DETAILED ACTION
This Office action is in response to the amendment filed 11/07/2025.
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) 1-5, 11, 15, 16, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2).
Concerning claim 1, as best understood, Carls et al. disclose a spinal implant system comprising: a superior element (see Fig. 4 below) having a superior base (see Fig. 4 below) and a superior insert (see Fig. 4 below), the superior base comprising a first material (see par. 0061) having a first coated portion thereof (see par. 0062), the superior insert comprising a first superior stop (see Fig. 3 below), a second superior stop (see Fig. 3 below) and a superior articulation surface (see Fig. 3 below) positioned between the first and second superior stops, the superior insert comprising a second material that is different from the first material (see par. 0061), the superior insert being coupled to the superior base (see Fig. 3 below); and an inferior element (see Fig. 4 below) having an inferior base (see Fig. 4 below) and a bridge potion (see Fig. 4 below) coupled to a posterior portion of the inferior base, the inferior base including a first inferior stop (see Fig. 3 below), a second inferior stop (see Fig. 3 below) and an inferior articulation component (see Fig. 3 below) positioned between the first and second inferior stops, the inferior base comprising a third material having a second coated portion thereof (see pars. 0061 and 0062); the inferior articulation component having an inferior articulation surface (see Fig. 3 below) which engages with the superior articulation surface to allow articulation of the superior element relative to the inferior element between a first relative position where the first superior stop contacts the first inferior stop and a second relative position where the second superior stop contacts the second inferior stop, the first relative position being different than the second relative position.
[AltContent: arrow][AltContent: textbox (Downwardly Extending Flange Portion)][AltContent: connector][AltContent: textbox (Bridge Portion)][AltContent: connector][AltContent: textbox (Inferior Base)][AltContent: arrow][AltContent: textbox (Inferior Element)][AltContent: textbox (Superior Insert)][AltContent: connector][AltContent: connector][AltContent: textbox (Superior Base)][AltContent: arrow][AltContent: textbox (Superior Element)]
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[AltContent: arrow][AltContent: textbox (Inferior Articulation Surface )][AltContent: connector][AltContent: textbox (Inferior Articulation Component)][AltContent: arrow][AltContent: textbox (2nd Inferior Stop)][AltContent: arrow][AltContent: textbox (1st Inferior Stop)][AltContent: arrow][AltContent: textbox (Superior Articulation Surface )][AltContent: arrow][AltContent: textbox (2nd Superior Stop)][AltContent: arrow][AltContent: textbox (1st Superior Stop)]
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Concerning claim 2, wherein the first material comprises a metal and the second material comprises a polymer (see par. 0061).
Concerning claim 3, wherein the superior articulation surface comprises a generally hemispherical concave surface and the inferior articulation surface comprises a generally hemispherical convex surface (see Fig. 3 above).
Concerning claim 4, wherein the inferior and superior articulation surfaces comprise a ball and socket-type articulating joint (see Fig. 3 above).
Concerning claim 5, wherein the polymer comprises an ultra-high weight molecular polyethylene (UHVWMPE) (see par. 0061).
Concerning claim 11, wherein the first coated portion comprises a bony ingrowth coating (see par. 0062).
Concerning claim 15, wherein the superior base includes a downwardly extending flanged portion (see Fig. 4 above).
Concerning claim 16, wherein at least a portion of the superior insert substantially surrounds the downwardly extending flanged portion (see Fig. 4 above).
Concerning claim 18, Carls et al. disclose a spinal implant system comprising: a superior element (see Fig. 4 below) having a superior base (see Fig. 4 below), a first superior stop (see Fig. 3 below), a second superior stop (see Fig. 3 below) and a superior insert (see Fig. 3 below), the superior base comprising a first material having a first coated portion thereof (see pars. 0061 and 0062), the superior insert comprising a superior articulation surface (see Fig. 3 below) positioned between the first and second superior stops, the superior articulation surface comprising a second material that is different from the first material (see pars. 0061 and 0062), the superior insert being coupled to the superior base (see Fig. 4 below); and an inferior element (see Fig. 4 below) having an inferior base (see Fig. 4 below) and a bridge potion (see Fig. 4 below) coupled to a posterior portion of the inferior base, the inferior base including a first inferior stop (see Fig. 3 below), a second inferior stop (see Fig. 3 below) and an inferior articulation component (see Fig. 3 below) positioned between the first and second inferior stops, the inferior base comprising a third material having a second coated portion thereof (see pars. 0061 and 0062); the inferior articulation component having an inferior articulation surface (see Fig. 3 below) which engages with the superior articulation surface (see Fig. 3 below) to allow articulation of the superior element relative to the inferior element between a first relative position where the first superior stop contacts the first inferior stop and a second relative position where the second superior stop contacts the second inferior stop, the first relative position being different than the second relative position.
