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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Claims 1-6 and 8-15 are pending. Claim 14 remains withdrawn.
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(s) 1, 8-11, 13 and 15, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geisler et al. (U.S. 2017/0020685 A1) in view of Bagga et al. (U.S. 2019/0099515 A1).
Concerning claim 1, Geisler et al. disclose a spinal implant (see Fig. 4, element 110) for insertion between two adjacent vertebrae, the spinal implant comprising: a frame (112) sized to be inserted between the two adjacent vertebrae; and a lattice structure (114) disposed at least partially within the frame and exposed on at least one side of the frame to permit bone growth into the lattice structure, wherein the frame further comprises a through bore (see opening in center), and wherein the lattice structure is further exposed to an interior surface of the through bore (116).
Concerning claim 8, wherein the frame comprises titanium (see par. 007), polyetheretherketone (PEEK), polyurethane, bone, or a cured osteostimulative material.
Concerning claim 10, wherein the lattice structure is a non-random lattice structure, i.e., a straight-through design (see par. 0063).
Concerning claim 11, wherein the lattice structure is a random lattice structure, i.e., having offset layers (see par. 0063).
Concerning claim 15, the frame includes a plurality of ridges (see Fig. 20, element 2030) that are used to secure the spinal implant between the two adjacent vertebrae during installation of the spinal implant.
However, Geisler et al. do not explicitly disclose that the lattice structure is a salt lattice comprising a magnesium phosphate material.
Bagga et al. disclose a spinal implant for insertion between two adjacent vertebrae comprising a magnesium phosphate material (see par. 0080, i.e. tricalcium phosphate (salt) with magnesium additive) in the same field of endeavor for the purpose of providing enhanced cellular activity to promote bone fusion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Geisler’s implant by utilizing a salt including a magnesium phosphate material, the concept of which is disclosed by Bagga et al., in order to provide a biocompatible and osteoconductive material to enhance fusion. Utilizing a material that is chemically similar to the mineral component of natural bone and encourages bone growth is desirable for fusion implants where the goal is for ingrowth and gradual replacement by natural bone during the healing process.
Concerning claim 9, Bagga et al. disclose that the frame is resorbable (see par. 0040 and Fig. 7, element 730 – the device is “fully resorbable”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form Geisler’s frame from a resorbable material, as taught by Bagga et al., in order to provide a frame that dissolves over time as new bone grows in to replace it eventually ending up with a solid fusion of natural bone instead of a permanent foreign object in the spine. A fully fused segment made of natural bone behaves more like the patient’s original anatomy compared to having permanent synthetic materials in the spine.
Claim 13 is a product by process claim. It is noted that Geisler et al. in view of Bagga et al. disclose the claimed product.
Claim(s) 2-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geisler et al. (U.S. 2017/0020685 A1) in view of Bagga et al. (U.S. 2019/0099515 A1) as applied to claim 1 above, in view of Morris et al. (U.S. 2020/0353123 A1).
Geisler et al. in view of Bagga et al. disclose the invention substantially as described above. However, Geisler et al. in view of Bagga et al. do not explicitly disclose that the lattice structure further includes monopotassium phosphate in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, a poly-lactic acid, amikacin as a bioactive therapeutic agent, or a sugar acid.
Morris et al. disclose a bone-implantable device comprising monopotassium phosphate in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, a poly-lactic acid (see pars. 0030; 0031), amikacin (see par. 0037), and sugar acids (see par. 0057) in the same field of endeavor for the purpose of fusing adjacent vertebrae.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the salt lattice structure to include monopotassium phosphate in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, a poly-lactic acid, amikacin, and sugar acids, the concept of which is disclosed by Morris et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 4-5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geisler et al. (U.S. 2017/0020685 A1) in view of Bagga et al. (U.S. 2019/0099515 A1), further in view of Morris et al. (U.S. 2020/0353123 A1) as applied to claim 2 above, further in view of Dawson et al. (U.S. 2016/0270920 A1).
Concerning claims 4 and 5, Geisler et al. in view of Bagga et al., further in view of Morris et al. do not disclose that the salt lattice structure further includes a bioactive therapeutic agent.
Dawson et al. teach a spinal fusion agent comprising a lattice structure that further includes a bioactive therapeutic agent (see par. 0042 of Dawson et al.) in the same field of endeavor for the purpose of accelerating bone growth and fusion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a therapeutic agent within the lattice structure, as disclosed by Dawson et al., in order to stimulate bone-forming cells to rapidly produce new bone thereby speeding up the fusion process and improving fusion rates.
Concerning claim 12, Geisler et al. in view of Bagga et al., further in view of Morris et al. do not disclose that the lattice structure is formed of sintered layers of powder that create a three-dimensional porous coating.
Dawson et al. teach a spinal fusion implant comprising a lattice structure that is formed of sintered layers of powder (see pars. 0020 and 0071) that create a three-dimensional porous coating in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the lattice structure from sintered layers of powder, the concept of which is disclosed by Dawson et al., in order to create controlled porosity. Sintering powder particles creates interconnected pores throughout the implant. This porous structure allows bone cells, blood vessels, and nutrients to penetrate deep into the implant, promoting better bone ingrowth and integration.
Response to Arguments
Applicant’s arguments filed 11/13/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773