DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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. Applicant’s Amendment filed March 26, 2026 (hereinafter “03/26/26 Amendment") has been entered, and fully considered. In the 03/26/26 Amendment, claims 1, 3, 6-8, 14, 17, 18, & 20 were amended. No claims were cancelled, or newly added. Therefore, claims 1-20 remain pending in the application.
3. The 03/26/26 Amendment has overcome the rejections under §§ 112(b) & 102 previously set forth in the Non-Final Office Action mailed 12/30/25 (“12/30/25 Action”)
4. New and updated rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Rejections - 35 USC § 103
6. 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.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
8. Claims 1-5, 8, 11, 12, & 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0067388 to Zellmer et al. (“Zellmer”) in view of U.S. Patent Application Publication No. 2020/0108252 to Zellmer et al. ("Zellmer ‘252").
9. Regarding claim 1, Zellmer teaches an electrode assembly comprising:
a first housing [broadly, an insulation composition in which electrodes are positioned at an “electrode site” - e.g., ¶’s [0069]-[0072]; FIG. 27] containing at least one electrode [an electrode from set of electrodes (130) - ¶’s [0062]-[0065]]; and
a control module [implant circuitry (140) within end cap (120) - ¶’s [0046]-[0048], [0077]-[0078]; FIG. 1] with a first connector for mating with a complementary connector on the first housing [e.g., ¶’s [0056], [0068] (“The set of electrodes 130 may include electrode circuitry. Electrode circuitry functions as the electrical conduit between the electrode stimulation site 132 of each electrode to the implant control circuitry within the end cap 120. The electrode circuitry can be one or more conductive traces, wires, and/or other suitable conductive paths connecting an electrode stimulation site 132 to the implant control circuitry”); NOTE: the foregoing interpretation is consistent with Applicant’s defined “connector” - see, e.g., Applicant’s published Specification (U.S. 2025/0268529) at, e.g., ¶[0060] (“Connectors can include electrical connectors for enabling electrical connection between electrodes 30 and the control module 40”)], the control module including a controller programmed [see, e.g., ¶’s [0100]-[0107] (& FIGS. 31-32) concerning execution of machine-executable instructions of software programs via processors] to initiate transmission of at least one of a measurement pattern [broadly, initiating impedance measurements - e.g., ¶’s [0029], [0095], [0096]] or a stimulation pattern to a patient with the at least one electrode [stimulation pattern - see, e.g., ¶[0062] (“The set of electrodes 130 function to provide electrical stimulation (e.g., for treatment). Each electrode, from the set of electrodes, includes a distinct stimulation site 132 and circuitry conductively coupled to the implant control circuitry within the end cap 120”); ¶[0092] (“The implant control circuitry may also enable operating modes for the orthopedic implant. These operating modes may be implementation specific. Examples of different types of operating modes may comprise: different types of electrode activation, both for sensory functionality and for providing tissue stimulation; operation of sensor components; application of externally provided stimulation activity (e.g., doctor prescribed); and/or other types of operation”); & ¶’s [0093], [0094]], [and]
wherein the first housing [insulation] and the control module [implant circuitry (140)] include a biocompatible material [the insulative material may comprise, e.g., PEEK (see ¶[0070) which is a known biocompatible material; and, the control module also comprises a biocompatible material - see ¶[0061] (“the end cap 120 may include a PEEK portion housing the antenna and a titanium housing the implant circuitry 140”)], and when connected, are sized to complement an orthopedic implant [as broadly as claimed, the insulation and implant circuitry are sized for inclusion as part of a surgical nail orthopedic implant - see ¶[0029] (“The system may have a particularly useful implementation as a surgical nail orthopedic implant (also referred to as intermedullary rod or intermedullary nail), wherein the electrodes are exposed along the shaft of the nail, and the control circuitry is contained in the end cap at the head of the surgical nail. The system may thus enable dynamic targeted stimulation to subregions along the length of the nail and/or in different subregions around the nail”)].
SIZED FOR GROOVE
As noted above, the electrode assembly of Zellmer comprises, inter alia, the first housing [insulation composition with its associated electrode (130) positioned at an “electrode site”] and the control module [implant circuitry (140)], which are connected via electrode circuitry. FIGS. 1 & 13 of Zellmer show that the electrode assembly may, for example, be positioned/received within a designated receptacle of an implant [the electrode assembly is provided in an interior cavity of the implant, which is defined by the shaft (implant body) and end cap].
