DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
This Office Action is responsive to the amendment filed 05/20/2026 (“Amendment”). Claims 1-5, 7-9, 15, and 17-20 are currently under consideration. The Office acknowledges the amendments to claims 1, 2, 4, 15, 18, and 20, as well as the cancellation of claims 6 and 10. Claims 11-14 and 16 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Claim Objections
Claim 18 is objected to because of the following informalities: the recitation of “an updated predetermined movement patterns” should instead read –updated predetermined movement patterns--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “power source” in claims 1 and 8 and “communication module” in claims 1, 3, 8, and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “power source,” a battery as in claim 9; and for “communication module,” a transceiver as in claim 17).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-9, 15, and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “switch” in claims 1, 3, 8, 18, and 20 is used by the claim to mean “filter” or “processor” while the accepted meaning is “a device for making, breaking, or changing the connections in an electrical circuit.” The term is indefinite because the specification does not clearly redefine the term. This is especially true based on e.g. claims 10 and 15, where the motion switch is described as including a machine learning classifier filter.
Regarding claim 15, there is insufficient antecedent basis for the recitation of “the reference value.”
Claims 2-5, 7-9, 15, and 17-20 are rejected because they depend on rejected claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2006/0052782 (“Morgan”) in view of US Patent Application Publication 2019/0350518 (“Bailey”).
Regarding claim 1, Morgan teaches [a]n implant (Abstract, orthopaedic implant) comprising: at least one sensor configured to detect implant data, the implant data being an implant condition (Abstract, sensors that receive physical stimulus from the implant or surrounding tissue); a power source (¶ 0006, a battery, ¶ 0046, an inductive coil, etc.); a … switch in communication with the at least one sensor to receive the implant data (¶ 0046, the microchip transmitting a wireless signal based on conditions of over-strain, under-pressure, etc. – also see Abstract and e.g. ¶ 0028, describing the microchip(s) monitoring the sensor(s)); and a communication module configured to wirelessly communicate with an external source (¶ 0045, wireless transmission to a receiver station), wherein the … switch is configured to … initiate wireless communication between the communication module and the external source when the implant data matches [a predetermined reference value] (¶ 0045, transmission based on increase in temperature over a predetermined temperature, based on over-strain, under-pressure, etc.).
Morgan does not appear to explicitly teach the switch being a motion switch which includes a kinematic filter configured to detect predefined movement patterns, the motion switch configured to transition the implant from a passive state to an active state when the implant data matches the predefined movement patterns (although ¶ 0043 does mention turning on and off to conserve power).
Bailey teaches an implantable device that alerts based on kinematic measurements, e.g., when the implant moves a threshold amount (¶¶s 0011, 0195, 0308, 0312, 0462 (kinematic data thresholds), etc.). The kinematic measurements include data from gyroscopes, accelerometers, etc. (¶¶s 0105, 0106). Alerts or other data transmission can occur in response to an event such as movement of the subject (¶ 0195). Notably, a predefined movement pattern can cause the implant to transition from a passive state to an active state (¶ 0219, e.g. a three step movement pattern). Other movement patterns can relate to particular movement of the patient or a portion of the patient’s body (¶ 0302).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement a motion switch based on a kinematic filter in Morgan as in Bailey, and to transition the implant from a passive to an active state and initiate wireless communication based on movement matching a predefined movement pattern, for the purpose of monitoring the implant and/or patient in an energy-efficient manner (Bailey: ¶¶s 0006, 0011, 0203, etc.), and for communicating relevant data at relevant times (Bailey: ¶ 0195).
Regarding claims 2 and 3, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the at least one sensor is any of an accelerometer, a gyroscope, an inertial measurement unit (IMU) and a Hall sensor operatively coupled to a controller of the implant, wherein the controller is a microcontroller in communication with the motion switch and the communication module (Morgan: Abstract, microchip, temperature, pressure, strain; Bailey: ¶¶s 0105, 0188, Fig. 35, etc. - It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a microcontroller with the contemplated microchip/controller, as the simple substitution of one know data processing structure for another with predictable results (processing of data – Bailey: ¶ 0188, Fig. 35, etc.)).
Regarding claims 4 and 5, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the implant condition includes any of an implant position, implant orientation, and implant movement, wherein the implant movement includes any of an implant acceleration, velocity, and rotation (Bailey: ¶¶s 0011 (gyroscopes, accelerometers), 0195, 0308, 0312, 0462 (velocity), etc.), wherein the adjacent surgical site condition includes any of a temperature, pressure, and pH (Morgan: Abstract, temperature, pressure, strain; Bailey: ¶ 0011, temperature and pressure).
