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 .
Claim Status
Claims 1-16 are currently pending and under examination herein.
Claims 1-16 are rejected.
Priority
The instant application claims priority as a DIV of US application 16768670 filed 30 May 2020, which is a 371 of PCT/EP18/83216 filed 30 November 2018, which is a CON of US application 15947495 filed 06 April 2018, and foreign priority to EP17306662.2 filed 30 November 2017. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16768670, filed on 30 May 2020. In this action, claims 1-16 are examined as though they had an effective filing date of 30 November 2017. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11 August 2023 (2 IDSs filed this date) and 10 September 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is acknowledged the NPL listed in the IDSs are found in the parent application 16768670 filed 30 may 2020. The foreign patent document GB2156983 filed 16 October 1985 was included on IDS2 filed 11 August 2023 and IDS3 filed 10 September 2025.
Drawings
The drawings filed 11 August 2023 are accepted.
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.
Claims 8 and 16 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.
Claim 8 recites “the first bone section and the second bone section”. Claim 16 recites “the reference”. There is insufficient antecedent basis for these limitations in the claim. This rejection can be overcome by changing “the” to “a”/”an” or other appropriate amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. In accordance with MPEP 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to a judicial exception (Step 2A, Prong 1). Claims 1-16 are directed to a method. In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites the limitation – computing from the received data a distraction indicator through at least the steps of determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; and generating a distraction indicator as a function of the first value. Based on the broadest reasonable interpretation, computing an indicator, determining a pattern, analyzing the evolution of a value, and generating an indicator as a function of a value encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 2 recites the limitation - determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period; performing a comparison between the first value and the second value; and generating a distraction indicator as a function of said comparison. Based on the broadest reasonable interpretation, determining a pattern, analyzing the evolution of values, performing a comparison between values, and generating an indicator as a function encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 3 recites the limitation - wherein generating the distraction indicator is performed when a comparison between the first value and the second value exceeds a predefined threshold. Based on the broadest reasonable interpretation, comparing a value to a threshold encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 4 recites the limitation - wherein the predefined threshold ranges from approximately 1 percent to approximately 7 percent of the first value. This limitation refines the comparing/generating judicial exceptions of claims 2 and 3. The refined comparing/generating indicated by this limitation still represents a judicial expectation.
Claim 5 recites the limitation - wherein the predefined threshold ranges from approximately 0.5 percent to approximately 10 percent of the first value. This limitation refines the comparing/generating judicial exceptions of claims 2 and 3. The refined comparing/generating indicated by this limitation still represents a judicial expectation.
Claim 6 recites the limitation - wherein the predefined threshold ranges from approximately 0.5 percent to approximately 20 percent of the first value. This limitation refines the comparing/generating judicial exceptions of claims 2 and 3. The refined comparing/generating indicated by this limitation still represents a judicial expectation.
Claim 8 recites the limitation - calculating a distraction indicator from the received vibration data as a function of an evolution of the vibration data over time. Based on the broadest reasonable interpretation, calculating an indicator encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea. The claim also recites wherein the evolution of the vibration data is an indicator of callus formation between the first bone section and the second bone section. This limitation refines the data of the calculating. The refined calculating indicated by this limitation still represents a judicial expectation.
Claim 12 recites the limitation - wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 20 Hertz (Hz) to approximately 10,000 Hz. Based on the broadest reasonable interpretation, the measuring the vibration could practically be done by the human mind. The frequency range indicated encompasses the range of human hearing. This draws the limitation to a mental process, which classifies the limitation as an abstract idea.
Claim 13 recites the limitation - wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 30 Hz to approximately 7,000 Hz. Based on the broadest reasonable interpretation, the measuring the vibration could practically be done by the human mind. The frequency range indicated encompasses the range of human hearing. This draws the limitation to a mental process, which classifies the limitation as an abstract idea.
Claim 14 recites the limitation - wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 40 Hz to approximately 5,000 Hz. Based on the broadest reasonable interpretation, the measuring the vibration could practically be done by the human mind. The frequency range indicated encompasses the range of human hearing. This draws the limitation to a mental process, which classifies the limitation as an abstract idea.
