DETAILED ACTION
This Office action is responsive to communications filed on 02/17/2026. Claims 1, 3-4, 7-8, 15, 17-18 have been amended. Claim 10 is canceled. Claims 19-20 newly added. Presently, Claims 1-9, 11-20 remain pending and are hereinafter examined on the merits.
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 .re
Response to Arguments
Previous objections to the Drawings are withdrawn in view of the amendments filed on 02/17/2026.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 02/17/2026.
Previous claim objections are withdrawn in view of the amendments filed on 02/17/2026.
The Applicant’s arguments with respect to rejections under 35 USC § 101 have been fully, considered, but are not persuasive.
Firstly, the Applicant cites the August 2025 Deputy Commission Memorandum for the principles that examiners should not exceed the mental process category to limitation that cannot practically be performed in the human mind. In response, the memo was only intended as a reminder with respect to the emerging technologies. This reminder memo is not intended to announce any new practice or procedure and is meant to be consistent with existing guidance. The Examiner agrees with these principles outlined by the reminder memo and is applied herein.
The Applicant argues that claim does not recite a mental process because a human mind cannot generate a control signal to adjust optical settings of a surgical imaging device. This argument is not persuasive because the abstract idea resides in the recitation of “determining a working time of an imaging agent”, see the rejection below, as the mental process. The claim does not recite any particular manner of determining the working time, any specific algorithm or calculation, or any process that cannot be performed mentally. A person can determined elapsed or working time after administration of an imaging agent in view of how its recited in the claim. The additional recitation of outputting an indicator and outputting a control signal based on that time does not remove the mental process nature of the determining limitation; rather, those outputs steps were considered as additional elements that do not place the judicial exception into a practical application, considered at STEP 2A, Prong Two, see the rejection below.
Applicant also argues that amended claim 1 requires a “surgical device [...]”. The argument is not commensurate within the language presented. Claim 1 is directed to a “timer for a surgical imaging device” not the surgical imaging device itself. Its just a tool used for obtaining data collection. There is no particular improvement in surgical imaging technology by stating claim 1 has a surgical imaging device.
Applicant’s Step 2A, Prong Two, arguments are also not persuasive. The claim recites outputting a control signal for controlling optical settings, “based on” working time. The phrase based on provides zero meaningful limit on the judicial exception. The claims as a whole even claim 19-20 provide not specifics for how it is controlled any particular manner, or specific technological improvement to surgical imaging device or imaging devices. The claims therefore do no tie the alleged time determination to a particular technological solution that’s solves a technological problem. Hence the claims do not ties the alleged time determination to a particular technological solution in the manner of the cases relied upon by the Applicant. The present claims recite the result of the controlling optical settings at a high level of generality.
Applicants regarding the concern of biological decay, fading of the imaging agent, degradation of image quality, etc, are not reflected in the claims. These alleged advantages may described intended benefits but they are not reflected in the claims. The claim broadly covers outputting a control signal based on working time without required compensation for fading, clearance, signal decay, or image degradation.
The Applicant’s reference to claim 19 and claim 20 is also not persuasive with respect to the present rejection of claim 1. The claims do not specify how the optical settings are adjusted. These claims merely provide the intended results of compensating for clearance or signal decay without reciting a particular technical implementation for achieving that result.
Furthermore, regarding the Applicant argument asserting if a 35 USC § 103 rejection does not teach a claimed limitation it overcomes the 35 USC § 101. This is not persuasive. A 35 USC § 103 allegedly not teaching a feature does not overcome a 35 USC § 101 rejection. The test for 35 USC § 101 and 35 USC § 103 is separate.
The amendments filed on 02/17/2026, have changed the scope of the invention. Accordingly, applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely Proksa et al (US 2014/0121510 A1) alone applied in the prior 35 USC § 102 rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1) rejected under 35 USC § 103.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 11, “[[an]]the output”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-9, 11-13, 19-20 are directed to an “apparatus” which describes one of the four statutory
categories of patentable subject matter, i.e., a machine.
Claim 14-17 is directed to an “apparatus” which describes one of the four statutory categories of
patentable subject matter, i.e., a machine.
Claims 18 are drawn to a “non-transitory computer-readable medium” which describes one of the
four statutory categories, i.e., a manufacture.
2. Step 2A of the subject matter eligibility test (see MPEP 2106.04).
a. Prong One:
i. Claim 1 recite (“sets forth” or “describes”) the abstract idea of “a mental process”
(MPEP 2106.04(a)(2).III.), substantially as follows:
“determining a working time of an imaging agent”
According the same applies to claim 18 for substantially identical recitation recited in the claim.
In claim 1, (claims 14 and 18 depend from claim 1 but introduce statutory matter (“A surgical
imaging device”-claim 14, “A non-transitory computer readable medium”-Claim 18), the above recited
steps can be practically performed in the human mind to perform the steps. Determining a working time of
an imaging agent as its recited merely constitutes a mental evaluation of information. Specifically,
recognizing when the agent was administered, mentally calculating the passage of time, and identifying
when that time reaches a point of interest. The claims as written don’t preclude this. There is nothing
recited in the claim to suggest an undue level of complexity in how the determining is done. Therefore,
the phrase is indeed abstract.
b. Prong Two: Claims 1, 14, 18 do not include additional elements that integrate the mental
process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims
recites (1) additional steps of a timer for surgical device-(claim 1), “a trigger to activate the timer or
activate a recorder, the trigger being at least one of: operationally coupled to a port for administrating the
imaging agent, user actuatable, or actuatable by detection of fluorescence at an imaging site.”-claim 14,
“A non-transitory, computer-readable medium comprising a program code that, when the program code is
executed on a processor, a computer, or a programmable hardware component, causes the processor,
computer, or programmable hardware component to perform to operate the timer of claim 1”-claim 18;
and (2) further an addition step of output[ing] an indicator based on the working time-claim 1 & 18, and
output a control signal for controlling optical setting of the surgical imaging device based on the workflow-
claim 1 & 18.
