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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 28, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 is indefinite because it is unclear what the fluctuation period of the pixel value is. The specification only repeats the claim language and does not provide a further description of the claimed term. Further, fluctuation period does not appear to be a term of art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, and 27-36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2014/0088418 A1 to Radulescu et al., in view of Forbrich et al., Photoacoustic imaging of lymphatic pumping, Journal of Biomedical Optics, 22(10), 106003 (October 2017) (as supplied by Applicant), U.S. Patent No. 6,760,611 B1 to Watanabe, in view of U.S. PG Pub. No. 2012/0165646 A1 to Yamauchi et al., in view of U.S. PG Pub. No. 2014/0198606 A1 to Morscher et al., and in view of U.S. PG Pub. No. 2017/0055842 A1 to Umezawa.
Regarding claims 1, 7, and 8, Radulescu discloses a device, method , and CRM, comprising a processor; and a memory storing a program which, when executed by the processor, causes the image processing apparatus to: perform data processing to generate first image data that based on acoustic waves generated by irradiating light on a subject into which a contrast agent has been injected and acquire a plurality of the first image data by repeating the generating of the first image data a plurality of times in a time series, and perform image processing to extract a region corresponding to the contrast agent in the plurality of the first image data acquired in the data processing, and generate second image data including the extracted region corresponding to the contrast agent (see abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1).
Forbrich discloses a similar photoacoustic imaging system and method, wherein contrast agent is used to image lymphatic tissue and vessels with irregular flow interval as a plurality of regions over time (see entire document, noting abstract, introduction, and discussion). Forbrich also discloses at Fig. 4 regions of contrast at four steps along a lymphatic vessel over time. Forbrich also appears to disclose still images (see entire document, noting abstract, introduction, and discussion).
It would have been obvious and predictable to have combined Radulescu and Forbrich to image lymphatic tissue because lymphatic tissue is related to the diagnosis of diseases such as obesity, diabetes, and cancer.
Similarly, Watanabe discloses a similar contrast agent image processing system and method, where regions of an anatomical vessel are filled with contrast, said contrast agent is imaged over time in time series to determine a plurality of regions, including first image data where the contrast agent has migrated, and combining said plurality of regions to provide a larger combined region where contrast agent has passed by over time (see Figs. 1-3, abstract, col 5 ln 43-col 7 ln 8, and col 7 ln 30-65).
It would have been obvious and predictable to have combined Radulescu and Forbrich with the further teaching of Watanabe to image lymphatic tissue because doing so would show the larger combined area over which contrast has migrated in the lymphatic vessels and because doing so would provide a better image contrast.
Examiner notes that for the device and CRM claims all of the lymphatic claim limitations are merely intended use and the device of the combined prior art is capable of performing said intended use. Further, regarding the method, the pulsatile nature of the lymphatic vessels does not impart a method step and is rather a property of the subject.
Radulescu does not specifically disclose how values are selected for extraction.
However, Yamauchi discloses a similar photoacoustic imaging device in which an image value in a predetermined range is used to extract contrast agent regions in an image (see para 116).
It would have been obvious and predictable to have combined the teachings of Radulescu and Yamauchi because doing so would predictably and automatically allow the imaging device to extract contrast agent regions so that said regions are easily identifiable in an image. Such an automated processor of selecting values of a high enough value would ensure an efficient computational process as well as ensure that only contrast agent portions were extracted. Examiner notes that selecting positive or negative values or magnitude levels of data would have been a mere matter of design.
Umezawa discloses a similar photoacoustic imaging device, wherein blood vessels are imaged and displayed separately from other tissues (see Figs. 2 and 3 and para 56-60, 68-73, and 92-93).
It would have been obvious and predictable to also image the blood vessels because doing so would provide a complete picture of the anatomy of the subject. For example, the combined references already teach imaging of contrast and of lymphatic vessels and adding blood vessels to the image would provide a more complete image, thus allowing a user to target, avoid, or analyze tissues in the subject.
Morscher discloses a similar photoacoustic imaging system, wherein contrast agent is imaged over time and displayed as still images and as video images over time (see para 41-54). Further, Morscher discloses displaying contrast agent images overlaid on anatomical images, the other regions other than the lymphatic vessels (see para 41-54, noting that at least Radulescu teaches contrast agent imaging, Forbrich teaches lymphatic vessel imaging, and Umezawa discloses blood vessel imaging).
