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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a first end plate and a second end plate which are in contact with adjacent vertebral bodies” in lines 2-3. Such a recitation includes a human organism and is therefore nonstatutory. Claims 2-15 depend from claim 1 and therefore also include a human organism. In order to overcome this rejection, the Examiner suggests reciting “a first end plate and a second end plate which are configured to be in contact with adjacent vertebral bodies.”
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 1-15 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 1 recites the limitation "a second vertical guide formed in the thickness direction of the first end plate or the second end plate to be slidable with the first vertical guide" in lines 2-4 of the paragraph beginning “wherein the vertical guide portion.” Applicant’s disclosure shows a first vertical guide (such as, for example, pillar 108) formed in a first end plate or a second end plate (pillar 108 is formed in first end plate 102) and a second vertical guide (extension portion 137) formed in the other of the first end plate or the second end plate (extension portion 137 is formed in second end plate 122) to be slidable with the first vertical guide. Applicant’s disclosure does not disclose a configuration where the first vertical guide and the second vertical guide are formed in the same end plate, which is included in the scope of the claim as currently written. Claims 2-15 are rejected because they depend from claim 1. In order to overcome this rejection, the Examiner suggests reciting "a second vertical guide formed in the thickness direction of the other of the first end plate or the second end plate to be slidable with the first vertical guide."
Claim 2 is 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 2 recites the limitation "the plate slope portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 5-13 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 limitation "the channel is formed by a first recessed portion arranged concavely in the first or second end plate" in lines 1-2. Claim 5 depends from claim 4, which recites “the first vertical guide is a pillar protruding from the first or second end plate” and “the second vertical guide has a channel surrounding part of the outer surface of the pillar.” Applicant’s disclosure shows a first vertical guide (such as, for example, pillar 108) formed in a first end plate or a second end plate (pillar 108 is formed in first end plate 102) and a second vertical guide (extension portion 137, which includes channel 139) formed in the other of the first end plate or the second end plate (extension portion 137 is formed in second end plate 122). Applicant’s disclosure does not disclose a configuration where the first vertical guide and the second vertical guide are formed in the same end plate, which is included in the scope of the claim as currently written. Claims 6-13 are rejected because they depend from claim 5. In order to overcome this rejection, the Examiner suggests reciting " the channel is formed by a first recessed portion arranged concavely in the other of the first or second end plate."
Claim 14 is 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 14 recites the limitation "the bottom surfaces" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 1-11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butler et al. (US 2017/0224505 A1).
Claim 1. Butler discloses a spinal fusion cage (implant 110), comprising:
a first end plate (first support 118) and a second end plate (second support 120) which are in contact with adjacent vertebral bodies;
a distal movable block (front portion 112) connected to be movable relative to distal portions of the first end plate and the second end plate;
a proximal movable block (rear portion 114) connected to be movable relative to proximal portions of the first end plate and the second end plate;
an adjustment member (control member 116) capable of adjusting the distance between the distal movable block and the proximal movable block by adjusting the distance between the proximal movable block and the distal movable block by rotation; and
a vertical guide portion (see “first vertical guide” in Fig. 30 inset in combination with alignment member 150) disposed in the first end plate and second end plate, to support a load in the longitudinal direction or width direction of the first end plate and the second end plate,
wherein the vertical guide portion has a first vertical guide (see Fig. 30 inset) formed in the thickness direction of the first end plate or the second end plate, and a second vertical guide (alignment member 150) formed in the thickness direction of the first end plate or the second end plate to be slidable with the first vertical guide,
wherein two pairs of the vertical guides are arranged, one pair of the vertical guides is arranged on one side of the first end plate and the second end plate in the width direction, and the other pair of the vertical guides is arranged on the other side of the first end plate and the second end plate in the width direction (Figs. 16-30; paras. 0044-0054).
Claim 2. Butler discloses wherein a block slider (projection 130 on front portion 112 and projection 140 on rear portion 114) is formed on the distal movable block and the proximal movable block, and a plate slider (channels 158 and 159) slidable relative to the block slider is formed on the plate slope portion (Figs. 16-30; paras. 0044-0054).
Claim 3. Butler discloses wherein the adjustment member has a threaded portion (threaded portion 104 – see control member 16 in Fig. 14; see para. 0044, which states that implant 110 is generally similar to implant 10) screw-coupled to the distal movable block on an end thereof and a rotation support place (counterbore rearward of the head portion – see para. 0049) fixed to be rotatable relative to the proximal movable block on the other end thereof, wherein a rotation support member (collar 124) is positioned in the rotation support place through the proximal movable block (Figs. 16-30; paras. 0044-0054).
Claim 4. Butler discloses wherein the first vertical guide is a pillar (see Fig. 30 inset) protruding from the first or second end plate in the thickness direction, and the second vertical guide has a channel (channel in alignment member 150 that receives “pillar” labeled in Fig. 30 inset) surrounding part of the outer surface of the pillar (Figs. 16-30; paras. 0044-0054).
Claim 5. Butler discloses wherein the channel is formed by a first recessed portion (see Fig. 30 inset; note that alignment member 150 is the same as alignment member 152) arranged concavely in the first or second end plate in the width direction and a second recessed portion (see Fig. 30 inset) formed by an extension portion (see Fig. 30 inset) protruding from the recessed portion in the thickness direction of the first or second end plate (Figs. 16-30; paras. 0044-0054).
