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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-9, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, and 19-20 of U.S. Patent No. 12,369,797 in view of “Rothberg et al.,” US 2017/0231500 (hereinafter Rothberg).
Instant Application 18/255,709
Claims-06/30/2025
U.S. Patent No. 12,369,797
1.A system comprising:
a memory storing instructions; and
a processor communicatively coupled to the memory and configured to execute the instructions to:
direct an imaging device included in a computer-assisted surgical system to detect, during a surgical procedure performed with the computer-assisted surgical
system, fluorescence emitted by a population of fluorophores present at a scene,
wherein: the imaging device comprises a detector having a plurality of distinct regions each configured to detect the fluorescence emitted by the population of
fluorophores, and the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals; and
determine, based on the plurality of fluorescence image signals, the lifetime of the fluorescence.
2. The system of claim 1, wherein the directing each region included in the plurality of distinct regions to sample the fluorescence in succession over the time period comprises activating each region of the plurality of distinct regions in succession over the time period.
3. The system of claim 1, wherein the processor is further configured to execute the instructions to:
direct the imaging device to detect, during the surgical procedure, additional fluorescence emitted by an additional population of fluorophores present at the scene, wherein the directing the imaging device to detect the additional fluorescence comprises directing the plurality of distinct regions to sample the additional fluorescence in succession over a time period that is less than a lifetime of the additional fluorescence to generate a plurality of fluorescence image signals, each
region included in the plurality of distinct regions generating a distinct additional fluorescence image signal included in the plurality of fluorescence image signals; and determine, based on the detected additional fluorescence, a lifetime of the additional fluorescence.
4. The system of claim 3, wherein:
the population of fluorophores emit the fluorescence in response to a first set of pulses of fluorescence excitation illumination having a first wavelength configured to
excite the population of fluorophores; and
the additional population of fluorophores emit the additional fluorescence in response to a second set of pulses of fluorescence excitation illumination having a
second wavelength configured to excite the additional population of fluorophores, wherein the first wavelength is different from the second wavelength.
5. The system of claim 4, wherein:
the directing the imaging device to detect the fluorescence comprises directing the imaging device to detect the fluorescence in sync with the first set of pulses; and the directing the imaging device to detect the additional fluorescence comprises directing the imaging device to detect the additional fluorescence in sync with the second set of pulses.
7.The system of claim 1, wherein the processor is further configured to execute the instructions to determine, based on the determined lifetime of the fluorescence, an identity of the fluorophore.
8.The system of claim 7, wherein the processor is further configured to execute the instructions to configure, during the surgical procedure and based on the
determined identity of the fluorophore, operation of the computer-assisted surgical system.
9. A method comprising:
directing an imaging device included in a computer-assisted surgical system to detect, during a surgical procedure performed with the computer-assisted surgical
system, fluorescence emitted by a population of fluorophores present at a scene,
wherein: the imaging device comprises a detector having a plurality of distinct regions each configured to detect the fluorescence emitted by the population of
fluorophores, and the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence to generate a plurality of
fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals; and
determine, based on the plurality of fluorescence image signals, the lifetime of the fluorescence.
15. The method of claim 9, further comprising:
determining, based on the determined lifetime of the fluorescence, an identity of the fluorophore.
16. The method of claim 15, further comprising:
configuring, during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system.
1.A system comprising:
a memory storing instructions; and a processor communicatively coupled to the memory and configured to execute the instructions to:
direct, during a surgical procedure performed with a computer-assisted surgical system, an illumination source included in the computer-assisted surgical system to illuminate a scene associated with the surgical procedure with fluorescence excitation illumination configured to excite a fluorophore present at the scene, direct an imaging device included in the computer-assisted surgical system to detect, during the surgical procedure, fluorescence emitted by the fluorophore in response to excitation of the fluorophore by the fluorescence excitation illumination,
wherein: the imaging device comprises a detector having a plurality of distinct regions each configured to detect the fluorescence emitted by the fluorophore, and the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals,
determine, based on the plurality of fluorescence image signals, the lifetime of the fluorescence, determine, based on the determined lifetime of the fluorescence, an identity of the fluorophore, and configure, during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system.
7. The system of claim 1, wherein: the fluorescence excitation illumination is further configured to excite an additional fluorophore present at the scene, and the processor is further configured to execute the instructions to: direct the imaging device to detect, during the surgical procedure, additional fluorescence emitted by the additional fluorophore in response to excitation of the additional fluorophore by the fluorescence excitation illumination, determine, based on the detected additional fluorescence, a lifetime of the additional fluorescence, and determine, based on the determined lifetime of the additional fluorescence, an identity of the additional fluorophore.
