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 species of Fig. 5 in the reply filed on August 17, 2026 is acknowledged. 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)).
Information Disclosure Statement
The information disclosure statement filed November 5, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: the Examiner believes that “implant” should be “implanted” (line 3). 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.
Claim 9 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 9 recites the limitation "the power supply" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the power supply” is intended to be inductive power transfer circuit or the external power coil as recited in claim 1 or some other component.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Haaja et al. (US 2011/0004246 A1) in view of Hallila et al. (US 2015/0369223 A1).
Claim 1. Haaja discloses a method of lengthening a bone with an implantable osteodistraction device, the method comprising:
operating an osteodistraction device (see Figs. 1A-1C) implanted in a bone (see para. 0026), wherein the osteodistraction device includes an inner tube (inner tube 6) disposed at least partially within an outer tube (outer tube 5), wherein operating the osteodistraction device causes a shape-memory-alloy element of a shape-memory-alloy actuator (spring 4; see para. 0028 regarding superelastic materials such as NiTi) connected to and at least partially within the one of the outer or inner tubes of the implanted osteodistraction device to transition from a first phase to a second phase with a corresponding change in shape responsive to threshold resistive heating (see paras. 0029-0030); and
converting the change in shape of the shape-memory-alloy element to an extension of the inner tube from within the outer tube and preventing contraction of the inner tube into the outer tube (see paras. 0026-0030).
Claim 3. Haaja discloses wherein converting a change in shape of the shape-memory-alloy element to an extension of the inner tube from within the outer tube takes place via a one-way linear movement locking clutch (see para. 0029).
Claim 4. Haaja discloses promoting extension of the shape-memory-alloy element when transitioning from the first phase to the second phase (see paras. 0027-0030).
Claim 5. Haaja discloses wherein promoting extension of the shape-memory-alloy element comprises applying a tensile force to the shape-memory-alloy element via a prestress spring (spring 4) (see paras. 0027-0030).
Haaja fails to disclose operating an inductive power transfer circuit of the osteodistraction device to receive power through inductive coupling to an external power coil, wherein the inductive power transfer circuit is connected to and at least partially within one of the outer tube or the inner tube (claim 1), wherein operating the inductive power transfer circuit comprises operating for a first defined time duration sufficient to transition the shape-memory-alloy element from the first phase to the second phase with the corresponding change in shape (claim 2) and preventing the inductive power transfer circuit from operating to power the shape-memory-alloy actuator for a second defined time duration sufficient to transition the shape-memory-alloy element from the second phase to the first phase (claim 2).
Hallila teaches operating an inductive power transfer circuit (cable 3017) of an osteodistraction device (Figs. 24 and 26) to receive power through inductive coupling to an external power coil (see paras. 0168-0169), wherein the inductive power transfer circuit is connected to and at least partially within one of an outer tube or an inner tube (see Fig. 26) of the osteodistraction device to provide a controlled current level (see claim 3) in order to provide energy to a shape-memory-alloy (see para. 0168), wherein operating the inductive power transfer circuit comprises operating for a first defined time duration sufficient to transition the shape-memory-alloy element from the first phase to the second phase with the corresponding change in shape (see para. 0087) and preventing the inductive power transfer circuit from operating to power the shape-memory-alloy actuator for a second defined time duration sufficient to transition the shape-memory-alloy element from the second phase to the first phase (see para. 0087).
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 Haaja by operating an inductive power transfer circuit of the osteodistraction device to receive power through inductive coupling to an external power coil, wherein the inductive power transfer circuit is connected to and at least partially within one of the outer tube or the inner tube (claim 1), wherein operating the inductive power transfer circuit comprises operating for a first defined time duration sufficient to transition the shape-memory-alloy element from the first phase to the second phase with the corresponding change in shape (claim 2) and preventing the inductive power transfer circuit from operating to power the shape-memory-alloy actuator for a second defined time duration sufficient to transition the shape-memory-alloy element from the second phase to the first phase (claim 2), as suggested by Hallila, to provide a controlled energy to the osteodistraction device.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Haaja et al. (US 2011/0004246 A1) in view of Hallila et al. (US 2015/0369223 A1) as applied to claim 1 above, and further in view of Ross et al. (US 2021/0307786 A1).
Haaja and Hallila fail to teach generating a patient treatment diary tracking each occurrence of operation of the inductive power transfer circuit to transition the shape-memory-alloy element from the first phase to the second phase with the corresponding change in shape (claim 6) and communicating the patient treatment diary to a health care provider (claim 7).
Ross teaches a method of adjusting the length of an osteodistraction device (rod 10) including generating a patient treatment diary tracking each occurrence of operation of a power supply (motor18) to adjust the length of the osteodistraction device, wherein the patient treatment diary includes a record of the adjustment (see para. 0025), and communicating the patient treatment diary to a health care provider (see para. 0057).
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 Haaja by generating a patient treatment diary tracking each occurrence of operation of the inductive power transfer circuit to transition the shape-memory-alloy element from the first phase to the second phase with the corresponding change in shape (claim 6) and communicating the patient treatment diary to a health care provider (claim 7), as suggested by Ross, to enable the patient’s health care provider to track progress throughout the term of treatment.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Haaja et al. (US 2011/0004246 A1) in view of Hallila et al. (US 2015/0369223 A1) as applied to claim 1 above, and further in view of Forsell (US 2011/0196435 A1).
Claim 9. Haaja in view of Hallila teach controlling the power supply to provide a controlled current level (see the rejections of claims 1-5 above).
Haaja and Hallila fail to teach receiving a prescribed activation schedule for a patient's use of the implantable osteodistraction device (claim 8) and controlling the power supply according to the prescribed activation schedule (claim 9).
Forsell teaches a method of adjusting the length of an osteodistraction device including receiving a prescribed activation schedule for a patient's use of the osteodistraction device (see para. 0270) and controlling a power supply to provide a controlled current level according to the prescribed activation schedule (see para. 0269).
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 Haaja by receiving a prescribed activation schedule for a patient's use of the implantable osteodistraction device (claim 8) and controlling the power supply according to the prescribed activation schedule (claim 9), as suggested by Forsell, to ensure that the bone lengthening proceeds as desired while minimizing the need for the patient to visit the health care provider.
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
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