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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite that the layers are stacked in a direction perpendicular to an axial direction of the fixture rod. Such a recitation constitutes new matter as the disclosure fails to state that the direction of stacking is perpendicular. Furthermore, the figures do not show such a configuration (note that Figs. 2-5 show a cross-section and as such cannot show whether the layers are stacked perpendicular to the axial direction). As such, claims 1-6 and 8-14 contain new matter.
Claims 11-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New claim 11 recites that the first plurality of layers and the second plurality of layers are planar. Such a recitation constitutes new matter as the disclosure fails to state that the plurality of layers are planar. Furthermore, the figures do not show such a configuration (note that Figs. 2-5 merely show a cross-section and as such cannot show whether the layers are planar). As such, claims 11-13 contain new matter.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hestad et al. (US 2008/0319486 A1) in view of Lange et al. (US 2006/0189982 A1).
Claim 1. Hestad discloses a fixture rod (flexible member 14) comprising:
a first plurality of layers (each of first portions 40 is a layer such that there are three layers) including reinforcing fiber layers (para. 0031 states that first portion 40 can be a polymer; para. 0051 states that the polymer can be impregnated with graphite or aramid fibers) and a second plurality of layers (each of second portions 44 is a layer such that there are three layers) including resin layers (para. 0031 states that second portion 44 can be a polymer), wherein
each of the first plurality of layers is alternately formed with each of the second plurality of layers (see Fig. 3) (Fig. 3; paras. 0031, 0036, and 0051).
Claim 2. Hestad discloses wherein each of the reinforcing fiber layers is a fiber-reinforced resin (para. 0031 states that first portion 40 can be a polymer; para. 0051 states that the polymer can be impregnated with graphite or aramid fibers), in which carbon, glass, boron, SiC, or aramid is used as fibers (para. 0051 states that the fibers can be graphite, which is a carbon fiber, or aramid), and epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK is used as a resin (para. 0051 states that the polymer can be polyethylene, polypropylene, polyamide, or polycarbonate) (Fig. 3; paras. 0031, 0036, and 0051).
Claim 3. Hestad discloses wherein a resin (para. 0031 states that second portion 44 can be a polymer) of each of the resin layers is epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK (para. 0051 states that the polymer can be polyethylene, polypropylene, polyamide, or polycarbonate) (Fig. 3; paras. 0031, 0036, and 0051).
Claim 4. Hestad discloses wherein the second plurality of layers further includes a reinforcing fiber layer having fibers different from those of the reinforcing fiber layers and comprises a fiber-reinforced resin (para. 0031 states that second portion 44 can be a polymer; para. 0051 states that the polymer can be impregnated with graphite or aramid fibers; para. 0036 states that the first and second portions 40 and 44 have different elasticities and para. 0031 states that the first and second portions 40 and 44 can be different materials, which would be achievable by using different fibers), in which carbon, glass, boron, SiC, or aramid is used as fibers (para. 0051 states that the fibers can be graphite, which is a carbon fiber, or aramid), and epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK is used as a resin (para. 0051 states that the polymer can be polyethylene, polypropylene, polyamide, or polycarbonate) (Fig. 3; paras. 0031, 0036, and 0051).
Claim 14. Hestad discloses wherein the fixture rod is rigid (see para. 0031) (Fig. 3; paras. 0031, 0036, and 0051).
Hestad fails to disclose that the first and second pluralities of layers are stacked in a direction perpendicular to an axial direction of the fixture rod (claim 1).
Lange teaches a fixture rod comprising a first plurality of layers (see Fig. 13 inset) and a second plurality of layers (see Fig. 13 inset), wherein the first and second pluralities of layers are stacked in a direction perpendicular to an axial direction (see Fig. 12 inset) of the fixture rod (rail 17) (Fig. 13 is a cross-section taken along line XIII-XIII of Fig. 12; Fig. 13 shows that layers A are stacked; para. 0029 states that layers A are parallel to each other and to surface 23; therefore layers A are stacked perpendicular to the axial direction) to resist bending forces (see para. 0029) (Figs. 12 and 13; para. 0029).
[AltContent: connector]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixture rod of Hestad such that the first and second pluralities of layers are stacked in a direction perpendicular to an axial direction of the fixture rod (claim 1), as suggested by Lange, as such a configuration can help resist bending forces.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hestad et al. (US 2008/0319486 A1) in view of Lange et al. (US 2006/0189982 A1) as applied to claim 1 above, and further in view of Joshi (US 2009/0093819 A1).
Claim 6. Hestad discloses wherein the second plurality of layers further includes a reinforcing fiber layer (para. 0031 states that second portion 44 can be a polymer; para. 0051 states that the polymer can be impregnated with graphite or aramid fibers) (Fig. 3; paras. 0031, 0036, and 0051).
Hestad and Lange fail to teach wherein in the reinforcing fiber layers, fibers are aligned in one direction, formed in a woven fabric form, or randomly oriented (claim 5) and wherein the fibers are obliquely oriented with respect to the fiber direction of the reinforcing fiber layers at an angle in a range of 10° to 90° (claim 6).
