DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 01 June 2025. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claim 5 is objected to because of the following informality:
In lines 5-6, it appears that the phrase “the lateral curvature” should read “a lateral curvature.”
Claim 6 is objected to because of the following informality:
In line 4, it appears that the phrase “wherein the interface” should read “wherein an interface.”
Claim 8 is objected to because of the following informality:
In lines 21-22, it appears that the phrase “and wherein the first endplate; wherein the first endplate” should read “and wherein the first endplate.”
Claim 18 is objected to because of the following informality:
In line 3, it appears that the phrase “wherein the interface” should read “wherein an interface.”
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.
Claims 7, 13 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 7 recites the limitation "the implant" in line 2 (i.e. two separate instances). There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending line 2 of claim 7 to read “the device when the device” would overcome this rejection (see line 1 of claim 1 for antecedent basis).
Claim 13 recites the limitation "the implant" in line 2 (i.e. two separate instances). There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending line 2 of claim 13 to read “the device when the device” would overcome this rejection (see line 1 of claim 8 for antecedent basis).
Claim 20 recites the limitation "the implant" in lines 2-3 (i.e. two separate instances). There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending lines 2-3 of claim 20 to read “the device when the device” would overcome this rejection (see line 1 of claim 14 for antecedent basis).
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.
Claims 1-4, 7, 14-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balasubramanian et al. (U.S. Patent 9,198,770).
Regarding claims 1-4 and 7, Balasubramanian et al. disclose (as to claim 1) an artificial disc replacement device (100) comprising a first endplate (110) capable of being disposed against a first vertebra (e.g. 702, see Figure 7) in a spine and a second endplate (140) capable of being disposed against a second vertebra (e.g. 704, see Figure 7) in the spine; a core member (120) disposed between the first endplate and the second endplate (disposition as best seen in Figure 2), the core member having a curved engaging surface (121) capable of engaging the first endplate; wherein the device is capable of articulating between the core member and the first endplate in an anterior-posterior direction (i.e. a direction defined along the X axis, see column 5, lines 11-19); wherein the core member and the second endplate are capable of remaining substantially fixed with respect to one another (i.e. via the use of 130); wherein the first endplate has a central axis (i.e. axis defined along Y and through center of 110); wherein, as the artificial disc replacement device undergoes flexion (e.g. resulting from a tilt of 110 about the Z axis), the central axis of the first endplate is also translated in an anterior direction (i.e. it is the examiner's position that the interaction between 113 and 121 seen in Figure 2 would allow a degree of translation, especially in view of 120 being capable of having a lubricious coating, see column 5, line 59 - column 6, line 2); wherein, as the artificial replacement device undergoes extension (e.g. resulting from a tilt of 110 about the Z axis), the central axis of the first endplate is also translated in a posterior direction (i.e. it is the examiner's position that the interaction between 113 and 121 seen in Figure 2 would allow a degree of translation, especially in view of 120 being capable of having a lubricious coating, column 5, line 59 - column 6, line 2); and wherein the device is capable of articulating between the core member and the first endplate in a lateral direction (i.e. a direction defined along Z, see column 5, lines 11-19) without lateral translation (i.e. the presence of 112 and 144 prevents lateral translation of the device relative to the spine, see column 5, lines 20-58 and column 6, lines 11-29), wherein (as to claim 2) the artificial disc replacement device further includes a matrix member (130) disposed between the core member and the second end plate (disposition as best seen in Figure 2), wherein (as to claim 3) the matrix member is substantially more compressible than the core member (e.g. where 120 is made from titanium (see column 5, line 59 - column 6, line 2) and 130 is made from a polymer (see column 5, lines 6-10)), wherein (as to claim 4) the matrix member substantially covers a superior side (i.e. side defining 141) of the second endplate to prevent the first endplate from contacting the second endplate (see Figure 2), and wherein (as to claim 7) the first endplate is capable of forming a superior portion of the device when the device is inserted between the first vertebra and the second vertebra (see Figure 2) (see Figures 1-2 and 7, and column 4, line 54 - column 6, line 29).