Claim 15 recites the limitation - wherein determining the at least one vibration pattern of the medium is performed continuously or semi-continuously. This limitation refines the determining judicial exception of claim 1. The refined determining indicated by this limitation still represents a judicial expectation (Paragraph 0085 of the published specification: continuously or semi-continuously records the vibration response of the medium during a predetermined time).
Claim 16 recites the limitation - wherein when the first value of the vibration pattern is determined, the first value becomes the reference. Based on the broadest reasonable interpretation, labeling a value as a reference could practically be done by the human mind. This draws the limitation to a mental process, which classifies the limitation as an abstract idea.
These limitations recite concepts of calculating, determining, analyzing, comparing information and values and detecting vibrations that are so generically recited that they can be practically performed in the human mind as claimed, which falls under the “Mental processes” and “Mathematical concepts” grouping of abstract ideas. A mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula (MPEP 2106.04(a)(2)). Additionally, both product claims and process claims may recite mental processes, which can include a claim that requires a computer (MPEP 2106.04(a)(2)). Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. As such, claims 1-16 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology (MPEP 2106.04(d)(1)) or particular treatment (MPEP 2106.04(d)(2)). Rather, the claims provide insignificant extra-solution activity (MPEP 2106.05(g)) and provide mere instructions to apply a judicial exception (MPEP 2106.05(f)). Specifically, the claims recite the following additional elements:
Claim 1 recites receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor.
Claim 7 recites wherein the at least one vibration sensor is implanted in a patient.
Claim 9 recites transmitting instructions to the implantable bone distraction device for providing a distraction when the distraction indicator is generated.
Claim 10 recites adjusting a space between two separated bone sections by increasing the space when the distraction indicator is generated.
Claim 11 recites adjusting a space between two separated bone sections by reducing the space when the distraction indicator is generated.
There are no limitations that indicate that the claimed calculating, determining, analyzing, comparing information and values and detecting vibrations require anything that cannot be accomplished mentally. There is no indication that these steps are affected by the judicial exception in any way and thus do not integrate the recited judicial exception into a practical application. As such, claims 1-16 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite conventional additional elements that equate to mere instructions to apply the recited exception in a generic way. The claims also recite conventional additional elements that represent insignificant extra-solution activities.
As discussed above, there are no additional limitations to indicate that the claimed calculating, determining, analyzing, comparing information and values and detecting vibrations require anything in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea do not render an abstract idea or natural law eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. As specified in MPEP 2106.05(g), extra-solution activities can be understood as incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Insignificant extra-solution activities include mere data gathering, selecting a particular data source or type of data to be manipulated, and displaying information. Additionally, Nowak et al. (US 20170135671 A1, see 102/103 rejection below), Jundt et al (US 20130138017 A1, Paragraphs 0017-0023), and Kim et al. (US 20150025587 A1, IDS 2 filed 11 August 2023, Paragraphs 0007and 0016 ) establish the use of bone distractors with implantable sensor in communication with controlling devices to adjust the spacing of bone sections are well understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, Claims 1-16 are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 7-16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Nowak et al. (US 20170135671 A1).
Applicable claims include:
Claim 1. A monitoring method for generating a distraction indicator, comprising: (Claim 1.i) receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor; (Claim 1.ii) computing from the received data a distraction indicator through at least the steps of: (Claim 1.iii) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; (Claim 1.iv) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; and (Claim 1.v) generating a distraction indicator as a function of the first value.
Claim 2. The method of claim 1, wherein computing the distraction indicator from the received data comprises: (Claim 2.i) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; (Claim 2.ii) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; (Claim 2.iii) analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period; (Claim 2.iv) performing a comparison between the first value and the second value; and (Claim 2.v) generating a distraction indicator as a function of said comparison.
Claim 3. The method of claim 2, wherein generating the distraction indicator is performed when a comparison between the first value and the second value exceeds a predefined threshold.
Claim 7. The method of claim 1, wherein the at least one vibration sensor is implanted in a patient.
Claim 8. The method of claim 1, further comprising (Claim 8.i) calculating a distraction indicator from the received vibration data as a function of an evolution of the vibration data over time, (Claim 8.ii) wherein the evolution of the vibration data is an indicator of callus formation between the first bone section and the second bone section.
