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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3, 7-9, 11-13, 16-23, 26, 27 and 33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor, or a joint inventor, regards as the invention.
Claim 1 is indefinite at least because of one or more of the following:
A) the recitation of “low dose” and the corresponding tube current settings for various generic x-ray systems do not establish a “low dose” to be received by the detector. Simply stating mA settings of a generic x-ray imaging application does not establish a concrete measure by which a “low” dose of x-rays is received at the detector. Much depends on filtration, anode material, SID, etc. In addition, these generic applications and mA settings also exhibit a wide range of potential doses received by the detector. Therefore, the nature of what amount of x-rays is “low” for the claimed invention is not clear. The meets and bounds of the claim are not ascertainable by one of ordinary skill in the art.
B) the generation of the transmitted data from the light is not clear. The connection between the collected light and the transmitted data is missing.
C) the limitation, “first and second amplifier circuit sets…configured to amplify the electrical signals…according to respective first and second native gain modes”, is not clear insofar as how the “first and second amplifier sets” achieve “first and second native gain modes”.
Claims 2, 3, 7-9, 11-13, 16-23, 26 and 27 are rejected under this section by virtue of their dependence upon claim 1, thus incorporating the indefinite subject matter, and further for failing to remedy any of the noted deficiencies.
Claim 17 is further indefinite at least because the structure encompassed by “WDR logic” is not clear, nor is it clear what structure or method steps are required by the various “readout techniques” recited in the claims.
Claim 22 is further indefinite at least because it is unclear whether the ADCs are the same or different than the ADCs of parent claim 1.
Claim 33 is indefinite at least because of one or more of the following:
A) the recitation of “low dose” and the corresponding tube current settings for various generic x-ray systems do not establish a “low dose” to be received by the detector. Simply stating mA settings of a generic x-ray imaging application does not establish a concrete measure by which a “low” dose of x-rays is received at the detector. Much depends on filtration, anode material, SID, etc. In addition, these generic applications and mA settings also exhibit a wide range of potential doses received by the detector. Therefore, the nature of what amount of x-rays is “low” for the claimed invention is not clear. The meets and bounds of the claim are not ascertainable by one of ordinary skill in the art.
B) in part (iv), the limitation, “first and second amplifier circuit sets…configured to amplify the electrical signals…according to respective first and second native gain modes”, is not clear insofar as how the “first and second amplifier sets” achieve “first and second native gain modes”.
C) in part (ii) it is unclear whether the “photosensitive areas” are the same as the “photosensitive layer”.
D) in part (v) the structure encompassed by “WDR logic” is not clear, nor is it clear what structure or method steps are required by the various “readout techniques” recited in the claim.
E) in part (v) it is unclear whether the ADCs are the same or different than the ADCs recited in part (iv).
Examiner’s Note #1: Regarding part (A), the Examiner recommends either:
reducing the limitations at issue to a single x-ray imaging environment with a clear establishment of x-ray dose or photon count (such as dental x-rays, which seems to be the environment in which the invention was developed);
deleting the limitations at issue and establishing a clear threshold x-ray flux or photon count; or
dropping the limitation entirely and focusing on the inventive structure and/or function of the detector that improves detector sensitivity over the prior art. As currently claimed, the limitations at issue do not distinguish over the prior art if the rest of the structures and functions are disclosed or rendered obvious.
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.
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.
Claims 1, 2, 7, 11-13, 16, 21, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over (US 5,464,984) in view of Saito (US 2024/0085353 A1).
Regarding claim 1, Cox discloses an imaging method (Figs.11-19), including:
a) causing an x-ray beam to travel from an emitter through an examination area;
b) receiving the x-ray beam at a detector after having passed through the examination area (for medical imaging, col.4, lines 1-7);
c) transforming the received x-ray beam into light using the detector (via scintillator 530);
d) transforming the light into electrical signals using the detector (via photosensitive layer 540);
e) transforming the electrical signals into data representative of digital images corresponding to the examination area using the detector (via circuitry 560, 620, 730); and
f) transmitting the data representative of digital images from the detector to a computing device for displaying the digital images to a user (col.13, lines 24-32); where
g) the detector includes:
i) a collector having a stacked, back-illuminated sensor having a photosensitive layer 540 and a plurality of wiring layers 560,620,730 disposed behind the photosensitive layer 540 relative to a direction of travel of the light (Figs.11-15), where the collector is configured to collect the light at the photosensitive layer 540 without the light first passing through any of the plurality of wiring layers 560,620,730, and the photosensitive layer 540 is configured to transform the collected light into the electrical signals; and
ii) the wiring layers 560,620,730 having stacked substrates attached together, each substrate having one or more processing circuits, where the processing circuits are configured to transform the electrical signals into the data corresponding to the digital images, including amplifier circuits 410 configured to amplify the electrical signals and one or more ADCs 706 configured to digitize samples of the amplified electrical signals for single or parallel multiple sampling readout (col.13, lines 8-14).
