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 . 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.
Election/Restrictions
Applicant’s election of Group I, claims 1-5, drawn to a method for fluorescent imaging of a subject comprising placing an illuminator in a surgical area of a subject, in the reply filed on 03/06/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/06/2020.
Claim Rejections - 35 USC § 103 - Obviousness
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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Dalma-Weiszhausz et al (US 2024/0049943A1).
Dalma-Weiszhausz taught a fluorescence evaluation apparatus to be inserted into a body [claim 56, and at the abstract], and methods thereof [claim 70]. Said methods comprised an imaging device (e.g., endoscope [0054, 0145, 0156]), configured to illuminate a scene within a body [0004] (e.g., a surgical area [0088, 0112, 0126, 0143-0144]). At ¶ [0002], Dalma-Weiszhausz disclosed that an imaging device (e.g., an endoscope) may be used during a surgical procedure to capture images of a surgical area associated with a patient. The images were generated based on detected fluorescence emitted by a fluorescence imaging agent [0002], wherein the fluorescence imaging agent was administered to the body [0008].
Dalma-Weiszhausz taught capturing one or more images of a scene [0087-0089, 0092-0093, 0099] (e.g., reads on acquiring a plurality of images) showing intensity over a definable parameter (e.g., reads on over a predetermined time period) [0054, 0060, 0098, 0135]; and, assessing the fluorescence to determine adjustment of the apparatus and fluorescent agent [0109-0113, 0118, 0128, 0130-0136] (e.g., reads on analyzing to determine changes). Additionally, Dalma-Weiszhausz taught that the image processor may be configured to selectively apply a gain to a fluorescence image, in order to adjust the illumination intensity of the fluorescing regions [0103, 0137, 0140].
Claim 1 is rendered prima facie obvious over the teachings of Dalma-Weiszhausz, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., fluorescent imaging, illuminator, fluorescent imaging agent, surgical area, exposure gain) were known in the prior art (e.g., Dalma-Weiszhausz) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., a fluorescence evaluation apparatus and methods of fluorescent imaging) to one of ordinary skill in the art. MPEP 2143.A.
Claim 5 is rendered prima facie obvious because Dalma-Weiszhausz taught indocyanine green [claim 59].
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dalma-Weiszhausz et al (US 2024/0049943A1), in view of Lund et al (US20200146564A1).
The 35 U.S.C. 103 rejection over Dalma-Weiszhausz was previously described.
Additionally, Dalma-Weiszhausz taught indocyanine green, as previously discussed; and, Dalma-Weiszhausz taught that the surgeon assessed the colon (e.g., reads on the surgical area is a portion of the gastrointestinal tract) [0112, 0114].
Dalma-Weiszhausz did not describe a perfusion slope, as recited in claims 2-4.
Lund taught a method of perfusion assessment of a tissue of an anatomical structure of a subject (e.g., during a surgical procedure [0007]), the method comprising, administering a fluorescent imaging agent (e.g., indocyanine green to visualize blood flow and perfusion, [claim 19, ¶s 0003, 0024, 0083]) to the subject, producing an analysis, acquiring and analyzing fluorescence images (e.g., by an endoscopic imaging system, [0028]) of the anatomical structure and determining a perfusion parameter (e.g., perfusion slope [claims 10 and 14 and at ¶ 0128]) the structure based on said analysis [claim 1].
Various parameters can be determined based on image analysis of fluorescence emission. From this analysis, relative and/or quantitative data for perfusion, blood volume and/or blood flow can be determined, i.e. based on results of the image analysis of the time series of fluorescence images. In particular, the perfusion slope of the flow of the fluorescent contrast agent through regions of interest can be determined. The perfusion slope is a key parameter, because it is a direct indication of the perfusion in the imaged tissue [0078, 0099].
At ¶ [0006], Lund taught that surgeons cannot afford to leave an insufficiently perfused organ or part of the bowel, because doing so can lead to tissue ischemia, necrosis, infections, anastomosis leakage and even death. At ¶ [0176], Lund taught various other risk factors associated with insufficient perfusion of the gastrointestinal tract.
Since Dalma-Weiszhausz taught administering indocyanine green into a surgical field, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Dalma-Weiszhausz, the determination of a perfusion slope, as taught by Lund. The ordinarily skilled artisan would have been so motivated, because, as a key parameter, the perfusion slope is a direct indication of the perfusion (e.g., blood flow), and as such, the skilled artisan would be motivated to determine blood flow through the imaged tissue and/or surgical field, as taught by Lund [0003, 0007, 0024, 0078, 0083, 0099, 0128, claims 10, 14 and 19].
Regarding claim 4, the claim requires that the perfusion slope indicate leakage in the surgical area.
The combined teachings of the prior art were not specific as the perfusion slope as an indication of leakage in the surgical field.
However, it would be prima facie obvious to one of ordinary skill in the art to determine, as per the perfusion slope, indication of leakage in the surgical field.
This is because Lund taught that surgeons cannot afford to leave an insufficiently perfused organ or part of the bowel, because doing so can lead to tissue ischemia, necrosis, infections, anastomosis leakage and even death. Additionally, Lund taught that there are various other risk factors associated with insufficient perfusion of the gastrointestinal tract. The ordinarily skilled artisan would be motivated to determine perfusion throughout the surgical field, as taught by Lund [0006, 0176].
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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