DETAILED ACTION
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.
Claims 1, 3-5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2011/0190888 (Bertele) in view of U.S. Patent Application Publication No. 2013/0138223 (Mawatari) and U.S. Patent Application Publication No. 2016/0296343 (Bost).
Regarding claim 1, Bertele discloses a method of manufacturing a spinal implant, the method comprising: forming a coating film (hydroxyapatite coating, see paragraphs [0010], [0068], [0087], [0105], and [0110]-[0113]) partially on a base (300), the coating film comprising a calcium phosphate-based material (hydroxyapatite).
Further regarding claim 1, Bertele fails to disclose the coating film comprising an antimicrobial agent. However, Mawatari discloses that bioimplants for treating bones or bone joints comprise a base and a hydroxyapatite coating, the coating further including a silver component to act as an antimicrobial agent (see paragraphs [0015]-[0022]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to add an antimicrobial agent as suggested by Mawatari to the coating film of Bertele in order to prevent microbes from infecting adjacent bone (see Mawatari, paragraphs [0003] and [0004]).
Further regarding claim 1, Bertele discloses forming an engagement portion (308C) configured to engage with an engagement tool (see paragraph [0089]) in a base before forming the coating film (see paragraph [0113]; forming of implant core features can occur before forming the coating film). Bertele is silent regarding wherein the engagement portion includes a locking mechanism comprising a recessed portion or a protruding portion configured to lock the engagement tool and the base; and forming the coating film partially on the base except at the engagement portion. However, Bertele discloses that the coating film should be formed at bone interface sides of the implant (see paragraphs [0112] and [0113]), and engagement portion 308C is not a bone interface side of the implant (engagement portion 308C engages with an insertion tool, not bone; see paragraph [0089]). Additionally, Bost discloses a method of manufacturing a spinal implant (10), wherein an engagement portion (36/42/34) of the implant is configured to engage with an engagement tool (100), wherein the engagement portion includes a locking mechanism (central screw hole 36 or opening 42) comprises a recessed portion or protruding portion (threaded opening, see paragraph [0056]) to lock the engagement tool and the implant (see paragraph [0056]), and wherein the coating film is formed on the implant except at the engagement portion (see paragraph [0043]). Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method such that the coating film is formed with the engagement portion excepted, as Bertele suggests forming the coating film only on bone interface sides of the implant, and the engagement portion interfaces with an insertion tool, not bone (see Bertele, paragraphs [0089], [0112], and [0113]), and Bost further suggests that tool engagement portions of the implant should be excepted from placement of bone growth enhancing coating, as these areas don’t need added bone purchase (see Bost, paragraph [0043]).
Regarding claim 3, Bertele fails to disclose forming a screw hole in the base. However, Bost discloses a spinal implant (10) wherein a base surface (22) of the implant is formed with a screw hole (36). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form a screw hole as suggested by Bost in order to facilitate threaded locking of a tool to the implant (see Bost, paragraph [0056]), and because such a modification merely involves substituting one known engagement portion (screw hole of Bost) for engaging with an engagement tool for another known engagement portion (recess 308C of Bertele) for engaging with an engagement tool without any unpredictable results. Further, it would be obvious to form the screw hole before forming the coating film as Bertele suggests forming implant core feature before forming the coating film (see paragraph [0113]).
Further regarding claim 3, Bertele fails to explicitly disclose the coating film is formed on the base except for at the screw hole. However, Bertele discloses that the coating film should be formed at bone interface sides of the implant (see paragraphs [0112] and [0113] of Bertele), and Bost suggests wherein a coating film is formed on the implant except at the screw hole (see paragraph [0043]). Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method such that the coating film is formed with the screw hole excepted, as Bertele suggests forming the coating film only on bone interface sides of the implant, and the engagement portion interfaces with an insertion tool, not bone (see Bertele, paragraphs [0089], [0112], and [0113]), and Bost further suggests that tool engagement screw hole of the implant should be excepted from placement of bone growth enhancing coating, as these areas don’t need added bone purchase (see Bost, paragraph [0043]).
Regarding claim 4, Bertele discloses further comprising forming a rough surface (313) on at least a part of a surface of the base (see paragraph [0111]) before forming the coating film (see paragraph [0113]; coating can occur after forming of endplate features).
Regarding claim 5, Bertele discloses wherein in the forming of the coating film, the coating film is formed to cover at least a part of the rough surface (see paragraphs [0010], [0068], [0087], [0105], and [0110]-[0113]).
Regarding claim 8, Bertele discloses wherein in the forming of the coating film, the coating film of a first region has a film thickness, and the coating film of a second region has a film thickness smaller than the film thickness of the first region (see paragraph [0087], [0105], and [0140]; the depth of the coating may vary). Thus, a region of the endplates 302 or 306 may have a smaller film thickness than another region of the endplates 302 or 306.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari and Bost, and further in view of U.S. Patent Application Publication No. 2016/0058571 (McLaughlin).