19. The system of claim 7, wherein: the fluorescence excitation illumination comprises a first set of pulses of fluorescence excitation illumination having a first wavelength configured to excite the fluorophore and a second set of pulses of fluorescence excitation illumination having a second wavelength configured to excite the additional fluorophore, wherein the first wavelength is different from the second wavelength; the directing the imaging device to detect the fluorescence comprises directing the imaging device to detect the fluorescence in sync with the first set of pulses; and the directing the imaging device to detect the additional fluorescence comprises directing the imaging device to detect the additional fluorescence in sync with the second set of pulses.
20. The system of claim 1, wherein the directing each region included in the plurality of distinct regions to sample the fluorescence in succession over the time period
12. A method comprising:
directing, by a fluorescence imaging control system during a surgical procedure performed with a computer-assisted surgical system, an illumination source included in the computer-assisted surgical system to illuminate a scene associated with the surgical procedure with fluorescence excitation illumination configured to excite a fluorophore present at the scene; directing, by the fluorescence imaging control system, an imaging device included in the computer-assisted surgical system to detect, during the surgical procedure, fluorescence emitted by the fluorophore in response to excitation of the fluorophore by the fluorescence excitation illumination, wherein: the imaging device comprises a detector having a plurality of distinct regions each configured to detect the fluorescence emitted by the fluorophore, and the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals; determining, by the fluorescence imaging control system based on the plurality of fluorescence image signals, a lifetime of the fluorescence; determining, by the fluorescence imaging control system based on the determined lifetime of the fluorescence, an identity of the fluorophore, and configuring, by the fluorescence imaging control system during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system.
Regarding to claims 1 and 7-8, patented claim 1 sets forth the above limitations except underlined limitations of instant application.
Patented claims 1 recites further limitations as bolded in the table above.
Claim 1 of instant application recites “a population of fluorophores” while patented claim 1 recites “a fluorophore.”
However, in the analogous field of endeavor in fluorescence imaging system, Rothberg teaches the fluorescence lifetime imaging ([0130]) which measures and distinguishes multiple fluorescence molecules [0129]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of patented claim 1 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Rothberg. One of ordinary skill in the art could have modified the elements as claimed by known method (e.g. providing illumination sources with plurality of wavelengths) with no change in their respective functions, and the combination and/or modification would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have provide identification and discrimination of fluorophores ([0208]), and there was reasonable expectation of success.
Regarding to claim 2, patented claim 20 sets forth the above limitations.
Regarding to claim 3, patented claim 7 sets forth the above limitations.
Regarding to claims 4-5, patented claim 19 sets forth the above limitations.
Regarding to claims 9 and 15-16, patented claim 12 sets forth the above limitations except underlined limitations of instant application.
Patented claims 12 recites further limitations as bolded in the table above.
Claim 9 and 15-16 of instant application recites “a population of fluorophores” while patented claim 12 recites “a fluorophore.”
However, in the analogous field of endeavor in fluorescence imaging method, Rothberg teaches the fluorescence lifetime imaging ([0130]) which measures and distinguishes multiple fluorescence molecules [0129]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of patented claim 12 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Rothberg. One of ordinary skill in the art could have modified the elements as claimed by known method (e.g. providing illumination sources with plurality of wavelengths) with no change in their respective functions, and the combination and/or modification would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have provide identification and discrimination of fluorophores ([0208]), and there was reasonable expectation of success.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,369,797.
Instant Application 18/255,709
Claims-06/30/2025
U.S. Patent No. 12,369,797
17. A system comprising:
a memory storing instructions; and a processor communicatively coupled to the memory and configured to execute the instructions to perform a process comprising:
accessing a plurality of fluorescence images representative of fluorescence detected by a detector having a plurality of distinct regions, wherein:
each fluorescence image is representative of the fluorescence detected by a distinct region of the detector, and the plurality of fluorescence images are captured in succession over a time period that is less than a lifetime of the fluorescence; and determining, based on the plurality of fluorescence images, a lifetime of the fluorescence.