. The steps in (1) represent merely data gathering or pre-solution activities that are necessary for
use of the recited judicial exception and are recited at a high level of generality with conventionally used
tools (see below Step IIB for further details). Data gathering and mere instructions to implement an
abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP
2106.05 (f and g)).Regarding the processor language written at such a high level of generality of
structural limitations, the processor language amounts to a generic computer component with mere
instructions to implement the abstract idea on a computer.
The step in (2) represents merely notification outputting by the abstract idea as a post-solution
activity and is recited at a high level of generality. It is noted that the limitation “output a control signal for controlling optical settings of the surgical imaging device based on the working time” does not recite any active or positive limitation of controlling optical settings based on the working time. Rather, the claim recites the limitation of outputting a control signal for controlling optical settings (i.e., with the future intent to control optical settings). The limitation is therefore considered mere post-extra solution activity recited at a very high level of generality.
As a whole, the additional elements merely serve to gather and feed information to the abstract
idea and to output a notification based on the abstract idea, while generically implementing it on
conventionally used tools. There is no practical application because the abstract idea is not applied, relied
on, or used in a meaningful way. No improvement to the technology is evident, and the estimated time
information is not outputted in any way such that a practical benefit is realized. Therefore, the additional
elements, alone or in combination, do not integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical
application because it does not impose any meaningful limits on practicing the abstract idea. Further,
there is no evidence of record that would support the assertion that this step is an improvement to a
computer or technological solution to a technological problem. Ultimately, the Applicant’s describe
improvement in the process of using timing contrast agent techniques, but this is not an improvement in
the function of a computer or other technology (See MPEP 2106.05(a)(ii); “the court determined that the
claimed user interface simply provided a trader with more information to facilitate market trades, which
improved the business process of market trading but did not improve computers or technology”; See
MPEP 2106.04(d)(1); 2106.05(a); and 2106.05(f)). The claims are directed to the abstract idea. Also,
there does not appear to be any particular structure or machine, treatment or prophylaxis, transformation,
or any other meaningful application that would render the claim eligible at step 2A, prong 2.
3.Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 14, 18 do not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above, the claims recite additional steps of a trigger to
activate the timer. These steps represents mere data gathering, data outputting or pre/post/extra-solution
activities that are necessary for use of the recited judicial exception and are recited at a high level of
generality. Furthermore, as discussed above, limitations with respect to the processor languages/terms,
respectively, amount to mere instructions to implement the abstract idea on a computer. As discussed
with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than
insignificant extra solution activity and mere instructions to apply the exception using a generic computer
component. The same analysis applies here in 2B and does not provide an inventive concept. The data
gathering steps that were considered insignificant extra-solution activity in Step 2A Prong Two, have
been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the
field.
As an evidence, Spiker et al (US 8,565,044) discloses:
[Col 5 l.30-35], ‘The timing mechanism 22, timer control 24, remaining time indicator 25, and
power supply 50 features of timer 20 comprise a digital timer which is well known in the art. Timing
mechanism 22 is a microprocessor which receives a time set input from timer control 24. Control buttons
26 of timer control 24 permit a user to set a desired period of time’
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when
viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
4.Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, recite
to an abstract idea for similar reasons and are not eligible:
i.(Claim 2) defining, wherein the working time is at least one of: a start time at which a signal from the imaging agent is observable at an imaging site, or an end time at which the imaging agent is cleared.
ii. (Claim 5) defining, wherein the working time is based on at least one of: patient information, optical settings, instrumental parameters, dose of the imaging agent, agent administration time, agent administration type, or the imaging agent.
iii.(Claim 7) defining, wherein the timer is configured such that: the working time is
determined by multiple linear regression based on at least one of: a signal arrival time, a
duration of signal, an end of signal time, patient information, optical settings, instrumental
parameters, dose of the imaging agent, imaging agent administration time, or imaging
agent administration type.
iv. (Claim 8) defining, wherein the multiple linear regression is based on a combination of at
least: the dose of the imaging agent, the imaging agent administration time, and the
patient information.
v. (Claim 13) defining, further configured to determine the working time by a machine
learning algorithm.
