DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim(s) 1-5, 9 and 16-17 are rejected under 35 U.S.C. 102(a1).
Claim(s) 6-8, 10-15, and 18-20 are rejected under 35 U.S.C. 103.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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(s) 1-5, 9 and 16-17 are rejected under 35 U.S.C. 102(a1) as being anticipated by US Patent 6,271,022 to Bochner.
In regards to claims 1-5 and 9, Bochner discloses and shows in Figures 1-3, an incubation system for monitoring an incubated biological specimen, the system comprising:
an incubation chamber (col. 1, ll. 8-25; col. 2, ll. 33-39; col. 5, ll. 36-62);
one or more specimen drawers each defining a plurality of receptacles, an individual receptacle sized and shaped for receiving a corresponding biological specimen vessel, wherein an individual specimen drawer of the one or more specimen drawers is configured to slide toward a closed position wherein the one or more specimen drawers is withdrawn into the incubation chamber and the plurality of receptacles are contained within the chamber and sealed from an external ambient environment (col. 1, 8-16; col. 1, ll. 62 to col. 2, ll. 22; wherein a plurality of sliding drawers are utilized to support a plurality of test panels and each test panel has a plurality of microwells or vessels; col. 5, ll. 36-62; col. 6, ll. 45-63; wherein a plurality of removable and interchangeable shelves may be slid in and out of the incubator cabinet);
a plurality of imagers (108), each corresponding with an individual receptacle of the plurality of receptacles and each configured to produce a digital image of a respective specimen vessel arranged in a corresponding receptacle, wherein the digital image includes a plurality of pixels (col. 2, ll. 23-33; col. 8, ll. 47-65; wherein a plurality of cameras or other imaging devices may be used; wherein each imaging device may a CCD or CMOS array configured to obtain a digital image of a desired field of view);
one or more illuminators (107) collectively arranged to provide like illumination to each of the plurality of receptacles of the one or more specimen drawers (col. 5, ll. 52-63; col. 9, ll. 54-68); and
an image processor configured to commence imaging via one or more imagers of the plurality of imagers (col. 2 ll. 40-65; col. 7, ll. 44-56; col. 10, ll. 28-47; wherein one or more conventional computers may be utilized for system control and image processing);
[claim 2] wherein the incubation system is configured to alternate between: an open position at least partially exposing the plurality of receptacles to be loaded or unloaded with specimen vessels; and the closed position, wherein the plurality of receptacles are contained within the chamber and sealed from the external ambient environment (col. 5, ll. 36-62; col. 6, ll. 45-62; wherein a plurality of interchangeable and removable sliding shelves are utilized);
[claim 3] comprising a system controller configured to: receive digital images, each corresponding with a respective receptacle (col. 1, ll. 62 to col. 2, ll. 6; col. 2, ll. 50 to 65); analyze the digital images to extract optical data corresponding with at least one of color, absorption, reflection, fluorescence, elastic scattering, or inelastic (Raman) scattering (col. 5, ll. 52-62; col. 6, ll. 64 to col. 7, ll. 43); and characterize a specified target biological specimen carried by a corresponding biological specimen vessel (col. 7, ll. 1-43; col. 14, ll. 27-52);
[claim 4] comprising a system controller configured to receive imaging data from the image processor (col. 2, ll. 40-65; col. 5, ll. 52-63; col. 7, ll. 44-56; col. 10, ll. 28-47; wherein one or more conventional computers may be utilized for system control and image processing);
[claim 5] comprising first and second processors, including the image processor, and further comprising a third processor including a system controller configured to receive imaging data from each of the first and second processors (col. 2, ll. 40-65; col. 5, ll. 52-63; col. 7, ll. 44-56; col. 10, ll. 28-47; wherein one or more conventional computers may be utilized for system control and image processing);
[claim 9] wherein the one or more illuminators include a plurality of illuminators, respectively corresponding with an individual receptacle of the plurality of receptacles (col. 5, ll. 52-63; col. 9, ll. 54-68).