It is the Examiner’s position that the electrode assembly of Zellmer, including its constituent components, may be similarly positioned elsewhere with respect to an implant body depending on, e.g., the size, shape, and configuration of the implant body with which it is intended to be used, such that the electrode assembly can be easily placed, and even removed from the implant as desired.
In fact, Zellmer explicitly recognizes variations in implant bodies, teaching that an implant body itself may be solid, tubular, and/or open [e.g., ¶[0050] (“Dependent on implementation, the surgical nail body may be solid, as shown in example FIG. 6; tubular (i.e., include an internal cavity), as shown in example FIG. 7; be open, as shown in example FIG. 8; and/or some combination of the three, as shown in example FIG. 9. That is, dependent on implementation the shaft of the surgical nail may be: entirely solid, tubular, or open; or comprise any combination of solid, tubular, and/or open section”)].
Zellmer also teaches that an implant body may have a variety of shapes [e.g., ¶’s [0040], [0041], [0043], [0049]].
Zellmer teaches that the foregoing variations concerning the implant body may result in different configurations or arrangements of the components of the electrode assembly [e.g., ¶’s [0053] (“The shape and positioning of the electrode sites may vary dependent on implementation”), [0064], [0068] (“Dependent on implementation, the electrode circuitry may comprise physical wiring, conductive traces on a flexible or rigid circuit board, conductive paths manufactured into the surgical nail body, silicon wafers, and/or any other type of durable electrically conducting material. In variations, where the surgical nail includes tubular and/or open regions, the electrode circuitry may travel through the interior of the surgical nail”); ¶[0073] (“the set of electrodes 130 may be positioned as desired per implementation, wherein the electrode stimulation sites 132 (or exposed electrodes) may be of any desired shape or size”); ¶[0074] (“for a solid shaft segment, the electrode circuitry may be housed on the exterior of the rod-like implant body 110”); and ¶[0076] (“for a tubular segment, the electrode circuitry may be generally housed on the interior of the implant body, but may also be positioned on the outside as per the solid segment”)].
Zellmer further contemplates the modularity and ease of connection of the components of the electrode assembly [see, e.g., ¶[0034] (“The system potentially provides the benefit of a seamless integration of electronics into a surgical nail”); ¶[0035] (“In some variations, modular electronic components may be incorporated with the surgical nail, which can then be removed later. This potentially provides the added benefit of an active treatment implant, while treatment is necessary while allowing the benefit of continued use of the surgical nail implant on a longer term that still provides a mechanical functionality”); ¶[0078] (“In many variations, the implant circuitry 140 is primarily situated on one, or more, printed circuit boards (PCBs)… The PCBs function to provide a circuitry surface for the implant circuitry and enable easy connection between electronic components”); ¶[0079] (“In preferred variations, the PCB itself may be flexible, wherein all or parts of the PCB are bendable (although electronic components on the PCB may not be bendable). In other words, the PCB includes a flexible substrate. As the PCB is preferably part of a medical implant, the PCB may be constructed of any appropriate non-toxic non-reactive material”); and ¶[0080] (“The PCB may include bends and/or folds”)].
While Zellmer contemplates the various configurations addressed above, including, e.g., positioning components on an exterior of the rod-like implant body [see ¶[0074] (“for a solid shaft segment, the electrode circuitry may be housed on the exterior of the rod-like implant body”), Zellmer does not explicitly teach that the electrode assembly is sized to fit within an exterior groove, or more particularly:
wherein the first housing and the control module are sized to sit within a groove disposed on an exterior surface of the orthopedic implant.
Zellmer ‘252, in a similar field of endeavor, teaches a system for altering bone growth on or within an orthopedic implant including, inter alia, an implant body (100), a plurality of electrodes (110), and a control system (120) that controls the activity of each electrode from the plurality of electrodes [¶[0036]].
Zellmer ‘252 teaches that the implant body “may or may not have an interior cavity” [¶[0048]].
Zellmer ‘252 teaches that implant body (100) “functions as a structural element, housing, or holding other implant subcomponents” [¶[0039]].
Similar to Zellmer, Zellmer ‘252 teaches variations in the size, shape, and/or placement of electrodes [e.g., ¶’s [0050]-[0052]].
Zellmer ‘252 teaches that the control system (120) may be implanted as part of the implant body [¶[0079]], and can include circuitry effectively connecting the control system with other system components [e.g., ¶[0038] (“The control system 120 preferably includes a processor and circuitry that connects the control system to the plurality of electrodes 110”); ¶[0049] (“An electrode is preferably a conductive element that includes an electrode site (e.g., a conductive pad exposed to body tissue) connected (directly or indirectly) to other implant components (e.g. control system 120 and power system 130)”); and ¶’s [0080]-[0081]].
