DETAILED ACTION
Response to Amendment
Applicant’s response to the last Office Action, filed on 12/19/2025 has been entered and made of record.
Applicant’s amendments necessitated the new ground of rejection set forth herein; therefore, this action is made Final.
Response to Arguments
Applicant's arguments filed on 12/19/2025 have been fully considered but they are not persuasive.
The Bradbury reference has been added in view of the recently amended claim 52. Examiner finds that the remaining newly added claims are taught by the existing prior art.
The independent claims were amended to require determining the property comprises: determining a ratio between an intensity level of the fluorescence emitted by the substance in the first wavelength band included in the first image information and an intensity level of the fluorescence emitted by the substance in the second wavelength band included in the second image information; and determining the property of the substance based on the ratio. Examiner points Applicant to the Wilson reference in which number of ratio-based techniques are taught to compare the first and second image intensity information to determine a property of the substance, see Q1 at ¶ 0028, Q2 at ¶ 0030 and Q3 at ¶ 0035.
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.
Claim(s) 1, 7-14, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US PGPub 2011/0042580).
Regarding claim 1, Wilson discloses a system comprising:
an imaging device configured to: (¶ 0050 teaches a fluorescence imaging system)
output first image information corresponding to a first wavelength band associated with fluorescence emitted by a substance; and (See one embodiment at ¶ 0024 and numeral 106 regarding the fluorescence signal. Another embodiment at ¶ 0028 teaches using two excitation wavelengths and one fluorophore with one emission wavelength. Another at ¶ 0033 teaches using two fluorophores with separate emission wavelengths. All of these embodiments include obtaining two wavelength bands associated with fluorescence emitted by the substance.)
output second image information corresponding to a second wavelength band different from the first wavelength band and associated with the fluorescence emitted by the substance; and (As above, see one embodiment at ¶ 0024 and numeral 106 regarding the fluorescence signal. Another embodiment at ¶ 0028 teaches using two excitation wavelengths and one fluorophore with one emission wavelength. Another at ¶ 0033 teaches using two fluorophores with separate emission wavelengths. All of these embodiments include obtaining two wavelength bands associated with fluorescence emitted by the substance.)
an image processing system configured to: receive the first image information and the second image information from the imaging device; and (¶ 0051-0052)
determine, based on a comparison of the first image information to the second image information, a property of the substance. (A number of techniques are taught to compare the first and second image information to determine a property of the substance, see Q1 at ¶ 0028, Q2 at ¶ 0030 and Q3 at ¶ 0035.)
wherein the determining the property comprises: determining a ratio between an intensity level of the fluorescence emitted by the substance in the first wavelength band included in the first image information and an intensity level of the fluorescence emitted by the substance in the second wavelength band included in the second image information; and determining the property of the substance based on the ratio. (A number of ratio-based techniques are taught to compare the first and second image intensity information to determine a property of the substance, see Q1 at ¶ 0028, Q2 at ¶ 0030 and Q3 at ¶ 0035.)
Wilson does not expressly disclose that all of the above-cited teachings are disclosed in the same embodiment. That is, there is no express disclosure that the details of the image output information, image processing system receiving step and the determination steps are all found in the same embodiment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Wilson’s teachings for image output information, image processing system receiving step and the determination steps in order to provide a single system capable of the tasks that Wilson discloses. In view of these teachings, this cannot be considered a non-obvious improvement over the prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 7, the above combination discloses the system of claim 1, wherein the image processing system is configured to determine the property of the substance by: determining, based on the comparison of the first image information to the second image information, a wavelength associated with a peak intensity level for the fluorescence; and determining the property of the substance based on the wavelength associated with the peak intensity level for the fluorescence. (¶ 0045 which teaches selecting the peak absorption intensity wavelength and determining the property of the substance on this basis.)
Regarding claim 8, the above combination discloses the system of claim 1, wherein: the substance is located in a body while the substance emits the fluorescence, and the substance comprises an exogenous substance introduced into the body. (¶ 0086 teaches introducing an exogenous fluorophore.)
Regarding claim 9, the above combination discloses the system of claim 1, wherein: the substance is located in a body while the substance emits the fluorescence, and the substance comprises an endogenous substance naturally located within the body. (¶ 0033 teaches using naturally occurring fluorophores in the body.)
Regarding claim 10, the above combination discloses the system of claim 1, wherein the property of the substance comprises an amount of the substance. (See rejection of claim 1.)
Regarding claim 11, the above combination discloses the system of claim 10, wherein the amount comprises one or more of a concentration of the substance or a total amount of the substance. (See rejection of claim 1.)
Regarding claim 12, the above combination discloses the system of claim 1, wherein the property of the substance comprises an identity of the substance. (¶ 0067 teaches the imaging to detect the identity of the fluorophore tissue in the image.)
