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 .
Response to Amendment
The amendment filed May 26, 2026 has been entered.
Claim 11 is cancelled. Claims 12-20 are new. Claims 1-10 and 12-20 are pending.
Applicant’s amendments obviate the previous objection to claim 7.
Applicant’s amendments obviate the previous rejection of claim 10 under 35 U.S.C. 112(b).
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 112(a).
Applicant’s amendments necessitate new objections to the Drawings.
Applicant’s amendments necessitate new grounds of prior art rejections.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s).
Claim 1: “a series of sensors disposed throughout a tissue-prosthesis interface”
Claim 1: “a series of LEDs, each LED thereof corresponding to a particular one of the series of sensors”
Claim 7: “a series of sensors disposable throughout a tissue-prosthesis interface of a prosthetic limb configured to continuously measure a particular physical condition at the sensor location”
Claim 7: “a series of LEDs, each LED thereof corresponding to a particular one of the series of sensors”
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 use the word “means.” Such claim limitation(s) is/are:
“means of notifying the user of the physical condition within the prosthetic limb” in claim 1;
“means of conveying to a user” in claim 7.
As best understood, the closest structure described in the Specification which performs the above functions appears to be RGB LEDs, as shown at Fig. 2 and described in Paragraphs [11], [14]-[18], and [21].
Because this/these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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 10 and 12 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.
Re. Claim 10: Claim 10 recites a method of improving system use, whereby a machine learning algorithm is applied to system data collected from use of a prosthetic limb, determining, using the machine learning algorithm, one or more patterns, and then notifying the user of one or more patterns. Phrases such as “train,” “machine learning algorithm,” and “determining” appear to indicate the claim to be directed to computer-implemented functional limitations. Applicant’s disclosure appears absent of sufficient support for the hardware and algorithm (e.g., the necessary steps and/or flowcharts) to perform the claimed function insufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing (see MPEP 2161.01). Particularly, the claim phrases “applying a machine learning algorithm” encompasses concepts such as inputting data into supervised or unsupervised algorithms; however, Applicant’s disclosure is absent any details as to how an algorithm is applied as claimed, particularly as it relates to a broadly-claimed “” (see rejection under 35 U.S.C. 112(b). As per MPEP 2161.01.I:
“It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. ”
Thus, Applicant’s disclosure is insufficient to provide adequate written description as to how a machine learning algorithm is “applied.”
Additionally, Claim 10 is 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.
Claim 10 recites “applying a machine learning algorithm to data collected from regular use of a prosthetic limb” and “determining, using the machine learning algorithm, one or more patterns about usage of said prosthetic limb.” Applicant’s original disclosure does not provide sufficient support the recited claim language. The closest support is in Paragraph [23] of Applicant’s Specification, which recites:
“Information fed to the microcontroller can also be used to improve the tissue- prosthesis interface sensor system in the future. The continuous feed of data can be used to improve the user's experience by giving insightful feedback about patterns of the prosthetics operation. Running a machine learning algorithm on the data can be useful for analytical purposes. The information can be used to identify the method or locations most and least prone to injury or in need of readjustment. The data can then present this data to the user for a better experience in the future.”
However, the above statement only provides a cursory statement that “running a machine learning algorithm on the data can be useful for analytical purposes,” and does not relate the end result of “running” a machine learning algorithm to the claimed limitation of identifying one or more patterns of usage of the prosthetic limb.
Re. Claim 12: Claim 12 is rejected due to dependency upon rejected claim 10.
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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Hurley et al. (US 20180020973 A1) (hereinafter – Hurley).
Re. Claim 10: Hurley teaches a method of improving prosthetic limb use comprising:
disposing a tissue-prosthesis interface sensor system between the prosthetic limb and a user’s residual limb (Paragraph 0151: “After a user is fit with a sensor-enabled prosthetic socket as described herein…;” Fig. 2);
applying a machine learning algorithm to data collected from regular use of a prosthetic limb (Paragraphs 0151, 0164, 0166);
determining, using the machine learning algorithm, one or more patterns about usage of said prosthetic limb (Paragraphs 0164, 0166);
notifying the user of the one or more patterns pertaining to the usage of the prosthetic limb (Paragraph 0166: “According to one embodiment, a method for using sensed prosthetic socket data may involve the following steps:… types of data collected over time are compared and analyzed automatically by the application programming or cloud based computing; qualitative recordings and their subsequent inputs are prompted at regular time intervals and available to the user at any time; and predictive algorithms and machine learning principles such as Bayes' Theorem are applied to yield prescriptive information or notifications that can be useful to the user, healthcare team, researchers, or family…”).