Zellmer ‘252 additionally teaches that the choice and/or design of the implant may influence positioning of electrodes, and that it was known to position electrodes in a groove of an implant [see, e.g., ¶[0118] (“Positioning of a subset of electrodes may occur prior to implantation of the implant, during the placement of the implant, after the implant has already been placed within a patient, and/or any combination of the prior, during, or after. Implants may have specific design features with electrode position in mind. For examples, implants may have holes or grooves for the placement of electrodes. Thus positioning of a subset of electrodes may occur, or be determined, by the choice and/or design of the implant”)].
Based on the foregoing teachings of Zellmer and Zellmer ‘252, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zellmer such that the electrode assembly of Zellmer, including its constituent components (i.e., the first housing and the control module) be sized to sit within a groove disposed on an exterior surface of the orthopedic implant, since such a known placement technique, i.e., placement of electrical components in a receptacle of an implant configured as a groove, was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Zellmer ‘252), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Zellmer, and the results [placement of the electrode assembly in a known, art-recognized receptacle on an exterior surface of an implant ] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while it is appreciated that the relied-upon portion of Zellmer ‘252 does not explicitly recite that the control module would also be placed in the groove, it is noted that the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
In the instant case, as established above, both Zellmer and Zellmer ‘252 recognize: (1) variations in implant bodies [i.e., an implant body may be solid or have an interior cavity]; (2) that implant bodies may have a variety of shapes; and (3) that the size, shape, and/or placement of electrodes may vary depending on different implementations. In view of these teachings, along with Zellmer’s teaching that the electrode circuitry (connecting the electrodes to the control moldule) may be housed on the interior or exterior of the implant body, and that the implant circuitry [control module] may be provided on one or more flexible PCBs that include bends or folds, placement of the electrode assembly (including the control module) in a groove disposed on an exterior surface of the orthopedic implant would have been a choice well within the ordinary creativity of a person of ordinary skill in the art (particularly in instances when the implant body itself comprises a solid body lacking an interior cavity) based on the straightforward teachings and objectives of Zellmer.
10. Regarding claim 2, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the controller is programmed to initiate transmission of both the measurement pattern and the stimulation pattern to the patient [e.g., ¶’s [0033], [0062], [0063],[0072], [0095], [0096], [0099]], and wherein the at least one electrode [(130)] is configured for use in both the measurement pattern and the stimulation pattern [e.g., ¶’s [0033], [0062], [0063], [0072], [0095], [0096], [0099]].
11. Regarding claim 3, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the least one electrode includes a plurality of electrodes [(“set of electrodes 130”) - ¶[0038], FIG. 27].
Zellmer was modified above (in the rejection of claim 1) such that the first housing and the control module be sized to sit within a groove disposed on an exterior surface of the orthopedic implant.
Zellmer ‘252 further teaches that it was known to have electrical components be either flush with, protruding from, or recessed within, an exterior surface of the implant body [e.g., ¶[0052] (“The electrode sites are preferably flush with the surface of the implant body 100 along the interior or exterior cavity of the implant body 100. Alternatively, the exposed electrode sites may protrude from the implant body 100 or be recessed within the implant body 100”).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer and Zellmer ‘252 such that the first housing and the control module be adapted to sit flush with an outermost surface of the orthopedic implant, depending on design objectives and/or intended placement location of the implant within the body (e.g., so as not to unintentionally irritate surrounding anatomy or tissue with protruding surfaces).
12. Regarding claim 4, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches a second housing containing at least one additional electrode [broadly, a second insulation composition in which electrodes are positioned at an “electrode site” - e.g., ¶’s [0069]-[0072]; see FIG. 27 wherein a second insulation composition (on the right) includes two electrodes], wherein the control module includes a second connector for mating with a complementary connector on the second housing [e.g., ¶’s [0056], [0068] (“The set of electrodes 130 may include electrode circuitry. Electrode circuitry functions as the electrical conduit between the electrode stimulation site 132 of each electrode to the implant control circuitry within the end cap 120. The electrode circuitry can be one or more conductive traces, wires, and/or other suitable conductive paths connecting an electrode stimulation site 132 to the implant control circuitry”); NOTE: the foregoing interpretation is consistent with Applicant’s defined “connector” - see, e.g., Applicant’s published Specification (U.S. 2025/0268529) at, e.g., ¶[0060] (“Connectors can include electrical connectors for enabling electrical connection between electrodes 30 and the control module 40”)].
