DETAILED ACTION
Claim Objections
Claim 17 is objected to because of the following informalities:
Regarding claim 17, “further comprising expanding the interbody device within the disc space” is redundant to subject matter already present in claim 15, from which claim 17 indirectly depends.
Appropriate correction is required.
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 1, 2, 5, 6, 14, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2011/0087329 (Poulos) in view of U.S. Statutory Invention Registration No. US H002261 H (Simmons).
Regarding claim 1, Poulos discloses a method (see Abstract) for performing spinal surgery, the method comprising: forming an access corridor through an aspect of a facet joint of a patient between an inferior articular process of a vertebra and a superior articular process of a vertebra such that an aspect of the inferior articular process is preserved on a medial side of the access corridor and an aspect of the superior articular process is preserved on a lateral side of the access corridor (see paragraph [0055] and marked-up Fig. 4B below; access corridor is formed through a facet joint of a patient between the L3 vertebra above the disc space DS and the L4 vertebra below the disc space DS such that an aspect of the inferior articular process on a medial side of the access corridor is preserved and an aspect of the superior articular process is preserved on a lateral side of the access corridor), advancing an interbody device (1) through the access corridor and into the disc space of the patient (see paragraph [0058]).
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While it appears part of the inferior articular process is preserved on the medial side and the part of the superior articular process is preserved on the lateral side, alternatively, Simmons suggests that portions of the inferior and superior articular processes should be taken only as necessary to access the intervertebral disc space (see col. 9, lines 44-65). Thus, 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 preserve an aspect of the inferior articular process on the medial side of the access corridor and an aspect of the superior articular process on the lateral side of the access corridor, in order to only remove portions of the articular processes necessary to access the disc space.
Regarding claim 2, Poulos discloses removing disc material from the disc space of the patient via one or more instruments advanced through the access corridor (see paragraph [0055]).
Regarding claim 5, Poulos discloses further comprising placing a graft material within the access corridor (see paragraph [0065]).
Regarding claim 6, Poulos discloses further comprising advancing the graft material into the disc space (see paragraph [0065]).
Regarding claim 14, Poulos discloses wherein the interbody device (1) is expandable from a compact configuration to an expanded configuration (see paragraph [0060]), and wherein advancing the interbody device through the access corridor and into the disc space comprises advancing the interbody device through the access corridor and into the disc space while the interbody device is in the compact configuration (see paragraph [0060]).
Regarding claim 15, Poulos discloses further comprising expanding the interbody device from the compact configuration to the expanded configuration within the disc space (see paragraph [0060]).
Regarding claim 18, Poulos discloses wherein the access corridor is formed in a lumber vertebra of the patient (see Abstract and paragraphs [0003] and [0053]).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent Application Publication No. 2021/0068975 (Choi).
Regarding claims 3 and 4, Poulos is silent on further comprising: decompressing a portion of a spinal canal of the patient proximate the disc space by removing the inferior articular process on the medial side of the access corridor (claim 3); and further comprising at least one of: excising a ligamentum flavum adjacent the disc space, or decompressing a distally exiting portion of a nerve root adjacent the disc space (claim 4). However, Choi discloses a surgical spinal method (see Abstract) that involves decompressing a portion of a spinal canal of the patient proximate a disc space by removing the inferior articular process on the medial side of the access corridor (see paragraph [0032]); and further comprising at least one of: excising a ligamentum flavum adjacent the disc space (se paragraph [0032]), or decompressing a distally exiting portion of a nerve root adjacent the disc space (see paragraph [0032]). 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 modify the method to include the decompression and excising steps suggested by Choi in order to treat spinal nerve compression, stenosis, and other diseases or conditions (see Choi, paragraph [0032]).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent Application Publication No. 2006/0111782 (Petersen).
Regarding claims 7 and 9, Poulos is silent on wherein forming the access corridor comprises forming an entry point of the access corridor in a middle aspect of the facet joint midway between the inferior articular process of a vertebra above the disc space and the superior articular process of a vertebra below the disc space (claim 7), and wherein an entry point of the access corridor is surrounded by bone on all sides (claim 9). However, Petersen discloses a facet joint surgical method (see Abstract) that involves forming an entry point (28) of an access corridor in a middle aspect of a facet joint (15) midway between an inferior articular process (30) of a vertebra above a disc space and a superior articular process (32) of a vertebra below a disc space (see Fig. 3 and Abstract and paragraph [0029]; a facet joint is formed by inferior and superior articular processes), and wherein an entry point of the access corridor is surrounded by bone on all sides (see Fig. 3). 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 modify the method of Poulos to form the entry point in a middle aspect of the facet joint midway between the articular processes such that the entry point is surrounded by bone on all sides as suggested by Petersen as there are a finite number of entry point locations in order to provide access through the facet joint, and Petersen suggests an entry point location midway between the processes is suitable for providing access through the facet joint.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent Application Publication No. 2013/0310942 (Abdou).
