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 Objections
Claim 10 is objected to because of the following informalities:
Claim 10, line 3 recites “a plurality of cantilevered and projection elements” and should be amended to recite “a plurality of cantilevered projection elements”.
Appropriate correction is required.
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 1-20 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 1 recites the limitation "the vertebrae" in line 12. It is unclear whether “the vertebrae” is referring to the upper or lower vertebrae disclose in line 10 of claim 1, or if it is referring to a different vertebrae. For the purpose of examining the claim, “within the vertebrae” will be interpreted as “between the upper and lower vertebrae”.
Claim 2 recites the limitation "the first and second projection elements" in line 1. It is unclear whether it is referring to the plurality of first and second projection elements disclosed in lines 3 and 5 of claim 1, certain first and second projection elements of the plurality of first and second projection elements, or if it is referring to new first and second projection elements. For the purpose of examining the claim, “the first and second projection elements” will be interpreted as “the plurality of first and second projection elements”.
Claim 2 recites the limitation "the intervertebral space" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the intervertebral space” will be interpreted as “an intervertebral space”.
Claim 5 recites the limitation "at least one stowable component" in line 8. It is unclear whether this is referring to the at least one stowable component disclosed in line 2 of claim 5, or if a new at least one stowable component is being claimed. For the purpose of examining the claim, “a geometric body having at least one stowable component” in line 2 will be interpreted as “a geometric body”.
Claim 5 recites the limitation "the first projection elements" in line 12. It is unclear whether it is referring to the plurality of first projection elements disclosed in line 5 of claim 5, certain first projection elements of the plurality of first projection elements, or if it is referring to new first projection elements. For the purpose of examining the claim, “the first projection elements” in line 12 will be interpreted as “the plurality of first projection elements”.
Claim 5 recites the limitation "the second projection elements" in line 14. It is unclear whether it is referring to the plurality of second projection elements disclosed in lines 9-10 of claim 5, certain second projection elements of the plurality of second projection elements, or if it is referring to new second projection elements. For the purpose of examining the claim, “the second projection elements” in line 14 will be interpreted as “the plurality of second projection elements”.
Claim 5 recites the limitation "an enlarged second form factor" in line 16. It is unclear whether it is referring to the second form factor disclosed in line 4 of claim 5, or if a new enlarged form factor is being claimed. For the purpose of examining the claim, “an enlarged second form factor” will be interpreted as “the second form factor”.
Claim 5 recites the limitation "the intervertebral space" in line 17. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the intervertebral space” will be interpreted as “an intervertebral space”.
Claim 5 recites the limitation "to accommodate a larger coverage area and volume” in lines 16-17. It is unclear as to what “larger” is in comparison to. For the purpose of examining the claim, “to accommodate a larger coverage area and volume” will be interpreted as “to accommodate a coverage area and volume in the second form factor that is larger than a coverage area and volume in the first form factor”.
Claim 5 recites the limitation "wherein in both stowed and unstowed configurations" in line 18. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “wherein both stowed and unstowed configurations” will be interpreted as “a stowed configuration and an unstowed configuration, wherein both stowed unstowed configurations”.
Claim 6 recites the limitation "the projection elements" in lines 1-2. It is unclear whether this is referring to the plurality of first projection elements, the plurality of second projection elements, or if new projection elements are being claimed. For the purpose of examining the claim, “the projection elements” will be interpreted as “the plurality of first projection elements”.
Claim 7 recites the limitation "the second projection elements" in line 1. It is unclear whether it is referring to the plurality of second projection elements disclosed in lines 9-10 of claim 5, certain second projection elements of the plurality of second projection elements, or if it is referring to new second projection elements. For the purpose of examining the claim, “the second projection elements” in line 1 will be interpreted as “the plurality of second projection elements”.
