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 .
Election/Restrictions
Applicant’s election of the following species in the reply filed on January 7, 2026 is acknowledged:
Spinal Adjustment Implant – Figs. 1-3C
Driving Element – Figs. 35A-B
Adjustment Structure – Fig. 28
Pivots – Figs. 46A-B
Gear – Fig. 37
Clutch – Fig. 40
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 7 and 8 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 7 recites “wherein transcutaneously actuating an actuator that includes a rotatable permanent magnet configured to be rotated by a rotating magnetic field.” It is unclear whether this recitation is intended to further limit the step of transcutaneously actuating the actuator as there are no additional method steps recited. Based on Applicant’s disclosure, it appears that the actuator includes a rotatable permanent magnet. Thus, the Examiner is interpreting claim 7 as reciting “wherein the actuator includes a rotatable permanent magnet configured to be rotated by a rotating magnetic field.” Claim 8 is rejected because it depends from claim 7.
Claims 10, 11, 19, and 20 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. Claims 10 and 19 recite that the speed reduction ratio is up to about 119:1 and claims 11 and 20 recite that the speed reduction ratio is up to about 7569:1. The scope of the term “about” in each of the aforementioned claims is unclear as the specification recites that the reduction ratio is up to 119:1 for single stage and up to 7569:1 for double stage (see para. 0191). For examination purposes, the Examiner is interpreting claims 10 and 19 as reciting “up to 119:1” and claims 11 and 20 as “up to 7569:1.”
Claims 14 and 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 14 recites “affixing a first end” (line 1). However, claim 13 already recites that the implant includes a first end. Thus, it is unclear whether “a first end” in claim 14 is intended to be the same first end introduced in claim 14 or an additional first end. For examination purposes, the Examiner is interpreting “affixing a first end” in claim 14 as “affixing the first end.” Claim 15 is rejected because it depends from claim 14.
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, 4-9, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner et al. (US 2017/0172624 A1) in view of Steele et al. (US 2012/0109126 A1).
Claim 1. Brunner discloses a method comprising:
transcutaneously actuating (see para. 0025, which states that the actuator is powered via an external energy source; see para. 0026, which states that the external energy source can be magnetic) an actuator (motor 35 and magnetic rotors 37 and 41) of an adjustable implant (distractor 10) implanted in a subject (see para. 0021, which states that the distractor is implanted in a medullary cavity of a bone), wherein the actuating causes:
a cycloidal drive (see para. 0030, which states that the distractor can include cycloidal gears) in the adjustable implant to rotate (it is well-known in the art that gears rotate when actuated); and
a distance between a first end (end with attachment point 31) and a second end (end with attachment point 61) of the adjustable implant to change (see para. 0033, which states that the distractor moves attachment points 31 and 61 relative to each other to either increase or decrease the length of the distractor) (Figs. 1-2b).
Claim 7. Brunner discloses wherein the actuator includes a rotatable permanent magnet (magnetic rotors 37 and 41) configured to be rotated by a rotating magnetic field (see para. 0026) (Figs. 1-2b).
Claim 8. Brunner discloses wherein the rotatable permanent magnet is disposed within an internal cavity of a magnet housing (see Fig. 2a, which shows that magnetic rotors 37 and 41 are located within an internal cavity of distractor 10) rotatably coupled to the cycloidal drive (it is well-known in the art that, in order for the cycloidal gears to be actuated, magnetic rotors 37 and 41 must necessarily be rotatable coupled, either directly or indirectly, to the cycloidal gears) (Figs. 1-2b).
Claim 9. Brunner discloses wherein the actuator comprises a motor (motor 35) coupled to a power source (see para. 0025, which states that the actuator is powered via an external energy source; see para. 0026, which states that the external energy source can be electric or magnetic) (Figs. 1-2b).