Joshi teaches a fixture rod (rod 200) comprising a first plurality of layers (each of stiff parts S1 is a layer such that there are two layers) including reinforcing fiber layers (para. 0053 states that stiff parts S1 are made of composites with fibers; para. 0053 states that the fibers of stiff parts S1 can be oriented in one direction) and a second plurality of layers (each of flexible parts F1 is a layer such that there are two layers) including a reinforcing fiber layer (para. 0053 states that flexible parts F1 are made of composite materials with fibers), wherein in the reinforcing fiber layers of the first plurality of layers, fibers are aligned in one direction (para. 0053 states that the fibers of stiff parts S1 can be oriented in one direction), wherein a fiber direction of the reinforcing fiber layer of the second plurality of layers has fibers obliquely oriented with respect to the fiber direction of the reinforcing fiber layer is obliquely oriented in a range of 10° to 90° (Fig. 19 shows that fibers 402 can be oriented along axes X and Y; thus, if fibers of stiff parts S1 are oriented along either axis X or Y, the fibers of flexible parts F1 that are oriented along the other of axis X or Y would be obliquely oriented; para. 0068 states that the fiber angle can be 28° to 57°), wherein such configurations allow for the varying of the modulus of elasticity of the fixture rod (see para. 0053) and provide the optimum fiber orientation for stabilizing flexion and extension of the spine (see para. 0068) (Figs. 12 and 19; paras. 0053, 0065, and 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the fixture rod of Hestad such that in the reinforcing fiber layers, fibers are aligned in one direction, formed in a woven fabric form, or randomly oriented (claim 5) and the fibers are obliquely oriented with respect to the fiber direction of the reinforcing fiber layers at an angle in a range of 10° to 90° (claim 6), as suggested by Joshi, as such configurations allow for the varying of the modulus of elasticity of the fixture rod and provide the optimum fiber orientation for stabilizing flexion and extension of the spine.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hestad et al. (US 2008/0319486 A1) in view of Lange et al. (US 2006/0189982 A1) as applied to claim 1 above, and further in view of Edwards (US 2007/0243368 A1).
Hestad and Lange fail to teach wherein fibers of the reinforcing fiber layers are long fibers (claim 8) and wherein a fiber content of the reinforcing fiber layers is 60 weight % or more (claim 9).
However, Hestad states that first and second portions 40 and 44 can have a range of elasticities, such as flexible, semi-rigid, and rigid, such that flexible member 14 can be tailored to a particular surgical application (see para. 0031).
Edward teaches that a fiber reinforced resin can include randomly oriented long fibers and have a fiber content of 75 weight % and that such a fiber configuration can impart enhanced properties (see para. 0027) and result in a structure that is more suited to carry loads in all directions (see para. 0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the fixture rod of Hestad such that fibers of the reinforcing fiber layers are long fibers (claim 8) and a fiber content of the reinforcing fiber layers is 60 weight % or more (claim 9), as suggested by Edward, as such a fiber configuration can impart enhanced properties and result in a structure that is more suited to carry loads in all directions.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hestad et al. (US 2008/0319486 A1) in view of Lange et al. (US 2006/0189982 A1) as applied to claim 1 above, and further in view of Joshi (US 2009/0093819 A1) and Trieu et al. (US 2006/0247638 A1).
Hestad and Lange fail to teach wherein fiber directions of the reinforcing fiber layers are aligned and thicknesses of the reinforcing fiber layers are in a range of 0.02 mm to 0.25 mm (claim 10).
Joshi teaches a fixture rod (rod 200) comprising a first plurality of layers (each of stiff parts S1 is a layer such that there are two layers) including reinforcing fiber layers (para. 0053 states that stiff parts S1 are made of composites with fibers; para. 0053 states that the fibers of stiff parts S1 can be oriented in one direction) and a second plurality of layers (each of flexible parts F1 is a layer such that there are two layers), wherein fiber directions of the reinforcing fiber layers are aligned (para. 0053 states that the fibers of stiff parts S1 can be oriented in one direction), wherein such configurations allow for the varying of the modulus of elasticity of the fixture rod (see para. 0053) (Figs. 12 and 19; paras. 0053 and 0065).
Trieu teaches a fixture rod (rod 20) with reinforcing layers (inner tube 24 and outer tube 26), wherein thicknesses of the layers are in a range of 0.02 mm to 0.25 mm (para. 0031 states that the thickness of the tubes can be 0.1mm and 0.25 mm), wherein the thickness can be varied as desired (see para. 0031) to achieve different flexibility characteristics of the fixture rod (see para. 0025) (Figs. 2 and 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the fixture rod of Hestad such that fiber directions of the reinforcing fiber layers are aligned and thicknesses of the reinforcing fiber layers are in a range of 0.02 mm to 0.25 mm (claim 10), as suggested by Joshi and Trieu, as such configurations allow for the varying of the modulus of elasticity of the fixture rod and allow the fixture rod to achieve different flexibility characteristics as desired.
Response to Arguments
Applicant’s arguments with respect to claim 1 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.
Conclusion
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773