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 .
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patent 12156678 at this time.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-19 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 1-19 of U.S. Patent No. 11446063. 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 include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 18/941006
US Patent 11446063
1. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field; and a bone anchor connected to the caudal rod portion of the spinal rod assembly.
Claims 1-10:
1. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial portion about a joint axis in response to a rotating magnetic field; a bone anchor connected to the caudal rod portion of the spinal rod assembly; and a fixing plate connected to the cranial rod portion of the spinal rod assembly.
2. The spinal fixation system of claim 1, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
2. The spinal fixation system of claim 1, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
3. The spinal fixation system of claim 1, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor, and the cranial rod portion is fastened to a rod receiver of the fixing plate.
3. The spinal fixation system of claim 1, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor, and the cranial rod portion is fastened to a rod receiver of the fixing plate.
4. The spinal fixation system of claim 1, wherein the fixing plate is configured to be fixed to an occipital bone.
4. The spinal fixation system of claim 1, wherein the fixing plate is configured to be fixed to an occipital bone.
5. The spinal fixation system of claim 1, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion.
5. The spinal fixation system of claim 1, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion.
6. The spinal fixation system of claim 1, further comprising: a second spinal rod assembly comprising a second caudal rod portion, a second cranial rod portion, and a second adjustment mechanism connected to the second caudal rod portion and the second cranial rod portion, the second adjustment mechanism comprising a second rotatable magnet configured to rotate the second caudal portion relative to the second cranial rod portion about a second joint axis in response to a second rotating magnetic field; and a second bone anchor connected to the second caudal rod portion of the second spinal rod assembly.
6. The spinal fixation system of claim 1, further comprising: a second spinal rod assembly comprising a second caudal rod portion, a second cranial rod portion, and a second adjustment mechanism connected to the second caudal rod portion and the second cranial rod portion, the second adjustment mechanism comprising a second rotatable magnet configured to rotate the second caudal portion relative to the second cranial rod portion about a second joint axis in response to a second rotating magnetic field; and a second bone anchor connected to the second caudal rod portion of the second spinal rod assembly; and a second fixing plate connected to the second cranial rod portion of the second spinal rod assembly.
7. The spinal fixation system of claim 5, comprising: a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent vertebrae, the cross bar comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion of the spinal rod assembly, and a second rod connector at a second end configured to connect the crossbar to the second caudal rod portion of the second spinal rod assembly.
7. The spinal fixation system of claim 5, comprising: a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent vertebrae, the cross bar comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion of the spinal rod assembly, and a second rod connector at a second end configured to connect the crossbar to the second caudal rod portion of the second spinal rod assembly.
8. The spinal fixation system of claim 1, wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material.
8. The spinal fixation system of claim 1, wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material.
9. The spinal fixation system of claim 1, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
9. The spinal fixation system of claim 1, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
10. The spinal fixation system of claim 1, wherein the rotating magnetic fields are above a pre-determined threshold.
10. The spinal fixation system of claim 1, wherein the rotating magnetic fields are above a pre-determined threshold.
11. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field, wherein the rotatable magnet rotates about a longitudinal axis of the caudal rod portion or the cranial rod portion; and a bone anchor connected to the caudal rod portion of the spinal rod assembly.
Claims 11-19:
11. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field, wherein the rotatable magnet rotates about a longitudinal axis of the caudal rod portion or the cranial rod portion; and a bone anchor connected to the caudal rod portion of the spinal rod assembly; a fixing plate connected to the cranial rod portion of the spinal rod assembly.
12. The spinal fixation system of claim 11, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
12. The spinal fixation system of claim 11, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
13. The spinal fixation system of claim 11, wherein the fixing plate is configured to be fixed to an occipital bone.
13. The spinal fixation system of claim 11, wherein the fixing plate is configured to be fixed to an occipital bone.
14. The spinal fixation system of claim 11, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion.
14. The spinal fixation system of claim 11, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion.
15. The spinal fixation system of claim 11, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor, and the cranial rod portion is fastened to a rod receiver of the fixing plate.
15. The spinal fixation system of claim 11, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor, and the cranial rod portion is fastened to a rod receiver of the fixing plate.
16. The spinal fixation system of claim 11, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
16. The spinal fixation system of claim 11, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
17. The spinal fixation system of claim 11, wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials.
17. The spinal fixation system of claim 11, wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials.
18. The spinal fixation system of claim 11, wherein the spinal rod assembly, the bone anchor, and the occipital plate are at least partially composed of a non-absorbable biocompatible material.
