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 .
CONTINUED EXAMINATION UNDER 37 CFR § 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/16/2026 (“09/16/2026 Amendment") has been entered, and fully considered.
RESPONSE TO AMENDMENT
3. In the 09/16/26 Amendment:
claims 1 & 17 were amended;
claim 15 was cancelled; &
claim 21 was newly added.
4. Therefore, claims 1-14 & 16-21 are now pending in the application.
5. The 09/16/26 Amendment has overcome the claim rejections under § 103 previously set forth in the Final Office Action mailed 06/16/26 (“06/16/26 Action”).
6. New claim objections and new grounds of rejection under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
CLAIM OBJECTIONS
7. Claims 1 & 17 are objected to because of the following informalities:
a. In claim 1, line 12, the recitation of “is configured to positioned” should instead recite --is configured to be positioned--.
b. In claim 1, line 13, the recitation of “femoral step” should instead recite --femoral stem--.
c. In claim 17, line 13, the recitation of “femoral step” should instead recite --femoral stem--.
Appropriate correction is required.
CLAIM REJECTIONS - 35 USC § 112(b)
8. 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.
9. Claims 1-14, & 16-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 1 recites the limitation “the length” in line 12. There is insufficient antecedent basis for this recitation in the claim.
11. Claim 1 recites the limitation “the femoral step” in lines 12-13. There is insufficient antecedent basis for this recitation in the claim.
12. Claim 1 recites the limitation “the acetabular cup” in line 13. There is insufficient antecedent basis for this recitation in the claim.
13. Claims 2-14, 16, & 21 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
14. Claim 17 recites the limitation “the length” in line 12. There is insufficient antecedent basis for this recitation in the claim.
15. Claims 18-20 are rejected as ultimately depending from a claim (claim 17) rejected under 35 U.S.C. 112(b).
16. Claim 21 recites the limitation “wherein the electrode assembly is positioned along a circumferential end of a acetabular cup” in lines 1-2. This recitation renders the claim indefinite, as it is not clear whether the recited “a circumferential end” is intended to be the same “a circumferential end” previously recited in claim 1 (from which claim 21 depends), or a separate/additional circumferential end. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
17. Claim 21 recites the limitation “wherein the electrode assembly is... configured to receive a flexible band electrode assembly” in lines 1-3. This recitation renders the claim indefinite, as it is not clear how an electrode assembly receives a flexible band electrode assembly. Further, is it not clear whether the recited “flexible band electrode assembly” is intended to be the “electrode assembly” of claim 1 (from which claim 21 depends), or a separate/additional electrode assembly. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
CLAIM REJECTIONS - 35 USC § 103
18. 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.
19. 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.
20. Claims 1-5, 8, 11, 12, 14, & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0067388 to Zellmer et al. (“Zellmer”) in view of U.S. 2020/0108252 to Zellmer et al. ("Zellmer ‘252"), and further in view of U.S. 2011/0238132 to Madjar et al. (“Madjar”).
21. 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 an 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”)].
A. 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, for the following reasons:
(1) 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”)];
(2) Zellmer also teaches that an implant body may have a variety of shapes [e.g., ¶’s [0040], [0041], [0043], [0049]].
(3) 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”)]; &
(4) 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).
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 module) 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.
B. HIP IMPLANT
Zellmer teaches that there is an impetus to enable orthopedic implants to have enhanced functionalities [e.g., ¶[0003] (“an impetus to enable the surgical nail, and other orthopedic implants, to have enhanced functionalities to improve tissue growth and to enable better and additional patient telemetry/monitoring”); and ¶[0004] (“there is a need in the medical implant field to create a new and useful system for embedding electronic components within an implant”)].
While Zellmer additionally teaches that the disclosed system may be applicable to the field of surgical orthopedic treatment, and orthopedic implants [see, e.g., ¶[0030] (“The system may be particularly applicable to the field of orthopedic treatment, particularly in the field of surgical orthopedic treatment... this document will be primarily directed towards surgical nails, but may be applied to a more general field of orthopedic implants”)], Zellmer does not explicitly teach:
wherein the orthopedic implant is a hip implant.
