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 .
Response to Amendment
According to the amendment filed October 8, 2025, claims 1-10 have been amended. The objections to the specification, objections to the claims, and rejection of claim 7 under 35 U.S.C. 112(b) set forth in the Office Action mailed July 16, 2025, have been withdrawn accordingly. Claims 1-10 are currently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 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.
Claim Objections
Claims 6 and 8 are objected to because of the following informalities:
In line 3 of claim 6, “Acid-etched acid-etched (SLA)” should read ---acid etched---
In line 3 of claim 8, “each of said second concave hole” should read ---each of said second concave holes---
Appropriate correction is required.
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.
Claims 2-4 are 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 2 recites the limitation "each of said second side surfaces is provided with at least one second hole penetrating each of said second side surfaces" (emphasis added) in lines 3-4. Claim 4, depending from claim 2, also refers to “second holes” in line 2. Where parent claim 1, as currently amended, recites “wherein said second tail tapered arc surfaces on opposite sides of said connection hole are each provided with a second hole penetrating the respective second side surfaces” (emphasis added) in the last three lines, it is unclear if the at least one second hole recited in claim 2 (provided on each of the second side surfaces) is the second hole provided on the second tail tapered arc surfaces or different holes provided on the second side surfaces. In view of the specification and drawings, particularly paragraph 0031 and Fig. 7, it is understood that the second holes provided on each side of connection hole 42 (i.e., the second holes recited in claim 1) are intended to receive blocks 206 of a tool 200), while the second holes recited in claim 2 refer to the other holes provided in the side surfaces, e.g. for bone ingrowth. Thus, for examination purposes, to provide clarity with regard to the “second hole” limitations, claim 1 will be interpreted as reciting ---wherein said second tail tapered arc surfaces on opposite sides of said connection hole are each provided with a tool engagement hole penetrating the respective second side surfaces”.
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 1-3, 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (US 2014/0277505 A1) in view of Farley (US 2012/0071981 A1), Schell (US 2014/0214164 A1) and Blain (US 2022/0192841 A1).
Regarding claim 1, Mitchell teaches an intervertebral supporting element (interbody spacer 300, shown in Figs. 23-25; para. 0067), comprising:
two first side surfaces (upper and lower surfaces, as viewed in Figs. 23 and 25, each parallel to an XY plane; see Examiner’s 1st Annotated Fig. 23 below), symmetrical about an axis and respectively provided on two opposite sides of said axis (see Examiner’s 1st Annotated Fig. 23 below, where upper and lower sides defining first side surfaces are symmetrical about an Implant Axis extending through threaded bore 308, and are provided on opposite upper and lower sides of said axis as viewed in Figs. 23 and 25), each of said first side surfaces comprising a ratchet surface (as shown in Figs. 23-25, the upper and lower surfaces, i.e. first side surfaces, each define a ratchet surface, understood to comprise the ridges 128 shown in analogous embodiment Figs. 1-3 and 6, described in para. 0060), said two ratchet surface spaced a distance and parallel to an XY plane formed by an X-axis and a Y-axis, said axis parallel to said X-axis (see Examiner’s 1st Annotated Fig. 23 below and Figs. 23-25), two ends of said ratchet surface parallel to said axis respectively arcuately extended toward said axis and the width thereof gradually decreased to form a head tapered arc surface and a first tail tapered arc surface (see Examiner’s 1st Annotated Fig. 23 below and Figs. 24-25, depicting the leading and trailing edges of the upper and lower first side surfaces arcuately tapering towards the Implant Axis to form a head tapered surface, i.e. partially defining the Conical Tapered Head identified below, and a tail tapered surface, i.e. partially defining the Conical Tapered Tail identified below), a plurality of unidirectional ratchets provided on said ratchet surface, and a tip of each of said unidirectional ratchets facing said first tail tapered arc surface (as described above, the ratchet surfaces shown in Figs. 23-25 are understood to comprise the ridges/ratchets 128 shown in the analogous embodiment of Figs. 1-6, where the unidirectional ratchets/ridges 128 have a tip 130 facing towards the tail end of the implant, i.e. towards the Conical Tapered Tail identified in Examiner’s 1st Annotated Fig. 23 below); and
