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
Applicant's election with traverse of Invention III (claims 15-25) in the reply filed on January 14, 2026 is acknowledged. The traversal is on the ground(s) that (a) “means for contacting” in claim 14 necessarily includes a fusion plate, (b) screws, tulips, and rods may be elements of a fixation system, and (c) “means for securing” would include at least screws and rods (pgs. 7-8). This is not found persuasive because (a) “means for contacting” does not necessarily include a fusion plate as the use of means-for language includes functional equivalents, which could for example be a bone graft wedge, (b) the fixation system does not necessarily include screws, tulips, and/or rods but merely may include such components, and (c) “means for securing” does not necessarily include screws and rods as the use of means-for language includes functional equivalents, which could for example be a bone staple. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 14, 2026.
Applicant's election with traverse of the following species in the reply filed on January 14, 2026 is acknowledged: Implant Held in Place B; Fusion Plate Contact A; Fusion Plate Cross-Section A; Implant Shape A; Fusion Plate Contact Surface B; Fusion Plate Upper Surface A; and Implant Configuration A. The traversal is on the ground(s) that there would not be a serious search and/or examination burden to examine the species together (see pgs. 10-13). This is not found persuasive because as stated in the Restriction Requirement the species require different fields of search, which includes classification and/or text search queries, due to their different features as described in the Restriction Requirement. The requirement is still deemed proper and is therefore made FINAL.
Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (Implant Held in Place A), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 14, 2026.
The Examiner further notes that Applicant helpfully pointed out that due to the different inventions and species identified by the Examiner, there are a potential “2,592 unique combinations” in the application (see pg. 9). Thus, the Examiner notes that the sheer number of combinations combined with Applicant’s admission that such combinations are unique presents a search and examination burden.
Claims 20-25 have been examined.
Drawings
Figures 1 and 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 23 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 23 recites the limitation "the porous material" in line 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 22 recites a porous material, the Examiner is interpreting claim 23 as depending from claim 22.
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 20-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abdou (US 2015/0032163 A1).
Claim 20. Abdou discloses a method of fusing adjacent vertebrae of a spine using a spinal implant (bone graft material 405 – see Figs. 27A-27B), the method comprising:
installing a fixation system (fixation device 105 – see Figs. 1-2, 7A-13B, and 27B) for securing adjacent vertebrae (see Fig. 27B, wherein fixation device 105 is attached to spinous processes of adjacent vertebrae), the fixation system including at least one bone fastener (locking nut 210 and deployment member 150) including a screw (locking nut 210, which includes threads 211 and is therefore a screw – see Figs. 10A-13B) and a tulip (deployment member 150, which includes elements 162 and is therefore a tulip – see Figs. 8A-8B and 11A-13B);
partially tightening the screw of the bone fastener such that a distance (distance between elements 162 of deployment member 150 and the lamina – see Fig. 27B and para. 0098) between the tulip and the spine is greater than a thickness (thickness of bone graft material 405) of the spinal implant (see Fig. 27B; see para. 0081, which states that rotation of locking nut 210 causes rotation arms 180 to be rotated towards a position parallel with respect to plate member 120);
inserting the spinal implant between the tulip and the spine without securing the spinal implant to the screw or the tulip (see Fig. 27B, which shows that fixation device 105 compresses bone graft material 405 against the vertebrae), wherein the spinal implant is configured to fuse unilateral transverse processes, lamina, or facet of adjacent vertebrae longitudinally along the spine (see para. 0098, which states that bone graft material 405 extends from the lamina of L4 to the lamina of L5 and forms a fusion mass); and
tightening the screw such that the spinal implant is maintained in compression by the tulip against the transverse processes, lamina, or facet to promote bone growth (see para. 0082, which states that further rotation of locking nut 210 results in compression of the spinous processes between rotation arms 180 and plate member 120).
Claim 21. Abdou discloses wherein the spinal implant includes:
a first portion (see Fig. 27A inset; see Fig. 27B) configured to be secured by, but not attached to the tulip; and
a fusion plate (see Fig. 27A inset; see Fig. 27B) configured to fuse the unilateral transverse processes, lamina, or facet of adjacent vertebrae longitudinally along the spine, the fusion plate extending from one or both sides of the first portion and offset from the first portion, such that, when the first portion is secured by the tulip, the fusion plate is maintained in compression against the transverse processes, lamina, or facet to promote bone growth.
