. 3, Hirata); and wherein
the securement member (2, Fig. 3, Hirata) extends through the second overlay member passageway and the second underlay member passageway (see annotated Fig. 3 below, Hirata).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Seid, Kugel, and further in view of Gainor et al. (US 6911037 B2) hereinafter, Gainor.
Regarding claim 2, Hirata in view of Seid does not teach the overlay member body defines a first curvilinear edge disposed between and connecting the first and second arms, a second curvilinear edge disposed between and connecting the second and third arms, a third curvilinear edge disposed between and connecting the third and fourth arms, and a fourth curvilinear edge disposed between and connecting the fourth and first arms. However, Gainor teaches a septal defect closure device (abstract, Gainor)
wherein the overlay member body (34, Fig. 4) defines a first curvilinear edge (40, Fig. 4, Gainor) disposed between and connecting the first (36, Fig. 4, Gainor) and second arms (2nd 36, Fig. 4, Gainor), a second curvilinear edge (2nd 40, Fig. 4, Gainor) disposed between and connecting the second and third arms (3rd 36, Fig. 4, Gainor), a third curvilinear edge (3rd 40, Fig. 4, Gainor) disposed between and connecting the third and fourth arms (4th 36, Fig. 4, Gainor), and a fourth curvilinear edge (4th 40, Fig. 4, Gainor) disposed between and connecting the fourth and first arms (Fig. 4, Gainor).
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 teachings of Hirata and Seid by the teachings above as taught by Gainor in order to reduce the chances that blood will freely shunt across the defect (col. 5 lines 34-35, Gainor).
Claim(s) 14-17 & 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Gainor and further in view of Kugel.
Regarding claim 14, Hirata teaches a medical device (Fig. 1, Hirata) for repairing a defect in a tissue of an animal (tympanic membrane, abstract, Hirata), said medical device comprising:
an overlay member (3, Fig. 5, Hirata) comprising an overlay member body (body of 3, Fig. 5, Hirata) having a first overlay member surface (one side of 3, Fig. 5, Hirata), a second, opposing overlay member surface (another side of 3, Fig. 5, Hirata),
a first overlay member passageway (see annotate Fig. 3 below, Hirata) extending through the overlay member body from the first overlay member surface (one side of 3, Fig. 5, Hirata) to the second overlay member surface (another side of 3, Fig. 5, Hirata), and
a second overlay member passageway (see annotated Fig. 3 below, Hirata) extending through the overlay member body from the first overlay member surface to the second overlay member surface (see annotated Fig. 3 below, Hirata);
an underlay member (1, Fig. 3, Hirata) comprising an underlay member body (body of 1, Fig. 3, Hirata) having a first underlay member surface and a second, opposing underlay member surface, the underlay member body defining a peripheral edge,
a first underlay member passageway (see annotated Fig. 3 below, Hirata) extending through the underlay member body from the first underlay member surface to the second underlay member surface (see annotated Fig. 3 below, Hirata), and
a second underlay member passageway (see annotated Fig. 3 below, Hirata) extending through the underlay member body from the first underlay member surface to the second underlay member surface (see annotated Fig. 3 below, Hirata); and
a securement member (2, Fig. 3, Hirata) extending through the first overlay member passageway, the first underlay member passageway, the second underlay member passageway, and the second overlay member passageway (see annotated Fig. 3 below, Hirata).
Hirata does not teach a first arm, a second arm, a third arm, and a fourth arm. However, Gainor teaches
a first arm (loop 36, Fig. 4, Gainor), a second arm (2nd loop 36, Fig. 4, Gainor), a third arm (3rd loop 36, Fig. 4, Gainor), and a fourth arm (4th loop 36, Fig. 4, Gainor),
the overlay member body defining a first curvilinear edge (40, Fig. 4, Gainor) disposed between and connecting the first and second arms, a second curvilinear edge (2nd 40, Fig. 4, Gainor) disposed between and connecting the second and third arms, a third curvilinear edge (3rd 40, Fig. 4, Gainor) disposed between and connecting the third and fourth arms, and a fourth curvilinear edge (4th 40, Fig. 4, Gainor) disposed between and connecting the fourth and first arms (Fig. 4, Gainor).
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 teachings of Hirata by incorporating the arms above as taught by Gainor in order to reduce the chances that blood will freely shunt across the defect (col. 5 lines 34-35, Gainor).