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, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe) in view of
Patt et al. (US 20140277588 A1) (hereinafter – Patt).
Re. Claim 1: Rincoe teaches a prosthetic limb (Abstract: “This monitoring apparatus and method is used, for example, to fit prosthetics…;” Fig. 5; Col. 4, lines 40-45: “The present invention is directed to pressure monitoring apparatus and systems specifically adapted for monitoring the force of pressure of a body part against a contact surface such as an article of furniture (bed, chairs, wheel chairs, etc.), orthopedic casts and prostheses (such as artificial limbs)” )
with interface conditions feedback (Abstract: “This monitoring apparatus and method is used, for example, to fit prosthetics, to monitor bed-ridden and wheelchair-bound patients, to reduce pain and sores caused by uneven distribution of pressure and to monitor pressure between a cast and a person;” Col. 2, lines 1 – 8: “A prosthesis is usually mounted by receiving the stump of a limb in a socket of the prosthesis so that pressure exists between a surface of the stump and the socket of the prosthesis. Changes in the body weight and musculature of the person resulting from use of the prosthesis may [a]ffect the fit of the prosthesis on the stump which again cause hot spots leading to pain and ulceration of the exterior surface of the stump;” Col. 4, lines 33-35: “This pressure can be monitored in order to determine any excess pressures which may cause discomfort or injury to the patient)
comprising:
a series of sensors disposed throughout a tissue-prosthesis interface of the prosthetic limb for continuously detecting a particular physical condition, at each of the respective locations of the sensors (see citations above – the sensors are necessarily placed at contact points of a prosthetic, i.e., within an interior cavity where a limb stump is received; Figs. 5, 6);
a series of multiplexers configured to receive signals from the sensors and output data indicative of the physical condition detected at a particular sensor (Fig. 1: see various MUX components; see similar components in Fig. 9).
Rincoe does not explicitly teach the invention comprising a series of LEDs, each LED thereof corresponding to a particular one of the series of sensors. Examiner is interpreting the claim language of “[a] prosthetic limb comprising… a series of LEDs, each LED thereof corresponding to a particular one of the series of sensors” as encompassing a prosthetic limb in communication with a series of LEDs, whereby a series of LEDs may include a subset of LEDs located in display screens used for displaying information corresponding to a particular one of the series of sensors. Rincoe teaches using a monitor to display magnitudes of force signals at corresponding sensor locations (Col. 2, line 64 – Col. 3, line 5), but does not teach the display itself comprising a series of LEDs.
Patt teaches analogous art in the technology of visual cues for prosthetic feedback systems (Abstract). Patt teaches the concept of utilizing display screens attached to sensors of a prosthetic (Fig. 1) to communicate feedback signals commensurate with pressure sensors of the prosthesis (Paragraph 0024). Patt further teaches that the use of display screens utilizing LED technology is considered well-known before the effective filing date of the invention (Paragraph 0024).
It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include LED displays for displaying pressure values of a prosthesis as taught by Patt in the system of Rincoe, since the claimed invention is merely a combination of old elements (Rincoe: a system which uses a non-descript display to indicate force signals per sensor location on a prosthesis; Patt: teaching that LED technology is well-known and also employed for an analogous technology), and in the combination each element merely would have performed the same function as it did separately (the modified Rincoe displaying force and location of pressure signals via an LED display), and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Rincoe as modified by Patt further teaches the invention comprising:
a microcontroller (Fig. 1: microcomputer 30)
programmed to receive the data output by the series multiplexers (Fig. 1: see signal paths to each MUX component to microcomputer 30; see similar components in Fig. 9)
and, for each one of the series of sensors, to compute and set a color value for the corresponding LED indicating the condition at the particular sensor (Col. 2, line 64 – Col. 3, line 5: “A monitor communicates with the array of sensors and receives the force signal produced by each respective sensor. This monitor then generates an output signal indicative of the pressure sensed by a respective sensor according to its location. A controller communicates with the monitor in order to receive and process the output signals in order to produce a force profile corresponding to the magnitude and location of the pressure exerted by the contact surface on the body part;” Examiner notes that a pressure output as excessive may be viewed as a ”signal indicating that the condition of the prosthetic limb” is unsafe; Examiner notes that control of the screen to compute and set color values for each LED corresponding to display of sensor information is implicit in order to display visible information on a screen, e.g., black text on a white display);
means of notifying the user of the physical condition within the prosthetic limb
(Col. 3, lines 49-54: “These output signals are then received and stored as a read event after which the pressure data correlated to the location of each sensor may be displayed as a force profile which corresponds to the magnitude and location of the pressure exerted by the contact surface on the body part;” Figs. 1, 2: computer 34, printer 38; Fig. 9: communication interface 280 in communication with computer 230);
and a power source electrically connected to the sensors and the microcontroller (Col. 6, lines 6-33: “Further, interface circuitry 74 contains a power supply which produces a voltage signal which is modulated by each of pressure sensors 20 proportionately to the force sensed thereby. Interface circuitry 74 is connected to the array of pressure sensors by means of a cable harness 76 which is electrically connected to the array of sensors by means of electrical connector 78;” Col. 7, lines 29-36: “Electrical contact to sensors 20 is made by means of a ground common wire 150 and a respective power wire, such as power lead 161 and 162 are provided to each sensor 20. Each of these power leads and ground wire 150 are bundled together and placed in electrical communication with a connector 170 at connector end 171 to which a respective lead 121-126 may be connected in electrical communication;” see each component in communication in Figs. 2, 5, 6, 7, 9).