13. Regarding claim 5, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein when the first housing and the control module are connected, the electrode assembly is pliable to complement at least one contour in the orthopedic implant [e.g., ¶[0068] (“the electrode circuitry may comprise physical wiring, conductive traces on a flexible or rigid circuit board”); ¶[0079] (“the PCB itself may be flexible”); note also the various curved implant bodies in FIG. 2].
14. Regarding claim 8, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the at least one electrode includes a plurality of electrodes [(“set of electrodes 130”) - ¶[0038]] interposed between adjacent insulative sections [clearly shown in FIG. 27], wherein each of the plurality of electrodes [(130)] is selectable for at least one of: measurement based on the measurement pattern or stimulation based on the stimulation pattern [e.g., ¶’s [0038], [0063] (“Each electrode, from the set of electrodes 130, may be individually controllable, such that any direction of current of a desired magnitude may be sent or received from each electrode”)].
15. Regarding claim 11, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the first housing [insulation] includes a flexible tubular body [as broadly as claimed, the insulation is disposed on the outer tubular surface of the implant body and therefore also has a tubular body - ¶’s [0069]-[0072]] and wherein the at least one electrode [(130)] is integrated in a wall of the flexible tubular body [e.g., FIG. 15] such that a primary axis of each electrode [(130)] is parallel with a primary axis of the flexible tubular body [e.g., FIGS. 15, 27].
16. Regarding claim 12, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the first housing [insulation] includes a flexible tubular body with an internal channel [as broadly as claimed, the insulation is disposed on the outer tubular surface of the implant body and therefore also has a tubular body - ¶’s [0069]-[0072]; FIG. 27], and wherein the at least one electrode [(130)] is integrated in a wall of the flexible tubular body [FIG. 15] such that a primary axis of each electrode [(130)] is off-axis relative to a primary axis of the flexible tubular body [note the curved implant bodies of FIG. 2].
17. Regarding claim 14, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the first housing [insulation composition] and the control module [implant circuitry (140)] have an arcuate outer dimension [as shown in FIG. 27, the insulation composition is disposed on the outer arcuate surface of the implant body, and therefore has an arcuate outer dimension; additionally, with reference to FIG. 1, implant circuitry (140), provided in end cap (120), likewise has an arcuate outer dimension] or an angled outer dimension.
18. Regarding claim 15, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the orthopedic implant includes a knee implant, a tibial insert, a hip implant, or a surgical nail [e.g., ¶[0029] (“The system may have a particularly useful implementation as a surgical nail orthopedic implant (also referred to as intermedullary rod or intermedullary nail), wherein the electrodes are exposed along the shaft of the nail, and the control circuitry is contained in the end cap at the head of the surgical nail”)].
19. Regarding claim 16, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the first housing [insulation composition] and the control module [implant circuitry (140)] are integrally assembled [broadly, they are both an integral part of the nail implant (FIG. 1)], or configured for assembly during a surgical procedure on the patient.
20. Regarding claim 17, Zellmer teaches an orthopedic implant comprising:
a body for securing in a patient [implant (110)], the body [(110)] including a mating feature [conductive connector - ¶[0046]]; and
an electrode assembly coupled with the body at the mating feature [¶[0046]], the electrode assembly including:
a first housing [broadly, an insulation composition in which electrodes are positioned at an “electrode site” - e.g., ¶’s [0069]-[0072]; FIG. 27] containing at least one electrode [an electrode from set of electrodes (130) - ¶’s [0062]-[0065]]; and
a control module [implant circuitry (140) within end cap (120) - ¶’s [0046]-[0048], [0077]-[0078]; FIG. 1] connected with the first housing [e.g., ¶’s [0056], [0068] (“The set of electrodes 130 may include electrode circuitry. Electrode circuitry functions as the electrical conduit between the electrode stimulation site 132 of each electrode to the implant control circuitry within the end cap 120. The electrode circuitry can be one or more conductive traces, wires, and/or other suitable conductive paths connecting an electrode stimulation site 132 to the implant control circuitry”); NOTE: the foregoing interpretation is consistent with Applicant’s defined “connector” - see, e.g., Applicant’s published Specification (U.S. 2025/0268529) at, e.g., ¶[0060] (“Connectors can include electrical connectors for enabling electrical connection between electrodes 30 and the control module 40”)], the control module including a controller programmed [see, e.g., ¶’s [0100]-[0107] (& FIGS. 31-32) concerning execution of machine-executable instructions of software programs via processors] to initiate transmission of at least one of a measurement pattern [broadly, initiating impedance measurements - e.g., ¶’s [0029], [0095], [0096]] or a stimulation pattern to a patient with the at least one electrode [stimulation pattern - see, e.g., ¶[0062] (“The set of electrodes 130 function to provide electrical stimulation (e.g., for treatment). Each electrode, from the set of electrodes, includes a distinct stimulation site 132 and circuitry conductively coupled to the implant control circuitry within the end cap 120”); ¶[0092] (“The implant control circuitry may also enable operating modes for the orthopedic implant. These operating modes may be implementation specific. Examples of different types of operating modes may comprise: different types of electrode activation, both for sensory functionality and for providing tissue stimulation; operation of sensor components; application of externally provided stimulation activity (e.g., doctor prescribed); and/or other types of operation”); & ¶’s [0093], [0094]], [and]
wherein the electrode assembly complements the mating feature on the body [broadly, the electrode assembly connects to the conductive connector to complete the connection - see ¶[0046]].
