DETAILED ACTION
This action is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION” filed 3 December 2025. The Examiner acknowledges the amendments to claims 1, 3-4, 6-7, 10-11, 17, and 19, as well as the cancelation of claims 13-15 and 20. Claims 1-12 and 16-19 are pending.
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 .
Claim Objections
Claim(s) 11 and 17 is/are objected to because of the following informalities:
Claim 11 should read “At least one non-transitory computer-readable medium comprising a set of instructions that, in response to being executed by a processor circuit cause the processor circuit to perform the set of instructions, wherein the set of instructions comprise steps to:” [lines 1-3] to clearly identify claim 11 as at least one non-transitory computer-readable medium comprising a set of instructions to be executed by a processor circuit instead of a processor circuit that performs a set of instructions stored on at least one non-transitory computer-readable medium. The Examiner notes that similar amendments should be made to claims 12 and 16.
Claim 11 should read “determine, via a first light detector, a first intensity value[s]” [line 4].
Claim 11 should read “reflects off of a target” [line 6].
Claim 17 should read “illuminating” [line 2], as the Examiner notes that the amended portion should not be capitalized.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 11-12 and 16-19 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 11 [representing all independent claims] recite(s):
At least one non-transitory computer-readable medium comprising a set of instructions that, in response to being executed by a processor circuit, cause the processor circuit to:
determine, via first light detector, a first intensity values based on first reflected laser light corresponding to a laser source, wherein the first reflected laser light enters a proximal end of an optical fiber, exits a distal end of the optical fiber, reflects of a target, and enters the distal end of the optical fiber;
determine, via a second and a third light detector, a second intensity value and a third intensity value based on second reflected laser light corresponding to the laser source, wherein the second reflected laser light is reflected off of the proximal end of the optical fiber;
compute a ratio based on the first intensity value, the second intensity value, and the third intensity value; and
estimate, during a urological surgical procedure, a distance between the distal end of the optical fiber and the target based on the ratio.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 11 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“compute a ratio based on the first intensity value, the second intensity value, and the third intensity value” – may be performed by merely observing previously collected or known data and drawing conclusions therefrom using known or derived mathematical formulas/equations using at least a limited amount of data under no particular time constraints [Applicant’s Specification ¶0132, Equation 2.1]
“estimate, during a urological surgical procedure, a distance between the distal end of the optical fiber and the target based on the ratio” – may be performed by merely observing previously collected or known data and drawing conclusions therefrom using known or derived mathematical formulas/equations using at least a limited amount of data under no particular time constraints [Applicant’s Specification ¶0132, Equation 2.2], wherein the Examiner notes that the estimation of the distance being performed “during a urological surgical procedure” merely limits when the abstract idea may be performed and does not impart any particular possible additional elements of specific methodology or equipment associated with or used during an urological surgical procedure
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “compute a ratio based on the first intensity value, the second intensity value, and the third intensity value”, “estimate, during a urological surgical procedure, a distance between the distal end of the optical fiber and the target based on the ratio”] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 11 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity of generic computer function [at least one non-transitory computer-readable medium, processor circuit of claim 11], data gathering [“determine, via first light detector, a first intensity” and “determine, via a second and a third light detector, a second intensity value and a third intensity value respectively” of claim 11, wherein the Examiner notes that the limitations of claim 11 “wherein the first reflected laser light enters a proximal end of an optical fiber, exits a distal end of the optical fiber, reflects of a target, and enters the distal end of the optical fiber” and “wherein the second reflected laser light is reflected off of the proximal end of the optical fiber” are considered to merely limit the type of light detected by the detector or where the reflected laser light came from, but is not considered to be a positive recitation of any step of laser emission/reception using an optical fiber; and similar “receiving…” and “measuring…” limitations of claim 17] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed generic computer function, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 12 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 16 and 18-19 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claim(s) 11 and 17 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function, data gathering] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps of electronic communication as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [generically recited non-transitory computer-readable medium, processor circuit, user interface (claim 16)], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and functions therein, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 11 recites “determine, via a first light detector, a first intensity values” and “determine, via a second and a third light detector, a second intensity value and a third intensity value respectively”; and 17 recites “measuring intensity of the first and second reflected light beams with a plurality of light detectors”, wherein claim 19 further recites “measuring a first intensity value of the reflected light beams corresponding to laser light of a first wavelength and a second intensity value of the reflected light beams corresponding to laser light of a second wavelength”. Such a light detector is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed light detectors, and recites the light detectors at a high level of generality [Light detectors may include devices that detect and/or measure characteristics of light beams and encode the detected and/or measured characteristics in electrical signals (Applicant’s Specification ¶0063)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of light detection. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Khatchaturov [Light beam 150 propagates along optical fiber 100 and illuminates tissue 90. Tissue 90 reflects some of the light (115) away from optical fiber 100, while a part of the light re-enters optical fiber 100 at the fiber's distal end 120 as reflection 110. Reflection 110 is transmitted backward in optical fiber 100 from distal end 120 to the fiber's proximal end 130 and is detected when emerging from proximal end 130 (Khatchaturov ¶0024, Fig. 2); Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026)]
Balicki [the optical sensor 114 is an optical coherence tomography (OCT) system. In other embodiments, one could include more than one OCT or other type of optical sensor into the surgical instrument 100 within broad concepts of the current invention (Balicki Col 4:49-54)]
Wang [The detection module also includes a first optical element in the first optical path to separate light at different wavelength bands into a first set of different beams, first light detectors to respectively receive and detector the first set of different beams from the first optical element, a second optical element in the second optical path to separate light at different wavelength bands into a second set of different beams, and second light detectors to respectively receive and detector the second set of different beams from the second optical element (Wang Col 4:40-49)]
Claim 11 recites “first reflected laser light corresponding to a laser source” and “second reflected laser light corresponding to the laser source”; and 17 recites “illuminating a target with a laser light of a plurality of different wavelengths”. Such a laser light is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed laser light, and recites the structure of the laser light at a high level of generality [The light source can be a laser light source. As an example, such a laser light sources may include, but is not limited to, solid-state lasers, gas lasers, diode lasers, and fiber lasers (Applicant’s Specification ¶0055)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of light irradiation. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Khatchaturov (US-20130123769-A1) [The term "laser" as used herein in this application refers to any type of laser--For example… diode (e.g. in various wavelengths, such as in the range 532-1600 nm) (Khatchaturov ¶0015)]
Balicki (US-10045882-B2) [In some embodiments of the current invention, the OCT system can make use of IR sources to provide significantly greater penetration depths into tissue than visible light, for example. Some embodiments of the current invention can include a broad band source in the OCT system, for example (see FIG. 4) (Balicki Col 5:9-14)]
Ikuta (US-20200154985-A1) [The broadband light source 110 may include a plurality of light sources or may be a single light source. The broadband light source 110 may include one or more of a laser, an OLED, a LED, a halogen lamp, an incandescent lamp, a supercontinuum light source pumped by a laser, and/or a fluorescent lamp. The broadband light source 110 may be any light source that provides light which can then be split up into at least three bands in which each band is further dispersed to provide light which is then used for spectral encoding of spatial information. The broadband light source 110 may be coupled by a light guiding component or may be free-space coupled to another component of the SEE probe system 100 (Ikuta ¶0021)]
Claim 11 recites “wherein the first reflected laser light enters a proximal end of an optical fiber, exits a distal end of the optical fiber, reflects of a target, and enters the distal end of the optical fiber” and “wherein the second reflected laser light is reflected off of the proximal end of the optical fiber”; and claim 17 recites “receiving first reflected light beams from the target via an optical fiber; receiving second reflected light beams from a proximal end of the optical fiber”, wherein claim 18 further recites “emitting the laser light of the plurality of different wavelengths via the optical fiber to illuminate the target”. Such an optical fiber is considered well-understood, routine, and conventional, as known by at least:
Khatchaturov [Khatchaturov ¶¶0024, 0026; The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99 (Khatchaturov ¶0059)]
Balicki [The optical coherence tomography system in the embodiment of FIG. 3 includes a single-mode optical fiber that provides the fixed end 116 of the optical sensor 114, the single-mode optical fiber being arranged to direct light to both the reference portion 112 of the surgical tool 102 and the tissue 118 proximate or in contact with the distal end 106 of the surgical tool 102 and to detect light reflected back from both the reference portion 112 of the surgical tool 102 and the tissue 118 to provide information regarding a relative distance of the distal end 106 of the surgical tool 102 to selected portions of the tissue 118 (Balicki Col 4:59-5:3, Figs. 2-3)]
Wang (US-7831298-B1) [the optical fiber probe device operable to direct probe light to and collect reflected light from the target area in the body through the probe optic fiber and the optical probe head and to further obtain information of the target area from the collected reflected light (Wang Col 2:57-61)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 11 and 17 recite subject matter regarding the claimed instructions/steps being performed “during a urological surgical procedure” [claim 11] and “during a surgical laser procedure” [claim 17], which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Examiner’s Note Regarding § 101 Analysis of Claims 1-10: The Examiner notes that claim(s) 1 recites a judicial exception [“estimate a distance between the distal end of the optical fiber and the target based on the intensity of the reflected light measured by the first light detector and the intensity of the portion of the laser light reflected from the proximal end measured by the second light detector and the third light detector”] at Step 2A Prong 1, which is considered to be an abstract idea using implicit mathematical formula(s) that may be performed by hand or in the mind using at least a limited amount of data under no particular time constraints. However, the Examiner further notes that claim(s) 1 recites limitation(s) [particularly “an optical fiber having a distal end and a proximal end, the optical fiber configured to receive laser light from the first and second laser sources at the proximal end, to reflect a portion of the laser light from the proximal end, to emit a portion pf the laser light out of the distal end, and to receive reflected laser light into the distal end” (emphasis applied), as well as the other additional elements directed towards the first laser source, second laser source, first light detector, second light detector, third light detector, and mirror] that is/are considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
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.
Claim(s) 1, 7-8, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov (US-20130123769-A1, previously presented) in view of Balicki (US-10045882-B2, previously presented).
Regarding claim 1, Khatchaturov teaches
A system, comprising:
a first laser source to generate laser light of a first wavelength and to generate laser light of a second wavelength [The term "laser" as used herein in this application refers to any type of laser--For example… diode (e.g. in various wavelengths, such as in the range 532-1600 nm) (Khatchaturov ¶0015)];
an optical fiber having a distal end and a proximal end, the optical fiber configured to receive laser light from the first laser source at the proximal end, to reflect a portion of the laser light from the first laser source from the proximal end, to emit a portion of the laser light from the first laser source out of the distal end, and to receive light reflected from a target into the distal end [Light beam 150 propagates along optical fiber 100 and illuminates tissue 90. Tissue 90 reflects some of the light (115) away from optical fiber 100, while a part of the light re-enters optical fiber 100 at the fiber's distal end 120 as reflection 110. Reflection 110 is transmitted backward in optical fiber 100 from distal end 120 to the fiber's proximal end 130 and is detected when emerging from proximal end 130 (Khatchaturov ¶0024, Fig. 2)];
a first light detector to measure intensity of the light reflected from the target [In particular, the measurement of the reflection intensities may be carried out on reflection 110 that is diverted after exiting proximal end 130 and directed to sensor 320 (Khatchaturov ¶0024, Fig. 2)];
a mirror to direct, to the light detector, the portion of the laser light reflected from the proximal end, the second light detector to measure intensity of the portion of the laser light reflected from the proximal end [Both entering light beam 150 and reflection 110 may be delivered to and from proximal end 130 (respectively) by optics such as lenses, minor, reflectors etc. In particular, the measurement of the reflection intensities may be carried out on reflection 110 that is diverted after exiting proximal end 130 and directed to sensor 320 (Khatchaturov ¶0024); Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026)]; and
a processor and memory comprising instructions that when executed by the processor cause the processor to estimate a distance between the distal end of the optical fiber and the target based on the intensity of the reflected light measured by the first light detector and the intensity of the portion of the laser light reflected from the proximal end measured by the light detector [The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99. Moreover, by comparing successive reflections from target tissue 90 that result from light beams of varying numerical aperture, a crude assessment of distance 125 between target tissue 90 and distal fiber end 110 may be achieved (Khatchaturov ¶0059), wherein differentiating between reflection 110 (reflected light into distal end) and reflection 99 (portion of light reflected from proximal end) is considered to read on forming a basis for estimating the claimed distance].
However, Khatchaturov fails to explicitly disclose wherein the laser light of the second wavelength is generated using a second laser source; a second light detector and a third light detector configured to measure the intensity of the portion of the laser light reflected from the proximal end.
Balicki discloses systems for measuring a distance between a distal end of an optical fiber and a target [The optical coherence tomography system in the embodiment of FIG. 3 includes a single-mode optical fiber that provides the fixed end 116 of the optical sensor 114, the single-mode optical fiber being arranged to direct light to both the reference portion 112 of the surgical tool 102 and the tissue 118 proximate or in contact with the distal end 106 of the surgical tool 102 and to detect light reflected back from both the reference portion 112 of the surgical tool 102 and the tissue 118 to provide information regarding a relative distance of the distal end 106 of the surgical tool 102 to selected portions of the tissue 118 (Balicki Col 4:59-5:3, Figs. 2-3)], wherein Balicki discloses the use of a plurality of light sources to illuminate the target via the optical fiber [In some embodiments of the current invention, the OCT system can make use of IR sources to provide significantly greater penetration depths into tissue than visible light, for example. Some embodiments of the current invention can include a broad band source in the OCT system, for example (see FIG. 4) (Balicki Col 5:9-14), wherein a broad band light source is considered to define a plurality of sources of laser lights of different wavelengths] and a plurality of light detectors to measure intensities of light reflected back through the optical fiber [the optical sensor 114 is an optical coherence tomography (OCT) system. In other embodiments, one could include more than one OCT or other type of optical sensor into the surgical instrument 100 within broad concepts of the current invention (Balicki Col 4:49-54)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Khatchaturov to employ wherein the laser light of the second wavelength is generated using a second laser source; a second light detector and a third light detector configured to measure the intensity of the portion of the laser light reflected from the proximal end, as this modification would amount to mere simple substitution of respective known elements [each of the laser source and light detector] for another with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 7, Khatchaturov in view of Balicki teaches
The system of claim 1, wherein the light detector measures a first intensity value of the light reflected from the target corresponding to the laser light of the first wavelength and a second intensity value of the light reflected from the target corresponding to the laser light of the second wavelength [Khatchaturov ¶¶0015, 0024, 0026, wherein Khatchaturov disclosing that the laser source may emit in various wavelengths is considered to read on the claimed limitation].
Regarding claim 8, Khatchaturov in view of Balicki teaches
The system of claim 7, wherein the instructions, when executed by the processor, further cause the processor to:
compute a ratio of the first intensity value and the second intensity value [Khatchaturov ¶0059, wherein determining a difference between reflection 110 (first intensity value) and reflection 99 (second intensity value) is considered to read on the broadest reasonable interpretation of computing a “ratio” based on the plain definition of “ratio” meaning the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio), wherein based on Khatchaturov ¶0015, it is understood that reflection 110 may be of a first wavelength and reflection 99 may be of a second wavelength]; and
estimate the distance between the distal end of the optical fiber and the target based on the ratio of the first intensity value and the second intensity value [Khatchaturov ¶0059, wherein differentiating between reflection 110 (reflected light into distal end) and reflection 99 (portion of light reflected from proximal end) is considered to read on forming a basis for estimating the claimed distance].
Regarding claim 17, Khatchaturov teaches
A method, comprising:
Illuminating, during a surgical laser procedure, a target with laser light of a plurality of different wavelengths [The term "laser" as used herein in this application refers to any type of laser--For example… diode (e.g. in various wavelengths, such as in the range 532-1600 nm) (Khatchaturov ¶0015); Light beam 150 propagates along optical fiber 100 and illuminates tissue 90. Tissue 90 reflects some of the light (115) away from optical fiber 100, while a part of the light re-enters optical fiber 100 at the fiber's distal end 120 as reflection 110. Reflection 110 is transmitted backward in optical fiber 100 from distal end 120 to the fiber's proximal end 130 and is detected when emerging from proximal end 130 (Khatchaturov ¶0024, Fig. 2), wherein assessing a distance between a medical laser tool and a target tissue as depicted in Khatchaturov Fig. 2 is considered to read on the broadest reasonable interpretation of the claimed step being performed during a surgical laser procedure (such as ablation, see Khatchaturov ¶0041)];
receiving, during a surgical laser procedure, first reflected light beams from the target via an optical fiber [In particular, the measurement of the reflection intensities may be carried out on reflection 110 that is diverted after exiting proximal end 130 and directed to sensor 320 (Khatchaturov ¶0024, Fig. 2)];
receiving, during a surgical laser procedure, second reflected light beams from a proximal end of the optical fiber [Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026)];
measuring, during a surgical laser procedure via a first light detector, a first intensity value of the first light beams with a plurality of light detectors [Khatchaturov ¶¶0024, 0026];
measuring, during a surgical laser procedure, a second and third intensity value respectively, of the second reflected light beams [Khatchaturov ¶0024, Fig. 2; The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99. Moreover, by comparing successive reflections from target tissue 90 that result from light beams of varying numerical aperture, a crude assessment of distance 125 between target tissue 90 and distal fiber end 110 may be achieved (Khatchaturov ¶0059), wherein any first measurement of light reflected from the proximal end may be the second intensity value and any additional measurement of light reflected from the proximal end may be the third intensity value];
computing, during the surgical laser procedure, a ratio based on the first intensity value, the second intensity value, and the third intensity value [Khatchaturov ¶¶0024, 0059, wherein determining a difference between reflection 110 (first intensity value) and successive reflections 99 (wherein any first reflection 99 may be the second intensity value and any additional reflection 99 may be the third intensity value) is considered to read on the broadest reasonable interpretation of computing a “ratio” based on the plain definition of “ratio” meaning the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio)]; and
estimating, during the surgical laser procedure, a distance between a distal end of the optical fiber and the target based on the ratio [Khatchaturov ¶0059].
However, Khatchaturov fails to explicitly disclose wherein the measuring of the second and third intensity value is via a second and a third light detector, respectively.
Balicki discloses systems for measuring a distance between a distal end of an optical fiber and a target [The optical coherence tomography system in the embodiment of FIG. 3 includes a single-mode optical fiber that provides the fixed end 116 of the optical sensor 114, the single-mode optical fiber being arranged to direct light to both the reference portion 112 of the surgical tool 102 and the tissue 118 proximate or in contact with the distal end 106 of the surgical tool 102 and to detect light reflected back from both the reference portion 112 of the surgical tool 102 and the tissue 118 to provide information regarding a relative distance of the distal end 106 of the surgical tool 102 to selected portions of the tissue 118 (Balicki Col 4:59-5:3, Figs. 2-3)], wherein Balicki discloses the use of a plurality of light detectors to measure intensities of light reflected back through the optical fiber [the optical sensor 114 is an optical coherence tomography (OCT) system. In other embodiments, one could include more than one OCT or other type of optical sensor into the surgical instrument 100 within broad concepts of the current invention (Balicki Col 4:49-54)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Khatchaturov to employ wherein the measuring of the second and third intensity value is via a second and a third light detector, respectively, as this modification would amount to mere simple substitution of respective known elements [each of the laser source and light detector] for another with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 18, Khatchaturov in view of Balicki teaches
The method of claim 17, comprising emitting the laser light of the plurality of different wavelengths via the optical fiber to illuminate the target [Khatchaturov ¶0024].
Regarding claim 19, Khatchaturov in view of Balicki teaches
The method of claim 17, comprising measuring a first intensity value of the first reflected light beams corresponding to laser light of a first wavelength and a second intensity value of the first reflected light beams corresponding to laser light of a second wavelength [Khatchaturov ¶¶0015, 0024, 0026, wherein Khatchaturov disclosing that the laser source may emit in various wavelengths is considered to read on the claimed limitation].
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov in view of Balicki, as applied to claim 1, and as evidenced by Deng (“Measuring pure water absorption coefficient in the near-infrared spectrum (900--2500 nm)”, NPL previously presented).
Regarding claim 2, Khatchaturov in view of Balicki teaches
The system of claim 1.
However, while based on the disclosure of Khatchaturov ¶0015, the wavelength range used may be any wavelength between 532-1600 nm, such that the first wavelength and the second wavelength exists within the disclosed range, specifically the first wavelength may be considered to be in a range of 1330nm and 1380nm and the second wavelength may be considered to be 1260nm to 1320nm, Khatchaturov does not disclose any relationship between the wavelength values and water absorption coefficients, and fails to explicitly disclose wherein the first wavelength has a first water absorption coefficient higher than a second water absorption coefficient of the second wavelength.
Deng discloses the relationship between wavelength and water absorption coefficients, wherein Deng discloses that wavelengths in the range of 1330nm and 1380nm have higher water absorption coefficients that are greater than wavelengths in the range of 1260nm to 1320nm [Deng Appendix discloses that for a wavelength range of 1330-1380nm, water has an absorption coefficient range of ~235-614 m-1; and for a wavelength range of 1260-1320nm, water has an absorption coefficient range of ~121-195 m-1]. As such, Deng is considered to provide evidence wherein the first wavelength has a first water absorption coefficient higher than a second water absorption coefficient of the second wavelength.
Regarding claim 3, Khatchaturov in view of Balicki, as evidenced by Deng, teaches
The system of claim 2, wherein a ratio of the first water absorption coefficient to the second water absorption coefficient is at least 2 to 1 [see analysis of claim 2 above; Khatchaturov ¶0015; Deng Appendix].
Regarding claim 4, Khatchaturov in view of Balicki, as evidenced by Deng, teaches
The system of claim 3, wherein the first wavelength is 1330nm to 1380nm [Khatchaturov ¶0015, wherein the disclosed range is considered to enable a first wavelength of the claimed range] and the second wavelength is 1260nm to 1320nm [Khatchaturov ¶0015, wherein the disclosed range is considered to enable a second wavelength of the claimed range] [the Examiner notes that with respect to the range of the first wavelength of 1330nm and 1380nm, Khatchaturov is considered to anticipate the specific range, as in light of the broad range disclosed by Khatchaturov of 532-1600 nm, there is no disclosure in Khatchaturov that any wavelength within the disclosed range would work any differently than any other wavelength across the disclosed range of Khatchaturov; the Examiner further notes that there is no allegation of criticality or any evidence demonstrating any difference across the range].
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov in view of Balicki as evidenced by Deng, as applied to claim 4 above, in further view of Koifman (US-20130235369-A1, previously presented).
Regarding claim 5, Khatchaturov in view of Balicki, as evidenced by Deng, teaches
The system of claim 4.
However, Khatchaturov in view of Balicki as evidenced by Deng fails to explicitly disclose a third laser source to generate laser light of a third wavelength utilized to characterize a condition of the optical fiber, wherein the third wavelength has a third water absorption coefficient higher than the first and the second water absorption coefficients.
Koifman discloses systems for estimating a distance between a distal end of an optical fiber and a target [In equation 1, F(t) is a time dependent function incorporating various geometrical and temporal variation of environment reflection, d(t) is a distance estimation between distal end 121 and a reflecting feature in environment 90, D is fiber core diameter, and NA(t) is the numerical aperture of light beam 150 (Koifman ¶0038)], wherein Koifman discloses a laser source to generate laser light of a third wavelength utilized to characterize a condition of the optical fiber [At block 404, a calibration beam is transmitted into the optical fiber. At block 406, the intensity of a reflection of the calibration beam is measured, such as with the sensor 110 described above… At block 414, the intensity of the reflection of the calibration beam is subtracted from the intensity of the reflection of the measurement beam. In this manner a reflection from the distal end of the fiber is separated from a reflection from the proximal end of the fiber. The reflection from the distal end of the fiber is related to the fiber integrity. Hence, the resultant intensity measurement after subtracting out the intensity of the calibration beam reflection is referred to herein as a calibrated intensity measurement. At block 416, the calibrated intensity measurement is analyzed to determine the integrity of the optical fiber (Koifman ¶0042)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Khatchaturov in view of Balicki as evidenced by Deng to employ a laser source to generate laser light of a third wavelength utilized to characterize a condition of the optical fiber, in order to determine the integrity of the optical fiber and allow for calibration of subsequent measurements [Koifman ¶0042].
The modified Khatchaturov in view of Balicki and Koifman as evidenced by Deng is further considered to teach wherein the third wavelength has a third water absorption coefficient higher than the first and the second water absorption coefficients, as Koifman discloses that the calibration beam is transmitted by a laser light source that emits wavelengths within a range of 532-1600nm [The term "laser" as used herein in this application refers to any type of laser--For example… diode (e.g. in various wavelengths, such as in the range 532-1600 nm) (Koifman ¶0012)], such that the third wavelength may be considered to be 1435nm. Deng discloses that a wavelength of 1435nm has a water absorption coefficient of ~3077m-1 [Deng Appendix], which is considered to provide evidence wherein the third wavelength has a third water absorption coefficient higher than the first and the second water absorption coefficients.
Regarding claim 6, Khatchaturov in view of Balicki and Koifman, as evidenced by Deng, teaches
The system of claim 5, wherein the third wavelength comprises 1435 nm [Koifman ¶0012, wherein the disclosed range is considered to enable a wavelength of 1435nm; the Examiner notes that Koifman is considered to anticipate the specific wavelength, as in light of the broad range disclosed by Koifman of 532-1600 nm, there is no disclosure in Koifman that any wavelength within the disclosed range would work any differently than any other wavelength across the disclosed range of Koifman; the Examiner further notes that there is no allegation of criticality or any evidence demonstrating any difference across the range], 2100nm, or a wavelength between 1870 nm and 2050nm.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov in view of Balicki, as applied to claim 1 above, in further view of Ikuta (US-20200154985-A1, previously presented).
Regarding claim 9, Khatchaturov in view of Balicki teaches
The system of claim 1.
However, Khatchaturov in view of Balicki fails to explicitly disclose wherein one or more of the first and second laser sources comprise a polarization maintaining pigtailed fiber laser, a single mode pigtailed fiber laser, or a free space laser.
Ikuta discloses systems for illuminating a target using an optical fiber, wherein Ikuta discloses the use of a free space laser operably coupled to the optical fiber [The broadband light source 110 may include a plurality of light sources or may be a single light source. The broadband light source 110 may include one or more of a laser, an OLED, a LED, a halogen lamp, an incandescent lamp, a supercontinuum light source pumped by a laser, and/or a fluorescent lamp. The broadband light source 110 may be any light source that provides light which can then be split up into at least three bands in which each band is further dispersed to provide light which is then used for spectral encoding of spatial information. The broadband light source 110 may be coupled by a light guiding component or may be free-space coupled to another component of the SEE probe system 100 (Ikuta ¶0021)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Khatchaturov in view of Balicki, as this modification would amount to mere simple substitution of one known element for another with similar expected results [MPEP § 2143(I)(B)].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov in view of Balicki, as applied to claim 1 above, in further view of Brennan (US-20100228238-A1, previously presented).
Regarding claim 10, Khatchaturov in view of Balicki teaches
The system of claim 1.
However, Khatchaturov in view of Balicki fails to explicitly disclose wherein the system comprises a wave division multiplexer (WDM) coupled to the proximal end of the optical fiber, the WDM to arrange the laser light of the first wavelength and the laser light of the second wavelength to enter the proximal end of the optical fiber at one or more of a same point and a same angle.
Brennan discloses systems for illuminating a target using an optical fiber to determine a distance to the target [In a preferred embodiment, information from the OCT signal itself may be used to determine the distance from the probe tip to the tissue of interest with or without the use of a trocar cannula system. Because the processed OCT signal includes a reflectance profile of the tissue of interest, the first measured reflection (excluding reflections at the lens interfaces) may be used to accurately determine distance to the surface of the tissue of interest (Brennan ¶0087)], wherein Brennan discloses the use of a wave division multiplexer (WDM) coupled to a proximal end of an optical fiber, the WDM to arrange laser light of a first wavelength and laser light of a second wavelength to enter the proximal end of the optical fiber at one or more of a same point and a same angle [two or more of the optical fibers (e.g., fibers 230 in FIG. 2A) are optically coupled into a single optical fiber within or before reaching the handle of the probe. For example, the optical coupling may be accomplished via use of an optical combiner, a fused-fiber coupler, a wavelength-division multiplexer that propagates all wavelengths simultaneously along the fiber (Brennan ¶0064, Fig. 2)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Khatchaturov in view of Balicki to employ a wave division multiplexer (WDM) coupled to the proximal end of the optical fiber, the WDM to arrange the laser light of the first wavelength and the laser light of the second wavelength to enter the proximal end of the optical fiber at one or more of a same point and a same angle, in order to allow for simultaneous illumination from each of the first laser light and the second laser light [Brennan ¶0064].
Claim(s) 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov (US-20130123769-A1, previously presented) in view of Balicki (US-10045882-B2, previously presented) and Bukesov (US-11957410-B2, effective filing date of 4 August 2020).
