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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-14) and Species B (Figs. 5-7) in the reply filed on June 22, 2026 is acknowledged.
Claims 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (the elected species does not include a cannula deploying member; nonelected Species D includes cannula deploying member 599 and nonelected Species E includes cannula deploying member 699), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Claims 1-9 and new claims 21-24 have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) filed December 22, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, the aforementioned IDS fails to include a copy of EP 4262636 and thus that document has not been considered.
Claim Objections
Claims 2-9 are objected to because of the following informalities: each of the claims should recite “vertebrae” instead of “vertebra” (line 1). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the claim should recite “vertebrae” instead of “vertebras” (line 5). Appropriate correction is required.
Claim 22 is objected to because of the following informalities: the claim should recite “positioned” instead of “position” (line 5). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 22 is 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. The term “generally midway” in claim 22 is a relative term which renders the claim indefinite. The term “generally midway” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, the scope of “generally” is unclear (for example, is “generally” equivalent to “substantially,” “approximately,” or some other term). Furthermore, the scope of “midway” is unclear (for example, does “midway” mean the midpoint or merely between). The Examiner notes that the specification fails to use or describe the phrase “generally midway,” and thus the scope of such cannot be determined. For examination purposes, the Examiner is interpreting “generally midway” as the orifice being positioned between the proximal and distal ends.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 6, 7, 9, and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wensel (US 8,551,175 B1).
Claim 1. Wensel discloses a method for fusing adjacent vertebra (vertebral bodies 2620), the method comprising steps of:
inserting an implantable vertebral interbody device (fusion member 120) between the adjacent vertebrae (see Figs. 26A-27B), the implantable vertebral interbody device comprising:
a body (see Fig. 16 inset) having an upper vertebral contacting surface (see Fig. 16 inset), a lower vertebral contacting surface (see Fig. 16 inset), and a sidewall (see Fig. 16 inset) extending between the upper vertebral contacting surface and the lower vertebral contacting surface,
a port (cavity 1685) through the sidewall,
at least one orifice (see Fig. 16 inset) passing through at least one of the upper vertebral contacting surface or the lower vertebral contacting surface; and
a moveable cannula (anchoring member 1410 in Figs. 14-16, which is labeled as anchoring member 2610 in Figs. 26A-27B) passing through the port and at least one orifice;
deploying the cannula by applying a force (via driving member 1430) to a first, force receiving end (see Fig. 16 inset) of the cannula (see Figs. 14-15), wherein the force inserts a second, engaging end (see Fig. 16 inset) of the cannula into a facing surface of a respective vertebra of the adjacent vertebrae (see Figs. 26A-26C); and
dispensing a stabilization material (polymer 2710) through the cannula (see Figs. 27A-27B and col. 16, ll. 11-21) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 2. Wensel discloses wherein the step of dispensing a stabilization material through the cannula dispenses the stabilization material into the respective vertebra (see Figs. 27A-27B and col. 16, ll. 11-21) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 3. Wensel discloses wherein the step of dispensing a stabilization material through the cannula dispenses the stabilization material into the respective vertebra (see Figs. 27A-27B and col. 16, ll. 11-21), wherein the stabilization material stabilizes the respective vertebra in an area proximate the respective surface of the implantable vertebral interbody device (see Figs. 27A-27B) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 4. Wensel discloses wherein the step of dispensing the stabilization material through the cannula is accomplished by using bone cement as the stabilization material (see col. 19, ll. 59-67, which states that polymer 2170 is bone cement) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 6. Wensel discloses a step of passing the cannula through the port through the sidewall (see Figs. 14-15) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 7. Wensel discloses wherein the step of deploying the cannula by applying a force to a first, force receiving end of the cannula is accomplished by utilizing a mechanically applied force (see Figs. 14-15; driving member 1430 constitutes a mechanically applied force) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 9. Wensel discloses wherein the second, engaging end of the cannula further comprises a pointed shape (see Fig. 16) and the method further comprising a step of using the pointed shape of the cannula to penetrate the respective vertebra of the adjacent vertebras (see Figs. 26A-26C) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
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[AltContent: connector][AltContent: textbox (Upper Vertebral
Contacting Surface)][AltContent: connector][AltContent: textbox (Lower Vertebral
Contacting Surface)][AltContent: connector][AltContent: textbox (Sidewall)][AltContent: connector][AltContent: textbox (Orifice)][AltContent: connector][AltContent: textbox (Force Receiving End)][AltContent: connector][AltContent: textbox (Engaging End)][AltContent: connector][AltContent: textbox (Body)]
Claim 21. Wensel discloses a method, comprising:
inserting an implantable vertebral interbody device (fusion member 120) between adjacent vertebrae (see Figs. 26A-27B), the implantable vertebral interbody device including an upper vertebral contacting member (see Fig. 16 inset), a lower vertebral contacting member (see Fig. 16 inset), at least one orifice (see Fig. 16 inset) passing through at least one of the upper vertebral contacting member or the lower vertebral contacting member, and a sidewall (see Fig. 16 inset) positioned between the upper vertebral contacting member and the lower vertebral contacting member, wherein the sidewall has an opening (cavity 1685);
moving a cannula (anchoring member 1410 in Figs. 14-16, which is labeled as anchoring member 2610 in Figs. 26A-27B) through the opening and the at least one orifice (see Figs. 14-15) such that a distal portion (see Fig. 16 inset) of the cannula is positioned within one of the vertebrae (see Figs. 26A-26C); and
dispensing a stabilization material (polymer 2710) through the cannula (see Figs. 27A-27B and col. 16, ll. 11-21), which is positioned in the opening and the at least one orifice, and into the one of the vertebrae (see Figs. 27A-27B) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 22. Wensel discloses wherein the at least one orifice is positioned generally midway between a distal end (see Fig. 16 inset) of the implantable vertebral interbody device and a proximal end (see Fig. 16 inset) of the implantable vertebral interbody device while dispensing the stabilization material (see Figs. 27A-27B), and wherein an outer periphery of the implantable vertebral interbody device is position inward of a periphery of a disc space between the adjacent vertebrae (see Figs. 26A-27B) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 23. Wensel discloses wherein the implantable vertebral interbody device includes an interbody lock actuating control conduit (see Fig. 16 inset) extending along a linear path (see Fig. 16 inset) between the opening and the at least one orifice (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Claim 24. Wensel discloses wherein the implantable vertebral interbody device is a cage (see Fig. 16), and the sidewall is connected to the upper vertebral contacting member and the lower vertebral contacting member (see Fig. 16) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
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Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 2012/0143335 A1).