Claim 9. The method of claim 1, further comprising transmitting instructions to the implantable bone distraction device for providing a distraction when the distraction indicator is generated.
Claim 10. The method of claim 1, further comprising adjusting a space between two separated bone sections by increasing the space when the distraction indicator is generated.
Claim 11. The method of claim 1, further comprising adjusting a space between two separated bone sections by reducing the space when the distraction indicator is generated.
Claim 12. The method of claim 1, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 20 Hertz (Hz) to approximately 10,000 Hz.
Claim 13. The method of claim 12, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 30 Hz to approximately 7,000 Hz.
Claim 14. The method of claim 13, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 40 Hz to approximately 5,000 Hz.
Claim 15. The method of claim 1, wherein determining the at least one vibration pattern of the medium is performed continuously or semi-continuously.
Claim 16. The method of claim 15, wherein when the first value of the vibration pattern is determined, the first value becomes the reference.
Regarding Claim 1, Nowak et al. teach (Claim 1.i) receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor (Paragraph 0056: monitor the bone restoration process and reports the condition and trends for all such distraction osteogenesis devices; Paragraph 0060: The sensors may be acoustic sensors; Paragraph 0164: monitoring a condition in the bone at the site, determining at least one pulse frequency and at least one pulse interval for stimulating osteogenesis in the bone based on the monitored condition, and applying a signal to the site at). Nowak et al. teach (Claim 1.ii) computing from the received data a distraction indicator (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone; Paragraph 0056: monitor the bone restoration process and reports the condition and trends for all such distraction osteogenesis devices). The distraction indicator is interpreted as any indication of the effects of the distraction. Nowak et al. teach (Claim 1.iii) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor (Paragraph 0068: at least one sensor will receive a wave that has propagated through the target site of the bone; Paragraph 0084: identifies and quantifies features in the data such as, but not limited to, the number of peaks, peak magnitudes, peak time of occurrence, valleys, valley magnitudes, valley time of occurrence). A wave is interpreted as a vibration pattern. Nowak et al. teach (Claim 1.iv) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period (Paragraph 0068: The controller receives a signal based on the wave and can process the signal. The healing state, progression, and trends are affected by fracture/osteotomy geometry, healing symmetry/asymmetry, subsequent wave velocity and attenuation, refraction, reflection, and other interactions with the healing environment that affect the signal patterns and features; Paragraph 0074: An algorithm can use the data to determine a condition of the bone quantitatively based on the data from the target site; Paragraph 0084: these features can be normalized and averaged; first order statistics will be calculated). Nowak et al. teach (Claim 1.v) generating a distraction indicator as a function of the first value (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone, including, but not limited to, internal body healing rates/trends or the healing stage of the bone. This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend and/or rate of change of the healing trend and/or when a bone has fully consolidated and/or to direct further treatment of the patient; Paragraph 0068: in addition to density, the healing state, progression, and trends are affected by fracture/osteotomy geometry, healing symmetry/asymmetry, subsequent wave velocity and attenuation, refraction, reflection, and other interactions with the healing environment that affect the signal patterns and features). The distraction indicator is interpreted as any indication of the effects of the distraction.
Regarding Claim 2, Nowak et al. teach (Claim 2.i) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor. This limitation is interpreted as equivalent to the limitation recited by Claim 1.iii (see regarding claim 1 for teachings). Nowak et al. teach (Claim 2.ii) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period. This limitation is interpreted as equivalent to the limitation recited by Claim 1.iv (see regarding claim 1 for teachings). Nowak et al. teach (Claim 2.iii) analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period (Paragraph 0078: the device cycles three or more times; Paragraph 0094: Trend analyses are conducted across the number of sampling periods for that day and across all days; Paragraph 0105: determine the new healing state, new healing rate, error states, reconfiguration states, and the like). Nowak et al. teach (Claim 2.iv) performing a comparison between the first value and the second value (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone, including, but not limited to, internal body healing rates/trends or the healing stage of the bone. This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend (e.g. rate) and/or rate of change of the healing trend (e.g. inflection points); between phases; Paragraph 0102: signal analysis performed by the algorithm of may be performed throughout the treatment; Paragraph 0161: Monitoring of the condition using method may be repeated or ongoing). Nowak et al. teach (Claim 2.v) generating a distraction indicator as a function of said comparison (Paragraph 0053: This provides a quantitative output). The output is interpreted as the indicator. The distraction indicator is interpreted as any indication of the effects of the distraction (see above for results determined through analysis of the sensor data).
