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 .
Election/Restrictions
The application includes disclosure and claims to multiple embodiments, i.e. species and/or subspecies. The examiner reserves the right to restrict the application if the multiple embodiments are claimed in a way that creates a serious burden for the examiner.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,279,967. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 2-16 and 18 of the current application and the invention of claims 1-20 of the patent lies in the fact that the invention of claims 1-20 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-20 of the patent is in effect a "species" of the "generic" invention of claims 2-16 and 18 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 2-16 and 18 are anticipated by claims 1-20, claims 2-16 and 18 are not patentably distinct from claims 1-20 (some terms such as “micro-struts” are not explicitly discussed in the claims of the patent, but the coil packs can be interpreted as “micro-struts”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7, 12, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cordaro (U.S. Publication 2017/0216036).
Cordaro discloses a device (for example see Figures 27-31) comprising:
(claim 7) a body (see Figure 31) including
(claim 7) a caudal surface
(claim 7) a cranial surface
(claim 7) wherein at least one of the caudal surface or the cranial surface is configured to receive a load from a bony endplate of a spinal segment along an axis of compression of the device
(claim 7) a porous structure disposed between the caudal surface and the cranial surface having
(claim 7) a first coil pack (for example the left half of the body is interpreted as a first coil pack) defining a plurality of pores
(claim 7) wherein the first coil pack is substantially aligned with the axis of compression of the device
(claim 13) wherein the first coil pack defines a plurality of pores of the porous structure
(claim 12) wherein the porous structure is configured, i.e. capable, of reducing the stiffness of the device to a stiffness similar to or less than a stiffness of trabecular bone (paragraphs 76 and 81-82; trabecular is known as cancellous bone found in long bone and the vertebral bodies)
Claims 7 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (U.S. Patent 7,309,357).
Kim discloses a device (for example see Figures 18-19) comprising:
(claim 7) a body (see Figures 18 and 19) including
(claim 7) a caudal surface
(claim 7) a cranial surface
(claim 7) wherein at least one of the caudal surface or the cranial surface is configured to receive a load from a bony endplate of a spinal segment along an axis of compression of the device
(claim 7) a porous structure disposed between the caudal surface and the cranial surface having
(claim 7) a first coil pack (240) defining a plurality of pores (element 240 is disclosed as being made from a material such as titanium which is a known porous material)
(claim 7) wherein the first coil pack is substantially aligned with the axis of compression of the device
(claim 13) wherein the first coil pack defines a plurality of pores of the porous structure
(claim 11) a second coil pack (244) that at least partially overlaps with the first coil pack
(claim 12) wherein the porous structure is configured, i.e. capable, of reducing the stiffness of the device to a stiffness similar to or less than a stiffness of trabecular bone
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.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cordaro (U.S. Publication 2017/0216036).
Cordaro discloses the invention as claimed except for the compression stiffness of the device along the axis of compression is less than 4 GPa or wherein the compression stiffness is less than 1.2 GPa. Cordaro discloses the device as discussed above wherein the device includes a stiffness approximating the stiffness of a bone, such as a vertebral body, in order to deal with the loads placed on the device while implanted in an intervertebral disc space (paragraphs 76 and 81-82) meeting the general conditions of the claim, i.e. the device having a stiffness capable for use within an intervertebral disc space. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the compression stiffness of the device along the axis of compression is less than 4 GPa or wherein the compression stiffness is less than 1.2 GPa, since it has been held that where the general conditions of the claims are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Cordaro (U.S. Publication 2017/0216036) in view of Stubstad (U.S. Patent 3,867,728).
Cordaro discloses the invention as claimed, see above, except for the pore size being less than 600 microns. Stubstad teaches a device comprising a body made from an osteoconductive material having a plurality of pores, wherein the pores have a size/diameter of 150 microns or larger, i.e. less than 600 microns; column 4 lines 52-57) in order to allow ingrowth into the pores to stimulate healing. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the pores have a diameter less than 600 microns in view of Stubstad, since it has been held that wherein the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (U.S. Patent 7,309,357).
Kim discloses the invention as claimed except for the compression stiffness of the device along the axis of compression is less than 4 GPa or wherein the compression stiffness is less than 1.2 GPa. Kim discloses the device as discussed above wherein the device includes a stiffness approximating the stiffness of a bone, such as a vertebral body, in order to deal with the loads placed on the device while implanted in an intervertebral disc space meeting the general conditions of the claim, i.e. the device having a stiffness capable for use within an intervertebral disc space. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Kim wherein the compression stiffness of the device along the axis of compression is less than 4 GPa or wherein the compression stiffness is less than 1.2 GPa, since it has been held that where the general conditions of the claims are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Claims 2, 3, 5, 6, 14, 15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cordaro (U.S. Publication 2017/0216036).
