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 .
Response to Preliminary Amendment
This Office Action is responsive to a preliminary amendment filed on 04/02/2024. Claims 1-14 are pending in the instant application. Claims 1, 11 and 14 are independent. Applicant submits no new matter has been added. An Office Action on the merits follows here below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2024 and 11/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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) 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: “an acquiring step” and “an evaluating step” at claim 11 and “image acquisition device comprises means for…” at claim 14.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) 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) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recites sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
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 11-13 is rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Bredno (US 20210397870 A1).
Regarding Claim 11: Bredno discloses an information processing method (Refer to para [007]; “systems and methods for estimating autofluorescence (AF) signals and other non-target signals within each channel of a multi-channel image of a biological sample (e.g. tissue section) stained with multiple fluorescent labels. In some embodiments, the estimated autofluorescence signal may be subtracted and/or masked from the multi-channel image. In some embodiments, the autofluorescence-removed multichannel image may be used for further processing (e.g. image analysis, etc.).”) for evaluating an immune response of a cell group to a test substance (Refer to para [057]; “examples of types of staining methods performed by the system include, without limitation, histochemical methods, immunohistochemical methods, and other methods based on reactions between molecules (including non-covalent binding interactions), such as hybridization reactions between nucleic acid molecules. Particular staining methods include, but are not limited to, primary staining methods (e.g., H&E staining, Pap staining, etc.), enzyme-linked immunohistochemical methods, and in situ RNA and DNA hybridization methods, such as fluorescence in situ hybridization (FISH).”) the information processing method comprising: an acquiring step of acquiring first autofluorescence information which is autofluorescence information of a first sample (As is very well known in the art; Refer to para [006]; “Multispectral imaging of fluorescent samples involves acquiring a series of images of the sample at different excitation wavelengths, emission wavelengths, or combinations of the two. The various images are assembled into an image cube, where two dimensions of the cube correspond to spatial position in the sample, and the third dimension corresponds to the spectrum associated with the various excitation and/or emission wavelengths.”) the first sample being prepared by adding the test substance to the cell group (Refer to para [080]; “In yet other embodiments, the contributions of autofluorescence within each channel are derived from one or more groupings of autofluorescence spectra. In some embodiments, autofluorescence spectra may be grouped by similarity. By way of a non-limiting example, autofluorescence spectra may be grouped according to their maximal wavelengths or spectral bands. For instance, a grouping of spectra may include those autofluorescence spectra whose maximal measured wavelength is about 610 to about 640 nm.”) an acquiring step of acquiring second autofluorescence information which is autofluorescence information of a second sample (Refer to para [033, 034 and 073]; “FIG. 5A illustrates a measured pixel spectrum and first and second retrieved autofluorescence spectra. For instance, if three spectra are fitted to a measured pixel spectrum, and the intensity values in channel 4 of the each fitted autofluorescence spectrum are about 0.25 (first fitted autofluorescence spectrum), about 0.15 (second fitted autofluorescence spectrum), and about 0.2 (third fitted autofluorescence spectrum), the intensity value of the first fitted spectrum would be utilized as the data point at channel 4 for generating the maximum fitted autofluorescence spectrum.”) the second sample serving as a control for the first sample (Refer to para [066]; “systems of the present disclosure include: (a) an imaging module 102 adapted to generate a multichannel image of a biological sample labeled with one or more fluorescent molecules (see, e.g., step 200); (b) an reference spectrum retrieval module 105 configured to retrieve one or more reference spectra (e.g. reference spectra from training images) from a database, such as a database within storage sub-system 104; (c) an autofluorescence contribution calculation module 106 adapted to derive an amount of autofluorescence in a multichannel image based at least on one or more retrieved reference spectra (see, e.g., step 201); and (d) an image generation module 107 to at least generate a autofluorescence removed image, i.e. a multichannel image where autofluorescence has been at least partially removed (see, e.g., step 202).”) and an evaluating step of evaluating the immune response of the cell group to the test substance by comparing the first autofluorescence information and the second autofluorescence information (Refer to para [070]; “systems of the present disclosure include: (a) an imaging module 102 adapted to generate a multichannel image of a biological sample labeled with one or more fluorescent molecules (see, e.g., step 200); (b) an reference spectrum retrieval module 105 configured to retrieve one or more reference spectra (e.g. reference spectra from training images) from a database, such as a database within storage sub-system 104; (c) an autofluorescence contribution calculation module 106 adapted to derive an amount of autofluorescence in a multichannel image based at least on one or more retrieved reference spectra (see, e.g., step 201); and (d) an image generation module 107 to at least generate a autofluorescence removed image, i.e. a multichannel image where autofluorescence has been at least partially removed (see, e.g., step 202).”).
