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 .
Response to Amendment
2. This action is responsive to the amendments filed 1/5/2026. Claim 1 and 13 been amended. No claims were newly added. Claims 8 and 11-12 have been canceled.
Response to Arguments
3. Applicant’s response with respect to the art rejections 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.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, and 6 are rejected under 35 U.S.C 103 as being unpatentable over Kraus et al. (US Pub.: 2007/0265628 A1, – Previously Cited) and further in view of McGinnis et al. (US Pub.: 2008/0172107 A1) and further in view of Zellmer et al. (US Pub.: 2020/0108252 A1).
Regarding claim 1, Kraus teaches a system for an electrically stimulating surgical nail comprising:
a surgical nail implant (e.g. Fig. 1; paragraph 0039), comprising a shaft with an elongated shape along a length of the surgical nail implant (e.g. Fig. 1 – nail member 12), the shaft comprising at least a partially tubular segment defining an internal cavity within the surgical nail implant and including openings along the shaft (e.g. Fig. 1 – apertures 58 and 62; abstract), having at least two distinct electrode sites situated along the surgical nail (e.g. Fig. 1 – electrode 16 and electrode 18);
an end cap, comprising a head of the surgical nail implant, connected and fixed in place to one end of the surgical nail implant (e.g. Fig. 1 – end cap 20);
a set of electrodes, each associated with a respective electrode site of the at least two electrode sites (e.g. Fig. 1 – electrode 16 and electrode 18):
comprises an active exposed segment at the respective electrode site (e.g. Fig. 1 – electrode 16 and electrode 18; paragraph 0021, – electric fields are generated via the surface electrodes at the nail member and at the end cap),
is conductively coupled to an implant control circuitry (e.g. Fig. 1; paragraph 0011), and
implant circuitry, situated within the end cap, (e.g. Fig. 2) comprising:
implant receiver circuitry configured to convert an electromagnetic field to an electrical current (e.g. Fig. 2 – coil assembly 14 and coil core 46) and
implant control circuitry configured to control current flow of the set through the set of electrodes (e.g. paragraph 0007, – “treatment parameters voltage, frequency, intensity, signal shape and treatment time with indication-specific programming of a function current generator).
However, Kraus does not explicitly teach having at least two distinct electrode sites situated along the length of the shaft and that the electrodes are individually controllable; wherein each electrode is conductively isolated from all other electrodes in the set of electrodes as well as electrode circuitry traveling through the internal cavity of the tubular segment to connect to the set of electrodes, wherein each electrode is exposed on an exterior surface of the shaft through a respective opening in the shaft.
McGinnis, in a same field of endeavor of osteosynthesis and electrical stimulation, discloses at least two distinct electrode sites situated along the length of the shaft (e.g. Fig. 1B – electrodes 14; paragraphs 0029; 0031) and also teaches wherein each electrode comprises an active exposed segment at the respective electrode site (e.g. Fig. 1B – electrodes 14).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kraus to include at least two distinct electrode sites situated along the length of the shaft, as taught and suggested by McGinnis, in order to increase the strength/intensity of the electric field along the shaft for treatment as well as to enhance the healing process of an osseous structure.
However, Kraus in view of McGinnis does not explicitly teach that the electrodes are individually controllable; wherein each electrode is conductively isolated from all other electrodes in the set of electrodes as well as electrode circuitry traveling through the internal cavity of the tubular segment to connect to the set of electrodes, wherein each electrode is exposed on an exterior surface of the shaft through a respective opening in the shaft.
Zellmer, in a same field of endeavor of osteosynthesis and electrical stimulation, discloses electrodes that are individually controllable (e.g. paragraph 0055, – each electrode can be independently controlled; paragraph 0080); wherein each electrode is conductively isolated from all other electrodes in the set of electrodes (e.g. paragraphs 0080) as well as electrode circuitry traveling through the internal cavity of the tubular segment to connect to the set of electrodes (e.g. paragraph 0038), wherein each electrode is exposed on an exterior surface of the shaft through a respective opening in the shaft (e.g. paragraph 0050).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus and McGinnis to include electrodes that are individually controllable; wherein each electrode is conductively isolated from all other electrodes in the set of electrodes, as well as electrode circuitry traveling through the internal cavity of the tubular segment to connect to the set of electrodes, wherein each electrode is exposed on an exterior surface of the shaft through a respective opening in the shaft, as taught and suggested by Zellmer, for the purpose of providing more tailored and controlled therapy to the patient (Zellmer, paragraph 0055).
Regarding claim 2, Kraus in view of McGinnis in view of Zellmer teaches the system of claim 1 as discussed above, and Kraus further teaches wherein the implant receiver circuitry comprises an antenna system, at least partially embedded in the end cap of the surgical nail implant and configured to send and receive communication and electric current (e.g. Fig. 2 – element 46; the coil core acts as an antenna system).