two second side surfaces (defined by lateral side surfaces, as viewed in Figs. 23-24, each generally parallel to the XZ plane; see Examiner’s 1st Annotated Fig. 23 below), symmetrical about said axis and respectively provided on two opposite sides of said axis (see Examiner’s 1st Annotated Fig. 23 below), each of said second side surfaces comprising a connection surface (lateral/second side surfaces define connection surfaces, connecting the upper and lower first side surfaces; Figs. 23-25), said two connection surface spaced a distance and parallel to an XZ plane formed by said X-axis and a Z-axis, said X-axis, said Y-axis and said Z-axis being three axes perpendicular to one another (see Examiner’s 1st Annotated Fig. 23 below, where lateral side surfaces define the connection surfaces, as described above), two opposite ends of said connection surface parallel to said axis respectively arcuately extended toward said axis and the width thereof gradually decreased to form a second head tapered arc surface and a second tail tapered arc surface (see Examiner’s 1st Annotated Fig. 23 below and Figs. 24-25, depicting the leading and trailing ends of the lateral second side surfaces arcuately tapering towards the Implant Axis, with the width gradually decreasing, to form a head tapered surface, i.e. partially defining the Conical Tapered Head identified below, and a tail tapered surface, i.e. partially defining the Conical Tapered Tail identified below);
said two second side surfaces positioned between said two first side surfaces (the two lateral, i.e. second side, surfaces are positioned between the upper and lower, i.e. first side, surfaces; Figs. 23-25), each of said connection surfaces parallel to two corresponding sides of said axis and respectively connected to an edge of said ratchet surface, said two first head tapered arc surfaces and said two second head tapered arc surface spaced apart and connected to each other to form a conical tapered head, the center of said head positioned on said axis (as shown, lateral connection surfaces connect to an edge of upper and lower ratchet surfaces forming a tapered head positioned on the Implant Axis, the tapered head having a truncated conical shape; see Examiner’s 1st Annotated Fig. 23 below), said two first tail tapered arc surfaces and said two second tail tapered arc surfaces separated apart and connected to each other to form a tail (as shown; see Examiner’s 1st Annotated Fig. 23 below), said tail provided with a connection hole (308; Fig. 23; para. 0067), and the center of said connection hole coaxial with said axis (see Examiner’s 1st Annotated Fig. 23 below).
Mitchell does not explicitly disclose (I) wherein a distance between said two first side surfaces is greater than a distance between said two second side surfaces, (II) the conical tapered head having a rounded pointed apex shape, and (III) wherein said second tail tapered arc surfaces on opposite sides of said connection hole are each provided with a second hole (which is being interpreted as a tool engagement hole, as noted above for examination purposes in view of the rejections under 35 U.S.C. 112(b)) penetrating the respective second side surfaces.
Regarding limitation (I), Farley teaches an intervertebral supporting element (spacer 10; Figs. 1-4; para. 0038) comprising two first side surfaces (top and bottom surfaces 24 and 26; Figs. 1-2; para. 0038), each comprising a bone engagement surface (46; Figs. 1-2; para. 0043), and two second side surfaces (defined by sides 20, 22; Figs. 1-4; para. 0038), each comprising a connection surface (as shown, sides 20, 22 having at least cutout 32 defining part of a connection surface for engaging with a tool, particularly shown in Fig. 1A), said two second side surfaces positioned between said two first side surfaces (Figs. 1-4), wherein a distance between said two first side surfaces is greater than a distance between said two second side surfaces (see Fig. 4 and para. 0038, where distance/height 30 between first side surfaces 24, 26 is greater than distance/width between side surfaces 20, 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitchell’s intervertebral supporting element to have a height greater than its width as taught by Farley (i.e., so that a distance between first side surfaces is greater than a distance between the second side surfaces, as claimed), because Farley is directed towards an implant having a function substantially similar to that of Mitchell and recognizes such relative dimensions suitable for the intended purpose.
Regarding limitation (II), Schell teaches an intervertebral supporting element (100; Figs. 6-10; para. 0059-0067) comprising two first side surfaces (defined by upper and lower surfaces, having gripping facets 130; Figs. 6-10; para. 0067), each tapering to a head tapered arc surface at a leading end (as shown, leading toward distal end 102; Figs. 6-7, 10), and two second side surfaces (defined by lateral surfaces of implant 100; Figs. 6-10), each tapering to a second head tapered arc surface at a leading end thereof (as shown, leading towards distal end 102; Figs. 6-7), wherein said two second side surfaces positioned between said two first side surfaces (Figs. 1-10), and Schell discloses wherein the head tapered arc surfaces form a conical tapered head having a rounded pointed apex shape (the bullet shaped distal end 102 defines a conical tapered head which, though shown in Figs. 6-10 as having a truncated conical shape, is disclosed as potentially having a conical shape in para. 0066, i.e. defining a rounded pointed apex shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitchell’s generally conical tapered head to have a rounded pointed apex shape, as taught by Schell, because Schell recognizes that such shapes “enable the implant to displace the existing nerve root in an atraumatic fashion” during insertion of the implant (see Schell, para. 0066).
