DETAILED ACTION
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 01/03/2025 have been considered by the Examiner and made of record in the application file.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yorav-Raphael (US 2019/0087953 A1) in view of Wardlaw (US 2009/0237665 A1).
Regarding claim 1, Yorav-Raphael discloses a method for determining defocus in image data related to a prepared blood sample, by means of a blood analyzer comprising an imaging system and a probing volume, the method comprising the steps of: (paragraphs 51-53, 58-59, 62-64 and 141-144; Yorav-Raphael discloses uses a digital microscope to image biological cell samples, including blood samples for blood count analysis. The blood sample is held in a sample chamber corresponding to the claimed probing volume.)
arranging a prepared blood sample in the probing volume of the blood analyzer; (paragraphs 58-59, 63 and 141-144; The sample carrier includes chambers configured to accommodate a cell sample, including slides and microfluidic cells, which is applied to prepared blood samples.)
obtaining image data related to the prepared blood sample by means of the imaging system of the blood analyzer, (paragraphs 85-87 and 131-133; Yorav-Raphael obtains images of the cell sample using a digital microscope and image sensor, including by brightfield imaging.) the image data comprising data related to at least one imaging plane corresponding to a depth of the prepared blood sample; and (paragraphs 85-90 and 132-133; Images are captured at corresponding depth levels along the Z axis with each image associated with a particular depth in the cell sample.)
analysing analyzing the obtained image data, (paragraphs 83-84, 90 and 96-97; Yorav-Raphael analyzes the acquired images to calculate focus configurations and evaluates changes in object appearance caused by position relative to the focal plane.) analyzing the obtained image data including the steps of: identifying an object region in the obtained image data, the object region (paragraphs 97 and 106; Yorav-Raphael analyzes depicted objects, including red blood cells. Figures 13 shows physical red blood cells in the image.)
identifying an optical feature of the identified object region, (paragraphs 97 and 106; Yorav-Raphael analyzes changes in red blood cell appearance and identifies ring shaped features surrounding red blood cell images at different focal positions.) (paragraph 106 and figure 13; The ring is described as an appearance of the red blood cell image associated with focus variation, not as a second physical structure in the sample.) and
determining at least a direction of defocus in the image data, based on an appearance of the identified optical feature. (paragraphs 105-106; Image data may define the direction of variation and that the appearance and colors of the ring shapes indicate both direction and degree of focus variation.)
Yorav-Raphael fails to specifically disclose that the object region comprises a group of pixels in the image data and that the optical feature originating from a difference in refractive index between the object and a medium of the prepared blood sample.
In related art, Wardlaw discloses a group of pixels in the image data (paragraphs 27 and 36-37; Wardlaw segments the digital image to locate and select physical lenslets and states that each lenslet image is represented by a group of pixels analyzed on a per pixel basis.) and that the optical feature originating from a difference in refractive index between the object and a medium of the prepared blood sample. (paragraphs 23-24; Wardlaw teaches that the lenslet has a refractive index different from the surrounding sample and that the resulting optical pattern is a function of the lenslet’s refractive index.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Wardlaw into the teachings of Yorav-Raphael to effectively provide and inexpensive means of ensuring rapid focusing of a biologic sample that is consistently accurate, one that can be used in a variety of imaging system configurations, and one that relies only on the imaging system itself.
Regarding claim 6, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the object is a blood cell. (paragraphs 97, 106 and 131-133)
Regarding claim 7, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the optical feature originates from a lens effect created by the object. (Wardlaw: paragraphs 23-24)
Regarding claim 8, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the step of identifying an optical feature of the identified object region comprises identifying a first ring shaped feature and a second ring shaped feature, and wherein the step of determining at least a direction of defocus in the image data comprises determining relative positions of the first and second ring shaped features. (paragraphs 105-106)
Regarding claim 9, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the step of determining at least a direction of defocus in the image data is further based on applying knowledge regarding optical properties of the object. (Wardlaw: paragraphs 23-25 and 38-44)
Regarding claim 10, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein further comprising the step of determining a magnitude of defocus in the image data. (paragraphs 101 and 104-106)
Regarding claim 11, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the image data comprises a plurality of images, each image being related to an imaging plane, the image data thereby forming a stack of images related to a plurality of imaging planes, and wherein the method further comprises the step of identifying an imaging plane among the plurality of imaging planes in which an image of the object is in focus. (paragraphs 8, 18-20, 54, 85-90 and 131-146)
Regarding claim 12, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention wherein the image data comprises data from only one imaging plane, and wherein the method further comprises the step of adjusting at least one setting of the imaging system, based on the determined direction of defocus. (paragraphs 97, 105-106, 131 and 146)
Claims 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yorav-Raphael in view of Wardlaw and in further view of Ozcan (US 2019/0333199 A1).
Regarding claim 2, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention except for wherein the step of obtaining image data related to the prepared blood sample comprises directing a light beam towards the prepared blood sample with a numerical aperture which is smaller than a numerical aperture of an objective of the imaging system.
In related art, Ozcan discloses obtaining image data related to the prepared blood sample comprises directing a light beam towards the prepared blood sample with a numerical aperture which is smaller than a numerical aperture of an objective of the imaging system. (paragraphs 79-80)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Ozcan into the teachings of Yorav-Raphael and Wardlaw for an effective system for outputting improved microscopy images.
Regarding claim 3, Yorav-Raphael, as modified by Wardlaw and Ozcan, discloses the claimed invention wherein the numerical aperture of the light beam is smaller than 80% of the numerical aperture of the objective of the imaging system. (Ozcan: paragraphs 79-80)
Regarding claim 4, Yorav-Raphael, as modified by Wardlaw and Ozcan, discloses the claimed invention wherein the numerical aperture of the light beam is between 5% and 50% of the numerical aperture of the objective of the imaging system. (Ozcan: paragraphs 79-80)
Regarding claim 5, Yorav-Raphael, as modified by Wardlaw, discloses the claimed invention except for wherein the step of obtaining image data comprises obtaining at least one holographic image.
In related art, Ozcan discloses obtaining image data comprises obtaining at least one holographic image. (Ozcan: paragraph 79)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Ozcan into the teachings of Yorav-Raphael and Wardlaw for an effective system for outputting improved microscopy images.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOBBAK SAFAIPOUR whose telephone number is (571)270-1092. The examiner can normally be reached Monday - Friday, 8:00am - 5:00pm.
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/BOBBAK SAFAIPOUR/Primary Examiner, Art Unit 2665
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