Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Original claims 1-4 filed 6/17/2021 are pending and under examination.
Priority
This application filed 6/17/2021 is a divisional of 14/679698 filed 4/16/2015, now abandoned, which is a continuation of 1/691313 filed 11/30/2012, now abandoned, which 10/662,765 filed 1/1/2003, now US Patent 8,346483 which claims benefit to US Provisional 60/410433 filed 9/13/2002.
Information Disclosure Statement
The four information disclosure statements (IDS) submitted between 9/29/2021 and 8/28/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. See for example citations in [0007] and [0008]. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8715955 (US Application 10/662765). Although the claims at issue are not identical, they are not patentably distinct from each other because both comprise steps for capturing an image of a tissue and using the image to process cell removal using film proximal to the tissue by use of a laser.
Pending independent claim is provided for comparison of claimed subject matter discussed. Instant application claim 1:
A computer-implemented method for image analysis, the computer-implemented method comprising:
receiving a first image of a first tissue sample using laser capture microdissection:
selecting a database containing parameters:
classifying the first image into at least one region of interest employing the parameters from the database:
updating the parameters of the database N ith data from the first image to produce updated parameters:
capturing a second image of a tissue sample using laser capture microdissection:
classifying the second image into regions of interest employing the updated parameters from the database based: and
updating the parameters of the database a second time with data from the second image.
Claim 1 for comparison:
A method for laser microdissection comprising:
providing a first substrate having a surface; applying a layer of biological material to the surface of the first substrate;
providing a second substrate having a surface with a transfer film disposed thereon, wherein the transfer film has adhesive characteristics upon activation by electromagnetic energy;
identifying at least one targeted portion of biological material to be microdissected, wherein the at least one targeted portion includes desired and undesired biological material;
bringing the transfer film into juxtaposition with the first substrate on the side of the biological material in the location of the at least one targeted portion of biological material;
activating a first laser source so as to describe at least one closed or substantially closed path around the at least one targeted portion of biological material to be microdissected, wherein the first laser source is configured to erode the biological material along the described path and defining an interior and exterior;
activating a second laser source and directing the second laser source at the interior of the at least one described path so as to activate at least one region of the transfer film so that the at least one activated region of transfer film adheres to the at least one interior portion of biological material, wherein the at least one activated region of transfer film adheres to at least one portion of the undesired biological material; and
separating the second substrate with its attached transfer film and the at least one adhered targeted portion of biological material from the remaining layer of biological material.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 7148966 (US Application 11/331758). Although the claims at issue are not identical, they are not patentably distinct from each other because both comprise steps for capturing an image of a tissue and using the image to process cell removal using film proximal to the tissue by use of a laser. Claim 1 for comparison:
A method for laser capture microdissection, comprising: providing a laser capture instrument comprising:
a microscope having a first optical axis;
a sample-receiving stage connected to the microscope for positioning a tissue sample;
a laser selectively activable to emit a light beam along the first optical axis; an acquisition system for capturing images along the first optical axis; and a camera for capturing images along a second optical axis; providing a tissue sample on the sample-receiving stage; aligning the tissue sample and second optical axis;
capturing, with the camera, a first image of the tissue sample while positioned in the second optical axis;
identifying a region of interest of the tissue sample from the first image; aligning the region of interest and the first optical axis;
capturing, with the acquisition system, a second image of the tissue sample while positioned in the first optical axis;
selecting at least one portion of the region of interest for microdissection; providing a transfer film;
juxtaposing the transfer film with the at least one portion of the region of interest in the first optical axis;
activating at least one area of the transfer film adjacent to the at least one portion of the region of interest with the laser;
adhering the transfer film to the at least one portion of the region of interest that is adjacent to the at least one activated area of the transfer film; and
transferring the at least one portion of the region of interest to the transfer film.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8722357 (US Application 11/236045). Although the claims at issue are not identical, they are not patentably distinct from each other because both comprise steps for capturing an image of a tissue and using the image to process cell removal using film proximal to the tissue by use of a laser. Claim 1 for comparison:
A method for laser microdissection, comprising:
applying a layer of biological material to a surface of a first substrate;
identifying a targeted portion of biological material located on the first substrate,
wherein the targeted portion of biological material includes a desired sample for further analysis and an undesired portion of biological material;
bringing a polymer layer into juxtaposition with the first substrate on the side of the biological material in the location of the targeted portion of biological material;
activating a laser source to describe a closed or substantially closed path around the targeted portion of biological material or to deliver energy directly to the targeted portion of biological material;
transferring a portion of biological material of the targeted portion to the polymer layer by activating a capture laser directed at a region of the undesired portion included in the targeted portion, wherein the portion of biological material includes the desired sample and the undesired portion of biological material;
moving the polymer layer to a quality control station configured for viewing the portion of biological material that is present on the polymer layer, generating an image of the portion of biological material, further ablating or capturing portions of the portion of the biological material, or any combination thereof;
identifying the desired sample present on the polymer layer while the polymer layer is located in the quality control station; and
activating the laser source and directing it at the portion of biological material that is present on the polymer layer while the polymer layer is located in the quality control station.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (US Patent 6,134,354) and Levenson et al. (US Pub 2003/0030801).