It would have been obvious and predictable in light of Morscher to display single still images or video images to show medical imaging data from a single instance or over time. Further, Morscher indicates that it is a mere design choice to highlight contrast agent data or to show a complete image of contrast agent data overlaid on a general anatomical image, which in combination includes blood and lymph vessels.
Regarding claims 2 and 3, Radulescu in combination with Watanabe discloses a device, wherein in the image processing a region for each of the plurality of first image data and takes a region, obtained by combining a plurality of extracted regions, as the region corresponding to the contrast agent; and wherein the image processing is configured to extract a region in the first image data included in a predetermined period among the plurality first image data acquired and takes the extracted region as the region corresponding to the contrast agent (see Radulescu abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1 and Watanabe Figs. 1-3, abstract, col 5 ln 43-col 7 ln 8, and col 7 ln 30-65).
Radulescu does not specifically disclose how values are selected for extraction.
However, Yamauchi discloses a similar photoacoustic imaging device in which an image value in a predetermined range is used to extract contrast agent regions in an image (see para 116).
It would have been obvious and predictable to have combined the teachings of Radulescu and Yamauchi because doing so would predictably and automatically allow the imaging device to extract contrast agent regions so that said regions are easily identifiable in an image. Such an automated processor of selecting values of a high enough value would ensure an efficient computational process as well as ensure that only contrast agent portions were extracted. Examiner notes that selecting positive or negative values or magnitude levels of data would have been a mere matter of design.
Regarding claim 4, Umezawa discloses a similar photoacoustic imaging device, wherein the data processing is further configured to acquire an absorption coefficient distribution in the subject, and the image processing is configured to exclude a region, in which the absorption coefficient does not exceed a predetermined threshold value, from the plurality of region corresponding to the contrast agent (see para 72, 73, 92, and 93, noting non-target areas are excluded from the mask of contrast agents).
It would have been obvious and predictable to have combined the teachings of Radulescu and Umezawa because doing so would predictably avoid noise and improve accuracy of contrast agent identification.
Regarding claim 5, Radulescu discloses a device, wherein the first image data are a spectral image generated by performing computations on a plurality of photoacoustic image data obtained by irradiating the subject with light of a plurality of wavelengths different from each other (see abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1).
Regarding claim 6, Examiner takes Official Notice that photoacoustic imaging at 797 nm and 835 nm is known in the art. Further, Radulescu specifically indicates that both wavelengths should be optimized to image the contrast agent used and the surrounding tissue (see abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1).
Consequently, a skilled artisan would have found it an obvious matter of engineering to have optimized the wavelengths used so that a given contrast agent could be imaged using the Radulescu method.
Regarding claims 27 and 28, Yamauchi in light of Radulescu teaches a skilled artisan that different materials have different imaging values; wherein the predetermined range is different from another predetermined range in the plurality of first image data that corresponds to a blood vessel region; and wherein the predetermined range and the another predetermined range correspond to image values having opposite signs (see citations to claim 1).
It would have been obvious and predictable to have combined the teachings of Radulescu and Yamauchi because doing so would predictably and automatically allow the imaging device to extract contrast agent regions so that said regions are easily identifiable in an image. Such an automated processor of selecting values of a high enough value would ensure an efficient computational process as well as ensure that only contrast agent portions were extracted. Examiner notes that selecting positive or negative values or magnitude levels of data would have been a mere matter of design.
Regarding claim 29, Morscher in combination with Radulescu discloses a similar imaging device, wherein the combining comprises superimposing, and wherein in the superimposing, a first region of the extracted plurality of regions, the first region corresponding to one of the plurality of first image data acquired at a first time, is superimposed with a second region of the extracted plurality of regions, the second region corresponding to one of the plurality of first image data acquired at a second time later than the first time (see para 41-54; see also citations to Radulescu for claim 1).
It would have been obvious and predictable in light of Morscher to display single still images or video images to show medical imaging data from a single instance or over time. Further, Morscher indicates that it is a mere design choice to highlight contrast agent data or to show a complete image of contrast agent data overlaid on a general anatomical image.
Regarding claim 30, Morscher in combination with Radulescu discloses a similar imaging device, wherein the second image data and the other regions are displayed as different in display color (see para 41-54; see also citations to Radulescu for claim 1).
