DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
It is noted that support claims 1- 29 have an effective filing date of May 15, 2009 as these claims are supported in US Provisional 61,178,315 filed May 14, 2009.
Response to Arguments
Applicant's arguments filed 4/4/2026 have been fully considered but they are not persuasive. The applicant argues that Hansell in view of Lee for claims 1, 11 and 20 does not disclose the retractor is “sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor” because Hansell is installed in a transforaminal approach and that the “sized and shaped” limitation is structurally limiting and cites “Snyders Heart Valve LLC v St Jude Medical, LLC” (hereinafter Snyders). The examiner notes that the claims are directed to an apparatus/system claim and not directed to a method of use and that the transforaminal approach of Hansell is exemplary (paragraph 43 “positioning or depth between adjacent vertebral bodies using, for example, a transforaminal approach”). With regards to the Snyder, the case involved using a frame that was used in “a larger space” and thus the federal circuit ruled that it did not anticipate the claims as it would be too big for the intended use limitation. In the instant application, applicant makes no argument regarding how the size of the retractor of Lee would fail to establish the corridor as claimed because it would be too big. In fact, applicant seems to argue the opposite, see page 21 of applicants remarks (“implant of claim 1 has a significantly larger footprint”) and thus an argument that the retractor of Hansell in view of Lee would too big to establish the corridor is moot. If applicant’s own larger retractor is able to establish the claimed corridor, then it stands to reason that the retractor of Lee would be just as big, if not smaller than applicant and thus size is not an issue to functionally establish the corridor as claimed. A smaller sized retractor would still be able to establish the corridor and would not be large enough to interfere or damage surrounding anatomy. Likewise, the shape of Lee is able to pass through tissue and meets the claimed structural features (see rejection below, paragraph 2, 37) and Lee is specifically sized and shaped to be used in various approaches and with various spinal implants (paragraph 2, 37). As such, the retractor of Lee is still capable of performing the intended use language of claim 1 to establish the corridor as claimed even though such intended use was not specifically disclosed in Lee. Applicant is not claiming a method of use and applicant is not claiming any additional structural features that allow the retractor to be “sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor.”
Applicant also argues that the spinal implant of Hansell does not “substantially occupy” the disc space. It is noted that this limitation is intended use and the applicant does not claim what is considered “substantially occupy” and examiner is interpreting this limitation as the spinal implant being able to occupy above 50% of the disc space. Looking at Fig 16 of Hansell, the implant is able to be implanted where the disc is not fully removed and thus able to “substantially occupy” the disc space. Likewise, Figs 13-16 are exemplary illustrations of the spinal implant in the disc space and that the implant of Hansell is able to be placed in a disc space of a particular patient where it would occupy at least greater than 50% of the disc space. It is noted that patients and their disc space come in various sizes and specific values of the implant as well as the retractor are not being claimed and applicant is not claiming a method of use.
The double patenting rejections are withdrawn as a result of applicant filing a terminal disclaimer.
Applicant’s arguments with respect to claim(s) 3, 12, 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New rejections were made in view of applicant’s amendments to claims 3, 12, 21.
Applicant is welcome to contact the examiner if they have any questions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-9, 11, 13-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hansell US 2010/0094422 in view of Lee US 2005/0080320.
