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 07/16/2026. 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. (e) 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. 13/439,981, 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.
Application 13/439,981 is a continuation-in-part of 13/226,092. The guide member subject matter recited in claims 1, 7, and 16, e.g., the guide member having a substantially rigid portion and a more flexible portion, the delivery of the plate over the guide member via central hole, and the keying tool 500/600 — corresponds to FIGS. 10–16D and paragraphs [0073]–[0084] of the published specification, which were first presented in the CIP application 13/439,981 and are not disclosed in 13/226,092. Under 35 U.S.C. § 120, a claim in a CIP is entitled only to the filing date of the parent for subject matter disclosed in the parent in the manner provided by § 112(a). See MPEP § 211.05.
Accordingly, the earliest effective filing date available to claims 1, 2, 4–17, and 19–20 based on the disclosed subject matter is April 5, 2012, and, for the reasons in the § 112(a) rejection below, claims 1, 7, and 16 as currently amended are entitled to no benefit date earlier than April 19, 2023.
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, 2, 4-17, 19 and 20 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. The claim(s) 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.
Independent claims 1, 7 and 16 were amended to recite “a plate having an opening configured to enter a proximal open end of the second flexible portion connected to the inserted spacer body, slide distally over the second flexible portion, and then the first rigid portion.” It is noted that the specification lacks support for the flexible portion having an "open end." The flexible portion 408 (see Fig. 10) is described throughout as a solid elongate member, i.e., "a nitinol wire" (see par. 0080), and "In addition, in some embodiments, the flexible portion 408 can comprise a stainless steel or titanium cable" (see par. 0081). A wire or cable has no open end, and no figure depicts a lumen, bore, or open proximal terminus in the flexible portion 408. The specification instead describes the plate being "inserted over the guide 400 via the central hole 104, where it can travel over the flexible portion 408" (see par. 0083). The plate passes over the exterior of the flexible portion, not into an open end of it.
The limitation that the plate enters a proximal open end of the second flexible portion constitutes new matter. The limitation is not supported by the specification as originally filed in any of applications 13/226,092, 13/439,981, 15/223,664, or 16/717,395, claims 1, 7, and 16 (and claims 2, 4–6, 8–15, 17, and 19–20 depending therefrom) are entitled to an effective filing date no earlier than April 19, 2023.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims, 1, 2, 4-17, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As noted above, claims 1, 7, and 16 were amended to include the recitation "configured to enter a proximal open end." It is unclear what structure enters what. Read literally, the opening of the plate enters an open end of the guide member, which is inconsistent with the specification, in which the guide member passes through the opening of the plate (see par. 0083). The metes and bounds of the claimed plate-to-guide relationship cannot be determined.
For purposes of examination below, this limitation has been construed as requiring an opening in the plate dimensioned to receive a proximal end of the second/flexible portion.
Claims 1, 7, and 16 recite "the inserted spacer body." Each independent claim recites "the second flexible portion connected to “the inserted spacer body." There is insufficient antecedent basis for this limitation in the claim; the claims recite only "a spacer body configured to be inserted into a disc space." It is further unclear whether the claims are attempting to positively recite an implanted state.
Claim 7 recites a guide member comprising "a first portion and a second portion, the second portion being more flexible than the first portion," and later recites "and then the first rigid portion." There is insufficient antecedent basis for "the first rigid portion" in claim 7. It is unclear whether Applicant intends this to refer to the previously recited "first portion" or to introduce a further structural requirement of rigidity.
Claims 1, 7, and 16 are directed to "A surgical system," yet the claims recite an ordered sequence of operational steps performed on the plate: the opening is configured to "enter a proximal open end” … “slide distally over the second flexible portion, and then the first rigid portion to be positioned adjacent the spacer body." A single claim covering both an apparatus and a method of using that apparatus is indefinite.
Claim 16 recites "a guide member configured to be connected adjacent to the spacer body." It is unclear whether the guide member is connected to the spacer body, or merely positioned adjacent to the spacer body and connected to something else. The specification describes the threaded attachment into aperture 36 of the spacer body (see par. 0080) but does not describe a guide member "connected adjacent to" the spacer body.