It would have been obvious and predictable in light of Morscher to display single still images or video images to show medical imaging data from a single instance or over time. Further, Morscher indicates that it is a mere design choice to highlight contrast agent data or to show a complete image of contrast agent data overlaid on a general anatomical image. Using color to highlight areas is a common place solution for efficiently demarking different types of data.
Claims 31, 32, and 35 fail to recite further structural limitations and the device of the combined prior art is capable of performing the intended uses claimed.
Examiner further notes that imaging blood vessels, including veins and arteries is common place in the art and would provide the obvious benefit of highlighting said tissues (see citations to Watanabe for claim 1).
Regarding claims 33 and 34, it would have been a mere matter of obvious design to use a single display or dual display to present both sets of image data, the movie and the second image data because the use of two monitors or a single monitor are both known and provide the same result of displaying both types of data.
It has also been held that duplicating parts is obvious. Therefore, using two monitors instead of one would have been obvious and predictable.
Lastly, Examiner notes that displaying data is a mere functional limitation and the combined prior art is capable of performing the recited functional limitations of claims 33 and 34.
Regarding claim 36, it would have been a mere matter of optimization to determine the optimal amount of time for collecting data. Further, it would have been predictable to have used the amount of time claimed because doing so would acquire sufficient data for data analysis.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Radulescu, Forbrich, Watanabe, Yamauchi, Morscher, and Imezawa as applied to claim 1 and further in view of U.S. PG Pub. No. 2013/0216114 A1 to Courtney et al.
Regarding claims 23 and 25, Courtney discloses a similar contrast-based imaging system, wherein in the generating, an image is generated that takes a region, in which an image value has changed over time in the plurality of the first image data, as a lymphatic vessel region (see para 150 and noting in combination Radulescu teaches imaging lymphatic vessel regions with contrast).
It would have been obvious and predictable to have combined the teachings of Courtney and Radulescu because doing so would predictably provide an extra way to identify contrast agent so that no contrast agent is missed in the image.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Radulescu, Forbrich, Watanabe, Yamauchi, Morscher, and Umezawa as applied to claim 1 and further in view of Umezawa and U.S. PG Pub. No. 2014/0005537 A1 to Asami et al.
Regarding claim 26, Umezawa discloses a similar photoacoustic imaging device, wherein the data processing is further configured to acquire an absorption coefficient distribution in the subject, and the image processing is configured to exclude a region, in which the absorption coefficient does not exceed a predetermined threshold value, from the plurality of region corresponding to the contrast agent (see para 72, 73, 92, and 93, noting non-target areas are excluded from the mask of contrast agents).
It would have been obvious and predictable to have combined the teachings of Radulescu and Umezawa because doing so would predictably avoid noise and improve accuracy of contrast agent identification.
Further, Asami discloses a similar photoacoustic imaging device, wherein the predetermined threshold value is changeable by a user (see para 64 and 65).
It would have been obvious and predictable to have combined the teachings of Radulescu, Umezawa, and Asami because doing so would predictably allow the user to fine tune values and adjust the image generated by the system.
Claims 37, 38, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2014/0088418 A1 to Radulescu et al., in view of Forbrich et al., Photoacoustic imaging of lymphatic pumping, Journal of Biomedical Optics, 22(10), 106003 (October 2017) (as supplied by Applicant), U.S. Patent No. 6,760,611 B1 to Watanabe, in view of U.S. PG Pub. No. 2012/0165646 A1 to Yamauchi et al., in view of U.S. PG Pub. No. 2014/0198606 A1 to Morscher et al., in view of U.S. PG Pub. No. 2017/0055842 A1 to Umezawa, and in view of U.S. PG Pub. No. 2013/0216114 A1 to Courtney et al.
Regarding claims 37 and 38, Radulescu discloses a device, method , and CRM, comprising a processor; and a memory storing a program which, when executed by the processor, causes the image processing apparatus to: perform data processing to generate first image data that based on acoustic waves generated by irradiating light on a subject into which a contrast agent has been injected and acquire a plurality of the first image data by repeating the generating of the first image data a plurality of times in a time series, and perform image processing to extract a region corresponding to the contrast agent in the plurality of the first image data acquired in the data processing, and generate second image data including the extracted region corresponding to the contrast agent (see abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1).
Forbrich discloses a similar photoacoustic imaging system and method, wherein contrast agent is used to image lymphatic tissue and vessels with irregular flow interval as a plurality of regions over time (see entire document, noting abstract, introduction, and discussion). Forbrich also discloses at Fig. 4 regions of contrast at four steps along a lymphatic vessel over time. Forbrich also appears to disclose still images (see entire document, noting abstract, introduction, and discussion).
