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 .
Claim Objections
Claim 17 is objected to because of the following informalities: the word “the” should be inserted between “in” and “inner” (line 2). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 12-17 are 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 12 recites that the vertebral disc member is configured to be sandwiched between two vertebral bone members, and as such, claim 12 is written as an intended use recitation (see “configured to be”) and not a positively performed method step. It is unclear whether Applicant intended for claim 12 to be an intended use recitation and therefore only include one vertebral bone member (positively recited in claim 7) or whether Applicant intended for claim 12 to be a positively recited configuration (for example, by not reciting the phrase “configured to be”) and therefore include two vertebral bone members. For examination purposes, the Examiner is interpreting claim 12 as an intended use recitation. Claims 13-17 are rejected because they depend from claim 12.
Claim 16 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. As stated above, claim 12 is being interpreted as an intended use recitation such that there is only one vertebral bone member. As such, there is also only one inner unit. Thus, it is unclear how a single inner unit has two triangular grooves, one for each of the upper triangular protrusion and the lower triangular protrusion. Furthermore, even if claim 12 were to be interpreted as including two vertebral bone members, none of claims 12, 13, or 16 indicate that each vertebral bone member has the structure recited in claim 7.
Claim 17 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 17 recites the limitation "inner body" in line 2. There is insufficient antecedent basis for this limitation in the claim as none of claims 7, 12, 14, 15, or 17 recite an inner body. Because claim 7 recites an inner unit, the Examiner is interpreting “inner body” as “inner unit.”
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 7, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kou et al. (CN 105534622 A) in view of Mullen et al. (US 2020/0188134 A1), Huang (CN 113940796 A1), and Iott et al. (US 2014/0163682 A1). English-language translations of Kou and Huang have been provided with the Non-Final Rejection mailed on August 6, 2025.
Claim 7. Kou discloses a method for correcting backbone defects in a patient, the method comprising:
3D printing (see pg. 2 of translation) an implantable vertebral segment (see Fig. 1), wherein the implantable vertebral segment comprises:
a vertebral bone member (see Fig. 1) comprising:
an outer unit (outer unit includes pedicles 3 and lamina 4), and
an inner unit (inner unit includes vertebral body 1 and transverse processes 2), wherein the outer unit is configured to be coupled to the inner unit through a fastening mechanism (screws passing through grooves 6 and screw holes 7; see pg. 3 of translation), the outer unit and the inner unit together forming a tunnel (conical hole 5) configured to receive a spinal cord; and
replacing a damaged vertebral bone of the backbone with the implantable vertebral segment (see claims 6 and 7 on pg. 4 of translation).
Kou fails to disclose imaging a backbone of the patient to generate a model specific to the patient, wherein the implantable vertebral segment is based on the model, wherein the fastening mechanism comprises a plug and socket that interlock to secure the outer unit with the inner unit, wherein the implantable vertebral segment also comprises a vertebral disc member, replacing the disc of the backbone, and wherein the implantable vertebral is biocompatible and anatomically similar to the vertebral bone and disc before damage (claim 7), wherein a lumbar portion is replaced with the implantable vertebral segment (claim 11), wherein the vertebral disc member is configured to be sandwiched between two vertebral bone members (claim 12), and wherein the implantable vertebral segment further comprises a capping vertebral disc member configured to cap a vertebral bone member (claim 14).
Mullen teaches a method for providing a patient-specific implant (see Fig. 1 and para. 0044) comprising imaging the site of the patient (step 15; see Fig. 1 and para. 0044), generating a model of an ideal implant based on the imaging (step 30; see Fig. 1 and para. 0044), and 3D printing the patient-specific implant corresponding to the modeled ideal implant (step 35; see Fig. 1 and para. 0044), wherein patient-specific implants are advantageous for patients where reliance on standard sized implants are not preferred (see para. 0003).
Huang teaches a biocompatible implantable vertebral segment (see Figs. 1 and 4; see abstract) comprising a vertebral bone member (vertebra 4), a vertebral disc member (intervertebral disc 6) configured to be sandwiched between two vertebral bone members (vertebrae 4 and 7), and a capping vertebral disc member (intervertebral disc 3) configured to cap the vertebral bone member (vertebra 4), wherein the implantable vertebral segment can include multiple vertebral bone members (vertebrae 1, 4, 7, 10, and 13) and multiple vertebral disc members (intervertebral disc members 3, 6, 9, and 12) to replace both the lumbar portion of the vertebral bone and disc of the backbone (see pg. 2 of translation), thereby allowing for multi-level repair and motion preservation of the patient’s spine (see pg. 2 of translation).
