DETAILED ACTION
Specification
The amendment filed March 31, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The concave shape having a depth of at least one-quarter of the first height.
The drawings by themselves do not clearly indicate to one of ordinary skill in the art that the inventors had possession of the entire scope of this feature, as the disclosure only provides a single drawing (Fig. 1A) showing one depth of the concave shape relative to the first height; yet, the subject matter describes the concave shape as having a broad range of possible relative depths. Additionally, the specification has no written text describing this subject matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim 1, from which claims 2-5 depend, contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites that the concave shape has “a depth of at least one-quarter of the first height”. The drawings by themselves do not clearly indicate to one of ordinary skill in the art that the inventors had possession of the entire scope of this feature, as the disclosure only provides a single drawing (Fig. 1A) showing one depth of the concave shape relative to the first height; yet, the subject matter describes the concave shape as having a broad range of possible relative depths. Additionally, the specification has no written text describing this subject matter.
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 Application Publication No. 2010/0191287 (Bucci).
Regarding claim 1, Bucci discloses a sternal bridge (10), comprising: a one-piece panel (12; see paragraph [0044]) having a first length and a first height (see marked-up Fig. 2 below); a first U-shaped notch of a second height less than the first height and a first depth on one end of the one-piece panel (see marked-up Fig. 2 below); a second U-shaped notch of a third height and a second depth on an opposite end of the one-piece panel (see marked-up Fig. 2 below); a concave shape (38) on a lower surface of the one-piece panel having a depth of at least one-quarter of the first height (see marked-up Fig. 2 below).
PNG
media_image1.png
592
881
media_image1.png
Greyscale
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, Bucci discloses the bridge being made from a bio-safe material that is one of stainless-steel, titanium or plastic (see paragraph [0018]).
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 Bucci 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 Bucci 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 Bucci 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 U.S. Patent No. 5,885,284 (Errico) in view of U.S. Patent Application Publication No. 2014/0222074 (Rathbun) and U.S. Patent No. 8,828,061 (Scrantz).
Regarding claim 6, Errico discloses an adjustable 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); a rectangular passage (passage between members 108a and 108b) extending into the second contiguous panel from the first end of the second contiguous panel (see Figs. 5 and 10), the rectangular passage positioned below a top surface of the second contiguous panel (see Figs. 5 and 10); an extension (126) having a rectangular cross-section extending from the first contiguous panel into the rectangular passage of the second contiguous panel (see Figs. 5, 7, and 10), the extension positioned on a second end of the first contiguous panel such that the top surfaces and bottom surfaces of the first and second contiguous panels are coplanar (see marked-up Fig. 10 below); 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).
PNG
media_image2.png
457
1138
media_image2.png
Greyscale
PNG
media_image3.png
260
898
media_image3.png
Greyscale
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.
Further regarding claim 6, Errico fails to disclose the rectangular passage positioned entirely above the second U-shaped notch. However, Scrantz discloses a surgical stabilization device (10) having two panels (12 and 14), the panels each including a U-shaped notch (defined by connector members 16/17, see Figs. 2 and 3), a rectangular passage (passage in panel 14, see Figs. 2 and 3 and col. 4, line 63 – col. 6, line 3) extending into the second panel from a first end of the second panel, the rectangular passage positioned below a top surface of the second panel and entirely above the U-shaped notch of the second panel (see marked-up Fig. 3 below), an extension (telescoping extension of panel 12, see Figs. 2 and 3 and col. 4, line 63 – col. 6, line 3) having the rectangular cross-section of the rectangular passage extending from the first panel into the rectangular passage of the second panel (see col. 4, line 63 – col. 6, line 3), the extension positioned on a second end of the first panel such that the top and bottom surfaces of the first and second panels are coplanar (see Figs. 2 and 3). It would have been a prima facie obvious matter of design choice to reposition the rectangular passage and extension such that they are entirely above the second U-shaped notch of the second panel, as Scrantz suggests a configuration still allows for adjustable telescoping of one panel relative to another, and it has been held that relocating parts of an invention involves only routine skill in the art when the relocation does not modify the operation of the device. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
PNG
media_image4.png
450
1031
media_image4.png
Greyscale
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 Scrantz, 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]).
Response to Arguments
Applicant’s arguments with respect to claims 1-10 have been considered but are moot in view of the new grounds of rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
Prosecution Insights