DETAILED ACTION
Claims 1-33 are currently pending and have been examined.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-33 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of copending Application No. 17769253 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending 253’ application also teaches using the same features, including: optical imaging system, electromagnetic radiation (fluorescence detection), processing system and generating images of biological structures data and forming the similar biological structures into identification buckets as profiles for determining risk of having certain disease in a subject. 253’ application uses the same illumination, light control, light detection systems . Also 253’ detect cytokeratin, CD31, and CD45 biomarkers in determining phenotypes of a cell and using same DAPI substrate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-41 of copending Application No. 18833513 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending 513’ application also teaches using the same features, including optical imaging system, electromagnetic radiation (fluorescence detection), processing system and generating images of biological structures data and forming the similar biological structures into identification buckets as profiles for determining risk of having cancer in a subject. 513’ application uses the same illumination, light control, light detection systems. Also 513’ detects cytokeratin, vimentin, CD31, and CD45 biomarkers in determining phenotypes of a cell and using same DAPI substrate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-20, 23, 29, & 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sethi (US 20180232883) in view of Kang (US20050092934) and Binning (US20110268331).
As per claim 1, Sethi teaches an imaging structure identification system comprising:
an optical imaging system configured to illuminate a liquid biopsy sample for a subject, (Fig. 1B; para. 5-8, 26, 40-41, 46: biopsy tissue of sample scanned using a scanner; scanner can have components including lens, light source, fluorescent source and computer); and
a processing system configured to:
generate images of the one or more biological structures for the subject from the image data (para. 4: images generated from scanner), detect and determine a plurality of features from the images or the image data, and form biological structure identification buckets from the plurality of features, each biological structure identification bucket identifying imaging structures that are similar in type (Fig. 7-8; para. 4-6: images analyzed to detect and obtain points of interest; points of interest include biological structures).
Sethi does not expressly teach the liquid biopsy sample having one or more biological structures that are labeled with one or more fluorophores associated with a fluorescence assay for a disease state allowing detection of emitted electromagnetic radiation from the liquid biopsy sample as image data.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light souce to obtain images from a patient tissue sample (para. 5, 18).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Sethi and Kang with Binning based on the motivation of assists a user to perform computer-aided detection by generating image-based patient profiles.
Sethi and Kang do not expressly teach
generate a subject profile of biological structure identification buckets for rare imaging events for the subject;
compare the subject profile with a first predetermined profile for subjects not having the disease state; and
identifying the subject as being at reduced risk for having the disease state if the subject profile is similar to the first predetermined profile for subjects not being in the disease state, wherein if the subject profile is not similar to the first predetermined profile for subjects not being in the disease state it is not determinative if the subject is in the disease state.
Binning, however, teaches to image-based patient profiles where a patient profile is generated based on patient image data (para. 37-39). Binning also teaches to comparing the patient profile to a population of normal patients and determining a presence of a disease (para. 95).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Sethi and Kang with Binning based on the motivation of identifies the most important information obtained from the analyzed digital images and guides the user to the source of that information (Binning – para. 3).
As per claim 2, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the rare imaging events include rare biological structures (para. 5: system can detect various rare events such as presence of cancer types and tumors).
As per claim 3, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the one or more biological structures include simultaneously identified multiple biological structures (para. 5: system can detect various rare events such as presence of cancer types and tumors).
As per claim 4, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi does not expressly teach wherein the optical imaging system includes:
a liquid biopsy sample carrier suitable for receiving and supporting the liquid biopsy sample;
an illumination system capable of illuminating the liquid biopsy sample at a specific wavelength or wavelengths that can be absorbed by the one or more fluorophores;
a light detection system configured to detect and determine an intensity and a wavelength of fluorescence emitted by the one or more fluorophores; and
a light controlling system configured to allow detection of emitted electromagnetic radiation from the liquid biopsy sample;
allow detection of electromagnetic radiation scattered by, reflected by, and/or transmitted through the liquid biopsy sample; and guide electromagnetic radiation from the illumination system to the liquid biopsy sample, and from the liquid biopsy sample to the light detection system.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light source to obtain images from a patient tissue sample (para. 5, 18).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 5, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the processing system configured to:
detect and determine morphology of each biological structure using each image; and
identify type of each biological structure from the plurality of features (para. 4-5, 40, 57: system detects points of interest in images and detects type of structures).
As per claim 6, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein at least a subset of the one or more biological structures includes a component selected from the group consisting of a structure with a membrane, a protein, DNA, RNA, and combinations thereof (para. 4-5, 40, 57: system detects points of interest in images and detects type of structures).
As per claim 7, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein at least a subset of the one or more biological structures is a structure with a membrane selected from the group consisting of a cell, a vesicle, and combinations thereof (para. 4-5, 40, 57: system detects points of interest in images and detects type of structures).
