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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Terminal Disclaimer
The terminal disclaimer filed on October 27, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent App. No. 18/027,818 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 13 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 13 is identical in scope to claim 1 because claim 13 only comprises the rod of claim 1. The phrase “configured to be fixed to a spine” is merely an intended use recitation and does not import additional structure to differentiate claim 13 from claim 1.
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.
Claim 6 is 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. Claim 6 recites that two or more recesses have a longest dimension that extends in different directions. Per Applicant’s disclosure, such a recitation appears to be directed to the embodiment shown in Fig. 6. However, in this embodiment, it is unclear whether each of the recesses have a longest dimension extending either in a circumferential direction of the core member or in an inclined direction relative to the circumferential direction as recited in amended claim 1. Thus, claim 6 contains new matter.
Claim 16 is 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. New claim 16 recites that the longest dimension of each recess extends around the entire circumference of the core member. Such a recitation constitutes new matter as the specification does not state that the longest dimension extends around the entire circumference. Furthermore, Figs. 3 and 5, which show recesses extending around the circumference, do not show the recesses extending around the entire circumference as these figures only show the view from one side of the core member, and it is therefore unknown what the recesses look like on the other side of the core member. Thus, claim 16 contains new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 3 recites “a longest dimension” (line 2). However, claim 1 has been amended to recite a longest dimension. Thus, it is unclear whether “a longest dimension” in claim 3 is intended to be the same longest dimension as recited in claim 1. For examination purposes, the Examiner is interpreting claim 3 as reciting “the longest dimension.”
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 3 recites “a circumferential direction” (line 3). However, claim 1 has been amended to recite a circumferential direction. Thus, it is unclear whether “a circumferential direction” in claim 3 is intended to be the same circumferential direction as recited in claim 1. For examination purposes, the Examiner is interpreting claim 3 as reciting “the circumferential direction.”
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 recites “a longest dimension” (line 2). However, claim 1 has been amended to recite a longest dimension. Thus, it is unclear whether “a longest dimension” in claim 5 is intended to be the same longest dimension as recited in claim 1. For examination purposes, the Examiner is interpreting claim 5 as reciting “the longest dimension.”
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 recites “a circumferential direction” (line 3). However, claim 1 has been amended to recite a circumferential direction. Thus, it is unclear whether “a circumferential direction” in claim 5 is intended to be the same circumferential direction as recited in claim 1. For examination purposes, the Examiner is interpreting claim 5 as reciting “the circumferential direction.”
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 6 recites “a longest dimension” (line 3). However, claim 1 has been amended to recite a longest dimension. Thus, it is unclear whether “a longest dimension” in claim 6 is intended to be the same longest dimension as recited in claim 1. For examination purposes, the Examiner is interpreting claim 6 as reciting “the longest dimension.”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (US 2011/0106162 A1) in view of Zylber et al. (US 2008/0234744 A1).
Claim 1. Ballard discloses a fixture rod comprising:
a core member (core 30) containing a resin (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,
wherein the resin of the core member and a resin of the reinforcing fiber layer are an identical resin (see above, which notes that para. 0019 states that core 30 and outer portion 40 are both carbon fiber reinforced PEEK), or the resin of the core member and the resin of the reinforcing fiber layer are different resins, and a critical surface tension of each of the resin of the core member and the resin of the reinforcing fiber layer is 20 mN/m or more (the critical surface tension of PEEK is greater than 20 mN/m – note that this is also supported by the presence of dependent claim 12, which includes PEEK as a resin for the core member) (Figs. 2A-2B; paras. 0017-0019).
Claim 8. Ballard discloses wherein the core member is formed using the resin containing fibers (para. 0019 states that core 30 is carbon fiber reinforced PEEK) (Figs. 2A-2B; paras. 0017-0019).
Claim 10. Ballard discloses wherein the fibers of the core member are 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 11. Ballard discloses wherein the fibers of the core member are short fibers (para. 0019 states that core 30 is short carbon fiber reinforced PEEK) (Figs. 2A-2B; paras. 0017-0019).
Claim 12. Ballard discloses wherein the resin of the core member is 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 a plurality of recesses are formed on an outer surface of the core member that each have a longest dimension extending in a circumferential direction of the core member or an inclined direction relative to the circumferential direction 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), wherein each of the plurality of recesses is elongate and has a longest dimension that extends in a circumferential direction of the core member (claim 3), and wherein each of the plurality of recesses is elongate (claim 15).
Zylber teaches a fixture rod comprising a core member (rod 56) having a region (end portion 54) with plurality of elongate recesses (see recesses extending circumferentially at end portion 54 as shown in Fig. 2) formed on an outer surface of the core member that each have a longest dimension extending in a circumferential direction (see Fig. 2) of the core member, wherein the region of the core member is configured to provide means to retain fibers of a reinforcing layer (cord 52) on the core member (see para. 0028) (Fig. 2; para. 0028).
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 plurality of recesses are formed on an outer surface of the core member that each have a longest dimension extending in a circumferential direction of the core member or an inclined direction relative to the circumferential direction of the core member (claim 1), wherein each of the plurality of recesses is elongate and has a longest dimension that extends in a circumferential direction of the core member (claim 3), and wherein each of the plurality of recesses is elongate (claim 15), as suggested by Zylber, as such a configuration provide means to retain fibers of the reinforcing layer on the core member. 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).
Claim 13. Ballard and Zylber 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 of Ballard).
Claim 14. Ballard and Zylber 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (US 2011/0106162 A1) in view of Zylber et al. (US 2008/0234744 A1) as applied to claim 8 above, and further in view of Takebe et al. (US 2016/0303824 A1).
Ballard and Zylber fail to teach wherein the fibers of the core member comprise fibers partially exposed from the core member (claim 9).
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 partially exposed from the core member (see Fig. 6), wherein the exposed fibers of the core member are embedded in the reinforcing fiber layer (see Fig. 6) (Figs. 3A and 6).
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 fibers of the core member comprise fibers partially exposed from the core member (claim 9), as suggested by Takebe, as the partially exposed fibers can provide for better adhesion between the reinforcing fiber layer and the core member.
Response to Arguments
Applicant's arguments filed October 27, 2025 with respect to the objection to claim 13 have been fully considered but they are not persuasive. Applicant argues that claim 13 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 13 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 13 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 filed October 27, 2025 with respect to the objection to the use of In re Boesch have been fully considered but they are not persuasive. Applicant argues that Orthobion does not mention the depth of the irregularities and thus does not disclose the general conditions (see pg. 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 previous 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. In the rejection above, the Examiner noted that Zylber states that the recessed configuration provides means to retain fibers of the reinforcing layer on the core member. These are 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/Zylber and Applicant have the same purpose for the recesses, 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.
Applicant’s arguments with respect to claim 1 and Orthobion 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773