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 Claims 1 – 11, 19 – 29 and 36 - 41 in the reply filed on 03/25/2026 is acknowledged.
Claims 12 – 18 and 30 – 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/25/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “spanning member” in claim 25.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the spanning member, paragraph [0189] discloses rods, wires, bands, plates, clamps, and/or the like. Therefore, for purpose of examination the structure determined sufficient to perform the function of coupling is a rod, wire, band, plate, clamp, or functional equivalents.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 4 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diwan (US 2011/0153021 A1).
Regarding claim 1, Diwan discloses a method of treating a spine of a patient (Abstract), the method comprising:
inserting a trocar (refs. 20, 24, 41) to proximate a diseased disc within a disc space of the spine along a lateral, transpedicular, transfacet, or transforaminal access path (paragraph [0095] discloses a plurality of approaches, such as lateral);
inserting a discectomy device through the trocar (Fig. 5(iii), ref. 40);
disrupting at least a portion of the diseased disc with the discectomy device (paragraph [0162]);
inserting an intervertebral device (ref. 43) through the trocar into the disc space (Figs. 6(ii-iii), paragraph [0171]);
expanding the intervertebral device within the disc space (the device is expanded via a filler ref. 50, paragraph [0172]); and
filling the intervertebral device with a fill material (ref. 50).
Regarding claim 4, Diwan discloses the method of claim 1 wherein the method further comprises: inserting a balloon (ref. 32) through the trocar into the disc space; and expanding the balloon within the disc space to distract the disc space (paragraph [0165-166]).
Regarding claim 9, Diwan discloses the method of claim 1, further comprising disrupting at least a portion of a ligamentous structure positioned around the diseased disc (paragraph [0096] discloses performing a discectomy and paragraph [0098] discloses distraction of the vertebral space afterwards, thus disrupting at least a portion of ligamentous structures).
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.
Claim(s) 2 - 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Yurek et al. (US 2011/0270399 A1).
Regarding claim 2, Diwan discloses the method of claim 1, except wherein the intervertebral device comprises a braid of filaments.
Yurek teaches an expandable device (Abstract, ref. 10) comprised of a braid of filaments (paragraph [0046]) to better aid in a change of shape from flattened to expanded (paragraph [0043]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the structure of the intervertebral device of Diwan to be comprised of a braid of filaments, as taught by Yurek, for the purpose of better aiding in a change of shape.
Regarding claim 3, Diwan in view of Yurek discloses the method of claim 2 wherein the method further comprises tensioning the braid of filaments after expanding the intervertebral device within the disc space (Diwan, paragraph [0173] discloses rotating the trocar/delivery device 41 which would tension the outer surface of the intervertebral device after expansion).
Claim(s) 5 - 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Virk et al. (US 2023/0346425 A1).
Regarding claim 5, Diwan discloses the method of claim 1, except wherein the trocar is a first trocar, wherein the method further comprises inserting a second trocar through the first trocar, and wherein the second trocar has a curved distal portion configured to extend from the first trocar.
Virk teaches a method of spinal surgery (Abstract) comprising a trocar (refs. 10, 30) wherein the trocar is a first trocar (ref. 30), wherein the method further comprises inserting a second trocar (ref. 10) through the first trocar (Fig. 3B), and wherein the second trocar has a curved distal portion configured to extend from the first trocar (Fig. 3B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the trocar of Diwan such that the trocar is a first trocar, wherein the method further comprises inserting a second trocar through the first trocar, and wherein the second trocar has a curved distal portion configured to extend from the first trocar, as taught by Virk, for the purpose of enabling the method to be minimally invasive (Virk, paragraph [0011]).
Regarding claim 6, Diwan in view of Virk discloses the method of claim 5 wherein inserting the discectomy device includes inserting the discectomy device through the second trocar (the method of Diwan as modified by Virk above would perform in such a manner).
Regarding claim 7, Diwan in view of Virk discloses the method of claim 5 wherein the method further comprises: inserting a balloon through the second trocar into the disc space (Diwan discloses the balloon ref. 32 and as modified by Virk would be inserted through the second trocar); and expanding the balloon within the disc space to distract the disc space (Dirk, Fig. 5(iv)).