Claim 1. Lee discloses a method for fusing adjacent vertebra (vertebral bodies 126 and 130; note that vertebral bodies 126 and 130 are adjacent after the removal of vertebral body 134), the method comprising steps of:
inserting an implantable vertebral interbody device (device 50) between the adjacent vertebrae, the implantable vertebral interbody device comprising:
a body (see Fig. 20 inset) having an upper vertebral contacting surface (see Fig. 20 inset), a lower vertebral contacting surface (see Fig. 20 inset), and a sidewall (see Fig. 20 inset) extending between the upper vertebral contacting surface and the lower vertebral contacting surface,
a port (see Fig. 20 inset) through the sidewall,
at least one orifice (see Fig. 20 inset) passing through at least one of the upper vertebral contacting surface or the lower vertebral contacting surface; and
a moveable cannula (hollowing instrument 276; see para. 0067, which states that hollowing instrument 276 is passed through device 50, indicating that hollowing instrument 276 is moveable) passing through the port and at least one orifice;
deploying the cannula by applying a force to a first, force receiving end (see Fig. 20 inset) of the cannula, wherein the force inserts a second, engaging end (see Fig. 20 inset) of the cannula into a facing surface (surface of vertebral body 130 in contact with the upper vertebral contacting surface of the body as shown in Fig. 20) of a respective vertebra of the adjacent vertebrae (see para. 0067, which states that hollowing instrument 276 is passed through device 50 to hollow out vertebral body 130); and
dispensing a stabilization material through the cannula (see para. 0067, which states that the cavity in vertebral body 130 receives bone cement via sleeve 280) (Fig. 20; para. 0067).
[AltContent: textbox (Upper Vertebral
Contacting Surface)][AltContent: textbox (Lower Vertebral
Contacting Surface)][AltContent: textbox (Orifice)][AltContent: textbox (Port)][AltContent: textbox (Sidewall)][AltContent: textbox (Body)][AltContent: textbox (Engaging End)][AltContent: textbox (Force Receiving End)]
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2012/0143335 A1).
Lee fails to disclose a step of withdrawing the cannula from the vertebra (claim 5).
However, Lee discloses that the cannula is moveable relative to the implantable vertebral interbody device and that the cannula includes sharp tip (cutting tip 288) (see para. 0076) (Fig. 20; para. 0067).
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 method of Lee by withdrawing the cannula from the vertebra (claim 5) in order to avoid leaving a sharp surgical instrument that is not in a fixed position relative to the body of the device within the patient after the completion of the surgical procedure.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wensel (US 8,551,175 B1) in view of Yedlicka et al. (US 2011/0196494 A1).
Wensel fails to disclose wherein the step of deploying the cannula by applying a force to a first, force receiving end of the cannula is accomplished by utilizing a pneumatically applied force (claim 8).
However, Wensel discloses applying a force to the first, force receiving end of the cannula by utilizing a mechanically applied force (see Figs. 14-15; driving member 1430 constitutes a mechanically applied force) (Figs. 14-16 and 26A-27B; col. 14, l. 10 through col. 19, l. 67).
Yedlicka teaches deploying a deployable element (staple 1620) from an implantable vertebral interbody device (cage 600) into a vertebral body (see Fig. 77 and para. 0136), wherein a force is applied to a force receiving end of the deployable element (see Fig. 77) by either a mechanically applied force (see para. 0136, which states that the force can be applied manually with a hammer) or a pneumatically applied force (see para. 0136, which states that the force can alternatively be applied by a pneumatic ram) (Fig. 77; para. 0136).
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 method of Wensel such that the step of deploying the cannula by applying a force to a first, force receiving end of the cannula is accomplished by utilizing a pneumatically applied force (claim 8), as suggested by Yedlicka, as such is a simple substitution of one type of force for another.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mueller et al. (US 2010/0274358 A1) disclose a method that anticipates at least claim 1 (see Figs. 23-25 and paras. 0207-0208). Oh (US 2022/0023067 A1) discloses a method that anticipates at least claim 1 (see Figs. 4-6 and paras. 0057-0071).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm 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 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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