DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to the amendment filed 10/14/2025. Claims 1-2, 4-17, 19 and 20 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. (120) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 13/226,092, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘092 application fails to disclose a spacer body or a guide member as claimed.
Accordingly, the effective filing date for the claimed subject matter in the current application is 04/05/2012 and will be treated as such for examination purposes.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-17, 19 and 20 are rejected under 35 U.S.C. 101 because in claim 1, applicant positively recites part of a human, i.e. "a second flexible portion that extends away from the incision.” Thus claim 1 includes a human within its scope and is non-statutory. Claim 7 includes the same recitation in lines 5-6, i.e., “the second portion extends away from the incision.” Claim 16 includes the same recitation in line 6, i.e., “the second portion extends away from the incision.”
A claim directed to or including a human within its scope is not considered patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
It is noted that claim 16 should also be amended to clarify that the plate is configured to be secured to the vertebral bodies. See line 8.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-7, 12, 14-17, 19 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCarthy (U.S. 2012/0172989 A1) in view of Steinberg (U.S. 2002/0107573 A1).
Concerning claim 1, McCarthy discloses a surgical system for fusing adjacent vertebral bodies comprising: a spacer body (see Fig. 1, element 1) configured to be inserted into a disc space; a guide member (see Fig. 9, element 50) configured to connect to the spacer body (see par. 0061 and Fig. 5, element 13), wherein the guide member includes a first portion (threaded end – see par. 0039) and a second portion (extension away from threaded end) configured to extend away from the first portion and extend away from the incision; a plate (see Fig. 1, element 2) configured to pass over the guide member to be positioned adjacent the spacer body (see Figs. 9 and 10), wherein the plate includes at least one hole (see Fig. 1, element 15) to receive a fastener (see Fig. 2) to secure the plate to the adjacent vertebral bodies.
Concerning claim 2, wherein the spacer body comprises an upper surface and a lower surface having ridges (see Fig. 1, upper and lower surface of element 1).
Concerning claim 4, wherein the second portion (extension away from the threaded end) of the guide is attached to the first portion (threaded) of the guide using an adhesive or mechanical fixation. It is noted that the threaded end of the rod is mechanically fixed to the extension of the rod.
Concerning claim 5, wherein the plate comprises a ridge (see Fig. 1 below) along its perimeter.
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Concerning claim 6, wherein the plate is configured to be positioned at substantially a 90-degree angle relative to the spacer body prior to securing the plate to a vertebral body (see Fig. 9).
Concerning claim 7, McCarthy discloses a surgical system for fusing adjacent vertebral bodies comprising: a spacer body (see Fig. 1, element 1) configured to be inserted into a disc space through an incision; a guide member (see Fig. 9, element 50) configured to connect to the spacer body, wherein the guide member comprises a first portion (threaded end) and a second portion (shaft extending away from the threaded end); wherein the second portion (shaft) is configured to extend away from the first portion and away from the incision (see Fig. 9, element 50); a plate (see Fig. 9, element 2) configured to pass over the guide member to be positioned adjacent the spacer body, wherein the plate is configured to be secured to the adjacent vertebral bodies.
Concerning claim 12, wherein the plate includes a ridge (see Fig. 1 above) around its perimeter.
Concerning claim 14, wherein the plate comprises a central hole (see Fig. 1, element 15).
Concerning claim 15, further comprising a keying tool (see Fig. 3, element 16 – tool received in element 16) configured to be inserted through the central hole of the plate to prevent rotation between the plate and the spacer body.
Concerning claim 16, McCarthy discloses a surgical system for fusing adjacent vertebral bodies comprising: a spacer body (see Fig. 1, element 1) to be inserted into a disc space through an incision, wherein the spacer body includes a recess (see Fig. 5, near element 12); a guide member (see Fig. 9, element 50) configured to be connected adjacent to the spacer body (see Fig. 5, element 13 and Fig. 9), wherein the guide member includes a first portion (a threaded end) and a second portion (rod extension) that extends away from the first portion and that is configured to extend away from the incision; a plate (see Fig. 1, element 2) configured to pass over the guide member to be positioned adjacent the spacer body and secured to the vertebral bodies.
Concerning claim 17, further comprising a keying tool (see Fig. 2) configured to be inserted into the plate to prevent rotation between the plate and the spacer body, wherein the keying tool is not cannulated.
Concerning claim 19, further comprising a keying tool (see Fig. 9, element 53; mates with element 16 – see Fig. 3) to prevent rotation between the plate and the spacer body (see par. 0069).
Concerning claim 20, wherein the keying tool (see Fig. 9, element 53) is cannulated and operates over the guide member (see Fig. 9, element 50 and par. 0069).
However, McCarthy does not explicitly disclose that the second portion of the guide member is flexible.
Steinberg teaches the concept of using flexible guide members (see Fig. 33A, elements 900) to install spinal implants (2700) in the same field of endeavor for the purpose of permitting surgeons to navigate complex trajectories (even curved) inside the vertebrae or disc space, offering better control, less tissue disruption, and potentially faster recovery (see also Figs. 54B and 56A, element 172).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McCarthy’s guide to includes a flexible shaft, the concept of which is disclosed by Steinberg, in order to permit less tissue disruption during implantation. A flexible shaft is capable of bending around nerves or regions of the spine that can’t be disrupted.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCarthy (U.S. 2012/0172989 A1) in view of Steinberg (U.S. 2002/0107573 A1) as applied to claim 7 above.
Regarding claim 10, McCarthy in view of Steinberg disclose the invention substantially as described above. However, McCarthy in view of Steinberg do not explicitly disclose that the spacer body includes a rectangular hole extending from a superior surface to an inferior surface. McCarthy’s spacer includes multiple holes extending from a superior surface to an inferior surface.
It would have been obvious to one having ordinary skill in the art before the invention was made to form the hole in the shape of a rectangle, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a fusion opening extending from a superior surface to an inferior surface. In re Dailey and Eilers, 149 USPQ 47 (1966).
Concerning claim 11, wherein the superior surface and inferior surface of the spacer body includes a plurality of teeth (see Fig. 1, element 1 of McCarthy).
Regarding claims 8 and 9, McCarthy in view of Steinberg disclose the claimed invention except for explicitly disclosing that the first portion of the guide member is formed of nitinol and the second portion of the guide member is formed of stainless steel. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize nitinol and stainless steel to form the guide member components since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Both nitinol and stainless steel are utilized in the orthopedic field to form insertion tools and implants.
Claim 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCarthy (U.S. 2012/0172989 A1) in view of Steinberg (U.S. 2002/0107573 A1) as applied to claim 7 above, further in view of Kirschman (U.S. 8,945,227 B2).
McCarthy in view of Steinberg disclose the invention substantially as described above. However, McCarthy in view of Steinberg do not disclose that the plate is secured to the vertebral bodies via at least two screws.
Kirschman teaches a surgical system for fusing adjacent vertebral bodies comprising a plate secured to the vertebral bodies via at least two screws (see Fig. 7A, element 28 – upper and lower) in the same field of endeavor for the purpose of stabilizing the spine.
It would have been obvious to one having ordinary skill in the art before the invention was made to modify McCarthy’s system by simply substituting the two spikes projections on the plate for screw openings and screws, the concept of which is disclosed by Kirschman, because doing so is a simple substitution of one known connecting mechanism for another in order to obtain the predictable result of attaching a vertebral plate to a vertebra.
Response to Arguments
Applicant’s arguments filed 10/14/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773