Regarding claims 14-17 and 19-20, Balasubramanian et al. disclose (as to claim 14) an artificial disc replacement device (100) comprising a first endplate (110) capable of being disposed against a first vertebra (e.g. 702, see Figure 7) in a spine and a second endplate (140) capable of being disposed against a second vertebra (e.g. 704, see Figure 7) in the spine; a core member (120) disposed between the first endplate and the second endplate (disposition as best seen in Figure 2), the core member having a curved engaging surface (121) capable of engaging the first endplate; wherein the first endplate has a recess (i.e. recess defining 113) that accommodates the curved engaging surface of the core member (accommodation as best seen in Figure 2); wherein the device is capable of articulating between the core member and the first endplate (i.e. via the interaction between 113 and 121); wherein the core member and the second endplate are capable of remaining substantially fixed with respect to one another (i.e. via the use of 130); wherein the first endplate is also capable of being translated in an anterior-posterior direction (i.e. a direction defined along Z, see column 5, lines 11-19) (i.e. it is the examiner's position that the interaction between 113 and 121 seen in Figure 2 would allow a degree of translation, especially in view of 120 being capable of having a lubricious coating, see column 5, line 59 - column 6, line 2); and wherein the first endplate is capable of articulating with respect to the core member in a lateral direction (i.e. a direction defined along Z, see column 5, lines 11-19) without lateral translation (i.e. the presence of 112 prevents lateral translation of the first endplate relative to the first vertebra, see column 5, lines 20-58 and column 6, lines 11-29), wherein (as to claim 15) the artificial disc replacement device further includes a matrix member (130) disposed between the core member and the second end plate (disposition as best seen in Figure 2), wherein (as to claim 16) the matrix member is substantially more compressible than the core member (e.g. where 120 is made from titanium (see column 5, line 59 - column 6, line 2) and 130 is made from a polymer (see column 5, lines 6-10)), wherein (as to claim 17) the matrix member substantially covers a superior side (i.e. side defining 141) of the second endplate to prevent the first endplate from contacting the second endplate (see Figure 2), wherein (as to claim 19) at least a portion (e.g. middle portion) of the recess has an arc radius (i.e. radius defined by 113) within a first plane (e.g. sagittal plane) that is substantially similar to the first arc radius of the core member to enable forward translation and tilting of the first endplate relative to the second endplate during flexion (see Figure 2, and column 4, lines 54-56), and wherein (as to claim 20) the first endplate is capable of forming a superior portion of the device when the device is inserted between the first vertebra and the second vertebra (see Figure 2) (see Figures 1-2 and 7, and column 4, line 54 - column 6, line 29).
Allowable Subject Matter
Claims 5-6 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 5-6 and 18 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the following:
Regarding claim 5, in combination with the limitations required by claim 1, no prior art reference could be found disclosing or making obvious wherein the device is configured to articulate in both the anterior-posterior direction and in the lateral direction but only translate in the anterior-posterior direction because the first endplate includes a recess that includes anterior and posterior portions with larger radii of curvature than mating portions of the core member, whereas a lateral curvature of the first endplate matches that of the core member.
Regarding claim 6, in combination with the limitations required by claim 1, no prior art reference could be found disclosing or making obvious wherein the first endplate includes a recess configured to mate with the curved engaging surface of the core member; and wherein an interface between the curved engaging surface and the recess of the first endplate has a geometry that enables the central axis of the first endplate to translate further in the anterior direction during flexion than in the posterior direction during extension..
Regarding claim 18, in combination with the limitations required by claim 14, no prior art reference could be found disclosing or making obvious wherein the first endplate has a central axis; wherein an interface between the curved engaging surface and the recess of the first endplate has a geometry that enables the central axis of the first endplate to translate further in the anterior direction during flexion than in the posterior direction during extension.
Claims 8-12 are allowed.
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 8-13 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the underlined limitations below, an artificial disc replacement device, comprising: a first endplate configured to be disposed against a first vertebra in a spine and a second endplate configured to be disposed against a second vertebra in the spine; a core member disposed between the first endplate and the second endplate, the core member having a curved engaging surface for engaging the first endplate; the core member including a sagittal plane that separates the core member into a first lateral side and a second lateral side; the core member also including a coronal plane that separates the core member into an anterior side and a posterior side; wherein the curved engaging surface includes a curved boundary that extends within a first plane that is parallel with the sagittal plane; wherein the curved boundary has a first arc radius along an anterior portion disposed on the anterior side of the core member; wherein the curved boundary has a second arc radius along a posterior portion disposed on the posterior side of the core member, wherein the second arc radius is substantially different from the first arc radius; wherein the curved boundary of the curved engaging surface has a substantially constant curvature in a second plane that is parallel with the coronal plane; and wherein the first endplate has a recess that accommodates the curved engaging surface of the core member; wherein the recess has an arc radius within the sagittal plane that is substantially similar to the first arc radius of the core member; and wherein the recess has an arc radius within the coronal plane that is substantially similar to the substantially constant curvature of the curved engaging surface of the core member.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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