The following dependent claims merely further describe the extra-solution activities and therefore,
do not amount to significantly more than the judicial exception or integrate the abstract idea into a
practical application for similar reasons and are not eligible:
(Claim 3) defining, wherein the indicator is a countdown timer showing at least one of a
first duration until the start time or a second duration until the end time; wherein the first duration is an expected duration of time for the imaging agent to travel from a point of introduction to the imaging site.
ii. (Claim 4) defining, wherein the countdown timer is configured to show the first duration until the start time, and, subsequently, the second duration until the end time.
iii. (Claim 6) defining, wherein the imaging agent is indocyanine green or fluorescein
sodium.
iv. (Claim 9) defining, further configured to at least one of: output a start recording signal for
documenting a surgical procedure, the start recording signal being based on a start time of
the working time; or output an end recording signal, the end recording signal being based
on an end time of the working time.
v. (Claim 11) defining, further comprising: at least one processor, and an output.
vi. (Claim 12) defining, further comprising a detector configured to detect an arrival of the
imaging agent at an imaging site.
vii. (Claim 15) defining, wherein the working time is at least one of: a start time at which a
signal from the imaging agent is observable at [[an]]the imaging site, or an end time at
which the imaging agent is cleared; wherein the indicator is a countdown timer showing at
least one of a first duration until the start time or a second duration until the end time;
wherein the timer is configured: to output a control signal for controlling optical settings of
the surgical imaging device; and to detect an imaging agent that is administered by
injection at a point of introduction which is remote from the imaging site; wherein the first
duration is an expected duration of time for the imaging agent to travel from [[a]]the point
of introduction to the imaging site.
viii. (Claim 16) defining, further comprising a display for displaying the indicator, the display
couplable with an eyepiece of the surgical imaging device.
ix. (Claim 17) defining, wherein the surgical imaging device is a near-infrared fluorescence
microscope, comprising a recorder for recording a surgical procedure.
x. (Claim 19) defining, wherein the control signal is configured to adjust at least one optical
setting of the surgical imaging device to compensate for a determined clearance of the
imaging agent, wherein the determined clearance corresponds to an end time of the
working time at which the imaging agent is cleared.
xi. (Claim 20) defining, wherein the control signal is configured to adjust the at least one
optical setting by increasing at least one of: a brightness of an excitation source, an
exposure time, or a detector gain.
For Claims (3-4, & 16) The Examiner agrees displaying information on a monitor cannot
performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical
application either. It is merely an insignificant post-solution activity. In addition, the abstract idea is not
applied, relied on, or used in a meaningful way. No improved to the technology is evident, and the
determined visualization of context is not outputted in any way such that the practical benefit is realized.
For Claims (3-4, 6, 9, 12, & 15-17, 19-20) The data gathering steps and pre/post-solution activity/
insignificant extra solution activity are conventional and recited at high level of generality. As such, the
abstract idea is not applied, relied on, or used in a meaningful way. No improved to the technology is
evident, and the determined visualization of context is not outputted in any way such that the practical
benefit is realized.
Taken alone and in combination, the additional elements do not integrate the judicial exception
into a practical application at least because the abstract idea is not applied, relied on, or used in a
meaningful way. They also do not add anything significantly more than the abstract idea. Their collective
functions merely provide computer/electronic implementation and processing, and no additional elements
beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that
is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology
other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being
directed to non-statutory subject matter.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claims 1, 5-6, 11-12, 14, & 18-20 are rejected under 35 U.S.C. 103 as being unpatentable Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1).
Claim 1: Proska discloses, A timer (310, FIG. 3-4) for a surgical imaging device (201-radiation imaging device, FIG. 2, ¶0019-0020), configured to:
determine a working time of an imaging agent; and output an indicator for display based on the working time; and
-Proska discloses timer 310 is utilized to measure a time duration from the administration of a photo-acoustic contrast material to the identification of its presence in the tissue of interest, ¶0033, Claim 19. This measured time duration is conveyed by the timer 310 to the console 220. The console 220 serves as an operator console and includes a human readable output device such as a monitor or display, ¶0025, ¶0033, ¶0035, ¶0060-0063. Conveying the duration information directly to the console equipped with a display/monitor constitutes that the time duration is available for display as an indicator. The time duration (i.e., working time) is used to initiate a subsequent contract enhance CT scan involving a different agent, Claim 19, ¶0064.
Proska fails to disclose:
further configured to: output a control signal for controlling optical settings of the imaging device based on the working time.
However, Dobashi in the context of fluorescent imaging discloses, further configured to: output a control signal for controlling optical settings of the imaging device based on the working time. (¶Abstract, ¶0006, the imaging device automatically adjust exposure setting to compensate for the changing concentration and loss of the fluorescent agent over time. Specifically, the apparatus of Dobashi uses an exposure determination and control means to adjust the light emission intensity of the imaging pickup light source and the fixed gain of the image pick-up elements, ¶¶0019-0020, ¶¶0054-0056. After an initial peak, the fluorescent illumination decreases during the middle phase of contract, which ends with a loss of the agent, ¶¶0005-0006. To compensate for this fading brightness as the agent dissipates, the apparatus uses a timer to track the elapsed time since the fluorescent agent was infused and calculated the fluorescent illumination curve, ¶0052, ¶¶0054-0055, FIG. 7-8. When the fluorescent illuminance drops past its maximum value, the system increases the image pickup illumination light intensity, and once that reaches a maximum, it increase the gain values to ensure a high-resolution, low noise image, ¶0057. See also ¶¶0022-0023, ¶¶0059-0061.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the timer of Prosk to be configured to include the teachings of the timer of Dobashi. The motivation to do this yield predictable results such as to ensure a high-resolution, low noise image, as suggested by Dobashi, ¶0057. The modified combination would disclose outputting the control signal for controlling optical settings of the surgical imaging device of Proska based on the working time.
Claim 5: Proska as modified discloses all the elements above in claim 1, Proska discloses, wherein the working time is based on at least one of: patient information, optical settings, instrumental parameters, dose of the imaging agent, agent administration time, agent administration type, or the imaging agent.
