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 Interpretation
Claim(s) 1-14 do not use “means for” (or “step for”) language, or generic placeholders for "means” coupled with functional language without recitation of sufficient structure for carrying out the claimed functions and therefore do not invoke 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1-14 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.[claims 1-14]
Claims 1-14 variously recite: capturing an image of a urine sample with video using an imaging device and storing the image of the urine sample captured with video in a storage device in cases in which movement of a material component contained in the urine sample has been detected from a plurality of still images captured as a time series by the imaging device of a urine sample to be tested encapsulated in a cell; and
storing an image of the urine sample captured as a still image in the storage device without capturing an image of the urine sample with video in cases in which a movement of a material component contained in the urine sample has not been detected from the plurality of still images.
Claims 1-14 recite “a urine sample” and “a urine sample to be tested encapsulated in a cell”. Claims 1-14 additionally recite “the urine sample” in various places.
The first and second instances of “the urine sample” would clearly refer to “a urine sample”. However, for the third, fourth and fifth instances of “the urine sample” it is unclear whether “the urine sample” refers to “a urine sample” or “a urine sample to be tested encapsulated in a cell”.
Alternatively, it is unclear whether “a urine sample encapsulated in a cell” refers to the same sample as “a urine sample” in the claims.
For the purposes of applying prior art, “a urine sample” and “a urine sample encapsulated in a cell” will be read as referring to the same sample, and each instance of “the urine sample” will be read as referring to the same sample as well. This is believed to be consistent with the specification which describes a single urine sample to be tested and images/videos thereof stored (e.g. Paragraph 0040, 0077-0079; Figures 2, 7 and 11).
Claims 2, 6-10 and 14 recite additional instances of “a urine sample”. It is similarly unclear whether these refer to the same urine sample or different urine samples. For the purposes of applying prior art, the urine samples described in these claims will similarly be read as being the same urine sample as recited in claims 1 or 11.
Clarification as to the relationship between “a urine sample”, “a urine sample to be tested encapsulated in a cell” and “the urine sample” is required.[claim 5]
Claim 5 recites “wherein the test category includes at least one category selected from the group consisting of a nitrite content in urine, a white blood cell content in urine, and a cloudiness level of urine”. There is insufficient antecedent basis for the limitation “the test category” in the claim.
For the purposes of applying prior art, claim 5 will be read as depending on claim 2 which recites “a predetermined test category”.[claim 11]
Claim 11 recites “wherein: an image of the urine sample contained in an area of the cell where the thickness of the cell is the second thickness is captured with video in cases in which the result of the test category satisfies the predetermined condition; and an image of the urine sample contained in an area of the cell where the thickness of the cell is the first thickness is captured as a still image in cases in which the result of the test category does not satisfy the predetermined condition, and an image of the urine sample contained in an area of the cell where the thickness of the cell is the second thickness is captured with video in cases in which movement of a material component contained in the urine sample has been detected from the plurality of still images”. There is insufficient antecedent basis for the limitation “the test category” in the claim.
For the purposes of applying prior art, claim 11 will be read as depending on claim 7 which depends on claim 2 and which recites “a predetermined test category”.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deindoerfer et al. (US 4,612,614).[claim 1]
Regarding claim 1, Deindoerfer teaches a control method of processing executed by a computer (Figure 2), the processing comprising:
capturing an image of a urine sample with video using an imaging device and storing the image of the urine sample captured with video in a storage device in cases in which movement of a material component contained in the urine sample has been detected from a plurality of still images captured as a time series by the imaging device of a urine sample to be tested encapsulated in a cell; and
storing an image of the urine sample captured as a still image in the storage device without capturing an image of the urine sample with video in cases in which a movement of a material component contained in the urine sample has not been detected from the plurality of still images (Figure 2, still images are captured by camera 34 and stored in floppy disc 62; p. 2, l. 37 – p. 3, l. 16; c. 3, l. 55 – c. 4, l. 11).
Since Deindoerfer captures only a series of still images, the still image is captured “without capturing an image of the urine sample with video”.
Furthermore, Deindoerfer discloses storing an image of a urine sample as a still image “in cases in which a movement of a material component contained in the urine sample has not been detected from the plurality of still images” since Deindoerfer does not detection movement of material components. Thus each still image stored is necessarily store in a case where motion has not been detected since no motion detection is present in the method.
While Deindoerfer does not disclose the first limitation of the claim (i.e. step A: “capturing an image of a urine sample with video using an imaging device and storing the image of the urine sample captured with video in a storage device in cases in which movement of a material component contained in the urine sample has been detected from a plurality of still images captured as a time series by the imaging device of a urine sample to be tested encapsulated in a cell”), it is noted that claim 1 is directed to a method and each step provided is a contingent limitation (i.e. “in cases in which…”).
As stated in MPEP 2111.04(II):
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
As written, claim 1 contains steps A and B which only happen if a certain condition is met. Therefore, step A need not be performed for Deindoerfer to anticipate the claim since the particular condition precedent is not met for performing step A.[claim 2]
Regarding claim 2, Deindoerfer discloses the control method of claim 1, wherein the processing comprises:
capturing an image of a urine sample with video using an imaging device and storing the image of the urine sample captured with video in the storage device in cases in which a result of a predetermined test category in a urine qualitative test satisfies a predetermined condition to suspect bacteria is present in urine, or in cases in which the result of the test category does not satisfy the predetermined condition and movement of a material component contained in the urine sample has been detected from a plurality of still images captured as a time series by the imaging device of a urine sample to be tested encapsulated in a cell; and
storing an image of the urine sample captured as a still image in the storage device without capturing an image of the urine sample with video in cases in which a movement of a material component contained in the urine sample has not been detected from the plurality of still images captured when the result of the test category has not satisfied the predetermined condition (Figure 2, still images are captured by camera 34 and stored in floppy disc 62; p. 2, l. 37 – p. 3, l. 16; c. 3, l. 55 – c. 4, l. 11; note Deindoerfer does not perform a predetermined test or motion detection, thus the result of a test category would not satisfy a predetermined condition (e.g. existing) and no motion would be detected).
