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 .
Priority
This application claims priority from a variety of applications, but the earliest support for the elected embodiment is found in application 16/565321, filed 09/09/2019.
Status of Claims
Claims 1, 10, 11, 13, 15, 18, 19, and 21-36 are pending.
Claims 2-9, 12, 16, 17, and 20 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Species 5 (Figures 68-74) in the reply filed on 03/17/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement filed on 07/25/2024, 07/14/2025, and 03/17/2026 has been considered by the examiner.
Applicant should note that the large number of references (over 10 pages) in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). It appears that not all of the cited references are relevant to the patentability of the claims. For example cited reference 7,232,594 is directed at a LCD Display Monitor. Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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.
Claim(s) 1, 10, 11, 13, 15, 18, 19, 21-29, and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Unger et al (Unger) USPN 10,675,158 B2).
1. Unger discloses a medical implant 100 (Figures 28-29), comprising:
a first independent endplate 101 comprising an upper surface and a lower surface (top and bottom surfaces) configured to contact a first segment of tissue upon implantation (4:60-65);
a second independent endplate 102 spaced apart from the first independent endplate (Figures 28-29), the second independent endplate comprising a lower surface and an upper surface (top and bottom) configured to contact a second segment of tissue upon implantation (4:60-65); and
a metallic (5:20-29) biocompatible (5:20-29) three-dimensionally printed body (140) (the claimed method of 3D printing amounts to a product by process limitation. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). In this case the 3D printing method is disclose 5:14-16) comprising a porous (surrounding struts 140) structure disposed between the upper surface of the first independent endplate and the lower surface of the second independent endplate (Figures 28-29) such that at least one portion of the first independent endplate is mechanically connected to the second independent endplate only via the body (there are numerous portions only supported by the struts of the body as seen in Figures 28-29), the porous structure comprising a porosity configured to promote bone growth (the entire open porous nature of the implant promotes ingrowth);
wherein an elastic modulus of the body is lower than an elastic modulus of the first independent endplate and an elastic modulus of the second independent endplate (as seen in Figures 28-29 the body has substantially less struts and much larger openings, noting the implant sections are made from the same material, the elastic modulus of the body is inherently less than that of the upper and lower plates).
10. 13. Unger discloses the medical implant comprises a lumbar implant including a Posterior implant, a Transverse implant, an Anterior implant, a Lateral implant (as explained above these types of recitation are considered to be intended use limitations and given limited weight, additionally Unger discloses his implant is capable of being used as these types of lumbar implant 4:60-65).
11. Unger discloses the first independent endplate and the second independent endplate comprises a plurality of ridges configured to mechanically anchor the first or the second independent endplate to an adjacent vertebra (the endplates of Unger include a variety of ridges formed by the peaks and valleys of the radially inward struts).
15. Unger discloses the first independent endplate, the second independent endplate, and the porous structure comprises titanium (3:47-54).
18. 19. Unger discloses the medical implant is implanted via an image guided surgery and via a robotic surgery (the claim recitations defining how and where the applicant’s invention is used are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the implant of Unger is fully capable of being inserted with any known medical approach including those using imaging and robotic guidance).
21. 22. Unger discloses the first segment or second segment of the tissue comprises at least one of a bony structure to fuse at least one of: multiple levels of a human spine, adjacent levels of the human spine, and non- adjacent levels of the human spine (as explained above these types of recitation are considered to be intended use limitations and given limited weight, additionally Unger discloses his implant is capable of being used as to engage and fuse bony structures of the spine 4:60-65).
23. 24. Unger discloses the medical implant and the body structure are configured to promote ingrowth of at least one of the first segment of tissue and the second segment of tissue (the entire open porous nature of the implant promotes ingrowth).
25. Unger discloses the medical implant is at least partially radiolucent (6:19-22).
26. Unger discloses the medical implant comprises at least one area comprising increased radiolucency along at least one X-ray viewing direction (when rotated the struts of the implant can be arranged to overlap more or less thereby increasing the radiolucency).
27. Unger discloses the medical implant comprises a variable radiodensity (when rotated the struts of the implant can be arranged to overlap more or less thereby varying the radiolucency).
28. Unger discloses the medical implant comprises a first radiodensity along a first X-ray viewing direction and a second radiodensity along a second X-ray viewing direction (when rotated the struts of the implant can be arranged to overlap more or less thereby defining multiple identifiable degrees of radiolucency).
29. Unger discloses the at least one of the first independent endplate, the second independent endplate, and the porous body comprises one or more interconnected openings (Figures 28-29).
32. Unger discloses the porous body comprises one or more pores having a diameter of between 300 pm to 900 pm (noting that the endplates and body of the implant of Unger are an integral monolith lattice of struts, one could identify the inner most portions of the smaller struts at the transition portions as either part of the end plates or part of the body, with that in mind Unger further discloses the porosity of the smaller strut areas can be 800 pm 6:48-49).
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.
Claim(s) 30, 31, and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Unger in view of Jones et al (Jones) US 2010/0010638 A1.
33. Under discloses an interbody implant 100 (Figures 28-29) comprising:
a first independent endplate 101 comprising a first side and a second side (top and bottom) configured to contact a first segment of tissue (4:60-65);
a second independent endplate 102 comprising a first side and a second side (top and bottom) configured to contact a second segment of tissue (4:60-65); and
a three-dimensionally printed porous body 140 (see explanation with respect to claim 1 above about the 3D printing product by process recitation) disposed between the first side of the first independent endplate and the first side of the second independent endplate (Figures 28-29),
wherein the porous body comprises at least one pore comprising a diameter of between 300 pm to 900 pm (see explanation with respect to claim 32 above) and the porous body is configured to provide independence and sole mechanical spacing between the first independent endplate and the second independent endplate (Figures 28-29 show the struts of the body as the only structure connecting the two end plates).
However, Unger does not disclose the actual value for the porosity of the porous body.
It is noted that the applicant has not disclosed the claimed porosity range solves any stated problem or is for any particular purpose. The applicant merely provides a variety of ranges of porosity without noting any inventive leap or unexpected benefits. Simply disclosing a range does not support that the range is critical and points towards the variety of ranges being routine optimization. Moreover it appears that porosity percentages above and below the claimed range would likely perform equally as well.
Jones teaches the use of a porous lattice bone engaging structure with a porosity in the range of 70-80% [0054] in the same field of endeavor for the purpose of promoting a strong connection with bone ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the porosity of the body section as 70-80% as taught by Jones in order to provide a structurally sound lattice that promotes substantial bone ingrowth.
34. Unger discloses the first independent endplate and the second independent endplate are movable independently of one another about the porous body (3:47-4:7).
35. Unger discloses an elastic modulus of the body is lower than an elastic modulus of the first independent endplate and an elastic modulus of the second independent endplate (as seen in Figures 28-29 the body has substantially less struts and much larger openings, noting the implant sections are made from the same material, the elastic modulus of the body is inherently less than that of the upper and lower plates).
36. Unger discloses the implant comprises a single-piece three- dimensional printed structure (Figures 28-29).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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