Regarding Claim 3, Nowak et al. teach generating the distraction indicator is performed when a comparison between the first value and the second value exceeds a predefined threshold (Paragraph 0053: This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend (e.g. rate) and/or rate of change of the healing trend (e.g. inflection points); between phases; and/or when a bone has fully consolidated and/or to direct further treatment of the patient; Paragraph 0081: Some examples of the pulse errors may include, but are not limited to “no signal received”, or “received signal power is low”). The healing state is determined by a comparison a values from different times. The unique state itself will be based on evaluating the compared metrics, which is interpreted as equivalent to a threshold. Additionally, the analysis will not proceed while the device in an error state. Error state based on a comparison of values to a threshold. Additionally, the “when” recited by the claim indicates this is a contingent limitation. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04).
Regarding Claim 7, Nowak et al. teach the at least one vibration sensor is implanted in a patient (Paragraph 0060: The sensors can be placed internally).
Regarding Claim 8, Nowak et al. teach (Claim 8.i) calculating a distraction indicator from the received vibration data as a function of an evolution of the vibration data over time. This limitation is interpreted as equivalent to the limitation recited by Claim 1.ii, Claim 1.v, and Claim 2.v (see regarding claim 1 and regarding claim for teachings). Nowak et al. teach (Claim 8.ii) wherein the evolution of the vibration data is an indicator of callus formation between the first bone section and the second bone section (Paragraph 0095: comparator can determine a healing state. The healing state may be a fracture and inflammatory phase in which a hematoma forms, granulation tissue formation in which a soft callus forms, cartilage callus formation in which a hard callus forms).
Regarding Claim 9, Nowak et al. teach transmitting instructions to the implantable bone distraction device for providing a distraction when the distraction indicator is generated (Paragraph 0061: At least one of the sensors can be a transmitter. the sensors can function as a load condition sensor which measures not only field intensity but reflection, which is used with a control system; Paragraph 0162: the method can be used in combination with other medical treatment in order to guide the treatment, one such example being osteogenesis stimulation). Controlling the system and guiding the treatment are interpreted as instructions.
Regarding Claim 10, Nowak et al. teach adjusting a space between two separated bone sections by increasing the space when the distraction indicator is generated (Paragraph 0005: distraction osteogenesis systems that enable limb lengthening). Limb lengthening is interpreted as increasing the space between bone sections. See Claim 9 for teaching of how the data/results are used to control the system.
Regarding Claim 11, Nowak et al. teach adjusting a space between two separated bone sections by reducing the space when the distraction indicator is generated (Paragraph 0054: the present invention can be used after a fracture or break due to injury, or after a surgical procedure involving cutting or breaking a bone). Healing a bone break or fracture is interpreted as reducing the space between bone sections. See Claim 9 for teaching of how the data/results are used to control the system.
Regarding Claim 12, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 20 Hertz (Hz) to approximately 10,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range.
Regarding Claim 13, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 30 Hz to approximately 7,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range.
Regarding Claim 14, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 40 Hz to approximately 5,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range.
Regarding Claim 15, Nowak et al. teach determining the at least one vibration pattern of the medium is performed continuously or semi-continuously (Figure 4). Figure 4 shows when the device is in pulse and record mode, unless there is an error, it will operate continuously collecting vibrational data until at least 3 confirmed signals have been generated.
Regarding Claim 16, Nowak et al. teach when the first value of the vibration pattern is determined, the first value becomes the reference (Paragraph 0095: a comparator can determine a healing state and a healing trend for the patient using data from the TOF and ATT analysis for the first arriving signal (FAS) and subsequent signals). The first signal of the signals compered is interpreted as the reference (i.e. the signal referenced by comparing). Also, see regarding claim 2 for teachings of relating to comparing values between time.
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.
