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(s) 8, 10 and 14-20 is/are objected to because of the following informalities:
Claim 8, lines 17-18 recites the limitation “the lateral expansion wedges” instead of “the right and left lateral expansion wedges” in order to be consistent with the previously used claim terminology.
Claim 10, line 3 is missing a period following “wedges”.
Claim 14, line 25 has a period following “complete” instead of a comma.
Claim 16, line 3 is missing a period following “wedges”.
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.
Claim(s) 9-10 and 14-20 is/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 9 recites the limitation “the end of limiting groove” in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “an end of a limiting groove” in order to provide sufficient antecedent basis for the limitation. For the purpose of compact prosecution, claim 9 will be interpreted below under this assumption.
Claim 10 recites the limitation “the vertical expansion wedges” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “the proximal and distal vertical wedges” in order provide sufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, claim 10 will be interpreted below under this assumption.
Claim 10 recites the limitation “the slots or cavities” in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “slots or cavities” in order provide sufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, claim 10 will be interpreted below under this assumption.
Claim 14 recites the limitation "the proximal housing and distal frame" in line 7. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 14, lines 3-4, should be amended to recite “a proximal housing having lateral expansion ramps; and a distal frame” in order to provide sufficient antecedent basis for the limitation in line 7 and for the subsequent dependent claims. For the purpose of compact prosecution, claim 14 will be interpreted below under this assumption.
Claim 16 recites the limitation “the slots or cavities” in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “slots or cavities” in order provide sufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, claim 16 will be interpreted below under this assumption.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Beach et al. (U.S. Pub. No. 2026/0060813 A1, hereinafter “Beach”).
Beach discloses, regarding claim 1, an expandable interbody spacer (100, see Figs. 1-2B) expanded in sequential steps for placement between adjacent vertebrae (see Fig. 28, see para. [0058]) comprising: a proximal housing (60); a distal frame (10); a drive screw (72) configured to axially translate the proximal housing toward the distal frame (see para. [0066]);
right and left lateral expansion wedges (see annotated Fig. 7 below) coupled to the proximal housing and distal frame (see Fig. 2A, see paras. [0059], [0061] and [0067]);
right and left upper endplates (21A, 22A, see para. [0059]); right and left lower endplates (21B,22B, see para. [0061]); and proximal and distal vertical wedges (see annotated Fig. 6 below) coupled to proximal and distal ends of the right and left upper and lower endplates (see Fig. 2A);
wherein the axial translation of the proximal housing toward the distal frame induces the following sequential steps expanding the expandable interbody spacer (see Fig. 28, see paras. [0066], [0073] and [0081]):
a) lateral expansion of the right and left expansion wedges by the proximal housing and distal frame (see paras. [0066]-[0067]), once lateral expansion is complete (see Fig. 28, see para. [0066]);
b) lordotic/angular expansion of the distal end of the upper endplates away from the distal end of the lower endplates by the distal vertical wedge resulting in a lordotic angle (see Fig. 11, see para. [0088]), once lordotic expansion is complete (see Fig. 28, see para. [0073]);
c) linear/vertical expansion of the upper endplates away from the lower endplates by the proximal and distal vertical wedges (see Fig. 28, see para. [0081]).
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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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoshtaev (U.S. Pub. No. 2018/0193164 A1, hereinafter “Shoshtaev”) and in view of Beach et al. (U.S. Pub. No. 2026/0060813 A1, hereinafter “Beach”).
Shoshtaev discloses, regarding claim 1, an expandable interbody spacer (1000) expanded in sequential steps for placement between adjacent vertebrae (see Figs. 6A-6E, see para. [0278]) comprising: a proximal housing (550); a distal frame (650); a drive screw (500) configured to axially translate the proximal housing toward the distal frame (see Fig. 4);
right and left lateral expansion wedges (see annotated Fig. 5 below) coupled to the proximal housing and distal frame (see Fig. 4);
right and left upper endplates (100, 250); right and left lower endplates (150, 200); and proximal and distal vertical wedges (see annotated Fig. 5 below) coupled to proximal and distal ends of the right and left upper and lower endplates (see Fig. 4);
wherein the axial translation of the proximal housing toward the distal frame induces the following sequential steps expanding the expandable interbody spacer (see para. [0278]):
a) lateral expansion of the right and left expansion wedges by the proximal housing and distal frame, once lateral expansion is complete (see para. [0278]);
c) linear/vertical expansion of the upper endplates away from the lower endplates by the proximal and distal vertical wedges (see para. [00278]).
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Regarding claim 2, wherein the proximal housing, distal frame and left and right lateral expansion wedges all contain angled ramps configured to induce lateral expansion during axial translation of the proximal housing and distal frame toward each other (see annotated Fig. 5 above).