Claim 12. Brunner discloses a method comprising:
transcutaneously actuating (see para. 0025, which states that the actuator is powered via an external energy source; see para. 0026, which states that the external energy source can be magnetic) an actuator (motor 35 and magnetic rotors 37 and 41) of an adjustable implant (distractor 10) implanted in a subject (see para. 0021, which states that the distractor is implanted in a medullary cavity of a bone), wherein the actuating causes:
a cycloidal drive (see para. 0030, which states that the distractor can include cycloidal gears) coupled to the actuator (it is well-known in the art that, in order for the cycloidal gears to be actuated, magnetic rotors 37 and 41 must necessarily be coupled, either directly or indirectly, to the cycloidal gears) to rotate (it is well-known in the art that gears rotate when actuated); and
a distance between a first end (end with attachment point 31) and a second end (end with attachment point 61) of the adjustable implant to change (see para. 0033, which states that the distractor moves attachment points 31 and 61 relative to each other to either increase or decrease the length of the distractor) (Figs. 1-2b).
Claim 18. Brunner discloses wherein the actuator comprises a motor (motor 35) coupled to a power source (see para. 0025, which states that the actuator is powered via an external energy source; see para. 0026, which states that the external energy source can be electric or magnetic) (Figs. 1-2b).
Brunner fails to disclose an output shaft coupled to the cycloidal drive, wherein actuating the actuator causes the output shaft to rotate (claim 1), wherein rotation of the cycloidal drive includes rotating an input shaft mounted to an eccentric bearing (claim 4), wherein the cycloidal drive includes a cycloidal disc having a central aperture configured to receive the eccentric bearing therein, and a plurality of holes circumferentially spaced about the central aperture (claim 5), wherein the cycloidal drive includes an output disc having a plurality of pins extending from a surface of the output disc, wherein the plurality of pins engage the plurality of holes in the cycloidal disc (claim 6), wherein the cycloidal drive includes an input shaft, a cycloidal disc coupled to the input shaft, an output disc coupled to the cycloidal disc, an output shaft coupled to the output disc, and wherein actuating the actuator causes the input shaft, the cycloidal disc, the output disc, and the output shaft to rotate (claim 12).
Steele teaches a cycloidal drive (cycloidal gear system 12) comprising: an input shaft (shaft extending from gear 20 as shown in Fig. 3) rotatably coupled to an actuator (torque adapter 110) (see para. 0055, which states that torque adapter 110 provides rotational force to drive gear 20), wherein the input shaft is mounted to an eccentric bearing (gear 80); a cycloidal disc (annular member 50) coupled to the input shaft, wherein cycloidal disc has a central aperture (central opening 56) configured to receive the eccentric bearing therein (see para. 0041), and a plurality of holes (apertures 57) circumferentially spaced about the central aperture; an output disc (drive plate 30) coupled to the cycloidal disc, wherein the output disc has a plurality of pins (posts 32) extending from a surface of the output disc, wherein the plurality of pins engage the plurality of holes in the cycloidal disc (see para. 0038); and an output shaft (shaft extending from drive plate 30 into biasing member 70 as shown in Fig. 3) coupled to the output disc; wherein actuating the actuator causes the input shaft, the cycloidal disc, the output disc, and the output shaft to rotate (see para. 0055, which states that torque adapter 110 provides rotational force to gear 20; see paras. 0068-0071, which state that rotation of gear 20 leads to rotation of gear 80, annular member 50, and drive plate 30) (Figs. 3-10).
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 Brunner such that an output shaft is coupled to the cycloidal drive, wherein actuating the actuator causes the output shaft to rotate (claim 1), wherein rotation of the cycloidal drive includes rotating an input shaft mounted to an eccentric bearing (claim 4), wherein the cycloidal drive includes a cycloidal disc having a central aperture configured to receive the eccentric bearing therein, and a plurality of holes circumferentially spaced about the central aperture (claim 5), wherein the cycloidal drive includes an output disc having a plurality of pins extending from a surface of the output disc, wherein the plurality of pins engage the plurality of holes in the cycloidal disc (claim 6), wherein the cycloidal drive includes an input shaft, a cycloidal disc coupled to the input shaft, an output disc coupled to the cycloidal disc, an output shaft coupled to the output disc, and wherein actuating the actuator causes the input shaft, the cycloidal disc, the output disc, and the output shaft to rotate (claim 12), as suggested by Steele, as such is a known configuration of a cycloidal drive.