Claim 7 recites the limitation "the first projection elements" in line 2. It is unclear whether it is referring to the plurality of first projection elements disclosed in line 5 of claim 5, certain first projection elements of the plurality of first projection elements, or if it is referring to new first projection elements. For the purpose of examining the claim, “the first projection elements” in line 2 will be interpreted as “the plurality of first projection elements”.
Claim 9 recites the limitation "the device’s design" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the device’s design” will be interpreted as “the device”.
Claim 9 recites the limitation "to change form factors" in line 2. It is unclear whether it is referring to the firs and second form factors disclosed in claim 5, or if it is referring to new form factors. For the purpose of examining the claim, “to change form factors” will be interpreted as “to transition from the first from factor to the second form factor”.
Claim 10 recites the limitation "the surfaces of the device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the surfaces of the device” will be interpreted as “the defined surfaces of the geometric body”.
Claim 10 recites the limitation "wherein these projection elements" in line 4. It is unclear whether this is referring to the plurality of cantilevered projection elements disclosed in line 3, or if new projection elements are being claimed. For the purpose of examining the claim, “wherein these projection elements” will be interpreted as “wherein the plurality of cantilevered projection elements”.
Claim 10 recites the limitation "at least one surface of the geometric body" in lines 4-5. It is unclear whether it is referring to the defined surfaces of the geometric body in line 2, or if a new surface is being claimed. For the purpose of examining the claim, “at least one surface of the geometric body” will be interpreted as “at least one surface of the defined surfaces of the geometric body”.
Claim 10 recites the limitation "the free end of the projection elements" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the free end of the projection elements” will be interpreted as “a free end of the projection elements”.
Claim 13 recites the limitation "the variable load bearing regions" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the variable load bearing regions” will be interpreted as “resiliently deformable load bearing regions” as disclosed in line 9 of claim 10
Claim 14 recites the limitation "the projection elements" in line 2. It is unclear whether it is referring to the plurality of cantilevered projection elements disclosed in line 3 of claim 10, certain projection elements of the plurality of cantilevered projection elements, or if it is referring to new projection elements. For the purpose of examining the claim, “the projection elements” will be interpreted as “the plurality of cantilevered projection elements”.
Claim 15 recites the limitation "the plurality of cantilevered and intersecting projection elements" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the plurality of cantilevered and intersecting projection elements” will be interpreted as “the plurality of cantilevered projection elements” as disclosed in line 3 of claim 10.
Claim 16 recites the limitation "in its implanted state" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “in its implanted state” will be interpreted as “in an implanted state”.
Claim 17 recites the limitation "at least one surface of the device" in lines 2-3. It is unclear whether it is referring to the defined surfaces of the geometric body in line 2 of claim 10, or if a new surface is being claimed. For the purpose of examining the claim, “at least one surface of the device” will be interpreted as “at least one surface of the defined surfaces of the geometric body”.
Claim 17 recites the limitation "the first projections" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first projections” will be interpreted as “the plurality of first projection elements”.
Claim 18 recites the limitation "where the structurally tailored first and second projections elements" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “where the structurally tailored first and second projections elements” will be interpreted as “wherein the plurality of structurally tailored first projection elements” and claim 18 will be interpreted to depend from claim 17.
Claim 19 recites the limitation "where the structurally tailored projection elements" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “where the structurally tailored projection elements” will be interpreted as “wherein the plurality of structurally tailored first projection elements” and claim 19 will be interpreted to depend from claim 17.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Compton et al. (U.S. Publication No.2010/0185290 A1; hereinafter “Compton”).