-Proska disclose that the working time (i.e., time duration0 is based on the agent administration, and the imaging agent itself, and instrumental parameters used for detection, ¶0028-0029, ¶0032-0033, Claim 6-7, Claim 10-12, Claim 19-20.
Claim 6: Proska as modified discloses all the elements above in claim 5, Proska discloses, wherein the imaging agent is indocyanine green or fluorescein sodium.
-Proska disclose that the teaching agent is indocyanine green, ¶0028, Claim 10.
Claim 11: Proska as modified discloses all the elements above in claim 1, Proska discloses, further comprising: at least one processor (¶0025-0027, ¶0065-0066), and an output (¶Abstract, ¶0008, ¶0025, ¶0032-0033, Claim 1-3).
Claim 12: Proska as modified discloses all the elements above in claim 1, Proska discloses, further comprising a detector (receiver 304) configured to detect an arrival of the imaging agent at an imaging site (¶0031-0032).
Claim 14: Proska discloses, A surgical imaging device (201-radiation imaging device, FIG. 2, ¶0019-0020), comprising the timer (timer 310) of claim 1, and
a trigger to activate the timer (¶0033) or activate a recorder, the trigger being at least one of:
operationally coupled to a port for administrating the imaging agent (¶0023-0024, ¶0033),
user actuatable, or
actuatable by detection of fluorescence at an imaging site (¶0028-0029, ¶0030-0033).
Claim 18: Proska discloses, A non-transitory, computer-readable medium comprising a program code that, when the program code is executed on a processor, a computer, or a programmable hardware component, causes the processor, computer, or programmable hardware component to perform to operate the timer (310, FIG. 3-4) of claim 1, according to a method comprising: (¶0010, ‘a computer readable instructions encoded on computer readable medium, which, when executed by a processor of a computing system causes the processor to: trigger a scan of a region of interest based on an identification of a presence of a photo-acoustic agent in the region of interest.’; Claim 20: ‘A computer readable storage medium encoded with one or more computer executable instructions, which, when executed by a processor of a computing system causes the processor to: trigger a scan of a region of interest based on an identification of a presence of a photo-acoustic agent in the region of interest.’, see also ¶0065-0066)
determining the working time of the imaging agent, outputting the indicator based on the working time.
-Proska discloses timer 310 is utilized to measure a time duration from the administration of a photo-acoustic contrast material to the identification of its presence in the tissue of interest, ¶0033, Claim 19. This measured time duration is conveyed by the timer 310 to the console 220. The console 220 serves as an operator console and includes a human readable output device such as a monitor or display, ¶0025, ¶0033, ¶0035, ¶0060-0063. Conveying the duration information directly to the console equipped with a display/monitor constitutes that the time duration is available for display as an indicator. The time duration (i.e., working time) is used to initiate a subsequent contract enhance CT scan involving a different agent, Claim 19, ¶0064.
Proska fails to disclose:
and outputting the control signal for controlling optical settings of the imaging device based on the working time.
However, Dobashi in the context of fluorescent imaging discloses, further configured to: output a control signal for controlling optical settings of the imaging device based on the working time. (¶Abstract, ¶0006, the imaging device automatically adjust exposure setting to compensate for the changing concentration and loss of the fluorescent agent over time. Specifically, the apparatus of Dobashi uses an exposure determination and control means to adjust the light emission intensity of the imaging pickup light source and the fixed gain of the image pick-up elements, ¶¶0019-0020, ¶¶0054-0056. After an initial peak, the fluorescent illumination decreases during the middle phase of contract, which ends with a loss of the agent, ¶¶0005-0006. To compensate for this fading brightness as the agent dissipates, the apparatus uses a timer to track the elapsed time since the fluorescent agent was infused and calculated the fluorescent illumination curve, ¶0052, ¶¶0054-0055, FIG. 7-8. When the fluorescent illuminance drops past its maximum value, the system increases the image pickup illumination light intensity, and once that reaches a maximum, it increase the gain values to ensure a high-resolution, low noise image, ¶0057. See also ¶¶0022-0023, ¶¶0059-0061.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the timer of Prosk to be configured to include the teachings of the timer of Dobashi. The motivation to do this yield predictable results such as to ensure a high-resolution, low noise image, as suggested by Dobashi, ¶0057. The modified combination would disclose outputting the control signal for controlling optical settings of the surgical imaging device of Proska based on the working time.
Claim 19: Proska as modified discloses all the elements above in claim 1, Proska fails to disclose wherein the control signal is configured to adjust at least one optical setting of the surgical imaging device to compensate for a determined clearance of the imaging agent, wherein the determined clearance corresponds to an end time of the working time at which the imaging agent is cleared.
