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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite “each radiographic marker comprising a region of the lattice structure having a density variation relative to surrounding regions of the lattice structure.” Such a recitation constitutes new matter. A density variation can mean that the radiographic marker has a greater density than surrounding regions or that the radiographic marker has a lesser density than surrounding regions. However, Applicant’s disclosure only provides support for the radiographic marker having a density greater than surrounding regions (see the abstract, para. 0004 on pg. 3 of the specification, and Embodiment 38 on pg. 33 of the specification). Because Applicant’s disclosure does not provide support for the radiographic marker having a lesser density than the surrounding regions, and such is within the scope of claim 1 as amended, claim 1 contains new matter. Claims 2-20 depend from claim 1 and are therefore also rejected.
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 1-10 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Unger et al. (US 2019/0133783 A1) in view of Gregersen et al. (US 2019/0183653 A1) and McCormack et al. (US 2015/0297357 A1).
Claim 1. Unger discloses a surgical implant comprising: a body (implant 100) comprising a lattice structure (microporous endplate structure 110 and microporous body lattice structure 120) comprising a plurality of intersecting beams (see Fig. 3), the lattice structure extending from a superior surface (upper bone contacting surface 101) of the body to an inferior surface (lower bone contacting surface 102) of the body and a first lateral edge (left side as shown in Fig. 1D) to a second lateral edge (right side as shown in Fig. 1D), the lattice structure defining (i) the superior surface and the inferior surface of the body, (ii) a central void (fusion aperture 103) of the body, (iii) a gradient of pore sizes (see Fig. 3; see para. 0041), and (iv) a gradient of beam diameters (see Fig. 3; see para. 0041),
both beam diameter and pore size varying from the superior and inferior surfaces of the body and from exterior to interior surfaces of the body (see Fig. 2B); and
one or more radiographic markers incorporated into the body, each radiographic marker comprising a region of the lattice structure having a density variation relative to surrounding regions of the lattice structure (see para. 0035, which states that implant 100 is made of a titanium alloy; the density of microporous endplate structure 110 is different than that of microporous body lattice structure 120 and titanium is radiopaque, thus enabling the density variation to serve as a radiographic marker) (Figs. 1-4E; paras. 0027-0044).
Claim 2. Unger discloses wherein the variability of pore sizes and beam diameters achieves varying zones of stiffness between the superior and/or inferior surfaces as compared to an interior zone of the body (see Fig. 2B; note that the interior zone can include struts 140) (see Fig. 2B) (Figs. 1-4E; paras. 0027-0044).
Claim 3. Unger discloses wherein the superior and/or inferior surfaces are less stiff than the interior zone (see Fig. 2B; the superior and/or inferior surfaces would be less stiff at an area not directly supported by struts 140 or instrument engagement feature 104) (Figs. 1-4E; paras. 0027-0044).
Claim 4. Unger discloses wherein the superior and/or inferior surfaces are stiffer than the interior zone (see Fig. 2B; the superior and/or inferior surfaces would be stiffer at an area directly supported by instrument engagement feature 104) (Figs. 1-4E; paras. 0027-0044).
Claim 5. Unger discloses wherein the variability of pore sizes and beam diameters achieves varying zones of stiffness between the exterior of the body as compared to an interior zone of the body (see Fig. 2B; note that the exterior can include surfaces 101 and 102 and interior zones can include struts 140) (Figs. 1-4E; paras. 0027-0044).
Claim 6. Unger discloses wherein the exterior is stiffer than the interior zone (see Fig. 2B; note that the exterior can include surfaces 101 and 102 and interior zones can include struts 140; the surfaces 101 and 102 would be stiffer at an area directly supported by instrument engagement feature 104) (Figs. 1-4E; paras. 0027-0044).
Claim 7. Unger discloses wherein the exterior is less stiff than the interior zone (see Fig. 2B; note that the exterior can include surfaces 101 and 102 and interior zones can include struts 140; surfaces 101 and 102 would be less stiff at an area not directly supported by struts 140 or instrument engagement feature 104) (Figs. 1-4E; paras. 0027-0044).
Claim 16. Unger discloses wherein the gradient of pores comprises (i) one or more regions of micropores beginning at the superior surface and having sizes ranging from 100 microns to 1,000 microns (see para. 0040), (ii) one or more regions of macropores in an internal portion of the lattice structure (see para. 0041), and (iii) one or more regions of micropores at the inferior surface (see para. 0040) (Figs. 1-4E; paras. 0027-0044).
Claim 17. Unger discloses wherein the micropores of the superior surface range in size from 300 microns to 800 microns (see para. 0040) (Figs. 1-4E; paras. 0027-0044).
Claim 18. Unger discloses wherein the one or more regions of micropores transition continuously to the one or more regions of macropores (see para. 0041) (Figs. 1-4E; paras. 0027-0044).
Claim 19. Unger discloses wherein the lattice structure is a stochastic lattice structure (see Fig. 3, and in particular, the zoomed in area, which shows a stochastic lattice) (Figs. 1-4E; paras. 0027-0044).
