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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 27, 2025 has been entered.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note that claim 15 is identical in scope to claim 1 because claim 15 only comprises the rod of claim 1. The phrase “is configured to be fixed to a spine” is merely an intended use recitation and does not import additional structure to differentiate claim 15 from claim 1.
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.
Claims 1, 3, 7, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (US 2011/0106162 A1) in view of Takebe et al. (US 2016/0303824 A1), and Orthobion GmbH (DE 10 2013 013 024 A1).
Claim 1. Ballard discloses a fixture rod comprising:
a core member (core 30) containing fibers (para. 0019 states that core 30 is carbon fiber reinforced PEEK); and
a reinforcing fiber layer (outer portion 40 – para. 0019 states that outer portion 40 is carbon fiber reinforced PEEK) provided on the core member,
the fibers of the core member comprise long fibers (para. 0019 states that core 30 includes continuous carbon fiber reinforced PEEK; note that it is understood that “continuous carbon fibers” are long carbon fibers) (Figs. 2A-2B; paras. 0017-0019).
Claim 3. Ballard discloses wherein the fibers of the core member are short fibers (para. 0019 states that core 30 includes short carbon fiber reinforced PEEK) (Figs. 2A-2B; paras. 0017-0019).
Claim 7. Ballard discloses wherein the fibers of the core member are carbon, glass, aramid, boron, or SiC (para. 0019 states that the fibers are carbon fibers) (Figs. 2A-2B; paras. 0017-0019).
Claim 14. Ballard discloses wherein the core member contains a resin, and the resin being any of epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK (para. 0019 states that core 30 is carbon fiber reinforced PEEK) (Figs. 2A-2B; paras. 0017-0019).
Ballard fails to disclose wherein one recess or a plurality of recesses are formed on an outer surface of the core member (claim 1), wherein a depth of the one recess or each of the plurality of recesses is in a range of 3 μm to 200 μm (claim 1), and wherein a portion of the long fibers each have an end portion that is exposed from a radially facing surface of the core member and have a part that is embedded in the reinforcing fiber layer (claim 1).
Takebe teaches a core member (core layer 28 – see Fig. 6) containing fibers (fibers 15-20 – see Fig. 3A) and a reinforcing fiber layer (skin layer 27 – see Fig. 6), wherein the fibers of the core member comprise fibers having an end portion exposed from the core member at locations where the core member contacts the reinforcing fiber layer (see Fig. 6), wherein the exposed end portion of the fibers is embedded in the reinforcing fiber layer (see Fig. 6), wherein the reinforcing fiber layer is located at a radially facing surface of the core member (see Fig. 6), and wherein the exposed end portion of the fibers is exposed from the radially facing surface of the core member (see Fig. 6) (Figs. 3A and 6).
Orthobion teaches that a core member (“core” – see para. 0022) contains a plurality of recesses (“irregularities” – see para. 0022) on the surface of the core member and that a reinforcing layer (“elastomeric material” – see para. 0022) fills the recesses to increase adhesion between the core member and the reinforcing layer (see para. 0022).
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 fixture rod of Ballard such that one recess or a plurality of recesses are formed on an outer surface of the core member (claim 1), as suggested by Orthobion, as such increases adhesion between the core member and the reinforcing layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for a depth of the one recess or each of the plurality of recesses is in a range of 3 μm to 200 μm (claim 1), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). As noted above, Orthobion states that the elastomeric material of the reinforcing layer fills the irregularities to increase adhesion between the core and the reinforcing layer. This is equivalent to the suppression of displacement between the core member and the reinforcing fiber layer stated by Applicant (see para. 0043). Thus, because both Orthobion and Applicant have the same purpose for the irregularities, it is clear that arriving at the range of 3 μm to 200 μm (claim 1) would merely require routine optimization and that doing so would have a reasonable expectation of success. 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 fixture rod of Ballard such that a portion of the long fibers each have an end portion that is exposed from a radially facing surface of the core member and have a part that is embedded in the reinforcing fiber layer (claim 1), as suggested by Takebe, as the surface irregularities created by the exposed fibers would provide for better adhesion between the reinforcing fiber layer and the core member.
Claim 15. Ballard, Takebe, and Orthobion teach a spinal fixture that is configured to be fixed to a spine and comprises the fixture rod according to claim 1 (see the rejection of claim 1 above) (Figs. 1-2B; paras. 0015-0019).
Claim 16. Ballard, Takebe, and Orthobion teach a screw (anchor 22 – para. 0016 states that anchor 22 is a threaded screw-like member) (Figs. 1-2B; paras. 0015-0019 of Ballard).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (US 2011/0106162 A1) in view of Takebe et al. (US 2016/0303824 A1), and Orthobion GmbH (DE 10 2013 013 024 A1) as applied to claim 1 above, and further in view of and Hudgins et al. (US 2009/0112265 A1).
Ballard, Takebe, and Orthobion fail to teach wherein the fibers of the core member further comprise fibers whose end portion are exposed from a longitudinally facing surface of the core member (claim 5).
