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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a pressure data reception unit” in claim 1;
“a posture and body portion estimation unit” in claim 1;
“a by-portion risk evaluation unit” in claim 1;
“a by-portion risk evaluation data output unit” in claim 1;
“a posture estimation unit” in claim 2;
“a body portion estimation unit” in claim 2; and
“a 3-D data generation unit” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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(a)
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 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 positively recites “a pressure data reception unit”, “a posture and body portion estimation unit”, “a by-portion risk evaluation unit”, and “a by-portion risk evaluation data output unit”. Claim 2 positively recites “a posture estimation unit” and “a body portion estimation unit”. Claim 6 positively recites “a 3-D data generation unit”.
The instant Specification appears devoid of any corresponding physical and/or hardware structure(s) corresponding to the claimed “unit” recitations. In light of the instant Specification, one of ordinary skill in the art would recognize the “unit”(s) as merely a black-box receiving an input and providing an output. There does not appear to be evidentiarily demonstrated possession of specific, corresponding physical structure(s) responsible for the function such that written description of the claimed subject matter is lacking. Depending claims 3-5 inherit and do not remedy the lack of written description given the lack of possession.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 positively recites “a pressure data reception unit”, “a posture and body portion estimation unit”, “a by-portion risk evaluation unit”, and “a by-portion risk evaluation data output unit”. Claim 2 positively recites “a posture estimation unit” and “a body portion estimation unit”. Claim 6 positively recites “a 3-D data generation unit”.
The instant Specification appears devoid of any corresponding physical and/or hardware structure(s) corresponding to the claimed “unit” recitations. In light of the instant Specification, one of ordinary skill in the art would recognize the “unit”(s) as merely a black-box receiving an input and providing an output. Given the infinite number of possibilities of structure(s) that may accomplish the function(s) of the claimed “unit”(s), one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is indeterminate what may and/or may not be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the claims. Depending claims 3-5 inherit and do not remedy the lack of written description given the lack of possession.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea comprises a mental process of evaluating pressure data for identifying bedsore occurrence risk.
For independent claim 1, the claim(s) recite(s) a system for evaluating bedsore risk by receiving pressure data, detect pressure points and regions of interest on body point estimations and estimating posture, evaluation of risk data, and outputting risk data into graded bedsore occurrence risks.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a bedsore evaluation from pressure data.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of receiving data from a plurality of pressure sensors is well-known, routine and conventional insignificant data gathering as pre-solution activity. The plurality of pressure sensors structure(s) is not even required for the scope of the claim; conversely, the data therefrom is merely received.
Depending claims 2-6 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying steps relating to stimulus application, feature extraction, and/or relaxation technique training treatment that could merely be provided verbally.
For independent claim 7, the claim(s) recite(s) a method of evaluating bedsore risk by receiving pressure data, detect pressure points and regions of interest on body point estimations and estimating posture, evaluation of risk data, and outputting risk data into graded bedsore occurrence risks.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a bedsore evaluation from pressure data.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of receiving data from a plurality of pressure sensors is well-known, routine and conventional insignificant data gathering as pre-solution activity. The plurality of pressure sensors structure(s) is not even required for the scope of the claim; conversely, the data therefrom is merely received.
Depending claims 8-11 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying steps relating to stimulus application, feature extraction, and/or relaxation technique training treatment that could merely be provided verbally.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Main et al. (WO 2011/091517 A1, hereinafter Main).
