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 16 is objected to because of the following informalities:
Claim 16, line 2, immediately preceding “contact-aided”, “A” should be changed to --a--.
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 1-15 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 1, line 12, “the second flexible components” lacks proper antecedent basis, making this limitation unclear.
Claims 2-15 are rejected because they depend from and include the limitations of independent claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. 12,611,313. This is a statutory double patenting rejection. It is noted that claim 3 of the issued patent appears as claim 12 of the present application; nevertheless, all relative dependencies remain the same such that the claims of the issued patent and those of the present application are drawn to identical subject matter.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10 and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halverson et al. (2010/0241232).
Regarding claim 1 Halverson et al. disclose a spinal disc replacement implant 151 (cf. Fig. 10) comprising a contact-aided compliant mechanism comprising:
a first rigid component 162;
a second rigid component 152, 156 (not including an optional axial-rotation core 160; para. 0064);
a third rigid component 164;
a first flexible component 154 (comprised of all three flexures; Fig. 10);
a second flexible component 158 (comprised of all three flexures; cf. Figs. 9 and 10);
each of the first and second flexible components 154, 158 comprising a first end, a second end, and a third end, e.g., the free ends of the flexures (cf. Fig. 10);
the first flexible component 154 disposed between the first rigid component 162 and the second rigid component 152, 156; (id.)
the second flexible component 158 disposed between the second rigid component 152, 156 and the third rigid component 164;
the first rigid component 162 further comprising a first bearing surface (e.g., underside), wherein the first bearing surface selectively engages an upper bearing surface 153 (Figs. 9 and 10) of the second rigid component 152, 156; and
the third rigid component 164 further comprising a third bearing surface (e.g., upper surface), wherein the third bearing surface selectively engages a lower bearing surface 157 (Fig. 10) of the second rigid component 152, 156.
Regarding claim 2, the first and second flexible components 154, 158 comprise a substantially V-shape with the rigid component (e.g., at the attached end where they merge away from the respective rigid component; Fig. 10 and paras. 0056-0057).
Regarding claim 3, the first rigid component 162 is positioned parallel to the second rigid component 152, 156 (Fig. 10).
Regarding claim 4, the first rigid component 162 is movable in at least one degree of freedom (e.g., rolling rotation 184 about axis 180; Fig. 10) with respect to the second rigid component 152, 156.
Regarding claim 5, the first bearing surface (underside of 162) extends from one side of the first rigid component toward the second rigid component 152, 156 (e.g., by its thickness).
Regarding claim 6, the upper bearing surface 153 (Figs. 9 and 10) extends arcuately (id.) from one side 152 of the second rigid component 152, 156 toward the first rigid component 162 (id.).
Regarding claim 7, the lower bearing surface 157 (Fig. 10) extends arcuately (id.) from one side 156 of the second rigid component 152, 156 toward the third rigid component 164 (id.).
Regarding claim 8. The spinal disc replacement implant of claim 1, wherein the third bearing surface (upper surface of the third rigid component 164; Fig. 10) extends from one side of the third rigid component toward the second rigid component (e.g., by its thickness).
Regarding claim 10, at least the upper bearing surface 153 and lower bearing surface comprise a rounded surface (Fig. 10; cf. also Fig. 14 and para. 0063).
Regarding claim 12, the first flexible component 154 is disposed perpendicular to the second flexible component 158 (Fig. 10).
Regarding claim 13, the first flexible component 154 (Fig. 10; supra) comprises a Euler spiral (i.e., because it comprises a cantilever, it comprises a continuously changing curvature when compressed).
Regarding claim 14, the second flexible component 154 (Fig. 10; supra) comprises a Euler spiral (i.e., because it comprises a cantilever, it comprises a continuously changing curvature when compressed).
Regarding claim 15, the first flexible component has a first stiffness (para. 0056; discussing elastic, spring-like behavior) and the second flexible component has a second stiffness (id.).
Regarding claim 16, Halverson et al. disclose a spinal disc replacement implant 151 (cf. Fig. 10) comprising:
a contact-aided compliant mechanism comprising:
a first rigid component 162, the first rigid component including a first bearing surface (e.g., underside);
a second rigid component 152, 156 (not including an optional axial-rotation core 160; para. 0064), the second rigid component including an upper and lower bearing surface (see annotated Fig. 10);
a third rigid component 164, the third rigid component including a third bearing surface (e.g., upper surface);
a plurality of flexible components 154 (comprised of all three flexures; Fig. 10) and 158 (comprised of all three flexures; cf. Figs. 9 and 10), each of flexible components 154 and 158 including at least a first end (attached end) (annotated Fig. 10, below), a second end (free end), and a third end (attached end), wherein the first end is attached to the second rigid component 152, 156 and wherein the third end is attached to the second rigid component (annotated Fig. 10) (and comparable structure of flexible component 158; cf. Figs. 9 and 10);
the first bearing surface (underside of the first rigid component 162) selectively engaging the upper bearing surface 153; and
the third bearing surface (upper surface of the third rigid component 164) selectively engaging the lower bearing surface 157.
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Regarding claim 17, at least the upper bearing surface 153 and lower bearing surface have a rounded contour (cf. also Fig. 14 and para. 0063).
Regarding claim 18, each of the flexible components 154, 158 further includes a first region (e.g., upper surface) disposed between the first end and the second end and a second region (e.g., inner side surface) disposed between the second end and the third end (annotated Fig. 10, above).
Regarding claim 19, the first region includes a first radius of curvature (Fig. 10).
Regarding claim 20. The contact-aided compliant mechanism of claim 18, wherein the second region includes a second radius of curvature (e.g., defined by the curved edge of the second region; Fig. 10).
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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Halverson et al. (2010/0241232) in view of Marney et al. (2005/0085917).
Regarding claim 9, Halverson et al. disclose the claimed invention except for explicitly reciting at least one keel.
Marney et al. disclose a spinal disc replacement implant 1 (Fig. 1) and teach that a keel 6 may be provided to securely anchor the implant to the vertebral bone (para. 0036).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the spinal disc replacement implant 151 of Halverson et al. with a keel, in view of Marney et al., to securely anchor the implant to the vertebral bone.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Halverson et al. (2010/0241232) in view of Sawyer et al. (2016/0000575).
Regarding claim 11, Halverson et al. disclose the claimed invention, including that the implant 151 (supra; including the first rigid component 162, second rigid component 152, 156, third rigid component 164, the first flexible component 154 and second flexible component 158) can be manufactured as a single part (i.e., formed wholly of one material as a single component; para. 0055), but do not explicitly recite using 3D printing.
Sawyer et al. teach a similar disc replacement implant 100 (Fig. 3) and teach that it can be manufactured as a single part using 3D printing (paras. 0017 and 0045), to advantageously allow for rapid prototyping (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to manufacture the spinal disc replacement implant 151 (including the first rigid component 162, second rigid component 152, 156, third rigid component 164, the first flexible component 154 and second flexible component 158) of Halverson et al. as a single part using 3D printing, in view of Sawyer et al., to advantageously allow for rapid prototyping.
Double Patenting
Claims 1-20 are rejected under statutory (35 U.S.C. 101) double patenting. See rejection under heading “Claim Rejections - 35 USC § 101” above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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