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 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 1-12 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.
Regarding Claims 1 and 10, it is unclear if the sample is separate from whatever is obtained from the specimen or whether the sample is obtained from the specimen. In addition, it is unclear whether the fluorescence information is obtained/detected from the sample or the specimen or both.
Furthermore, it is unclear how acidity information (such as pH) is calculated based upon a correlation between the acidity information (i.e. pH) and the fluorescence information obtained from either the sample or the specimen. Furthermore, it is unclear if the acidity information obtained in the obtainment part is different from the acidity information calculated in the acidity information calculation part or whether each of these acidity information values are different.
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 fluorescence information obtainment part configured… is interpreted as being a confocal scanning system using a pulse laser or similar (such as a laser generator, a light distributor, a scanner, lens unit or detector) (see [0049]).
An acidity information obtainment part configured…interpreted as any means through which acidity (pH) is measured (see [0063])
A derivation part configured …. Interpreted as any means which derives correlation between the fluorescence lifetime information and the acidity information on each sample (see [0066]).
An acidity information calculation part configured.. interpreted as any means which calculates acidity information of the specimen based on the fluorescence information obtained from the specimen (see [0009]).
A diagnostic part configured.. interpreted as any means which performs diagnosis on the specimen based on the fluorescence information and the acidity information (see [0076]).
A storage part configured… interpreted as any part in which the correlation information is stored (see [0069]).
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 Objections
Claim 9 is objected to because of the following informalities: claim 9 recites “ using the correlation on the cancel cell”, and it appears that the “cancel cell” is a typographical error and should be the cancer cell. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: [0017] and [0045] each recite the term “cancel cell”, however it appears that the term “cancel cell” is a typographical error and should be the cancer cell.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adachi et al (US PGPub 2011/0224513), cited in the IDS.
Regarding Claim 1, Adachi et al teaches a diagnosis system (referred to as a living matter analysis apparatus 3, illustrated in Figure 1) comprising:
a fluorescence information obtainment part (referred to as an excitation light generation means 10) configured to obtain fluorescence information from a sample and a specimen subject to diagnosis (see Figure 1 and [0083]-[0085]);
an acidity information obtainment part (referred to as measurement means 60) configured to obtain acidity information (pH) from the sample (see [0079] and Figure 1);
a derivation part (referred to as analysis means 70) configured to derive a correlation between the fluorescence information and the acidity information (see Figure 1 and [0147]);
an acidity information calculation part (referred to as abnormal region detection means 80) configured to calculate acidity information of the specimen based on the fluorescence information obtained from the specimen, using the correlation (see [0141] and [0143]); and
a diagnostic part (referred to as display means 81) configured to perform cancer diagnosis on the specimen based on the fluorescence information obtained from the specimen and the calculated acidity information (see Figure 1, [0005] and [0143]).
Regarding Claim 3, Adachi et al teaches that the fluorescence information comprises fluorescence intensity information and fluorescence lifetime information (see [0081], [0092] and [0106]).
Regarding Claim 5, Adachi et al teaches that the derivation part (i.e. analysis means 70) is configured to derive the correlation between the fluorescence lifetime information (detected by detection means 50) among the fluorescence information and the acidity information (measured by measurement means 60), wherein the acidity information calculating part is configured to calculate the acidity information of the specimen based on the fluorescence lifetime information among the fluorescence information obtained from the specimen (see [0059], [0089], [0092], [0120] and [0127]).
Regarding Claim 6, Adachi et al teaches that the diagnostic part (i.e. display 81) is configured to perform cancer diagnosis on the specimen based on the fluorescence intensity information and the acidity information (see [0143]).
Regarding Claim 7, Adachi et al teaches that the fluorescence information obtainment part is a confocal scanning system using a pulse laser, wherein the acidity information obtainment part is configured to obtain acidity (i.e. pH) information on the sample, based on the correlation between acidity of fluorescent contrast agent and the fluorescence information (see [0082]-[0083]).
Regarding Claim 8, Adachi et al teaches that the sample is cancer cells of each type that are the target of diagnosis, wherein the derivation part is configured to derive the correlation between the fluorescence information for each type cancer cell and the acidity information (see [0150]-[0157]).
Regarding Claim 9, Adachi et al teaches that the acidity information calculation part (i.e. detection means 80) is configured to calculate the acidity information of the specimen, using the correlation on the cancer cell corresponding to the specimen among the derived correlation from the derivation part (see [0143] and [0157]).
Regarding Claim 10, Adachi et al teaches a diagnosis method comprising: storing information (i.e. a calibration curve) on a correlation between fluorescence information and acidity information (see Figure 2 and [0157] ;
obtaining the fluorescence information from a specimen subject to diagnosis (using an excitation light generation means 10) (see claim 1 and [0083] ) ;
calculating the acidity information (i.e. pH) of the specimen based on the fluorescence information obtained from the specimen, using the correlation (using measurement means 60, abnormal region detection means 80 and analysis means 70) (see claim 1 [0147]-[0150]; and
performing cancer diagnosis on the specimen based on the fluorescence information obtained from the specimen and the calculated acidity information (see [0050] and [0164]).
Regarding Claims 11-12 , Adachi et al teaches that wherein in the storing the information on the correlation between the fluorescence information and the acidity information (i.e. the calibration curves, shown in Figure 2), obtaining the fluorescence information from a sample; obtaining the acidity information from the sample; and deriving the correlation between the fluorescence information and the acidity information (see [0098]-[0103] and [0155]-[0157]). In addition, Adachi et al teaches storing the information on the correlation between the fluorescence information and the acidity information (i.e. the calibration curves , such as shown in Figure 2 would be stored in some sort of computer system), and the information on the correlation between cancer cells of each type is stored as a sample, wherein in calculating the acidity information, the correlation for the cancer cell corresponding to the specimen is used among the correlation (and this information is displayed on display 81) (see [0143] and [0155]-[0157]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Adachi et al as applied to claims 1 and 3 above, and further in view of Tizhoosh et al; (US PGPub 2022/0198787).
Regarding Claim 2, Adachi et al does not explicitly disclose a storage part configured to store the correlation derived from the derivation part.
However, in the analogous art of systems and methods for managing image data, Tizhoosh et al teaches an image management system 110 in communication with an imaging device 120, a system storage component 140, and a computing device 150 via a network 130 (see [0116]). Furthermore, Tizhoosh et al teaches that the storage component 114 may include one or more databases (not shown) for storing image data, information relating to the image data, such as, for example, patient data with respect to the image data, information related to reports associated with the images, such as, for example, diagnoses with respect to the image data. For example, the storage component 114 can store image identifiers for the images. Each image identifier can also be associated with additional information, such as but not limited to information on the tissue type and cancer type, and can be accompanied by relevant pathology reports (see [0135]). It would have been obvious to one of ordinary skill in the art to modify the system of Adachi et al by further incorporating a storage part (as taught by Tizhoosh et al) for the benefit of providing efficient storage of image data such that this data may then be transferred to exterior devices.
Regarding Claim 4, Adachi et al teaches that the fluorescence information is obtained by directly measuring a fluorescence lifetime from a detected light (see [0079] and [0085]).
Adachi et al does not teach using a digitizer which samples a frequency over a gigabyte.
However, in the analogous art of systems and methods for managing image data, Tizhoosh et al teaches imaging devices which undergo visual or numerical investigation for medical diagnoses and research. Modern pathology uses digital scanners to digitize microscopic images of biopsy samples on glass slides in high resolution. These images are called “whole slide images” (WSIs) and are generally large in size (i.e., can be in the order of 100 megabytes and gigabytes) (see [0109]). It would have been obvious to one of ordinary skill in the art to utilize a digitizer to digitize sample images for the benefit or providing clear, digital images of the samples.
Furthermore, it is noted that claim 4 is an apparatus claims and "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Adachi et al as applied to claims 1 and 3 , and further in view of Ragan et al (US PGPub 2011/0320174).
Regarding Claim 2, Adachi et al does not explicitly disclose a storage part configured to store the correlation derived from the derivation part.
However, in the analogous art of devices and methods for sampling an analog signal in order to perform data analysis, Ragan et al teaches that results obtained from the data analysis can be continuously transferred to a storage device, such as a personal computer (PC), or a hard disk. In one embodiment, the sampling device further includes a memory device coupled to the logic circuit for buffering the data analysis outputted by the logic circuit. An interface, such as a PCI, Firewire, PCI-e, e-sata, dedicated link to a storage device, or universal serial bus (USB), may also be coupled to the memory device for streaming the data analysis to an external display, memory or computational device, or a PC (see [0025]). It would have been obvious to one of ordinary skill in the art to modify the system of Adachi et al by further incorporating a storage part with memory (as taught by Ragan et al) for the benefit of providing efficient storage of image data such that this data may then be transferred to exterior devices through an interface.
Regarding Claim 4, Adachi et al teaches that the fluorescence information is obtained by directly measuring a fluorescence lifetime from a detected light (see [0079] and [0085]).
Adachi et al does not teach using a digitizer which samples a frequency over a gigabyte.
However, in the analogous art of devices and methods for sampling an analog signal in order to perform data analysis, Ragan et al teaches the use of a gigahertz digitizer and that the digitized signal will be transferred from the ADC08D1500 18 to a logic circuit 22, here, a Xilinx Virtex4 Field Programmable Gate Array (FPGA) on the card 12 (see [0063]-[0064]). It would have been obvious to one of ordinary skill in the art to modify the system of Adachi et al by utilizing to utilize a digitizer (as taught by Ragan et al) for the benefit or providing clear, digital images of the samples that may be transferred to external circuitry.
Furthermore, it is noted that claim 4 is an apparatus claims and "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797