18. The spinal fixation system of claim 11, wherein the spinal rod assembly, the bone anchor, and the occipital plate are at least partially composed of a non-absorbable biocompatible material.
19. The spinal fixation system of claim 18, wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene.
19. The spinal fixation system of claim 18, wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene.
Claim(s) 1, 2, 6, 8, 9, 11, 12 and 16-19 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) of U.S. Patent No. 10610261. 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 include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 18/941006
US Patent 10610261
1. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field; and a bone anchor connected to the caudal rod portion of the spinal rod assembly.
Claims 1-19:
1. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal rod portion and the cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; and a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism comprises a magnetically-activated locking mechanism configured to prevent rotation of the caudal rod portion relative to the cranial rod portion when not engaged.
18. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal and cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism is operatively linked to a first magnet configured to rotate when exposed to a rotating magnetic field; and wherein the adjustment mechanism is configured to rotate the caudal rod portion relative to the cranial rod portion is response to the rotation of the first magnet; and the first magnet is mounted on the adjustment mechanism to allow said first magnet to rotate about a longitudinal axis of one of the caudal rod portion and the cranial rod portion.
19. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal and cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism is operatively linked to a first magnet configured to rotate when exposed to a rotating magnetic field; and wherein the adjustment mechanism is configured to rotate the caudal rod portion relative to the cranial rod portion is response to the rotation of the first magnet; wherein the first magnet directly drives the adjustment mechanism.
2. The spinal fixation system of claim 1, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
Claims 1-19 (see bolded sections of claims 1, 18, 19 above)
6. The spinal fixation system of claim 1, further comprising: a second spinal rod assembly comprising a second caudal rod portion, a second cranial rod portion, and a second adjustment mechanism connected to the second caudal rod portion and the second cranial rod portion, the second adjustment mechanism comprising a second rotatable magnet configured to rotate the second caudal portion relative to the second cranial rod portion about a second joint axis in response to a second rotating magnetic field; and a second bone anchor connected to the second caudal rod portion of the second spinal rod assembly.
3. The cervical fixation system of claim 1, comprising: a second spinal rod assembly; and a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent cervical vertebra, and comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion, and a second rod connector at a second end configured to connect the crossbar to a rod portion of the second spinal rod assembly; wherein: the second spinal rod assembly comprises a second caudal rod portion connected to a second adjustment mechanism; and a second cranial rod portion connected to the second spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone; the second adjustment mechanism is configured to rotate the second caudal and second cranial rod portions relative to one another about a second joint axis that is generally perpendicular to the longitudinal axes of the second caudal and cranial rod portion; the cervical fixation system comprises a second bone anchor dimensioned to accept the second caudal rod portion; and the occipital plate member has a second receiver dimensioned to accept the second cranial rod portion.
8. The spinal fixation system of claim 1, wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material.
5. The spinal fixation system of claim 1, wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material.
9. The spinal fixation system of claim 1, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
Claims 1-19 (see bolded sections of claims 1, 18, 19 above)
11. A spinal fixation system of a subject, the system comprising: a spinal rod assembly comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field, wherein the rotatable magnet rotates about a longitudinal axis of the caudal rod portion or the cranial rod portion; and a bone anchor connected to the caudal rod portion of the spinal rod assembly.
Claims 1-19:
1. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal rod portion and the cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; and a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism comprises a magnetically-activated locking mechanism configured to prevent rotation of the caudal rod portion relative to the cranial rod portion when not engaged.
18. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal and cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism is operatively linked to a first magnet configured to rotate when exposed to a rotating magnetic field; and wherein the adjustment mechanism is configured to rotate the caudal rod portion relative to the cranial rod portion is response to the rotation of the first magnet; and the first magnet is mounted on the adjustment mechanism to allow said first magnet to rotate about a longitudinal axis of one of the caudal rod portion and the cranial rod portion.
19. A cervical fixation system for fixing the relative positions of a cervical vertebra and an occipital bone in a subject, the system comprising: a jointed spinal rod assembly having a longitudinal length sufficient to extend from the vertebra to the occipital bone, and comprising a caudal rod portion, a cranial rod portion, and an adjustment mechanism connectable to the caudal rod portion and the cranial rod portion, and configured to rotate the caudal and cranial rod portions relative to one another about a joint axis that is generally perpendicular to the longitudinal axes of the caudal and cranial rod portions, said rotation occurring in response to a rotating magnetic field; a bone anchor having a bone fastener connected to a rod housing, said rod housing dimensioned to accept the caudal rod portion of the spinal rod assembly; and an occipital plate member having a fixation screw, and a rod receiver dimensioned to accept the cranial rod portion of the spinal rod assembly, wherein the adjustment mechanism is operatively linked to a first magnet configured to rotate when exposed to a rotating magnetic field; and wherein the adjustment mechanism is configured to rotate the caudal rod portion relative to the cranial rod portion is response to the rotation of the first magnet; wherein the first magnet directly drives the adjustment mechanism.