The factual inquiries 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US 20170135671 A1), as applied to claims 1-3 and 7-16 in the 35 USC 102 Rejection above, in view of Ravaud et al. (1999, JOURNAL OF BONE AND MINERAL RESEARCH, Vol. 14, No. 8: 1149-1456). Italicized text from reference art.
Applicable claims include:
Claim 1. A monitoring method for generating a distraction indicator, comprising: (Claim 1.i) receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor; (Claim 1.ii) computing from the received data a distraction indicator through at least the steps of: (Claim 1.iii) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; (Claim 1.iv) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; and (Claim 1.v) generating a distraction indicator as a function of the first value.
Claim 2. The method of claim 1, wherein computing the distraction indicator from the received data comprises: (Claim 2.i) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor; (Claim 2.ii) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period; (Claim 2.iii) analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period; (Claim 2.iv) performing a comparison between the first value and the second value; and (Claim 2.v) generating a distraction indicator as a function of said comparison.
Claim 3. The method of claim 2, wherein generating the distraction indicator is performed when a comparison between the first value and the second value exceeds a predefined threshold.
Claim 4. The method of claim 3, wherein the predefined threshold ranges from approximately 1 percent to approximately 7 percent of the first value.
Claim 5. The method of claim 3, wherein the predefined threshold ranges from approximately 0.5 percent to approximately 10 percent of the first value.
Claim 6. The method of claim 3, wherein the predefined threshold ranges from approximately 0.5 percent to approximately 20 percent of the first value.
Claim 7. The method of claim 1, wherein the at least one vibration sensor is implanted in a patient.
Claim 8. The method of claim 1, further comprising (Claim 8.i) calculating a distraction indicator from the received vibration data as a function of an evolution of the vibration data over time, (Claim 8.ii) wherein the evolution of the vibration data is an indicator of callus formation between the first bone section and the second bone section.
Claim 9. The method of claim 1, further comprising transmitting instructions to the implantable bone distraction device for providing a distraction when the distraction indicator is generated.
Claim 10. The method of claim 1, further comprising adjusting a space between two separated bone sections by increasing the space when the distraction indicator is generated.
Claim 11. The method of claim 1, further comprising adjusting a space between two separated bone sections by reducing the space when the distraction indicator is generated.
Claim 12. The method of claim 1, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 20 Hertz (Hz) to approximately 10,000 Hz.
Claim 13. The method of claim 12, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 30 Hz to approximately 7,000 Hz.
Claim 14. The method of claim 13, wherein the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 40 Hz to approximately 5,000 Hz.
Claim 15. The method of claim 1, wherein determining the at least one vibration pattern of the medium is performed continuously or semi-continuously.
Claim 16. The method of claim 15, wherein when the first value of the vibration pattern is determined, the first value becomes the reference.
Regarding Claim 1, Nowak et al. teach (Claim 1.i) receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor (Paragraph 0056: monitor the bone restoration process and reports the condition and trends for all such distraction osteogenesis devices; Paragraph 0060: The sensors may be acoustic sensors; Paragraph 0164: monitoring a condition in the bone at the site, determining at least one pulse frequency and at least one pulse interval for stimulating osteogenesis in the bone based on the monitored condition, and applying a signal to the site at). Nowak et al. teach (Claim 1.ii) computing from the received data a distraction indicator (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone; Paragraph 0056: monitor the bone restoration process and reports the condition and trends for all such distraction osteogenesis devices). The distraction indicator is interpreted as any indication of the effects of the distraction. Nowak et al. teach (Claim 1.iii) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor (Paragraph 0068: at least one sensor will receive a wave that has propagated through the target site of the bone; Paragraph 0084: identifies and quantifies features in the data such as, but not limited to, the number of peaks, peak magnitudes, peak time of occurrence, valleys, valley magnitudes, valley time of occurrence). A wave is interpreted as a vibration pattern. Nowak et al. teach (Claim 1.iv) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period (Paragraph 0068: The controller receives a signal based on the wave and can process the signal. The healing state, progression, and trends are affected by fracture/osteotomy geometry, healing symmetry/asymmetry, subsequent wave velocity and attenuation, refraction, reflection, and other interactions with the healing environment that affect the signal patterns and features; Paragraph 0074: An algorithm can use the data to determine a condition of the bone quantitatively based on the data from the target site; Paragraph 0084: these features can be normalized and averaged; first order statistics will be calculated). Nowak et al. teach (Claim 1.v) generating a distraction indicator as a function of the first value (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone, including, but not limited to, internal body healing rates/trends or the healing stage of the bone. This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend and/or rate of change of the healing trend and/or when a bone has fully consolidated and/or to direct further treatment of the patient; Paragraph 0068: in addition to density, the healing state, progression, and trends are affected by fracture/osteotomy geometry, healing symmetry/asymmetry, subsequent wave velocity and attenuation, refraction, reflection, and other interactions with the healing environment that affect the signal patterns and features). The distraction indicator is interpreted as any indication of the effects of the distraction.
