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 .
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, 3, and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trieu (US 20060247638) in view of Crudden (US 20190298886).
With respect to claims 1 and 14-16, Trieu teaches a composite rod for spinal instrumentation (see para. 8-9) comprising: a metal rod (12) forming an inner core (see para. 20-21, fig. 1 embodiment B below); and a PEEK layer (13) forming an outer coating around at least a top portion of the inner core (see fig. 1 embodiment B below and also fig. 5a), wherein the inner core and the outer coating each have a variable thickness (see para. 25) and the composite rod has a uniform overall thickness (e.g., see fig. 5a).
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Trieu does not teach a composite polymer coating derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules; wherein no positively (+) charged heavy metal ion is included as part of the outer coating.
Crudden, also drawn to composite implants (see para. 2, 13 and also 31 and 34 below), teaches a composite polymer coating derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules (see para. 31 and 34 below); and wherein no positively (+) charged heavy metal ion is included as part of the outer coating (see para. 31, 35, 36) in order to provide the implant with a known PEEK/zeolite combination that will increase the ability of antimicrobial moieties to permeate in and kill the bacterial pathogen rather than be repelled by the hydrophobic surface properties of naked PEEK (see para. 12 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 Trieu wherein the composite polymer coating is derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules; and wherein no positively (+) charged heavy metal ion is included as part of the outer coating, in view of Crudden, in order to provide the implant with a known PEEK/zeolite combination that will increase the ability of antimicrobial moieties to permeate in and kill the bacterial pathogen rather than be repelled by the hydrophobic surface properties of naked PEEK.
As for claim 3, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the inner core is formed of chrome cobalt or titanium alloy (see para. 19).
As for claim 7, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the composite rod is capable of use in screw capture (see abstract and note that this device is capable of performing this function if one so desires).
As for claim 8, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the composite rod is capable of use in a scaffolding function for osteocytes to travel along to promote fusion (see abstract and note that this device is capable of performing this function, if one so desires- also see Crudden para. 31 above).
As for claim 9, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the composite rod is formed through plasma coating or machining (see para. 44, 45).
As for claim 10, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the inner core has at least one portion including the outer coating (see fig. 1 above and note embodiments B and C).
As for claim 11, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein at least some portion of the composite rod is metal only or the composite polymer only (see fig. 1 above).
As for claim 12, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein segmental stiffness, bend, and/or length of the composite rod are customizable (see para. 25, 38).
As for claim 13, Trieu, as modified by Crudden, further teaches the composite rod of claim 1, wherein the composite rod provides improved radiopacity (e.g., via metal rod).
Claim(s) 2, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trieu (US 20060247638) and Crudden (US 20190298886), as applied to claims 1 and 14 above, in view of Roth (WO2017/004483A1).
As for claims 2 and 17, Trieu, as modified by Crudden, does not appear to teach wherein the composite rod is formed through 3D printing.
Roth, also drawn to composite rods (see fig. 11, para. 5, 39, 80) teaches teach wherein the composite rod is formed through 3D printing in order to provide a known cost-effective manner to construct a complex composite implant in a one-step operation (see para. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Trieu, as modified by Crudden, wherein the composite rod is formed through 3D printing, in view of Roth, in order to provide a known cost-effective manner to construct a complex composite implant in a one-step operation.
With respect to claim 20, Trieu teaches a composite rod for spinal instrumentation (see fig. 1 embodiment B above) comprising: a metal rod forming an inner core (see fig. 1 embodiment B above); and a composite polymer derived from a PEEK forming an outer coating around at least a top portion of the inner core (see fig. 1 embodiment B above), wherein the inner core and the outer coating each have a variable thickness and the composite rod has a uniform thickness (see para. 25).
Trieu does not teach a composite polymer coating derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules; wherein no positively (+) charged heavy metal ion is included as part of the outer coating; and wherein the composite rod is formed through 3D printing.
Crudden, also drawn to composite implants (see para. 2, 13, 31 and 34), teaches a composite polymer coating derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules (see para. 31 and 34); and wherein no positively (+) charged heavy metal ion is included as part of the outer coating (see para. 31, 35, 36) in order to provide the implant with a known PEEK/zeolite combination that will increase the ability of antimicrobial moieties to permeate in and kill the bacterial pathogen rather than be repelled by the hydrophobic surface properties of naked PEEK (see para. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Trieu wherein the composite polymer coating is derived from a hybrid of PEEK and negatively (-) charged ceramic aluminum silicate molecules; and wherein no positively (+) charged heavy metal ion is included as part of the outer coating, in view of Crudden, in order to provide the implant with a known PEEK/zeolite combination that will increase the ability of antimicrobial moieties to permeate in and kill the bacterial pathogen rather than be repelled by the hydrophobic surface properties of naked PEEK.
Trieu, as modified by Crudden, does not appear to teach wherein the composite rod is formed through 3D printing.
Roth, also drawn to composite rods (see fig. 11, para. 5, 39, 80) teaches teach wherein the composite rod is formed through 3D printing in order to provide a known cost-effective manner to construct a complex composite implant in a one-step operation (see para. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Trieu, as modified by Crudden, wherein the composite rod is formed through 3D printing, in view of Roth, in order to provide a known cost-effective manner to construct a complex composite implant in a one-step operation.
Claim(s) 4-6, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trieu (US 20060247638) and Crudden (US 20190298886), as applied to claims 1 and 14 above, in view of Trieu (US 20110071570).
As for claims 4-6, 18 and 19, Trieu, as modified by Crudden, does not appear to teach wherein the inner core has a diameter up to 6 millimeters; wherein the inner core has a diameter of 5.5 millimeters; and wherein the outer coating has a diameter up to 6 millimeters.
Trieu (‘570), also drawn to composite rods (see para. 87) teaches a rod can be 4.75 and/or 5.5 millimeters (see para. 87-88) in order to provide the desired amount of flexibility or stiffness (see para. 87-88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Trieu, as modified by Crudden, wherein a rod diameter can be 4.75 and/or 5.5 millimeters, in view of Trieu (‘570), in order to provide the desired amount of flexibility or stiffness.
As for wherein the inner core has a diameter up to 6 millimeters; wherein the inner core has a diameter of 5.5 millimeters; and wherein the outer coating has a diameter up to 6 millimeters, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to construct the apparatus of Trieu, as modified by Crudden and Trieu (‘570), wherein the inner core has a diameter up to 6 millimeters; wherein the inner core has a diameter of 5.5 millimeters; and wherein the outer coating has a diameter up to 6 millimeters, as a matter of engineering design choice, to work within a certain spinal procedure and patient, since it has been held that where the general conditions of a claim are disclosed, in the prior art, discovering optimum or workable ranges involves only routine skill in the art (in re Aller, 105 USPQ 233).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773