Regarding limitation (III), Blain teaches an intervertebral supporting element (500; Figs. 42-44; para. 0436-0445) comprising two first side surfaces (defined by upper lid 540 and lower wall 532; Figs. 42; para. 0440, 0443), and two second side surfaces (lateral side walls 524, 526; Fig. 42; para. 0438), each comprising a connection surface (lateral side surfaces 524, 526 each have connection feature 528, thus defining connection surfaces; Figs. 42-44; para. 0438), said two second side surfaces positioned between said two first side surfaces (Figs. 42-44), a connection hole (threaded opening 523 for receiving an insertion tool; Fig. 42; para. 0437) defined on a tail of the supporting element (as shown formed on tail end surface 522; Figs. 42-44), wherein said second surfaces on opposite side of said connection hole are each provided with second hole, i.e. a tool engagement hole, penetrating the respective second side surface (second surfaces defined by lateral side surfaces 524, 526 each have a connection feature 528 including a slot 529 defining a tool engagement hole penetrating the respective surface; Figs. 42-44; para. 0438-0439; Examiner notes that, regarding a similar embodiment shown in Fig. 9 with a connection feature 128, it is understood that the connection feature can extend along a minimal portion of the length of the device, i.e. 10%, as stated in para. 0349).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitchell’s intervertebral supporting element to include the lateral side tool engagement holes as taught by Blain, because where Mitchell and Blain each disclose the implant having an internally threaded connection hole on a tail surface thereof, Blain recognizes that including additional holes/recesses on the lateral sides can facilitate insertion of the implant by providing additional engagement features for coupling with an insertion tool (see Blain, para. 0438-0439).
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Examiner’s 1st Annotated Fig. 3 of Mitchell
Regarding claims 2 and 3, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 1, and Mitchell discloses [Claim 2] wherein each of said first side surfaces (upper and lower sides; Fig. 23) is provided with at least one first hole penetrating each of said first side surfaces (see Examiner’s 2nd Annotated Fig. 23 below) and each of said second side surfaces (lateral side surfaces; Fig. 23) is provided with at least one second hole penetrating each of said second side surfaces (see Examiner’s 2nd Annotated Fig. 23 below), and each of said first holes and each of said second holes are in communication with each other (as depicted in Figs. 23-25, the first and second holes identified in Examiner’s 2nd Annotated Fig. 23 below are in communication with each other to facilitate and support bone growth by receiving bone growth materials into the hollowed out portion of the implant, as described with reference to analogous holes 110 in Figs. 1-3; para. 0059), [Claim 3] wherein two sides of each of said first holes parallel to said axis are respectively provided with a plurality of said unidirectional ratchets (as shown; see Examiner’s 2nd Annotated Fig. 23 below).
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Examiner’s 2nd Annotated Fig. 23 of Mitchell
Regarding claim 5, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 1, and Mitchell discloses wherein said connection hole (308; Fig. 23) has inner threads (threaded bore 308; Fig. 23; para. 0067).
Regarding claim 10, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 1, and Mitchell discloses wherein said tail has a plane parallel to said YZ formed by said Y-axis and said Z-axis (see Examiner’s 1st Annotated Fig. 23 above, where the tail having threaded connection hole 308 has an end plane in the YZ plane), and said plane and said head are opposite ends of said spine process supporting element, and said connection hole is located on said plane (as shown; see Examiner’s 1st Annotated Fig. 23 above).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (US 2014/0277505 A1), Farley (US 2012/0071981 A1), Schell (US 2014/0214164 A1) and Blain (US 2022/0192841 A1), as applied to claim 2 above, further in view of Liu (US 2003/0023306 A1).
Regarding claim 4, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 2, wherein each of said connection surfaces is provided with said two second holes (see Examiner’s 2nd Annotated Fig. 23 above).
Mitchell and the other above references do not specifically disclose wherein said second tail tapered arc surfaces is provided with one of said second holes.