Regarding Claim 2, Nowak et al. teach (Claim 2.i) determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor. This limitation is interpreted as equivalent to the limitation recited by Claim 1.iii (see regarding claim 1 for teachings). Nowak et al. teach (Claim 2.ii) analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period. This limitation is interpreted as equivalent to the limitation recited by Claim 1.iv (see regarding claim 1 for teachings). Nowak et al. teach (Claim 2.iii) analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period (Paragraph 0078: the device cycles three or more times; Paragraph 0094: Trend analyses are conducted across the number of sampling periods for that day and across all days; Paragraph 0105: determine the new healing state, new healing rate, error states, reconfiguration states, and the like). The analyses performed for the first data collected are performed for each subsequent data collected over time. Additionally, the instant application is directed to the ability to assess a condition over time. Therefore, it would be obvious to repeat the measurement and analysis step at a different time. Nowak et al. teach (Claim 2.iv) performing a comparison between the first value and the second value (Paragraph 0053: use measurements taken at a target site of a bone to characterize a condition of the bone, including, but not limited to, internal body healing rates/trends or the healing stage of the bone. This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend (e.g. rate) and/or rate of change of the healing trend (e.g. inflection points); between phases; Paragraph 0102: signal analysis performed by the algorithm of may be performed throughout the treatment; Paragraph 0161: Monitoring of the condition using method may be repeated or ongoing). Nowak et al. teach (Claim 2.v) generating a distraction indicator as a function of said comparison (Paragraph 0053: This provides a quantitative output). The output is interpreted as the indicator. The distraction indicator is interpreted as any indication of the effects of the distraction (see above for results determined through analysis of the sensor data).
Regarding Claim 3, Nowak et al. teach generating the distraction indicator is performed when a comparison between the first value and the second value exceeds a predefined threshold (Paragraph 0053: This provides a quantitative output that can be used to determine healing progress within each phase of fracture healing that can be defined by the absolute bone formation and/or the healing trend (e.g. rate) and/or rate of change of the healing trend (e.g. inflection points); between phases; and/or when a bone has fully consolidated and/or to direct further treatment of the patient; Paragraph 0081: Some examples of the pulse errors may include, but are not limited to “no signal received”, or “received signal power is low”). The healing state is determined by a comparison a values from different times. The unique state itself will be based on evaluating the compared metrics, which is interpreted as equivalent to a threshold. Additionally, the analysis will not proceed while the device in an error state. Error state is based on a comparison of values to a threshold.
Regarding Claim 7, Nowak et al. teach the at least one vibration sensor is implanted in a patient (Paragraph 0060: The sensors can be placed internally).
Regarding Claim 8, Nowak et al. teach (Claim 8.i) calculating a distraction indicator from the received vibration data as a function of an evolution of the vibration data over time. This limitation is interpreted as equivalent to the limitation recited by Claim 1.ii, Claim 1.v, and Claim 2.v (see regarding claim 1 and regarding claim 2 for teachings). Nowak et al. teach (Claim 8.ii) wherein the evolution of the vibration data is an indicator of callus formation between the first bone section and the second bone section (Paragraph 0095: comparator can determine a healing state. The healing state may be a fracture and inflammatory phase in which a hematoma forms, granulation tissue formation in which a soft callus forms, cartilage callus formation in which a hard callus forms).