12. The spinal fixation system of claim 11, wherein the rotating magnetic field originates from a rotating magnet external to the subject.
Claims 1-19 (see bolded sections of claims 1, 18, 19 above)
16. The spinal fixation system of claim 11, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both.
Claims 1-19 (see bolded sections of claims 1, 18, 19 above)
17. The spinal fixation system of claim 11, wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials.
12. The spinal fixation system of claim 11, wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials.
18. The spinal fixation system of claim 11, wherein the spinal rod assembly, the bone anchor, and the occipital plate are at least partially composed of a non-absorbable biocompatible material.
5. The spinal fixation system of claim 1, wherein the spinal rod assembly, the bone anchor, and the occipital plate are at least partially composed of a non-absorbable biocompatible material.
19. The spinal fixation system of claim 18, wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene.
6. The spinal fixation system of claim 1, wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene.
Thus, the invention of US Patent 11446063, claims 1-19, and US Patent 10610261, claims 1, 2, 6, 8, 9, 11, 12 and 16-19, respectively, are 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 4, 10, 13 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the fixing plate" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the fixing plate" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the rotating magnetic fields" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the fixing plate" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the fixing plate" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-6, 9, and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Refai (US 20140214083) in view of Chang (US 20130338714).
With respect to claims 1, 2, 6, 11, 12 and 17, Refai teaches a spinal fixation system (200) (see fig. 2 below) of a subject, the system comprising: a spinal rod assembly (210) comprising a caudal rod portion (210a), a cranial rod portion (210b), and an adjustment mechanism (270) connected to the caudal rod portion and the cranial rod portion, the adjustment mechanism configured to rotate the caudal portion relative to the cranial rod portion about a joint axis (see para. 38-39); and a bone anchor connected to the caudal rod portion of the spinal rod assembly (see fig. 2 below); further comprising: a second spinal rod assembly comprising a second caudal rod portion (see fig. 2 below, note that para. 11 describes fig. 2 as a truncated perspective showing only one of the spinal rod assemblies instead of both, also see para. 31 below, note that the second caudal rod portion is similar to the first caudal rod portion annotated in fig. 2 below), a second cranial rod portion (similar to the first cranial rod portion as annotated in fig. 2 below), and a second adjustment mechanism (similar to the first adjustment mechanism as annotated in fig. 2 below) connected to the second caudal rod portion and the second cranial rod portion; and a second bone anchor (similar to the first bone anchor annotate din fig. 2 below) connected to the second caudal rod portion of the second spinal rod assembly.
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Refai does not teach the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field; wherein the rotating magnetic field originates from a rotating magnet external to the subject; and the second adjustment mechanism comprising a second rotatable magnet configured to rotate the second caudal portion relative to the second cranial rod portion about a second joint axis in response to a second rotating magnetic field; and wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials.
Chang, also drawn to vertebral support assemblies, teaches an adjustable rod assembly (see fig. 8, 10 17a-c), the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field (see para. 58, 59, 66); wherein the rotating magnetic field originates from a rotating magnet external to the subject (see para. 58, 59, 66); and wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials (see para. 20, 58, 69), in order to provide the surgeon, the advantageous ability to adjust the rod assembly after implantation, and accommodate the patient’s needs over time without having to perform any further percutaneous procedures (see para. 16, 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Refai to include the adjustment mechanism comprising a rotatable magnet configured to rotate the caudal portion relative to the cranial rod portion about a joint axis in response to a rotating magnetic field; wherein the rotating magnetic field originates from a rotating magnet external to the subject; and the second adjustment mechanism comprising a second rotatable magnet configured to rotate the second caudal portion relative to the second cranial rod portion about a second joint axis in response to a second rotating magnetic field; and wherein the adjustment mechanism apart from the rotatable magnet only comprises one or more non-magnetic or weakly magnetic materials, in view of Chang, as a matter of engineering design choice, in order to provide the surgeon, the advantageous ability to adjust the rod assembly after implantation, and accommodate the patient’s needs over time without having to perform any further percutaneous procedures.
As for claim 3, Refai, as modified by Chang, further teaches the spinal fixation system of claim 1, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor (see fig. 2 above), and the cranial rod portion is fastened to a rod receiver of the fixing plate (see fig. 2 above).