Regarding Claim 1, 11 Hansell discloses a spinal implant system (Fig 6-12), advanceable along an oblique anterolateral retroperitoneal operative corridor to an intervertebral disc space located between the L5 and S1 vertebral bodies of a subject positioned in a lateral decubitus position (it is noted that this limitation is intended use and the system is capable of being implanted in an oblique anterolateral approach such that it would be advanceable along an oblique anterolateral retroperitoneal operative corridor to an intervertebral disc space located between the L5 and S1 vertebral bodies of a subject positioned in a lateral decubitus position),
the spinal implant system comprising:
a spinal implant (Fig 1) the spinal implant sized and shaped to being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (as discussed above, this limitation is intended use and the spinal implant is capable of being implanted in an oblique anterolateral approach such that it would be advanceable along an oblique anterolateral retroperitoneal operative corridor), the spinal implant further sized and shaped to substantially occupy the intervertebral space (see Response to Arguments above where this limitation is intended use and the implant is able to be placed in an intervertebral space where it would occupy at least greater than 50% of the space, likewise looking at Fig 16, the implant can be implanted where the disc is not fully removed and thus able to “substantially occupy” the disc space), the spinal implant including:
a top bearing face (see Fig below) having upper bone engagement protuberances (#24, paragraph 37, see Fig below);
a bottom bearing face (see Fig below) located opposite the top bearing face, the bottom bearing face having lower bone engagement protuberances (#24, paragraph 37, see Fig below);
an anterior face located between the top bearing face and the bottom bearing face (see Fig below);
a posterior face located between the top bearing face and the bottom bearing face, the posterior face located opposite the anterior face (see Fig below);
an ipsilateral face located between the top bearing face and the bottom bearing face and between the anterior face and the posterior face (see Fig below);
a contralateral face located between the top bearing face and the bottom bearing face and between the anterior face and the posterior face (see Fig below), the contralateral face located opposite the ipsilateral face (see Fig below); and
an internally threaded opening (#34) located between the top bearing face and the bottom bearing face (see Fig below); and
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an introducer instrument (Fig 6-7), the introducer instrument including:
a sheath having a distal tip (see Fig below), the sheath defining a longitudinal axis (line #84, Fig 6) of the introducer instrument (see Fig below); and
a rotatable shaft extending through the sheath (see Fig below, paragraph 40, rotatable via thumbwheel #80), the rotatable shaft including an externally threaded end (#44) projecting externally from the distal tip of the sheath (see Fig below, paragraph 38),
wherein the externally threaded end of the rotatable shaft of the introducer instrument is configured to threadedly mate with the internally threaded opening of the spinal implant (paragraph 43),
wherein rotation of the rotatable shaft in a first rotational direction about the longitudinal axis of the introducer instrument couples the introducer instrument to the spinal implant (paragraph 40, 43 threaded end #44 is threaded in a first rotation direction to engage threaded hole #38 of the spinal implant), and
wherein rotation of the rotatable shaft in a second rotational direction about the longitudinal axis of the introducer instrument opposite the first rotational direction releases the introducer instrument from the spinal implant (paragraph 44 where unthreading threaded end #44 from the threaded hole #38 of the spinal implant in a second rotational direction releases the instrument from the implant).
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Regarding Claim 11, Hansell also discloses a tissue ingrowth window (#22) extending through the top bearing face and the bottom bearing face (as seen in Fig 1-2, paragraph 37) the tissue ingrowth window located between the anterior face and the posterior face (Fig 1-2, see fig above, paragraph 37).
Hansell discloses the introducer instrument is used to implant the spinal implant (paragraph 43-44) and the spinal implant is used for interbody fusion (paragraph 25, 37) but does not disclose a retractor sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor, the retractor including:
a first unitary retractor blade insertable into the oblique anterolateral retroperitoneal operative corridor, the first unitary retractor blade sized and shaped to lateralize a left common iliac vein and a left common iliac artery when the first unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor; and a second unitary retractor blade insertable into the oblique anterolateral retroperitoneal operative corridor, the second unitary retractor blade movable relative to the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor, the second unitary retractor blade sized and shaped to lateralize a right common iliac vein and a right common iliac artery when the second unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor, wherein a distal tip of the second unitary retractor blade is shaped differently relative to a distal tip of the first unitary retractor blade; the spinal implant sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the spinal implant being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor, the introducer instrument sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor. Regarding Claims 2, 11, Hansell does not disclose the retractor sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor.
Lee discloses a retractor sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor (see Response to Arguments above, paragraph 2, 37, the blades are capable of being used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of the oblique anterolateral retroperitoneal operative corridor), including:
a first unitary retractor blade (#131L, Fig 1) insertable into the oblique anterolateral retroperitoneal operative corridor (Fig 1-4, paragraph 2, where the blade is capable of being inserted into an oblique anterolateral retroperitoneal operative corridor), the first unitary retractor blade sized and shaped to lateralize a left common iliac vein and a left common iliac artery when the first unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor (paragraph 51, Fig 2-2a where the distal end of the blade is “flared” to “facilitate soft tissue engagement” and would be capable of being placed in the body in an orientation/position that the blade would be capable of lateralizing a left common iliac vein and a left common iliac artery); and
a second unitary retractor blade (#131R, Fig 1) insertable into the oblique anterolateral retroperitoneal operative corridor (Fig 1-4, paragraph 2, where the blade is capable of being inserted into an oblique anterolateral retroperitoneal operative corridor), the second unitary retractor blade movable relative to the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor (paragraph 40, Fig 1, movable by manipulating handles), the second unitary retractor blade sized and shaped to lateralize a right common iliac vein and a right common iliac artery when the second unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor (paragraph 51, Fig 2-2a where the distal end of the blade is “flared” to “facilitate soft tissue engagement” and would be capable of being placed in the body in an orientation and position such that the blade is able to lateralize a right common iliac vein and a right common iliac artery),
wherein a distal tip of the second unitary retractor blade is shaped differently relative to a distal tip of the first unitary retractor blade (paragraph 51 where the flared ends of each blade can have a different angle and thus each blade would have a different shape);
where the retractor is used to create access opening, and hold back soft tissue or organs to allow visibility and/or access for surgical instruments to the location in the patient’s body to be operated on for interbody fusion (paragraph 2, 37).
