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 1 is objected to because of the following informalities:
Claim 1 recites the limitation “transmsit”, however, the limitation should read “transmit”.
Appropriate correction is required.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claim 1 is found to recite a judicial exception (i.e. abstract idea). In this instance, claim 1 recites the limitation “calculate a volume of a bladder included in an ultrasound image generated based on the reception ultrasound signal according to an area of the bladder”. The cited limitation, under its broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of calculating a volume of a bladder which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably take measurements of the bladder and calculate a volume in the mind or with the aid of pen and paper. Examiner notes that with the exception of generic computer-implemented steps (e.g. calculation unit recited in claim 1), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
An ultrasound probe configured to transmit an ultrasound signal to an inside of a human body and to receive an ultrasound signal reflected from the inside of the human body
A calculation unit
The additional element(s) in the cited independent claim(s) are not found to integrate the judicial exception into a practical application. In this case, the ultrasound probe is considered merely a generic component of an ultrasound system and is used for mere data gathering found to be insignificant extra solution activity and the calculation unit amounts to merely implementing the judicial exception using a computer. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claim 1 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above, the limitations amount to merely generic components of an ultrasound system and mere data gathering as well as a generic computer for implementing the judicial exception. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim does not amount to significantly more and the independent claim remains patent ineligible.
Dependent claims 2-4 further limit the abstract idea of independent claim 1. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
Calculate a largest maximum area among the areas of the bladder included in the ultrasound images generated at every scan interval (claim 4)
Calculating the volume of the bladder according to the maximum area (claim 4)
The cited limitations, under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably calculate a largest maximum area and calculate the volume of the bladder according to the maximum area Examiner notes that with the exception of generic computer-implemented steps (e.g. a maximum unit and volume unit of claim 4), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 2-4, present additional elements which only further narrow the judicial exceptions (e.g. claim 2 which recites an image providing unit to provide ultrasound images and a scan adjusting unit to adjust the scan interval, where such limitations are considered merely generic components of an ultrasound system (e.g. computer/circuitry) recited with such high generality that they amount to merely insignificant extra-solution activity of data gathering/processing and claim 2 which recites reducing the scan interval which is considered merely insignificant extra-solution activity) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
Examiner notes that claim 5 is found to amount to significantly more than the judicial exception. Specifically claim 5 sets forth an ultrasound array included in the ultrasound probe including a first ultrasound array and a second ultrasound array disposed perpendicular to the first ultrasound array at one end of the first ultrasound array. Such an ultrasound array is found to be a particular machine for which the judicial exception is applied, thus amounts to significantly more than the judicial exception.
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.
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:
The limitation “a calculation unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to calculate a volume of a bladder”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “an image providing unit” in claim 2 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to provide the ultrasound images”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a scan adjusting unit” in claim 2 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to adjust the scan interval”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a maximum unit” in claim 4 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to calculate a largest maximum area”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a volume unit” in claim 4 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to calculate the volume”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a directional image providing unit” in claim 6 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to generate…”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a first area scoring unit” in claim 7 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to score areas”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a second area scoring unit” in claim 7 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to score areas”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a ranking determination unit” in claim 8 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to determine priorities..”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a comparison unit” in claim 8 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to compare a higher area score”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a weighting unit” in claim 9 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to provide weight values”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a weighting scoring unit” in claim 9 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to apply the weight values”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a summing unit” in claim 9 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to sum the weighted scores”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a result unit” in claim 10 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to compare the sum score”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “a volume calculation unit” in claim 10 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to calculate the volume”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
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 1-10 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 recites the limitation “a calculation unit configured to calculate a volume of a bladder included in an ultrasound image”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “calculating a volume of a bladder included in an ultrasound image”. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 2 recites the limitations “an image providing unit” and “a scan adjusting unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “providing the ultrasound images” and “adjusting the scan interval”, respectively. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 4 recites the limitations “a maximum unit” and “a volume unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “calculating a largest maximum area” and “calculating the volume”, respectively. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 6 recites the limitations “directional image providing unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “generating first directional ultrasound images” and “generating second directional ultrasound images”. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 7 recites the limitations “a first area scoring unit” and “a second area scoring unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “scoring areas of the bladder”. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 8 recites the limitations “a ranking determination unit” and “a comparison unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “determining priorities of the first area score and the second area score” and “comparing a higher area score with a higher priority among the first area score and the second area score”, respectively. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 9 recites the limitations “a weighting unit” and “a weighting scoring unit”, and “a summing unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “providing weight values”, “applying the weight values”, and “summing the weighted scores”, respectively. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 9 recites the limitation “provide weight values applied to a lower area score with a lower priority and higher area score among the first area score and the second area score”. Examiner notes that while there is literal textual support for the limitation in the specification, there is insufficient written description of the nature of the weight values and how they are provided (i.e. determined) in order to apply them to the scores respectively. In other words, there is no disclosure for the algorithm/steps for providing such weight values which would indicate to a person having ordinary skill in the art that the inventor had possession of the claimed invention at the original time of filing.