Claims 2, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner et al. (US 2017/0172624 A1) in view of Steele et al. (US 2012/0109126 A1) as applied to claims 1 and 12 above, and further in view of Eksler et al. (US 7,753,915 B1).
Claim 2. Brunner discloses: attaching the first end of the adjustable implant to a first bone portion (see para. 0033, which states that “31” corresponds to an attachment point; see para. 0021, which states that distractor 10 is inserted into a medullary cavity of a bone; thus, it is clear that distractor 10 is attached to a first bone portion at attachment point 31) of the subject; and attaching the second end of the adjustable implant to a second bone portion (see para. 0033, which states that “61” corresponds to an attachment point; see para. 0021, which states that distractor 10 is inserted into a medullary cavity of a bone; thus, it is clear that distractor 10 is attached to a second bone portion at attachment point 61) of the subject such actuating the actuator increases the distance between the first bone portion and the second bone portion (see para. 0033, which states that actuation moves attachment points 31 and 61 relative to each other to increase the length of distractor 10; thus, it is clear that doing so would increase the distance between the first bone portion and the second bone portion) (Figs. 1-2b).
Claim 13. Brunner discloses: affixing a first end (end with attachment point 31) of the adjustable implant to a first bone portion of the subject (see para. 0033, which states that “31” corresponds to an attachment point; see para. 0021, which states that distractor 10 is inserted into a medullary cavity of a bone; thus, it is clear that distractor 10 is attached to a first bone portion at attachment point 31); and affixing a second end (end with attachment point 61) of the adjustable implant to a second bone portion of the subject (see para. 0033, which states that “61” corresponds to an attachment point; see para. 0021, which states that distractor 10 is inserted into a medullary cavity of a bone; thus, it is clear that distractor 10 is attached to a second bone portion at attachment point 61) (Figs. 1-2b).
Brunner and Steele fail to teach that the first bone portion is a first bone and the second bone portion is a second bone (claim 2), that the first bone portion is a first vertebral body and the second bone portion is a second vertebral body (claim 13), wherein affixing the first end includes affixing the first end of the adjustable implant to a spinal screw adapted for insertion into a vertebral body of the subject (claim 14).
Eksler teaches an adjustable implant (implantable part 10) having a first end (end that receives nail 18 as shown in Fig. 1a) attached to a first bone portion (portion 12a) and a second end (end that receives nail 22 as shown in Fig. 1a) attached to a second bone portion (portion 12b), wherein the implant is used as an intramedullary distractor (see Fig. 1a) (Fig. 1a). However, Eksler teaches that the adjustable implant is also used as a spinal distractor (see Fig. 11; see col. 11, ll. 30-44), wherein the first end is attached to a first vertebral body (bone 58a) via a spinal screw (screw 54) and the second end is attached to a second vertebral body (bone 58c) via a spinal screw (screw 56), wherein the adjustable implant is used to correct spinal deformities (see col. 11, ll. 30-44) (Fig. 11).
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 Brunner such that the first bone portion is a first bone and the second bone portion is a second bone (claim 2), that the first bone portion is a first vertebral body and the second bone portion is a second vertebral body (claim 13), wherein affixing the first end includes affixing the first end of the adjustable implant to a spinal screw adapted for insertion into a vertebral body of the subject (claim 14), as suggested by Eksler, as such an implant can also be used to correct spinal deformities.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Brunner et al. (US 2017/0172624 A1) in view of Steele et al. (US 2012/0109126 A1) and Eksler et al. (US 7,753,915 B1) as applied to claim 14 above, and further in view of Walker et al. (US 2009/0112207 A1).