With regards to Claim 11, Lee also discloses retractor sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor (paragraph 2, 37, the blades are able to be used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of the oblique anterolateral retroperitoneal operative corridor).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the system of Hansell to include the retractor as claimed in view of Lee above because the retractor is used to create access opening, and hold back soft tissue or organs to allow visibility and/or access for surgical instruments to the location in the patient’s body to be operated on for interbody fusion.
The examiner notes that with Hansell as modified by Lee, Hansell as modified discloses the spinal implant sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the spinal implant being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor, the introducer instrument sized and shape to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (see Response to Arguments above, as discussed with the modification above, the blades are able to be used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of the oblique anterolateral retroperitoneal operative corridor, for placement of the introducer instrument and spinal implant).
Regarding Claims 4, 13, Hansell as modified discloses, wherein the spinal implant has a longitudinal length that extends from the ipsilateral face to the contralateral face and that is configured to be arranged parallel to the coronal plane of the intervertebral disc space (as seen in annotated Fig 2 of Hansell above, the implant has a longitudinal length that extends from the ipsilateral face to the contralateral face and the implant is capable of being placed in the disc space such that the longitudinal length would be arranged parallel to the coronal plane of the intervertebral disc space).
Regarding Claims 5, 14, Hansell as modified disclose the spinal implant has a maximum width that extends from the posterior face to the anterior face and that is configured to be arranged parallel to a medial plane of the intervertebral disc space (as seen in annotated Fig 2 of Hansell, the implant has a max width between the posterior and anterior face that is capable of being placed in the disc space such that it is arranged parallel to a medial plane of the disc space).
Regarding Claims 6, 15, Hansell as modified by Lee disclose the first unitary retractor blade and the second unitary retractor blade collectively define a longitudinal axis of the retractor (as seen in Fig 1 of Lee, the longitudinal axis would extend out from the page), wherein a distal portion of at least one of the first unitary retractor blade or the second unitary retractor blade is curved outwardly away from the longitudinal axis of the retractor (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that is curved outwardly, at an angle or radius #118, from the longitudinally axis).
Regarding Claims 7, 16, Hansell as modified by Lee disclose a longitudinal curvature of a distal portion of the second unitary retractor blade differs from a longitudinal curvature of a distal portion of the first unitary retractor blade (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that defines a longitudinal curvature defining an angle or radius #118, where the angle or radius #118 can be different for each blade).
Regarding Claims 8, 17, Hansell as modified by Lee disclose a radial curvature of a distal portion of the second unitary retractor blade differs from a radial curvature of a distal portion of the first unitary retractor blade (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that defines a radial curvature defining an angle or radius #118, where the angle or radius #118 can be different for each blade).
Regarding Claims 9, 18, Hansell as modified by Lee disclose the first unitary retractor blade and the second unitary retractor blade collectively define a longitudinal axis of the retractor (as seen in Fig 1 of Lee, the longitudinal axis would extend out from the page), wherein a length of the second unitary retractor blade along the longitudinal axis of the retractor differs from a length of the first unitary retractor blade along the longitudinal axis of the retractor (end of paragraph 53 of Lee, where the lengths can be different, likewise, see also Fig 2a, paragraph 51 in Lee where the distal portions of each blade has a flared portion #137 with a radius or angle #118 that can be different between the blades such that the lengths would also be different).
Claims 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hansell US 2010/0094422 in view of Lee US 2005/0080320.
