DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Response to Amendment
Applicant’s response to the last Office Action, filed on 4/13/2026 has been entered and made of record.
Claim rejection under 35 USC 112(a) is added below.
Response to Arguments
Applicant's arguments filed on 4/13/2026 have been fully considered but they are not persuasive.
Examiner finds that the existing references teach the newly amended claim language. Wilson ¶ 0042 teaches using three fluorophores, two targets and a reference, each with separate emissions wavelengths. This embodiment at ¶ 0042 include obtaining three wavelength bands associated with fluorescence emitted by the substance. See detailed analysis below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 4, 6, 7, 13, 30, 32, 35, 50-52 and 54 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The original disclosure does not contain support for the language with which third image information/third wavelength bands are used in these claims. Examiner notes that the bulk of the original disclosure is directed at first and second image information/ wavelength bands and how these measurements are used to compute a property of a substance. Examiner also notes that there is some broad disclosure for using third image information/third wavelength bands or “other wavelength bands” such as the disclosures at ¶ 0065, 0094, 0097 and 0104. ¶ 0094 for examples mentions generally “other wavelength bands” and ¶ 0097 mentions generally “Additionally or alternatively, the image processing system may access relationship data that specifies relationships between different ratios and the property of the substance and determine the property of the substance based on the ratio and the relationship data.” This disclosure mentions different ratios which would presumably be related to the three wavelength bands. Further ¶ 0104 disclosures, “In some examples, the imaging processing system may optionally obtain third image information corresponding to a third wavelength band different from the first and second wavelength bands and associated with the fluorescence emitted by the substance and perform the other operations described in connection with FIG. 16 based on the first, second, and third image information.”
However, there is no support for including the third image information in any of the more detailed steps more computing the property of a substance, such as the following:
Claims 54, 3, 4, 30, 32, 35 and 52 require details of the ratio determined between wavelength bands. There is disclosure for computing this between the first and second image information/wavelength bands, but there is no support for adding the third image information to this ratio computation. Applicant does not have support to simply insert the third image information into detailed steps such as these without adequate disclosure for doing this and disclosure of how this would be done. Also, in this case it is not clear to Examiner what a ratio between these three measurements would mean or how it would be set up, absent any disclosure.
Claims 6 and 35 relate to determining a slope between the image information measurements. Applicant does not have support to simply insert the third image information into detailed steps such as these without adequate disclosure for doing this and disclosure of how this would be done.
Claims 7 and 13 relate to comparison in order determine the wavelength of the peak intensity of fluorescence. Here again, Applicant does not have support to simply insert the third image information into detailed steps such as these without adequate disclosure for doing this and disclosure of how this would be done.
Claims 50 and 51 relate to the wavelength bands being located on certain sides of the peak (same or opposite). While the language of claims 50 and 51 do not contain third image information themselves, they depend on claim 1 and the original disclosure does not provide support for doing computations with the three wavelength bands while specifying which of the first and second bands are located on which sides of the peak. Applicant does not have support to simply extend the third image information into this concept without adequate disclosure for doing this and disclosure of how this would be done.
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, 30, 50, 51, 53 and 54 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. ¶ 0033 teaches background on using two fluorophores, a target and a reference, with separate emission wavelengths. ¶ 0042 teaches using three fluorophores, two targets and a reference, each with separate emissions wavelengths. This embodiment at ¶ 0042 include obtaining three 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, ¶ 0042 teaches using three fluorophores, two targets and a reference, each with separate emissions wavelengths. This embodiment at ¶ 0042 include obtaining three wavelength bands associated with fluorescence emitted by the substance.)
output third image information corresponding to a third wavelength band different from the first and second wavelength bands and associated with the fluorescence emitted by the substance; (As above, ¶ 0042 teaches using three fluorophores, two targets and a reference, each with separate emissions wavelengths. This embodiment at ¶ 0042 include obtaining three wavelength bands associated with fluorescence emitted by the substance.)
an image processing system configured to: receive the first image information, the second image information, and the third image information from the imaging device; and (¶ 0051-0052)
determine, based on a comparison of the third image information to the first image information and 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 two wavelength techniques at Q1 at ¶ 0028, Q2 at ¶ 0030 and Q3 at ¶ 0035. ¶ 0042 teaches using two target fluorophores and one reference and comparing three wavelength image information bands. Step 104 provides excitation at three wavelengths, step 106 measures at three wavelengths, step 108 performs dividing both target measurements (first and second image information) by the reference measurement (third image information). Step 110 shows computing the two ratios at equations 5a and 5b.)
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 third image information to the first image information and 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. Wilson discloses 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, an intensity level of the fluorescence emitted by the substance in the second wavelength band included in the second image information, and an intensity level of the fluorescence emitted by the substance in the third wavelength band included in the third image information; and determining the property of the substance based on the ratio (see rejection of claim 1 regarding ¶ 0042’s ratio computation among the three image information wavelength bands). 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.)
Regarding claim 54, 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 ratio between an intensity level of the fluorescence emitted by the substance in the first wavelength band included in the first image information, an intensity level of the fluorescence emitted by the substance in the second wavelength band included in the second image information, and an intensity level of the fluorescence emitted by the substance in the third wavelength band included in the third image information, and determining the property of the substance based on the ratio. (See rejection of claims 1 and 30)
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 54, 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, a characteristic of the second image information and a characteristic of the third information, determining the property of the substance based on the slope. (See Wilson ¶ 0030 and 0042 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 54, 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
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.
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/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671
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