As for claim 4, Refai, as modified by Chang, further teaches the spinal fixation system of claim 1, wherein the fixing plate is configured to be fixed to an occipital bone (see fig. 2 above and also para. 3).
As for claim 5, Refai, as modified by Chang, further teaches the spinal fixation system of claim 1, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion (see fig. 2 above).
As for claim 9, Refai, as modified by Chang, further teaches the spinal fixation system of claim 1, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both (see para. 31 above- polyaxial movement, also see para. 66 of Chang).
As for claim 13, Refai, as modified by Chang, further teaches the spinal fixation system of claim 11, wherein the fixing plate is configured to be fixed to an occipital bone (see para. 3).
As for claim 4, Refai, as modified by Chang, further teaches the spinal fixation system of claim 11, wherein the adjustment mechanism is at an inferior end of the cranial portion and a superior end of the caudal portion (see fig. 2 above).
As for claim 15, Refai, as modified by Chang, further teaches the spinal fixation system of claim 11, wherein the caudal rod portion is fixedly seated in a rod housing of the bone anchor, and the cranial rod portion is fastened to a rod receiver of the fixing plate (see fig. 2 above).
As for claim 16, Refai, as modified by Chang, further teaches the spinal fixation system of claim 11, wherein the joint axis is generally perpendicular to a longitudinal axis of the caudal rod portion, the cranial rod portion, or both (see para. 31 above- polyaxial movement, also see para. 66 of Chang).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Refai (US 20140214083) and Chang (US 20130338714), as applied to claim 5 above, in view of Logroscinco (US 5507745).
As for claim 7, Refai, as modified by Chang, does not teach the system further including a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent vertebrae, the cross bar comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion of the spinal rod assembly, and a second rod connector at a second end configured to connect the crossbar to the second caudal rod portion of the second spinal rod assembly.
Logroscinco, also drawn to spinal fixation systems (see abstract), teaches a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent vertebrae (see fig. 8 below), the cross bar comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion of the spinal rod assembly (see fig. 8 below), and a second rod connector at a second end configured to connect the crossbar to the second caudal rod portion of the second spinal rod assembly (see fig. 8 below) in order to provide further support and reinforcement to the system with the inclusion of a transverse connector that is very well known in the field of spinal stabilization (see col. 4 lines 54-61 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Refai, as modified by Chang, to include a crossbar, said crossbar dimensioned to fit between two spinous processes of two adjacent vertebrae, the cross bar comprising: a first rod connector at a first end configured to connect the crossbar to the caudal rod portion of the spinal rod assembly, and a second rod connector at a second end configured to connect the crossbar to the second caudal rod portion of the second spinal rod assembly, in view of Logroscino, in order to provide further support and reinforcement to the system with the inclusion of a transverse connector that is very well known in the field of spinal stabilization.
Claim(s) 8, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Refai (US 20140214083) and Chang (US 20130338714), as applied to claims 1 and 11 above, in view of Culbert (US 7998176).
As for claims 8, 18 and 19, Refai, as modified by Chang, does not appear to teach wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material; and wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene.
Culbert, also drawn to spinal stabilization systems (see abstract), teaches a variety of suitable implant materials, including a non-absorbable biocompatible material, wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene (see col. 21 lines 36-44) in order to provide known material with the desired biocompatibility as material properties as dictated by the procedure (see col. 21 lines 36-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Refai, as modified by Chang, wherein the spinal rod assembly, bone anchor, and occipital plate are at least partially composed of a non-absorbable biocompatible material; and wherein the non-absorbable biocompatible material is selected from the group consisting of: titanium, alloys of titanium, steel, stainless steel, austenitic stainless steel, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polypropylene, in view of Culbert, as a matter of engineering design choice, in order to provide known material with the desired biocompatibility as material properties as dictated by the procedure.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Refai (US 20140214083) and Chang (US 20130338714), as applied to claim 1 above, in view of Fening (US 20140296918).
As for claim 10, Refai, as modified by Chang, appears to be silent regarding wherein the rotating magnetic fields are above a pre-determined threshold.
Fening, also drawn to spinal stabilization systems, teaches adjustment of a pre-determined threshold (e.g., expected orientation or distance based on surgical planing) of the magnetic field in order to allow the surgeon to generate the desired magnetic field that will cause the necessary adjustment of the system (see para. 72 and 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Refai, as modified by Chang, wherein the rotating magnetic fields are above a pre-determined threshold, in view of Fening, in order to allow the surgeon to generate the desired magnetic field that will cause the necessary adjustment (actuation) of the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20060058792.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773