Regarding Claim 20, Hansell discloses a spinal implant system (Fig 6-12), advanceable along an oblique anterolateral retroperitoneal operative corridor to an intervertebral disc space located between the L5 and S1 vertebral bodies of a subject positioned in a lateral decubitus position (it is noted that this limitation is intended use and the system is capable of being implanted in an oblique anterolateral approach such that it would be advanceable along an oblique anterolateral retroperitoneal operative corridor to an intervertebral disc space located between the L5 and S1 vertebral bodies of a subject positioned in a lateral decubitus position),
a spinal implant (Fig 1) the spinal implant sized and shaped to being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (as discussed above and see Response to Arguments above, this limitation is intended use and the spinal implant is capable of being implanted in an oblique anterolateral approach such that it would be advanceable along an oblique anterolateral retroperitoneal operative corridor), the spinal implant further sized and shaped to substantially occupy the intervertebral disc space (see Response to Arguments above where this limitation is intended use and the implant is able to be placed in an intervertebral space where it would occupy at least greater than 50% of the space, likewise looking at Fig 16, the implant can be implanted where the disc is not fully removed and thus able to “substantially occupy” the disc space), the spinal implant including:
a top bearing face (see Fig below) having upper bone engagement protuberances (#24, paragraph 37, see Fig below);
a bottom bearing face (see Fig below) located opposite the top bearing face, the bottom bearing face having lower bone engagement protuberances (#24, paragraph 37, see Fig below);
an anterior face located between the top bearing face and the bottom bearing face (see Fig below);
a posterior face located between the top bearing face and the bottom bearing face, the posterior face located opposite the anterior face (see Fig below);
and a tissue ingrowth window (#22) extending through the top bearing face and the bottom bearing face (Fig 1-2, paragraph 37), the tissue ingrowth window located between the anterior face and the posterior face (Fig 1-2, see Fig below, paragraph 37); and
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an introducer instrument (#28, Figs 6-7) sized and shaped to place the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (paragraph 38, 43, the instrument is capable of placing the instrument into the disc space via the oblique anterolateral retroperitoneal operative corridor),
the introducer instrument including a distal end (as seen in Fig 9, the distal end is engaged to a portion of the spinal implant) configured to engage a portion of the spinal implant (as seen in Fig 9) such that the spinal implant and the engaged distal end of the introducer instrument collectively introduce the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (paragraph 38, 43, see also Figs 13-15 where the instrument is capable of placing the instrument into the disc space via the oblique anterolateral retroperitoneal operative corridor).
Hansell does not disclose a retractor sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor, the retractor including: a first unitary retractor blade insertable into the oblique anterolateral retroperitoneal operative corridor, the first unitary retractor blade sized and shaped to lateralize a left common iliac vein and a left common iliac artery when the first unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor; and a second unitary retractor blade insertable into the oblique anterolateral retroperitoneal operative corridor, the second unitary retractor blade movable relative to the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor, the second unitary retractor blade sized and shaped to lateralize a right common iliac vein and a right common iliac artery when the second unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor, wherein a distal tip of the second unitary retractor blade is shaped differently relative to a distal tip of the first unitary retractor blade;
the spinal implant sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the spinal implant being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor; and
the introducer instrument sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor, the spinal implant and the engaged distal end of the introducer instrument collectively pass between first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor.
Lee discloses a retractor (Fig 1-4) sized and shaped to assist in establishing at least a portion of the oblique anterolateral retroperitoneal operative corridor (see Response to Arguments above, paragraph 2, 37, the blades are capable of being used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of the oblique anterolateral retroperitoneal operative corridor), including:
a first unitary retractor blade (#131L, Fig 1) insertable into the oblique anterolateral retroperitoneal operative corridor (Fig 1-4, paragraph 2, where the blade is capable of being inserted into an oblique anterolateral retroperitoneal operative corridor), the first unitary retractor blade sized and shaped to lateralize a left common iliac vein and a left common iliac artery when the first unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor (paragraph 51, Fig 2-2a where the distal end of the blade is “flared” to “facilitate soft tissue engagement” and would be capable of being placed in the body in an orientation/position that the blade would be capable of lateralizing a left common iliac vein and a left common iliac artery); and
a second unitary retractor blade (#131R, Fig 1) insertable into the oblique anterolateral retroperitoneal operative corridor (Fig 1-4, paragraph 2, where the blade is capable of being inserted into an oblique anterolateral retroperitoneal operative corridor), the second unitary retractor blade movable relative to the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor (paragraph 40, Fig 1, movable by manipulating handles), the second unitary retractor blade sized and shaped to lateralize a right common iliac vein and a right common iliac artery when the second unitary retractor blade is inserted into the oblique anterolateral retroperitoneal operative corridor (paragraph 51, Fig 2-2a where the distal end of the blade is “flared” to “facilitate soft tissue engagement” and would be capable of being placed in the body in an orientation and position such that the blade is able to lateralize a right common iliac vein and a right common iliac artery),
wherein a distal tip of the second unitary retractor blade is shaped differently relative to a distal tip of the first unitary retractor blade (paragraph 51 where the flared ends of each blade can have a different angle and thus each blade would have a different shape);
where the retractor is used to create access opening, and hold back soft tissue or organs to allow visibility and/or access for surgical instruments to the location in the patient’s body to be operated on for interbody fusion (paragraph 2, 37).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the system of Hansell to include the retractor as claimed in view of Lee above because the retractor is used to create access opening, and hold back soft tissue or organs to allow visibility and/or access for surgical instruments to the location in the patient’s body to be operated on for interbody fusion.
