DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions
Claim Objections
Claim 22 is objected to because of the following informalities: As amended claim 22 ends “(PEEK),.” The comma should be canceled from the claim. Appropriate correction is required.
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 16-34 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. In claims 16, 21 and 29 the claims have been amended such that the “an external layer comprising titanium is bonded to entireties of external surfaces of the body” there is not support for all of the external surfaces to have titanium only the bearing surfaces as disclosed in paragraph 417, 476 or 482.
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 16-29 and 31-35 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Garcia et al. (US Pub 2003/0135275).
With respect to claim 16, Garcia discloses an implant comprising: a body (FIG 1, 40) comprising polyether ether ketone (PEEK) (PARAGRAPH 73), the body having external surfaces (fig 1); an external layer comprising titanium (paragraph 71, outer surfaces have a “titanium plasma spray coating”), wherein the external layer is bonded to entireties of the external surfaces of the body (paragraph 71); and an interface layer between the external surfaces of the body and the external layer, wherein the interface layer is formed during bonding of the external layer to the entireties of external surfaces of the body when the coating is plasma sprayed on the boundary between the PEEK and the titanium from an interface layer). With respect to claim 17, Garcia discloses wherein the implant is at least a component of a knee, hip, ankle, and or shoulder implant (abstract). With respect to claim 18, Garcia discloses wherein the implant is a spinal implant (abstract). With respect to claim 19, Garcia discloses wherein further comprising at least one passage (for fastener 44 or fig 6, 60) through the spinal implant defines at least one cavity. With respect to claim 20, Garcia discloses wherein the external layer is at least one of textured (paragraph 71), porous, and configured for ingrowth of tissue, or combinations thereof.
With respect to claim 16, Garcia discloses an implant comprising: a body comprising a polymeric material (paragraph 73, PEEK) , the body having external surfaces (paragraph 71); an external layer (paragraph 71) comprising a metallic material bonded to entireties of the external surfaces of the body (paragraph 71 titanium plasma spray coating) ; and an interface layer (interface where the titanium is sprayed on) between the external surfaces of the body and the external layer, wherein the interface layer is formed during bonding of the external layer to the entireties of external surfaces of the body. With respect to claim 22, Garcia discloses wherein the polymeric material is at least one of ,polysulfone, or polyether ether ketone (PEEK) (paragraph 73). With respect to claim 23, Garcia discloses wherein the external layer comprises titanium (paragraph 71). With respect to claim 24, Garcia discloses wherein the external layer comprises at least one of foam metal, foam titanium, and tantalum, or combinations thereof (paragraph 76 can include a tantalum wire). With respect to claim 25, Garcia discloses wherein the implant is at least a component of a knee implant, a hip implant, an ankle implant, and or a shoulder implant (abstract). With respect to claim 26, Garcia discloses wherein the implant is a spinal implant (abstract). With respect to claim 27, Garcia discloses wherein further comprising at least one passage (fig 6, 60) through the spinal implant defines at least one cavity. With respect to claim 18, Garcia discloses wherein the external layer is at least one of textured, porous, and configured for ingrowth, or combinations thereof (paragraph 71, textured).
With respect to claim 29, Garcia discloses method of making the implant set forth in claim 21,the method comprising: bonding the external layer (paragraph 71, plasma sprayed titanium) to the entireties of the external surfaces of the body with energy to form the interface layer between the body and the external layer (paragraph 71). With respect to claim 31, Garcia discloses wherein the implant is at least a component of a knee implant, a hip implant, an ankle implant, and or a shoulder implant (abstract). With respect to claim 32, Garcia discloses wherein the implant is a spinal implant (abstract). With respect to claim 33, Garcia discloses wherein further comprising at least one passage (fig 6, 60) through the spinal implant defines at least one cavity. With respect to claim 34, Garcia discloses wherein the external layer is at least one of textured, porous, and configured for ingrowth, or a combination thereof (paragraph 71).
With respect to claim 35, Garcia discloses an implant comprising: a body (fig 6, 40) comprising polyether ether ketone (PEEK) (paragraph 73), the body having multiple external surfaces; a nano-metallic layer ( Paragraph 71, plasma sprayed titanium) comprising titanium bonded to the multiple external surfaces of the body; and an interface layer (where the titanium meets the PEEK body) between the multiple external surfaces of the body and the nano-metallic layer, wherein the interface layer is formed during bonding of the nano-metallic layer to the multiple external surfaces of the body (plasma spraying).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garcia et al (US Pub 2003/0135275) in view of Cardinal (US Patent 4,601,893).
Garcia discloses the claimed invention except for the bonding being performed under vacuum.
Cardinal discloses bonding being performed under vacuum (col. 21, ll. 57) to remove air bubbles (col. 21, ll. 58).
It would have been obvious at the time of the invention to one of ordinary skill in the art to modify the method of Garcia for the bonding to be performed under vacuum in view of Cardinal in order to remove air bubbles.
Response to Arguments
Applicant’s arguments, see remarks, filed 9/2/2025, with respect to the U.S.C. 112 rejection of claims 29-34 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 29-34 has been withdrawn.
Applicant’s arguments with respect to claim(s) 16-35 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6610095 B1 discloses an implant with a PEEK body and an external titanium coating
US 5509933 A discloses an implant with a PEEK body and an external titanium coating
US 5571190 A discloses an implant with porous metal foam
US 5545227 A discloses an implant with a PEEK body and an external titanium coating
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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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