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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 5-6, 8, 11-12 and 15 are objected to because of the following informalities:
In claim 1, line 7, “which are” should read ---which is---
In claim 1, line 8, “portion and comprising” should read ---portion, the motorized electro-mechanical device comprising
In claim 1, line 11, “connected and adapted to providing” should read ---connected to and adapted to provide---
In claim 5, line 1, “provides” should read ---comprises---
In claim 6, line 2, “are coupled” should read ---is coupled---
In claim 6, line 3, “adapted to provide” should read ---said control unit adapted to provide---
In claim 8, line 2, “comprise” should read ---comprises---
In claim 9, line 2, “a endless screw” should read ---an endless screw---
In claim 10, line 2, “a proximal part with” should read ---the proximal part comprising---
In claim 11, line 2, “are housed” should read ---is housed---
In claim 12, line 3, “sliding” should read ---slidable---
In claim 15, line 1, “provides” should read ---comprises---
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 1-11 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 1, line 3, recites “a first tubular portion extending in a prevalent axial direction of the intramedullary nail”, where the term “prevalent” is generally unclear. For examination purposes, the claim is interpreted as reciting ---a first tubular portion extending in an axial direction of the intramedullary nail---.
Claim 1 recites the limitation "the proximal part" in line 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation is interpreted as ---a proximal part---.
The term “about” in claim 5 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed ranges for the "maximum transversal dimension", "maximum longitudinal dimension" and "maximum" depth are rendered indefinite due to the presence of the term "about" in the claim.
The term “about” in claim 15 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed ranges for the "maximum transversal dimension", "maximum longitudinal dimension" and "maximum" depth are re
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner (US 2016/0172624 A1) in view of Betz (US 6,245,075 B1).
Regarding claim 1, Brunner teaches a motorized intramedullary nail (10; Fig. 1; para. 0082) for bone lengthening or transport, of the type comprising:
- a first tubular portion (sleeve 50; Fig. 1; para. 0028) extending in a prevalent axial direction of the intramedullary nail;
- a second rod-shaped portion (plunger 60; Fig. 1; para. 0028) telescopically sliding inside said first tubular portion and along said axial direction (as indicated by the bidirectional arrow in Fig. 1; );
- motorized electro-mechanical device (collectively defined by electric motor 35, gearbox 45, lead-screw 48 and nut 49; Fig. 1; para. 0022, 0028) for driving the rod-shaped portion which are inserted inside said first tubular portion (for effecting linear motion between rod-shaped portion/plunger 60 and tubular portion/sleeve 50);
- an power supply (electrical energy source 32; Figs. 1, 2b) with biocompatible features (hermetic capsule 20; Figs. 1, 2b; para. 0023, 0040-0041) for subcutaneous and prolonged implantation (as described in para. 0023), connected and adapted to providing electrical power to operate said motorized electro-mechanical device (as described in para. 0022),
wherein said power supply comprises a biocompatible casing (20; Figs. 1, 2b; para. 0023) and at least one power supply battery housed in said casing (para. 0022-0023 describe energy source 32 as a stack of lithium cells or another suitable electrical battery, housed in hermetic casing/capsule 20; Figs. 1-2b).
Brunner does not specifically disclose the electro-mechanical device comprising electrical terminals accessible through the proximal part of the nail, and the power supply being an independent power supply.
Betz, in analogous art, is directed towards a motorized intramedullary nail (see Fig. 1), comprising a tubular portion and a rod-shaped portion (portions 2 and 3, respectively; Fig. 1), and a motorized electro-mechanical device for driving the rod-shaped portion relative to the tubular portion (see electric motor 14; Fig. 1; column 5, lines 15-25), and Betz discloses the electromechanical device comprising terminals accessible through the proximal part of the nail (as shown for connecting with leads 6, the terminals considered accessible through the proximal end of the device at end piece 12; Fig. 1), and the power supply (5; Fig. 1; column 5, lines 1-4) for the electromechanical device being an independent power supply (connected via electrical leads 6, as shown; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brunner’s electro-mechanical device, i.e. electrical motor, to have electrical terminals accessible through the proximal end of the drive casing of the nail, the electric terminals coupling to electrical leads as taught by Betz so as to supply power via a subcutaneous power supply (i.e., Brunner’s lithium battery cells), because Betz recognizes that such a configuration is suitable for supplying electrical power to a telescoping intramedullary nail (see Betz, Abstract, Fig. 1).