Regarding claim 8, Poulos fails to disclose wherein forming the access corridor comprises forming an entry point of the access corridor at a position closer to one of the inferior articular process and the superior articular process than the other of the inferior articular process and the superior articular process of the vertebra. However, Abdou discloses a method of forming an access corridor through an aspect of a facet joint wherein the access corridor is formed positioned closer to the superior articular process of the vertebra above the disc space than the inferior articular process of the vertebra about the disc space (see paragraph [0153]; SAP need only be removed). 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 modify the method of Poulos to have the access corridor positioned closer to the superior articular process than the inferior articular process, as the access corridor need not be centered exactly in the middle of the facet joint for access to the disc space to be obtained, and such a modification is one of a finite number of possible trajectories through the facet joint in order to provide access to the disc space.
Regarding claim 10, Poulos fails to disclose wherein forming the access corridor comprises using a robotic system, MRI assisted navigation, CT assisted navigation, O-Arm assisted navigation, or fluoroscopic assisted navigation, or any combination thereof. However, Abdou discloses a method of forming an access corridor to and through the facet joint that comprises using a robotic system, MRI assisted navigation, CT assisted navigation, O-Arm assisted navigation, or fluoroscopic assisted navigation, or any combination thereof (see paragraphs [0012] and [0081]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the inventions to modify the method of Poulos to utilize the navigation technique suggested by Abdou in order to guide the formation of the access corridor to the facet joint and obviate any intra-operative confusion (see Abdou, paragraphs [0012] and [0081]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent No. 6,083,225 (Winslow).
Regarding claims 11 and 12, Poulos fails to disclose the recited steps for forming the access corridor. However, Winslow discloses a method of forming an access corridor that comprises: advancing a first drill bit (48) (see col. 9, line 53 – col. 10, line 7); and advancing a first threaded tap (70), wherein the first threaded tap has a greater diameter than the first drill bit (see col. 10, lines 8-55); wherein advancing the first threaded tap through the aspect of the facet joint comprises advancing the first threaded tap into a posterior third of the disc space (see Fig. 13 and col. 10, lines 8-55). 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 modify the method of Poulos of forming the access corridor through the facet joint to the disc space to include drilling and tapping steps of Winslow in order to facilitate cutting of the bone to form a corridor through the facet joint to the disc space for placement of an interbody device in the disc space.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent Application Publication No. 2011/0245924 (Kuslich).
Regarding claim 16, Poulos fails to disclose wherein expanding the interbody device from the compact configuration to the expanded configuration comprises placing graft material within the interbody device. However, Kuslich discloses a method of expanding an interbody device from a compact configuration to an expanded configuration that comprises placing graft material within the interbody device (see Abstract and paragraph [0101] and claim 2). 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 modify the method of Poulos to include expanding the interbody device by placing graft material within the interbody device as such a modification merely involves substituting one known mechanism for expanding an interbody device (graft filling, see paragraph [0101] of Kuslich) for another known mechanism for expanding an interbody device (distractor blades, see paragraph[ 0062] of Poulos) without any unpredictable results. Such a modification additionally facilitates fusion between the interbody device and the adjacent vertebrae, thus helping prevent against undesired migration of the interbody device.
Regarding claim 17, Poulos discloses further comprising expanding the interbody device within the disc space, wherein placing graft material within the access corridor comprises placing graft material within the access corridor after expanding the interbody device within the disc space (see paragraph [0065]).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of Simmons, and further in view of U.S. Patent Application Publication No. 2018/0228623 (Benson).