SIZED FOR GROOVE
As noted above, the electrode assembly of Zellmer comprises, inter alia, the first housing [insulation composition with its associated electrode (130) positioned at an “electrode site”] and the control module [implant circuitry (140)], which are connected via electrode circuitry. FIGS. 1 & 13 of Zellmer show that the electrode assembly may, for example, be positioned/received within a designated receptacle of an implant [the electrode assembly is provided in an interior cavity of the implant, which is defined by the shaft (implant body) and end cap].
It is the Examiner’s position that the electrode assembly of Zellmer, including its constituent components, may be similarly positioned elsewhere with respect to an implant body depending on, e.g., the size, shape, and configuration of the implant body with which it is intended to be used, such that the electrode assembly can be easily placed, and even removed from the implant as desired.
In fact, Zellmer explicitly recognizes variations in implant bodies, teaching that an implant body itself may be solid, tubular, and/or open [e.g., ¶[0050] (“Dependent on implementation, the surgical nail body may be solid, as shown in example FIG. 6; tubular (i.e., include an internal cavity), as shown in example FIG. 7; be open, as shown in example FIG. 8; and/or some combination of the three, as shown in example FIG. 9. That is, dependent on implementation the shaft of the surgical nail may be: entirely solid, tubular, or open; or comprise any combination of solid, tubular, and/or open section”)].
Zellmer also teaches that an implant body may have a variety of shapes [e.g., ¶’s [0040], [0041], [0043], [0049]].
Zellmer teaches that the foregoing variations concerning the implant body may result in different configurations or arrangements of the components of the electrode assembly [e.g., ¶’s [0053] (“The shape and positioning of the electrode sites may vary dependent on implementation”), [0064], [0068] (“Dependent on implementation, the electrode circuitry may comprise physical wiring, conductive traces on a flexible or rigid circuit board, conductive paths manufactured into the surgical nail body, silicon wafers, and/or any other type of durable electrically conducting material. In variations, where the surgical nail includes tubular and/or open regions, the electrode circuitry may travel through the interior of the surgical nail”); ¶[0073] (“the set of electrodes 130 may be positioned as desired per implementation, wherein the electrode stimulation sites 132 (or exposed electrodes) may be of any desired shape or size”); ¶[0074] (“for a solid shaft segment, the electrode circuitry may be housed on the exterior of the rod-like implant body 110”); and ¶[0076] (“for a tubular segment, the electrode circuitry may be generally housed on the interior of the implant body, but may also be positioned on the outside as per the solid segment”)].
Zellmer further contemplates the modularity and ease of connection of the components of the electrode assembly [see, e.g., ¶[0034] (“The system potentially provides the benefit of a seamless integration of electronics into a surgical nail”); ¶[0035] (“In some variations, modular electronic components may be incorporated with the surgical nail, which can then be removed later. This potentially provides the added benefit of an active treatment implant, while treatment is necessary while allowing the benefit of continued use of the surgical nail implant on a longer term that still provides a mechanical functionality”); ¶[0078] (“In many variations, the implant circuitry 140 is primarily situated on one, or more, printed circuit boards (PCBs)… The PCBs function to provide a circuitry surface for the implant circuitry and enable easy connection between electronic components”); ¶[0079] (“In preferred variations, the PCB itself may be flexible, wherein all or parts of the PCB are bendable (although electronic components on the PCB may not be bendable). In other words, the PCB includes a flexible substrate. As the PCB is preferably part of a medical implant, the PCB may be constructed of any appropriate non-toxic non-reactive material”); and ¶[0080] (“The PCB may include bends and/or folds”)].
