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 .
Status of the Claims
This Office Action is responsive to the amendment filed October 29, 2025. As directed by the amendment: Claims 1, 4, 5, 9, 12, 13, 17, and 19 have been amended. Claims 2, 3, 16, and 21 have been cancelled. Claim 20 was withdrawn. Claims 1, 4-15, and 17-20 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1, 4, 5, 12-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess (WO 2017/029476 A1).
Regarding claim 1, Burgess discloses a device comprising a compression moulded body portion (104) (page 13, ll. 7-9 and figures 6a, 6b) comprising layers of composite material (page 3, ll. 17-28) comprising reinforcement fibres (page 3, ll. 17-28, page 6, ll. 1-6) and polyaryletherketone (page 3, ll. 30-31), wherein at least one layer (120+122) of composite material (page 3, ll. 17-28) has a first region (120) and a second region (122).
Yet, Burgess lacks wherein the polyaryletherketone (PAEK) content in the first region is higher than the polyaryletherketone content of the second region.
However, Burgess teaches the composite material suitably includes at least 30 vol%, more preferably at least 40 vol%, especially at least 50vol% of the polymeric material. Said composite material may include up to 70vol%, up to 65vol%, up to 50vol% of carbon fibres. Said composite material may include to 50vol% of said polymeric material and 40 to 65vol% of carbon fibre.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burgess’s device with the polyaryletherketone (PAEK) content in the first region is higher than the polyaryletherketone content of the second region, since it would be obvious to try by one of ordinary skill in the art as there are finite number of identified, predictable solutions with a reasonable expectation of success. Furthermore, one of ordinary skill in the art would consider to optimize the material composition to arrive at an implant with optimal properties for the intended use.
Thus, the modified Burgess’s device has wherein the reinforcement fibres of the second region (the modified Burgess’s second region) form continuous filaments (e.g. continuous carbon fibres) that extend in substantially the same direction (figures 6a, 6b), and wherein these continuous filaments (e.g. continuous carbon fibres) are interrupted in the first region (the modified Burgess’s first region) to provide the first region (the modified Burgess’s first region) with the higher PAEK content.
Regarding claim 4, the modified Burgess’s device discloses all the features/elements as claimed but lacks wherein a volume ratio of reinforcement fibres to PAEK in the second region is 0.5-2:1.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Burgess’s device with wherein a volume ratio of reinforcement fibres to PAEK in the second region is 0.5-2:1, since it is known that discovering optimum or workable ranges involves routine experimentation in the art.
Regarding claim 5, the modified Burgess’s device has wherein the first region (the modified Burgess’s first region) is substantially free from reinforcement fibres (due to having a higher PAEK).
Regarding claim 12, the modified Burgess’s device has wherein the at least one layer (120+122) of composite material (page 3, ll. 17-28) that has the first region (the modified Burgess’s first region) and the second region (the modified Burgess’s second region) forms an outer layer of the compression moulded body portion (104) (figures 6a, 6b).
Regarding claim 13, the modified Burgess’s device has wherein the polyaryl ether ketone is polyether ether ketone (PEEK) (page 4, ll. 17-20) and wherein the reinforcement fibres are carbon fibres (page 6, ll. 1-6).
Regarding claim 14, the modified Burgess’s device has which is an implantable medical device (page 7, ll. 26-28).
Regarding claim 15, the modified Burgess’s device has which is a bone plate (page 7, ll. 26-28).
Regarding claim 17, the modified Burgess’s device has wherein the compression moulded body portion (104) comprises layers of composite material (page 3, ll. 17-28) comprising reinforcement fibres that form continuous filaments (e.g. continuous carbon fibres), the continuous filaments being interrupted in an outer layer (figure 6b) of the compression moulded body (104) to provide the outer layer (figure 6b) with a first region having a higher PAEK content.
Regarding claim 18, Burgess discloses wherein the continuous filaments in one layer (figure 5) are positioned at an angle (page 11, ll. 24-29) to the continuous filaments in an adjacent layer (figure 5).
Regarding claim 19, Burgess discloses wherein the continuous filaments in the outer layer are positioned substantially at right angles (page 11, ll. 24-29 and figure 5) to the continuous filaments of an underlying layer (page 11, ll. 24-29 and figure 5).
Claim(s) 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess as applied to claim 1 above, and further in view of Turner et al. (US 4,662,887), herein referred to as Turner.
Regarding claims 6, 7, the modified Burgess’s device discloses all the features/elements as claimed but lacks a detailed description on wherein the compression moulded body portion comprises an aperture, wherein the aperture is a screw hole. However, Burgess discloses the implantable medical device is a trauma plate for fracture fixation (page 7, ll. 26-28).
Furthermore, Turner teaches a compression moulded endoprosthetic (Abstract and claim 11) and other devices such as bone plates (figures 3 and 4) comprising an aperture (figures 4-6), wherein the aperture is a screw hole (figures 4-6).
Therefore, 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 modified Burgess’s device with the compression moulded body portion comprises an aperture, wherein the aperture is a screw hole as taught by Turner, since such a modification would allow the user to place screws to fix the medical device.
Regarding claim 8, the modified Burgess’s device has herein the first region (the modified Burgess’s first region) is adjacent to the aperture (the modified Burgess’s device having an aperture).
Regarding claim 9, the modified Burgess’s device has wherein the first region (the modified Burgess’s first region) defines at least part of a wall of the aperture (the modified Burgess’s device having an aperture).
Regarding claim 10, the modified Burgess’s device has wherein the first region (the modified Burgess’s first region) extends from the aperture (the modified Burgess’s device having an aperture) to an outer edge of the compression moulded body portion (104 of Burgess).
Regarding claim 11, the modified Burgess’s device has which comprises at least two apertures (the modified Burgess’s device having apertures) and wherein the first region (the modified Burgess’s first region) extends between the two apertures (the modified Burgess’s device having apertures).
Response to Arguments
Applicant's arguments filed October 29, 2025 have been fully considered. Applicant’s arguments with respect to the reference Ainsworth has 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.
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/SI MING KU/Primary Examiner, Art Unit 3775