For claim 1, Main discloses a system for evaluating a bedsore risk (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39), comprising inter alia:
a pressure data reception unit configured to receive pressure data from a plurality of pressure sensors (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39);
a posture and body portion estimation unit configured to detect coordinates of key points that are feature points of a body and estimate a posture based on pressure data, to output coordinate data of a pressure region of interest (PROI) based on the coordinates of the key points and the posture, and to estimate a body portion (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39);
a by-portion risk evaluation unit configured to evaluate a degree of risk for each body portion based on the coordinate data of the PROI, statistical data, and learning data and to generate by-portion risk evaluation data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39); and
a by-portion risk evaluation data output unit configured to output the by-portion risk evaluation data by dividing the by-portion risk evaluation data into grades according to bedsore occurrence risks (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 2, Main discloses the system of claim 1, wherein the posture and body portion estimation unit comprises:
a posture estimation unit configured to store a posture estimation model that outputs the coordinates of the key points and the posture by using the pressure data as an input (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39); and
a body portion estimation unit configured to store a body portion estimation model that outputs the coordinate data of the PROI by using the coordinates of the key points and the posture as an input (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 3, Main discloses the system of claim 2, wherein the posture estimation model calculates a depth based on a pressure intensity of the pressure data and detects the coordinates of the key points in a three-dimensional (3-D) space based on the calculated depth (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 4, Main discloses the system of claim 2, wherein the body portion estimation model activates the key point having coordinates, which is required for each posture, and generates a clipping mask on the basis of the coordinates of the activated key point, and extracts the coordinate data of the PROI by projecting the generated clipping mask onto the pressure data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 5, Main discloses the system of claim 1, wherein: the by-portion risk evaluation unit outputs the by-portion risk evaluation data by assigning an accumulation weight over time to the by-portion risk evaluation data, and the accumulation weight comprises at least one of an accumulated time, a presence or absence of bedsores, a nutrition state, or a skin state (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 6, , Main discloses the system of claim 1, further comprising a 3-D data generation unit configured to generate and provide the pressure data as 3-D data based on the coordinate data of the PROI, wherein the generated 3-D data are supplemented by using pre-stored posture image data and are displayed by incorporating the by-portion risk evaluation data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 7, Main discloses a method of evaluating a bedsore risk (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39), comprising steps of inter alia:
a) receiving pressure data from a plurality of pressure sensors (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39);
b) detecting coordinates of key points that are feature points of a body and estimating a posture by inputting the pressure data to a posture estimation model (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39);
c) outputting coordinate data of a pressure region of interest (PROI) that is an interested pressure region by inputting the coordinates of the key points and the posture to a body portion estimation model and estimating a body portion (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39); and
d) evaluating a degree of risk for each body portion and generating by-portion risk evaluation data based on the coordinate data of the PROI, statistical data, and learning data and outputting the by-portion risk evaluation data by dividing the by-portion risk evaluation data into grades according to bedsore occurrence risks (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 8, Main discloses the method of claim 7, wherein the step b) comprises: calculating a depth based on a pressure intensity of the pressure data, and detecting the coordinates of the key points in a three-dimensional (3-D) space based on the calculated depth (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 9, Main discloses the method of claim 7, wherein the step c) comprises: activating a key point having coordinates, which is required for each posture; generating a clipping mask on the basis of coordinates of the activated key point (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39); and extracting the coordinate data of the PROI by projecting the generated clipping mask onto the pressure data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 10, Main discloses the method of claim 7, wherein: the step d) comprises outputting the by-portion risk evaluation data by assigning an accumulation weight over time to the by-portion risk evaluation data, and the accumulation weight comprises at least one of an accumulated time, a presence or absence of bedsores, a nutrition state, or a skin state (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
For claim 11, Main discloses the method of claim 7, further comprising a step e) of generating and providing pressure data as 3-D data based on the coordinate data of the PROI, wherein the step e) comprises: supplementing the generated 3-D data by using pre-stored posture image data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39), and displaying the supplemented 3-D data by incorporating the by-portion risk evaluation data into the supplemented 3-D data (Figs 1-7 & 10-16, especially 10, 14 & 16) (Pgs 9-43, especially 32-39).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for evaluating and grading bedsore risk based on pressure sensed data for ascertaining pressure ulcer risk and/or severity from evaluated posture data models.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/Primary Examiner, Art Unit 3791
Prosecution Insights