However, Dobashi is relied upon discloses, wherein the control signal is configured to adjust at least one optical setting of the surgical imaging device to compensate for a determined clearance of the imaging agent, wherein the determined clearance corresponds to an end time of the working time at which the imaging agent is cleared. (¶Abstract, ¶0006, the imaging device automatically adjust exposure setting to compensate for the changing concentration and loss of the fluorescent agent over time. Specifically, the apparatus of Dobashi uses an exposure determination and control means to adjust the light emission intensity of the imaging pickup light source and the fixed gain of the image pick-up elements, ¶¶0019-0020, ¶¶0054-0056. After an initial peak, the fluorescent illumination decreases during the middle phase of contract, which ends with a loss of the agent, ¶¶0005-0006. To compensate for this fading brightness as the agent dissipates, the apparatus uses a timer to track the elapsed time since the fluorescent agent was infused and calculated the fluorescent illumination curve, ¶0052, ¶¶0054-0055, FIG. 7-8. When the fluorescent illuminance drops past its maximum value, the system increases the image pickup illumination light intensity, and once that reaches a maximum, it increase the gain values to ensure a high-resolution, low noise image, ¶0057. See also ¶¶0022-0023, ¶¶0059-0061.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the timer of modified Prosk to be configured to include the teachings of the timer of Dobashi. The motivation to do this yield predictable results such as to ensure a high-resolution, low noise image, as suggested by Dobashi, ¶0057.
Claim 20: Proska as modified discloses all the elements above in claim 19, Proska fails to disclose wherein the control signal is configured to adjust the at least one optical setting by increasing at least one of: a brightness of an excitation source, an exposure time, or a detector gain.
However, Dobashi is relied upon discloses, wherein the control signal is configured to adjust the at least one optical setting by increasing at least one of: a brightness of an excitation source, an exposure time, or a detector gain. (¶Abstract, ¶0006, the imaging device automatically adjust exposure setting to compensate for the changing concentration and loss of the fluorescent agent over time. Specifically, the apparatus of Dobashi uses an exposure determination and control means to adjust the light emission intensity of the imaging pickup light source and the fixed gain of the image pick-up elements, ¶¶0019-0020, ¶¶0054-0056. After an initial peak, the fluorescent illumination decreases during the middle phase of contract, which ends with a loss of the agent, ¶¶0005-0006. To compensate for this fading brightness as the agent dissipates, the apparatus uses a timer to track the elapsed time since the fluorescent agent was infused and calculated the fluorescent illumination curve, ¶0052, ¶¶0054-0055, FIG. 7-8. When the fluorescent illuminance drops past its maximum value, the system increases the image pickup illumination light intensity, and once that reaches a maximum, it increase the gain values to ensure a high-resolution, low noise image, ¶0057. See also ¶¶0022-0023, ¶¶0059-0061.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the timer of modified Prosk to be configured to include the teachings of the timer of Dobashi. The motivation to do this yield predictable results such as to ensure a high-resolution, low noise image, as suggested by Dobashi, ¶0057.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 1, in further view of Korporall et al (US 11,857,356 B2).
Claim 2: Modified Proska discloses all the elements above in claim 1, Proska fails to explicitly disclose, wherein the working time is at least one of: a start time at which a signal from the imaging agent is observable at an imaging site, or an end time at which the imaging agent is cleared.
However, Korporall in the context of acquiring data and signaling the start and end of administration of a contrast medium in temporal relation to the scan for acquiring data discloses, wherein the working time is at least one of: a start time at which a signal from the imaging agent is observable at an imaging site, or an end time at which the imaging agent is cleared.
-Korporall discloses “a start time at which a signal form the imaging agent is observable at an imaging site” by defining the characteristic time interval ΔT (a first duration) as the time difference between the point of signal the start of manual contrast administration and the arrival of the contrast agent at a predefined position in the body (ROI), [Col 4 l.21-64], [Col. 6 l.52-55], Claim 20 & 33. This arrival is determined when a defined threshold value such as attenuation value, gray level, CT value, or signal level is attained at the imaging site during a monitoring scan (i.e., a start time at which a signal from the imaging agent is observable at an imaging site), Claim 20 & 33, [Col 1 l.40-56], [Col 5 l.11-21], [Col 6 l.5-15], [Col 6 l.40-66].
-Korporall disclose “or an end time at which the imaging agent is cleared.” (i.e., determining an end time for the contrast administration), This end time is calculated to ensure contrast administration stops at a point when the contrast agent injected thereafter would no longer have an effect on the image, which constitutes the agent’s clearance from the effective imaging period, [Col 1-2 l.58-66 to l.1-6], [Col 6 l.40-66],
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the working time of modified Proska in view of the known techniques and teachings of Korporall. The motivation to do this yields predictable results reducing or even minimizing the risk for patient while optimizing the contrast administration, as suggested by Korporalll, [Col 2 l.10-18]
Claim 3: Modified Proska discloses all the elements above in claim 2, Proska fails to disclose: the indicator is a countdown timer showing at least one of a first duration until the start time or a second duration until the end time; wherein the first duration is an expected duration of time for the imaging agent to travel from a point of introduction to the imaging site.
However, Korporall is relied upon above discloses, the indicator is a countdown timer showing at least one of a first duration until the start time or a second duration until the end time; wherein the first duration is an expected duration of time for the imaging agent to travel from a point of introduction to the imaging site.
-Korporall defines the characteristic time interval ΔT (a first duration) as the time difference between the point of signal the start of manual contrast administration and the arrival of the contrast agent at a predefined position in the body (ROI), [Col 4 l.21-64], [Col. 6 l.52-55], Claim 20 & 33. This ΔT is precisely a first duration that elapses for a patient between the start of the injection (the point of introduction) and the arrival of the contrast agent at the desired position in the body (i.e., ROI).