As per claim 8, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample is a non-solid biological sample (para. 90: liquid biopsy).
As per claim 9, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample is a body fluid sample (para. 90: liquid biopsy from patient).
As per claim 10, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample comprises a blood sample, a bone marrow sample, a peritoneal fluid sample, a urine sample, a saliva sample, a vaginal fluid sample, a semen sample, a tear sample, a mucus sample, an aqueous humor sample, a cerebrospinal fluid (CSF) sample, or a combination thereof (para. 40-41: sample includes point of interests such as blood vessels).
As per claim 11, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample comprises a blood sample (para. 40-41: sample includes point of interests such as blood vessels).
As per claim 12, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample comprises common immune cells and rare biological structures (para. 29: patient tissue sample with biological constituents including cells and other biomarkers and proteins; a cancer patient’s blood samples inherently contain immune cells and circulating tumor cells).
As per claim 13, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the rare biological structures are:
epithelial cells, endothelial cells, mesenchymal cells, other stromal cells, cells that are in various transitional states, or a mixture thereof;
immune cells (para. 29: patient tissue sample with biological constituents including cells and other biomarkers and proteins; a cancer patient’s blood samples inherently contain immune cells and circulating tumor cells);
vesicles, or
mixtures thereof.
As per claim 14, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the liquid biopsy sample comprises common biological structures and rare biological structures such that a total number of biological structures being a sum of the number of common biological structures and rare biological structures, and wherein the rare biological structures are present in an amount equal to or less than 10%, 5%, 1%, 0.1%, or 0.01% of the total number of biological structures (Fig. 1-2 & 5-8; para. 9, 27; claims 1, 4-6: followed by processing and data collection by the system, the final results can be used to detect or monitor stages or grades of various cancer; note, the cancer cells (i.e. rare biological structure) exist in the body inherently would have been varies from less than 10%-0.01% depending on the stages or grades of cancer development).
As per claim 15, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the emitted electromagnetic radiation is a fluorescent radiation (para. 27: fluorescent imaging).
As per claim 16, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi does not expressly teach wherein the optical imaging system comprises an excitation filter, an emission filter, a (dichroic) mirror, a lens, an optical fiber, or a combination thereof.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light source to obtain images from a patient tissue sample (para. 5, 18).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 17, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi does not expressly teach wherein the optical imaging system comprises a fluorescence microscope, a brightfield microscope, or a combination thereof.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light source to obtain images from a patient tissue sample (para. 5, 18).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 18, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the processing system comprises a control system, a hardware processor, a memory system, and an information conveying system (para. 4: computing system).
As per claim 19, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi does not expressly teach wherein the imaging structure identification system has at least one fluorescence channel.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light source to obtain images from a patient tissue sample (para. 5, 18).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 20, Sethi, Kang, and Binning teach the imaging structure identification system of claim 19. Sethi does not expressly teach wherein the imaging structure identification system applies 1 to 10 fluorescence channels.
Kang, however, teaches to fluorescence imaging that uses excitation filter with a light source to obtain images from a patient tissue sample (para. 5, 18).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 23, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the disease state is cancer (para. 5: disease state of cancer).
As per claim 29, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein a biological structure's morphology is determined by using at least one feature from the images or the image data (para. 29: patient tissue sample with biological constituents including cells and other biomarkers and proteins; a cancer patient’s blood samples inherently contain immune cells and circulating tumor cells).
As per claim 32, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1. Sethi teaches wherein the imaging structure identification system further comprises an information conveying system that is configured to convey to a user information related to types of the biological structures present in the liquid biopsy sample, biological structure identification buckets, disease maps, disease atlases, or a combination thereof (para. 4, 47: computing system with processor and display outputs results to user).
As per claim 33, Sethi, Binning, and Kang teach a method for evaluating a subject with the imaging structure identification system of claim 1. Sethi teaches the method comprising:
receiving a liquid biopsy sample from a subject comprising biological structures (Fig. 1B; para. 5-8, 26, 40-41, 46: biopsy tissue of sample scanned using a scanner; scanner can have components including lens, light source, fluorescent source and computer);
preparing a sample comprising a single biological structure layer sample from the liquid biopsy sample, the single biological structure layer sample being a single layer of biological structures (Fig. 1B; para. 5-8, 26, 40-41, 46: biopsy tissue of sample scanned using a scanner; scanner can have components including lens, light source, fluorescent source and computer);
staining the biological structures of the single layer biological structure sample with a fluorescence assay for a disease state (Fig. 1B; para. 5-8, 26, 40-41, 46: biopsy tissue of sample scanned using a scanner; scanner can have components including lens, light source, fluorescent source and computer); and
1) analyzing the sample with an imaging structure identification system configured to identify rare biological structures through their fluorescence and morphology (Fig. 1B; para. 5-8, 26, 40-41, 46: biopsy tissue of sample scanned using a scanner; scanner can have components including lens, light source, fluorescent source and computer) and form one or more biological structure identification buckets based on an identified biological structure type, wherein each biological structure identification bucket contains a similar type of biological structures (Fig. 7-8; para. 4-6: images analyzed to detect and obtain points of interest; points of interest include biological structures).