The examiner notes that with Hansell as modified by Lee, Hansell as modified disclose the spinal implant sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the spinal implant being introduced into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor; and the introducer instrument sized and shaped to pass between the first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor, the spinal implant and the engaged distal end of the introducer instrument collectively pass between first unitary retractor blade and the second unitary retractor blade in connection with the introducer instrument introducing the spinal implant into the intervertebral disc space via the oblique anterolateral retroperitoneal operative corridor (see Response to Arguments above, as discussed above, paragraph 2, 37, in Lee, the blades are capable of being used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of the oblique anterolateral retroperitoneal operative corridor; where the distal end of the introducer instrument and the spinal implant of Hansell are capable of passing between the first and second unitary blades and through the oblique anterolateral retroperitoneal operative corridor into the disc space, see paragraph 38, 43, see also Figs 13-15 in Hansell).
Regarding Claim 22, Hansell as modified discloses the spinal implant has a longitudinal length that extends from an ipsilateral face of the spinal implant to a contralateral face of the spinal implant and that is configured to be arranged parallel to the coronal plane of the intervertebral disc space (as seen in annotated Fig 2 of Hansell above, the implant has a longitudinal length that extends from the ipsilateral face to the contralateral face and the implant is capable of being placed in the disc space such that the longitudinal length would be arranged parallel to the coronal plane of the intervertebral disc space).
Regarding Claim 23, Hansell as modified disclose the spinal implant has a maximum width that extends from the posterior face to the anterior face and that is configured to be arranged parallel to a medial plane of the intervertebral disc space (as seen in annotated Fig 2 of Hansell, the implant has a max width between the posterior and anterior face that is capable of being placed in the disc space such that it is arranged parallel to a medial plane of the disc space).
Regarding Claim 24, Hansell as modified by Lee disclose the first unitary retractor blade and the second unitary retractor blade collectively define a longitudinal axis of the retractor (as seen in Fig 1 of Lee, the longitudinal axis would extend out from the page), wherein a distal portion of at least one of the first unitary retractor blade or the second unitary retractor blade is curved outwardly away from the longitudinal axis of the retractor (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that is curved outwardly, at an angle or radius #118, from the longitudinally axis).
Regarding Claim 25, Hansell as modified by Lee disclose a longitudinal curvature of a distal portion of the second unitary retractor blade differs from a longitudinal curvature of a distal portion of the first unitary retractor blade (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that defines a longitudinal curvature defining an angle or radius #118, where the angle or radius #118 can be different for each blade).
Regarding Claim 26, Hansell as modified by Lee disclose a radial curvature of a distal portion of the second unitary retractor blade differs from a radial curvature of a distal portion of the first unitary retractor blade (Fig 2a, paragraph 51 in Lee where the distal portion of each blade can have a flared tip #137 that defines a radial curvature defining an angle or radius #118, where the angle or radius #118 can be different for each blade).
Regarding Claim 27, Hansell as modified by Lee disclose the first unitary retractor blade and the second unitary retractor blade collectively define a longitudinal axis of the retractor, wherein a length of the second unitary retractor blade along the longitudinal axis of the retractor differs from a length of the first unitary retractor blade along the longitudinal axis of the retractor (end of paragraph 53 of Lee, where the lengths can be different, likewise, see also Fig 2a, paragraph 51 in Lee where the distal portions of each blade has a flared portion #137 with a radius or angle #118 that can be different between the blades such that the lengths would also be different).