-This characteristic time interval ΔT is then used to calculate end time for ending the manual contrast injection. The apparatus of Korporall is configured to compute Ti, off such that is precedes the end of the medical image scan TE (i.e., Ti,off = TE – ΔT), Claim 3, Claim 21, Claim 28, , Claim 34, [Col 6 l.40-66], This ensures that the contrast agen injected would no longer have an effect on the image (i.e., avoidance) effectively marking the end of the contrast agent’s working time during the scan, [Col 1-2 l.58-66 to l.1-6], [Col 6 l.40-66]. Korporall specifically teaches displaying a duration related to the end time (Ti,off) derevied using the first duration ΔT. A second advanced signal is produced comprising a countdown, Claim 37-38. The second advanced before signaling the end of the manual contrast administration, Claim 33. This displayed countdown helps the user “hit the [...] end point of manual injection more closely, [Col 5 l.45-51].
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the indicator of modified Proska in view of the known techniques and teachings of Korporall. The motivation to do this yields predictable results reducing or even minimizing the risk for patient while optimizing the contrast administration, as suggested by Korporalll, [Col 2 l.10-18].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1) in view of Korporall et al (US 11,857,356 B2), as applied to claim 3, in further view of Hashimoto (US 2004/0133107 A1).
Claim 4: Proska as modified discloses all the elements above in claim 3, Proska fails to disclose, wherein the countdown timer is configured to show the first duration until the start time, and, subsequently, the second duration until the end time.
Hashimoto in the context of contrast agent protocols discloses, wherein the countdown timer is configured to show the first duration until the start time, and, subsequently, the second duration until the end time.
-Hashimoto discloses that apparatus includes a countdown display region 56 which displays the time remaining up to the scheduled time of the next operation after an operation at start of injection, ¶Abstract, ¶0083-0086. Regarding the subsequent display, Hashimoto indicates that the operation at start of injection, multiple time readouts are concurrently displayed which include elapsed time after injection, ¶Abstract, ¶0083-0086. Specifically, the elapsed time after injection the display region 55 shows the time elapsed time (i.e., until the end time). In addition, Hashimoto discloses the injection freeze countdown, which measures the time remaining until a planned freeze event. This mechanism displays the time remaining to the time a freeze operation is to be made after the operation of the start of the injection hence subsequently until the end time, ¶0086.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the countdown timer of modified Proksa such that the display of the countdown timer shows show the first duration until the start time, and, subsequently, the second duration until the end time as taught by Hashimoto. The motivation to do this yields predictable results such as eliminating the need to check a separately provided watch such that the operator can concentrate on a display screen to move ahead with diagnosis, thus improving work efficiency as suggested by Hashimoto, ¶0041.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 1, in further view of Chau et al (lEstimation of time to peak contrast enhancement of the aorta and liver for dual-phase computed tomography on the basis of contrast medium arrival time, injection duration, and injection technique in dogs. Am J Vet Res. 2016 Oct;77(10):1093-100).
Claim 7: Modified Proska discloses all the elements above in claim 1, Proska fails to disclose: wherein the timer is configured such that: the working time is determined by multiple linear regression based on at least one of: a signal arrival time, a duration of signal, an end of signal time, patient information, optical settings, instrumental parameters, dose of the imaging agent, agent administration time, or imaging agent administration type.
However, Chau in the context of estimation of time to peak contrast enhancement on the basis of contrast medium discloses, the working time is determined by multiple linear regression based on a combination of at least: the dose, the imaging agent administration time, and the patient information.
-Chau discloses that the time to peak enhancement (TPE) is representing timing of the contrast medium effectiveness estimated using a multiple linear regression based on a combination of variables, [pg 1098 left col]. Specifically, the estimate of TPE is based on three predicator variables: contrast medium arrival time, injection duration, and injection technique, [pg 1096 Statistical analysis].
-The injection duration and injection technique (agent administration time) were used in the multiple linear regression, [pg. 1097 right col]. The contrast medium arrival time is considered a physiological patent factor as it gauges the time required for contrast medium to circulate and is dependent on cardiac output (patent information), [pg 1098 left col]. The dose (dose of the imaging agent) was fixed and the regression for aortic TPE varied depending on body weight because body weight includes the required volume of contrast medium administered hence the regression is based on the dose of the imaging agent, [pg. 1095 left col last paragraph], [pg. 1097 right col], Table 2 pg 1098.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the working time of modified Proksa to be configured to be determined by multiple linear regression based on a combination of at least: the dose, the imaging agent administration time, and the patient information as taught by Chau. The motivation to do this yields predictable results such as improve the efficiency of CT, as suggested by Chau Abstract, pg 1093.
Claim 8: Proska as modified discloses all the elements above in claim 7, Proska fails to disclose: wherein multiple linear regression is based on a combination of at least: the dose of the imaging agent, the imaging agent administration time, and the patient information.
However, Chau in the context of estimation of time to peak contrast enhancement on the basis of contrast medium discloses, wherein multiple linear regression is based on a combination of at least: the dose of the imaging agent, the imaging agent administration time, and the patient information.
-Chau discloses that the time to peak enhancement (TPE) is representing timing of the contrast medium effectiveness estimated using a multiple linear regression based on a combination of variables, [pg 1098 left col]. Specifically, the estimate of TPE is based on three predicator variables: contrast medium arrival time, injection duration, and injection technique, [pg 1096 Statistical analysis].