Regarding Claim 12: Bredno discloses an information processing device configured to execute the information processing method of claim 11 (Refer to para [007]; “The present disclosure provides systems and methods for estimating autofluorescence (AF) signals and other non-target signals within each channel of a multi-channel image of a biological sample (e.g. tissue section) stained with multiple fluorescent labels. In some embodiments, the estimated autofluorescence signal may be subtracted and/or masked from the multi-channel image. In some embodiments, the autofluorescence-removed multichannel image may be used for further processing (e.g. image analysis, etc.).”).
Regarding Claim 13: Bredno discloses non-transitory storage medium storing an information processing program (Refer to para [061]; “The computer system 14 can include a desktop computer, a laptop computer, a tablet, or the like, digital electronic circuitry, firmware, hardware, memory, a computer storage medium, a computer program or set of instructions (e.g. where the program is stored within the memory or storage medium), one or more processors (including a programmed processor), and any other hardware, software, or firmware modules or combinations thereof.”) for causing an information processing device to execute the information processing method of claim 11 (Refer to para [007]; “In some embodiments, the autofluorescence-removed multichannel image may be used for further processing (e.g. image analysis, etc.).”).
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.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bredno in combination with Barron (US 20200309702 A1).
Regarding Claim 14: Bredno discloses an image pickup and analysis system for evaluating an immune response of a cell group to a test substance (Refer to para [007]; “The present disclosure provides systems and methods for estimating autofluorescence (AF) signals and other non-target signals within each channel of a multi-channel image of a biological sample (e.g. tissue section) stained with multiple fluorescent labels. In some embodiments, the estimated autofluorescence signal may be subtracted and/or masked from the multi-channel image. In some embodiments, the autofluorescence-removed multichannel image may be used for further processing (e.g. image analysis, etc.).”) the image pickup and analysis system comprising:
an image acquisition device (Refer to para [022]; “FIG. 1A illustrates a representative digital pathology system including an image acquisition device and a computer system, in accordance with some embodiments..”) and an image processing device comprising a display unit (Refer to para [061]; “For example, the computing system 14 illustrated in FIG. 1A may comprise a computer with a display device 16 and an enclosure 18. The computer can store digital images in binary form (locally, such as in a memory, on a server, or another network connected device).”), wherein the image acquisition device comprises means for acquiring: an autofluorescence image of a first sample prepared by adding the test substance to the cell group (As is very well known in the art; Refer to para [006]; “Multispectral imaging of fluorescent samples involves acquiring a series of images of the sample at different excitation wavelengths, emission wavelengths, or combinations of the two. The various images are assembled into an image cube, where two dimensions of the cube correspond to spatial position in the sample, and the third dimension corresponds to the spectrum associated with the various excitation and/or emission wavelengths.”) and an autofluorescence image of a second sample serving as a control for the first sample (Refer to para [033, 034 and 073]; “FIG. 5A illustrates a measured pixel spectrum and first and second retrieved autofluorescence spectra. For instance, if three spectra are fitted to a measured pixel spectrum, and the intensity values in channel 4 of the each fitted autofluorescence spectrum are about 0.25 (first fitted autofluorescence spectrum), about 0.15 (second fitted autofluorescence spectrum), and about 0.2 (third fitted autofluorescence spectrum), the intensity value of the first fitted spectrum would be utilized as the data point at channel 4 for generating the maximum fitted autofluorescence spectrum.”) wherein the image processing device comprises means for generating, from the autofluorescence images, first autofluorescence information which is autofluorescence information of the first sample and second autofluorescence information which is autofluorescence information of the second sample (Refer to para [066]; “systems of the present disclosure include: (a) an imaging module 102 adapted to generate a multichannel image of a biological sample labeled with one or more fluorescent molecules (see, e.g., step 200); (b) an reference spectrum retrieval module 105 configured to retrieve one or more reference spectra (e.g. reference spectra from training images) from a database, such as a database within storage sub-system 104; (c) an autofluorescence contribution calculation module 106 adapted to derive an amount of autofluorescence in a multichannel image based at least on one or more retrieved reference spectra (see, e.g., step 201); and (d) an image generation module 107 to at least generate a autofluorescence removed image, i.e. a multichannel image where autofluorescence has been at least partially removed (see, e.g., step 202).”) and wherein the display unit is configured to display a result of comparing the first autofluorescence information and the second autofluorescence information (Refer to para [070]; “systems of the present disclosure include: (a) an imaging module 102 adapted to generate a multichannel image of a biological sample labeled with one or more fluorescent molecules (see, e.g., step 200); (b) an reference spectrum retrieval module 105 configured to retrieve one or more reference spectra (e.g. reference spectra from training images) from a database, such as a database within storage sub-system 104; (c) an autofluorescence contribution calculation module 106 adapted to derive an amount of autofluorescence in a multichannel image based at least on one or more retrieved reference spectra (see, e.g., step 201); and (d) an image generation module 107 to at least generate a autofluorescence removed image, i.e. a multichannel image where autofluorescence has been at least partially removed (see, e.g., step 202).”).
