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 without traverse of Claims 1-2 and 5-29 in the reply filed on March 2, 2026 is acknowledged.
Applicant should have changed the dependence for Claim 29. Examiner will treat the claim as dependent on Claim 1, but Applicant should correct the Claim prior to return.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 5-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (US 2018/0296343) in view of Ullrich, et al. (US 2012/0312778) and Sameoto (US 2014/0363610).
In reference to Claim 1, Wei discloses creating a porous implant ([0010]) (a method of making a spinal implant device or orthopedic device or bone implant device) by 3-D printing ([0012]) (the structure is produced through a 3D printing additive process) a tool to etch after it is removed from the printing surface ([0169]) creating pores on the nano scale ([293]) for attachment ([0118]) (then further processed with a laser etching technology that results in a nanotechnology structure at the surface that facilitates bone attachment and growth).
Ullrich discloses laser etching an implant ([0050]).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method of Wei using the laser etching of Ullrich because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Ullrich to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
Sameoto discloses a creation of microfluidic channels through direct printing ([0151]) using a laser ([0151]) (with a laser etching technology).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method of Wei using the structure and laser etching of Sameoto because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Sameoto to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
In reference to Claim 2, modified Wei discloses the method of Claim 1, as described above.
Wei discloses 3-D printing ([0012]) to create a porous implant to mimic trabecular bone ([0304]) (the 3D printing additive process creates a structure at the implant surface that mimics trabecular bone structure).
In reference to Claim 5, modified Wei discloses creating a porous implant ([0010]) (a method of making a spinal implant device or orthopedic device or bone implant device) by 3-D printing ([0012]) (comprises the steps of: fabricating an implant body structure using 3D printing to create the implant body structure); using an ink strong enough to be load bearing comparable to bone ([0237]) (additively building the body structure having a superior load bearing surface and an inferior load bearing surface and a wall structure); and creating a porous hollow structure ([0075]) (wherein the body structure has at least a portion having a plurality of interconnected struts forming porous walls with openings extending inwardly) with a thickness from 2-30 mm ([0089]) (from an exterior surface to a depth of 1.0 mm or greater forming a porous portion with a void volume to solid mass volume mimicking trabecular bone).
In reference to Claim 6, modified Wei discloses the method of Claim 5, as described above.
Wei discloses 70% or more ([0113]) (the average or nominal ratio of void volume to mass volume in the porous portion is in the range of 65 percent or more, preferably 75 percent replicating that of trabecular bone in an adult male).
In reference to Claim 7, modified Wei discloses the method of Claim 6, as described above.
Wei discloses the bone fibers can be formed in curved shapes ([0045]) (the struts of the porous walls are curved or arch shaped with openings communicating with adjacent walls).
In reference to Claim 8, modified Wei discloses the method of Claim 7, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the porous portion of the implant body structure extends at least partially across the implant body structure to the exterior surfaces forming conduits for fluid passage throughout the device).
In reference to Claim 9, modified Wei discloses the method of Claim 8, as described above.
Wei discloses formed in curved shapes ([0045]) using an ink strong enough to be load bearing comparable to bone ([0237]) (the curved or arch shaped struts of the porous walls create a load bearing capacity to withstand vertical loads without collapsing).
In reference to Claim 10, modified Wei discloses the method of Claim 5, as described above.
Wei discloses channels may be formed in the bone ([0314]) (the implant fusion device has the superior load bearing surface and the inferior load bearing surface, each load bearing surface having nano channels etched on exposed surfaces).
In reference to Claim 11, modified Wei discloses the method of Claim 6, as described above.
Wei discloses channels may be formed in the bone ([0314]) (the nano channels are made into a network of features in either a random pattern or an organized pattern).
In reference to Claim 12, modified Wei discloses the method of Claim 11, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the nano channels are formed by emitting laser beams unobstructed to surfaces within the path of the laser beams).
In reference to Claim 13, modified Wei discloses the method of Claim 11, as described above.
Wei discloses the printing surface is moveable ([0077]) (the implant body structure is stationary and a laser moves about the implant body structure to create the network of features or wherein a laser is stationary and the implant body structure moves relative to the laser to create the network of features).
In reference to Claim 14, Wei discloses creating a porous implant ([0010]) (a method of making a spinal implant device or orthopedic device or bone implant device) creating a porous implant ([0010]) (comprises the steps of: providing an implant body structure); and the laser forms the product ([0165]) a tool to etch ([0169]) channels may be formed in the bone ([0314]) (laser etching nano channels on at least a portion of an exterior surface or surfaces of the implant body structure, the nano channels creating new bone growth attachment features to enhance osteoinductivity of the spinal implant fusion device).
Ullrich discloses laser etching an implant ([0050]).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method of Wei using the laser etching of Ullrich because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Ullrich to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
Sameoto discloses a creation of microfluidic channels through direct printing ([0151]) using a laser ([0151]) (with a laser etching technology).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method of Wei using the structure and laser etching of Sameoto because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Sameoto to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
In reference to Claim 15, modified Wei discloses the method of Claim 14, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the laser etched nano channels are made into a network of features in either a random pattern or an organized pattern).