Re. Claim 2: Rincoe as modified by Patt teaches the invention according to claim 1. Rincoe further teaches the invention wherein the series of multiplexers comprises one or more layers (Fig. 1: row multiplexers 41-46 can be interpreted as one layer; column multiplexer 48 is interpreted as another layer; see also Fig. 9: row multiplexers 241-246 and column multiplexer 248; Examiner notes that a layer is not provided with structural definition in the claims, such as requiring a component overlying another).
Re. Claim 3: Rincoe as modified by Patt teaches the invention according to claim 2. Rincoe further teaches the invention wherein the microcontroller is configured to receive and process data output from a lowest layer of the series of multiplexers (Figs. 1, 9: microcomputer 30 and CPU 232 each receive data from row multiplexers and column multiplexers; Examiner notes that “lowest” has not been structurally defined in the claims; thus, row multiplexers can be viewed as a “lowest layer” of multiplexers, i.e., requiring the most degrees of processing separation prior to input to microcomputer 30 and CPU 232).
Re. Claim 4: Rincoe as modified by Patt teaches the invention according to claim 1. Rincoe further teaches the invention wherein the microcontroller is further programmed to loop continuously over the receiving, computing, and setting steps (Abstract: “The sensors may be scanned as a read event in variety of manners, including periodic, continuous and triggered scanning;” Col. 5, lines 37-64: “microcomputer 30 may receive from the array of pressure sensors 20 force signals corresponding to the force of pressure monitored by each of sensors 20 by executing a "read event" which may be defined as a scan of the array of pressure sensors to derive a force profile correlated to the location of each pressure sensor and the respective force detected thereby… At the completion of the read event, memory 36 has stored pressure data corresponding to each of the sensors as it existed at the time of the read event. This array of data thus comprises a force profile for the pressure distribution across the array of sensors 20 on sheet 22. This data can be displayed in a variety of formats; the data may also be interpolated to give pressure estimates between sensor locations;” Col. 6, lines 22-25; “The force profile of a read event may be displayed on display screen 34 or may be output in hard form by means of printer 38, all as is known in the art”).
Re. Claim 5: Rincoe as modified by Patt teaches the invention according to claim 4. Rincoe further teaches the invention wherein the notification informs the user that adjustment of the prosthetic limb is necessary (see previous citations regarding display of pressure profile data in combination with: Abstract: “This monitoring apparatus and method is used, for example, to fit prosthetics;” Examiner notes that adjustment of a fit is necessarily performed in fitting prosthetics based on pressure profile information; Col. 9, lines 30-35: “Also, as discussed with respect to FIGS. 2 and 3, monitoring of excessive pressure may be used to prevent ulceration of the skin or other unwanted pain associated with excess localized pressure at a specific location between an article of furniture, a cast, etc. and a body part;” Examiner notes that since Rincoe contemplates monitoring of pressures applied by a prosthetic against a body of a user, the term “etc.” reasonably encompasses prostheses).
Re. Claim 13: Rincoe as modified by Patt teaches the invention according to claim 1. Rincoe further teaches the invention wherein the series of sensors are pressure sensors (Abstract: “…a plurality of pressure sensors…”).