However, as stated above with respect to claim 1, Takebe teaches that the fibers (fibers 15-20 – see Fig. 3A) of the core member (core layer 28 – see Fig. 6) comprise fibers having an end portion exposed from the core member at locations where the core member contacts the reinforcing fiber layer (skin layer 27 – see Fig. 6) and the exposed end portion of the fibers is embedded in the reinforcing fiber layer (see Fig. 6) (see Fig. 6) (Figs. 3A and 6).
Hudgins teaches that a core member (elastomeric members 26 and 32) is enclosed by a reinforcing layer (cover 68) such that the reinforcing layer is located at both a radially facing surface and a longitudinally facing surface (surface adjacent ends 38 and 40) of the core member (Fig. 15; para. 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the fixture rod of Ballard such that the reinforcing fiber layer encloses the core member such that the reinforcing fiber layer is located at both a radially facing surface and a longitudinally facing surface of the core member, as suggested by Hudgins, as such a reinforcing layer would protect the core member from damage due to contact with other mechanical components or tissue of the patient. In view of such a modification, and because Takebe teaches that the fibers of the core member comprise fibers having an end portion exposed from the core member at locations where the core member contacts the reinforcing fiber layer and the exposed end portion of the fibers is embedded in the reinforcing fiber layer, it would have been obvious to one of ordinary skill in the art for the fibers of the core member to further comprise fibers whose end portion are exposed from a longitudinally facing surface of the core member (claim 5).
Claims 9-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (US 2011/0106162 A1) in view of Takebe et al. (US 2016/0303824 A1), and Orthobion GmbH (DE 10 2013 013 024 A1) as applied to claim 1 above, and further in view of Berry et al. (US 2006/0276788 A1).
Claim 12. Orthobion teaches that the core member (“core” – see para. 0022) comprises the plurality of recesses (“irregularities” – see para. 0022) (see also the rejection of claim 1 above).
Ballard, Takebe, and Orthobion fail to teach wherein the one recess or the plurality of recess are elongate and have a longest dimension that extends in a circumferential direction of the core member (claim 9), wherein the one recess or the plurality of recess are elongate and have a longest dimension that extends in an axial direction of the core member (claim 10), wherein the one recess or the plurality of recess are elongate and have a longest dimension that extends in a direction inclined with respect to a circumferential direction of the core member (claim 11), wherein each of the plurality of recesses is elongate and two or more recesses of the plurality of recesses have a longest dimension that extends in different directions (claim 12), and wherein the one recess or each of the plurality of recesses are elongate (claim 17).
Berry teaches a fixture rod (rod 12) comprising a plurality of recesses (porous construction 18 includes recesses as depicted by black dots in Fig. 1), wherein numerous recesses are elongate (see Fig. 1) having a longest dimension in a variety of different directions, including a circumferential direction, an axial direction, and a direction inclined with respect to the circumferential direction (see Fig. 1, which shows the black dots as irregular and elongated in multiple different directions) (Figs. 1-3; paras. 0036-0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the fixture rod of Ballard such that the one recess or the plurality of recess are elongate and have a longest dimension that extends in a circumferential direction of the core member (claim 9), the one recess or the plurality of recess are elongate and have a longest dimension that extends in an axial direction of the core member (claim 10), the one recess or the plurality of recess are elongate and have a longest dimension that extends in a direction inclined with respect to a circumferential direction of the core member (claim 11), each of the plurality of recesses is elongate and two or more recesses of the plurality of recesses have a longest dimension that extends in different directions (claim 12), and the one recess or each of the plurality of recesses are elongate (claim 17), as suggested by Berry, as having recesses elongated in a variety of directions provides for better overall strength of the fixture rod.
Response to Arguments
Applicant's arguments with respect to the objection to claim 15 have been fully considered but they are not persuasive. Applicant argues that claim 15 is not a duplicate of claim 1 because it would be understood that the fixture rod is a subcomponent of the fixture (see pg. 4). The Examiner disagrees. There is no indication in claim 15 that the spinal fixture includes other components as it only positively recites the fixture rod. Furthermore, as stated above, the phrase “is configured to be fixed to a spine” is merely an intended use recitation and does not import additional structure to differentiate claim 15 from claim 1. It is further noted that Applicant cites to paragraph 0022 of the specification to provide support for Applicant’s argument (see pg. 4). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments with respect to Zylber 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.
Applicant's arguments with respect to Orthobion have been fully considered but they are not persuasive. Applicant argues that Orthobion does not disclose the general conditions because Orthobion does not mention the depth of the irregularities (see pgs. 6-7). The Examiner disagrees. First of all, the Examiner relied upon rationale focused on routine optimization (see the rejection of claim 1 above referencing In re Boesch). Regarding routine optimization, MPEP 2144.05(II)(B) states that the Examiner must articulate rationale as to why it would have been routine optimization and why a person of ordinary skill in the art would have had a reasonable expectation of success. In the rejection, the Examiner noted that Orthobion states that the elastomeric material of the reinforcing layer fills the irregularities to increase adhesion between the core and the reinforcing layer. This is equivalent to the suppression of displacement between the core member and the reinforcing fiber layer stated by Applicant (see para. 0043). Thus, because both Orthobion and Applicant have the same purpose for the irregularities, it is clear that arriving at the claimed range would merely require routine optimization and that doing so would have a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773