8. A system comprising:
a memory storing instructions; and a processor communicatively coupled to the memory and configured to execute the instructions to:
direct an illumination source to illuminate a scene with fluorescence excitation illumination configured to excite a fluorophore present at the scene, direct an imaging device to detect fluorescence emitted by the fluorophore in response to excitation of the fluorophore by the fluorescence excitation illumination, wherein: the imaging device comprises a detector having a plurality of distinct regions each configured to detect the fluorescence emitted by the fluorophore, and the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals, and generate, based on the detected fluorescence, a fluorescence image comprising a plurality of pixels, the generating of the fluorescence image comprising: determining, based on the plurality of fluorescence image signals, the lifetime of the detected fluorescence at each of the plurality of pixels, and pseudo-coloring the plurality of pixels based on the lifetime of the detected fluorescence at each of the plurality of pixels.
Regarding to claim 17, patented claim 8 sets forth all the limitations and patented claim 8 further recites bolded limitations.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims are essentially similar as all the limitations of instant application ( claim 17) are included in patented claim 8.
Thus, patented limitations set forth above in claim 8 is a species to a generic claim 17 of instant application (i.e. entire scope of the reference claim falls within the scope of the examined claim), and species claimed in patent anticipates the claimed genus in the application being examined and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species should the genus issue as a patent after the species.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over “Rothberg et al.,” US 2017/0231500 (hereinafter Rothberg) and “Nicholls et al.,” US 2012/0032095 (hereinafter Nicholls).
Regarding to claim 1, Rothberg teaches a system comprising:
a memory storing instructions (memory storing computer readable instructions [0287], memory 1003 Figure 26 [0325]); and
a processor communicatively coupled to the memory and configured to execute the instructions ( a processor coupled to memory and execute computer program instructions [0325]) to:
direct an imaging device included in a computer-assisted surgical system to detect, during a surgical procedure performed with the computer-assisted surgical system, fluorescence emitted by a population of fluorophores present at a scene (The imaging device using fluorescence lifetime imaging [0130]; fluorescence lifetime measurements in image-guided surgeries [0133]; multiple fluorescence molecules [0129]), wherein:
the imaging device comprise a detector (photodetector such as integrated CCDs and CMOS image sensors [0002]) having a plurality of distinct regions each configured to detect the fluorescence emitted by the population of fluorophores (a photodetector having a pixel array provide ability to image a region by detecting temporal characteristics of light received at individual pixels from different areas of regions [0130], a pixel includes four sub-pixels, each sub-pixel configured to receive light of a different wavelengths to be transmitted to sub-pixels [0281] Figure 12),
the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period (trigger event can be a repeating periodic event [0196]; measurement repeated binning a sufficient number of charge carriers in each bin [0201]; repeating the sequence of excitation, charge capture, and transfer into respective bins many times [0204]; temporal and spectral discrimination of light [0281]) to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals (multiple types of fluorescent molecules with different lifetimes present and time profile of emitted fluorescence [0126]-[0127], each sub-pixels configured to receive light of different wavelengths allowing temporal and spatial discrimination of incident light, different types of fluorescent molecules having different lifetimes [0281]); and
determine, based on the plurality of fluorescence image signals, the lifetime of the fluorescence (a histogram of number of photons registered in different bins may be produced that allows determining or approximating the lifetime of a fluorophore [0204]).
Rothberg does not explicitly teach following limitations of “ to sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence.”
However, in the analogous field of endeavor in fluorescence imaging system, Nicholls teaches that the duration of excitation light for imaging should be significantly shorter than the fluorescence lifetime of the fluorophore ([0022]-[0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify imaging condition as taught by Rothberg to incorporate teaching of Nicholls, since a time-correlated single photon counting measurement was well known in the art as taught by Nicholls. One of ordinary skill in the art could have combined the elements as claimed by Rothberg with no change in their respective functions, configuring duration of imaging to be shorter than the lifetime of fluorophore, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to obtain reliable lifetime measurements ([0022]), and there was reasonable expectation of success.
Regarding to claim 2, Rothberg and Nicholls together teach all limitations of claim 1 set forth above.
Rothberg further teaches wherein the directing each region included in the plurality of distinct regions to sample the fluorescence in succession over the time period comprises activating each region of the plurality of distinct regions in succession over the time period (temporally multiplex detection of photons in response to light excitation pulses of different wavelengths [0208]; Figure 12 shows a pixel includes four sub-pixels, wherein each sub-pixel receive light of a different wavelengths to be transmitted to sub-pixels, temporal [0281])
Regarding to claim 3, Rothberg and Nicholls together teach all limitations of claim 1 set forth above.