It would have been obvious and predictable to have combined Radulescu and Forbrich to image lymphatic tissue because lymphatic tissue is related to the diagnosis of diseases such as obesity, diabetes, and cancer.
Similarly, Watanabe discloses a similar contrast agent image processing system and method, where regions of an anatomical vessel are filled with contrast, said contrast agent is imaged over time in time series to determine a plurality of regions, including first image data where the contrast agent has migrated, and combining said plurality of regions to provide a larger combined region where contrast agent has passed by over time (see Figs. 1-3, abstract, col 5 ln 43-col 7 ln 8, and col 7 ln 30-65).
It would have been obvious and predictable to have combined Radulescu and Forbrich with the further teaching of Watanabe to image lymphatic tissue because doing so would show the larger combined area over which contrast has migrated in the lymphatic vessels and because doing so would provide a better image contrast.
Examiner notes that for the device and CRM claims all of the lymphatic claim limitations are merely intended use and the device of the combined prior art is capable of performing said intended use. Further, regarding the method, the pulsatile nature of the lymphatic vessels does not impart a method step and is rather a property of the subject.
Radulescu does not specifically disclose how values are selected for extraction.
However, Yamauchi discloses a similar photoacoustic imaging device in which an image value in a predetermined range is used to extract contrast agent regions in an image (see para 116).
It would have been obvious and predictable to have combined the teachings of Radulescu and Yamauchi because doing so would predictably and automatically allow the imaging device to extract contrast agent regions so that said regions are easily identifiable in an image. Such an automated processor of selecting values of a high enough value would ensure an efficient computational process as well as ensure that only contrast agent portions were extracted. Examiner notes that selecting positive or negative values or magnitude levels of data would have been a mere matter of design.
Umezawa discloses a similar photoacoustic imaging device, wherein blood vessels are imaged and displayed separately from other tissues (see Figs. 2 and 3 and para 56-60, 68-73, and 92-93).
It would have been obvious and predictable to also image the blood vessels because doing so would provide a complete picture of the anatomy of the subject. For example, the combined references already teach imaging of contrast and of lymphatic vessels and adding blood vessels to the image would provide a more complete image, thus allowing a user to target, avoid, or analyze tissues in the subject.
Morscher discloses a similar photoacoustic imaging system, wherein contrast agent is imaged over time and displayed as still images and as video images over time (see para 41-54). Further, Morscher discloses displaying contrast agent images overlaid on anatomical images, the other regions other than the lymphatic vessels (see para 41-54, noting that at least Radulescu teaches contrast agent imaging, Forbrich teaches lymphatic vessel imaging, and Umezawa discloses blood vessel imaging).
It would have been obvious and predictable in light of Morscher to display single still images or video images to show medical imaging data from a single instance or over time. Further, Morscher indicates that it is a mere design choice to highlight contrast agent data or to show a complete image of contrast agent data overlaid on a general anatomical image, which in combination includes blood and lymph vessels.
Courtney discloses a similar contrast-based imaging system, wherein in the generating, an image is generated that takes a region, in which an image value has changed over time in the plurality of the first image data, as a lymphatic vessel region (see para 150 and noting in combination Radulescu teaches imaging lymphatic vessel regions with contrast).
It would have been obvious and predictable to have combined the teachings of Courtney and Radulescu because doing so would predictably provide an extra way to identify contrast agent so that no contrast agent is missed in the image.
Regarding claim 38, using a threshold for a comparison is well known and obvious in the art for determining when a condition is met. Accordingly, a skilled artisan would have recognized that using a threshold to determine a change condition already known in the prior art is obvious.
Regarding claim 41, Radulescu, discloses a device, wherein the pixel value of the first image data is a pixel value of a spectral signal based on a plurality of photoacoustic signals obtained by irradiating the subject with light of a plurality of different wavelengths (see abstract, Figs. 1-3, para 24, 33-41, 48, 50, and 51, and claim 1).
Response to Arguments
Although moot in view of the new grounds of rejection, Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive.
Applicant’s remarks are unpersuasive for the reasons noted in the Final Rejection dated June 4, 2025.
Claim 39 could be allowable if written in proper independent form.
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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/RAJEEV P SIRIPURAPU/ Primary Examiner, Art Unit 3798