Regarding claim 3, wherein lateral expansion stops when lateral expansion limiting balls reach the end of limiting groove slots (see para. [0280] “fasteners such as … balls” and “fasteners are affixed in one component and travel in a mating feature (such as a track)”).
Regarding claim 4, wherein the right and left upper and lower endplates include proximal and distal upper and lower endplate ramps configured to engage the proximal and distal vertical wedges (see annotated Fig. 5 above).
Shoshtaev discloses, regarding claim 8, an expandable interbody spacer (1000) for placement between adjacent vertebrae (see Figs. 6A-6E, see para. [0278]) comprising:
a proximal housing (550); a distal frame (650); a drive screw (500) configured to axially translate the proximal housing toward the distal frame (see Fig. 4);
right and left lateral expansion wedges (see annotated Fig. 5 above) slidingly coupled to the proximal housing and distal frame (see Fig. 4); wherein the proximal housing (550), distal frame (650), and left and right lateral expansion wedges (see annotated Fig. 5 above) all contain angled ramps (see annotated Fig. 5 above) configured to induce lateral expansion during translation of the proximal housing toward the distal frame (see para. [0278]); right and left upper and lower endplates (100, 150, 200, 250);
proximal and distal vertical wedges (see annotated Fig. 5 above) coupled to the right and left upper and lower endplates (see Fig. 4);
wherein:
initial axial translation induces lateral expansion of the right and left lateral expansion wedges until a lateral expansion stop is reached (see para. [0278]); and further axial translation induces linear expansion of the right and left upper and lower endplates by both the proximal and distal vertical wedges (see para. [0278]).
Regarding claim 9, wherein lateral expansion stops when lateral expansion limiting balls reach the end of limiting groove slots (see para. [0280] “fasteners such as … balls” and “fasteners are affixed in one component and travel in a mating feature (such as a track)”).
Regarding claim 10, wherein the vertical expansion wedges are positioned in the slots or cavities of the lateral expansion wedges and laterally translated with the lateral expansion wedges (see annotated Fig. 5 above, note positioned in slots or cavities of lateral expansion wedges of the proximal housing / distal frames via the lateral expansion wedges of 300 / 350 / 400 / 450).
Regarding claim 11, wherein the right and left upper and lower endplates include proximal and distal upper and lower endplate ramps (see annotated Fig. 5 above) configured to engage the proximal and distal vertical wedges (see Fig. 4).
Shoshtaev discloses, regarding claim 14, an expandable interbody spacer (1000) expanded in sequential steps for placement between adjacent vertebrae (see Figs. 6A-6E, see para. [0278]) comprising:
a proximal housing (550) having lateral expansion ramps (see annotated Fig. 5 above); and a distal frame (650); lateral expansion wedges (see annotated Fig. 5 above) having lateral wedge ramps slidingly coupled to the housing lateral expansion ramps (see Fig. 4);
a drive screw (500) rotatably coupled to the proximal housing and distal frame (see Fig. 4), wherein, rotation of the drive screw translates the proximal housing toward the distal frame and induces lateral expansion the right and left lateral expansion wedges away from each other (see Figs. 6A-6E, see para. [0278]);
right and left upper endplates (100, 250) having proximal and distal endplates ramps (see annotated Fig. 5 above); right and left lower endplates having proximal and distal endplates ramps (see annotated Fig. 5 above); and vertical expansion wedges having proximal vertical ramps (see annotated Fig. 5 above) configured to slidingly engage the proximal endplate ramps (see Fig. 4), and distal vertical ramps (see annotated Fig. 5 above) configured to slidingly engage the distal endplate ramps (see Fig. 4), and a matching angle between the proximal and distal vertical ramps results in linear/vertical expansion of the upper and lower endplates (see Figs. 6A-6E, see para. [0278]); wherein the axial translation of the proximal housing toward the distal frame induces:
a) lateral expansion of the right and left expansion wedges away from each (see para. [0278]);
and
c) once lordotic expansion is complete, linear/vertical expansion of the upper endplates away from the lower endplates (see para. [0278]).
Regarding claim 15, wherein the proximal housing, distal frame and left and right lateral expansion wedges contain angled ramps configured to induce lateral expansion during axial translation of the proximal housing and distal frame toward each other (see annotated Fig. 5 above).
Regarding claim 16, wherein the vertical expansion wedges are positioned in the slots or cavities of the lateral expansion wedges and laterally translated with the lateral expansion wedges (see annotated Fig. 5 above, note positioned in slots or cavities of lateral expansion wedges of the proximal housing / distal frames via the lateral expansion wedges of 300 / 350 / 400 / 450).