Regarding claim 13, the above combination discloses the system of claim 1, wherein the property of the substance comprises a wavelength associated with a peak intensity level for the fluorescence. (See rejection of claim 7.)
Regarding claim 14, the above combination discloses the system of claim 1, wherein the image processing system is further configured to present content indicating the property of the substance. (¶ 0067 teaches the imaging to detect the identity of the fluorophore tissue in the image and present content overlaying the content of the substance.)
Claims 30 are the apparatus claims corresponding to the system of claims 1-2, and 5. ¶ 0065 teaches a processor and memory. Remaining limitations are rejected similarly. See detailed analysis above.
Regarding claim 50, the above combination discloses the system of claim 1, wherein the first wavelength band is located on an opposite side of a spectral peak of a spectral intensity plot than the second wavelength band. (As above, Wilson teaches spectral imaging measuring light across a wide spectrum of wavelength bands, see ¶ 0056-0063. As is seen in Figs. 3A-C and Fig. 4 this includes measuring spectral intensity across a range of wavelengths including on the same side and on different sides of intensity peaks.)
Regarding claim 51, the above combination discloses the system of claim 1, wherein the first wavelength band is located on a same side of a spectral peak of a spectral intensity plot than the second wavelength band. (See rejection of claim 50.)
Regarding claim 53, the above combination discloses the system of claim 1, wherein the image processing system is further configured to present content indicating the property of the substance, wherein the presenting the content comprises directing a display device to display a graphic indicating the property of the substance together with an image depicting the fluorescence. (See overlay in display at ¶ 0067.)
Claim(s) 3, 4, 6, 32, 33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US PGPub 2011/0042580) in view of Ring (WO 2000042418 A1; provided by Applicant).
Regarding claim 3, the above combination discloses the system of claim 2, wherein the image processing system is further configured to: use relationship data that specifies relationships between different ratios and possible values for the property of the substance, and wherein determining the property of the substance based on the ratio comprises determining the property of the substance based on the ratio and the relationship data. (¶ 0032 and 0081 teach the relationship data between the quantification ratio, such as Q1 or Q3, and the marker concentration. ¶ 0091 teaches deriving and using the relationship.)
In the field of fluorescence-based imaging Ring teaches accessing said relationship data for use in determining the property of the substance (Ring teaches using optical sensors for fluorescence ratio measurements to determine the concentration of analytes in a biological sample. See pg. 16, first full paragraph and pg. 19, ¶ 4.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Wilson’s fluorescence-based imaging with Ring’s fluorescence-based imaging. Wilson and Ring both teach fluorescence-based imaging using intensity ratios of light in different wavelengths to quantify the concentration of fluorescent analytes. Both references teach the basic relationship between the ratios and concentration. Ring expressly teaches the step of accessing this relationship for use in determining concentration. This cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 4, the above combination discloses the system of claim 3, wherein the image processing system is configured to maintain the relationship data in a memory of the image processing system. (As above see Ring pg. 16, first full paragraph and pg. 19, ¶ 4 and Wilson ¶ 0083 which both teach image processing systems with memory.)
Regarding claim 6, the above combination discloses the system of claim 1, wherein the image processing system is configured to determine the property of the substance by: determining a slope between a characteristic of the first image information and a characteristic of the second image information and determining the property of the substance based on the slope. (See Wilson ¶ 0030 and Ring pg. 9, ll. 21-29.)
Claims 32-33 and 35 are the apparatus claims corresponding to the system of claims 3-4. ¶ 0065 teaches a processor and memory. Remaining limitations are rejected similarly. See detailed analysis above.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US PGPub 2011/0042580) in view of Bradbury (US PGPub 2015/0182118)
Regarding claim 52, the above combination discloses the system of claim 1, but not the remaining limitations.
In the field of fluorescence guided surgery Bradbury teaches that the intensity level of the fluorescence emitted by the substance in the first wavelength band includes an average intensity level representative of an average of each intensity level of the fluorescence within the first wavelength band, and wherein the intensity level of the fluorescence emitted by the substance in the second wavelength band includes an average intensity level representative of an average of each intensity level of the fluorescence within the second wavelength band. (Bradbury teaches a system for fluorescence guided surgery. ¶ 0226-0227 teaches capturing the average intensity of first and second wavelength bands that is then used in a ratio to determine corrected average intensity.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Wilson’s fluorescence-based imaging with Bradbury’s fluorescence-based imaging. Wilson teaches fluorescence-based imaging using intensity ratios of light in different wavelengths bands. Bradbury teaches a system for fluorescence guided surgery using average intensity of first and second wavelength bands. Simply averaging spectral intensity cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Conclusion
Based on these facts, THIS ACTION IS MADE FINAL. 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Raphael Schwartz whose telephone number is (571)270-3822. The examiner can normally be reached Monday to Friday 9am-5pm CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent Rudolph can be reached at (571) 272-8243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671