However, like Zellmer, Zellmer ‘252 also teaches that disclosed system and method may be used with other forms of orthopedic implants [Zellmer ‘252, ¶[0025] (“The system and method may be applied to spinal fusion implants. However, the system and method may alternatively be used in other forms of orthopedic implants”)].
Zellmer ‘252 also explicitly recites “hip implants” as an example of an implant wherein localized charge may be implemented to aid a patient [Zellmer ‘252, ¶[0048] (“In alternate variations the implant body may be an orthopedic implant that may or may not have an interior cavity. Orthopedic and non-orthopedic implants that may implement localized bone growth preferably include joint and extremity implants and other connective implants[.] Examples of these implants include: hip implants, knee implants, implant plates, implant nails, and implant screws. The system may additionally be implemented with any other system implant wherein localized charge may be implemented to aid a patient”)].
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 orthopedic implant be a hip implant, or more particularly such that the electrode assembly (comprising the first housing and the control module) is sized to sit within a groove disposed on an exterior surface of a hip implant, since utilizing the claimed electrode assembly with a hip implant would provide the benefit/advantage of allowing for electrical stimulation to enhance/aid bone growth to aid a patient that has received a hip implant [Zellmer ‘252, e.g., ¶[0048]].
C. POSITIONING OF ELECTRODE ASSEMBLY ON HIP IMPLANT
Finally, while the combination of Zellmer and Zellmer ‘252 (as set forth above) teaches that the electrode assembly (comprising the first housing and the control module) is sized to sit within a groove disposed on an exterior surface of the hip implant, the combination of Zellmer and Zellmer ‘252 does not teach the position/location of the groove on the hip implant, or more particularly:
wherein the electrode assembly is configured to positioned along the length of the femoral [[step]] stem or along a circumferential end of the acetabular cup of the orthopedic implant (hip implant).
Madjar, in a similar field of endeavor, relates to processes of accelerating bone growth (osteogenesis) and bone tissue healing with both dental and orthopedic (non-dental) implants, e.g. hip implants, knee implants, etc. [¶[0001]].
With reference to FIG. 10, Madjar teaches a hip implant (1000) comprising an elongated member (1002) [a femoral stem] with a length axis (1004) [¶[0063]]. Madjar further teaches that elongated member (1002) is typically solid, and includes an “inlaid electrode” into a surface of the implant (in an insulated groove) [see ¶[0064] (“Preferably and advantageously, the present invention minimizes any changes in this external surface and in the general shape of the implant, while providing the necessary electrical stimulation function to accelerate osteogenesis. The stimulation requires ideally uniformly distributed electric fields (and currents) proximate to the implant surface, the fields and currents supplied by two electrodes... in an appropriate geometry around member 1002 inside an electrically insulated groove 1012 formed in the member, preferably such that the spun electrode is externally flush with surface 1006”); and ¶[0065] (“The use of the term "inlaid" herein means to cover all geometries of an electrode conductor sunken flush into an implant member surface, preferably (but not necessarily) such that the original member surface topology remains essentially unchanged”); note also the various electrode configurations in FIGS 11-15].
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 be configured to positioned along the length of the femoral stem of the orthopedic implant, since such a particular known electrode placement position/configuration was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Madjar, and one of ordinary skill in the art would have been capable of applying this known placement position/configuration to the known device of Zellmer and Zellmer ‘252, and the results [stimulating bone growth by placement of an electrode assembly along a portion of an implant known to be effective for stimulating bone growth] 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).
22. Regarding claim 2, the combination of Zellmer, Zellmer ‘252, & Madjar 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]].
23. Regarding claim 3, the combination of Zellmer, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar 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).
24. Regarding claim 4, the combination of Zellmer, Zellmer ‘252, & Madjar 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”)].
25. Regarding claim 5, the combination of Zellmer, Zellmer ‘252, & Madjar 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].
26. Regarding claim 8, the combination of Zellmer, Zellmer ‘252, & Madjar 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”)].