Re. Claim 14: Rincoe as modified by Patt teaches the invention according to claim 1. Rincoe further teaches the invention further configured to provide an indication that an injurious load has been detected (Col. 6, lines 33-35: “This pressure can be monitored in order to determine any excess pressures which may cause discomfort or injury to the patient”).
Claims 6-9, 15, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe) in view of
Patt et al. (US 20140277588 A1) (hereinafter – Patt).
Kane et al. (US 20160331563 A1) (hereinafter – Kane).
Re. Claim 6: Rincoe as modified by Patt teaches the invention according to claim 1, but does not teach the invention wherein the power source comprises a grounded source or one or more batteries.
Kane teaches analogous art in the technology of socket-limb interface pressure monitoring for prosthetics (Abstract). Kane further teaches the use of a battery in order to power electronics of a prosthetics system (Paragraph 0042).
It would have been obvious to one having skill in the art before the effective filing date to have modified Rincoe as modified by Patt to utilize a battery as a power source as taught by Kane, the motivation being that the system can be used without connection to a wall socket.
Re. Claim 7: Rincoe teaches a tissue-prosthesis interface sensor system for continuously monitoring a physical condition of a cavity of a prosthetic limb to ensure that injurious conditions are promptly corrected comprising (see rejection of claim 1);
a series of sensors disposable throughout a tissue-prosthesis interface of a prosthetic limb configured to continuously measure a particular physical condition at the sensor location (see rejection of claim 1);
at least one layer of multiplexers configured to receive input signals from the sensors and converts the signal into a value which is then output (see rejection of claim 1).
Rincoe does not teach a series of LEDs, each LED thereof corresponding to a particular one of the series of sensors. This aspect is taught by Patt (see rejection of claim 1 including the modification of Patt).
Rincoe as modified by Patt further teaches the invention comprising a microcontroller which is configured to, for a selected one for each one of the series of sensors, receive the value output from the at least one layer of multiplexers (see rejection of claim 1).
Rincoe as modified by Patt does not teach the invention wherein the microcontroller compares the value with predetermined values which are known to be safe, and
outputs an indication as to whether the prosthetic limb is safely attached or is potentially injurious.
Kane further teaches a microcontroller (Fig. 4) which
compares a value with predetermined values which are known to be safe (Paragraph 0041: “…the pressure measured at a sensor location can be compared to a specified value of pressure which corresponds to a pressure level which should not be exceeded to ensure safe use of the prosthetic device;” Paragraph 0042: “Pressure readings can be taken over a specified period of time and compared to a specified cumulative value of pressure which corresponds to a cumulative pressure level which should not be exceeded to ensure safe use of the prosthetic device”), and
output an indication as to prosthetic limb safety or potentially injuriousness (Paragraph 0068: “According to some embodiments, the device can alert the user to adjust the fit of the socket if abnormal pressure is detected”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Rincoe to include comparison to predetermined values of pressure to determine safety of a socket-limb interface of a prosthetic as taught by Kane, the motivation being that doing so removes the need for a professional or caregiver to observe pressure profile data to make a judgement of fit, and provides identification of pressures specific to measured pressures of a user of the device over time (Paragraphs 0041-0042).
Rincoe as modified by Patt and Kane above also teaches output an indication as to prosthetic limb safety or potentially injuriousness to the LED corresponding to the selected one of the sensors (see citations of rejection of claim 1 in light of modification of Patt incorporating LED display of sensor values).
Re. Claim 8: Rincoe as modified by Patt and Kane teaches the invention according to claim 7. Rincoe further teaches the invention wherein the sensors are configured to continuously output the particular physical condition at respective locations, to the at least one layer of multiplexers (Abstract: “The sensors may be scanned as a read event in variety of manners, including periodic, continuous and triggered scanning;” Figs. 1, 9).
Re. Claim 9: Rincoe as modified by Patt and Kane teaches the invention according to claim 7. Rincoe further teaches the invention wherein the at least one layer of multiplexers comprises means for sequentially directing each sensor's output of the particular physical condition at the sensor, to the microcontroller (Figs. 1, 9: see connections between row and column multiplexers and singular output to each microcontroller shown).
Re. Claim 15: Rincoe as modified by Patt teaches the invention according to claim 13, but does not teach the invention wherein the microcontroller is further configured to set a color of one of the series of LEDs red when an injurious load is detected at the sensor corresponding to the one of the series of LEDs.