Regarding claim 6, Kraus in view of McGinnis in view of Zellmer teaches the system of claim 2 as discussed above, and Zellmer further teaches wherein the implant circuitry is wirelessly powered by an external component via the implant receiver circuitry (e.g. paragraphs 0058, 0092).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, and Zellmer to include wherein the implant circuitry is wirelessly powered by an external component via the implant receiver circuitry, as taught and suggested by Zellmer, in order to reduce the need for invasive surgeries to repair/replace the device as well as to make it easier/more convenient to use the device.
Claims 3-5 is rejected under 35 U.S.C 103 as being unpatentable over Kraus and further in view of McGinnis and further in view of Zellmer and further in view of Sierra Circuits et al. (NPL reference, “The Benefits of Flex PCBs and their Applications”, published February 2020, hereafter referred to as “Sierra”, – Previously Cited).
Regarding claim 3, Kraus in view of McGinnis in view of Zellmer teaches the system of claim 2 as discussed above, and Kraus further teaches wherein the implant circuitry is situated inside the end cap (e.g. Fig. 2). However, Kraus in view of McGinnis in view of Zellmer does not explicitly teach wherein the implant circuitry is situated on a folded printed circuit board.
Sierra, in a same field of endeavor of medical devices, discloses wherein the implant circuitry is situated on a folded printed circuit board (e.g. page 6, – use in implantable medical equipment).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, and Zellmer to include wherein the implant circuitry is situated on a folded printed circuit board, as taught and suggested by Sierra, in order to reduce the weight of the system as well as to lower the cost of the system (Sierra, page 2).
Regarding claim 4, Kraus in view of McGinnis in view of Zellmer in view of Sierra teaches the system of claim 3 as discussed above, and Kraus further teaches wherein the end cap is connected to the surgical nail implant through a conductive connector that includes an electrical conduit that connects the implant circuitry and the set of electrodes (e.g. paragraphs 0012-0013).
Regarding claim 5, Kraus in view of McGinnis in view of Zellmer in view of Sierra teaches the system of claim 4 as discussed above, and Kraus further teaches and wherein the end cap is hermetically sealed (e.g. paragraphs 0012, 0041, – gas and fluid-tight is construed as hermetically sealed).
Claims 7, 9-10, 13-16 and 18-19 are rejected under 35 U.S.C 103 as being unpatentable over Kraus and further in view of McGinnis and further in view of Zellmer and further in view of Crabtree et al. (NPL reference, “Titanium in the Medical Industry. Orthopedic Design Technology”, published 2020, – Previously Cited) and further in view of Panayotov et al. (NPL reference, “(PEEK) for medical applications”, published 2016, – Previously Cited).
Regarding claim 7, Kraus in view of McGinnis in view of Zellmer teaches the
system of claim 2 as discussed above. Kraus specifically teaches the surgical nail, however, Kraus in view of McGinnis in view of Zellmer does not explicitly teach wherein the surgical nail implant is primarily composed of titanium and the end cap is primarily composed of poly ether ketone.
Crabtree, in a same field of endeavor of medical devices, discloses that titanium is a preferred material for forming orthopedic implants (e.g. page 2, – titanium is a metal used in various medical devices including implantable devices).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have formed the surgical nail implant of Kraus in view of McGinnis in view of Zellmer from titanium as suggested by Crabtree, in order to increase the biocompatibility and flexibility of the system as well as decrease the weight of the system (Crabtree, page 2).
Kraus teaches that the end cap is formed from polyethylene (e.g. paragraph 0014), however, Kraus in view of McGinnis in view of Zellmer and Crabtree does not explicitly teach that the end cap is primarily composed of PEEK (e.g. Examiner notes that “primarily” is being interpreted as greater than or equal to 50%).
Panayotov, in a same field of endeavor of medical devices, discloses the use of PEEK in orthopedic medical devices (e.g. page 1, – Polyetheretherketone (PEEK) is a polyaromatic
semi-crystalline thermoplastic polymer used in various biomedical applications).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, Zellmer, and Crabtree to form the end cap from PEEK as taught and suggested by Panayotov, for the purpose of increasing the radiolucency and MRI compatibility of the end-cap portion of the system (Panayotov, page 2).
Regarding claim 9, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 7 as discussed above, and Kraus further teaches wherein the shaft comprises an at least partially solid segment (e.g. Fig. 2 – element 12; paragraph 0044).
Regarding claim 10, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 9 as discussed above, and Kraus further teaches wherein the electrode sites are etched onto the surface of the surgical nail (e.g. Fig. 1 – elements 16 and 18; abstract, – “at least one section of the contact surface forms the first electrode and that at least one section of the nail member forms the second electrode”).