Brunner, Steele, and Eksler fail to teach wherein the spinal screw is a pedicle screw that has been inserted into a pedicle of the first vertebral body (claim 15).
Walker teaches an adjustable implant (adjustable rod 142), wherein the adjustable implant is secured to a pedicle of a first vertebral body via a pedicle screw (see para. 0078, which states that the anchor 161 at either end of rod 142 can include a pedicle screw) (Fig. 4).
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 Brunner such that the spinal screw is a pedicle screw that has been inserted into a pedicle of the first vertebral body (claim 15), as attachment to a pedicle is a well-known posterior vertebral attachment point.
Claims 3, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner et al. (US 2017/0172624 A1) in view of Steele et al. (US 2012/0109126 A1) as applied to claims 1 and 12 above, and further in view of Walker et al. (US 2009/0112207 A1).
Claim 3. Brunner discloses wherein the actuator includes a rotatable permanent magnet (magnetic rotors 37 and 41) configured to be rotated by a rotating magnetic field (see para. 0026) (Figs. 1-2b).
Claim 16. Brunner discloses wherein the actuator includes a rotatable permanent magnet (magnetic rotors 37 and 41) configured to be rotated by a rotating magnetic field (see para. 0026) (Figs. 1-2b).
Claim 17. Brunner and Steele teach wherein the rotatable permanent magnet is disposed within an internal cavity of a magnet housing (see Fig. 2a of Brunner, which shows that magnetic rotors 37 and 41 are located within an internal cavity of distractor 10) rotatably coupled to the input shaft (it is well-known in the art that, in order for the cycloidal gears to be actuated, magnetic rotors 37 and 41 of Brunner must necessarily be rotatable coupled, either directly or indirectly, to the cycloidal gears, which include the input shaft as taught by Steele) (Figs. 1-2b of Brunner; Figs. 3-10 of Steele).
Brunner and Steele fail to teach wherein transcutaneously actuating the actuator includes generating the rotating magnetic field (claims 3 and 16).
Walker teaches generating a rotating magnetic field with an external adjustment device (see claim 13; see also para. 0190, which states that external adjustment device 1130 creates a rotating magnetic field) to transcutaneously actuate an actuator (internal magnet 1064) of an adjustable implant (distraction device 140) (see para. 0105) (Figs. 13A-13D).
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 Brunner such that transcutaneously actuating the actuator includes generating the rotating magnetic field (claims 3 and 16), as suggested by Walker, as such would allow for non-invasive adjustment of the adjustable implant over a period of time.
Claims 10, 11, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner et al. (US 2017/0172624 A1) in view of Steele et al. (US 2012/0109126 A1) as applied to claims 1 and 12 above, and further in view of Zhang et al. (CN 101439239 A).
Brunner and Steel fail to teach wherein the cycloidal drive comprises a single gear stage and has a speed reduction ratio of up to 119:1 (claims 10 and 19) and wherein the cycloidal drive comprises two gear stages and has a total speed reduction ratio of up to 7569:1 (claims 11 and 20).
However, Brunner discloses that the cycloidal drive can be configured to achieve desired reduction ratios (see para. 0030), wherein such can be achieved by the use of one or more gear stages (see para. 0029).
Zhang teaches that a cycloidal drive can include a single gear stage with a speed reduction ratio up to 87:1 or can include two gear stages with a speed reduction ratio up to 7569:1 (see boxed area on pg. 3 of the provided English-language translation), wherein such a configuration allows for a device that is smaller in size and lighter in weight (see boxed area on pg. 3 of the provided English-language translation).
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 Brunner such that the cycloidal drive comprises a single gear stage (claims 10 and 19) and has a speed reduction ratio of up to 87:1, as suggested by Zhang, and the cycloidal drive comprises two gear stages and has a total speed reduction ratio of up to 7569:1 (claims 11 and 20), as suggested by Zhang, as such configurations would allow the implant to be smaller in size and lighter in weight. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the speed reduction ratio to be up to 119:1 (claims 10 and 19), 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).
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