Rothberg further teaches wherein the processor is further configured to execute the instructions to:
direct the imaging device to detect, during the surgical procedure, additional fluorescence emitted by an additional population of fluorophores present at the scene (different luminescent molecules (e.g. fluorophores) [0207]),
wherein the directing the imaging device to detect the additional fluorescence comprises directing the plurality of distinct regions to sample the additional fluorescence in succession over a time period to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct additional fluorescence image signal included in the plurality of fluorescence image signals; and determine, based on the detected additional fluorescence, a lifetime of the additional fluorescence (fluorophores identified [0207]; wherein each sub-pixel receive light of a different wavelengths to be transmitted to sub-pixels, discriminate different types of fluorescence molecules, Figure 12 [0281]).
With regards to “sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence,” in the analogous field of endeavor in fluorescence imaging system, Nicholls teaches that the duration of excitation light for imaging should be significantly shorter than the fluorescence lifetime of the fluorophore ([0022]-[0023]), as set forth above in claim 1.
Regarding to claims 4-5, Rothberg, Dixon, and Nicholls together teach all limitations of claim 3 set forth above.
Rothberg further teaches the limitations:
Of claim 4, wherein: the population of fluorophores emit the fluorescence in response to a first set of pulses of fluorescence excitation illumination having a first wavelength configured to excite the population of fluorophores ([0207]); and the additional population of fluorophores emit the additional fluorescence in response to a second set of pulses of fluorescence excitation illumination having a second wavelength configured to excite the additional population of fluorophores, wherein the first wavelength is different from the second wavelength (different wavelengths [0207]-[0208]).
Of claim 5, wherein: the directing the imaging device to detect the fluorescence comprises directing the imaging device to detect the fluorescence in sync with the first set of pulses; and the directing the imaging device to detect the additional fluorescence comprises directing the imaging device to detect the additional fluorescence in sync with the second set of pulses (trigger events may be excitation light pulses of different wavelengths which excite different luminescent molecules [0207]).
Regarding to claim 6, Rothberg, Dixon, and Nicholls together teach all limitations of claim 1 set forth above.
Rothberg further teaches wherein the imaging device comprises an endoscope (endoscope [0115] and [0133]).
Regarding to claim 7, Rothberg, Dixon, and Nicholls together teach all limitations of claim 1 set forth above.
Rothberg further teaches wherein the processor is further configured to execute the instructions to determine, based on the determined lifetime of the fluorescence, an identity of the fluorophore (fluorophores are identified and discriminated from each other based on the response to different wavelengths and fluorescent molecules are identified and/or discriminated based upon measuring their fluorescence lifetime [0207]).
Regarding to claim 8, Rothberg and Nicholls together teach all limitations of claim 1 set forth above.
Rothberg teaches wherein the processor is further configured to execute the instructions to configure, during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system (The imaging device perform imaging of tissue based on the temporal characteristics of light received from the tissue, which may enable physician performing a procedure (e.g. surgery) to identify an abnormal or diseased region of tissue, imaging performed using fluorescence lifetime imaging [0130]; detecting cancers on tissue exposed during surgery [0133]; provide immediate treatment to patients based on tissue condition [0106]; image-guided surgeries [0133]).
Regarding to claim 9, Rothberg teaches a method comprising:
directing an imaging device included in a computer-assisted surgical system to detect, during a surgical procedure performed with the computer-assisted surgical system, fluorescence emitted by a population of fluorophores present at a scene (The imaging device using fluorescence lifetime imaging [0130]; fluorescence lifetime measurements in image-guided surgeries [0133]; multiple fluorescence molecules [0129]),
wherein: the imaging device comprises a detector (photodetector such as integrated CCDs and CMOS image sensors [0002]) having a plurality of distinct regions each configured to detect the fluorescence emitted by the population of fluorophores (a photodetector having a pixel array provide ability to image a region by detecting temporal characteristics of light received at individual pixels from different areas of regions [0130], a pixel includes four sub-pixels, each sub-pixel configured to receive light of a different wavelengths to be transmitted to sub-pixels [0281] Figure 12),
the directing the imaging device to detect the fluorescence comprises directing the plurality of distinct regions to sample the fluorescence in succession over a time period (trigger event can be a repeating periodic event [0196]; measurement repeated binning a sufficient number of charge carriers in each bin [0201]; repeating the sequence of excitation, charge capture, and transfer into respective bins many times [0204]; temporal and spectral discrimination of light [0281]) to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct fluorescence image signal included in the plurality of fluorescence image signals (multiple types of fluorescent molecules with different lifetimes present and time profile of emitted fluorescence [0126]-[0127], each sub-pixels configured to receive light of different wavelengths allowing temporal and spatial discrimination of incident light, different types of fluorescent molecules having different lifetimes [0281]); and
determine, based on the plurality of fluorescence image signals, the lifetime of the fluorescence (a histogram of number of photons registered in different bins may be produced that allows determining or approximating the lifetime of a fluorophore [0204]).