Hirata in view of Gainor does not teach a first slit extending inwardly from the peripheral edge, a second slit extending inwardly from the peripheral edge, a third slit extending inwardly from the peripheral edge, a fourth slit extending inwardly from the peripheral edge. However, Kugel teaches
a first slit extending inwardly from the peripheral edge, a second slit extending inwardly from the peripheral edge, a third slit extending inwardly from the peripheral edge, a fourth slit extending inwardly from the peripheral edge (multiples of 58, Fig. 5, Kugel).
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 teachings of Hirata and Gainor by incorporating at least one slit extending inwardly from the peripheral edge as taught by Kugel in order to create scalloped or fringed edges to fill uneven voids in the patient's tissue surface (col. 5 lines 3-5, Kugel).
Regarding claim 15, Hirata teaches
wherein the underlay member comprises a natural material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 16, Hirata teaches
wherein the underlay member comprises a bioremodelable material (lyophyrized human dura, col. 4 lines 33-34, Hirata).
Regarding claim 17, Hirata teaches
wherein the underlay member comprises extracellular matrix (collagen fiber membrane, col. 1 lines 43, Hirata).
Regarding claim 19, Hirata teaches
wherein the overlay member comprises a synthetic material (artificial material, col. 4 lines 31-32, Hirata).
Regarding claim 20, Hirata teaches a medical device (Fig. 1, Hirata) for repairing a defect in a tissue of an animal (tympanic membrane, abstract, Hirata), said medical device comprising:
an overlay member (3, Fig. 5, Hirata) formed of a synthetic material (artificial material, col. 4 lines 31-32, Hirata), the overlay member comprising an overlay member body (body of 3, Fig. 5, Hirata) having a first overlay member surface (one side of 3, Fig. 5, Hirata), and a second, opposing overlay member surface (another side of 3, Fig. 5, Hirata),
the overlay member body (body of 3, Fig. 5, Hirata) defining a first overlay member passageway (see annotate Fig. 3 below, Hirata) extending through the overlay member body from the first overlay member surface to the second overlay member surface(see annotate Fig. 3 below, Hirata);
an underlay member (1, Fig. 3, Hirata) formed of a bioremodelable material (artificial material, col. 4 lines 31-32, Hirata),
the underlay member (1, Fig. 3, Hirata) comprising an underlay member body (body of 1, Fig. 3, Hirata) having a first underlay member surface (one side of 1, Fig. 5, Hirata) and a second, opposing underlay member surface (another side of 1, Fig. 5, Hirata), the underlay member body defining a peripheral edge,
a first underlay member passageway (see annotate Fig. 3 below, Hirata) extending through the underlay member body from the first underlay member surface (one side of 1, Fig. 5, Hirata) to the second underlay member surface (see annotate Fig. 3 below, Hirata) and
a securement member (2, Fig. 3, Hirata) extending through the first overlay member passageway and the first underlay member passageway (see annotate Fig. 3 below, Hirata).
Hirata does not teach a cross-shaped overlay member. However, Gainor teaches
a cross-shaped overlay member (Fig. 4, Gainor).
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 teachings of Hirata by incorporating the cross-shaped overlay member above as taught by Gainor in order to pull the membrane relatively taut. (col. 5 lines 19-20, Gainor).
Hirata in view of Gainor does not teach a slit extending inwardly from the peripheral edge. However, Kugel teaches
a slit (58, Fig. 5, Kugel) extending inwardly from the peripheral edge (Fig. 5, Kugel).
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 teachings of Hirata and Gainor by incorporating at least one slit extending inwardly from the peripheral edge as taught by Kugel in order to create scalloped or fringed edges to fill uneven voids in the patient's tissue surface (col. 5 lines 3-5, Kugel).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Gainor and Kugel and further in view of Malaviya et al. (US 20030021827 A1) hereinafter, Malaviya.
Regarding claim 18, Hirata does not teach the underlay member comprises small intestine submucosa. However, Malaviya teaches a porous extracellular matrix scaffold for repairing or regenerating body tissue (¶0003, Malaviya)
wherein the underlay member comprises small intestine submucosa (¶0005, Malaviya).
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 teachings of Hirata, Gainor, and Kugel by incorporating small intestine submucosa as taught by Malaviya in order to repair, support, and stabilize a wide variety of anatomical defects and traumatic injuries that can remodel the qualities of its host when implanted in human soft tissues (¶0004, Malaviya).
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Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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