While Zellmer contemplates the various configurations addressed above, including, e.g., positioning components on an exterior of the rod-like implant body [see ¶[0074] (“for a solid shaft segment, the electrode circuitry may be housed on the exterior of the rod-like implant body”), Zellmer does not explicitly teach that the electrode assembly is sized to fit within an exterior groove, or more particularly:
wherein the mating feature includes a groove, and the first housing and the control module are sized to be retained in the groove of the body.
Zellmer ‘252, in a similar field of endeavor, teaches a system for altering bone growth on or within an orthopedic implant including, inter alia, an implant body (100), a plurality of electrodes (110), and a control system (120) that controls the activity of each electrode from the plurality of electrodes [¶[0036]].
Zellmer ‘252 teaches that the implant body “may or may not have an interior cavity” [¶[0048]].
Zellmer ‘252 teaches that implant body (100) “functions as a structural element, housing, or holding other implant subcomponents” [¶[0039]].
Similar to Zellmer, Zellmer ‘252 teaches variations in the size, shape, and/or placement of electrodes [e.g., ¶’s [0050]-[0052]].
Zellmer ‘252 teaches that the control system (120) may be implanted as part of the implant body [¶[0079]], and can include circuitry effectively connecting the control system with other system components [e.g., ¶[0038] (“The control system 120 preferably includes a processor and circuitry that connects the control system to the plurality of electrodes 110”); ¶[0049] (“An electrode is preferably a conductive element that includes an electrode site (e.g., a conductive pad exposed to body tissue) connected (directly or indirectly) to other implant components (e.g. control system 120 and power system 130)”); and ¶’s [0080]-[0081]].
Zellmer ‘252 additionally teaches that the choice and/or design of the implant may influence positioning of electrodes, and that it was known to position electrodes in a groove of an implant [see, e.g., ¶[0118] (“Positioning of a subset of electrodes may occur prior to implantation of the implant, during the placement of the implant, after the implant has already been placed within a patient, and/or any combination of the prior, during, or after. Implants may have specific design features with electrode position in mind. For examples, implants may have holes or grooves for the placement of electrodes. Thus positioning of a subset of electrodes may occur, or be determined, by the choice and/or design of the implant”)].
Based on the foregoing teachings of Zellmer and Zellmer ‘252, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zellmer such that the electrode assembly of Zellmer, including its constituent components (i.e., the first housing and the control module) be sized to sit within a groove disposed on an exterior surface of the orthopedic implant or, more particularly, wherein the mating feature includes a groove, and the first housing and the control module are sized to be retained in the groove of the body, since such a known placement technique, i.e., placement of electrical components in a receptacle of an implant configured as a groove, was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Zellmer ‘252), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Zellmer, and the results [placement of the electrode assembly in a known, art-recognized receptacle on an exterior surface of an implant ] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while it is appreciated that the relied-upon portion of Zellmer ‘252 does not explicitly recite that the control module would also be placed in the groove, it is noted that the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
In the instant case, as established above, both Zellmer and Zellmer ‘252 recognize: (1) variations in implant bodies [i.e., an implant body may be solid or have an interior cavity]; (2) that implant bodies may have a variety of shapes; and (3) that the size, shape, and/or placement of electrodes may vary depending on different implementations. In view of these teachings, along with Zellmer’s teaching that the electrode circuitry (connecting the electrodes to the control moldule) may be housed on the interior or exterior of the implant body, and that the implant circuitry [control module] may be provided on one or more flexible PCBs that include bends or folds, placement of the electrode assembly (including the control module) in a groove disposed on an exterior surface of the orthopedic implant would have been a choice well within the ordinary creativity of a person of ordinary skill in the art (particularly in instances when the implant body itself comprises a solid body lacking an interior cavity) based on the straightforward teachings and objectives of Zellmer.
21. Regarding claim 18, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the at least one electrode includes a plurality of electrodes [(“set of electrodes 130”) - ¶[0038]] interposed between adjacent insulative sections [clearly shown in FIG. 27], wherein each of the plurality of electrodes [(130)] is selectable for at least one of:
measurement based on the measurement pattern or stimulation based on the stimulation pattern [e.g., ¶’s [0038], [0063] (“Each electrode, from the set of electrodes 130, may be individually controllable, such that any direction of current of a desired magnitude may be sent or received from each electrode”)].