Iott teaches an outer unit (fixation portion 124; see Fig. 38) secured to an inner unit (endplate 110; see Fig. 38) via a fastening mechanism (connection 286; see Fig. 38) in the form of a plug (projection 290; see Fig. 38) and socket (aperture 288; see Fig. 38) that interlock to secure the outer unit with the inner unit (see para. 0107), wherein such a fastening mechanism is an alternative to a screw fastening mechanism (see para. 0107).
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 method of Kou by imaging a backbone of the patient to generate a model specific to the patient, wherein the implantable vertebral segment is based on the model (claim 7), as suggested by Mullen, as patient-specific implants are advantageous for patients where reliance on standard sized implants are not preferred. In view of such a modification, it is obvious that the implantable vertebral segment is anatomically similar to the vertebral segment before damage (claim 7). 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 method of Kou wherein the implantable vertebral segment is biocompatible and also comprises a vertebral disc member (claim 7) to replace the disc of the backbone (claim 7), wherein the portion replaced is the lumbar portion (claim 11), wherein the vertebral disc member is configured to be sandwiched between two vertebral bone members (claim 12), and wherein the implantable vertebral segment further comprises a capping vertebral disc member configured to cap a vertebral bone member (claim 14), as suggested by Huang, in order to enable the implantable vertebral segment to be used with additional vertebral bone members and vertebral disc members, as needed, to allow for multi-level repair and motion preservation of the patient’s spine. 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 method of Kou wherein the fastening mechanism comprises a plug and socket that interlock to secure the outer unit with the inner unit (claim 7), as suggested Iott, instead of the screw fastening mechanism of Kou, as such is a simple substitution of one type of fastening mechanism for another.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kou et al. (CN 105534622 A) in view of Mullen et al. (US 2020/0188134 A1), Huang (CN 113940796 A1), and Iott et al. (US 2014/0163682 A1) as applied to claim 7 above, and further in view of Xiao et al. (US 2019/0029842 A1).
Kou, Mullen, Huang, and Iott fail to teach wherein the vertebral bone member is made of titanium.
Xiao teaches that an artificial vertebral bone member is made of titanium (see para. 0292).
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 method of Kou wherein the vertebral bone member is made of titanium, as suggested by Xiao, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kou et al. (CN 105534622 A) in view of Mullen et al. (US 2020/0188134 A1), Huang (CN 113940796 A1), Iott et al. (US 2014/0163682 A1), and Xiao et al. (US 2019/0029842 A1) as applied to claim 8 above, and further in view of Shelokov (US 6,039,763 A).
Kou, Mullen, Huang, Iott, and Xiao fail to teach wherein the vertebral disc member is made of a biocompatible hard rubber substance.
Shelokov teaches an artificial vertebral disc member made of a biocompatible hard rubber substance (see col. 10, ll. 15-20).
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 method of Kou wherein the vertebral disc member is made of a biocompatible hard rubber substance, as suggested by Shelokov, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kou et al. (CN 105534622 A) in view of Mullen et al. (US 2020/0188134 A1), Huang (CN 113940796 A1), Iott et al. (US 2014/0163682 A1), Xiao et al. (US 2019/0029842 A1), and Shelokov (US 6,039,763 A) as applied to claim 9 above, and further in view of Arramon et al. (US 2019/0183654 A1).
Kou, Mullen, Huang, Iott, Xiao, and Shelokov fail to teach wherein the vertebral bone member and the vertebral disc member comprise an interlocking mechanism for coupling the vertebral bone member and the vertebral disc member.
However, Huang teaches that a vertebral bone member (vertebra 1) and a vertebral disc member (intervertebral disc 3) have complementary surfaces (see Fig. 4) to enable motion preservation (see pg. 2 of translation).
Arramon teaches that a vertebral disc member (core 16) and a vertebral bone member (plate 12) have complementary surfaces (see Figs. 1 and 2) to enable motion preservation (see Figs. 1 and 2), and wherein the vertebral bone member and the vertebral disc member comprise an interlocking mechanism (projection 24 of plate 12 and opening 36 of core 16) for coupling the vertebral bone member and the vertebral disc member (see para. 0038) and for preventing over-articulation of the vertebral disc member relative to the vertebral bone member (see para. 0037).
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 method of Kou wherein the vertebral bone member and the vertebral disc member comprise an interlocking mechanism for coupling the vertebral bone member and the vertebral disc member, as suggested by Arramon, in order to prevent over-articulation of the vertebral disc member relative to the vertebral bone member.
Response to Arguments
Applicant’s arguments with respect to claims 7-10 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
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 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