Regarding claim 8, Diwan in view of Virk discloses the method of claim 5 wherein inserting the intervertebral device includes inserting the intervertebral device through the second trocar (the method of Diwan as modified by Virk would perform in such a manner).
Claim(s) 10 - 11 and 36 – 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Smith (US 8,790,406 B1).
Regarding claim 10, Diwan discloses the method of claim 1 except wherein the disc space is an L4/L5 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L4/L5 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient.
Regarding claim 11, Diwan discloses the method of claim 1 except wherein the disc space is an L5/S 1 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient.
Smith teaches a method of spinal surgery (Abstract) wherein the disc space is an L5/S1 disc space of the spine (Fig. 4), and wherein inserting a trocar (ref. 30) to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient (Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan such that disc space is an L5/S 1 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient, as taught by Smith, for the purpose of avoiding multiple changes of position of the patient and avoiding nerves blood vessels (Background/Summary (7, 10, 11)).
Regarding claim 10, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan in view of Smith such that the disc space is an L4/L5 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L4/L5 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient, since Smith also states that other levels of the spine may be accessed (Background/Summary (7)).
Regarding claim 36, Diwan discloses a method of treating a spine of a human patient (Abstract), the method comprising:
inserting a trocar to proximate a diseased disc (refs. 20, 24, 41);
inserting an intervertebral device (ref. 43) through the trocar into the disc space (Fig. 6(iii)); and
expanding the intervertebral device within the disc space (the device is expanded via filler ref. 50).
Diwan is silent that the disc is an L4/L5 disc space between an L4 vertebra and an L5 vertebra of the spine along a lateral access path that extends through an iliac crest of the patient.
Smith teaches a method of spinal surgery (Abstract) wherein the disc space is an L5/S1 disc space of the spine (Fig. 4), and wherein inserting a trocar (ref. 30) to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient (Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan such that disc space is an L5/S 1 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient, as taught by Smith, for the purpose of avoiding multiple changes of position of the patient and avoiding nerves blood vessels (Background/Summary (7, 10, 11)).
Diwan in view of Smith specifically discloses a disc space of the L5/S1, but is silent regarding the L4/L5 space. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan in view of Smith such that the disc space is an L4/L5 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L4/L5 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient, since Smith also states that other levels of the spine may be accessed (Background/Summary (7)).
Regarding claim 37, Diwan in view of Smith discloses the method of claim 36 wherein the method further comprises filling the intervertebral device with a fill material (Diwan, ref. 50).
Regarding claim 38, Diwan in view of Smith discloses the method of claim 36 wherein the method further comprises:
inserting a balloon (Diwan, ref. 32) through the trocar into the disc space (Diwan, Fig. 5(iv)); and
expanding the balloon within the disc space to distract the disc space and create lordosis between the L4 vertebra and the L5 vertebra (Diwan, paragraph [0082] discloses restoring the kinematics of the vertebral motion and thus lordosis and [165-166] expanding the balloon).
Regarding claim 39, Diwan discloses a method of treating a spine of a human patient (Abstract), the method comprising:
inserting a trocar (refs. 20, 24, 41) to proximate a diseased disc (Fig. 5(i));
inserting an intervertebral device (ref. 43) through the trocar into the disc space (Fig. 6(iii)); and
expanding the intervertebral device within the disc space (the device is expanded via filler ref. 50).
Diwan is silent that the disc is within an L5/S 1 disc space between an L5 vertebra and an S1 vertebra of the spine along a lateral access path that extends through an iliac crest of the patient and a sacrum of the spine of the patient.
Smith teaches a method of spinal surgery (Abstract) wherein the disc space is an L5/S1 disc space of the spine (Fig. 4), and wherein inserting a trocar (ref. 30) to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient (Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan such that disc space is an L5/S 1 disc space of the spine, and wherein inserting the trocar to proximate the diseased disc within the L5/S 1 disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient, as taught by Smith, for the purpose of avoiding multiple changes of position of the patient and avoiding nerves blood vessels (Background/Summary (7, 10, 11)).