Claim 10 recites the limitations “a result unit” and “a volume calculation unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “compare the sum score with a predetermined reference sum score” and “calculate the volume of the bladder”, respectively. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
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 1-10 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 limitations “calculation unit”, “image providing unit”, “scan adjusting unit”, “maximum unit”, “volume unit”, “directional image providing unit”, “first area scoring unit”, “second area scoring unit”, “ranking determination unit”, “comparison unit”, “weighting unit”, “weighting scoring unit”, “summing unit”, “result unit”, “volume calculation unit” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is therefore unclear what the structure of each “unit” recited above are for performing the corresponding structure. For examination purposes, it has been interpreted that each unit is a processor or elements of a processor or anything merely capable of performing the corresponding structure, however, clarification is required.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 2 recites the limitation “the ultrasound images at every scan interval”. There is insufficient antecedent basis for the ultrasound images and for every scan interval, rendering the claim unclear. In other words, it is unclear if the ultrasound images include the ultrasound image recited in claim 1 or if the ultrasound image of claim 1 is intended to be ultrasound images, and further whether every scan interval corresponds with a timing at which the transmitted/received ultrasound signal occurs or if these are different scan intervals. For examination purposes, it has been interpreted to mean any ultrasound images at any scan intervals, however, clarification is required.
Claim 2 recites the limitation “adjust the scan interval according to the area of the bladder included in the ultrasound images generated at every scan interval”. There is insufficient antecedent basis for “the scan interval” as the claim previously recites every scan interval, thus making it unclear which scan interval the claim is referring to or if every scan interval is intended to mean a scan interval. It is further unclear what constitutes a “scan interval” (e.g. a spatial interval, a transmission or reception interval or other scan interval) Furthermore, the limitation appears to include circular logic of adjusting the scan interval according to data at every scan interval, thus it is unclear if every scan interval corresponds to an adjusted scan interval or if there is some other adjusting occurring which does not affect every scan interval. For examination purposes, it has been interpreted to mean adjust the scan interval according to the area of the bladder included in the ultrasound images, however, clarification is required.
Claim 3 recites the limitation “a largest maximum area among the areas of the bladder”. The limitation “the areas of the bladder” lacks sufficient antecedent basis. It is unclear if the claim is intending to further narrow the area of the bladder recited previously to be “areas” or if these are different areas of the bladder. For examination purposes, it has been interpreted to mean any areas, however, clarification is required.
Claim 4 recites the limitation “calculate the volume of the bladder according to the maximum area”. It is unclear if this is a different calculation of the volume or if the claim is intending to define that the volume is calculated according to both the area of claim 1 and the maximum area or if the claim is intending to define the area of claim 1 to be a maximum area. For examination purposes, it has been interpreted that it may be the same calculation and the maximum area and area are the same or are used together or that this is a different calculation, however, clarification is required.