Further regarding claim 1, Cox does not specifically disclose that the amplifier circuits include first and second amplifier circuits, the first amplifier circuit applying a first gain and the second amplifier circuit applying a second gain different from the first gain, where the first and second amplifier circuits amplify the electrical signals transformed by the photosensitive layer by applying the first gain or the second gain according to a selected gain mode.
Saito teaches the practice of providing an x-ray detector (Fig.1) having first and second amplifier circuits for selectively amplifying electrical signals from a photosensitive layer of the x-ray detector, the first amplifier circuit 41A applying a first gain and the second amplifier circuit 41B applying a second gain different from the first gain, where the first and second amplifier circuits 41A,B amplify the electrical signals from the photosensitive layer by applying the first gain or the second gain according to a selected gain mode 51. In this manner, the dynamic range of the detector is dramatically improved by selectively amplifying the electrical signal based on the anticipated x-ray signal level such that the amplified signal remains within the acceptable range of downstream components (ADC) in order to avoid saturation. This enables the ability of the apparatus to be effective in a wider range of applications (par.0038).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to have first and second amplifier circuits, the first amplifier circuit applying a first gain and the second amplifier circuit applying a second gain different from the first gain, where the first and second amplifier circuits amplify the electrical signals transformed by the photosensitive layer by applying the first gain or the second gain according to a selected gain mode in order to significantly improve the dynamic range of the detector for improved precision and versatility, as taught by Saito.
With respect to claim 2, Cox further discloses that the photosensitive layer 540 includes a CCD or CMOS architecture (par.0037).
With respect to claim 7, Cox further discloses that the collector has a pixel size from 0.001 microns to 500 microns (center-to-center pixel pitch of 50 to 100 microns: col.9, lines 54-57).
With respect to claim 11, Cox further discloses that the imaging method is used in indirect radiography in which the detector includes a scintillator 530.
With respect to claim 12, Cox anticipates the claim at least because the limitations are, at best, product-by-process limitations (the claims are directed to “an imaging method” and not to a method of manufacture), where the resulting structure of electrically and mechanically stacked substrates containing the wiring layers is the result.
With respect to claim 13, Cox anticipates the claim at least because the limitations are, at best, product-by-process limitations (the claims are directed to “an imaging method” and not to a method of manufacture), where the resulting structure of electrically and mechanically stacked substrates containing the wiring layers is the result.
Further, Cox does disclose butted wafers (Fig.17).
With respect to claim 16, Cox further discloses that the plurality of wiring layers 560,620,730 is oriented behind one or more photosensitive areas 540 in the direction of travel of the light within the detector (backlit, Figs.13 and 15-19).
With respect to claim 21, Cox further discloses that the detector includes one or more FPGAs 774 for transmitting the data representative of digital images from the detector for display of the digital images to a user on a computing device (via connector 775).
With respect to claim 23, Cox further discloses that the computing device is a PC (PC interface 709; see col.13, lines 8-33, and/or col.16, lines 28-32).
With respect to claim 26, Cox further discloses aiming the light to the photosensitive areas 560 of the collector within the detector (fiber optic plate: col.8, lines 32-37).
Claims 3, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cox and Saito, as applied to claim 1 above, in view of Saliba (US 2020/0379131 A1).
With respect to claims 3, 8 and 9, Cox does not specifically disclose one of the recited x-ray converters. Cox utilizes scintillators available at the time.
However, the skilled artisan is well aware of the growing prevalence of scintillators utilizing metal-halide perovskites in particular, and of quantum-dot scintillators in general.