Rothberg does not specifically disclose that a time period is less than a lifetime of the fluorescence as claimed.
However, in the analogous field of endeavor in fluorescence imaging system, Nicholls teaches that the duration of excitation light for imaging should be significantly shorter than the fluorescence lifetime of the fluorophore ([0022]-[0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify imaging condition as taught by Rothberg to incorporate teaching of Nicholls, since a time-correlated single photon counting measurement was well known in the art as taught by Nicholls. One of ordinary skill in the art could have combined the elements as claimed by Rothberg with no change in their respective functions, configuring duration of imaging to be shorter than the lifetime of fluorophore, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to obtain reliable lifetime measurements ([0022]), and there was reasonable expectation of success.
Regarding to claim 10, Rothberg and Nicholls together teach all limitations of claim 9 as set forth above.
Rothberg further teaches following limitations:
Of claim 10, wherein the directing each region included in the plurality of distinct regions to sample the fluorescence in succession over the time period comprises activating each region of the plurality of distinct regions in succession over the time period ( a pixel receives light in response to different type trigger events in different time periods [0207]; temporally multiplex detection of photons in response to light excitation pulses of different wavelengths [0208]; Figure 12 shows a pixel includes four sub-pixels, wherein each sub-pixel receive light of a different wavelengths to be transmitted to sub-pixels, temporal [0281]).
Regarding to claim 11, Rothberg and Nicholls together teach all limitations of claim 9 as set forth above.
Rothberg further teaches following limitations:
directing the imaging device to detect, during the surgical procedure, additional fluorescence emitted by an additional population of fluorophores present at the scene (different luminescent molecules (e.g. fluorophores) [0207]),
wherein the directing the imaging device to detect the additional fluorescence comprises directing the plurality of distinct regions to sample the additional fluorescence in succession over a time period to generate a plurality of fluorescence image signals, each region included in the plurality of distinct regions generating a distinct additional fluorescence image signal included in the plurality of fluorescence image signals; and determining based on the detected additional fluorescence, a lifetime of the additional fluorescence (fluorophores identified [0207]; wherein each sub-pixel receive light of a different wavelengths to be transmitted to sub-pixels, discriminate different types of fluorescence molecules, Figure 12 [0281]).
With regards to “sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence,” in the analogous field of endeavor in fluorescence imaging system, Nicholls teaches that the duration of excitation light for imaging should be significantly shorter than the fluorescence lifetime of the fluorophore ([0022]-[0023]), as set forth above in claim 9.
Regarding to claim 12, Rothberg and Nicholls together teach all limitations of claim 11 as set forth above.
Rothberg further teaches wherein the population of fluorophores emit the fluorescence in response to a first set of pulses of fluorescence excitation illumination having a first wavelength configured to excite the population of fluorophores (wavelength λ 1 [0207]); and the additional population of fluorophores emit the additional fluorescence in response to a second set of pulses of fluorescence excitation illumination having a second wavelength configured to excite the additional population of fluorophores (wavelength λ 2 [0207]), wherein the first wavelength is different from the second wavelength (different wavelengths [0207]-[0208]).
Regarding to claim 13, Rothberg and Nicholls together teach all limitations of claim 12 as set forth above.
Rothberg further teaches wherein the directing the imaging device to detect the fluorescence comprises directing the imaging device to detect the fluorescence in sync with the first set of pulses; and the directing the imaging device to detect the additional fluorescence comprises directing the imaging device to detect the additional fluorescence in sync with the second set of pulses (trigger events may be excitation light pulses of different wavelengths which excite different luminescent molecules [0207]).
Regarding to claims 14-16, Rothberg and Nicholls together teach all limitations of claim 9 as set forth above.
Rothberg further teaches following limitations:
Of claim 14, wherein the imaging device comprises an endoscope (endoscope [0133]).
Of claim 15, further comprising: determining, based on the determined lifetime of the fluorescence, an identity of the fluorophore (fluorophores are identified and discriminated from each other based on the response to different wavelengths and fluorescent molecules are identified and/or discriminated based upon measuring their fluorescence lifetime [0207]).