Sethi does not expressly teach generating a subject profile of biological structure identification buckets for rare biological structures for the subject;
comparing the subject profile with a first predetermined profile for subjects not being in the disease state; and
identifying the subject being at reduced risk for being in the disease state if the subject profile is similar to the first predetermined profile for subjects not being in the disease state, wherein if the subject profile is not similar to the first predetermined profile for subjects not being in the disease state it is not determinative for the subject being in the disease state.
Binning, however, teaches to image-based patient profiles where a patient profile is generated based on patient image data (para. 37-39). Binning also teaches to comparing the patient profile to a population of normal patients and determining a presence of a disease (para. 95).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sethi (US 20180232883) in view of Kang (US20050092934) and Binning (US20110268331) as applied to claim 19, and in further view of Meng (“Clinical Cancer Research 2004 10:8152-8162”).
As per claim 21, Sethi, Kang, and Binning teach the imaging structure identification system of claim 19, but do not expressly teach wherein the imaging structure identification system has 4 to 7 fluorescence channels.
Meng, however, teaches to optical imaging in detecting cancer in a patient by illuminating a blood sample having biological interest molecules labeled with fluorescence (materials and methods; Fig. 1). Meng also teaches to different color labels (e.g. tri-color and dual-color) for immunostaining (see Methods).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Meng with Sethi, Kang, and Binning based on the motivation of providing a sensitive and specific test for early detection of circulating tumor cells (Meng – Introduction).
As per claim 22, Sethi, Kang, and Binning teach the imaging structure identification system of claim 19, but do not expressly teach wherein the imaging structure identification system has only four fluorescence channels.
Meng, however, teaches to optical imaging in detecting cancer in a patient by illuminating a blood sample having biological interest molecules labeled with fluorescence (materials and methods; Fig. 1). Meng also teaches to different color labels (e.g. tri-color and dual-color) for immunostaining (see Methods).
The motivations to combine the above mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Claims 24 & 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sethi (US 20180232883) in view of Kang (US20050092934) and Binning (US20110268331) as applied to claim 19, and in further view of Davis (US 20200110090) and Yao (US 20050158804).
As per claim 24, Sethi, Kang, and Binning teach the imaging structure identification system of claim 19. Sethi, Kang, and Binning do not expressly teach detection useful for nuclear segmentation and characterization; detect a cytokeratin (CK) for its epithelial-like phenotype; detect a vimentin for its endothelial/mesenchymal-like phenotype; detect both a CD31 for its endothelial-like phenotype, and a CD45 for its immune cell phenotype.
Davis teaches using immunoassay, such as antibodies, for detection cancer from samples of suspected patients. The target markers include cytokeratin, vimentin, CD31, CD45 and DAPI (section 0118, 0141).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method taught by Davis to have cytokeratin, vimentin, CD31 and CD45 detected using specific antibodies for evaluation of cancer and/or monitoring development stages thereof with reasonable expectation of success. Using antibody detecting specific target molecule is well-known and commonly practiced in the field.
Sethi, Kang, Binning, & Davis do not expressly teach
wherein the imaging structure identification system has only four fluorescence channels, wherein the four fluorescence channels detect various molecules.
Concerning use of different fluorescent channel, i.e. different color fluorophores, in identifying target molecules in a sample, such technique is well-known and commonly practiced in the field. For instance, Yao teaches using different colorful fluorophores for different target molecules in imaging identification, including blue, red, orange and green that emit different wavelengths for differential detection (section 0095).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method taught by Yao to use different color fluorophores, such as blue, red, orange and green, for differential detection. One ordinary skilled person would have been motivated to employ the different color labels for better efficiency in detection. Note, one ordinary skilled person can assign different color fluorophores
As per claim 26, Sethi, Kang, Binning, Davis, and Yao teach the imaging structure identification system of claim 25. Sethi does not expressly teach wherein the first fluorescence channel is configured to detect 4′,6-diamidino-2-phenylindole (DAPI) for nuclear segmentation and characterization.
Davis teaches using immunoassay, such as antibodies, for detection cancer from samples of suspected patients. The target markers include cytokeratin, vimentin, CD31, CD45 and DAPI (section 0118, 0141).
The motivations to combine the above mentioned references are discussed in the rejection of claim 24, and incorporated herein.