[AltContent: arrow][AltContent: textbox (Downwardly Extending Flange Portion)][AltContent: connector][AltContent: textbox (Bridge Portion)][AltContent: connector][AltContent: textbox (Inferior Base)][AltContent: arrow][AltContent: textbox (Inferior Element)][AltContent: textbox (Superior Insert)][AltContent: connector][AltContent: connector][AltContent: textbox (Superior Base)][AltContent: arrow][AltContent: textbox (Superior Element)]
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[AltContent: arrow][AltContent: textbox (Inferior Articulation Surface )][AltContent: connector][AltContent: textbox (Inferior Articulation Component)][AltContent: arrow][AltContent: textbox (2nd Inferior Stop)][AltContent: arrow][AltContent: textbox (1st Inferior Stop)][AltContent: arrow][AltContent: textbox (Superior Articulation Surface )][AltContent: arrow][AltContent: textbox (2nd Superior Stop)][AltContent: arrow][AltContent: textbox (1st Superior Stop)]
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Concerning claim 19, wherein the first material comprises a metal and the second material comprises a polymer (see par. 0061).
It is noted that independent claims 1 and 18 are not claiming that the superior insert is formed as a separate structure and thereafter attached to the superior base. In fact, par. 0081 of the specification broadly states that “The articulating component 106a, 106b may be coupled to the base 110a, 110b as a multi-piece assembly. Coupling may include adhesives, screws, quick release mechanisms, compression or friction coupling, ultrasonic welding, insert molding, compression molding and/or over molding. Alternatively, the articulating component 106a, 106b may be fixed with the base 110a, 110b as a one-piece component.” However, for purposes of examination the examiner will interpret claims 1 and 18 as reciting separate components.
Under the separate component interpretation, Carls et al. does not explicitly disclose that the superior base is a separate component from the superior insert. Carls et al. does disclose that the prosthetic system may be formed of any suitable biocompatible material including metals such as cobalt chrome (see par. 0061), and polymer materials such as UHMWPE. Carls et al. goes on to disclose that the various components comprising the prosthetic system may be formed of different materials thus permitting metal on polymer constructions.
Additionally, Carls et al. do not explicitly disclose that the first coated portion comprises a different coating than a second coating of the second coated portion.
Coppes et al. disclose an articulating insert (see Fig. 3) comprising a polymer (see par. 0101) which is attached to a metal endplate in the same field of endeavor for the purpose of “permitting a surgeon to have several different options for the materials of the articulating surface.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Carls’ system by incorporating an upper articulating insert made of UHMWPE, the concept of which is taught by Coppes et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Furthermore, Carls et al. discloses the concept of using different materials to form the various components comprising the prosthetic system permitting metal on polymer constructions. Accordingly, 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 articulating insert from UHMWPE 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.
Trieu discloses a spinal implant load-bearing component having at least one soft tissue-facing surface with a coating (see col. 17, lines 5-12) that reduces friction, tissue irritation, and inflammation. This coating is functionally and compositionally distinct from the bone-ingrowth-promoting coatings (e.g., titanium or hydroxyapatite) applied to bone-contacting surfaces of the same implant. Trieu thus explicitly teaches applying different coatings to different regions of a single spinal implant based on the functional requirements of each surface.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply different coatings to the first and second coated portions of Carls’ implant system, as taught by Trieu, since it is a well-known and routine practice in the spinal implant art to tailor coatings to the functional demands of each surface region of an implant.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claims 1 and 2 above, in view of Rufner et al. (U.S. 2011/0028600 A1).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the polymer comprises an antioxidant stabilized and cross-linked ultra-high weight molecular polyethylene (UHWMPE), or the incorporation of vitamin E into the UHMWPE.
Rufner et al. teach the use of an antioxidant stabilized and cross-linked ultra-high weight molecular polyethylene in the same field of endeavor for the purpose of decreasing wear rate of prosthetic articulating components.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an antioxidant stabilized and cross-linked ultra-high weight molecular polyethylene for the articulating components of Carls’ implant, as taught by Rufner 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. Furthermore, it is well established in the art that “incorporating vitamin E into UHMWPE can enhance its mechanical properties, particularly its fatigue strength, ultimate tensile strength, and fatigue toughness” (publication listed in U.S. Patent No. 6,800,670 B2).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claims 1 and 2 above, in view of Coates et al. (U.S. 2004/0068318 A1).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above (see pars. 0061 and 0062). However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the metal comprises cobalt chrome molybdenum (CoCrMo), or that the first material and the third material comprise cobalt chrome molybdenum (CoCrMo).