Claim 6. Butler discloses wherein an accommodation groove (recesses 154) accommodating the extension portion is formed around the pillar (Figs. 16-30; paras. 0044-0054).
Claim 7. Butler discloses wherein the first recessed portion is formed concavely by a first recessed wall (see Fig. 30 inset) disposed on the side of the proximal portion, a second recessed wall (see Fig. 30 inset) spaced part from the first recessed wall and disposed on the side of the distal portion, and a third recessed wall (see Fig. 30 inset) connecting the first recessed wall and second recessed wall (Figs. 16-30; paras. 0044-0054).
Claim 8. Butler discloses wherein the thickness of the pillar in the width direction is the same as the depth of the first recessed portion in the width direction, and the thickness of the pillar in the longitudinal direction is the same as the distance between the first recessed wall and the second recessed wall in the longitudinal direction (Figs. 16-30; paras. 0044-0054).
Claim 9. Butler discloses wherein the second recessed portion is formed by an extension portion (see Fig. 30 inset) including a first extension wall (see Fig. 30 inset) protruding from the first or second end plate in the thickness direction and disposed on the side of the proximal portion, a second extension wall (see Fig. 30 inset) protruding from the first or second end plate in the thickness direction and disposed on the side of the distal portion, and a third extension wall (see Fig. 30 inset) protruding from the first or second end plate in the thickness direction and connecting the first extension wall and the second extension wall, wherein the first extension wall and the first recessed wall form a plane, the second extension wall and the second recessed wall form a plane, and the third extension wall and the third recessed wall form a plane (Figs. 16-30; paras. 0044-0054).
Claim 10. Butler discloses wherein the depth of the second recessed portion in the width direction is smaller than the depth of the first recessed portion in the width direction (Figs. 16-30; paras. 0044-0054).
Claim 11. Butler discloses wherein a guide groove (see Fig. 30 inset) guiding the insertion of the pillar is formed around the first recessed portion (Figs. 16-30; paras. 0044-0054).
Claim 14. Butler discloses wherein an expansion groove (channels 158 and 159 on first support 118; see para. 0050, which states that second support 120 includes similar channels) is arranged on the bottom surfaces facing each other in the first and second end plates (Figs. 16-30; paras. 0044-0054).
[AltContent: textbox (First Recessed Portion)][AltContent: textbox (Second Recessed Portion)][AltContent: textbox (Extension Portion)][AltContent: textbox (First Vertical Guide (Pillar))][AltContent: textbox (Guide Groove)]
[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector]
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.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (US 2017/0224505 A1).
Butler fails to disclose wherein the sum of the thicknesses of the first extension wall and the second extension wall in the longitudinal direction is greater than or equal to the thickness of the pillar in the longitudinal direction (claim 12) and wherein the thickness of the third extension wall in the width direction is the same as the thickness of the pillar in the width direction (claim 13).
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal fusion cage of Butler such that the sum of the thicknesses of the first extension wall and the second extension wall in the longitudinal direction is greater than or equal to the thickness of the pillar in the longitudinal direction (claim 12) and the thickness of the third extension wall in the width direction is the same as the thickness of the pillar in the width direction (claim 13), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (US 2017/0224505 A1) in view of Hu et al. (CN 110013366 A) and Bal et al. (US 2015/0305881 A1).
Butler fails to disclose wherein a through hole is formed in the adjustment member, a communication hole in communication with the through hole is formed in the distal movable block, and a discharge hole in communication with the communication hole is formed on the side portion of the distal movable block (claim 15).
However, Butler discloses that the distal movable block includes a shaft with a communication hole (hole in shaft of front portion 112 that receives control member 116) that receives the adjustment member (Figs. 16-30; paras. 0044-0054).
Hu teaches a spinal fusion cage comprising: a first end plate (plate 2) and a second end plate (plate 6); a distal movable block (sleeve 3); and an adjustment member (screw 4), wherein a through hole is formed in the adjustment member (see Fig. 2, which shows that screw 4 is hollow along its entire length), wherein a communication hole (hole in sleeve 3 that receives screw 4) in communication with the through hole is formed in the distal movable block, wherein the communication hole receives the adjustment member, and wherein such a configuration allows for the insertion of bone graft material (see last full paragraph on pg. 7 of the English-language translation) (Figs. 1-2).
Bal teaches a spinal fusion cage including a shaft (shaft 2) having a communication hole (graft filling hole 2.5) and a discharge hole (graft hole 2.4) in communication with the communication hole, wherein the discharge hole is formed on a side portion of the shaft, and wherein such a configuration allows for the insertion of bone graft material into the middle of the spinal fusion cage (see para. 0066) (Figs. 1-3
It would have been an obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adjustment member of Butler to include a through hole in communication with the communication hole (claim 15), as suggested by Hu, and to modify the shaft of the distal movable block of Butler to include a discharge hole in communication with the communication hole, wherein the discharge hole is formed on the side portion of the shaft of the distal movable block (claim 15), as suggested by Bal, in order to provide means for introducing bone graft material into the middle of the spinal fusion cage.
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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