As evidence of this, Saliba teaches the practice of using halide perovskites and/or quantum-dot perovskites (see at least pars.0042, 0046 and 0071) for an x-ray scintillator 10 in an x-ray imaging system (Fig.2A) in order to provide the superior quantum efficiency and x-ray stopping power that quantum-dot scintillators and perovskite-based scintillators are known.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to use a quantum-dot perovskite scintillator in order to improve the x-ray conversion efficiency over traditional scintillators, as taught by Saliba.
Claims 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Saito and of Wakabayashi et al. (IEEE Feb.2015, see IDS filed 8/8/2024).
With respect to claim 17, Cox and Saito, as applied to claim 1, further discloses:
h) DRAM (buffers 773);
i) WDR logic (first and second amplifier circuits and corresponding logic, as taught by Saito);
j) readout circuitry (800, 772, 773 and/or 774);
k) ADCs 772 which necessarily include clocks or synch with external clocks;
l) CMS effects readout circuits (800, 772, 773 and/or 774); and
m) frame buffers 773.
Further regarding claim 17, Cox does not specifically disclose a DAC, nor does Cox disclose that the ADCs include the particular clock as claimed.
Wakabayashi et al. teaches the practice of providing CMS circuits including a DAC (Figs.1 and 8) for providing the necessary data interfaces between digital and analog components, and further including ADCs having SLVS interfaces and driven by embedded clocks (SLVS-EC) in order to improve readout speeds with improved precision (Fig.10).
Wakabayashi does not specifically disclose a DDR-SSC clock; however, such clocks are also known in digital image sensors, used in tandem with ADCs, in order to further improve the precision of the digital conversion through the superior clocking.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to further have CMS circuits including DACs for providing the necessary data interfaces between digital and analog components, and for including ADCs having SLVS interfaces and DDR-SSC clocks for improved digital conversion precision for improved image quality, as taught by Wakabayashi and as recognized by one of ordinary skill in the art.
With respect to claim 22, Cox does not specify the details of the clocks corresponding to the ADCs.
Wakabayashi teaches the practice of providing CMS circuits including ADCs having SLVS interfaces and driven by embedded clocks (SLVS-EC) in order to improve readout speeds with improved precision (Fig.10).
Wakabayashi does not specifically disclose a DDR-SSC clock; however, such clocks are also known in digital image sensors, used in tandem with ADCs, in order to further improve the precision of the digital conversion through the superior clocking.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to further have ADCs having SLVS interfaces and DDR-SSC clocks for higher-precision digital conversion for improved image quality, as taught by Wakabayashi and as recognized by one of ordinary skill in the art.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Saito, as applied to claim 1 above, in view of Kato (US 2017/0150932 A1).
With respect to claim 18, Cox does not specifically disclose that the photosensitive areas are SPAD arrays.
Kato teaches the practice of providing SPAD arrays for improved detection efficiency of low-intensity or single-photon x-rays in order to reduce the dose to the patient and to enable and/or improve energy discrimination for improved tissue contrast in the diagnostic image .
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to use SPAD arrays in order to reduce the dose to the patient and improve diagnostic capabilities.
With respect to claim 19, Kato further teaches that the SPAD arrays include a bit counter 81 in order to enable precise counting of the photons.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to use SPAD arrays with bit counters in order to reduce the dose to the patient and improve diagnostic capabilities.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Saito and Kato, as applied to claim 19 above, in view of Yin (US 2020/0018642 A1).
With respect to claim 20, Cox/Kato does not specifically disclose a TDC.
Yin teaches the practice of including a TDC for a SPAD imaging array in order to improve temporal resolution for reduced artifact imaging.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox/Kato to include a TDC in order to improve diagnostic image quality.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Cox and Saito, as applied to claim 26 above, in view of Ueki (US 2008/0279330 A1).
With respect to claim 27, Cox does not specifically disclose a microlens array. Cox teaches an optical fiber plate.
Ueki teaches the routine practice of using either a fiber optic plate or a microlens array for efficiently focusing scintillation light to photosensitive areas of a detector (par.0057).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Cox to use a microlens array as a functionally-equivalent substitution, according to known tradeoffs and subject to availability and cost constraints, with a reasonable expectation of success and without undue experimentation.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Saito, Saliba, and Wakabayashi et al., as applied to the above corresponding claims (1, 3, 8, 9, 17 and 21), for the same reasons, motivations and advantages taught by the prior art and/or as known to one of ordinary skill in the art.