Regarding claims 2 and 3, Brunner and Betz disclose the motorized intramedullary nail according to claim 1, and Brunner discloses [Claim 2] wherein said power supply battery is a lithium battery (para. 0022 describes energy source 32 as a stack of lithium cells, i.e. a lithium battery; Fig. 1), and [Claim 3] wherein said power supply battery is a lithium hydride battery or a lithium ion battery (para. 0040 describes the lithium cells as lithium-ion cells).
Regarding claim 4, Brunner and Betz disclose the motorized intramedullary nail according to claim 1, and Brunner discloses wherein said casing is a metal or silicone casing (para. 0023 describes hermetic casing/capsule 20 being made of titanium; Figs. 1, 2b).
Regarding claim 5, Brunner and Betz disclose the motorized intramedullary nail according to claim 4.
Neither Brunner nor Betz specifically disclose wherein said casing provides a maximum transversal dimension between about 20 mm and 50 mm, a maximum longitudinal dimension between about 20 mm and 50 mm, and a maximum depth between about 4 mm and 10 mm.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Brunner’s casing to have maximum transversal and longitudinal dimensions and a depth within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CPA 1955).
Regarding claims 6 and 7, Brunner and Betz disclose the motorized intramedullary nail according to claim 1, and Brunner discloses [Claim 6] wherein said motorized electro-mechanical device are coupled to a control unit which is electrically powered and inserted in said casing (external controller 90 and microcontroller 33, coupled to motor 35 of the electro-mechanical device and inserted in casing 20; Figs. 6a-b, 7; para. 0041, 0079), adapted to provide power according to a selected operating mode to said electro-mechanical device (via external control unit 90, operable by a user and communicating with microcontroller, thus capable to provide power according to a selected operating mode; Figs. 1, 6a-b, 7; para. 0040-0041), and [Claim 7] further comprising a plurality of displacement sensors, said control unit being programmable and functionally connected to said plurality of sensors for the collection of raw data from said plurality of sensors, the internal processing of said data and sending via a communication protocol to the outside, for the detection of a lengthening or shortening of said intramedullary nail (para. 0034 describes the controllable command circuit, understood to be associated with controllers 90/35, including magnetic field sensors such as hall effect sensors positioned at spaced-apart locations for determining distraction of the device, e.g. by collection of data via the controller(s) from the sensors, processing said data, and capable for sending data; Figs. 1, 6a-b, 7).
Regarding claims 8 and 9, Brunner and Betz disclose the motorized intramedullary nail according to claim 1, and Brunner discloses [Claim 8] wherein said motorized electro-mechanical device (35, 45, 48, 49; Figs. 1, 2a-b; para. 0028) comprise an electrical motor (35; Figs. 1, 2a-b) or gearmotor and a screw drive (48, 49; Figs. 1, 2a), and [Claim 9] wherein said screw drive comprises a endless screw (48; Fig. 1) and a nut screw (49; Fig. 1), said nut screw being operable in translation with respect to said endless screw, said second rod-shaped portion being integral in translation with said nut screw and said first tubular portion being integral in translation with said endless screw (as described in para. 0028; Figs. 1, 2a-b), or vice versa.
Regarding claim 10, Brunner and Betz disclose the motorized intramedullary nail according to claim 1, and Brunner discloses wherein the intramedullary nail is of the trochanteric type with a proximal part with centrally-obtained transversal and tilted holes for trochanteric screws (see Fig. 1, nail 10 having transversal holes 31, 61; Fig. 1; para. 0021, 0033).
Regarding claim 11, Brunner and Betz disclose the motorized intramedullary nail according claim 1, wherein said motorized electro-mechanical device for driving the rod-shaped portion are housed in a cartridge or capsule having a bottom or distal wall from which the electrical terminals emerge (Brunner’s electro-mechanical device 32 is housed in hermetic capsule 20, modified as described above so that electrical terminals are accessible via, i.e. emerging from, a bottom wall thereof; see Fig. 1 of Brunner).
Regarding claim 12, Brunner teaches a motorized intramedullary nail for bone lengthening or transport, comprising:
- a first nail tubular portion (sleeve 50; Fig. 1; para. 0028);
- a second rod-shaped portion (plunger 60; Fig. 1; para. 0028) telescopically sliding inside said first nail tubular portion (as indicated by the bidirectional arrow in Fig. 1);
- a motorized electro-mechanical actuator for driving the rod-shaped portion (collectively defined by electric motor 35, gearbox 45, lead-screw 48 and nut 49; Fig. 1; para. 0022, 0028);
- an power supply (electrical energy source 32; Figs. 1, 2b) having biocompatible features (hermetic capsule 20; Figs. 1, 2b; para. 0023, 0040-0041) for subcutaneous and prolonged implantation (as described in para. 0023);
the biocompatible power supply being connected for powering said motorized electro-mechanical actuator (as described in para. 0022).