The claims are directed to a method of image analysis using a laser microdissection comprising using a computer-implemented method for image analysis to classify the images.
Method to acquire and analyze images were known as evidenced by Lee et al. who teach at col. 4, lines 58-64 and col. 5, lines 19-27 describe a system that acquires digital images and performs image analysis through various stages with each stage applying classifiers. Lee et al. at col 6, line 27 describe acquiring multiple images. Lee et al. further describe at col. 5, lines 35-45 wherein during classifier development the apparatus calculates and stores many features associated with each object to be entered into an object classifier training database, which also stores information provided by expert cytologists for each object in the training database. Lee et al. describe at col. 7 lines 60-67 through col. 9 wherein the images go through an image segmentation process occurs, which occurs at the pixel level of abstraction, i.e. contrast enhancement, threshold imaging, and object refinement. Lee et al. further describe using different levels of abstraction during the various stages for classifying such as using texture, see col. 10, lines 42 to -49, which read on using or selecting different levels of abstraction such as sub-image processing and objection processing (i.e. based on textures as described by applicant in the specification, see paragraph [0060] of the published application). Therefore Lee describes an apparatus that acquires images, transforms the images into a feature space, uses different levels of abstraction at the various stages of classifying, such as at the initial stage applies a pixel level of abstraction, generates and updates a database based on the features and classifies the images.
The classification algorithm is trained on image data whereby the images are received and the training uses and refines the parameters, i.e. updates the parameters based on the received image data. Lee describes at col. 5, lines 15-17 wherein the invention is trained from a cell library of training slides. Lee further describes at col. 5, lines 35-45 wherein the extracted features are stored in an object classifier training database. The object classifier training database uses a multitude of images for training wherein each images adds to the database for the training, i.e. updates the database with the new parameters. In addition, the training itself uses previously selected parameters (i.e. selects a database containing parameters based on a selected level of abstraction) to train, i.e. classify an image. Once classifiers have been designed and implemented, the apparatus of the invention described by Lee uses them to generate classification results, i.e. uses the updated parameters to classify a second image. Lee describes an embodiment of the invention applied to object classification wherein the classification consists of a series of classifiers in stages. Each stage takes potentially abnormal objects from previous stage and refines (i.e. updates) the classification results further using sets of new features (updated parameters) to improve the accuracy of classification.
In addition, Lee et al. further describe using the parameters at the second stage of classifying of to distinguish normal cells (e.g. non-regions of interest) from abnormal cells. Lee et al. suggest but do not explicitly teach updating database parameters based on the image or image analysis when comparing, but Lee et al. suggests this because the apparatus described is directed towards the image analysis of biological samples and in particular pap smears. Lee et al. describes at the abstract wherein an automated system performs an analysis, but also a stain evaluation of the slide is performed as well as a typicality evaluation. Thus Lee et al. describes the use of a combination of techniques for evaluating a pap smear image. Similar to Lee et al., Levenson et al. is also directed to an apparatus of performing image analysis on biological samples such as pap smears, see paragraph [0026]. Levenson et al. describes wherein the method of performing image analysis and classification of a target tissue described may further include automating a subsequent process, which may include laser capture microdissection. The function of the method assists in determining the extent of a condition or disease in a target sample.
It would have been obvious to one of ordinary skill in the art at the time of the instant invention to have combined the image analysis method taught by Lee et al. with a subsequent automated process of using laser capture microdissection as taught by Levenson. This is because Levenson describes wherein the further use of LCM assists in determining the extent of the disease. Both Lee and Levenson are directed to the same goal of using image analysis to classify biological tissue samples such as pap smears. Levenson exemplifies the advantage of using a subsequent automated process involving LCM, which will assist in determining the extent of the disease. A person of ordinary skill in the art would have immediately recognized the advantage of using further automated processing, such as using automated LCM as taught by Levenson, in order to enable an improved determination and classification such as having a cancer and to what extent.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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, Karlheinz R Skowronek can be reached at 571 272-9047. 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.
/Joseph Woitach/Primary Examiner, Art Unit 1687
Prosecution Insights