Regarding claim 1, Compton discloses a dynamically morphing, intervertebral implantable device with a modularly scalable structure having at least one stowable component (see the embodiment of Figures 2A and 2B), the device comprising: a plurality of first projection elements (projections 40 formed on top member 20) formed on a common base on at least one surface of a geometric body (top member 20) defined by contiguous surfaces (see nodules 41 on top member 20); a plurality of second projection elements (projections 40 formed on bottom member 30) formed on the at least one stowable component (bottom member 30) being pivotably and modularly coupled (via flexible section 14) to the at least one surface of the geometric body (Figures 2A-2B); and each of the plurality of second projection elements being configured to pivotably stow within the geometric body by engaging with and forming a versatile and scalable structure intersecting with the corresponding first projection elements of the geometric body (para.0055-0056) forming a compact first form factor (see implant position in Figure 2A) for implant between an upper and lower vertebrae, and forming a second form factor (see opened position in Figure 2B) when the second projection elements are unstowed extending outward to cover a larger area and volume between the upper and lower vertebrae (Figure 2B).
Regarding claim 2, Compton further discloses wherein the plurality of first and second projection elements (projections 40 from top and bottom members 20, 30) form one of a plurality of cantilevered structures (nodules 41) having enclosed structures providing adjustable load bearing areas to enable segment stabilization between the upper and lower vertebrae within an intervertebral space therebetween (para.0052 and 0054).
Regarding claim 3, Compton further discloses wherein the geometric body (20) and the stowable structure (30) form a modularly connected and buildable device (10’) offering structural flexibility to add, remove or rearrange modules to adapt to various vertebral bone anomalies such as one of structural deterioration of spinal disc desiccation and other various metabolic bone disease, presenting varying mechanical stresses (para.0055-0056).
Regarding claim 4, Compton further discloses wherein the first and second projection elements (projections 40 from top and bottom members 20, 30) form a plurality of structures (Figures 2A and 2B) having variable flexing strengths, to enable segment stabilization between upper and lower vertebrae, and being modularly custom designed to accommodate patient specific requirements (para.0099).
Regarding claim 5, Compton discloses an implantable device for insertion between vertebral bodies (see the embodiment of Figures 2A and 2B), the device comprising: a) a geometric body (top member 20), wherein said geometric body is dynamically scalable in structure and being modularly configurable to transform from a first form factor (open position in Figure 2B) to a second form factor (implant position in Figure 2A); b) a plurality of first projection elements (projections 40 formed on top member 20) formed on a common base on at least one surface of the geometric body (20), wherein said first projection elements being an integral part of the geometric body (Figures 2A-2B); c) at least one stowable component (bottom member 30) coupled pivotably and modularly with the at least one surface of the geometric body (Figures 2A and 2B), said stowable component having a plurality of second projection elements (projections 40 formed on bottom member 30); d) wherein each of said plurality of second projection elements being configured to be pivotable (via flexible section 14) for stowage within the geometric body by intersecting with the plurality of first projection elements and compose the first form factor for implantation (see open position in Figure 2B); e) whereupon unstowing, the plurality of second projection elements (projections 40 formed on bottom member 30) extend outwardly, dovetailing with corresponding first projection elements of the geometric body (para.0055), thereby transitioning the device to the second form factor (implant position in Figure 2A), engineered to accommodate a coverage area and volume in the second form factor that is larger than a coverage area and volume in the first form factor within an intervertebral space (the implant position in Figure 2A covers a greater surface area and volume of an intervertebral space than open position in Figure 2B which occurs prior to insertion); and f) a stowed configuration, and an unstowed configuration, wherein in both stowed and unstowed configurations, the device maintains its structural integrity and ductility while maintaining effective support between the vertebral bodies (para.0055).
Regarding claim 6, Compton further discloses wherein the geometric body (top member 20) and the plurality of first projection elements (projections 40 formed on top member 20) include flexible and ductile structures to absorb and distribute applied loads due to compressive loads between the vertebral space at the implant site (para.05-054-0055).
Regarding claim 7, Compton further discloses wherein the plurality of second projection elements (projections 40 formed on bottom member 30) interact with the plurality of first projection elements (projections 40 formed on top member 20) in a manner forming a secure and stable enlarged surface area, when in the second form factor (Figure 2A), thereby preventing inadvertent detachment or displacement post-implantation (para.0054-0055).