Regarding claims 19 and 20, Poulos is silent regarding wherein the access corridor is formed in a thoracic vertebra of the patient (claim 19); and wherein the access corridor is formed in a cervical vertebra of the patient (claim 20). However, Benson discloses surgical spinal methods (see Abstract) wherein treatment that involves inserting an interbody implant between adjacent vertebrae can be used at any selected levels of the human spine, including cervical, thoracic, and/or lumbar (see paragraph [0042]). It would have been prima facie obvious to utilize the method on other areas of the spine, such as thoracic or cervical portions of the spine, as Benson suggests these portions of the spine are suitable for treatment via an interbody implant (see Benson, paragraph [0042]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Poulos in view of U.S. Patent Application Publication No. 2010/0274250 (Wallace)
Regarding claim 21, Poulos discloses a method (see Abstract) for performing spinal surgery, the method comprising: forming an access corridor through an aspect of a facet joint of a patient between an inferior articular process of a vertebra and a superior articular process of a vertebra, wherein the inferior articular process on a medial side of the access corridor is at least partially removed, and wherein an aspect of the superior articular process on a lateral side of the access corridor is preserved (see paragraph [0055] and Fig. 4B; access corridor is formed through a facet joint of a patient between the L3 vertebra above the disc space DS and the L4 vertebra below the disc space DS such that at least part of the inferior articular process on a medial side of the access corridor is removed and an aspect of the superior articular process on a lateral side of the access corridor is preserved); and advancing an interbody device (1) through the access corridor and into a disc space of the patient (see paragraph [0058]).
Pouls does not disclose wherein the inferior articular process on a medial side of the access corridor is completely removed. However, Wallace discloses a spinal surgical method (see Abstract) in which all portions of an inferior articular process are removed as preparation for an interbody fusion procedure (see paragraph [0082]). 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 modify the method to completely remove the inferior articular process as Wallace suggests that such a step may be necessary to prepare for an interbody fusion procedure (see paragraphs [0007], [0008], and [0082]).
Regarding claim 22, Poulos discloses further comprising removing disc material from the disc space of the patient via one or more instruments advanced through the access corridor before and/or after the interbody device is positioned in the disc space (see paragraph [0055]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-7, 10-15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 9, 11, 14, and 15 of U.S. Patent No. 11,925,566 (El-Naggar ‘566).
Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims disclose all of the subject matter of the application claims while including additional features. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim 1 of El-Naggar ‘566 below discloses all of the subject matter of claim 1.
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Claim 5 is anticipated by claim 15 of El-Naggar ‘566.
Claim 6 is anticipated by claim 11 of El-Naggar ‘566.
Claim 7 is anticipated by claim 1 of El-Naggar ‘566.
Claim 10 is anticipated by claim 1 of El-Naggar ‘566.
Claim 11 is anticipated by claim 3 of El-Naggar ‘566.
Claim 12 is anticipated by claim 4 of El-Naggar ‘566.
Claim 13 is anticipated by claim 5 of El-Naggar ‘566.
Claim 14 is anticipated by claim 8 of El-Naggar ‘566.
Claim 15 is anticipated by claim 9 of El-Naggar ‘566.
Claim 17 is anticipated by claim 14 of El-Naggar ‘566.
Claims 1-5, 8, and 10-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 8, 9, 11, 12, 14, 16, 23, and 24 of copending Application No. 18/428,295 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the reference claims lies in the fact that the reference claims disclose all of the subject matter of the application claims while including additional features. Thus, the invention of the reference claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the reference claims, they are not patentably distinct from the reference claims.
Claim 1 of the reference application below discloses all of the subject matter of claim 1.
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Claim 2 is anticipated by claim 1 of the reference application.
Claims 3 and 4 are anticipated by claims 23 and 24 of the reference application, respectively.
Claim 5 is anticipated by claim 16 of the reference application.
Claim 8 is anticipated by claim 12 of the reference application.
Claim 10 is anticipated by claim 2 of the reference application.
Claim 11 is anticipated by claim 1 of the reference application.
Claim 12 is anticipated by claim 4 of the reference application.
Claim 13 is anticipated by claim 1 of the reference application.
Claim 14 is anticipated by claim 8 of the reference application.
Claim 15 is anticipated by claim 9 of the reference application.
Claim 16 is anticipated by claim 11 of the reference application.
Claim 17 is anticipated by claim 14 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. A terminal disclaimer(s) would also be required.
The following is a statement of reasons for the indication of allowable subject matter: claim 13 has not been rejected because no reference, or reasonable combination of references, can be found which disclose or suggest the recited method steps. The Poulos, Simmons, and Winslow references suggest a similar method as outline in the rejection of claims 1, 11, and 12 above, but fail to suggest advancing a second threaded tap through the aspect of the facet joint, wherein the second threaded tap has a greater diameter than the first threaded tap; and advancing a second drill bit through the aspect of the facet joint, wherein the second drill bit has a greater diameter than the second threaded tap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yuan discloses a surgical method involving excising the ligamentum flavum.
Sturm discloses a facet joint surgical method.
Hoogland discloses a spinal decompression method.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773