Of claim 16, further comprising: configuring, during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system (The imaging device perform imaging of tissue based on the temporal characteristics of light received from the tissue, which may enable physician performing a procedure (e.g. surgery) to identify an abnormal or diseased region of tissue, imaging performed using fluorescence lifetime imaging [0130]; detecting cancers on tissue exposed during surgery [0133]; provide immediate treatment to patients based on tissue condition [0106]).
Regarding to claim 17, Rothberg teaches a system comprising:
a memory storing instructions (memory storing computer readable instructions [0287], memory 1003 Figure 26 [0325]); and
a processor communicatively coupled to the memory and configured to execute the instructions to perform a process comprising ( a processor coupled to memory and execute computer program instructions [0325]):
accessing a plurality of fluorescence images ( fluorescence lifetime images [0130]-[0131]) representative of fluorescence detected by a detector having a plurality of distinct regions (a photodetector having a pixel array provide ability to image a region by detecting temporal characteristics of light received at individual pixels from different areas of regions [0130], a pixel includes four sub-pixels, each sub-pixel configured to receive light of a different wavelengths to be transmitted to sub-pixels [0281] Figure 12), wherein:
each fluorescence image is representative of the fluorescence detected by a distinct region of the detector (a pixel includes four sub-pixels, each sub-pixel configured to receive light of a different wavelengths to be transmitted to sub-pixels [0281] Figure 12), and the plurality of fluorescence images are captured in succession over a time period (trigger event can be a repeating periodic event [0196]; measurement repeated binning a sufficient number of charge carriers in each bin [0201]; repeating the sequence of excitation, charge capture, and transfer into respective bins many times [0204]; temporal and spectral discrimination of light [0281]); and
determining, based on the plurality of fluorescence images, a lifetime of the fluorescence (mapping the decay time in the resulting image, pixel values in the image based on the fluorescence lifetime [0131]).
Rothberg does not teach “sample the fluorescence in succession over a time period that is less than a lifetime of the fluorescence.”
However, in the analogous field of endeavor in fluorescence imaging system, Nicholls teaches that the duration of excitation light for imaging should be significantly shorter than the fluorescence lifetime of the fluorophore ([0022]-[0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify imaging condition as taught by Rothberg to incorporate teaching of Nicholls, since a time-correlated single photon counting measurement was well known in the art as taught by Nicholls. One of ordinary skill in the art could have combined the elements as claimed by Rothberg with no change in their respective functions, configuring duration of imaging to be shorter than the lifetime of fluorophore, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to obtain reliable lifetime measurements ([0022]), and there was reasonable expectation of success.
Regarding to claim 18-20, Rothberg and Nicholls together teach all limitations of claim 17 set forth above.
Rothberg further teaches following limitations:
Of claim 18, wherein the determining the lifetime of the fluorescence comprises: generating a decay curve based on a combination of the plurality of fluorescence images ([0131], [0124], [0128]); and determining the lifetime of the fluorescence based on the decay curve (lifetime can be determined by fitting a single exponential decay to the luminescence signal [0129]).
Of claim 19, wherein the process is performed during a surgical procedure performed with a computer-assisted surgical system ( surgery and surgical imaging tool [0130]; imaging device incorporated into a surgical instrument to perform fluorescence lifetime imaging [0133], fluorescence lifetime imaging map changes in biological tissues in a tissue section or surgical resection [0135]).
Of claim 20, the computer-assisted surgical system comprises an endoscope; and the plurality of fluorescence images are captured by the endoscope (endoscope [0133]).
Alternatively, Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg and Nicholls as applied to claims 7 and 15 above, and further in view of “Dixon et al.,” US 2020/0026051 (hereinafter Dixon).
Regarding to claims 8 and 16, Rothberg and Nicholls together teach all limitations of claims 7 and 15 as set forth above.
Rothberg and Nicholls do not further disclose wherein the processor is configured to execute the instructions to configure, during the surgical procedure and based on the determined identity of the fluorophore, operation of the computer-assisted surgical system.
However, in the analogous field of endeavor in fluorescence imaging system and method, Dixon teaches for changing illumination light source and emission filter for specific fluorophore ([0028] and [0114]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify imaging as taught by Rothberg to incorporate teaching of Dixon, since selecting imaging parameters for chosen fluorophore was well known in the art as taught by Dixon. One of ordinary skill in the art could have combined the elements as claimed by Rothberg with no change in their respective functions, configuring its imaging system and method to select imaging parameter specific for chose fluorophore, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide multiple fluorophores imaging ([0114]), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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