Regarding Claim 9, Nowak et al. teach transmitting instructions to the implantable bone distraction device for providing a distraction when the distraction indicator is generated (Paragraph 0061: At least one of the sensors can be a transmitter. the sensors can function as a load condition sensor which measures not only field intensity but reflection, which is used with a control system; Paragraph 0162: the method can be used in combination with other medical treatment in order to guide the treatment, one such example being osteogenesis stimulation). Controlling the system and guiding the treatment are interpreted as instructions.
Regarding Claim 10, Nowak et al. teach adjusting a space between two separated bone sections by increasing the space when the distraction indicator is generated (Paragraph 0005: distraction osteogenesis systems that enable limb lengthening). Limb lengthening is interpreted as increasing the space between bone sections. See Claim 9 for teaching of how the data/results are used to control the system.
Regarding Claim 11, Nowak et al. teach adjusting a space between two separated bone sections by reducing the space when the distraction indicator is generated (Paragraph 0054: the present invention can be used after a fracture or break due to injury, or after a surgical procedure involving cutting or breaking a bone). Healing a bone break or fracture is interpreted as reducing the space between bone sections. See Claim 9 for teaching of how the data/results are used to control the system.
Regarding Claim 12, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 20 Hertz (Hz) to approximately 10,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range. Additionally, the device produces vibrations at a frequency of 1000 Hz so it would be obvious for the sensor to measure the frequency of 1000 HZ, especially in light of the frequency being FDA approved. (Paragraph 0172: the stimulation device can deliver ultrasound pulsed at 1000 Hz (1 kHz); This pulse frequency and pulse interval are FDA approved for the non-invasive treatment of non-unions).
Regarding Claim 13, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 30 Hz to approximately 7,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range. Additionally, the device produces vibrations at a frequency of 1000 Hz so it would be obvious for the sensor to measure the frequency of 1000 HZ, especially in light of the frequency being FDA approved. (Paragraph 0172: the stimulation device can deliver ultrasound pulsed at 1000 Hz (1 kHz); This pulse frequency and pulse interval are FDA approved for the non-invasive treatment of non-unions).
Regarding Claim 14, Nowak et al. teach the implantable bone distraction device is configured to measure a vibration response of the medium at a frequency range of from approximately 40 Hz to approximately 5,000 Hz (see at least Figures 23, 24, and 25). The figures show data for at least the range of 0 to 2 megahertz which indicate the sensors are configures to measure vibrations within the recited range. Additionally, the device produces vibrations at a frequency of 1000 Hz so it would be obvious for the sensor to measure the frequency of 1000 HZ, especially in light of the frequency being FDA approved. (Paragraph 0172: the stimulation device can deliver ultrasound pulsed at 1000 Hz (1 kHz); This pulse frequency and pulse interval are FDA approved for the non-invasive treatment of non-unions).
Regarding Claim 15, Nowak et al. teach determining the at least one vibration pattern of the medium is performed continuously or semi-continuously (Figure 4). Figure 4 shows when the device is in pulse and record mode, unless there is an error, it will operate continuously collecting vibrational data until at least 3 confirmed signals have been generated. Additionally, continuous operation is considered obvious (MPEP 2144.04).
Regarding Claim 16, Nowak et al. teach when the first value of the vibration pattern is determined, the first value becomes the reference (Paragraph 0095: a comparator can determine a healing state and a healing trend for the patient using data from the TOF and ATT analysis for the first arriving signal (FAS) and subsequent signals). The first signal of the signals compered is interpreted as the reference (i.e. the signal referenced by the comparing). Also, see regarding claim 2 for teachings of relating to comparing values between time. It is obvious that an initial value would be considered the reference (i.e. the value compered to for determining a change). Additionally, this limitation is interpreted a generating a label for a value, which is equivalent to non-functional descriptive material and holds no patentable weight (MPEP 2111.05).
Nowak et al. teach does not teach some specific values for thresholds recited (Claims 4-6).