Regarding claim 7, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the implant is a joint implant (Bailey: ¶ 0011, obvious to use for monitoring movement of the joint).
Regarding claim 9, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the power source is a battery (Morgan: ¶¶s 0006 and 0043; Bailey: ¶ 0109, etc.).
Regarding claims 17 and 18, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the communication module is a transceiver configured to wirelessly transmit the implant data to the external source and receive external data from the external source (Morgan: ¶ 0039, the receiver 160 of Fig. 4 can both send data to and receive data from the microchip 100, which suggests that transmitter 130 is a transceiver; Bailey: ¶ 0484, a communications transceiver, which would have been obvious to use for the purpose of efficiently implementing wireless communication), wherein the external data includes an updated predetermined movement patterns, the transceiver transmitting the updated predetermined movement patterns to the motion switch (Morgan: ¶ 0040, threshold values may be selected by the surgeon; Bailey: ¶¶s 0237 and 0303, configuration or reconfiguration after the subject returns home for recovery and normal activities, ¶¶s 0326, 0328, 0329, 0331, etc., sending updated configuration information).
Regarding claim 19, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the external source is any of a smartphone, computer, tablet, and a network (Morgan: Fig. 4 and ¶ 0045, the receiver station being a computer).
Regarding claim 20, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the motion switch is configured to transition the implant from a low-power mode to a high-power mode when the implant data matches the predetermined movement patterns, the implant consuming greater energy from the power source in the high-power mode relative to the low-power mode (Bailey: ¶¶s 0219, 0315, 0348, etc., a particular movement that triggers a change in mode of operation, e.g. from a low-power to a high-power mode (¶¶s 0184, 0356, 0366, 0369, 0370, etc.)).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan-Bailey in view of International Application Publication WO 2013/044174 (“Stein”).
Regarding claim 8, Morgan-Bailey teaches all the features with respect to claim 7, as outlined above. Morgan-Bailey does not appear to explicitly teach wherein the joint implant is a knee implant including a tibial component and a femoral component, the at least one sensor, the power source, the motion switch, and the communication module being disposed within the tibial component.
Stein teaches a joint implant that is a knee implant including a tibial and femoral component (Fig. 1, components 104 and 106). The tibial component includes a sensor, power source, switch/controller, and communication module (¶¶s 0023, 00171 (tibial prosthetic component 3100), including electronics 3110 as shown in Fig. 39, ¶¶s 00178, 00180 (conversion circuitry, logic circuitry, power management circuitry, transmit and receive circuitry), etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Morgan-Bailey in a knee implant structure as in Stein, for the purpose of enabling long-term monitoring of joint health (Stein: Abstract).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan-Bailey in view of US Patent Application Publication 2018/0279915 (“Huang”).
Regarding claim 15, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey does not appear to explicitly teach wherein the kinematic filter is a machine learning classifier filter configured to compare the implant data with the predefined movement patterns to initiate the wireless communication between the communication module and the external source when the implant data matches the reference value.
Huang teaches performing machine-learning based classification by comparing sensor data with a reference (¶ 0041).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a machine learning classifier filter that compares data into the combination as in Huang, as the simple substitution of one known comparison means for another with predictable results (determining whether a condition is met).
Response to Arguments
Applicant’s arguments filed 05/20/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 112(b), they are not persuasive. The specification does not describe how e.g. a pH sensor is used, even in a machine learning classifier, for kinematic filtering.
Regarding the term “switch,” the Office maintains that it is used contrary to its ordinary meaning, and is not adequately (re)defined in the specification. A filter (or some type of controller or processor) is not a switch, even if it can e.g. change a setting. The same reasoning applies to the phrase “motion switch.” Applicant asserts that this phrase is defined through consistent and detailed description. But description is not the same as definition. See MPEP 2111.01(IV), which states “The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess.”
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. Bailey teaches motion-triggered initiation of wireless communication, as noted above (e.g. ¶ 0195, in response to a movement event).
Applicant argues against the motivation for combination, but ignores a large part of Bailey’s teachings. And, there is nothing preventing achieving energy efficiency in multiple ways.
All claims remain rejected in light of the prior art.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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