Bredno does not expressly teach “an irradiation unit configured to emit excitation light of 320 nm to 490 nm.”
Barron teaches “In some examples, the excitation light source(s) 102 may emit an excitation light that may cause microorganisms (e.g., bacteria, contamination, etc.) to fluoresce…” an image acquisition device (Refer to para [082]; “FIG. 11 illustrates an example contamination sensing device 100 in communication with a processor 1100 (e.g., processor capable of computer vision algorithms) and a user interface 1102 (e.g., interface to display data). The contamination sensing device 100 may make use of processors 1100 such as, for example, central processing units (CPU), application specific processors (APU), graphics processing units (GPU), or digital signal processor (DSP) to process data. The contamination sensing device 100 may have wireless antennas and/or chips for Bluetooth (BLE), Wi-Fi, long or short-range radio, and/or cellular connections. Components of the contamination sensing device 100 (e.g., excitation light source(s) 102, sensor(s) 104, control system 602, etc.) may be electrically connected and/or may be wirelessly connected via the wireless antennas and/or chips.”) with an irradiation unit configured to emit excitation light of 320 nm to 490 nm (Refer to para [046]; “an excitation light may be emitted by the excitation light source(s) 102 and may be a specific wavelength. In some examples, the excitation wavelength may be a range of wavelengths. In some examples, the excitation light may be UV (e.g., UV-A around approximately 365 nanometers (nm)) or visible/near UV (e.g., 405 nm). In some examples, the excitation wavelength used may be between 300 nm and 500 nm. In some examples, the excitation wavelength or wavelength range may be between 300 nm and 400 nm. In some examples, the excitation wavelength used may be between 350 nm and 380 nm. In some examples, the excitation wavelength used may be between 380 nm and 420 nm. In some examples, the excitation wavelength or wavelength range may be between 200 nm and 350 nm. In some examples, the excitation wavelength may be approximately 230 nm and/or approximately 280 nm, for example, to initiate the autofluorescence of tryptophan, which may be found in many bacteria. In some examples, multiple excitation peak wavelengths may be used.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Brendo by enhancing the irradiation unit as rejected above by Barron.
The suggestion/motivation for combining the teachings of Brendo and Barron would have been in order to make available the “excitation light may be detectable by the sensor(s) 104. The filter or coating may be adjusted to block/reduce excitation that may enter the sensor(s) 104. In some examples, the filter or coating may block/reduce all wavelengths except for wavelengths that may be emitted through autofluorescence of a target bacteria/microorganism. The contamination sensing device 100 (e.g., the control system 610) may adjust the filter or coating to determine the presence of a target bacteria. For example, the contamination sensing device 100 may emit an excitation light having a wavelength known to cause autofluorescence in a target bacteria towards the target surface 210. The sensor(s) 104 may comprise a filter or coating that may be adjusted to filter/reduce the excitation light from entering the sensor(s) 104. The filter or coating may, for example, be adjusted to block/reduce wavelengths that do not autofluoresce from the target bacteria, allowing wavelengths that fluoresce from the target bacteria to be detected by the sensor(s) 104.” (at para [094]. Barron).
Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Brendo and Barron in order to obtain the specified claimed elements of Claim 14. It is for at least the aforementioned reasons that the Examiner has reached a conclusion of obviousness with respect to the claim in question.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 20220351371 A1).
