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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/25/2025 has been entered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 9 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quantitative tool for rapid disease mapping using optical coherence tomography images of azoxymethane-treated mouse colon by Winkler et al. (hereafter Winkler, of record).
Regarding claim 1, Winkler teaches: 1. (Currently Amended) A method for real-time characterization of spatially resolved tissue optical properties over a given tissue volume to differentiate tumor from non-tumor, comprising the steps of:
acquiring imaging data of the given tissue volume (see Winkler’s section 2.1 and/or 2.3 showing the acquisition of OCT image data, additionally as per the Abstract note that the basic premise of the invention is that this can be done for a 3D tissue sample (i.e. for a tissue volume per se));
calculating optical attenuation values for the given tissue volume using exponential fitting, or a Frequency-domain analysis algorithm (Winkler uses a frequency domain algorithm for calculating attenuation, e.g. page 2 paragraph 2 states “One prominent feature in OCT images is light attenuation, which can be quantified by fitting a line to averaged A-scans” so as to quantify (i.e. calculate) the attenuation of the optical CT data. As far as being frequency domain per se, note that the data is Fourier transformed. This can either be seen from the very Abstract or from section 2.1 as cited above to describe the data acquisition. As far as this being “for characterization”, this limitation is inherent as best understood, but for compact prosecution purposes the examiner notes that Winkler explicitly uses this in a step of characterizing which tissues are or are not tumor tissues as noted below in the rejection of the “determining” step below);
determining a diagnostic threshold from the calculated optical attenuation values for the given tissue volume; characterizing the given tissue volume as tumor versus non-tumor tissue (regarding these together see Winkler’s 2.5.3 noting that each of the metrics were calculated for each A-scan of the volume, and see also 3.1 noting that Winkler describes that the optical attenuation was “statistically significant for differentiating adenomas from normals and adenomas from GINs” and noting that this is applied to other “optical properties” such as the standard deviation of the attenuation and as previously iterated below the diagnostic threshold is used to label/characterize tissues as tumor versus non-tumor, e.g. “see Fig. 5 and read the key thereto which shows this to be a disease map that has been color coded; noting also that “Locations of adenomas (Ad), GINs (G), and LA, verified both in OCT and histology, are labeled.” Such that each label on the tissue, including labels for cancer (Ad) and non-cancer (all others) are based off of the OCT analysis. Then none that the OCT analysis is a threshold of the optical properties as per both section 2.5.3 and 3.1 which discusses that the cancer and non-cancer can be distinguished and that the threshold can be set to multiple levels to tailor the sensitivity and specificity in making this determination”) wherein if the calculated optical attenuation values for tissue within the given tissue volume is at or above the diagnostic threshold the tissue is non-tumor tissue and if the calculated optical attenuation values for tissue within the given tissue volume are below the diagnostic threshold the tissue is tumor tissue (As iterated Winkler’s section 2.5.3 in relevant part: “To assess the correlation between the quantitative metrics and disease, p-values using the z-test were calculated as well as the sensitivity and specificity to disease at different metric value thresholds”. That is, for each of the metrics (i.e. grey scale value, slope [i.e. attenuation], and slope standard deviation [i.e. standard deviation of the attenuation]) statistical analysis was performed to see if certain thresholds could differentiate between healthy and diseased tissues. Then Winkler states in 3.1 in salient part that: “The difference in slope was statistically significant between normals and GINs, with GINs have steeper slopes than normals” which can also be seen in Fig. 4. that a threshold analysis of the slope (i.e. attenuation) is a statistically significant differentiator between healthy and diseased tissues and which preserves the same base relationship as the claim, i.e. that normal tissue has higher attenuation and tumor tissue has lower attenuation. From there the only thing not explicitly taught by Winkler in this section is the formatting (i.e. that “at or above” instead of just “above” will correspond to normal tissue versus “below” instead of “at or below” will correspond to tumor tissue); however there are exactly and only those two ways/species to format this threshold and as such both are both can be immediately envisaged in the manner set forth in MPEP2131.02(III));
generating a quantitative, color-coded, and high-resolution optical property map for the given tissue volume, wherein the diagnostic threshold is used to label tissue within the given tissue volume as cancer or non-cancer on the quantitative, color-coded and high-resolution optical property map (see Fig. 5 and read the key thereto which shows this to be a disease map that has been color coded; noting also that “Locations of adenomas (Ad), GINs (G), and LA, verified both in OCT and histology, are labeled.” Such that each label on the tissue, including labels for cancer (Ad) and non-cancer (all others) are based off of the OCT analysis. Then none that the OCT analysis is a threshold of the optical properties as per both section 2.5.3 and 3.1 which discusses that the cancer and non-cancer can be distinguished and that the threshold can be set to multiple levels to tailor the sensitivity and specificity in making this determination); and
superimposing the quantitative, color-coded, and high-resolution optical property map onto the imaging data in real-time to enable data display to the user in real-time (see Fig. 5 wherein the overlay is self-evident or, for a textual explanation, see Winkler’s 3.2. As for being real time, see the title itself and/or see the explanation provided in the 1. introduction section noting that the endoscopy images are used by the endoscopist in real time, e.g. page 2 paragraph 3).
Regarding claim 2, Winkler teaches: 2. The method of claim 1, wherein the step of acquiring imaging data comprises acquiring imaging data from a group consisting of one dimensional (1D), two dimensional (2D), and three dimensional (3D) imaging data (notably this covers all possible groups and is therefore inherent; however and merely for compact prosecution purposes the examiner notes that at least 1D and 3D are explicitly covered insofar as the basic unit of scanning is A-scans, see Winkler’s section 2.1, and this is aggregated into a 3D scan as explained in Winkler’s Abstract).