Claim 6 recites the limitation “first directional ultrasound images based on a first directional reception ultrasound signal” and “second directional ultrasound images”. It is unclear if the first/second direction ultrasound images include the ultrasound image and if the firs/second directional reception ultrasound signals include the reception ultrasound signal of claim 1, if they include or are included in the ultrasound images or claim 2 or if these are different/distinct ultrasound images based on different/distinct reception signals. In other words, it is unclear whether the claim is intending to further define the ultrasound image from which the area/areas are included and the volume is calculated from to be included in or to include the first directional ultrasound images and second directional ultrasound images or if these are different/distinct images. For examination purposes, it has been interpreted to mean any ultrasound images based on any reception signals, however, clarification is required.
Claim 7 recites the limitation “score areas of the bladder”. It is unclear what the metes and bounds of scoring areas of the bladder are. For example, it is unclear if the score is a qualitative, quantitative, binary, or other type of scoring and unclear what determines a score for an area of the bladder. For examination purposes, it has been interpreted to mean any type of scoring of the areas of the bladder, however, clarification nis required.
Claim 7 recites the limitation “to provide a first area score” and “to provide a second area score”. The claim previously recites score areas of the bladder, thus there would appear to be multiple scores provided (i.e. one for each area of the bladder). It is therefore unclear which “score” of the plurality of scores is intended to be the first area score and second area score, respectively. For examination purposes, it has been interpreted to mean that any of the area corresponding scores from the corresponding directional ultrasound images is considered to be the first area score and second area score respectively, however, clarification is required.
Claim 8 recites the limitation “determine priorities of the first area score and the second area score”. It is unclear what is meant by determining priority and how a priority is determined. In other words, what standard is provided to prioritize one score over another. For examination purposes, it has been interpreted that any prioritization of one score over another is interpreted to be a determination of priorities, however, clarification is required.
Claim 9 recites the limitation “provide weight values applied to a lower area score with a lower priority and the higher area score among the first area score and the second area score”. It is unclear what is meant by weight values and how such weight values are provided. It is further unclear if the weight values are the same as the priority or score or if these are different elements. It is further unclear what is meant by “provide weight values applied to a lower area score with a lower priority and the higher area score”. In other words, it is unclear if the weight values have already been applied to the lower area score and the higher area score and they are provided to another element or how they are provided and applied. For examination purposes, it has been interpreted that the weight value may merely be a priority value, score, or a multiplication of 1, however, clarification is required.
Claim 9 recites the limitation “apply the weight values to the higher area score and the lower area score to provide weighted scores”. The limitation is unclear as the claim recites providing weight values applied already. In other words, it is unclear at what point the weight value is applied/provided and whether the claim is redundant or if the intention of providing and applying the weight values is intended to be different. For examination purposes, it has been interpreted that they are applied at either the providing or applying function, however, clarification is required.
Claim 10 recites the limitation “a volume calculation unit calculate the volume of the bladder according to the sum result”. It is unclear if the volume calculation unit is the same as or different from the volume unit of claim 4 and if the calculation is intended to be a different calculation of the volume according to a different element. In other words, claim 4 recites “a volume unit configured to calculate the volume of the bladder according to a maximum area”. It is therefore unclear if the sum result represents a maximum area, if the volume of the bladder is calculated according to both the maximum area and the sum result or if the calculation of the volume is performed separately according to the maximum area in one instance and the sum result in another. For examination purposes, it has been interpreted that the volume calculation unit calculates the volume of the bladder according to the sum result which may be the same as the volume unit or different and may be the same or different calculation of the volume, however, clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ebata (US 20220378397 A1), hereinafter Ebata.
Regarding claim 1,
Ebata discloses a bladder volume measuring device comprising:
an ultrasound probe (at least fig. 1 (21) and corresponding disclosure in at least [0041]) configured to transmit an ultrasound signal to an inside of a human body and to receive an ultrasound signal reflected from the inside of the human body ([00544] which discloses the transducer array 2 of the ultrasound probe 21 illustrated in FIG. 1 has a plurality of transducers arranged in a one-dimensional or two-dimensional manner. According to a drive signal supplied from the transmission and reception circuit 3, each of the transducers transmits an ultrasonic wave and receives an ultrasound echo from a subject to output a signal based on the ultrasound echo); and
A calculation unit (at least fig. 1 (22) and corresponding disclosure in at least [0043]) configured to calculate a volume of a bladder included in an ultrasound image generated based on the reception ultrasound signal according to an area of the bladder ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. In this manner, the urine volume measurement unit 13 can calculate the volume of the urinary bladder B of the subject)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ebata in view of WIPO Srinivasan et al. (WO 2023177397 A1), hereinafter Srinivasan.