Regarding Claim 4, Ravaud et al. suggests the predefined threshold ranges from approximately 1 percent to approximately 7 percent of the first value. Ravaud et al. teaches the natural variation in bone density ranges between 0.9% and 2.6% (Page 1449, Column 2, Paragraph 2: Evaluation of short-term variability is usually carried out through repeated BMD measurements performed over a short period of time. The result is expressed as the coefficient of variation (CV); Page 1451, Table 2: CV(%)). Therefore to detect if there was a significant change from the distraction, it would be obvious to set a threshold percentage greater than 2.6% which includes values from within the recited range, to know that the effect is it not caused from natural variation. Ravaud et al. teaches the application of these values as thresholds (Page 1453. Column 2, Paragraph 2: Determination of the cut-offs allows us to express results as a dichotomous variable).
Regarding Claim 5, Ravaud et al. suggests the predefined threshold ranges from approximately 0.5 percent to approximately 10 percent of the first value. Ravaud et al. teaches the natural variation in bone density ranges between 0.9% and 2.6% (Page 1449, Column 2, Paragraph 2: Evaluation of short-term variability is usually carried out through repeated BMD measurements performed over a short period of time. The result is expressed as the coefficient of variation (CV); Page 1451, Table 2: CV(%)). Therefore to detect if there was a significant change from the distraction, it would be obvious to set a threshold percentage greater than 2.6% which includes values from within the recited range, to know that it not caused from natural variation. Ravaud et al. teaches the application of these values as thresholds (Page 1453. Column 2, Paragraph 2: Determination of the cut-offs allows us to express results as a dichotomous variable).
Regarding Claim 6, Ravaud et al. suggests the predefined threshold ranges from approximately 0.5 percent to approximately 20 percent of the first value. Ravaud et al. teaches the natural variation in bone density ranges between 0.9% and 2.6% (Page 1449, Column 2, Paragraph 2: Evaluation of short-term variability is usually carried out through repeated BMD measurements performed over a short period of time. The result is expressed as the coefficient of variation (CV); Page 1451, Table 2: CV(%)). Therefore to detect if there was a significant change from the distraction, it would be obvious to set a threshold percentage greater than 2.6% which includes values from within the recited range, to know that it not caused from natural variation. Ravaud et al. teaches the application of these values as thresholds (Page 1453. Column 2, Paragraph 2: Determination of the cut-offs allows us to express results as a dichotomous variable).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine the methods of Ravaud et al. with Nowak et al. Ravaud et al. teach methods that overcome previous analysis issues associated with individual variation in bone characteristics which will allow for enhanced analyses related to bone density (Page 1453. Column 2, Paragraph 2: Defining the SDD in BMD measurement, reflecting, at the individual level, organic changes rather than measurement errors is a major challenge for monitoring the progression of disease or the efficacy of a treatment. Determination of the cut-offs allows us to express results as a dichotomous variable). Bone density is a major consideration of Nowak et al. (see above rejection). Furthermore, one of ordinary skill in the art would predict that the methods could be readily combined with a reasonable expectation of success because both are within the same technical field – utilizing data generated from bones to evaluate changes to patient health. Additionally, both utilize thresholds within in their bone metric calculations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11376043 (reference patent). Although the claims at issue are not identical, they are not patentably distinct.
Claim 17 of the reference patent recites:
A monitoring method for generating a distraction indicator, comprising:
receiving data from an implantable bone distraction device, corresponding to a mechanical vibration response of a medium comprising the implantable bone distraction device, as measured by at least one vibration sensor (Instant application claim 1); and
computing from the received data a distraction indicator through at least steps of (Instant application claim 1):
determining at least one vibration pattern of said medium from the vibration response measured by the at least one vibration sensor (Instant application claim 1 and 2),
analyzing the evolution of a first value of the at least one vibration pattern of said medium determined from the measured vibration response during a first period (Instant application claim 1 and 2),
generating a distraction indicator as a function of the first value (Instant application claim 1 and 2),
analyzing the evolution of a second value of the at least one vibration pattern of said medium determined from the measured vibration response during a second period (Instant application claim 2),
performing a comparison between the first value and the second value (Instant application claim 2),
performing a comparison between the first value and the second value until the comparison between the first value and the second value exceeds a predefined threshold (Instant application claim 3).
Therefore, the limitations of instant claims 1-3 are recited by claim 17 of U.S. Patent No. 11376043.
Conclusion
No claims are allowed.
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/B.H.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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