Regarding Claim 1: Rowe discloses a method of evaluating an immune response of a cell group to a test substance (Refer to para [001]; “The present disclosure relates generally to methods for diagnosing neurodegenerative diseases, such as motor neuron diseases, and for monitoring the progression of such diseases over time, utilizing hyperspectral autofluorescence imaging of live, viable cells.”) the method comprising: preparing a first sample by adding the test substance to the cell group (Refer to para [009-013]; “… obtaining from the subject a sample comprising at least one live blood cell; optionally isolating at least one live blood cell from the sample; generating one or more multispectral or hyperspectral images of the at least one live blood cell; and analyzing spectral characteristics of autofluorescence from the at least one live blood cell. Typically the spectral characteristics of autofluorescence are compared to spectral characteristics of autofluorescence from a cell(s) in or derived from one or more reference samples known to be free of the neurodegenerative disease.”) preparing a second sample serving as a control for the first sample (Refer to para [009-013, 023, 028 and 029]; “(a) obtaining from a subject a sample comprising at least one live blood cell, and optionally isolating at least one live blood cell from the sample; executing steps of generating one or more multispectral or hyperspectral images of the at least one live blood cell from the first sample, and analysing spectral characteristics of autofluorescence from the at least one live blood cell; (c) obtaining from the same subject a second sample at a time point after commencement of treatment and after the first sample is obtained, wherein the second sample comprises at least one live blood cell, and optionally isolating at least one live blood cell from the sample;”) acquiring first autofluorescence information which is autofluorescence information of the first sample (Refer to para [098 and 109]; “Step 210 may be repeated for each excitation spectral channel in a set of excitation spectral channels. For each excitation spectral channel, autofluorescence of the cells may be detected in an emission spectral channel of a set of emission spectral channels.”)
acquiring second autofluorescence information which is autofluorescence information of the second sample (Refer to para [098 and 109]; “Step 210 may be repeated for each excitation spectral channel in a set of excitation spectral channels. For each excitation spectral channel, autofluorescence of the cells may be detected in an emission spectral channel of a set of emission spectral channels.”) and evaluating the immune response of the cell group to the test substance based on a comparison between the first autofluorescence information and the second autofluorescence information (Refer to para [031 and 032]; “(d) executing steps of generating one or more multispectral or hyperspectral images of the at least one live blood cell from the second sample, and analysing spectral characteristics of autofluorescence from the at least one live blood cell; and (e) comparing said spectral characteristics of cells from the first and second samples, wherein the comparison between said spectral characteristics between the at least one live blood cell from the first sample and the at least one live blood cell from the second sample is indicative of whether or not the subject is responding to the therapeutic treatment.”).
Rowe teaches (at para [098]) “The above method or protocol may further comprise obtaining and executing steps in respect of a third or subsequent sample. A change in spectral characteristics of autofluorescence between cells from the first and second (or subsequent) sample may be indicative of an effective therapeutic treatment or regimen and positive response of the subject to a treatment. Where the method or protocol indicates that the therapeutic treatment or regimen is ineffective and/or the subject is not responding sufficiently to the treatment (i.e. no or insignificant change in spectral characteristics), the method or protocol may further comprise altering or otherwise modifying the therapeutic treatment or regimen with a view to providing a more efficacious or aggressive treatment. This may comprise administering to the subject additional doses of the same agent with which they are being treated or changing the dose and/or type of medication or other treatment.”
One of ordinary skill in the art would know and understand that the altering and modifications described at para [098] would include first and second autofluorescence image information. Therefore, it would have been obvious to one of ordinary skill in the art to utilize the teachings of Rowe with common knowledge of the are in order to obtain the specified claimed elements of Claim 1.
Allowable Subject Matter
Claims 2-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art either singly or in combination does not teach, disclose or suggest at least the following claim limitation(s): “… omitting addition of the test substance to the cell group, adding the test substance to the cell group in an amount different from an amount of the test substance in the first sample, adding a substitute substance for the test substance to the cell group, or adding the test substance to the cell group, with a time elapsed since the addition varied from an elapsed time of the first sample.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Related Application: 18/605551 (US 20240310361 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIA M THOMAS whose telephone number is (571)270-1583. The examiner can normally be reached M-Th 8:30am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen (Steve) Koziol can be reached at (408) 918-7630. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MIA M. THOMAS
Primary Examiner
Art Unit 2665
/MIA M THOMAS/Primary Examiner
Art Unit 2665