Regarding claim 3, Winkler teaches: 3. The method of claim 1, wherein the step of acquiring imaging data comprises acquiring imaging data from a group consisting of optical coherence tomography and low coherence interferometry (see Winkler’s Abstract, noting the use of OCT).
Regarding claim 4, Winkler teaches: 4, The method of claim 1, further comprising programming the steps of the method on one or more non-transitory computer readable medium (the fact that the methodology of Winkler is computer implemented is inherent, e.g. humans cannot control electronics or read the sensor output directly at all, much less in rapid/real time. However and to compact prosecution the examiner also notes that the Introduction on page 2 paragraph 2 sets forth that this is computer analysis of OCT images and section 4. Discussion sets forth that the tissue classification steps are computer implemented).
Regarding claim 9, Winkler teaches: 9. The method of claim 1, further comprising processing imaging data for speckle reduction and then analyzing the imaging data for optical property quantification by one selected from a group consisting of fitting intensity decay versus depth over a given depth range of interest and using a Frequency domain harmonics analysis method, wherein a ratio between two harmonic components of a Fourier transformed intensity signal is identified (see first Winkler’s 2.5.1 noting that as a preprocessing step median filter was used to reduce speckle; then see Winkler’s 2.5.2 wherein to calculate the metrics the intensity decay, that is the slope of the log of intensity, was quantified over a 90 um range).
Regarding claim 12, Winkler teaches: 12. The method of claim 1, further comprising applying an aiming beam to visualize the given tissue volume (see Winkler’s section 2.1 and/or 2.3 showing the acquisition of OCT image data using a beam of light, then see Winkler’s sections 2.5 and/or 3.2 which describe, and through Figs. 3 and 5, also depict visualizing the tissue with this beam. For compact prosecution purposes the examiner notes that while the foregoing rejects the broad claim wording that only requires that a beam is used to visualize the tissue, a reference has been added into the conclusion section which shows that for an OCT endoscope using invisible (IR) light for scanning it is useful to add a second visible light beam that can be used for directing or aiming the OCT imaging which the applicant may find instructive given the contents of their specification)
Regarding claim 17, Winkler teaches: 17. (Currently Amended) The method of claim 1, further comprising maintaining a working distance of a compact imaging probe using a cap or a spacer (see Winkler’s section 2.1 noting the use of a 1.435 mm long glass spacer and/or see the same section that notes that a 2 mm glass encloses the optics so as to have multiple spacing elements that serve to maintain the working distance).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Winkler.
Regarding claim 10, Winkler does not address using Doppler imaging and therefore fails to teach: “10. (Currently Amended) The method of claim 1, further comprising overlaying the optical property map with Doppler information to identify critical structures such as blood vessels, avoiding potential injury during surgical interventions.”
However, the examiner notes that it is old and well known to overlay Doppler information. This is done in many modalities, for many reasons. For surgical applications it is well known to provide the utility of allowing the operator to avoid cutting a blood vessel accidentally and to determine if severed or clamped vessels are properly dealt with but, insofar as the applicants intended reasoning is not part of the actual overlay step under examination, the examiner notes that there are many other well-known reasons to include Doppler information in many other contexts such as assessing tissue health, cancer angiogenesis, ablation’s coagulatory effect, etc. in numerous other contexts well before the date of invention. For compact prosecution purposes the examiner has included a reference showing how Doppler can be enacted in optical systems such as Winkler have been previously made of record.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to improve the device of Winkler with the use of a Doppler overlay in order to advantageously allow for usage of blood flow data.
Response to Arguments
Applicant’s arguments, see page 5, filed 04/25/2025, with respect to the 112 rejections not maintained above have been fully considered and are persuasive. The associated rejections have been withdrawn.
Applicant's arguments filed 04/25/2025 with respect to the 102/103 rejections have been fully considered but they are not persuasive with each argument being responded to in the order presented as follows:
On pages 5-6 the applicant opines that the new claim wording is not taught by Winkler. In this instance the examiner notes that it appears that the applicant may have focused on Winkler’s preferred metric, the standard deviation of the attenuation, which did not confirm to the new claim language of “wherein if the calculated optical attenuation values for tissue within the given tissue volume is at or above the diagnostic threshold the tissue is non-tumor tissue and if the calculated optical attenuation values for tissue within the given tissue volume are below the diagnostic threshold the tissue is tumor tissue”; however, the examiner notes that while Winkler did teach that the standard deviation of the attenuation was the most effective metric for differentiating between cancerous and healthy tissues, he also taught using the grey scale intensity and attenuation directly in the same analysis in section 2.5.3 and taught that the optical attenuation in particular was a statistically significant metric which confirmed to this greater than/less than arrangement in 3.1 – both of which were previously cited with more direct quotations added to emphasize the relevant subject matter in the rejection above. As such, the examiner was not convinced by the applicant’s argument.
On page 6 the applicant opines that all other claims including claim 10 should be patentable at least by virtue of dependency. The examiner is not convinced by this argument at the current juncture because the foregoing argument was not convincing with regards to parent claim 1 as iterated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
US 20110082335 A1 by Omori et al. is an OCT imaging endoscope using IR light for scanning for cancer including GI cancers (i.e. in seemingly identically the same field of endeavor as the base art of Winkler used above) that also includes and describes the advantages of incorporating a visible aiming beam in such systems in e.g. [0061]-[0064].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
./PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798