Regarding claim 8, Compton further discloses wherein the geometric body (top member 20) and the at least one stowable component (bottom member 30) are manufactured in a variety of sizes and dimensions to accommodate a range of intervertebral spaces, ensuring a tailored fit for individual patient anatomies (para.0098).
Regarding claim 9, Compton further discloses wherein the device facilitates minimally invasive insertion techniques due to its ability to transition from the first form factor to the second form factor dynamically, promoting quicker recovery times and reduced surgical risk (para.0055).
Regarding claim 10, Compton discloses a dynamically morphing intervertebral implantable device (see the embodiment in Figures A and 2B) comprising: a geometric body (top member 20 and bottom member 30) having defined surfaces (Figure 2B); a plurality of cantilevered projection elements (projections 40 formed on top member 20) having a fixed end attached to the define surfaces of the geometric body (Figures 2A and 2B), wherein the plurality of cantilevered projection elements (projections 40 formed on top member 20) are formed on at least on one surface of the defined surfaces of the geometric body (surface of nodules 41); and wherein said plurality of projection elements (projections 40 formed on top of member 20), initially exhibiting a first form factor (open position in Figure 2B), are resiliently adjustable to assume a second form factor (implant position in Figure 2A) when subjected to a compressive load generated between an upper and lower vertebrae (when top and bottom members 20 and 30 are folded over, see para.0055), such that a free end of the projection elements forms resiliently deformable load bearing regions (projections 40 and modules 41 comprise varying thicknesses, see para.0054).
Regarding claim 11, Compton further discloses wherein the first form factor (open position in Figure 2B) is larger in volume than the second form factor (Figure 2A).
Regarding claim 12, Compton further discloses wherein the transition from the first form factor to the second form factor is one of linearly and non-linearly responsive to the magnitude of the compressive load (para.0055).
Regarding claim 13, Compton further discloses wherein the resiliently deformable load bearing regions are configured to distribute loads across a vertebral interface to mimic physiological load distribution (para.0054).
Regarding claim 14, Compton further discloses a bone fusion material within or around the plurality of cantilevered projection elements (para.0073).
Regarding claim 15, Compton further discloses wherein the geometric body (top member 20) includes unique configuration of the plurality of cantilevered projection elements on both an upper and corresponding lower surface of the device (Figures 2A and 2B).
Regarding claim 16, Compton further discloses wherein the second form factor is pre-configured (Figure 2A) based on desired biomechanical properties of the implant in an implanted state.
Regarding claim 17, Compton further discloses wherein a plurality of structurally tailored first projection elements (projections 40 formed on bottom member 30) are formed on at least one surface of the defined surfaces of the geometric body (surface of bottom member 30), wherein the plurality of first projection elements adaptively support different load conditions dictated by patient-specific needs (para.0054-0055).
Regarding claim 18, Compton further discloses wherein the plurality of structurally tailored first projection elements (projections 40 formed on bottom member 30) are designed based on biomechanical studies and simulations to support a range of vertebral load conditions (para.0054-0055).
Regarding claim 19, Campton further discloses wherein the structurally tailored first projection elements (projections 40 formed on bottom member 30) are customizable based on the patient's weight, physical activity level, location of implantation and to adapt to various vertebral bone anomalies such as one of structural deterioration of spinal disc desiccation or other various metabolic bone disease, presenting varying mechanical stresses (para.0054-0055).
Regarding claim 20, Compton further discloses wherein the geometric body is cylindrical (see Figure 1).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolters et al. U.S. Publication No.2013/0197647 A1
Middleton U.S. Publication No.2002/0116064 A1
Kohm U.S. Publication No.2010/0010633 A1
Manwill et al. U.S. Publication No.2020/0093603 A1
Butler et al. U.S. Publication No.2006/0224241 A1
Peterman U.S. Publication No.2006/0030943 A1
Brett U.S. Patent No.6,126,689
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773