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 Objections
Claim 6 is objected to because of the following informalities:
Regarding claim 6, “fist” should be “first”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,885,284 (Errico).
Regarding claim 1, Errico discloses a sternal bridge, comprising: a contiguous panel (100/102, see Figs. 5-10; all parts of the panel are touching so as to form one contiguous structure) having a first length and a first height (see marked-up Fig. 10 below); a first U-shaped notch of a second height less than the first height and a first depth on one end of the contiguous panel (see marked-up Fig. 10 below); a second U-shaped notch of the second height and the first depth on an opposite end of the contiguous panel (see marked-up Fig. 10 below); a concave shape on a lower surface of the contiguous panel (inward indentation in lower surface of panel 100; see marked-up Fig. 10 below); and a first through hole (107) passing from the lower surface of the panel through both sides of the first U-shaped notch (through hole 107 passes from the lower surface of panel 100 and is in communication with both sides of the U-shaped notch; claim does not require through hole to pass through the upper surface), and a second through hole (107; see col. 5, lines 18-21 and Figs. 7 and 10, end 122 is substantially identical to end 102, including both ends having a through hole 107) passing from the lower surface of the panel through both sides of the second U-shaped notch (through hole 107 passes from the lower surface of panel 100 and is in communication with both sides of the U-shaped notch; claim does not require through hole to pass through the upper surface), the first and second through holes enabling the sternal bridge to be sutured onto the chest wall on either side.
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Further regarding claim 1, a recitation of the intended use of the claimed invention (“a sternal bridge”; “enabling the sternal bridge to be sutured onto the chest wall on either side”) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 2 and 3, Errico discloses the bridge being made from a bio-safe material that is one of stainless-steel, titanium or plastic (see col. 4, lines 50-56).
Regarding claims 4 and 5, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). As the bridge of Errico is structurally similar to the claimed bridge (see analysis of claim 1 above), the product-by-process claims 4 and 5 are unpatentable.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of U.S. Patent Application Publication No. 2019/0321193 (Casey).
Alternatively regarding claims 4 and 5, Casey discloses that orthopedic implants can be manufactured via multiple methods, including 3D printing and machining (see paragraph [0076]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to manufacture the bridge of Errico via 3D printing or machining, as Casey suggests such manufacturing methods are suitable for manufacturing orthopedic implants (see Casey, paragraph [0076]).
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of U.S. Patent Application Publication No. 2014/0222074 (Rathbun).
Regarding claim 6, Errico discloses a sternal bridge, comprising: a first contiguous panel (120) having a first length and a first height (see marked-up Fig. 7 below); a first U-shaped notch of a second height less than the first height and a first depth from the first end of the first contiguous panel, the first depth less than the first length (see marked-up Fig. 7 below); a second contiguous panel (100) having the first length from a first end of the second contiguous panel and the first height (see marked-up Fig. 5 below; see also col. 5, lines 18-21, ends 122 and 102 of panels 120 and 100 are substantially identical); a second U-shaped notch of the second height and the first depth from a second end of the second contiguous panel (see marked-up Fig. 5 below; see also col. 5, lines 18-21, ends 122 and 102 of panels 120 and 100 are substantially identical), the second U-shaped notch facing opposite the first U-shaped notch (see Fig. 10); an extension (126) having a rectangular cross-section extending from the first contiguous panel toward the second contiguous panel and into a rectangular passage (passage between members 108a and 108b) in the second contiguous panel (see Figs. 5, 7, and 10); a hole (128) of a first diameter extending upward through the extension; a retainer hole (109) downward into the second contiguous panel near the first end of the second contiguous panel; a retainer (130) having a vertical post (132) of a diameter less than the retainer hole, extending downward from a handle (134) joined to the post, such that the post may be passed into the retainer hole and through the hole in the extension, fixing the first and the second contiguous panels at a fixed distance apart (col. 5, line 37 – col. 6, line 14); a first through hole (107; see col. 5, lines 18-21 and Figs. 7 and 10, end 122 is substantially identical to end 102, including both ends having a through hole 107) passing upward from a lower surface through both sides of the first U-shaped notch (through hole 107 passes from the lower surface of panel 100 and is in communication with both sides of the U-shaped notch; claim does not require through hole to pass through the upper surface), and a second through hole (107) passing from the lower surface through both sides of the second U-shaped notch (through hole 107 passes from the lower surface of panel 100 and is in communication with both sides of the U-shaped notch; claim does not require through hole to pass through the upper surface), the first and second through holes enabling the adjustable sternal bridge to be sutured onto a portion of a chest wall on either side; wherein the post may be withdrawn by the handle from the retainer hole and the first and second contiguous panels may be repositioned at a different distance apart, resetting the distance between the first and second contiguous panels (col. 5, line 37 – col. 6, line 14).
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Further regarding claim 6, a recitation of the intended use of the claimed invention (“a sternal bridge”; “enabling the adustable sternal bridge to be sutured onto a portion of a chest wall on either side”) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Further regarding claim 6, Errico fails to disclose a plurality of holes of a first diameter extending upward through the extension, sequentially spaced along a length of the extension; the retainer hole diameter being greater than the first diameter of the plurality of holes; wherein the post may be returned through a different hole in the extension after the first and second contiguous panels have been repositioned at a different distance apart. However, Rathbun discloses a bone support apparatus (see Abstract) including an adjustable-length connector (106) including a first component (254) received within a second component (260), the first component having an extension (296) including a plurality of holes (310) of a first diameter extending upward through the extension, sequentially spaced along a length of the extension (see Fig. 24), and the second component (260) having a retainer hole (268), the retainer hole diameter being greater than the first diameter of the plurality of holes (see Fig. 24), wherein a post (140a) may be returned through different holes in the extension during repositioning of the first and second components at different distances apart (see paragraphs [0115], [0119], and [0128]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the length-adjustment mechanism of Rathbun (discrete openings along the extension) for the length-adjustment mechanism of Errico (elongated slot along the extension) in order to prevent unintentional length adjustment via sliding of a loosened the post in a slot of the extension by utilizing discrete openings instead. Additionally, such a modification is a simple substitution of one adjustment mechanism from a known surgical implant device for another known adjustment mechanism from another known surgical implant device without any unpredictable results.
Regarding claims 7 and 8, Errico discloses the bridge being made from a bio-safe material that is one of stainless-steel, titanium or plastic (see col. 4, lines 50-56).
Regarding claims 9 and 10, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). As the bridge of Errico in view of Rathbun is structurally similar to the claimed bridge (see analysis of claim 6 above), the product-by-process claims 9 and 10 are unpatentable.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of Rathbun, and further in view of Casey.
Alternatively regarding claims 9 and 10, Casey discloses that orthopedic implants can be manufactured via multiple methods, including 3D printing and machining (see paragraph [0076]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to manufacture the bridge of Errico via 3D printing or machining, as Casey suggests such manufacturing methods are suitable for manufacturing orthopedic implants (see Casey, paragraph [0076]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Mundis, Samuel, Moore, and Slivka references disclose additional surgical bridges.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773