22. Regarding claim 19, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the controller is programmed to initiate transmission of both the measurement pattern and the stimulation pattern to the patient [e.g., ¶’s [0033], [0062], [0063],[0072], [0095], [0096], [0099]], and wherein the at least one electrode [(130)] is configured for use in both the measurement pattern and the stimulation pattern [e.g., ¶’s [0033], [0062], [0063], [0072], [0095], [0096], [0099]].
23. Regarding claim 20, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Claim 20 further requires “when the electrode assembly is retained in the groove, the first housing and the control module are adapted to sit flush with an outermost surface of the body.”
Zellmer ‘252 further teaches that it was known to have electrical components be either flush with, protruding from, or recessed within, an exterior surface of the implant body [e.g., ¶[0052] (“The electrode sites are preferably flush with the surface of the implant body 100 along the interior or exterior cavity of the implant body 100. Alternatively, the exposed electrode sites may protrude from the implant body 100 or be recessed within the implant body 100”).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer & Zellmer ‘252 such that when the electrode assembly is retained in the groove, the first housing and the control module are adapted to sit flush with an outermost surface of the body, depending on design objectives and/or intended placement location of the implant within the body (e.g., so as not to unintentionally irritate surrounding anatomy or tissue with protruding surfaces).
24. Claims 6 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer and Zellmer ‘252, as applied to claim 5 above, and further in view of U.S. Patent Application Publication No. 2013/0131679 to Janna et al. ("Janna").
25. Regarding claim 6, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Zellmer and Zellmer ‘252 does not, however, teach:
wherein the electrode assembly is sized to snap-fit in the groove of the orthopedic implant.
Janna, in a similar field of endeavor, relates to orthopedic implants [¶[0002]], particularly instrumented intramedullary (IM) nails [¶’s [0006], [0008]].
More particularly, Janna teaches an implant (30) comprising a probe (50) disposed within a longitudinal groove (60) formed in the implant (30) [e.g., ¶[0046]]. Janna further teaches that the probe (50) may be secured along the length of the groove (60) via, e.g., an interference, press, friction, or snap fit between the probe (50) and the groove (60) [see, e.g., ¶[0051]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer and Zellmer ‘252 such that the electrode assembly is sized to snap-fit in the groove of the orthopedic implant, since such a known securement technique for securing electrical components in a groove of an implant was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Janna), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Zellmer and Zellmer ‘252, and the results [securing the electrode assembly in the groove of the orthopedic implant] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
26. Regarding claim 7, the combination of Zellmer, Zellmer ‘252, & Janna teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the first housing includes a flexible insulative section adjacent the at least one electrode [¶’s [0069]-[0072]; FIG. 27].
Claim 7 further requires “when the electrode assembly is snap-fit into the groove, the electrode assembly sits flush with an outermost exterior surface of the orthopedic implant.”
Zellmer ‘252 further teaches that it was known to have electrical components be either flush with, protruding from, or recessed within, an exterior surface of the implant body [e.g., ¶[0052] (“The electrode sites are preferably flush with the surface of the implant body 100 along the interior or exterior cavity of the implant body 100. Alternatively, the exposed electrode sites may protrude from the implant body 100 or be recessed within the implant body 100”).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer, Zellmer ‘252, & Janna such that when the electrode assembly is snap-fit into the groove, the electrode assembly sits flush with an outermost exterior surface of the orthopedic implant, depending on design objectives and/or intended placement location of the implant within the body (e.g., so as not to unintentionally irritate surrounding anatomy or tissue with protruding surfaces).
27. Claims 9 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer and Zellmer ‘252, as applied to claim 8 above, and further in view of U.S. Patent Application Publication No. 2025/0066512 to Buchanan et al. (“Buchanan”) and U.S. Patent Application Publication No. 2010/0113907 to Schwind et al. (“Schwind”).
28. Regarding claim 9, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches wherein the plurality of electrodes [(130)] includes at least three electrodes [FIG. 27], wherein according to the stimulation pattern:
a first electrode is selected as an anode and a second electrode is selected as a cathode [e.g., ¶[0093]].
The combination of Zellmer and Zellmer ‘252 does not, however, teach:
wherein according to the measurement pattern:
a first electrode is selected as a working electrode… and a third electrode is selected as a reference electrode.
