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 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 12, 13, and 18 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 12 recites the limitation "the interbody space" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the two adjacent vertebrae" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “large surface contact area” in claim 18 is a relative term which renders the claim indefinite. The term “large surface contact area” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much surface contact area is required to be considered “large.” Appropriate clarification is required.
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.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2014/0025181 to Vanasse et al.
As to Claim 15, Vanasse discloses a method of manufacturing an orthopedic implant device (10, Fig. 1, [0008]). The method comprises inputting a 3-dimensional model to an additive manufacturing device [0026-0028], and using the additive manufacturing device to manufacture the orthopedic implant device [0029].
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-12 and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2012/0191200 to Choren in view of U.S. Patent Pub. 2012/0312778 to Ullrich, Jr. et al.
As to Claim 1, Choren discloses a method of treatment [0049-0053]. The method includes providing an orthopedic implant device [0077]. The implant comprises a porous structure that approximates the shape of a bone [0050, 0053] and has a modulus of elasticity similar to that of the bone [0050, 0051, 0053].
As to Claim 3, Choren discloses a method of treatment wherein the mammal is human [0002].
As to Claim 4, Choren discloses a method of treatment wherein the mammal is an animal [0002].
As to Claim 9, Choren discloses a method wherein the orthopedic device is inserted inside a bone structure [0105].
As to Claims 1-12 and 14, Choren discloses the claimed invention for wherein the method includes implanting the orthopedic device in a mammal, wherein the disease is osteoporosis, Paget's disease, osteogeneis imperfecta, bone cancer, rickets, osteomalacia, acromegaly, Perthes' disease, fibrous dysplasia, or oteromyelitis. wherein treating comprises healing, wherein treating comprises strengthening, wherein treating comprises straightening, wherein the orthopedic device is inserted adjacent to a bone structure, wherein the orthopedic device is an intervertebral interbody, wherein the intervertebral interbody has a variable entry angle to first maximize the contact surface area to the vertebral body, and wherein the entry angle is gradually decreased to offset the increasing insertion force, wherein the orthopedic device is inserted diagonally across the interbody space relative to the sagittal and coronal planes, wherein the orthopedic device is manufactured using a series of steps of subsequently laser melting thin metal layers to create complex geometries.
Ullrich, Jr. discloses a method of treatment including an orthopedic implant device (1) wherein the implant is an intervertebral interbody (1 and [0043, 0092]). The method includes implanting the orthopedic device in a mammal [0154-0166]. The disease is osteoporosis, Paget's disease, osteogeneis imperfecta, bone cancer, rickets, osteomalacia, acromegaly, Perthes' disease, fibrous dysplasia, or oteromyelitis (described in [0003-0004, 0008]). Treating comprises healing [0008, 0013, 0051], treating comprises strengthening [0008, 0013, 0051], and treating comprises straightening [0008, 0013, 0051]. The orthopedic device is inserted adjacent to a bone structure [0092]. The device has a variable entry angle (Fig. 14 and [0146]). The variable entry angle maximizes the contact surface area to the vertebral body (Fig. 14 and [0155, 0157]). The entry angle is gradually decreased to offset the increasing insertion force [0159]. The orthopedic device is inserted diagonally across the interbody space relative to the sagittal and coronal planes [0154]. The orthopedic device is manufactured using a series of steps of subsequently laser melting thin metal layers to create complex geometries [0050] in order to provide an interbody fusion device capable of bone ingrowth within [0043-0044].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Choren with the interbody fusion member modification of Ullrich, Jr. in order to provide an interbody fusion device capable of bone ingrowth within.
Claim 13 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2012/0191200 to Choren in view of U.S. Patent Pub. 2012/0312778 to Ullrich, Jr. et al. in view of U.S. Patent Pub. No. 2007/0142914 to Jones et al.
As to Claim 13, Choren and Ullrich, Jr. disclose the claimed invention except for wherein the orthopedic device facilitates motion between the two adjacent vertebrae.
Jones discloses a method of treatment [0045] including an orthopedic device facilitates motion between the two adjacent vertebrae [0049] in order to allow for natural motion to be maintained at the implant site [0048-0049].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Choren and Ullrich, Jr. with the motion modification of Jones in order to allow for natural motion to be maintained at the implant site.
Claims 16 and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2012/0191200 to Choren.
As to Claims 16 and 17, Vanasse discloses the claimed invention for wherein the orthopedic implant device comprises a porous structure that approximates the shape of a bone and has a modulus of elasticity similar to that of the bone, and wherein the porous structure has a porosity of 15% to 65%, the porous structure has a porosity of 25-35%, and the modulus of elasticity is less than 50 GPa.
Choren discloses a method of treatment [0049-0053]. The method includes providing an orthopedic implant device [0077]. The implant comprises a porous structure that approximates the shape of a bone [0050, 0053] and has a modulus of elasticity similar to that of the bone [0050, 0051, 0053]. The porous structure has a porosity of 15% to 65% [0098] and the modulus of elasticity is less than 50 GPa [0096] in order to provide an implant with desired characteristics for a particular application [0049].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse with the porous structure modification of Choren in order to provide an implant with desired characteristics for a particular application.
Claim 18 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2012/0191200 to Choren in view of U.S. Patent Pub. 2012/0312778 to Ullrich, Jr. et al.
As to Claim 18, Vanasse and Choren disclose the claimed invention except for wherein the orthopedic implant device has a large surface contact area to the endplates to prevent linear subsidence while carrying a sufficiently large volume of bone graft area within the device to fuel the natural occurrence of a fusion, the orthopedic implant device having internal voids for bone graft and a variable entry angle, where the variable entry angle maximizes the contact surface area to the vertebral body, and the variable entry angle is gradually decreased to offset the increasing insertion force.
Ullrich, Jr. discloses a method of treatment including an orthopedic implant device (1) wherein the implant is an intervertebral interbody (1 and [0043, 0092]). The orthopedic implant device has a large surface contact area (10) to the endplates to prevent linear subsidence [0092-0098] while carrying a sufficiently large volume of bone graft area [0099] within the device to fuel the natural occurrence of a fusion [0100], the orthopedic implant device having internal voids for bone graft [0099] and a variable entry angle(Fig. 14 and [0146]), where the variable entry angle maximizes the contact surface area to the vertebral body, and the variable entry angle is gradually decreased to offset the increasing insertion force. (Fig. 14 and [0155, 0157]) in order to provide an interbody fusion device capable of bone ingrowth within [0043-0044].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse and Choren with the interbody fusion member modification of Ullrich, Jr. in order to provide an interbody fusion device capable of bone ingrowth within.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775