Regarding claim 6, Bertele is silent regarding in the forming of the rough surface, the rough surface is formed by at least one of thermal spraying and blasting. However, McLaughlin discloses a method of forming an intervertebral implant where forming a rough surface on the implant is done by blasting (see McLaughlin, paragraph [0109]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form the rough surface by blasting in order to help provide enhanced surfaces for bone growth (see McLaughlin, paragraph [0109]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari and Bost, and further in view of U.S. Patent Application Publication No. 2016/0022430 (Wickham).
Regarding claim 7, Bertele is silent regarding the forming of the rough surface comprising forming the rough surface by an additive manufacturing method. However, Wickham discloses a method of forming an intervertebral implant where forming a rough surface on the implant is done by an additive manufacturing method (see Wickham, paragraph [0019]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form the rough surface by an additive manufacturing method as Wickham suggests such a method efficiently forms a roughened surface on an implant (see Wickham, paragraph [0019]), and because such a modification merely involves substituting one known method for forming a rough surface on an implant for another known method for forming a rough surface on an implant without any unpredictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari.
Regarding claim 9, Bertele discloses a method of manufacturing a spinal implant, the method comprising: preparing a base (300) (see paragraphs [0110]-[0113]); forming a coating film (hydroxyapatite coating, see paragraphs [0010], [0068], [0087], [0105], and [0110]-[0113]) on the base (300), the coating film comprising a calcium phosphate-based material (hydroxyapatite).
Further regarding claim 9, Bertele discloses wherein the coating film comprises a first region having a film thickness and a second region having a smaller film thickness than the film thickness of the first region (see paragraph [0087], [0105], and [0140]; the depth of the coating may vary). Thus, a region of the endplates 302 or 306 may have a smaller film thickness than another region of the endplates 302 or 306.
Further regarding claim 9, Bertele fails to disclose the coating film comprising an antimicrobial agent. However, Mawatari discloses that bioimplants for treating bones or bone joints comprise a base and a hydroxyapatite coating, the coating further including a silver component to act as an antimicrobial agent (see paragraphs [0015]-[0022]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to add an antimicrobial agent as suggested by Mawatari to the coating film of Bertele in order to prevent microbes from infecting adjacent bone (see Mawatari, paragraphs [0003] and [0004]).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari, Bost, and U.S. Patent Application Publication No. 2009/0118831 (Trieu).
Regarding claim 10, Bertele discloses a method of manufacturing a spinal implant, the method comprising: forming a coating film (hydroxyapatite coating, see paragraphs [0010], [0068], [0087], [0105], and [0110]-[0113]) partially on a base (300), the coating film comprising a calcium phosphate-based material (hydroxyapatite).
Further regarding claim 10, Bertele fails to disclose the coating film comprising an antimicrobial agent. However, Mawatari discloses that bioimplants for treating bones or bone joints comprise a base and a hydroxyapatite coating, the coating further including a silver component to act as an antimicrobial agent (see paragraphs [0015]-[0022]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to add an antimicrobial agent as suggested by Mawatari to the coating film of Bertele in order to prevent microbes from infecting adjacent bone (see Mawatari, paragraphs [0003] and [0004]).
Further regarding claim 10 and regarding claim 11, Bertele discloses forming an engagement portion (308C) configured to engage with an engagement tool (see paragraph [0089]) in a base before forming the coating film (see paragraph [0113]; forming of implant core features can occur before forming the coating film). Bertele is silent regarding wherein the engagement portion is a screw hole; and forming the coating film on the base except at the screw hole. However, Bertele discloses that the coating film should be formed at bone interface sides of the implant (see paragraphs [0112] and [0113]), and engagement portion 308C is not a bone interface side of the implant (engagement portion 308C engages with an insertion tool, not bone; see paragraph [0089]). Additionally, Bost discloses a method of manufacturing a spinal implant (10), wherein a screw hole (36 or 42) of the implant is configured to engage with an engagement tool (100) (threaded opening, see paragraph [0056]), and wherein the coating film is formed on the implant except at the screw hole (see paragraph [0043]). Regarding claim 11, Bost suggests further comprising forming an engagement portion (34) other than the screw hole in the implant, and in the forming of the coating film, the coating film is formed except for at the engagement portion (see paragraph [0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form a screw hole with engagement portions as suggested by Bost in order to facilitate threaded locking of a tool to the implant (see Bost, paragraph [0056]), and because such a modification merely involves substituting one known engagement portion (screw hole + engagement grooves of Bost) for engaging with an engagement tool for another known engagement portion (recess 308C of Bertele) for engaging with an engagement tool without any unpredictable results. Further, it would be obvious to form the screw hole and engagement portion grooves before forming the coating film as Bertele suggests forming implant core feature before forming the coating film (see paragraph [0113]). Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method such that the coating film is formed with screw hole excepted, as Bertele suggests forming the coating film only on bone interface sides of the implant, and the engagement portion interfaces with an insertion tool, not bone (see Bertele, paragraphs [0089], [0112], and [0113]), and Bost further suggests that tool engagement portions such as screw holes of the implant should be excepted from placement of bone growth enhancing coating, as these areas don’t need added bone purchase (see Bost, paragraph [0043]).