Buchanan, in a similar field of endeavor, teaches that it was known for an implant to include an electrochemical sensor (analyte sensor) including a working electrode and a reference electrode [see ¶[0148] (“An implantable element can comprise an electrochemical sensor, e.g., an electrochemical sensor including a working electrode and a reference electrode”); and ¶[0137] (“Exemplary implantable elements include a stent, shunt, dressing, ocular device, port, sensor, orthopedic fixation device, implant (e.g., a dental implant, ocular implant, silicon implant, corneal implant, dermal implant, intragastric implant, facial implant, hip implant, bone implant, cochlear implant, penile implant, implants for control of incontinence…”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer (which already teaches the use of electrodes for both monitoring and stimulation - ¶[0092]) and Zellmer ‘252 such that the electrodes are used as an electrochemical sensor for detecting analytes including having a first electrode as a working electrode and an additional electrode selected as a reference electrode, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [analyte sensing] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, the combination of Zellmer, Zellmer ‘252, and Buchanan does not explicitly teach the following emphasized claim limitation:
a first electrode is selected as a working electrode, a second electrode is selected as a counter electrode, and a third electrode is selected as a reference electrode.
Schwind, in a similar field of endeavor, teaches an implantable sensor for determining a concentration of at least one analyte in a medium, particularly in a body tissue and/or a body fluid [Abstract]. More particularly, Schwind teaches a sensor element mounted circumferentially on an implantation needle, comprising electrode rings suitably functionalized in order to form in each case a counter electrode, a reference electrode, and a working electrode [see ¶’s [0066]-[0067]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer, Zellmer ‘252, and Buchanan such that the electrode configuration comprise a first electrode selected as a working electrode, a second electrode selected as a counter electrode, and a third electrode selected as a reference electrode, since such a modification amounts merely to the simple substitution of one known electrochemical sensor configuration for another, yielding only predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
29. Regarding claim 10, the combination of Zellmer, Zellmer ‘252, Buchanan, and Schwind teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Zellmer (as modified) further teaches wherein the controller is configured to change selection of one or more of the plurality of electrodes according to the stimulation pattern or the measurement pattern [“mode selection” - e.g., ¶’s [0092]-[0095]].
30. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer and Zellmer ‘252, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2017/0100580 to Olson ("Olson").
31. Regarding claim 13, the combination of Zellmer and Zellmer ‘252 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zellmer further teaches:
wherein the control module includes a hermetically sealed housing [e.g., ¶’s [0028], [0034], [0046], [0055], [0057]] constructed from an implantable metal or a biocompatible polymer [e.g., ¶[0061]], wherein the housing includes:
the controller [¶’s [0046]-[0048], [0077]-[0078], [0101]-[0107]], memory [¶’s [0087], [0098], [0101]]… a power system [¶’s [0081]-[0082]], and a communication system [¶’s [0084]-[0087]],
wherein the power system enables wireless power transfer [¶[0084] (“wireless delivery of power and/or communication with the implant and implant components”); [0086], [0087]] to the control module and wherein the communication system enables wireless communication with an external control device [¶’s [0084]-[0087]].
While Zellmer further teaches that, during the electrode stimulation mode, the implant control circuitry may activate one, multiple, or all electrodes from the set of electrodes (130) to provide electric stimulation (i.e., activates a subset of electrodes from the set of electrodes) [see ¶[0093]], the combination of Zellmer and Zellmer ‘252 does not explicitly teach that the housing includes a multiplexer.
Olson, in a similar field of endeavor, teaches that it was well known to use a multiplexer to selectively provide stimulation energy to selected electrodes [see ¶[0056] (“switch module 15 may be a switch array, switch matrix, multiplexer, or any other type of switching module or electrical switching circuitry configured to selectively couple stimulation energy to selected electrodes 38”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Zellmer and Zellmer ‘252 such that the housing includes a multiplexer, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [selectively providing stimulation energy to selected electrodes] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
32. As noted above, the 03/26/26 Amendment has overcome the rejections under §§ 112(b) & 102 previously set forth in the 12/30/25 Action.
33. New and updated rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
34. In the 03/26/26 Amendment, independent claim 1 was amended to incorporate limitations from original claim 6 (without the limitations of intervening claim 5), while additionally specifying that the first housing and the control module are sized to sit within a groove disposed on an exterior surface of the orthopedic implant. As a result, a new rejection is set forth in detail above, necessitated by Applicant’s Amendment, establishing the obviousness of independent claim 1 under § 103 based on the combination of Zellmer and Zellmer ‘252.
35. Independent claim 17 was amended to incorporate limitations from original claim 20, while additionally limiting the mating feature to a groove, and more broadly reciting that the first housing and the control module are sized to be retained in the groove. As a result, the prior rejection of independent claim 17 under § 103 based on the combination of Zellmer and Zellmer ‘252 has been updated to address the amendment, and maintained.
Conclusion
36. Applicant's amendment necessitated the new ground(s) of rejection presented in this
Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is
reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
37. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M. Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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