Regarding claim 13, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 7 as discussed above, and Kraus further teaches wherein the surgical nail comprises an at least partially open segment, such that along the open segment of the surgical nail, the interior surface and the external surface of the surgical nail form a continuous surface (e.g. Fig. 1 – element 32; paragraph 0039).
Regarding claim 14, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 7 as discussed above, and Kraus further teaches wherein electrode stimulation sites are positioned along the length of the surgical nail (e.g. Fig. 1 – elements 16 and 18; abstract). Additionally, McGinnis also teaches electrode stimulation sites positioned along the length of the surgical nail (e.g. Fig. 1B – electrodes 14; paragraphs 0029; 0031).
Regarding claim 15, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 14 as discussed above, and Kraus further teaches wherein electrode stimulation sites comprise rings around the shaft of the surgical nail (e.g. paragraph 0012).
Regarding claim 16, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 14 as discussed above, and Zellmer further teaches wherein the implant control circuitry provides an electrode stimulation mode, wherein during the electrode stimulation mode, the implant control circuitry activates a subset of electrodes from the set of electrodes to provide electric stimulation (e.g. paragraph 0083).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, Zellmer, Crabtree, and Panayotov to include wherein the implant control circuitry provides an electrode stimulation mode, wherein during the electrode stimulation mode, the implant control circuitry activates a subset of electrodes from the set of electrodes to provide electric stimulation, as taught and suggested by Zellmer, for the purpose of making it easier to provide more tailored therapy to the patient (Zellmer, paragraph 0083).
Regarding claim 18, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 7 as discussed above, and Kraus further teaches wherein the system further includes insulation, wherein insulation is situated on each electrode site thereby conductively isolating the electrode stimulation site from the surgical nail (e.g. paragraphs 0011, 0022).
Regarding claim 19, Kraus in view of McGinnis in view of Zellmer in view of Crabtree in view of Panayotov teaches the system of claim 7 as discussed above, and Zellmer further teaches wherein the implant control circuitry provides an impedance measuring operating mode, such that in an impedance measuring operating mode, the impedance between a pair of electrodes is measured (e.g. paragraphs 0090-0091). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, Zellmer, Crabtree, and Panayotov to include wherein the implant control circuitry provides an impedance measuring operating mode, such that in an impedance measuring operating mode, the impedance between a pair of electrodes is measured, as taught and suggested by Zellmer, for the purpose of approximating bone growth and determining whether treatment is effective (Zellmer, paragraph 0090).
Claim 20 is rejected under 35 U.S.C 103 as being unpatentable over Kraus and further in view of McGinnis and further in view of Zellmer and further in view of Viswanathan et al. (International Publication No.: WO 2019/217300 A1– Previously Cited).
Regarding claim 20, Kraus in view of McGinnis in view of Zellmer teaches the system of claim 1 as discussed above. However, Kraus in view of McGinnis in view of Zellmer do not explicitly teach the surgical nail implant comprising regional designators that physically mark subsets of electrodes on the shaft.
Viswanathan, in a same field of endeavor of electrical stimulation, discloses regional designators that physically mark subsets of electrodes on the shaft (e.g. paragraphs 0072, 0084, – fiducials/markings which can be identified and differentiated by color).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, and Zellmer to include regional designators that physically mark subsets of electrodes on the shaft, as taught and suggested by Viswanathan, for the purpose of increasing the precision and accuracy of the therapy.
Claim 17 is rejected under 35 U.S.C 103 as being unpatentable over Kraus and further in view of McGinnis and further in view of Zellmer and further in view of Viswanathan and further in view of Wizeman et al. (US Pub.: 2008/0097424 A1– Previously Cited).
Regarding claim 17, Kraus in view of McGinnis in view of Zellmer teaches the system of claim 20 as discussed above. Zellmer further teaches that the implant control circuitry is configured to operate under different modes of operation (e.g. paragraphs 0082, 0084). However, Kraus in view of McGinnis in view of Zellmer in view of Viswanathan does not explicitly teach wherein the regional designators use color, and wherein during an electrode stimulation mode, the implant control circuitry provides color-based excitation, wherein a color coincides to a lengthwise position along the shaft of the surgical nail.
Wizeman, in a same field of endeavor of electrical stimulation, discloses wherein the regional designators use color, and wherein during an electrode stimulation mode, the implant control circuitry provides color-based excitation, wherein a color coincides to a lengthwise position along the shaft (e.g. paragraph 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kraus, McGinnis, Zellmer, and Viswanathan to incorporate color-based excitation, wherein a color coincides to a lengthwise position along the shaft, as taught and suggested by Wizeman, in order to provide visual indicators of depth to the clinician during treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792