In reference to Claim 16, modified Wei discloses the method of Claim 15, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the laser etching is formed by emitting laser beams unobstructed to the exterior surfaces).
In reference to Claim 17, modified Wei discloses the method of Claim 16, as described above.
Wei discloses the laser forms the product ([0165]) (the step of moving a laser about the implant body structure to create the network of features).
In reference to Claim 18, modified Wei discloses the method of Claim 16, as described above.
Wei discloses the printing surface is moveable ([0077]) (the step of moving the implant body structure about a laser to create the network of features).
In reference to Claim 19, Wei discloses creating a porous implant ([0010]) (a method of making a spinal implant device or orthopedic device or bone implant device) by 3-D printing ([0012]) (comprises the steps of: fabricating an implant body structure using 3D printing to create the implant body structure); using an ink strong enough to be load bearing comparable to bone ([0237]) (additively building the body structure having a superior load bearing surface and an inferior load bearing surface and a wall structure); and creating a porous hollow structure ([0075]) (wherein the body structure has at least a portion of the body structure having a plurality of walls with openings extending inwardly) with a thickness from 2-30 mm ([0089]) (from an exterior surface to a depth of 1.0 mm or greater forming a porous portion with a void volume to solid mass volume mimicking trabecular bone) the laser forms the product ([0165]) a tool to etch after it is removed from the printing surface ([0169]) channels may be formed in the bone ([0314]) (after the 3D printing, laser etching nano channels on at least a portion of the exterior surface or surfaces of the implant body structure, the nano channels creating new bone growth attachment features to enhance osteoinductivity of the spinal implant fusion device).
Ullrich discloses laser etching an implant ([0050]).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method or Wei using the laser etching of Ullrich because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Ullrich to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
Sameoto discloses a creation of microfluidic channels through direct printing ([0151]) using a laser ([0151]) (with a laser etching technology).
It would have been obvious to one of ordinary skill in the art to complete the porous implant creation method of Wei using the structure and laser etching of Sameoto because the subtractive process can be used to shape the implant to promote bone healing and fusion ([0051]). One of ordinary skill in the art would be motivated to use the laser etching of Sameoto to promote bone healing and fusion. One of ordinary skill in the art would reasonably expect the laser etching to ensure proper adhesion of the implant and success for implantation.
In reference to Claim 20, modified Wei discloses the method of Claim 19, as described above.
Wei discloses 70% or more ([0113]) (the average or nominal ratio of void volume to mass volume of the porous portion is in the range of 65 percent or more, more preferably 75 percent replicating that of trabecular bone in an adult male).
In reference to Claim 21, modified Wei discloses the method of Claim 19, as described above.
Wei discloses formed in curved shapes ([0045]) using an ink strong enough to be load bearing comparable to bone ([0237]) (one or more of the plurality of walls is curved or arch shaped with openings communicating with adjacent walls).
In reference to Claim 22, modified Wei discloses the method of Claim 19, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the porous portion of the implant body structure extends across the implant body structure from the exterior surfaces inwardly forming conduits for fluid passage throughout the porous portion of the implant body structure).
In reference to Claim 23, modified Wei discloses the method of Claim 22, as described above.
Wei discloses formed in curved shapes ([0045]) using an ink strong enough to be load bearing comparable to bone ([0237]) (the curved or arch shaped walls create a load bearing capacity to withstand vertical loads without collapsing).
In reference to Claim 24, modified Wei discloses the method of Claim 19, as described above.
Wei discloses channels may be formed in the bone ([0314]) (the implant fusion device has the superior load bearing surface and the inferior load bearing surface having nano channels etched on exposed surfaces).
In reference to Claim 25, modified Wei discloses the method of Claim 24, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the nano channels are made into a network of features in either a random pattern or an organized pattern).
In reference to Claim 26, modified Wei discloses the method of Claim 19, as described above.
Wei discloses the laser forms the product ([0165]) channels may be formed in the bone ([0314]) (the nano channels are formed by emitting laser beams unobstructed to surfaces within the path of the laser beams).
In reference to Claim 27, modified Wei discloses the method of Claim 25, as described above.
Wei discloses the printing surface is moveable ([0077]) (the implant body structure is stationary and a laser moves about the implant body structure to create the network of features).
In reference to Claim 28, modified Wei discloses the method of Claim 25, as described above.
Wei discloses the printing surface is moveable ([0077]) (a laser is stationary and the implant body structure moves relative to the laser to create the network of features).
In reference to Claim 29, modified Wei discloses the method of Claim 1, as described above.
Wei discloses a spinal fusion device ([0051]) (the device is one of a spinal implant fusion device, a bone screw or fastener, a dental implant, a hip implant, or a knee implant).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY C GRACE whose telephone number is (571)270-1113. The examiner can normally be reached Monday-Thursday 7:00 AM - 5:00 PM EST, Friday 7:00 AM - 11:00 AM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at (571)272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KELSEY C. GRACE
Examiner
Art Unit 1742
/CHRISTINA A JOHNSON/Supervisory Patent Examiner, Art Unit 1742
Prosecution Insights