Claims 2, 4–6 depend from claim 1; claims 8–15 depend from claim 7; and claims 17 and 19–20 depend from claim 16. They are rejected for the same reasons as the claims from which they depend.
20. **"A surgical system for fusing adjacent vertebral bodies comprising: a spacer body configured to be inserted into a disc space through an incision."** Dewey discloses an intervertebral device 10 for spacing apart vertebral members 100, comprising shims 20/20a that are "individually inserted into the intervertebral space 101" formed between adjacent vertebral members (Dewey, FIGS. 7–17; col. — , "The present application is directed to an intervertebral device 10 to space apart vertebral members"). Dewey further teaches that the first end 21 of the shim "may include a rounded shape to facilitate insertion through soft tissue and into the intervertebral space 101," establishing insertion through a surgical access path, and teaches anterior, lateral, and posterior approaches.
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) extending proximally away from the first portion; a plate (see Fig. 1, element 2) having an opening (see Fig. 1, element 15) 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.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Ridge)]
PNG
media_image1.png
316
590
media_image1.png
Greyscale
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 proximally away from the first portion and away from the incision (see Fig. 9, element 50); a plate (see Fig. 9, element 2) having an opening (see Fig. 1, element 15) 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 include 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. McCarthy's rod must be rigid at its distal end 50a in order to be threaded into the tapped distal portion 13 of the implant hole and to withstand the impaction forces transmitted during placement, while the proximal length of the rod serves only to guide components into the operative corridor and would benefit from flexibility. McCarthy expressly teaches that the object of the equipment is to permit "a narrow and not very invasive approach," and a more flexible proximal portion would predictably further reduce the size of the access opening required by allowing components to be loaded onto the rod at an angle to the access axis. The modification amounts to the use of a known technique to improve a similar device in the same way.
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, and the selection of a known biocompatible material for a surgical guide member on the basis of its suitability for the intended use is a matter of obvious design choice absent a showing of criticality.
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 07/16/2026 have been fully considered but they are not persuasive.
Applicant argues that modifying rigid guide 50 of McCarthy with the flexible guide member of Steinberg (Fig. 33A, element 900) would destroy McCarthy’s purpose, because guide 50 contributes to the rigidity of instrument 51 during impaction of spacer body 1 via tubular sleeve 60, and a flexible member would increase the likelihood that sleeve 60 bends and that spacer 1 strikes the vertebral bodies at an incorrect angle. The Examiner respectfully disagrees. Applicant has not identified any disclosure in McCarthy stating that guide 50 is required to resist impaction forces, nor has Applicant provided evidence, such as a declaration under 37 CFR 1.132, that the proposed modification would cause sleeve 60 to bend or spacer 1 to be misaligned. The asserted structural weakening is therefore speculative.
The rejection does not propose replacing guide 50 in its entirety with a flexible member. As set forth in the rejection above, the modified guide member of McCarthy retains a first rigid portion and includes a second flexible portion. Further, impaction in McCarthy is applied through tubular sleeve 60 which is not modified. McCarthy as modified would therefore remain capable of inserting spacer body 1 by impaction. A proposed modification is improper only if it renders the prior art unsatisfactory for its intended purpose or changes its principle of operation, and Applicant has not shown either.
To the extent Applicant contends that McCarthy teaches away, a reference teaches away only when it criticizes, discredits, or otherwise discourages the claimed solution. McCarthy contains no such teaching. Moreover, even if the modification involved some tradeoff in rigidity, the existence of disadvantages does not negate a motivation to combine where, as here, the combination provides the advantage identified in the rejection, namely a flexible guide portion capable of navigating around delicate spinal structures.
Applicant argues that no such concern exists in the present invention because the guide member of claim 1 is designed to be connected to an already inserted spacer body (see page 5, paragraph 5 of the Remarks). The fact that Applicant recognized another advantage, or had a different purpose, does not render the claimed invention nonobvious. The motivation to combine need not be the same as Applicant’s.
Further, the guide member of McCarthy as modified is connected to spacer body 1, and it remains connected to spacer body 1 once the spacer body has been inserted. The recitation that the plate is “configured to” enter and slide over the guide member is a functional limitation. The prior art structure need only be capable of performing the recited function.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
Prosecution Insights