-The injection duration and injection technique (agent administration time) were used in the multiple linear regression, [pg. 1097 right col]. The contrast medium arrival time is considered a physiological patent factor as it gauges the time required for contrast medium to circulate and is dependent on cardiac output (patent information), [pg 1098 left col]. The dose (dose of the imaging agent) was fixed and the regression for aortic TPE varied depending on body weight because body weight includes the required volume of contrast medium administered hence the regression is based on the dose of the imaging agent, [pg. 1095 left col last paragraph], [pg. 1097 right col], Table 2 pg 1098.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the working time of the timer of modified Proksa to be configured to be determined by multiple linear regression based on a combination of at least: the dose, the agent administration time, and the patient information as taught by Chau. The motivation to do this yields predictable results such as improve the efficiency of CT, as suggested by Chau Abstract, pg 1093.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1), as applied to claim 1, in further view of Tashiro (WO 2020121373 A1).
Claim 9: Modified Proska discloses all the elements above in claim 1, Proska fails to disclose, further configured to at least one of: output a start recording signal for documenting a surgical procedure, the start recording signal being based on a start time of the working time; or output an end recording signal, the end recording signal being based on an end time of the working time.
However, Tashiro in the context of image recording of contrast mediums discloses:
output a start recording signal for documenting a surgical procedure, the start recording signal being based on a start time of the working time; (¶0040-0042, ¶0045, ¶0052, ¶0054, ¶0058, ¶0062-0063, ¶0065) or
output an end recording signal, the end recording signal being based on an end time of the working time. (¶0045, ¶0051-0054, ¶0059, ¶0086)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the system of modified Proska to be configured to output a start recording signal for documenting a surgical procedure, the start recording signal being based on a start time of the working time; or output an end recording signal, the end recording signal being based on an end time of the working time as taught by Tashiro. The motivation to do this yields predictable results such as to improve the accuracy of the imaging assessment regardless of the procedure and to reliably automate recording, as suggested by Tashiro, ¶0011.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 1, in further view of Sharma et al (US 2018/0071452 A1).
Claim 13: modified Proska discloses all the elements above in claim 1, Proska fails to disclose: further configured to determine the working time by a machine learning algorithm.
However, Sharma in the context of optimizing contrast imaging of a patient discloses: further configured to determine the working time by a machine learning algorithm. (¶0101-0104, ¶0106, Claim 10)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the determined working time of modified Proska in view of the teachings of Sharma. The motivation to do this yields predictable results such as providing improvements in computer related technology as suggested by Sharma, ¶0034.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 14, in further view of Korporall et al (US 11,857,356 B2) in view of Yabugami (US 2013/0077750 A1).
Claim 15: Modified Proska discloses all the elements above in claim 14, Proska fails to disclose: wherein the timer is configured: to output a control signal for controlling optical settings of the surgical imaging device;
However, Dobashi in the context of fluorescent imaging discloses, wherein the timer is configured: to output a control signal for controlling optical settings of the imaging device; (¶Abstract, ¶0006, the imaging device automatically adjust exposure setting to compensate for the changing concentration and loss of the fluorescent agent over time. Specifically, the apparatus of Dobashi uses an exposure determination and control means to adjust the light emission intensity of the imaging pickup light source and the fixed gain of the image pick-up elements, ¶¶0019-0020, ¶¶0054-0056. After an initial peak, the fluorescent illumination decreases during the middle phase of contract, which ends with a loss of the agent, ¶¶0005-0006. To compensate for this fading brightness as the agent dissipates, the apparatus uses a timer to track the elapsed time since the fluorescent agent was infused and calculated the fluorescent illumination curve, ¶0052, ¶¶0054-0055, FIG. 7-8. When the fluorescent illuminance drops past its maximum value, the system increases the image pickup illumination light intensity, and once that reaches a maximum, it increase the gain values to ensure a high-resolution, low noise image, ¶0057. See also ¶¶0022-0023, ¶¶0059-0061.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the timer of modified Prosk to be configured to include the teachings of the timer of Dobashi. The motivation to do this yield predictable results such as to ensure a high-resolution, low noise image, as suggested by Dobashi, ¶0057. The modified combination would disclose wherein the timer is configured: to output a control signal for controlling optical settings of the surgical imaging device.
Proska fails to disclose: wherein the working time is at least one of:
a start time at which a signal from the imaging agent is observable at the imaging site, or an end time at which the imaging agent is cleared;
wherein the indicator is a countdown timer showing at least one of a first duration until the start time or a second duration until the end time;
wherein the timer is configured:
to detect an imaging agent that is administered by injection at a point of introduction which is remote from the imaging site; wherein the first duration is an expected duration of time for the imaging agent to travel from the point of introduction to the imaging site.
However, Korporall in the context of acquiring data and signaling the start and end of administration of a contrast medium in temporal relation to the scan for acquiring data discloses,
wherein the working time is at least one of:
a start time at which a signal from the imaging agent is observable at the imaging site, or an end time at which the imaging agent is cleared;
-Korporall discloses “a start time at which a signal form the imaging agent is observable at an imaging site” by defining the characteristic time interval ΔT (a first duration) as the time difference between the point of signal the start of manual contrast administration and the arrival of the contrast agent at a predefined position in the body (ROI), [Col 4 l.21-64], [Col. 6 l.52-55], Claim 20 & 33. This arrival is determined when a defined threshold value such as attenuation value, gray level, CT value, or signal level is attained at the imaging site during a monitoring scan (i.e., a start time at which a signal from the imaging agent is observable at an imaging site), Claim 20 & 33, [Col 1 l.40-56], [Col 5 l.11-21], [Col 6 l.5-15], [Col 6 l.40-66].