27. Regarding claim 11, the combination of Zellmer, Zellmer ‘252, & Madjar 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].
28. Regarding claim 12, the combination of Zellmer, Zellmer ‘252, & Madjar 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].
29. Regarding claim 14, the combination of Zellmer, Zellmer ‘252, & Madjar 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.
30. Regarding claim 16, the combination of Zellmer, Zellmer ‘252, & Madjar 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.
31. 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]].
A. 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, for the following reasons:
(1) 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”)].
(2) Zellmer also teaches that an implant body may have a variety of shapes [e.g., ¶’s [0040], [0041], [0043], [0049]].
(3) 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”)].
(4) 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.
B. HIP IMPLANT
Zellmer teaches that there is an impetus to enable orthopedic implants to have enhanced functionalities [e.g., ¶[0003] (“an impetus to enable the surgical nail, and other orthopedic implants, to have enhanced functionalities to improve tissue growth and to enable better and additional patient telemetry/monitoring”); and ¶[0004] (“there is a need in the medical implant field to create a new and useful system for embedding electronic components within an implant”)].
While Zellmer additionally teaches that the disclosed system may be applicable to the field of surgical orthopedic treatment, and orthopedic implants [see, e.g., ¶[0030] (“The system may be particularly applicable to the field of orthopedic treatment, particularly in the field of surgical orthopedic treatment... this document will be primarily directed towards surgical nails, but may be applied to a more general field of orthopedic implants”)], Zellmer does not explicitly teach:
wherein the orthopedic implant is a hip implant.
However, like Zellmer, Zellmer ‘252 also teaches that disclosed system and method may be used with other forms of orthopedic implants [Zellmer ‘252, ¶[0025] (“The system and method may be applied to spinal fusion implants. However, the system and method may alternatively be used in other forms of orthopedic implants”)].
Zellmer ‘252 also explicitly recites “hip implants” as an example of an implant wherein localized charge may be implemented to aid a patient [Zellmer ‘252, ¶[0048] (“In alternate variations the implant body may be an orthopedic implant that may or may not have an interior cavity. Orthopedic and non-orthopedic implants that may implement localized bone growth preferably include joint and extremity implants and other connective implants[.] Examples of these implants include: hip implants, knee implants, implant plates, implant nails, and implant screws. The system may additionally be implemented with any other system implant wherein localized charge may be implemented to aid a patient”)].
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 orthopedic implant be a hip implant, or more particularly such that the electrode assembly (comprising the first housing and the control module) is sized to sit within a groove disposed on an exterior surface of a hip implant, since utilizing the claimed electrode assembly with a hip implant would provide the benefit/advantage of allowing for electrical stimulation to enhance/aid bone growth to aid a patient that has received a hip implant [Zellmer ‘252, e.g., ¶[0048]].
C. POSITIONING OF ELECTRODE ASSEMBLY ON HIP IMPLANT
Finally, while the combination of Zellmer and Zellmer ‘252 (as set forth above) teaches that the electrode assembly (comprising the first housing and the control module) is sized to sit within a groove [mating feature] disposed on an exterior surface of the hip implant, the combination of Zellmer and Zellmer ‘252 does not teach the position/location of the groove on the hip implant, or more particularly that:
the mating feature is positioned along the length of a femoral step and configured to receive the electrode assembly.
Madjar, in a similar field of endeavor, relates to processes of accelerating bone growth (osteogenesis) and bone tissue healing with both dental and orthopedic (non-dental) implants, e.g. hip implants, knee implants, etc. [¶[0001]].