Regarding claim 2,
Ebata teaches the elements of claim 1 as previously stated. Ebata further teaches wherein the calculation unit includes:
An image providing unit (at least fig. 1 (4) and corresponding disclosure in at least [0049]) configured to provide the ultrasound images at every scan interval, while the ultrasound probe scans the inside of the human body in a first direction ([0050] which discloses the image generation unit generates an ultrasound image of a frame including the urinary bladder region, the user usally scans the urinary bladder by changing a position or angle of the probe)
A scan adjustment unit configured to control a scan interval ([0045] which discloses under the control of the device control unit 14, the transmission/reception circuit 3 transmits ultrasonic waves from the transducer array).
Ebata, fails to explicitly teach wherein the scan adjustment unit is configured to adjust a scan interval according to the area of the bladder included in the ultrasound images generated at every scan interval.
Srinivasan, in a similar field of endeavor involving ultrasound imaging, teaches wherein a calculation unit includes a scan adjustment unit configured to adjust a scan interval ([055] which discloses the scanning condition or parameter may comprise, for example, the transmit pulse, pulse width, pulse power, pulse repetition interval, pulse order, pulse timing, pulse cycle, transmit frequency, pulse start time, pulse end time, pulse duration, or pulse type (e.g., unipolar pulses, multi-state bipolar pulses), or any other property associated with a pulse that is transmittable by the imaging device and [084] which discloses the scan table may comprise one or more events and one or more scanning conditions associated with the one or more events. The one or more scanning conditions may comprise one or more scanning parameters (or sets of scanning parameters) that dictate or control an operation of the imaging device (e.g., a scanning operation performable using the imaging device) and [012] which discloses the map enables a dynamic selection of one or more optimal scan tables comprising one or more predetermined sets of operating conditions for one or more imaging events) according to an area of interest included in the ultrasound images generated at every scan interval ([047] which discloses Such imaging event or imaging operation may involve obtaining or capturing one or more images or videos or extracting one or more image frames from such images or videos. In some cases, the event may be defined by or associated with a specific imaging device, an imaging location or region or field of view, an imaging time, an imaging parameter (e.g., scan frequency), or an imaging vector (i.e., a vector or a series of vectors defining a path along which imaging can be performed)..
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata to include a scan adjustment unit as taught by Srinivasan in order to enable live adaption and selection of optimal scanning parameters (Srinivasan [052]) and to optimize imaging for different features of interest ([076]).
Examiner notes that in the modified system the scan adjustment unit would function to adjust the scan interval according to the feature of interest, thus according to the area of the bladder of Ebata.
Regarding claim 3,
Ebata, as modified, teaches the elements of claim 2 as previously stated. Ebata, as currently modified, further teaches wherein the scan adjusting unit reduces the scan interval. Examiner thus notes that the scan adjusting unit thus functions to reduce the scan interval in any instance including as the area of the bladder generated at every scan interval increases.
Alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include reducing the scan interval as the area of the bladder generated at every scan interval increases in order to provide optimal scanning parameters for the larger area of the bladder. Such a modification amounts to merely routine optimization yielding predictable results with respect to ultrasound imaging thereby rendering the claim obvious (MPEP 2144).