Similarly see the rejection of claim 1 and the discussion of contingent limitations.[claim 3]
Regarding claim 3, Deindorfer discloses wherein the image of the urine sample stored in the storage device is transmitted to an external device through a communication line (Figure 2; transfer of images to external color monitor 52 through attached communication line).[claim 4]
Regarding claim 4, Deindorfer discloses wherein the image of the urine sample stored in the storage device is displayed on a display device (Figure 2; transfer of images to external color monitor 52 through attached communication line).[claim 5]
Regarding claim 5, Deindorfer disclose wherein the test category includes at least one category selected from the group consisting of a nitrite content in urine, a white blood cell content in urine, and a cloudiness level of urine (note that the images of Deindorfer are stored as still images when results of tests including a nitrite content in urine, a white blood cell content in urine, and a cloudiness level of urine do not meet a predetermined condition, i.e. the results do not exist and therefore do not meet a predetermined condition of existing).
Note that the claims do not require that these tests actually be performed to practice the method, merely that the results of the test meet or do not meet some undefined “predetermined condition”.
[claims 6-10]
Regarding claims 6-10, Deindorfer discloses wherein: a urine sample is encapsulated in the cell having different thicknesses configured with a thickness along an imaging direction by the imaging device including a first thickness and a second thickness thinner than the first thickness (Figure 1A; c. 3, ll. 18-39; first thickness at outlet on left hand side and second thickness thinner than the first thickness at remaining portions of the cell), and an image of the urine sample is captured by the imaging device (c. 3, ll. 18-39).
See also flow cells disclosed in U.S. Pat. No. 4,338,024 as referenced by Deindorfer (c. 3, ll. 19-20).
Allowable Subject Matter
Claims 11 and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 13 and 14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.[claims 11 and 12]
Regarding claims 11 and 12, the prior art does not teach or reasonably suggest wherein: an image of the urine sample contained in an area of the cell where the thickness of the cell is the second thickness is captured with video in cases in which the result of the test category satisfies the predetermined condition; and an image of the urine sample contained in an area of the cell where the thickness of the cell is the first thickness is captured as a still image in cases in which the result of the test category does not satisfy the predetermined condition, and an image of the urine sample contained in an area of the cell where the thickness of the cell is the second thickness is captured with video in cases in which movement of a material component contained in the urine sample has been detected from the plurality of still images.
While Deindorfer teaches a cell having first and second thicknesses, Deindorfer does not teach the particular steps of capturing images with video or still images in different areas of the cell with different thicknesses according to the particular case conditions recited.
However, the above 35 USC 112(b) rejections must be overcome before the claims can be considered allowable if rewritten.[claims 13 and 14]
Regarding claims 13 and 14, the prior art does not teach or reasonably suggest a non-transitory computer-readable storage medium stored with a control program that causes processing to be executed by a computer, the processing comprising: capturing an image of a urine sample with video using an imaging device and storing the image of the urine sample captured with video in a storage device in cases in which movement of a material component contained in the urine sample has been detected from a plurality of still images captured as a time series by the imaging device of a urine sample to be tested encapsulated in a cell; and storing an image of the urine sample captured as a still image in the storage device without capturing an image of the urine sample with video in cases in which a movement of a material component contained in the urine sample has not been detected from the plurality of still images.
While Deindorfer teaches a similar method (see the rejection of claim 1), the broadest reasonable interpretation of claims 13 and 14 would require a control program having code/structures for performing each step should the claimed conditions occur. See MPEP 2111.04(II):
The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed.
Thus, the broadest reasonable interpretation differs from that of claim 1. Since Deindorfer does not perform the first step recited in the claim when the recited condition is met, Deindorfer does not teach or reasonably suggest the limitations of claims 13 and 14.
Furthermore, while determining motion present in a scene and storing images as video or still images is generally known in the prior art (e.g. Kim (US 2003/0123551 A1), the prior art does not teach or reasonably suggest the particular combination of capturing images with or without video according to movement of a material component present in a plurality of still images captured as a time series of a urine sample as required in these claims.
Kinou et al. (JP H09-89752A) describes a urine precipitate analysis system which reduces an amount of data to be stored in a storage device (e.g. Abstract) by setting a reference value for a number of particles to a urine sediment automatic analyzer and transferring images which meet the reference value for further image review (e.g. Paragraph 0010). However, Kinou does not teach or reasonably suggest selecting between a video or still image to store based on movement of a material component present in a plurality of still images captured as a time series of a urine sample as required in these claims.
Therefore, while the prior art teaches similar systems, the prior art does not teach or reasonably suggest the particular combination of features recited in claims 13 and 14. However, the above 35 USC 112(b) rejections must be overcome before the claims can be considered allowable if rewritten.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Manri et al. WO 20099/125678 A1
Fang et al. US 2021/0398296 A1
Son et al. US 2018/0216155 A1
Train et al. US 2013/0050254 A1
Toyo et al. JP 4085297 B2
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/Timothy J Henn/Primary Examiner, Art Unit 2639
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