In regards to claims 16-17, Bochner discloses and shows in Figures 1-3, a method for monitoring an incubated biological specimen, the method comprising:
illuminating, via one or more illuminators (107), each of a plurality of biological specimen vessels, arranged in a sealed incubation chamber, at a same illumination (col. 5, ll. 52-63; col. 9, ll. 54-68);
receiving respective digital images from a plurality of imagers, each imager individually corresponding with one of the plurality of biological specimen vessels arranged in a sealed incubation chamber and each imager configured to produce a digital image of a respective specimen vessel, wherein the digital image includes a plurality of pixels (col. 2, ll. 23-33; col. 8, ll. 47-65; wherein a plurality of cameras or other imaging devices may be used; wherein each imaging device may a CCD or CMOS array configured to obtain a digital image of a desired field of view);
analyzing the digital images to extract optical data corresponding with at least one of color, absorption, reflection, fluorescence, elastic scattering, or inelastic (Raman) scattering (col. 5, ll. 52-62; col. 6, ll. 64 to col. 7, ll. 43); and
characterizing a specified target biological specimen carried by a corresponding biological specimen vessel (col. 7, ll. 1-43; col. 14, ll. 27-52);
[claim 17] comprising: moving one or more specimen drawers, each defining a plurality of receptacles with each receptacle sized and shaped for receiving a corresponding biological specimen vessel, between: an open position wherein an individual specimen drawer extends from the incubation chamber to expose the plurality of receptacles to an external ambient environment (col. 5, ll. 36-62; col. 6, ll. 45-62; wherein a plurality of interchangeable and removable sliding shelves are utilized); and a closed position wherein each the one or more specimen drawers is withdrawn into the incubation chamber and the plurality of receptacles are contained within the chamber and sealed from the external ambient environment (col. 5, ll. 36-62; col. 6, ll. 45-62; wherein a plurality of interchangeable and removable sliding shelves are utilized).
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.
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.
Claim(s) 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bochner, in view of US Publication 2014/0278136 to Shamsheyva et al.
In regards to claims 6 and 18, Bochner discloses and shows in Figures 1-3, a system and method for monitoring an incubated biological specimen further comprising:
identifying a specified target biological specimen for a corresponding biological specimen vessel, the subsequent identification including at least one of: detection of an infectious microorganism; or identification of growth properties, antibiotic susceptibility, genus, species, or strain of the microorganism (col. 5, ll. 52-62; col. 6, ll. 64 to col. 7, ll. 43; col. 14, ll. 27-52).
Bochner differs from the limitations in that it is silent to the system and method further comprising calculating respective probabilities of subsequent identification.
However, Shamsheyeva teaches and shows a system and method for the determination of microbial growth and identification, wherein digital images of a sample are analyzed by “identification algorithms”, which include calculating probability scores (par. 219, 242). Further, calculating probabilities is well-known to those of ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Bochner to include the probability calculations discussed above for the advantage of utilizing a well-known statistical method to accurately identify a specimen, with a reasonable expectation of success.
Claim(s) 7-8, 11-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bochner, in view of US Publication 2004/0227822 to Cartlidge et al.
In regards to claims 7-8, 11-14 and 19-20, Bochner discloses and shows in Figures 1-3, an incubation system for monitoring an incubated biological specimen, the system comprising:
an incubation chamber (col. 1, ll. 8-25; col. 2, ll. 33-39; col. 5, ll. 36-62);
one or more specimen drawers each defining a plurality of receptacles, an individual receptacle sized and shaped for receiving a corresponding biological specimen vessel, wherein an individual specimen drawer of the one or more specimen drawers is configured to slide toward a closed position wherein the one or more specimen drawers is withdrawn into the incubation chamber and the plurality of receptacles are contained within the chamber and sealed from an external ambient environment (col. 1, 8-16; col. 1, ll. 62 to col. 2, ll. 22; wherein a plurality of sliding drawers are utilized to support a plurality of test panels and each test panel has a plurality of microwells; col. 5, ll. 36-62; col. 6, ll. 45-63; wherein a plurality of removable and interchangeable shelves may be slid in and out of the incubator cabinet);
a plurality of imagers (108), each corresponding with an individual receptacle of the plurality of receptacles and each configured to produce a digital image of a respective specimen vessel arranged in a corresponding receptacle, wherein the digital image includes a plurality of pixels (col. 2, ll. 23-33; col. 8, ll. 47-65; wherein a plurality of cameras or other imaging devices may be used; wherein each imaging device may a CCD or CMOS array configured to obtain a digital image of a desired field of view);
one or more illuminators (107) collectively arranged to provide like illumination to each of the plurality of receptacles of the one or more specimen drawers (col. 5, ll. 52-63; col. 9, ll. 54-68);
at least two image processors configured to commence imaging via one or more imagers of the plurality of imagers (col. 2, ll. 40-65; col. 5, ll. 52-63; col. 7, ll. 44-56; col. 10, ll. 28-47; wherein one or more conventional computers may be utilized for system control and image processing); and
a system controller configured to receive imaging data from each of the at least two image processors (col. 2, ll. 40-65; col. 5, ll. 52-63; col. 7, ll. 44-56; col. 10, ll. 28-47; wherein one or more conventional computers may be utilized for system control and image processing);
[claim 12] wherein the incubation system is configured to alternate between: an open position at least partially exposing the plurality of receptacles to be loaded or unloaded with specimen vessels; and the closed position, wherein the plurality of receptacles are contained within the chamber and sealed from the external ambient environment (col. 5, ll. 36-62; col. 6, ll. 45-62; wherein a plurality of interchangeable and removable sliding shelves are utilized).