Liu, in analogous art, teaches an implant (1; Fig. 1) having side surfaces (longitudinal walls 4, 5; Figs. 1, 4; para. 0076) defining a tail tapered arc surfaces (shown tapering towards end/tail wall 7; Fig. 1), wherein the side surfaces include holes (18, 16; Fig. 1), with at least one of said holes is provided on the tail tapered arc surfaces (see Fig. 1 and para. 0083, describing hole/groove 16 provided in each side surface to engage in blades on a hand tool).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitchell’s implant to have an additional second hole provided on each of the second side surfaces (i.e., lateral side surfaces) on the tail tapered arc surfaces of the lateral surfaces, as claimed, because Liu teaches that such a configuration enables the implant to be grasped by a hand tool (see Liu, para. 0083; Figs 1-8).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (US 2014/0277505 A1), Farley (US 2012/0071981 A1), Schell (US 2014/0214164 A1) and Blain (US 2022/0192841 A1), as applied to claim 1 above, further in view of Ogawa (US 2009/0283701 A1).
Regarding claim 6, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 1.
Mitchell also teaches wherein said intervertebral supporting element is made of a biocompatible material (see Abstract: “orthopedic implants constructed from biocompatible material”).
However, Mitchell and the other above references do not specifically teach wherein said spine process supporting element is made of biocompatible metal or plastic and is sandblasted, large grit, acid-etched (SLA).
Ogawa teaches a method for surface treating a medical implant to enhance tissue-to-implant and bone cement-to-implant integration (see Abstract; para. 0002), and teaches the implant being made of a biocompatible metal material (see claim 4) which is physically treated by sand-blasting and chemically treated by acid-etching (see claims 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Mitchell’s implant from a biocompatible metal that is then treated in the claimed manner, i.e. sandblasted, large grit, acid-etched, because Ogawa recognizes that such a material and surface treatment can beneficially enhance tissue-to-implant and bone cement-to-implant integration (see Ogawa, para. 0002), and further because the selection of a known material based on its suitability for its intended use requires only ordinary skill in the art. See Sinclair & Carroll Co. v. Intermchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (US 2014/0277505 A1), Farley (US 2012/0071981 A1), Schell (US 2014/0214164 A1) and Blain (US 2022/0192841 A1), as applied to claim 1 above, further in view of Mather (US 2011/0301710 A1).
Regarding claims 7 and 9, Mitchell, Farley, Schell and Blain teach the intervertebral supporting element according to claim 1, wherein a first concave hole is provided at a corresponding position of said two first side surfaces (as shown in Fig. 23 and described in para. 0067, the first upper and lower side surfaces have a plurality of pockets, i.e. concave holes, positioned thereon for receiving “bioactive glass markers 110” for imaging purposes).
Mitchell and the other above references do not disclose [Claim 7] the element comprising a second concave hole is provided at a corresponding position of said two second side surfaces. Further, Mitchell does not disclose [Claim 7] wherein the first and second concave holes are for embedding the metal for imaging during operation, and [Claim 9] wherein said metal for development is tantalum alloy, titanium alloy, or pure titanium.
Mather, in analogous art, teaches a spinal implant (Fig. 1A) with radiographic markers provided on first top/bottom surfaces and on second lateral surfaces of the implant (see radiopaque markers 30 in Figs. 1A-1F, described in para. 0072 for facilitating visualization of the implant 10 during the procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitchell’s implant to further include a second concave hole on the second side surfaces (i.e. lateral surfaces), as taught by Mather, because Mather recognizes that providing such radiographic markers on top, bottom and side surfaces of the implant facilitates visualization of the implant during the procedure so as to confirm that the implant is being delivered along a desirable delivery pathway and that the implant is maintaining a desirable orientation (see Mather, para. 0072). Further, it would have been obvious to have formed these markers of a metal material, such as a tantalum or titanium alloy, or pure titanium, as claimed, because one of ordinary skill in the art would recognize that these materials are known radiopaque materials used for imaging during surgical operations, and the selection of a known material based on its suitability for its intended use requires only ordinary skill in the art. See Sinclair & Carroll Co. v. Intermchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 8, Mitchell, Farley, Schell, Blain and Maher teach the intervertebral supporting element according to claim 7, and Mitchell teaches wherein each of said first concave holes is provided on said the first head tapered arc surface (first concave holes/pockets 118 are shown to be formed on the upper and lower surfaces towards the tapered right head end of the implant, as shown in Figs. 23 and 25).
The above references do not explicitly disclose wherein each of said second concave hole is provided on said second tail tapered arc surface.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the claimed location for the second holes, formed on the second (i.e. lateral) side surfaces of the implant, so that the holes are provided at the tail tapered arc surface, because the rearrangement/repositioning of such pockets for receiving radiographic metal markers would require only routine experimentation in the art without affecting the operation of the device. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
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 ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p 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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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773