Regarding claim 17, wherein lateral expansion stops when lateral expansion limiting balls reach the end of limiting groove slots (see para. [0280] “fasteners such as … balls” and “fasteners are affixed in one component and travel in a mating feature (such as a track)”).
Shoshtaev further discloses, adjusting the lordotic angle of the distal end (see Fig. 14B2) and adjusting the angle of the wedges / ramps (see para. [0296]), however fails to explicitly disclose, regarding claim 1, b) lordotic/angular expansion of the distal end of the upper endplates away from the distal end of the lower endplates by the distal vertical wedge resulting in a lordotic angle, once lordotic expansion is complete; regarding claim 8, the distal vertical wedge having a steeper angle than the proximal vertical wedge; and continued axial translation induces lordotic expansion of the right and left upper and lower endplates by the distal vertical wedge until the proximal vertical wedge engages the right and left upper and lower endplate; and regarding claim 14, wherein: a difference in angle between the proximal and distal vertical ramps results in angular/lordotic expansion of the upper and lower endplates; and b) once lateral expansion is complete, lordotic/angular expansion of the upper and lower endplates away from each other. Shoshtaev further fails to disclose, regarding claim 5, wherein the distal vertical wedge has a steeper angle than the proximal vertical wedge endplate ramps configured to induce lordotic expansion of the distal end of the upper and lower endplate during axial translation; regarding claim 6, wherein lordotic expansion stops when the when the proximal and distal plate ramps reach a point where their ramp angle matches the angle of the proximal and distal vertical ramps; regarding claim 7, wherein when lordotic expansion stops expansion transitions to linear expansion once the proximal vertical wedge engages the proximal upper and lower endplate ramps; regarding claim 12, wherein the distal vertical wedge has a steeper angle than the proximal vertical wedge endplate ramps configured to induce lordotic expansion of the distal end of the upper and lower endplate during axial translation; regarding claim 13, wherein lordotic expansion stops when the when the proximal and distal plate ramps reach a point where their ramp angle matches the angle of the proximal and distal vertical ramps; regarding claim 18, wherein the distal vertical wedge has a steeper angle than the proximal vertical wedge endplate ramps configured to induce lordotic expansion of the distal end of the upper and lower endplate during axial translation; regarding claim 19, wherein lordotic expansion stops when the when the proximal and distal plate ramps reach a point where their ramp angle matches the angle of the proximal and distal vertical ramps; and regarding claim 20, wherein when lordotic expansion stops expansion transitions to linear expansion once the proximal vertical wedge engages the proximal upper and lower endplate ramps.
Beach discloses an expandable interbody spacer (100, see Figs. 6-13), wherein the interbody spacer is expanded laterally (see Fig. 28, see para. [0058]), prior to b) lordotic/angular expansion of the distal end of the upper endplates away from the distal end of the lower endplates by the distal vertical wedge resulting in a lordotic angle (see Fig. 28, see para. [0058]), and before linear / vertical expansion (see Fig. 28, see para. [0058]); the distal vertical wedge (10) having a steeper angle than the proximal vertical wedge (60, see Figs. 6 and 11, see also para. [0073]); and continued axial translation induces lordotic expansion of the right and left upper and lower endplates by the distal vertical wedge until the proximal vertical wedge engages the right and left upper and lower endplate (see annotated Fig. 11 below); and wherein: a difference in angle between the proximal and distal vertical ramps results in angular/lordotic expansion of the upper and lower endplates (see Fig. 11); wherein lordotic expansion stops when the when the proximal and distal plate ramps reach a point where their ramp angle matches the angle of the proximal and distal vertical ramps (see annotated Fig. 11 below) in order to facilitate expansion of the expandable interbody implant in three directions and enable the expandable interbody implant to expand in a lordotic / angular direction (see para. [0058]) and enable the lateral expansion to be maintained during lordotic expansion (see para. [0073]) and to enable the lordotic expansion to be maintained during the linear / vertical expansion (see para. [0080]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the expandable interbody spacer in Shoshtaev to include lordotic/angular expansion of the distal end of the upper endplates away from the distal end of the lower endplates by the distal vertical wedge resulting in a lordotic angle before linear / vertical expansion and to modify the distal vertical wedge to have a steeper angle than the proximal vertical wedge; wherein lordotic expansion stops when the when the proximal and distal plate ramps reach a point where their ramp angle matches the angle of the proximal and distal vertical ramps in view of Beach in order to facilitate expansion of the expandable interbody implant in three directions and enable the expandable interbody implant to expand in a lordotic / angular direction and enable the lateral expansion to be maintained during lordotic expansion and to enable the lordotic expansion to be maintained during the linear / vertical expansion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