With reference to FIG. 10, Madjar teaches a hip implant (1000) comprising an elongated member (1002) [a femoral stem] with a length axis (1004) [¶[0063]]. Madjar further teaches that elongated member (1002) is typically solid, and includes an “inlaid electrode” into a surface of the implant (in an insulated groove) [see ¶[0064] (“Preferably and advantageously, the present invention minimizes any changes in this external surface and in the general shape of the implant, while providing the necessary electrical stimulation function to accelerate osteogenesis. The stimulation requires ideally uniformly distributed electric fields (and currents) proximate to the implant surface, the fields and currents supplied by two electrodes... in an appropriate geometry around member 1002 inside an electrically insulated groove 1012 formed in the member, preferably such that the spun electrode is externally flush with surface 1006”); and ¶[0065] (“The use of the term "inlaid" herein means to cover all geometries of an electrode conductor sunken flush into an implant member surface, preferably (but not necessarily) such that the original member surface topology remains essentially unchanged”); note also the various electrode configurations in FIGS 11-15].
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 be configured to positioned along the length of the femoral stem of the orthopedic implant, or more particularly that the mating feature is positioned along the length of a femoral stem and configured to receive the electrode assembly, since such a particular known electrode placement position/configuration was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Madjar, and one of ordinary skill in the art would have been capable of applying this known placement position/configuration to the known device of Zellmer and Zellmer ‘252, and the results [stimulating bone growth by placement of an electrode assembly along a portion of an implant known to be effective for stimulating bone growth] 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).
32. Regarding claim 18, the combination of Zellmer, Zellmer ‘252, & Madjar 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”)].
33. Regarding claim 19, the combination of Zellmer, Zellmer ‘252, & Madjar 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]].
34. Regarding claim 20, the combination of Zellmer, Zellmer ‘252, & Madjar 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).
35. Claims 6 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer, Zellmer ‘252, & Madjar, as applied to claim 5 above, and further in view of U.S. 2013/0131679 to Janna et al. ("Janna").
36. Regarding claim 6, the combination of Zellmer, Zellmer ‘252, & Madjar teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Zellmer, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar, 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).
37. Regarding claim 7, the combination of Zellmer, Zellmer ‘252, Madjar, & 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, Madjar, & 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).
38. Claims 9 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer, Zellmer ‘252, & Madjar, as applied to claim 8 above, and further in view of U.S. 2025/0066512 to Buchanan et al. (“Buchanan”) and U.S. No. 2010/0113907 to Schwind et al. (“Schwind”).
39. Regarding claim 9, the combination of Zellmer, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar 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]) Zellmer ‘252, & Madjar 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, Madjar, 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, Madjar, 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).
40. Regarding claim 10, the combination of Zellmer, Zellmer ‘252, Madjar, 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]].
41. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer, Zellmer ‘252, & Madjar, as applied to claim 1 above, and further in view of U.S. 2017/0100580 to Olson ("Olson").
42. Regarding claim 13, the combination of Zellmer, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar 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, Zellmer ‘252, & Madjar 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).
43. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zellmer, Zellmer ‘252, & Madjar, as applied to claim 1 above, and further in view of U.S. 2012/0095526 to Roche ("Roche").
44. Regarding claim 21, the combination of Zellmer, Zellmer ‘252, & Madjar teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejections under § 112(b) above], the combination of Zellmer, Zellmer ‘252, & Madjar does not teach:
wherein the electrode assembly is positioned along a circumferential end of a acetabular cup and configured to receive a flexible band electrode assembly.
Roche, in a similar field of endeavor, teaches that it was known to place stimulation electrodes/leads on, or integrated into, the perimeter (circumference) of an acetabulum cup [e.g., ¶’s [0056]-[0058]] as well as along the stem of a femoral implant [e.g., ¶[0056]].
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, & Madjar such that an electrode assembly also be positioned along a circumferential end of a acetabular cup and configured to receive a flexible band electrode assembly, since such a particular known electrode placement position/configuration was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Roche, and one of ordinary skill in the art would have been capable of applying this known placement position/configuration to the known device of Zellmer, Zellmer ‘252, & Madjar, and the results 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).
RESPONSE TO ARGUMENTS
45. As noted above, the 09/16/26 Amendment has overcome the claim rejections under § 103 previously set forth in the Final Office Action mailed 06/16/26 (“06/16/26 Action”).
46. New claim objections and new grounds of rejection under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
CONCLUSION
47. 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, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. 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, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights