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 .
Response to Amendment
This Office action is responsive to the amendment filed on November 12, 2025. As directed by the amendment, claims 1 and 20 have been amended, claims 2 and 21 have been cancelled and claim 29 has been added. Thus, claims 1, 3-8, 12-16, 20, 22-23 and 25-27 and 29 are presently pending, with claims 15-16 being withdrawn from further consideration.
The amendment to the specification is hereby acknowledged and will be entered.
The amendments to the claims noted above are sufficient to overcome the objection to claim 1 and the 35 U.S.C 112(b) rejection of claim 23 from the Office action of June 18, 2026. Accordingly, the objection to claim 1 and the 35 U.S.C 112(b) rejection of clam 23 are hereby withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: controller configured for or is configured for directly correlating a temperature of ... in claims 1 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 3-5, 12-14, 20, 22, 25-27 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by previously cited Baker, JR et al., US 20110077547 A1, hereinafter "Baker".
Regarding claims 1 and 29, Baker discloses a system ([abstract], Fig. 6 [0025]) comprising: a light source configured to providing a beam of light to a sample of biological tissue, the beam of light including wavelengths over a range of at least 50 nm (emitter “74”, wavelength of red to infrared range is at least 50 nm [0025]); a spectrometer configured for measuring a spectrum of an amount of light reflected from the biological tissue in response to the beam of light provided to the biological tissue (spectroscopic sensor “72” [0025]); and a controller configured for directly correlating a temperature of the biological tissue with a wavelength of a water absorption peak in the measured spectrum to determine a temperature of the biological tissue (monitor “82” may include appropriate processing circuitry for determining temperature parameters, such as a microprocessor 92 [0027]; As shown in FIG. 8, a sensor 72 may incorporate detectors spaced apart different distances (shown as distances di, d2 , d3 ,and d4) from an emitter 74. If the distances correspond with characteristic water absorption profiles and mean photon penetration depths, then any change that occurs during an ablation may be correlated to an empirically or mathematically derived tissue temperature [0030]; the sensor 72 may collect data during the ablation (block 138). The sensor 72 may also collect post-ablation data (block 140). The monitor 82 may perform analysis of the signals from the sensor 72 and calculation of the tissue temperature (block 142) based on the signal obtained [0031]; For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032], changes in the water absorption peaks are discussed in relation to Fig. 1, [0018], ( “… the water at 60° C. is shown to have a different characteristic absorption profile”) and/or claim 4 “determining the tissue temperature comprises determining a change in a magnitude, shape, or position of at least one water absorption peak” - the different graphs or changes in magnitude, shape or position of at least one water absorption peak that correlate with a temperature does not involve calculating any tissue property form the spectrum, much less, an absorption coefficient, a scattering coefficient and/or an anisotropy factor).
Regarding claim 3, Baker discloses the system of claim 1, wherein correlating the temperature of the biological tissue with the spectrum of the light reflected from the biological tissue includes correlating a slope of the spectrum with the temperature of the biological tissue (see claim 4 “determining the tissue temperature comprises determining a change in a magnitude, shape, or position of at least one water absorption peak” - change in a shape of a water absorption peak e.g., as depicted in Fig. 1 includes changes in a slope associated with said peak).
Regarding claim 4, Baker discloses the system of claim 1 further comprising an optical fiber configured for providing the beam of light to the biological tissue ([0025] “Depending on the particular arrangement of the sensor 72, the emitter 74 may be associated with an optical fiber for transmitting the emitted light into the tissue”).
Regarding claim 5, Baker discloses the system of claim 1 further comprising further comprising an optical fiber configured for providing the light reflected from the biological tissue to the spectrometer ([0025] “Depending on the particular arrangement of the sensor 72, the emitter 74 may be associated with an optical fiber for transmitting the emitted light into the tissue”).
Regarding claim 12, Baker discloses the system of claim 1 wherein the spectrometer is configured for measuring the spectrum of the amount of light reflected from the biological tissue in response to the beam of light provided to the biological tissue as the biological tissue is heated (the sensor 72 may collect data during the ablation (block 138). The sensor 72 may also collect post-ablation data (block 140). The monitor 82 may perform analysis of the signals from the sensor 72 and calculation of the tissue temperature (block 142) based on the signal obtained [0031]; For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032]); and wherein the controller is configured for directly correlating a temperature of the biological tissue with a change of spectrum of the light reflected from the biological tissue as the biological tissue is heated to determine a temperature of the biological tissue (The monitor 82 may perform analysis of the signals from the sensor 72 and calculation of the tissue temperature (block 142) based on the signal obtained [0031]; For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032]).
Regarding claim 13, Baker discloses the system of claim 12 wherein the change in the spectrum includes a change in a wavelength of a water absorption peak in the measured spectrum as the biological tissue is heated (For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032]).
Regarding claim 14, Baker discloses the system of claim 12wherein the change in the spectrum includes a change in a slope of the spectrum with the temperature of the biological tissue as the biological tissue is heated (see claim 4 “determining the tissue temperature comprises determining a change in a magnitude, shape, or position of at least one water absorption peak” - change in a shape of a water absorption peak e.g., as depicted in Fig. 1 includes changes in a slope associated with said peak).
Regarding claim 20, Baker discloses a method ([abstract], Fig. 6 [0025]) comprising: providing a beam of light to a sample of biological tissue, the beam of light including wavelengths over a range of at least 50nm (see illustration Fig. 6, beam of light is provided from emitter 74, wavelength of red to infrared range is at least 50 nm [0025]); measuring a spectrum of an amount of light reflected from the biological tissue in response to the beam of light provided to the biological tissue ( reflected light detected by detector 72 is measured by spectroscopic sensor “72” [0025]; and directly correlating a temperature of the biological tissue with a wavelength of a water absorption peak in the measured spectrum to determine a temperature of the biological tissue (the sensor 72 may collect data during the ablation (block 138). The sensor 72 may also collect post-ablation data (block 140). The monitor 82 may perform analysis of the signals from the sensor 72 and calculation of the tissue temperature (block 142) based on the signal obtained [0031]; For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032], this process does not involve calculation of any optical properties of the biological tissue from the spectrum, as discussed in [0018], ( “… the water at 60° C. is shown to have a different characteristic absorption profile”) and/or claim 4 “determining the tissue temperature comprises determining a change in a magnitude, shape, or position of at least one water absorption peak” - the different graphs or changes in magnitude, shape or position of at least one water absorption peak that correlate with a temperature does not involve calculating any tissue property form the spectrum).
Regarding claim 22, Baker discloses the method of claim 20 wherein directly correlating the temperature of the biological tissue with the spectrum of the light reflected from the biological tissue includes correlating a slope of the spectrum with the temperature of the biological tissue (see claim 4 “determining the tissue temperature comprises determining a change in a magnitude, shape, or position of at least one water absorption peak” - change in a shape of a water absorption peak e.g., as depicted in Fig. 1 includes changes in a slope associated with said peak and temperature would be determined by correlating a slope of the spectrum with temperature of the biological tissue).
Regarding claim 25, Baker discloses the method of claim 20 further comprising providing electromagnetic radiation to the sample of biological tissue to heat the sample of biological tissue (Ablation can be achieved by various techniques, including the application of radio frequency energy, microwave energy, lasers, and ultrasound [0003]).
Regarding claim 26, Baker discloses the method of claim 25 wherein directly correlating the temperature of the biological tissue with the spectrum of the light reflected from the biological tissue to determine a temperature of the biological tissue includes directly correlating a temperature of the biological tissue with a change of spectrum of the light reflected from the biological tissue as the biological tissue is heated to determine a temperature of the biological tissue (The monitor 82 may perform analysis of the signals from the sensor 72 and calculation of the tissue temperature (block 142) based on the signal obtained [0031]; For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032]).
Regarding claim 27, Baker discloses the method of claim 26 wherein the change in the spectrum includes a change in a wavelength of a water absorption peak in the measured spectrum as the biological tissue is heated or a change in a slope of the spectrum with the temperature of the biological tissue as the biological tissue is heated (For example, in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation [0032]).
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.
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.
Claims 6-8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Baker as applied to claim 1 or 20 above, and further in view of previously cited Wehner et al. EP 3449815 A1 hereinafter “Wehner”.
Regarding claim 6, Baker discloses in [0025] “Depending on the particular arrangement of the sensor 72, the emitter 74 may be associated with an optical fiber for transmitting the emitted light into the tissue”, however, Baker does not explicitly disclose at least one illuminating optical fiber, each illuminating optical fiber being configured for providing the beam of light to the biological tissue, each of the at least one illuminating optical fibers including a first end located proximate to the biological tissue from which the beam of light is provided to the biological tissue; and a plurality of detection optical fibers, each detection optical fiber having a second end configured for collecting the light reflected from the biological tissue and for providing the collected light to the spectrometer.
However, Wehner discloses several fibers can be used to separate different functions, e.g. one fiber for guiding light towards the site and one for collecting the backscattered light. Preferably the optical axes of the two optical fibers at their fiber ends facing the predetermined region of the tissue, [0016]. The heated area is at the same time illuminated with a light source 2, e.g. a white light or multi wavelength LED source, via illumination fiber or fiber bundle 6, The reflectance signal is captured by fiber or fiber bundle 8 and fed to a spectral detector 3, [0028] and illustration Fig. 7, i.e., Wehner teaches the use of a single fiber or a fiber bundle to perform the same function as art recognized alternatives. Inasmuch as Wehner discloses the use of a single fiber or a fiber bundle for illumination or for capturing the reflectance signal, it would have been obvious to one of ordinary skill in the exercise art at the time of filing the claimed invention to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute the optical fiber associated with the sensor 72 and emitter 74 of Baker with at least one illuminating fiber and a plurality of detection fibers as taught by Wehner, to predictably perform the same function of transmitting illumination light and collecting reflection signals form the tissue.