Regarding claim 40, Diwan in view of Smith discloses the method of claim 39 wherein the method further comprises filling the intervertebral device with a fill material (Diwan, ref. 50).
Regarding claim 41, Diwan in view of Smith discloses the method of claim 39 wherein the method further comprises:
inserting a balloon (Diwan, ref. 32) through the trocar into the disc space (Diwan, Fig. 5(iv)); and
expanding the balloon within the disc space to distract the disc space and create lordosis between the L5 vertebra and the S1 vertebra (Diwan, paragraph [0082] discloses restoring the kinematics of the vertebral motion and thus lordosis and [165-166] expanding the balloon).
Claim(s) 19 – 22 and 25 - 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Donovan et al. (US 2023/0255676 A1).
Regarding claim 19, Diwan discloses a method of treating a spine of a patient (Abstract), the method comprising:
inserting a trocar (refs. 20, 24, 31, 41) into the disc space (Fig. 5(i));
inserting a balloon (ref. 32) through the trocar into the disc space (Fig. 5(iv));
expanding the balloon within the disc space to distract the disc space and create lordosis between the first vertebra and the second vertebra (paragraph [0082] discloses restoring the kinematics of the vertebral motion segment, thus lordosis and paragraphs [0166-167] discloses expanding the balloon to distract the space); and
deploying an intervertebral device (ref. 43) within the disc space (Fig. 6(iii)).
Diwan is silent regarding the steps of attaching a first posterior fixation member to a first vertebra of the spine;
attaching a second posterior fixation member to a second vertebra of the spine adjacent the first vertebra, wherein a disc space is positioned between the first vertebra and the second vertebra;
locking a position and orientation of a first portion of the first posterior fixation member to a first portion of the second posterior fixation member;
locking a position and orientation of a second portion of the first posterior fixation member relative to a position and orientation of a second portion of the second posterior fixation member to maintain the created lordosis.
Donovan teaches a method of spinal surgery (Abstract) comprising the steps of attaching a first posterior fixation member to a first vertebra of the spine (Fig. 2B, ref. 204);
attaching a second posterior fixation member to a second vertebra of the spine adjacent the first vertebra (Fig. 2B shows two adjacent vertebra 201A, 201B, each with a fixation member ref. 204), wherein a disc space is positioned between the first vertebra and the second vertebra (at ref. 206 as shown in Fig. 2B);
locking a position and orientation of a first portion of the first posterior fixation member to a first portion of the second posterior fixation member (the first portions are considered the receivers, see Fig. 2C which are locked via set screws);
locking a position and orientation of a second portion of the first posterior fixation member relative to a position and orientation of a second portion of the second posterior fixation member to maintain the created lordosis (the second portions are considered the screws, which are locked once rod ref. 202 and set screws are fully tightened). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan to include the first and second posterior fixation members and the associated steps as outlined above and as taught by Donovan, for the purpose of treating secondary sources of pain during/after a fusion procedure with an interverbal device (Donovan, ref. 205, paragraph [0007]).
Regarding claim 20, Diwan in view Donovan discloses the method of claim 19 wherein locking the position and orientation of the second portion of the first posterior fixation member relative to the position and orientation of the second portion of the second posterior fixation member comprises tightening a first set screw of the first posterior fixation member and tightening a second set screw of the second posterior fixation member (Donovan, refs. 204a, 204b, paragraph [0053]).
Regarding claim 21, Diwan in view Donovan discloses the method of claim 19 wherein the method further comprises filling the intervertebral device with a fill material (Diwan, ref. 50).
Regarding claim 22, Diwan in view Donovan discloses the method of claim 19 wherein inserting the trocar into the disc space comprises inserting the trocar via a lateral approach (Diwan, paragraph [0095]).
