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.
Election/Restriction
This application contains claims directed to the following patentably distinct species:
wherein the filter is (please choose one):
a relative motion filter,
a position filter,
a motion sequence filter,
a velocity magnitude filter, or
a machine learning classifier filter.
wherein the communication module is (please choose one):
a receiver, or
a transceiver.
The species are independent or distinct because the claims to the different species describe the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, at least claim 1 is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries), making it necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Wilfred Patrick (Reg. # 74,814) on 02/12/2026 a provisional election was made without traverse to prosecute the inventions of species a.v. (a machine learning classifier filter – claim 15) and b.vii. (a transceiver – claim 17). Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-14 and 16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 4 is objected to because of the following informalities: the recitation of “include” should instead read –includes--.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 3, and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 2 and 6, there is no description of a “motion switch” being triggered by things like a pH sensor, temperature sensor, pressure sensor, load sensor, etc. The drawings show triggering based on different kinds of inputs via a kinematic filter. These sensors do not necessarily have kinematic aspects. See e.g. ¶ 0041 of the specification as filed.
Claim 3 is rejected because it depends on a rejected claim.
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 1-20 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, 10, 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 2, the acronym “IMU” is unclear because it has not been defined.
Claims 2-20 are rejected because they depend on rejected claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 4-6, they do not further limit the claims from which they depend, since claim 1 does not require the implant data to be both an implant condition and an adjacent surgical site condition. Thus, when one is selected, the other is not required, and details pertaining to it are not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-7, 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 any of an implant condition or adjacent surgical site 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.
Bailey teaches an implantable device that alerts based on kinematic measurements, i.e., when the implant moves a threshold amount (¶¶s 0011, 0195, 0308, 0312, 0462 (kinematic data thresholds), 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 gather kinematic data in Morgan as in Bailey, and to initiate wireless communication based on a threshold in the kinematic data, for the purpose of monitoring implant movement in an energy-efficient manner (Bailey: ¶¶s 0006, 0011, 0203, etc.).
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 a pH sensor, a temperature sensor, a pressure sensor, a load sensor, an accelerometer, a gyroscope, an 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 4-6, Morgan-Bailey teaches all the features with respect to claim 1, as outlined above. Morgan-Bailey further teaches wherein the implant condition include 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 reference value, the transceiver transmitting the updated predetermined reference value 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 reference value, the implant consuming greater energy from the power source in the high-power mode relative to the low-power mode (Bailey: ¶¶s 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).
Claims 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan-Bailey in view of US Patent Application Publication 2018/0279915 (“Huang”).
Regarding claims 10 and 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 motion switch includes a filter configured to compare the implant data with the reference value, wherein the filter is a machine learning classifier filter configured to compare the implant data with the reference value 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).
Conclusion
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