-Korporall disclose “or an end time at which the imaging agent is cleared.” (i.e., determining an end time for the contrast administration), This end time is calculated to ensure contrast administration stops at a point when the contrast agent injected thereafter would no longer have an effect on the image, which constitutes the agent’s clearance from the effective imaging period, [Col 1-2 l.58-66 to l.1-6], [Col 6 l.40-66],
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the working time of modified Proska in view of the known techniques and teachings of Korporall. The motivation to do this yields predictable results reducing or even minimizing the risk for patient while optimizing the contrast administration, as suggested by Korporalll, [Col 2 l.10-18]
Korporall further discloses: wherein the indicator is a countdown timer showing a second duration until the end time;
wherein the timer is configured: to detect an imaging agent that is administered by injection at a point of introduction which is remote from the imaging site; wherein the first duration is an expected duration of time for the imaging agent to travel from the point of introduction to the imaging site.
-Korporall defines the characteristic time interval ΔT (a first duration) as the time difference between the point of signal the start of manual contrast administration and the arrival of the contrast agent at a predefined position in the body (ROI), [Col 4 l.21-64], [Col. 6 l.52-55], Claim 20 & 33. This ΔT is precisely a first duration that elapses for a patient between the start of the injection (the point of introduction) and the arrival of the contrast agent at the desired position in the body (i.e., ROI).
-This characteristic time interval ΔT is then used to calculate end time for ending the manual contrast injection. The apparatus of Korporall is configured to compute Ti, off such that is precedes the end of the medical image scan TE (i.e., Ti,off = TE – ΔT), Claim 3, Claim 21, Claim 28, , Claim 34, [Col 6 l.40-66], This ensures that the contrast agen injected would no longer have an effect on the image (i.e., avoidance) effectively marking the end of the contrast agent’s working time during the scan, [Col 1-2 l.58-66 to l.1-6], [Col 6 l.40-66]. Korporall specifically teaches displaying a duration related to the end time (Ti,off) derevied using the first duration ΔT. A second advanced signal is produced comprising a countdown, Claim 37-38. The second advanced before signaling the end of the manual contrast administration, Claim 33. This displayed countdown helps the user “hit the [...] end point of manual injection more closely, [Col 5 l.45-51].
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the indicator of modified Proska in view of the known techniques and teachings of Korporall. The motivation to do this yields predictable results reducing or even minimizing the risk for patient while optimizing the contrast administration, as suggested by Korporalll, [Col 2 l.10-18].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 14, in further view of Hashimoto (US 2004/0133107 A1) in view of Hannaford et al (US 2011/0238079 A1)
Claim 16: Modified Proska discloses all the elements above in claim 14, Proska discloses: further comprising a display (¶0035, ‘One or more of the images can be visually presented via a display of the non-ionizing radiation source 218, the console 220, and/or other display. ‘)
Proska fails to disclose: for displaying the indicator,
However, Hashimoto in the context of contrast agent protocols discloses, displaying the indicator
-Hashimoto discloses that apparatus includes a countdown display region 56 which displays the time remaining up to the scheduled time of the next operation after an operation at start of injection, ¶Abstract, ¶0083-0086. Regarding the subsequent display, Hashimoto indicates that the operation at start of injection, multiple time readouts are concurrently displayed which include elapsed time after injection, ¶Abstract, ¶0083-0086. Specifically, the elapsed time after injection the display region 55 shows the time elapsed time (i.e., until the end time). In addition, Hashimoto discloses the injection freeze countdown, which measures the time remaining until a planned freeze event. This mechanism displays the time remaining to the time a freeze operation is to be made after the operation of the start of the injection hence subsequently until the end time, ¶0086.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of Modified Proksa such that the displays the indicator as taught by Hashimoto. The motivation to do this yields predictable results such as eliminating the need to check a separately provided watch such that the operator can concentrate on a display screen to move ahead with diagnosis, thus improving work efficiency as suggested by Hashimoto, ¶0041.
Proska in view of Hashimoto fail to disclose: the display couplable with an eyepiece of the surgical imaging device.
However, Hannaford in the context of surgery interfaces discloses, the display couplable with an eyepiece of the surgical imaging device. (¶0006, ¶0014, ¶0055)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of modified Proksa to be couplable with an eyepiece of the surgical imaging device as taught by Hannaford. The motivation to do this yields predictable results such as providing improve surgical expertise to desired areas of surgery, as suggested by Hannaford, ¶0005.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Proksa et al (US 2014/0121510 A1) in view of Dobashi (US20040263677A1), as applied to claim 14, in further view of Butte et al (US 2016/0364858 A1).
Claim 17: Modified Proska discloses all the elements above in claim 14, Proska fails to disclose: wherein the surgical imaging device is a near-infrared fluorescence microscope, comprising a recorder for recording a surgical procedure.
However, Butte in the context of recording simultaneously visible light image and infrared light image from fluorophores: wherein the surgical imaging device is a near-infrared fluorescence microscope, comprising a recorder for recording a surgical procedure. (¶Abstract, ¶0007, ¶0167, ¶0170)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify substitute the device of Modified Proska to be a near-infrared fluorescence microscope, comprising a recorder for recording a surgical procedure as taught by Butte for the advantage of providing an improved system without the need of multiple camera attachments, as suggested by Butte, ¶0006.
Conclusion
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.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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