Regarding claim 25, Diwan in view Donovan discloses the method of claim 19 wherein locking the position and orientation of the first portion of the first posterior fixation member to the first portion of the second posterior fixation member comprises attaching a limiter (Donovan ref. 203A) to a spanning member (Donovan, ref. 202) coupling the first portion of the first posterior fixation member to the first portion of the second posterior fixation member (Donovan, Fig. 3A).
Regarding claim 26, Diwan in view Donovan discloses the method of claim 19 wherein the first portion of the first posterior fixation member comprises a first tulip, wherein the first portion of the second posterior fixation member comprises a second tulip, wherein the second portion of the first posterior fixation member comprises a first screw body, and wherein the second portion of the second posterior fixation member comprises a second screw body (Donovan, Fig. 2C).
Claim(s) 23 - 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Donovan et al. (US 2023/0255676 A1) and in view of Walters et al. (US 2012/0203279 A1).
Regarding claim 23, Diwan in view Donovan discloses the method of claim 19 except wherein the method further comprises: attaching a first tower member to the first posterior fixation member; and attaching a second tower member to the second posterior fixation member.
Walters teaches a method of spinal surgery (Abstract) comprising the steps of attaching a first tower member (ref. 102, Fig. 2) to a first posterior fixation member (best shown in Fig. 10); and attaching a second tower member to the second posterior fixation member (Fig. 2 shows a plurality of towers and fixation members). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan in view of Donovan such that the method comprises attaching a first tower member to the first posterior fixation member; and attaching a second tower member to the second posterior fixation member, as taught by Walters, for the purpose of allowing a surgeon to selectively maneuver two or more vertebrae at a time (paragraph [0029]).
Regarding claim 24, Diwan in view Donovan and in view of Walters discloses the method of claim 23 wherein locking the position and orientation of the first portion of the first posterior fixation member to the first portion of the second posterior fixation member comprises clamping the first tower member to the second tower member (Walters discloses clamping the first and second tower members to one another via clip ref. 142).
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Donovan et al. (US 2023/0255676 A1) and in view of Smith (US 8,790,406 B1).
Regarding claim 27, Diwan in view Donovan discloses the method of claim 19 wherein the first vertebra is an L4 vertebra of the spine, wherein the second vertebra is an L5 vertebra of the spine, wherein the disc space is an L4/L5 disc space of the spine (Donovan, paragraph [0040]), but is silent wherein inserting the trocar into the disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient.
Regarding claim 28, Diwan in view Donovan discloses the method of claim 19 wherein the first vertebra is an L5 vertebra of the spine, wherein the second vertebra is an S1 vertebra of the spine, wherein the disc space is an L5/S 1 disc space of the spine (Donovan, paragraph [0040], Fig. 2B), but is silent wherein inserting the trocar into the disc space comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient.
Smith teaches a method of spinal surgery (Abstract) wherein inserting a trocar (ref. 30) proximate the diseased disc comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient (Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan in view of Donovan such that inserting the trocar to proximate the diseased disc comprises inserting the trocar along a lateral approach that extends through an iliac crest of the patient and a sacrum of the spine of the patient, as taught by Smith, for the purpose of avoiding multiple changes of position of the patient and avoiding nerves blood vessels (Background/Summary (7, 10, 11)).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diwan (US 2011/0153021 A1) in view of Donovan et al. (US 2023/0255676 A1) and in view of Sutton (US 2006/0074431 A1).
Regarding claim 29, Diwan in view Donovan discloses the method of claim 19 wherein the method further comprises mapping the spine in real time or near real time while expanding the balloon within the disc space to create the lordosis between the first vertebra and the second vertebra (Diwan discloses real time mapping of the surgical area, paragraphs [0035 – 36]), but is silent regarding measuring the lordotic angle specifically.
Sutton teaches a disc distraction instrument and measuring device (Abstract) for real time measurement of the lordotic angle of a distracted intervertebral space (Abstract, paragraph [0009]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Diwan in view of Donovan to include the measurement device such that measuring the lordotic angle in real time or near real time while expanding the space is accomplished, as taught by Sutton, for the purpose of determining the correct sized artificial disc thereby eliminating a step in previous procedures (Sutton, paragraph [0011]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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