The only remaining limitation is that Cox anticipates “the one or more emitters having a focal spot size within the range of 0.001 microns through 3 mm.” This represents substantially the entire known range of focal spot sizes in medical imaging, the lower end is questionably unfeasible with commercially available medical x-ray tube technology. Regardless, the staggering breadth of the limitation guarantees anticipation by the prior art.
Response to Arguments
Applicant's arguments with respect to the 35 USC 112 rejections of record have been fully considered but they are not persuasive. Although the present amendments to the claims have overcome some issues, others remain, and new issues have been raised. The manner in which the rejection of claim 1 has been written provides a template that resolves all of the issues.
For other issues, for example, the recitations of readout types, such limitations are not clear functions nor positively-set forth method steps insofar as the steps or structures required to effect the recited desired results are not established. The scope of the claims cannot be ascertained by one of ordinary skill in the art.
Applicant's arguments with respect to the 35 USC 103 rejections over Cox in view of various prior art references have been fully considered but they are not persuasive. Particularly regarding claim 1, although the claims do not clearly set forth the nature of the dual native gain, the subsequent rejection establishes the best understanding of the examiner. Specifically, the assigning of first and second gains to the first and second amplifier, respectively, where the first and second gains are different, and that the gain is selectable by switching between one or the other of the first and second amplifiers according to a predetermined gain mode.
With this understanding, the Examiner agrees that Soh does not teach such an arrangement. However, Saito teaches such an arrangement in an X-ray detector in order to dramatically improve the dynamic range of the detector, and thus the usefulness of the detector in a wider range of analyses.
Examiner’s Note #2: In general, the inventive concept is not clear from the claims. The long “laundry lists” of specific, well-known scintillators, optics, photoelectric converters, ICs, bonding methods, etc., obscure the inventive concept. The skilled artisan is going to use known materials, architectures, circuitry and manufacturing methods, weighing the known advantages and drawbacks of each, in order to implement an inventive concept. The current stage of prosecution is basically a “whack-a-mole” situation where the laundry lists get smaller, but are no less obvious, to one of ordinary skill with a reasonable expectation of success and without undue experimentation. Prosecution patterns like this rarely advance toward inventive subject matter.
What is the inventive concept? What does the claimed detector do to the x-rays, scintillation light, and/or electrical signals that improves the detector sensitivity to x-rays over the prior art? What particular structure, or arrangement thereof, and/or steps, enables that improvement? Combinations of known elements may be patentable, particularly if there is a secondary consideration that may apply, such as establishing a long-felt need, establishing that the combination of features required going beyond the level of routine experimentation in order to function as a whole or to physically integrate, etc.
The Background of the Specification suggests that the invention is actually an intraoral photon-counting x-ray detector having flexible readout capabilities and a wide dynamic range (with the first and second amplifiers as noted in the above rejection of claim 1), including enabling processing. That could be novel. The Examiner has seen very few photon-counting detectors in dentistry, much less such detectors having the presumed a wide dynamic range and the enabling electronics in one ergonomic package for intraoral use. The prior art applied thus far represent standard-format medical imaging detectors (arm, chest, etc.), where there is room for every sort of x-ray downconverter, photosensitive architecture, readout architecture, data processing…, all packaged using known manufacturing methods. Claiming that the detector is configured for intraoral x-ray digital imaging makes various parameters clear – it specifies a size without resorting to concrete dimensions or limiting manufacturing steps, and it establishes the general x-ray dose environment without resorting to x-ray tube parameters or anything beyond the detector itself.
Whatever the inventive concept is, it lies with the detector.
The Examiner strongly recommends an interview at this stage of prosecution, prior to the filing of an After-Final response, RCE, or Appeal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US patent documents to Morton teach a dual-amplifier readout architecture; however, the amplifiers have identical gain, where the architecture is for essentially doubling the readout speed of the detector; and the remaining newly-cited prior art describes perovskite scintillator technologies.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm.
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, David Makiya can be reached on 571.272.2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884