Coates et al. disclose the use of CoCrMo for spinal baseplates (see par. 0017) 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 use a metal that comprises cobalt chrome molybdenum (CoCrMo), the concept of which is disclosed by Coates et al., and to use the same material for the first and third material 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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claim 1 above, in view of von Recum et al. (U.S. 4,871,366).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the first coated portion comprises a titanium (Ti) coated portion.
Von Recum et al. disclose titanium coating in the same field of endeavor in order to promote tissue adhesion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use titanium to coat the first portion of Carls’ implant system, the concept of which is disclosed by von Recum 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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claim 1 above, in view of Homsy (U.S. 3,971,670).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the superior insert is pressure molded into a recess in the superior base.
Homsy teaches the method of pressure molding (see col. 3, lines 60-65) to form implants 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 pressure mold the superior insert into a recess in the superior base, the concept of which is disclosed by Homsy, in order to secure two separate implant components together.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2)
Carls et al. in view of Coppes et al. disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. do not explicitly disclose that the inferior articulation component includes a centroid region having a minimum polymer height of at least 3 mm or greater.
It would have been an obvious matter of design choice to form the inferior articulation component centroid region having a minimum polymer height of at least 3 mm or greater, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claim 1 above, further in view of Sherman et al. (U.S. 2005/0085814 A1).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the superior insert is over-molded over the downwardly extending flanged portion.
Sherman et al. teach a spinal implant including separate components that are over molded (see par. 0048) to each other for connection purposes.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to over mold the superior insert over the downwardly extending flanged portion, the concept of which is disclosed by Sherman et al., in order to secure two separate implant components together.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) and Trieu (U.S. 8,100,971 B2) as applied to claims 18 and 19 above, in view of Coates et al. (U.S. 2004/0068318 A1) and Rufner et al. (U.S. 2011/0028600 A1).
Carls et al. in view of Coppes et al. and Trieu disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. and Trieu do not explicitly disclose that the polymer comprises a double cross- linked ultra-high weight molecular polyethylene (UHWMPE) and Vitamin E and the metal comprises cobalt chrome molybdenum (CoCrMo).
Coates et al. disclose the use of CoCrMo for spinal baseplates (see par. 0017), and Rufner et al. teach the use of an antioxidant stabilized and cross-linked ultra-high weight molecular polyethylene in the same field of endeavor for the purpose of decreasing wear rate of prosthetic articulating components.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a metal that comprises cobalt chrome molybdenum (CoCrMo), the concept of which is disclosed by Coates et al., and to use an antioxidant stabilized and cross-linked ultra-high weight molecular polyethylene for the articulating components of Carls’ implant, as taught by Rufner 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. Furthermore, it is well established in the art that “incorporating vitamin E into UHMWPE can enhance its mechanical properties, particularly its fatigue strength, ultimate tensile strength, and fatigue toughness” (publication listed in U.S. Patent No. 6,800,670 B2).
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive. Applicant argues that the amended limitation requiring the first coated portion to comprise a different coating than the second coated portion is not disclosed or suggested by the cited art. Applicant’s argument is not convincing because it attacks the references individually rather than addressing the combined teachings of the prior art.
Furthermore, Applicant’s argument is rebutted by the prior art of record and newly cited art. It is well-established in the spinal implant art that different coatings are intentionally applied to different portions of an implant depending on their functional role. Specifically, Trieu (U.S. 8,100,971 B2) expressly discloses a spinal implant load-bearing component having at least one soft tissue-facing surface with a coating (see col. 17, lines 5-12) that reduces friction, tissue irritation, and inflammation. This coating is functionally and compositionally distinct from the bone-ingrowth-promoting coatings (e.g., titanium or hydroxyapatite) applied to bone-contacting surfaces of the same implant. Trieu thus explicitly teaches applying different coatings to different regions of a single spinal implant based on the functional requirements of each surface.
Additionally, von Recum et al. (U.S. 4,871,366), already of record, discloses titanium coating applied to promote tissue adhesion on bone-contacting surfaces. This coating is distinct from other surface treatments applied elsewhere on an implant. Carls et al. broadly disclose that the various components of the prosthetic system may comprise different materials (par. 0061), and Coates et al. disclose the use of CoCrMo for spinal baseplates.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply different coatings to the first and second coated portions of Carls’ implant system, as taught by Trieu and von Recum, since it is a well-known and routine practice in the spinal implant art to tailor coatings to the functional demands of each surface region of an implant.
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
Prosecution Insights