[AltContent: textbox (First Portion)][AltContent: textbox (Fusion Plate)]
Claim 22. Abdou discloses wherein the spinal implant comprises a porous material (see para. 0098, which refers to bone graft material 405 – it is well-known in the art that bone graft material is porous in order to promote fusion) selected to promote bone growth.
Claim 24. Abdou discloses wherein the spinal implant has an H-shaped cross section (see para. 0098, which states that bone graft material 405 has an “H” shape).
Claims 20-22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullard (US 2010/0292734 A1).
Claim 20. Bullard discloses a method of fusing adjacent vertebrae of a spine using a spinal implant (carrier 100 – see Figs. 1a and 4b), the method comprising:
installing a fixation system (rod clip 300, rod 305, and pedicle screws 405 – see Figs. 3 and 4b) for securing adjacent vertebrae (see Fig. 4b, wherein pedicle screws 405 on the left side are attached to adjacent vertebrae), the fixation system including at least one bone fastener (rod clip 300 and pedicle screw 405 – see Figs. 3 and 4b) including a screw (fastener 360 – see Fig. 3; see para. 0054, which states that fastener 360 can be a screw) and a tulip (pedicle screw 405, which is a tulip due to its receipt of rod 305 as shown in Fig. 4b – see Fig. 4b);
partially tightening the screw of the bone fastener such that a distance (distance between pedicle screw 405 and the transverse processes as shown in Fig. 4b) between the tulip and the spine is greater than a thickness (thickness of carrier 100 positioned against the transverse processes – see Fig. 4b) of the spinal implant (such occurs prior to fully tightening fastener 360 within stem 330 – see Fig. 3);
inserting the spinal implant between the tulip and the spine without securing the spinal implant to the screw or the tulip (see Fig. 4b), wherein the spinal implant is configured to fuse unilateral transverse processes, lamina, or facet of adjacent vertebrae longitudinally along the spine (see Fig. 4b, which shows that far left carrier 100 is positioned against adjacent transverse processes; see para. 0038, which states that carrier 100 is used for fusion); and
tightening the screw such that the spinal implant is maintained in compression by the tulip against the transverse processes, lamina, or facet to promote bone growth (such occurs through fully tightening fastener 360 within stem 330 – see Fig. 3; see also Fig. 4b).
Claim 21. Bullard discloses wherein the spinal implant includes:
a first portion (third layer 130 – see Fig. 1a; see para. 0046, which states that third layer 130 interfaces with rod clips 300) configured to be secured by, but not attached to the tulip; and
a fusion plate (first layer 110 – see Fig. 1a; see para. 0045, which states that first layer 110 is compressed against the vertebrae) configured to fuse the unilateral transverse processes, lamina, or facet of adjacent vertebrae longitudinally along the spine, the fusion plate extending from one or both sides of the first portion and offset from the first portion, such that, when the first portion is secured by the tulip, the fusion plate is maintained in compression against the transverse processes, lamina, or facet to promote bone growth.
Claim 22. Bullard discloses wherein the spinal implant comprises a porous material (see para. 0039, which states that first layer 110 of carrier 100 is porous; see para. 0040, which states that second layer 120 of carrier 100 is porous) selected to promote bone growth.
Claim 25. Bullard discloses wherein the fixation system further includes at least a second bone fastener (rod clip 300 and pedicle screw 405 – see Figs. 3 and 4b) having a screw (fastener 360 – see Fig. 3; see para. 0054, which states that fastener 360 can be a screw) and a tulip (pedicle screw 405, which is a tulip due to its receipt of rod 305 as shown in Fig. 4b – see Fig. 4b), and the method includes securing the spinal implant under the tulip of each bone fastener (see Fig. 4b).
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Abdou (US 2015/0032163 A1) in view of Henderson et al. (US 2009/0177230 A1).
Abdou fails to disclose wherein the porous material comprises porous titanium (claim 23).
Henderson teaches a spinal implant (osteointegration apparatus 700 – see Fig. 30A) comprising a porous material (porous member 570 is made from a porous material – see para. 0168), wherein the porous material can be fabricated from titanium (see para. 0168), and wherein the porous material can also include bone graft material (see para. 0172).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Abdou such that the porous material comprises porous titanium (claim 23) in addition to bone graft material, as suggested by Henderson, as the inclusion of titanium would provide additional rigidity to the spinal implant prior to the occurrence of significant fusion of bone into the spinal implant.
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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