Regarding claim 4,
Ebata, as modified, teaches the elements of claim 3 as previously stated. Ebata further teaches wherein the calculation unit further includes:
A maximum unit configured to calculate a largest maximum area among the areas of the bladder included in the ultrasound images generated at every scan interval ([0139] which discloses thus, for example, the measurement frame selection unit 12 can analyze the graph representing the time-series change of the feature quantity, extract all the local maximum values of the feature quantity, acquire the maximum value among the extracted local maximum values, and select the ultrasound image of the frame corresponding to the acquired maximum value as the ultrasound image UD of the measurement frame); and
A volume unit configured to calculate the volume of the bladder according to the maximum area ([0141] which discloses the ultrasound image UD of the measurement frame is selected from among the ultrasound images of the frames for which the feature quantity of the urinary bladder region BR becomes a local maximum, so that it is more likely that the ultrasound image UD of the measurement frame suitable for urine volume measurement is selected).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ebata and Srinivasan as applied to claim 4 above, and further in view of Foreign Yoo (KR 102375824 B1 and cited by applicant), hereinafter Yoo (Examiner notes that citations to Yoo are with respect to the translated copy provided herein).
Regarding claim 5,
Ebata, as modified, teaches the elements of claim 4 as previously stated. Ebata further teaches an ultrasound array included in the ultrasound probe.
Ebata fails to explicitly teach wherein the ultrasound array includes a first ultrasound array and a second ultrasound array, and the second ultrasound array is disposed perpendicular to the first ultrasound array at one end of the first ultrasound array.
Yoo, in a similar field of endeavor involving ultrasound volume measurement, teaches an ultrasound array including a first ultrasound array (at least fig. 1 (120) and corresponding disclosure in at least pg. 2) and a second ultrasound array (at least fig. 1 (110) and corresponding disclosure in at least pg. 2) and the second ultrasound array is disposed perpendicular to the first ultrasound array (120) at one end of the first ultrasound array (120) (See at least fig. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include a first ultrasound array and a second ultrasound array as taught by Yoo in order to provide multi-directional ultrasound image data for identifying the height and width of the bladder for enhanced accuracy of the bladder volume (Yoo Summary of invention pg. 8). Furthermore, Ebata recognizes the benefit of performing measurement one ultrasound images of two frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other in [0063], therefore, such a modified ultrasound transducer to include the first ultrasound array and a second ultrasound array would be beneficial to the system of Ebata for providing such orthogonal ultrasound images without having to rotate the orientation of the probe.
Regarding claim 6,
Ebata, as modified, teaches the elements of claim 5 as previously stated. Ebata further teaches wherein the calculation unit further includes a directional image providing unit (at least fig.1 (4) and corresponding disclosure in at least [0049]) configured to: when the ultrasound probe is placed at a first point of the human body, generate first directional ultrasound images based on a first directional reception ultrasound signal and to generate second directional ultrasound images based on a second directional reception ultrasound signal ([0118] which discloses it is determined that the ultrasound images of the two measurement frames corresponding to the two scan cross-sections of the urinary bladder B of the subject orthogonal to each other are not selected, the process returns to step S3, in which the scan with the ultrasonic beam is resumed. At this time, the user rotates the orientation of the ultrasound probe 21 by 90 degrees and performs the scan with the ultrasonic beam).
Yoo, as applied to claim 5 above, further teaches a calculation unit including a directional image providing unit configured to: generate first directional ultrasound images based on a first directional reception ultrasound signal using the first ultrasound array and to generate second directional ultrasound images based on a second directional reception signal using the second ultrasound array (see at least figs. 5-7 and 8-9 and corresponding disclosure in at least pg. 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include providing first directional ultrasound images and second directional ultrasound images as taught by Yoo in order to provide multi-directional ultrasound image data for identifying the height and width of the bladder for enhanced accuracy of the bladder volume (Yoo Summary of invention pg. 8). Furthermore, Ebata recognizes the benefit of performing measurement one ultrasound images of two frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other in [0063], therefore, such a modified ultrasound transducer to include the first ultrasound array and a second ultrasound array would be beneficial to the system of Ebata for providing such orthogonal ultrasound images without having to rotate the orientation of the probe.