Further regarding claim 10, Bost is silent regarding the method comprising wherein forming the coating film in a state in which a screw for the forming of the coating film is inserted in the screw hole, and then removing the screw to such that the coating film is excepted from the screw hole. However Trieu discloses a method of applying a coating to a spinal implant in which apertures in the spinal implant can be plugged during application of the coating in order to avoid applying the coating to the apertures, followed by removal of the plug (see Trieu, paragraph [0044]). It would have been prima facie obvious to modify the method of Bertelle in view of Mawatari and Bost to use a screw as a plug to block the screw hole during application of a coating, followed by removal of the screw plug as Trieu suggests such a plugging mechanism as one of many mechanisms for applying a coating to a spinal implant with apertures of the spinal implant excepted (see Trieu, paragraph [0044]).
Regarding claim 12, Bertele discloses further comprising forming a rough surface (313) on at least a part of a surface of the base (see paragraph [0111]) before forming the coating film (see paragraph [0113]; coating can occur after forming of endplate features).
Regarding claim 13, Bertele discloses wherein in the forming of the coating film, the coating film is formed to cover at least a part of the rough surface (see paragraphs [0010], [0068], [0087], [0105], and [0110]-[0113]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari, Bost, and Trieu, and further in view of McLaughlin.
Regarding claim 14, Bertele is silent regarding in the forming of the rough surface, the rough surface is formed by at least one of thermal spraying and blasting. However, McLaughlin discloses a method of forming an intervertebral implant where forming a rough surface on the implant is done by blasting (see McLaughlin, paragraph [0109]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form the rough surface by blasting in order to help provide enhanced surfaces for bone growth (see McLaughlin, paragraph [0109]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari, Bost, and Trieu, and further in view of Wickham.
Regarding claim 15, Bertele is silent regarding the forming of the rough surface comprising forming the rough surface by an additive manufacturing method. However, Wickham discloses a method of forming an intervertebral implant where forming a rough surface on the implant is done by an additive manufacturing method (see Wickham, paragraph [0019]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Bertele to form the rough surface by an additive manufacturing method as Wickham suggests such a method efficiently forms a roughened surface on an implant (see Wickham, paragraph [0019]), and because such a modification merely involves substituting one known method for forming a rough surface on an implant for another known method for forming a rough surface on an implant without any unpredictable results.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bertele in view of Mawatari, Bost, and Trieu, and further in view of U.S. Patent Application Publication No. 2006/0282166 (Molz).
Regarding claim 16, Bertele discloses wherein the coating film comprises a first region having a film thickness and a second region having a film thickness smaller than the film thickness of the first region (see paragraph [0087], [0105], and [0140]; the depth of the coating may vary). Thus, a region of the endplates 302 or 306 may have a smaller film thickness than another region of the endplates 302 or 306. Alternatively, Molz discloses a spinal implant (400) in which a bone-growth promoting coating (440, see paragraph [0002] and [0055]) has a variable thickness (444 and 442) in different regions of the same implant (see paragraph [0093]), and it would be obvious to modify the method of Bertele to have different regions of the implant have different coating film thicknesses in order to provide added support to parts of the implant that experience higher load bearing and stress (see Molz, paragraph [0093]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new ground of rejection.
Applicant's arguments with respect to claim 9 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 of the Remarks that Bertele fails to suggest different regions of the implant having different thicknesses of the coating.
First, Applicant argues paragraph [0140] of Bertele only suggests that the overall depth/placement of the coating can be selected for an intended implant site (cervical, thoracic, or lumbar, e.g.), and that it does not suggest regional thickness variation on the same implant. The examiner notes that Applicant does not address paragraph [0087], which states depth of the coating may be varied to achieve on-growth, in-growth efficiency, with no indication to this describing the coating being varied on different implants rather than regions of the same implant.
Further, Applicant does not provide evidence that one of ordinary skill in the art would understand paragraph [0140] of Bertele to only refer to an overall depth and placement of the coating among various spinal implants. In response, the examiner provides evidence that one of ordinary skill in the art would have understood paragraph [0140] of Bertele to refer to regional depth variations of the coating on the same implant. U.S. Patent Application Publication No. 2006/0282166 (Molz) discloses a spinal implant (400) in which a bone-growth promoting coating (440, see paragraph [0002] and [0055]) has a variable thickness (444 and 442) in different regions of the same implant to provide added support to parts of the implant that experience higher load bearing and stress (see paragraph [0093]). Thus, one of ordinary skill in the art would have understood Bertele to be referring to variable coating depth on regions of the same implant, not overall coating depths on the same implant.
Second, Applicant argues on page 6 of the Remarks that Mawatari is silent regarding any thickness variation of the coating film; however, the Examiner does not rely on Mawatari for suggesting this feature of the claim.
Third, Applicant argues on page 7 of the Remarks that Bertele and Mawatari do not recognize the advantage of the needing to reduce the amount of expensive antimicrobial agent, and thus, it would not be obvious to have regional differences in the coating on the implant. Nevertheless, the fact that there may be additional benefits (such as reducing the antimicrobial agent used) not recognized by the prior art is irrelevant to whether the prior art discloses or suggests the claimed features.
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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m. 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 on 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.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