Regarding Claim 29, Hansell as modified discloses the spinal implant further includes an internally threaded opening (#34 in Hansell, paragraph 38) located between the top bearing face and the bottom bearing face of the spinal implant (see annotated Figs in Hansell above in claim 20 and Fig 3 in Hansell),
wherein the introducer instrument (Fig 6-7 in Hansell, see annotated Fig 6 of Hansell below) further includes:
a sheath having a distal tip (see fig below), the sheath defining a longitudinal axis (line #84 in Fig 6 of Hansell) of the introducer instrument; and
a rotatable shaft extending through the sheath (see Fig below, paragraph 40 in Hansell, rotatable via thumbwheel #80), the rotatable shaft including an externally threaded end (#44 in Hansell, paragraph 38) projecting externally from the distal tip of the sheath (see Fig below, paragraph 38 in Hansell),
wherein the externally threaded end of the rotatable shaft of the introducer instrument is configured to threadedly mate with the internally threaded opening of the spinal implant (paragraph 38 in Hansell),
wherein rotation of the rotatable shaft in a first rotational direction about the longitudinal axis of the introducer instrument couples the introducer instrument to the spinal implant (paragraph 40, 43 in Hansell, threaded end #44 is threaded in a first rotation direction to engage threaded hole #38 of the spinal implant), and
wherein rotation of the rotatable shaft in a second rotational direction about the longitudinal axis of the introducer instrument opposite the first rotational direction releases the introducer instrument from the spinal implant (paragraph 44 in Hansell where unthreading threaded end #44 from the threaded hole #38 of the spinal implant in a second rotational direction releases the instrument from the implant).
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Claims 3, 12, 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hansell US 2010/0094422 in view of Lee US 2005/0080320 as applied to claims 1, 11, 20 above, and further in view of Paul US 6,143,033
Hansell as modified discloses the claimed invention as discussed above wherein the anterior face of the spinal implant has a front maximum height (as seen in Fig 4d in Hansell) and the posterior face of the spinal implant has a rear maximum height (as seen in Fig 1, 4a, 4c in Hansell) but does not disclose, wherein the rear maximum height is less than the front maximum height, wherein the spinal implant tapers continuously in height from the front maximum height of the anterior face to the rear maximum height of the posterior face.
Paul discloses a similar implant (Fig 4) having an anterior face (#22, Fig 4) and posterior face (#24, Fig 4) where the anterior face of the spinal implant has a front maximum height (“H1” Fig 4) and the posterior face of the spinal implant has a rear maximum height (“H2” Fig 4), wherein the rear maximum height is less than the front maximum height (Fig 4, Col 3 lines 55-63 ), wherein the spinal implant continuously tapers in height from the front maximum height of the anterior face to the rear maximum height of the posterior face (Fig 4, Col 3 lines 50-63) to help restore the natural curvature of the spine (Col 4 lines 50-63).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the spinal implant of Hansell as modified to have the rear maximum height be less than the front maximum height, wherein the spinal implant tapers in height from the front maximum height of the anterior face to the rear maximum height of the posterior face in view of Dye above because this helps to restore the natural curvature of the spine
Claims 10, 19, 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hansell US 2010/0094422 in view of Lee US 2005/0080320 as applied to claims 1, 11, 20 above, and further in view of Pimenta US 2007/0100212.
Hansell as modified discloses the claimed invention as discussed above but does not disclose a shim couplable to the first unitary retractor blade, the shim including a distal tip sized and shaped to engage one of the L5 and S1 vertebral bodies to secure a position of the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor.
Pimenta discloses a retractor (Fig 4) with first and second unitary blades (#18, #16), each blade has a groove (#29, Fig 1, paragraph 68) where a shim (#25) couplable to the first unitary retractor blade (via groove #29, paragraph 68), the shim including a distal tip (#45, Figs 10-11) sized and shaped to engage one of the L5 and S1 vertebral bodies (paragraph 10, able to be used in different regions of the spine and capable of engaging one of L5 and S1) to secure a position of the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor (paragraph 10, 71, the blades are capable of being used in an oblique anterolateral approach such that when the blades move apart, they help create at least a portion of an oblique anterolateral retroperitoneal operative corridor, and see paragraph 66, where the distal tip is able to secure a position of the first unitary retractor blade within the oblique anterolateral retroperitoneal operative corridor), the shim used to augment the structural stability of the retractor blades and thereby ensure the operative corridor (for example, the oblique anterolateral retroperitoneal operative corridor) (paragraph 14).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Hansell as modified to have at least the first unitary blade to include a groove, a shim to be received in the groove in view of Pimenta above because the shim used to augment the structural stability of the retractor blades and thereby ensure the operative corridor (for example, the oblique anterolateral retroperitoneal operative corridor). [Examiner notes that with the modification, the shim is inserted along the interior of the blade (Fig 1, 14 in Pimenta) and would not affect the flared distal ends of the blades of Lee.]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for other spinal implants that have a continuous taper in height.
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773
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