Kane teaches the invention wherein the microcontroller is further configured to set a color of one of the series of LEDs red when an injurious load is detected at the sensor corresponding to the one of the series of LEDs (Paragraph 0098: “According to some embodiments, when the socket-limb interface is experiencing dangerous pressure readings, the patient will be alerted via text messaging or email service. According to some embodiments, the patient will have access to a pressure map ranging from green/blue to red, where red indicates dangerous pressure readings. Providing a pressure map will allow the patient to discern where abnormal pressures are located and prevent possible ulcerations from occurring”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the LED output of Rincoe as modified by Patt to include the color mapping of Kane, the motivation being that doing so allows a third party to easily view a difference between an injurious load compared to a safe load since the color mapping of Kane places complementary colors (green and red) to opposite ends of spectrum of pressure readings.
Re. Claim 16: Rincoe as modified by Patt teaches the invention according to claim 1, but does not teach the invention wherein the computation of a color employs a color map.
Kane teaches such an aspect. See rejection of claim 15; motivation to modify Rincoe as modified by Patt are identical.
Re. Claim 18: Rincoe as modified by Patt and Kane teaches the invention according to claim 7. Rincoe further teaches the invention wherein the series of sensors are pressure sensors (Abstract: “…a plurality of pressure sensors…”).
Re. Claim 19: Rincoe as modified by Patt and Kane teaches the invention according to claim 18, but does not teach the invention wherein the indication as to safety is setting the LED to green and the indication as to potential injuriousness is setting the LED to red.
Kane teaches such an aspect. See rejection of claim 15; motivation to modify Rincoe as modified by Patt and Kane are identical.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hurley et al. (US 20180020973 A1) (hereinafter – Hurley) in view of
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe).
Re. Claim 12: Hurley the invention according to claim 10, but does not teach the invention wherein notifying the user includes identifying information about locations of the residual limb most or least prone to injury.
Rincoe teaches the invention wherein notifying the user includes identifying information about locations of the residual limb most or least prone to injury (Col. 2, line 64 – Col. 3, line 5: “A monitor communicates with the array of sensors and receives the force signal produced by each respective sensor. This monitor then generates an output signal indicative of the pressure sensed by a respective sensor according to its location. A controller communicates with the monitor in order to receive and process the output signals in order to produce a force profile corresponding to the magnitude and location of the pressure exerted by the contact surface on the body part;” Examiner notes that a pressure output as excessive may be viewed as a ” identifying information about locations of the residual limb most or least prone to injury”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the notification of Hurley to include information as to location of the limb most or least prone to injury as taught by Rincoe, the motivation being that doing so provides more granular information as to the fit of the sensor-enabled prosthetic socket of Hurley.
Claim 17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe) in view of
Patt et al. (US 20140277588 A1) (hereinafter – Patt).
Applicant-Admitted Prior Art (hereinafter – AAPA).
Re. Claim 17: Rincoe as modified by Patt teaches the invention according to claim 1, but does not teach the invention wherein the computation of a color employs gamma correction.
AAPA teaches wherein the computation of a color employs gamma correction (“At 207, the color mapped in 206 is then corrected for gamma using methods known to somebody of skill in the art”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the display of information of Rincoe as modified by Patt to include gamma correction, the motivation being that such a practice is a common operation to encode/decode luminance in images and video to match the perception of brightness of the human eye.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe) in view of
Patt et al. (US 20140277588 A1) (hereinafter – Patt) in further view of
Kane et al. (US 20160331563 A1) (hereinafter – Kane) in further view of
Ly et al. (US 20190224841 A1) (hereinafter – Ly).
Re. Claim 20: Rincoe as modified by Patt and Kane teaches the invention according to claim 18. Kane teaches wherein the indication as to safety is setting the LED to green and the indication as to potential injuriousness is setting the LED to red (see rejection of claim 19). Thus, Rincoe as modified by Patt and Kane are solely deficient in teaching a flashing red LED to indicate potential injuriousness.
Ly teaches analogous art in the technology of body-worn sensors (Abstract). Ly further teaches the use of a flashing red indicator to indicate dangerous conditions (Paragraph 0106: “…the exosuit can flash bright red and white LED lights and blasts a message such as “Help, Man Down” over the exosuit's audio speaker”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Rincoe as modified by Patt and Kane to include a flashing indication for dangerous conditions as taught by Ly, the motivation being that doing so aids in drawing attention to an unsafe condition (Paragraph 0106).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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