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 1 is objected to because of the following informalities: the word “which” should be deleted from between “lower surface” and “are custom contoured” (line 4). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the word “surfaced” should be “surface” (line 6). 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 5 and 6 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 5 recites the limitations "the customized upper surface" and “the customized lower surface” in line 2. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites an upper surface and a lower surface. Claim 6 is rejected because it depends from claim 5.
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 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cordonnier (US 2022/0387191 A1).
Claim 1. Cordonnier discloses a custom patient-specific interbody implant (device 130 having expansion body 131 replaced with driver device 1800 of Fig. 21; see para. 0025, which indicates that Fig. 21 includes an alternative expansion mechanism) comprising:
a body having an upper surface (first surface 142) having an irregular surface topography (see Figs. 1A-1B, which show that first surface 142 is irregular) and a lower surface (first surface 152) having an irregular surface topography (see Figs. 1A-1B, which show that first surface 152 is irregular) configured to contact adjacent vertebral bodies, wherein the upper surface and the lower surface are custom contoured to fit between adjacent vertebral endplates of a specific patient (see para. 0045, which states that first surface 142 is customized to the patient-specific topology of inferior vertebral surface 112 of vertebra 110; see para. 0047, which states that first surface 152 is customized to the patient-specific topology of superior surface 122 of vertebra 120),
wherein the irregular surface topography of the upper surface and the irregular surface topography of the lower surface are predetermined from a virtual implant model generated by overlapping a portion of the virtual implant model with a portion of a virtual three-dimensional model of a spine of the patient simulated pre-operatively with a desired correction to the spine, such that any intersecting areas are subtracted from the virtual implant model to mimic the topography of the adjacent vertebral endplates of the patient, and wherein the virtual three-dimensional model of the spine of the patient is simulated based on segmentation of pre-operative two-dimensional and three-dimensional imaging of the patient, thereby converting the virtual three-dimensional model of the spine to represent a standing posture instead of a lying posture of the patient (Figs 1A-1B and 21-22; paras. 0038-0054 and 0183-0184).
Note that the italicized limitation above is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an implant having custom contoured upper and lower surfaces with irregular surface topographies. Manufacturing steps, such as the use of a virtual implant model and a virtual three-dimensional model of the spine, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113.
Claim 4. Cordonnier discloses wherein the implant is an expandable implant (driver device 1800 is an expansion mechanism) (Figs 1A-1B and 21-22; paras. 0038-0054 and 0183-0184).
Claim 5. Cordonnier discloses wherein the expandable implant includes an upper endplate (endplate 140) defining the customized upper surface, a lower endplate (endplate 150) defining the customized lower surface, and a central actuator (drive mechanism 1820) with ramps (wedges 1810 and 1812, upper member 1830, and lower member 1840 all include ramps) configured to expand the upper endplate and the lower endplate (Figs 1A-1B and 21-22; paras. 0038-0054 and 0183-0184).
Claim 6. Cordonnier discloses wherein the upper endplate and the lower endplate are each represented in the virtual implant model as two separate meshes each comprising a modifiable mesh portion that is subtracted to form the irregular surface topography and an unmodifiable mesh portion that is retained for structural integrity of the upper and lower endplates (Figs 1A-1B and 21-22; paras. 0038-0054 and 0183-0184).
Note that the italicized limitation above is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an implant having custom contoured upper and lower surfaces with irregular surface topographies. Manufacturing steps, such as the use of a virtual implant model and meshes, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casey et al. (US 2022/0160518 A1).
Claim 1. Casey discloses a custom patient-specific interbody implant (cage 310) comprising:
a body having an upper surface (upper surface 312) having an irregular surface topography (see Fig. 3A, which shows that upper surface 312 is irregular) and a lower surface (lower surface 314) having an irregular surface topography (see Fig. 3A, which shows that lower surface 314 is irregular) configured to contact adjacent vertebral bodies, wherein the upper surface and the lower surface are custom contoured to fit between adjacent vertebral endplates of a specific patient (see para. 0039, which states that upper surface 312 is designed with a topography that mates with an inferior surface of the L3 vertebra and lower surface 314 is designed with a topography that mates with a superior surface of the L4 vertebra),
wherein the irregular surface topography of the upper surface and the irregular surface topography of the lower surface are predetermined from a virtual implant model generated by overlapping a portion of the virtual implant model with a portion of a virtual three-dimensional model of a spine of the patient simulated pre-operatively with a desired correction to the spine, such that any intersecting areas are subtracted from the virtual implant model to mimic the topography of the adjacent vertebral endplates of the patient, and wherein the virtual three-dimensional model of the spine of the patient is simulated based on segmentation of pre-operative two-dimensional and three-dimensional imaging of the patient, thereby converting the virtual three-dimensional model of the spine to represent a standing posture instead of a lying posture of the patient (Figs. 3A-3B; paras. 0038-0042).
Note that the italicized limitation above is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an implant having custom contoured upper and lower surfaces with irregular surface topographies. Manufacturing steps, such as the use of a virtual implant model and a virtual three-dimensional model of the spine, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113.
Claim 3. Casey discloses wherein the implant is a static implant (see Fig. 3A, which shows that cage 310 is not an expandable implant, and is therefore a static implant) (Figs. 3A-3B; paras. 0038-0042).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (US 2022/0160518 A1) in view of Dang et al. (US 2021/0022882 A1).
Claim 2. Casey discloses wherein the upper surface and the lower surface are constructed from a mapped topography of the adjacent vertebral endplates for the specific patient (Figs. 3A-3B; paras. 0038-0042).
Note that the italicized limitation above is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered an implant having custom contoured upper and lower surfaces with irregular surface topographies. Manufacturing steps, such as the use of a mapped topography of the vertebral endplates, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113.
Casey fails to disclose that the upper surface and the lower surface are filled in with a trabecular lattice (claim 2).
Dang teaches an interbody implant (implant 101) comprising a body having an upper surface (superior surface as shown in Fig. 1B) and a lower surface (inferior surface as shown in Fig. 1B), wherein the upper surface and the lower surface are filled in with a trabecular lattice (see para. 0015, which states that outer ring 102 is filled with a trabecular inspired lattice), wherein the trabecular lattice mimics the natural trabecular bone structure, thereby providing appropriate strength and porosity to the implant (see paras. 0012-0013) (Figs. 1A-1B; paras. 0012-0013 and 0015).
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 interbody implant of Casey such that the upper surface and the lower surface are filled in with a trabecular lattice (claim 2), as suggested by Dang, as such mimics the natural trabecular bone structure, thereby providing appropriate strength and porosity to the implant.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (US 2022/0160518 A1) in view of Lakshminarayanan et al. (US 2014/0264995 A1).
Casey fails to disclose wherein the implant comprises a solid shell surrounding an inner porous center (claim 7).
Lakshminarayanan teaches an interbody implant (spacer 100) comprising a body having an upper surface (upper surface 106) and a lower surface (lower surface 108), wherein the implant comprises a solid shell (shell 102) surrounding an inner porous center (core 104), wherein the solid shell mimics cortical bone and the inner porous core mimics cancellous bone to provide a strong mechanical load bearing structure while allowing bone ingrowth (see para. 0046) (Fig. 1; para. 0046).
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 implant of Casey such that it comprises a solid shell surrounding an inner porous center (claim 7), as suggested by Lakshminarayanan, in order to mimic cortical and cancellous bone, thereby providing a strong mechanical load bearing structure while allowing bone ingrowth.
Conclusion
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.
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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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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