As per claim 27, Sethi, Kang, Binning, Davis, and Yao teach the imaging structure identification system of claim 25. Sethi does not expressly teach wherein the imaging structure identification system has only four fluorescence channels.
Concerning use of different fluorescent channel, i.e. different color fluorophores, in identifying target molecules in a sample, such technique is well-known and commonly practiced in the field. For instance, Yao teaches using different colorful fluorophores for different target molecules in imaging identification, including blue, red, orange and green that emit different wavelengths for differential detection (section 0095).
The motivations to combine the above mentioned references are discussed in the rejection of claim 24, and incorporated herein.
As per claim 28, Sethi, Kang, Binning, Davis, and Yao teach the imaging structure identification system of claim 27, wherein the imaging structure identification system has only four fluorescence channels and is configured to identify the endothelial cells and the immune cells from the plurality of features, and to differentiate the endothelial cells from the immune cells, wherein the endothelial cells have more elongated morphologies as compared to the immune cells, and the immune cells have more round morphologies as compared to the endothelial cells (The Examiner asserts that the system has the necessary reagents for detection nuclei, cytokeratin, vimentin, CD31 and CD45, therefore the intended use for detection and differentiation of endothelial cells and immune cells can also be performed because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Applicants are reminded the current claims direct toa PRODUCT (system), not a method. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sethi (US 20180232883) in view of Kang (US20050092934) and Binning (US20110268331) in view of Claim 1 above, and in further view of Veltri (US 6025128).
As per claim 30, Sethi, Kang, and Binning teach the imaging structure identification system of claim 1, but do not expressly teach wherein a biological structure's morphology is determined from at least 10 features, at least 100 features, at least 500 features, or at least 1,000 features from the images or the image data.
Veltri teaches measuring a plurality of cancer related biological features in assessment of cancer. The features include size, shape, sum optical density, angular second moment, sum average, sum variance, DNA ploidy, PD-41 antigenic expression, Her-2-neu antigenic expression, post-op Gleason DNA ploidy, Markovian texture features (see claims 1-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the method taught by Veltri, such as the above features for a more thorough and complete evaluating cancer cells in a subject.
As per claim 31, Sethi, Kang, and Binning teach the imaging structure identification system of claim 30, but do not expressly teach wherein at least a subset of the features are related to size, shape, texture and structure of the one or more biological structures.
Veltri teaches measuring a plurality of cancer related biological features in assessment of cancer. The features include size, shape, sum optical density, angular second moment, sum average, sum variance, DNA ploidy, PD-41 antigenic expression, Her-2-neu antigenic expression, post-op Gleason DNA ploidy, Markovian texture features (see claims 1-20).
The motivations to combine the above mentioned references are discussed in the rejection of claim 30, and incorporated herein.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sethi, Kang, and Binning as applied to claim 19, and in further view of Yao (US 20050158804).
As per claim 25, Sethi, Kang, and Binning teach the imaging structure identification system of claim 19. Sethi, Kang, and Binning do not expressly teach wherein the imaging structure identification system has only four fluorescence channels, wherein the four fluorescence channels are:
a first fluorescence channel configured for detection of fluorescence emission at a blue color wavelength region;
a second fluorescence channel configured for detection of fluorescence emission at a red color wavelength region;
a third fluorescence channel configured for detection of fluorescence emission at an orange color wavelength region; and
a fourth fluorescence channel configured for detection of fluorescence emission at a green color wavelength region.
Concerning use of different fluorescent channel, i.e. different color fluorophores, in identifying target molecules in a sample, such technique is well-known and commonly practiced in the field. For instance, Yao teaches using different colorful fluorophores for different target molecules in imaging identification, including blue, red, orange and green that emit different wavelengths for differential detection (section 0095).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method taught by Yao to use different color fluorophores, such as blue, red, orange and green, for differential detection. One ordinary skilled person would have been motivated to employ the different color labels for better efficiency in detection. Note, one ordinary skilled person can assign different color fluorophores
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Poore (US 20240124941) teaches to a method of determining a disease of a subject, comprising: receiving a biological sample, electronic medical record information, and one or more radiologic images of a subject; sequencing one or more nucleic acid molecules isolated from the biological sample thereby generating one or more nucleic acid molecule sequencing reads; and determining a disease of the subject as an output of a predictive model when the predictive model is provided the subject's one or more nucleic acid molecule sequencing reads, electronic medical record information, and data derived from one or more radiologic images as an input.
Ebot (US20250272835) teaches to identifying an image of a tissue sample obtained from a subject. The tissue sample includes at least one cancer cell and at least one non-cancer cell. The example method further includes identifying the at least one non-cancer cell depicted in the image; generating a metric based on the at least one non-cancer cell depicted in the image; and predicting, based on the metric, whether the at least one cancer cell is susceptible to at least one treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619