[claim 13] comprising a system controller configured to: receive digital images, each corresponding with a respective receptacle (col. 1, ll. 62 to col. 2, ll. 6; col. 2, ll. 50 to 65); analyze the digital images to extract optical data corresponding with at least one of color, absorption, reflection, fluorescence, elastic scattering, or inelastic (Raman) scattering (col. 5, ll. 52-62; col. 6, ll. 64 to col. 7, ll. 43); and characterize a specified target biological specimen carried by a corresponding biological specimen vessel (col. 7, ll. 1-43; col. 14, ll. 27-52);
[claim 14] wherein the system controller is further configured to calculate respective probabilities of subsequent identification of the specified target biological specimen for a corresponding biological specimen vessel, the subsequent identification including at least one of: detection of an infectious microorganism; or identification of growth properties, antibiotic susceptibility, genus, species, or strain of the microorganism (col. 5, ll. 52-62; col. 6, ll. 64 to col. 7, ll. 43; col. 14, ll. 27-52).
Bochner differs from the limitations in that it is silent to the system and method further comprising: [claims 7 and 19] wherein the digital image includes resolution of at least 100 pixels per inch (PPI); [claim 8 and 20] wherein each of the plurality of imagers includes an array of detectors, wherein the array is greater than 100 x 100 individual detectors and each individual detector corresponds to an individual pixel of the at least 100 PPI.
However, Cartlidge teaches and shows an imaging system and methodology with various applications, wherein a digital imaging device (CCD or CMOS) is utilized to obtain an image of a sample, and wherein image resolution is “the primary design parameter” (par. 7). Further, the reference explicitly discloses a PPI of 72 and wherein 2,000 to 1,000,000 pixels may be obtained by the sensor (par. 45-46). Specifically, 10,000 pixels is understood to be a 100 x 100 pixel array, and arrays with a larger number of pixels are understood to be above 100 PPI.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Bochner to include detector array and imaging parameters discussed above for the advantage of improving system resolution and maximizing the amount of useful information in each image pixel (par. 45), with a reasonable expectation of success.
Claim(s) 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bochner, in view of US Publication 2022/0050095 to Barry JR. et al.
In regards to claims 10 and 15, Bochner discloses and shows a digital imaging system wherein a plurality of light sources (107) are utilized to uniformly illuminate and image an area of 20 x 20 cm (col. 4, ll. 33-63; col. 9, ll. 54-68).
Bochner differs from the limitations in that it is silent to the incubation system, wherein an individual one of the plurality of illuminators includes a ring of emitters configured to provide substantially even illumination.
However, Barry teaches and shows a digital imaging system wherein a ring illuminator may be utilized to illuminate a sample (par. 40). Further, ring light sources are well-known to those of ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Bochner to include illuminator array discussed above for the advantage of utilizing a well-known light source to uniformly illuminate a sample and obtain a desired configuration, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANSEN whose telephone number is (571)270-1736. The examiner can normally be reached Monday to Friday, 8am to 4pm.
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877