Unger fails to disclose a plurality of superior surface projections extending superiorly from respective beam intersections at the superior surface, each of the plurality of superior surface projections having a directionality for reducing migration of the surgical implant after placement of the surgical implant during a surgical procedure (claim 1), wherein the plurality of superior surface projections are disposed radially about the central void of the body and extend from the central void to a first boundary of the body (claim 8), wherein the plurality of superior surface projections are disposed radially relative to a proximal end of the body and extend toward a distal end of the body (claim 9), wherein the plurality of superior surface projections are disposed radially relative to a distal end of the body, forming a radial pattern, and wherein the plurality of superior surface projections extend toward a proximal end of the body (claim 10), wherein the directionality of the plurality of superior surface projections is toward a proximal end of the body (claim 12), wherein each of the plurality of superior surface projections is located at a respective vertex of the pores (claim 13), wherein the superior surface projections exhibit varying heights with taller surface projections located near the central void and shorter surface projections located toward the first and second lateral edges (claim 14), wherein the superior surface projections are grouped into a plurality of bands extending across the superior surface from the first lateral edge to the second lateral edge (claim 15), wherein the one or more regions of macropores have sizes ranging from 1,000 microns to 8,000 microns (claim 16), and wherein the macropores of the internal portion range in size from 1,000 microns to 6,000 microns (claim 17).
Gregersen teaches a surgical implant comprising: a body (implant 10) comprising a lattice structure (grating 30) comprising a plurality of intersecting beams (rods 32A and 32B); and a plurality of superior surface projections (teeth 62) extending superiorly from respective beam intersections (nodes 34) at a superior surface (wall 12) of the body; wherein the plurality of superior surface projections are disposed radially about a central void (cavity 22) of the body and extend from the central void to a first boundary of the body; wherein the plurality of superior surface projections are disposed radially relative to a proximal end (at wall 40) of the body and extend toward a distal end (at wall 42) of the body; wherein the plurality of superior surface projections are disposed radially relative to the distal end of the body, forming a radial pattern, and wherein the plurality of superior surface projections extend toward the proximal end of the body; wherein each of the plurality of superior surface projections is located at a respective vertex of the pores; wherein the superior surface projections are grouped into a plurality of bands (see Fig. 4) extending across the superior surface from a first lateral edge (at wall 44) to a second lateral edge (at wall 46); and wherein the surface projections provide means for engaging the adjacent vertebra (see para. 0125) (Figs. 1-9; paras. 0119-0143).
McCormack teaches a surgical implant comprising: a body (implant 100) comprising a plurality of superior surface projections (features 118) extending from a superior surface (face 102) of the body; wherein each of the plurality of superior surface projections have a directionality for reducing migration of the surgical implant after placement of the surgical implant during a surgical procedure to prevent the implant from self-displacing once implanted (see para. 0051); wherein the directionality of the plurality of superior surface projections is toward a proximal end (end 108) of the body; and wherein the superior surface projections exhibit varying heights (the height of each feature 118 is shorter closer to end 106 than end 108) with taller surface projections located near a central void (window 112) and shorter surface projections located toward first and second lateral edges (Figs. 1A-1B; paras. 0049-0052).
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 surgical implant of Unger such that it includes a plurality of superior surface projections extending superiorly from respective beam intersections at the superior surface, each of the plurality of superior surface projections having a directionality for reducing migration of the surgical implant after placement of the surgical implant during a surgical procedure (claim 1), wherein the plurality of superior surface projections are disposed radially about the central void of the body and extend from the central void to a first boundary of the body (claim 8), wherein the plurality of superior surface projections are disposed radially relative to a proximal end of the body and extend toward a distal end of the body (claim 9), wherein the plurality of superior surface projections are disposed radially relative to a distal end of the body, forming a radial pattern, and wherein the plurality of superior surface projections extend toward a proximal end of the body (claim 10), wherein the directionality of the plurality of superior surface projections is toward a proximal end of the body (claim 12), wherein each of the plurality of superior surface projections is located at a respective vertex of the pores (claim 13), wherein the superior surface projections exhibit varying heights with taller surface projections located near the central void and shorter surface projections located toward the first and second lateral edges (claim 14), wherein the superior surface projections are grouped into a plurality of bands extending across the superior surface from the first lateral edge to the second lateral edge (claim 15), as suggested by Gregersen and McCormack, in order to provide means for engaging the adjacent vertebra and to prevent the implant from self-displacing once implanted. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the one or more regions of macropores to have sizes ranging from 1,000 microns to 8,000 microns (claim 16) wherein the macropores of the internal portion to range in size from 1,000 microns to 6,000 microns (claim 17), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Unger et al. (US 2019/0133783 A1) in view of Gregersen et al. (US 2019/0183653 A1) and McCormack et al. (US 2015/0297357 A1) as applied to claim 1 above, and further in view of Harris et al. (US 2023/0114676 A1).
Unger, Gregersen, and McCormack fail to teach wherein the lattice structure is a mesh structure (claim 20).
Harris teaches a surgical implant comprising: a body (implant 200) comprising a lattice structure (mesh 124), wherein the lattice structure is a mesh structure (mesh 124) (Figs. 8-14; paras. 0095-0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the surgical implant of Unger such that the lattice structure is a mesh structure (claim 20), as suggested by Harris, as such is a simple substitution of one type of lattice structure for another.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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.
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.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights