DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/26.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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 limitations use 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 limitations are:
a separation unit,
a generation unit,
an evaluation unit of claims 1 and 19,
a correction unit of claim 2, and
a presentation unit of claim 9.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 and 15-19 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 pre-AIA the applicant regards as the invention.
The claim limitations “a separation unit”, a generation unit, an evaluation unit” “a correction unit” and “a presentation unit” listed above 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. The Applicant's specification does not provide an association between the structure and the function. Therefore, claims 1-6 are indefinite and are 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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12, 15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bamford et al. US Publication 2016/0035100 (hereafter “Bamford”).
Referring to claim 1, Bamford discloses an information processing device, comprising:
a separation unit that separates at least one of a stained fluorescence component or an autofluorescence component from a fluorescence component obtained from a specimen image of fluorescent staining (paragraph 54, The method begins upon receipt of a plurality of component signals that are derived from a spectral unmixing of an image or a region of an image using a reference spectra matrix to enable extraction of one or more desired signals (S570));
a generation unit that calculates separation accuracy for each of pixels from a difference between the specimen image and an image after separation obtained by separating at least one of the stained fluorescence component or the autofluorescence component from the fluorescence component (paragraph 56, The retrieved sets of known components may be compared with the measured component signals to determine whether any noise or impossible spectra exist (S575-S577). For instance, a system for anatomical or clinical pathology may compare measured quantum dots in an image of a tissue sample with known quantum dot sets to determine if any noisy components, or co-incidence of quantum dots that are unable to co-exist in that tissue sample exist), and generates a separation accuracy image indicating the separation accuracy for each of the pixels (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest); and
an evaluation unit that identifies a pixel including an outlier of the separation accuracy from the separation accuracy image (paragraph 35, The set of target signals may further be refined by a postprocessing/refining module 123 that eliminates known or obvious sources of noise by, for instance, being compared to known or ideal sets of signals from similar materials).
Referring to claim 2, Bamford discloses a correction unit that performs processing on the basis of the pixel including the outlier (paragraph 35, The set of target signals may further be refined by a postprocessing/refining module 123 that eliminates known or obvious sources of noise by, for instance, being compared to known or ideal sets of signals from similar materials).
Referring to claim 3, Bamford discloses wherein the correction unit performs mask processing on a separated image including the stained fluorescence component or the autofluorescence component on the basis of the pixel including the outlier (paragraph 61, For instance, autofluorescence, DAPI, and other undesired signatures may be subtracted from a scanned image of a tissue sample, leaving behind only biologically relevant information).
Referring to claim 4, Bamford discloses wherein the correction unit generates a mask image by setting a value of a pixel located at a same position as the pixel including the outlier of the separation accuracy image to zero and setting values of other pixels to one (paragraph 56, If any noise is found, the method eliminates known or obvious sources of noise by removing the offending component signal (S576)).
Referring to claim 5, Bamford discloses wherein the correction unit generates a mask image by setting a value of a pixel in a predetermined region (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest) including the pixel located at a same position as the pixel including the outlier of the separation accuracy image to zero and setting values of other pixels to one (paragraph 56, If any noise is found, the method eliminates known or obvious sources of noise by removing the offending component signal (S576)).
Referring to claim 6, Bamford discloses wherein the correction unit excludes a pixel located at a same position as the pixel including the outlier of the separation accuracy image (paragraph 56, If any noise is found, the method eliminates known or obvious sources of noise by removing the offending component signal (S576)) in a subsequent process (paragraph 57, generating a clean image suitable for subsequent analysis or diagnosis).
Referring to claim 7, Bamford discloses wherein the correction unit changes a value of a pixel located at a same position as the pixel including the outlier of the separation accuracy image in an image for obtaining a signal separation value indicating signal separation performance to zero (paragraph 56, If any noise is found, the method eliminates known or obvious sources of noise by removing the offending component signal (S576)).
Referring to claim 8, Bamford discloses wherein the correction unit excludes a cell region (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest) including a pixel located at a same position as the pixel including the outlier of the separation accuracy image in an image for obtaining a signal separation value indicating signal separation performance (paragraph 56, If any noise is found, the method eliminates known or obvious sources of noise by removing the offending component signal (S576)).
Referring to claim 9, Bamford discloses a presentation unit that presents an identification result by the evaluation unit to a user (paragraph 49, FIG. 4 shows a user interface 450 for tagging regions of a scanned image, according to an exemplary embodiment of the present subject disclosure).
Referring to claim 10, Bamford discloses wherein the presentation unit presents the separation accuracy image including the pixel including the outlier (paragraph 49, FIG. 4 shows a user interface 450 for tagging regions of a scanned image, according to an exemplary embodiment of the present subject disclosure).
Referring to claim 11, Bamford discloses wherein the presentation unit presents a region including the pixel including the outlier (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest).
Referring to claim 12, Bamford discloses wherein the generation unit calculates a difference value between the specimen image and the image after separation as the separation accuracy for each pixel (paragraph 37, Component signals having a broadband profile may be compared with known broadband signatures specific to the sample material being analyzed. For instance, a system for anatomical or clinical pathology may compare a scanned image of a tissue sample with a calibration slide of a similar tissue sample having a known broadband signature to identify the measured broadband signals in the scanned image).
Referring to claim 15, Bamford discloses wherein the generation unit normalizes the separation accuracy for each of the pixels of the separation accuracy image (paragraph 35, Further, other refinement operations such as adjusting a minimum or a maximum of intensities may be applied to the target signals to highlight a specific range and eliminate signals outside the range).
Referring to claim 17, Bamford discloses wherein the separation unit separates at least one of the stained fluorescence component or the autofluorescence component from the fluorescence component by color separation calculation including at least one of a least squares method, a weighted least squares method, or non- negative matrix factorization (paragraph 39, For example, a linear spectral unmixing process using a least squares method may be utilized to separate the component fluorescent channels in the scanned image).
Referring to claim 18, Bamford discloses wherein the separation unit separates at least one of the stained fluorescence component or the autofluorescence component from the fluorescence component again using a spectrum of a pixel whose separation accuracy exceeds the outlier (paragraph 58, For instance, depending on the sample type, it may be known that quantum dots 684 and 687 are unable to co-exist, whereas quantum dots 684, 685, 686 and 688 are all able to co-exist for the particular sample type. Therefore, a post-processing refinement method as shown in FIG. 5 would indicate such impossibility, and would remove the offending signal 687 from the refined set of signals).
Referring to claim 19, Bamford discloses a biological sample observation system, comprising:
an imaging device that acquires a specimen image of fluorescent staining (paragraph 26, System 100 comprises a source 101 for generating a fluorescent image. For instance, source 101 may be a spectral camera, a scanner, or a fluorescence microscope associated with or including a scanner or spectral camera that is used for imaging a slide containing a sample of a material stained with a fluorescent stain); and
an information processing device that processes the specimen image (paragraph 26, Source 101 is in communication with a memory 110, which includes a plurality of processing modules or logical instructions that are executed by processor 125 coupled to computer 120),
a separation unit that separates at least one of a stained fluorescence component or an autofluorescence component from a fluorescence component obtained from a specimen image of fluorescent staining (paragraph 54, The method begins upon receipt of a plurality of component signals that are derived from a spectral unmixing of an image or a region of an image using a reference spectra matrix to enable extraction of one or more desired signals (S570));
a generation unit that calculates separation accuracy for each of pixels from a difference between the specimen image and an image after separation obtained by separating at least one of the stained fluorescence component or the autofluorescence component from the fluorescence component (paragraph 56, The retrieved sets of known components may be compared with the measured component signals to determine whether any noise or impossible spectra exist (S575-S577). For instance, a system for anatomical or clinical pathology may compare measured quantum dots in an image of a tissue sample with known quantum dot sets to determine if any noisy components, or co-incidence of quantum dots that are unable to co-exist in that tissue sample exist), and generates a separation accuracy image indicating the separation accuracy for each of the pixels (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest); and
an evaluation unit that identifies a pixel including an outlier of the separation accuracy from the separation accuracy image (paragraph 35, The set of target signals may further be refined by a postprocessing/refining module 123 that eliminates known or obvious sources of noise by, for instance, being compared to known or ideal sets of signals from similar materials).
Referring to claim 20, Bamford discloses an image generation method, comprising:
calculating separation accuracy for each of pixels from a difference between a specimen image of fluorescent staining and an image after separation obtained by separating at least one of a stained fluorescence component or an autofluorescence component from a fluorescence component obtained from the specimen image (paragraph 56, The retrieved sets of known components may be compared with the measured component signals to determine whether any noise or impossible spectra exist (S575-S577). For instance, a system for anatomical or clinical pathology may compare measured quantum dots in an image of a tissue sample with known quantum dot sets to determine if any noisy components, or co-incidence of quantum dots that are unable to co-exist in that tissue sample exist); and
generating a separation accuracy image indicating the separation accuracy for each of the pixels (paragraph 33, As the broadband signals are typically constant or slow-varying through a single image, the predominantly noisy regions may be automatically tagged by region selection interface 117, with a user being provided an option to untag certain regions of interest).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER K HUNTSINGER whose telephone number is (571)272-7435. The examiner can normally be reached Monday - Friday 8:30 - 5:00.
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/PETER K HUNTSINGER/ Primary Examiner, Art Unit 2682
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