Brunner does not specifically disclose electrical terminals of said electro-mechanical actuator accessible through the proximal part of the nail, and the power supply being an independent power supply.
Betz, in analogous art, is directed towards a motorized intramedullary nail (see Fig. 1), comprising a tubular portion and a rod-shaped portion (portions 2 and 3, respectively; Fig. 1), and a motorized electro-mechanical device for driving the rod-shaped portion relative to the tubular portion (see electric motor 14; Fig. 1; column 5, lines 15-25), and Betz discloses the electromechanical device comprising terminals accessible through the proximal part of the nail (as shown for connecting with leads 6, the terminals considered accessible through the proximal end of the device at end piece 12; Fig. 1), and the power supply (5; Fig. 1; column 5, lines 1-4) for the electromechanical device being an independent power supply (connected via electrical leads 6, as shown; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brunner’s electro-mechanical device, i.e. electrical motor, to have electrical terminals accessible through the proximal end of the drive casing of the nail, the electric terminals coupling to electrical leads as taught by Betz so as to supply power via a subcutaneous power supply (i.e., Brunner’s lithium battery cells), because Betz recognizes that such a configuration is suitable for supplying electrical power to a telescoping intramedullary nail (see Betz, Abstract, Fig. 1).
Regarding claims 13-14 and 16-17, Brunner and Betz disclose the motorized intramedullary nail according to claim 12, and Brunner discloses [Claim 13] wherein said independent power supply comprises a biocompatible casing (20; Figs. 1, 2b; para. 0023) and at least one power supply battery housed in said casing (para. 0022-0023 describe energy source 32 as a stack of lithium cells or another suitable electrical battery, housed in hermetic casing/capsule 20; Figs. 1-2b), [Claim 14] wherein said casing is a metal or silicone casing (para. 0023 describes hermetic casing/capsule 20 being made of titanium; Figs. 1, 2b), [Claim 16] wherein said motorized electro-mechanical actuator is coupled to a control unit which is electrically powered and inserted in said casing (external controller 90 and microcontroller 33, coupled to motor 35 of the electro-mechanical device and inserted in casing 20; Figs. 6a-b, 7; para. 0041, 0079), adapted to provide power according to a selected operating mode to said electro-mechanical device (via external control unit 90, operable by a user and communicating with microcontroller, thus capable to provide power according to a selected operating mode; Figs. 1, 6a-b, 7; para. 0040-0041), and [Claim 17] further comprising a plurality of displacement sensors, said control unit being programmable and functionally connected to said plurality of sensors for the collection of raw data from said plurality of sensors, the internal processing of said data and sending via a communication protocol to the outside, for the detection of a lengthening or shortening of said intramedullary nail (para. 0034 describes the controllable command circuit, understood to be associated with controllers 90/35, including magnetic field sensors such as hall effect sensors positioned at spaced-apart locations for determining distraction of the device, e.g. by collection of data via the controller(s) from the sensors, processing said data, and capable for sending data; Figs. 1, 6a-b, 7).
Regarding claim 15, Brunner and Betz disclose the motorized intramedullary nail according to claim 12.
Neither Brunner nor Betz specifically disclose wherein said casing provides a maximum transversal dimension between about 20 mm and 50 mm, a maximum longitudinal dimension between about 20 mm and 50 mm, and a maximum depth between about 4 mm and 10 mm.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Brunner’s casing to have maximum transversal and longitudinal dimensions and a depth within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CPA 1955).
Regarding claims 18 and 19, Brunner and Betz disclose the motorized intramedullary nail according to claim 12, and Brunner discloses [Claim 18] wherein said power supply battery is a lithium battery (para. 0022 describes energy source 32 as a stack of lithium cells, i.e. a lithium battery; Fig. 1), and [Claim 19] wherein said power supply battery is a lithium hydride battery or a lithium ion battery (para. 0040 describes the lithium cells as lithium-ion cells).
Regarding claim 20, Brunner and Betz disclose the motorized intramedullary nail according to claim 12, and Brunner discloses wherein said motorized electro-mechanical device (35, 45, 48, 49; Figs. 1, 2a-b; para. 0028) comprise an electrical motor (35; Figs. 1, 2a-b) or gearmotor and a screw drive (48, 49; Figs. 1, 2a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ANNA V. LITTLE/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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