Regarding claims 2, 3, 5, and 6:
Cordaro discloses a device (for example see Figures 27-31) comprising:
(claim 2) a cranial surface
(claim 2) a caudal surface
(claim 2) a porous structure extending between the cranial surface and the caudal surface (paragraph 5) including
(claim 2) a plurality of pores configured to facilitate bone growth (paragraphs 81-82; the body between the top and bottom surfaces includes a plurality of pores capable of facilitating bone growth)
(claim 2) a coil pack (the left side of the body is formed of a plurality of coils and can be interpreted as a coil pack)
(claim 2) wherein the coil pack is configured to bear a load placed on at least one of the cranial surface and the caudal surface to provide a device having a stiffness approximating the modulus of elasticity, i.e. stiffness, of a bone (paragraphs 81-82)
(claim 6) wherein the entire portion of the device between the cranial surface and the caudal surface comprises part of the porous structure
Cordaro fails to disclose the device wherein the stiffness of the device is between 0.3 GPa and 4 GPa (claim 2), wherein the stiffness of the device is less than 1.2 GPa (claim 3), and wherein the coil pack has a coil diameter of between 400 microns and 600 microns (claim 5).
Regarding the device wherein the stiffness of the device is between 0.3 GPa and 4 GPa and wherein the stiffness of the device is less than 1.2 GPa, Cordaro discloses the device as discussed above wherein the device includes a stiffness approximating the stiffness of a bone, such as a vertebral body, in order to deal with the loads placed on the device while implanted in an intervertebral disc space (paragraphs 76 and 81-82) meeting the general conditions of the claim, i.e. the device having a stiffness capable for use within an intervertebral disc space. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the stiffness of the device is between 0.3 GPa and 4 GPa or wherein the stiffness is less than 1.2 GPa, since it has been held that where the general conditions of the claims are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Regarding the coil pack having a coil diameter of between 400 microns and 600 microns, Cordaro discloses the device as discussed above wherein the coil pack includes a coil having a diameter (as shown in Figure 27 each coil has a diameter defining the circular cross-section of each coil) meeting the general conditions of the claim. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the coil pack includes a coil having a diameter between 400 microns and 600 microns, since it has been held that where the general conditions of the claims are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 14, 15, and 17-21:
Cordaro discloses a device (for example see Figures 27-31) comprising:
(claim 14) an interbody spacer implant including
(claim 14) a cranial surface
(claim 14) a caudal surface
(claim 17) wherein at least one of the cranial surface and the caudal surface includes an increased contact area configured to mitigate overloading of local bone at a bone-to-device interface (paragraphs 5 and 70)
(claim 14) a porous structure
(claim 14) wherein the porous structure comprises a material having a stiffness that is greater than a stiffness of trabecular bone (paragraphs 64 and 81-82; the device is made from titanium alloy which has a stiffness greater than trabecular bone which is known to have an average stiffness of about 10 Mpa (0.01 GPa) to 3,000 MPa (3 GPa))
(claim 15) wherein the porous structure includes a plurality of flexible micro-struts (the columns shown in Figure 27 are coils/micro struts that have a modulus of elasticity and are flexible when acted upon with a large enough force)
(claim 18) wherein the porous structure includes a plurality of coils (the columns shown in Figure 27 are coils)
(claim 19) wherein a first coil of the plurality of coils is positioned adjacent to one of a ventral face, dorsal face, and a lateral face of the device
(claim 20) wherein a second coil of the plurality of coils is positioned adjacent a different one of the ventral face, the dorsal face, and the lateral face of the device
(claim 21) wherein the second coil is mirrored with respect to the first coil
Cordaro fails to disclose the device wherein the stiffness is near a lower end of the stiffness of trabecular bone (claim 14). Cordaro discloses the device as discussed above wherein the device includes a stiffness approximating the stiffness of a bone, such as a vertebral body, in order to deal with the loads placed on the device while implanted in an intervertebral disc space (paragraphs 76 and 81-82) meeting the general conditions of the claim, i.e. the device having a stiffness capable for use within an intervertebral disc space. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the stiffness of the device is near a lower end of the stiffness of trabecular bone, since it has been held that where the general conditions of the claims are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cordaro (U.S. Publication 2017/0216036) in view of Stubstad (U.S. Patent 3,867,728).
Cordaro discloses the invention as claimed, see above, except for the pore size of the porous structure being between 150 microns and 600 microns. Stubstad teaches a device comprising a body made from an osteoconductive material having a plurality of pores, wherein the pores have a size/diameter of 150 microns or larger, i.e. less than 600 microns; column 4 lines 52-57) in order to allow ingrowth into the pores to stimulate healing. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the pores have a diameter between 150 microns and 600 microns in view of Stubstad, since it has been held that wherein the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cordaro (U.S. Publication 2017/0216036) in view of Stubstad (U.S. Patent 3,867,728).
Cordaro discloses the invention as claimed, see above, except for the pore size of the porous structure being approximately 600 microns. Stubstad teaches a device comprising a body made from an osteoconductive material having a plurality of pores, wherein the pores have a size/diameter of 150 microns or larger, i.e. approximately 600 microns; column 4 lines 52-57) in order to allow ingrowth into the pores to stimulate healing. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Cordaro wherein the pores have a diameter being approximately 600 microns in view of Stubstad, since it has been held that wherein the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routing skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775