Regarding claim 7, Baker in view of Wehner substantially discloses the claimed invention as discussed in claim 6 above, but for wherein each of the second ends is located at a different distance from the first end from which the beam of light is provided to the sample of biological tissue. However, Baker discloses that it was known to arrange detectors with varied spacings (As shown in FIG. 8, a sensor 72 may incorporate detectors spaced apart different distances ( shown as distances d1, d2 , d3 , and d4) from an emitter 74. If the distances correspond with characteristic water absorption profiles and mean photon penetration depths, then any change that occurs during an ablation may be correlated to a empirically or mathematically derived tissue temperature). In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified each of the second ends to be located at a different distance from the first end from which the beam of light is provided to the sample of biological tissue in Wehner, so as to accurately derive the temperature of tissue when a distance corresponds with a characteristic water absorption profile and mean photon penetration.
Regarding claim 8, Baker in view of Wehner as discussed in claim 6 above does not explicitly disclose a heating optical fiber configured for providing electromagnetic radiation to the sample of biological tissue to heat the sample of biological tissue, wherein each of the illuminating optical fibers, each of the plurality of detection optical fibers, and the heating optical fiber are contained within a common fiber bundle.
However, Wehner discloses [T]he tissue sample 1 is irradiated by laser source 5 with fiber coupling 7 [0028]),wherein each of the illuminating optical fibers, each of the plurality of detection optical fibers, and the heating optical fiber are contained within a common fiber bundle (When targeting sites inside the body either through natural body cavities such as the mouth, endoscopically, or through surgical openings, optical setups with one or more optical fibers are used … In another option, several fibers can be used to separate different functions, e.g. one fiber for guiding light towards the site and one for collecting the backscattered light [0016]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified Baker to include a heating optical fiber configured for providing electromagnetic radiation to the sample of biological tissue to heat the sample of biological tissue, wherein each of the illuminating optical fibers, each of the plurality of detection optical fibers, and the heating optical fiber are contained within a common fiber bundle s taught by Wehner, to allow for targeting of tissue targets inside the body either through natural body cavities such as the mouth, endoscopically, or through surgical openings.
Regarding claim 23, Baker substantially discloses the claimed invention as discussed in claim 20 above, and further comprising providing the beam of light to a sample of biological tissue in an illuminating optical fiber (Depending on the particular arrangement of the sensor 72, the emitter 74 may be associated with an optical fiber for transmitting the emitted light into the tissue [0025]); and collecting the reflected light from a plurality of detectors from the sample of biological tissue and for providing the collected light to a collection detector (sensor 72 may also incorporate additional detectors 76 with varied spacing around the emitter 74. As shown in FIG. 8, a sensor 72 may incorporate detectors spaced apart different distances (shown as distances d1, d2 , d3 , and d4) from an emitter 74 [0030]) and wherein each detector is located at a different distance from the ablation device (note: the different arrangement of detectors 76 infer that the detectors will be located at different distances from the ablation device), and the method further comprising: selecting a detector form the plurality of detectors the detector being selected to define an average depth of the sample from which the collected light is collected (As shown in FIG. 8, a sensor 72 may incorporate detectors spaced apart different distances ( shown as distances d1, d2 , d3 , and d4) from an emitter 74. If the distances correspond with characteristic water absorption profiles and mean photon penetration depths, then any change that occurs during an ablation may be correlated to a empirically or mathematically derived tissue temperature [0029], i.e., correlation requires selecting the data from a detector that coincides with the mean (i.e., average) photon penetration depth).
Baker thus differs with the claimed invention, in the aspect of collecting the reflected light in a collection fiber of a plurality of collection optical fibers, each having a second end configured for collecting the light. However, Wehner discloses that it was known in the prior art to collect reflectance signal by a fiber or a fiber bundle to feed to a Spectral detector ([0028] and illustration Figs. 7-8, optical detection means 8) and that it was within the ordinary abilities of those skilled in the art at the time of filing the claimed invention, to select an optical setup based on a site of application ([0016]). In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have selected an optical setup that includes a plurality of optical fibers each having a second end configured for collecting the light e.g., as depicted in Figs. 7-8 of Baker, for the added advantage of application site inside the body that would need to be accessed through natural body cavity, endoscopically or through surgical openings.
Response to Arguments
Applicant’s arguments directed to 35 U.S.C 102 rejections in view of Wehner have been considered but are moot as those rejections have been withdrawn because Wehner does not teach “correlating a temperature of the biological tissue with a wavelength of a water absorption peak in measured spectrum” as required by the pending claims.
Applicant’s arguments directed to 35 U.S.C 102 rejections in view of Baker have been considered, but are not persuasive. Applicant’s sole argument is to be found in page 12 of the remarks that Baker describes calculating a water absorption value from the spectra, examiner respectfully disagrees. As noted in [0018] of Baker, the water absorption value is measured spectroscopically and not calculated [0018] "the absorption of water or other constituents whose absorption, as measured spectroscopically, changes with temperature” e.g., as depicted in Fig. 1, and [0032] “… in one embodiment, the tissue temperature may be determined by examining changes in the water absorption peaks over the course of the ablation”. Examiner notes that Applicant disclosure also discloses a similar water absorption value that is obtained from spectrum and is not considered and/or characterized as a calculated optical property of the biological tissue.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797