Regarding claim 7,
Ebata, as modified, teaches the elements of claim 6 as previously stated. Ebata further teaches wherein the calculation unit further includes:
A first area scoring unit configured to score areas of the bladder included in the first directional ultrasound images and to provide a first area score ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that acquiring the largest diameters requires scoring the areas (e.g. by diameter) of the bladder included in the first directional ultrasound images (i.e. a measurement frame in the first directional ultrasound images)); and
A second area scoring unit configured to score areas of the bladder included in the second directional ultrasound images and to provide a second area score ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that acquiring the largest diameters requires scoring the areas (e.g. by diameter) of the bladder included in the second directional ultrasound images (i.e. a measurement frame in the second directional ultrasound images)).
Regarding claim 8,
Ebata, as modified, teaches the elements of claim 7 as previously stated. Ebata further teaches wherein the calculation unit further includes:
A ranking determination unit configured to determine priorities of the first area score and the second area score ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that determining a largest diameter LX, LY, and LZ requires determining priority (e.g. priority via diameter) of the first area score and the second area score); and
A comparison unit configured to compare a higher area score with a higher priority among the first area score and the second area score with a predetermined reference score and to provide a comparison result ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that determining a largest diameter LX, LY, and LZ requires comparing a higher area score with a higher priority among the first area score and the second area score with other area scores (e.g. other diameters) which may be referred to a predetermined reference score and would provide a comparison result, where any of the largest diameters are considered the comparison result).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ebata and Srinivasan, and Yoo as applied to claim 8 above, and further in view of Ganguly et al. (US 6213949 B1), hereinafter Ganguly.
Regarding claim 9,
Ebata, as modified, teaches the elements of claim 8 as previously stated. Ebata, as modified, fails to explicitly teach wherein the calculation unit further includes:
a weighting unit configured to provide weight values applied to a lower area score with a lower priority and the higher area score among the first area score and the second area score; a weight scoring unit configured apply the weight values to the higher area score and the lower area score to provide weighted scores; and a summing unit configured to sum the weighted scores to provide a sum score.
Ganguly, in a similar field of endeavor involving ultrasound bladder imaging, teaches a weighting unit configured to provide weight values applied to a lower area score with a lower priority and the higher area score among the first area score and the second area score; a weight scoring unit configured apply the weight values to the higher area score and the lower area score to provide weighted scores; and a summing unit configured to sum the weighted scores to provide a sum score (Col. 4 lines 45-47 which discloses after determining the cross-sectional areas in the P planes, the processor 18 calculates an estimate of the volume of urine in the bladder, by weighting and combining the P areas. See also Col. 7 lines 48-54).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include applying weight values to the higher area score and the lower area score and summing the weighted scores as taught by Ganguly in order to provide an estimate of the volume of the bladder which takes into account the angle at which the ultrasound image was obtained with respect to a horizontal plane (Ganguly Col. 7 lines 48-54). Such a modification would enhance the volume estimation by ensuring that all image planes are summed and take into account the plane at which the images were captured.
Regarding claim 10,
Ebata, as modified, teaches the elements of claim 9 as previously stated. Ebata, as currently modified, fails to explicitly teach wherein the calculation unit further includes:
A result unit configured to compare the sum score with a predetermined reference sum score to provide a sum result The estimated volume may be compared with a predetermined overflow threshold, to determine if the user should then void; and
A volume calculation unit configured to calculate the volume of the bladder according to the sum result.
Nonetheless, Ganguly further teaches wherein the calculation unit further includes a result unit configured to compare the sum score with a predetermined reference sum score to provide a sum result The estimated volume may be compared with a predetermined overflow threshold, to determine if the user should then void (Col. 4 lines 47-52); and
A volume calculation unit configured to calculate the volume of the bladder according to the sum result (Col. 4 lines 45-47 which discloses the processor 18 calculates an estimate of the volume of urine in the bladder, by weighting and combining the P areas. Examiner notes that the volume is calculated necessarily according to the sum result as the sum result has a direct correspondence with the volume).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include a result unit and volume calculation unit as taught by Ganguly in order to provide an alert that the volume of urine in the bladder has crossed an overflow threshold (Ganguly Col. 4 lines 47-52) which may prevent overdistention and subsequent kidney damage/renal failure (Ganguly Col. 1 lines 15-20) as well as to prevent leakage accidents (Ganguly Col. 1 lines 60-64).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797 334