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 Objections
Claim 7 is objected to because of the following informalities:
line 3, “comprising;” should read as “comprising:”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that 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.
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.
Re. Claim 10: Claim 10 recites a method of improving system use, whereby the system is “trained” using “training data” collected from use of a prosthetic limb, determining one or more patterns, and then notifying a user of such patterns. Phrases such as “train,” “training data,” 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 “train” and “training data” encompasses concepts such as training supervised or unsupervised algorithms or processing details of a system which changes over time; however, Applicant’s disclosure is absent any details as to how an algorithm is “trained,” particularly as it relates to a broadly-claimed “system” (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 of “training” a system since such a term implies a computer-implemented algorithm whose steps are undefined or undisclosed in Applicant’s figures or Specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 10: Claim 10 recites “training the system;” when looking to Applicant’s Specification to identify what “system” is trained, the only usage of the term “train” is found in Paragraphs [2] and [5], which discuss practicing the use of a prosthetic limb irrespective of a “system” capable of intaking training data, determining patterns therefrom, and providing an output related thereto. Thus, it is unclear what the term “system” is directed to, and how such a system is improved.
Should the system be defined as, e.g., a machine learning model, training the model itself to produce a particular output is not an improvement to the system, but rather implementation of a learning model. In other words, causing a “learning model” to “learn” based on training data does not improve the model itself, but merely implements it.
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.
Claims 1-5 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe).
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)” )
for detecting injurious conditions (intended use; additionally, see 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 throughout a cavity of the prosthetic limb for continuously detecting a particular physical condition, at each of the respective locations of the sensors, of the prosthetic limb (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);
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 to compute and output a signal indicating that the condition of the prosthetic limb is either safe or unsafe 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);
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 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 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 teaches the invention according to claim 1. Rincoe further teaches the invention wherein the means of notifying the user of the physical condition performs the notification in real time (the term “real time” is not given definition in the claims – any action can be interpreted as occurring in “real time;” actions such as continuous scanning and output of data after such scanning may be considered “real-time;” 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 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 11: Rincoe a system for detecting a triggering event (Examiner notes that claim 11 is significantly broader than the technology of prosthetic devices; for instance, any system that utilizes layers of multiplexers to monitor physical conditions at a variety of locations is capable of reading on claim 11; however, the art of Rincoe is applied again for convenience: Abstract; Examiner notes that detection of pressure and/or force can be interpreted as “triggering events” in the sense that 1) pressure and/or force are what cause the triggering of the sensors to produce a signal and/or 2) a visualization corresponding to the pressure and/or force detected may cause the observer of the visualization to perform some action; the term “triggering” is not provided with further definition in the claims and is not used after the present limitation)
comprising:
a series of sensors continuously detecting either a particular physical condition or various physical conditions, at each of the respective locations of the sensors (see rejection of claim 1);
a series of multiplexers configured to receive signals from the sensors and output data indicative of a particular physical condition detected at a particular one of the sensors (see rejection of claim 1);
a microcontroller programmed to receive the data output by the series of multiplexers and to compute and output a signal indicating the particular physical condition (see rejection of claim 1);
means of notifying the user of the particular physical condition (see rejection of claim 1); and
a power source electrically connected to the sensors and the microcontroller (see rejection of claim 1).
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Davoodi et al. (US 20070016265 A1) (hereinafter – Davoodi).
Re. Claim 10: Davoodi teaches, as best understood, a method of improving system use (Abstract: “Disclosed are methods and systems for a virtual reality simulation and display of limb movement that facilitate the development and fitting of prosthetic control of a paralyzed or artificial limb”)
comprising:
training the system using training data collected from regular use of a prosthetic limb (Abstract: “Alternatively or additionally, the errors produced by the virtual limb and/or the responses of the user during the training process can provide information for adapting the properties of the control system itself;” Fig. 3);
determining one or more patterns about usage of said prosthetic limb (Fig. 3: steps 42, 44, 46, 48, 50, 52, 54);
notifying a user of the patterns pertaining to the usage of the prosthetic limb and implications of the patterns (Fig. 3: display animation to user at step 56; Abstract: “The computed movements of the model limb are displayed to the user as a 3D animation from the perspective of the user so as to give the impression that the user is watching the actual movements of his/her own limb. The user learns to adjust his/her command signals to perform tasks successfully with the virtual limb. Alternatively or additionally, the errors produced by the virtual limb and/or the responses of the user during the training process can provide information for adapting the properties of the control system itself”).
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over:
Rincoe et al. (US 5253656 A) (hereinafter – Rincoe) in view of
Kane et al. (US 20160331563 A1) (hereinafter – Kane).
Re. Claim 6: Rincoe 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 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 (see rejection of claim 1)
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 throughout the cavity of the prosthetic limb configured to continuously measure a particular physical condition within the cavity (see rejection of claim 1);
at least one layer of multiplexers that receives input signals from the sensors and converts the signal into a value which is then output (see rejection of claim 1);
a microcontroller which receives the value output from the at least one layer of multiplexers (see rejection of claim 1).
Rincoe 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 the 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
outputs an indication as to whether the prosthetic limb is safely attached or is potentially injurious (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 Kane teaches a means of conveying to a user that the prosthetic limb is currently attached safely or is potentially injurious, based on the indication output by the microcontroller (see citations of rejection of claim 1 in light of modification).
Re. Claim 8: Rincoe as modified by 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 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791