Regarding claim 11, Khatchaturov teaches
At least one non-transitory computer-readable medium comprising a set of instructions that, in response to being executed by a processor circuit, cause the processor circuit to:
determine, via a first light detector, a first intensity values based on first reflected laser light corresponding to a laser source, wherein the first reflected laser light enters a proximal end of an optical fiber, exits a distal end of the optical fiber, reflects of a target, and enters the distal end of the optical fiber [Light beam 150 propagates along optical fiber 100 and illuminates tissue 90. Tissue 90 reflects some of the light (115) away from optical fiber 100, while a part of the light re-enters optical fiber 100 at the fiber's distal end 120 as reflection 110. Reflection 110 is transmitted backward in optical fiber 100 from distal end 120 to the fiber's proximal end 130 and is detected when emerging from proximal end 130 (Khatchaturov ¶0024, Fig. 2)];
determine, via the light detector, a second intensity value and a third intensity value respectively, based on second reflected laser light corresponding to the laser source, wherein the second reflected laser light is reflected off of the proximal end of the optical fiber [Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026)];
compute a ratio based on the first intensity value, the second intensity value, and the third intensity value [The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99. Moreover, by comparing successive reflections from target tissue 90 that result from light beams of varying numerical aperture, a crude assessment of distance 125 between target tissue 90 and distal fiber end 110 may be achieved (Khatchaturov ¶0059), wherein determining a difference between reflection 110 (first intensity value) and successive reflections 99 (wherein any first reflection 99 may be the second intensity value and any additional reflection 99 may be the third intensity value) is considered to read on the broadest reasonable interpretation of computing a “ratio” based on the plain definition of “ratio” meaning the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio)]; and
estimate a distance between the distal end of the optical fiber and the target based on the ratio [Khatchaturov ¶0059].
However, Khatchaturov fails to explicitly disclose wherein the determination of the second intensity value and the third intensity value is by a second and a third light detector, respectively.
Balicki discloses systems for measuring a distance between a distal end of an optical fiber and a target [The optical coherence tomography system in the embodiment of FIG. 3 includes a single-mode optical fiber that provides the fixed end 116 of the optical sensor 114, the single-mode optical fiber being arranged to direct light to both the reference portion 112 of the surgical tool 102 and the tissue 118 proximate or in contact with the distal end 106 of the surgical tool 102 and to detect light reflected back from both the reference portion 112 of the surgical tool 102 and the tissue 118 to provide information regarding a relative distance of the distal end 106 of the surgical tool 102 to selected portions of the tissue 118 (Balicki Col 4:59-5:3, Figs. 2-3)], wherein Balicki discloses the use of a plurality of light detectors to measure intensities of light reflected back through the optical fiber [the optical sensor 114 is an optical coherence tomography (OCT) system. In other embodiments, one could include more than one OCT or other type of optical sensor into the surgical instrument 100 within broad concepts of the current invention (Balicki Col 4:49-54)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one non-transitory computer-readable medium comprising a set of instructions of Khatchaturov to employ wherein the determination of the second intensity value and the third intensity value is by a second and a third light detector, respectively, as this modification would amount to mere simple substitution of respective known elements [each of the laser source and light detector] for another with similar expected results [MPEP § 2143(I)(B)].
However, while Khatchaturov is generally directed towards estimating a distance to a target tissue, Khatchaturov fails to explicitly disclose wherein the distance estimation is performed during a urological surgical procedure.
Bukesov discloses systems for estimating a distance between a distal end of an optical fiber and a target tissue, wherein the distance is estimated during an urological procedure [The first laser system 102 may also include a first optical fiber 108 operatively coupled with the first laser source 106. The first optical fiber 108 may be configured for transmission of laser outputs from the first laser source 106 to the target tissue 122 (Bukesov Col 7:66-8:3); FIGS. 25A-25B illustrate an impact of distances between the tissue and spectroscopic probe distal end on the spectra of the reflect light from the target. FIG. 25A illustrates exemplary normalized UV-VIS reflection spectra of various soft tissue types, including bladder endothelial spectra 2511, stomach endothelial spectra 2512, stomach smooth muscle spectra 2513, under ureter spectra 2514, ureter endothelial 2515, calyx spectra 2516, bladder muscle spectra 2517, and medulla spectra 2518 (Bukesov Col 27:11-19)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one non-transitory computer-readable medium comprising a set of instructions of Khatchaturov in view of Balicki to employ wherein the distance estimation is performed during a urological surgical procedure, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
Regarding claim 16, Khatchaturov in view of Balicki and Bukesov teaches
The at least one non-transitory computer-readable medium of claim 11, wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to determine an internal reflection value based on third reflected laser light corresponding to laser light of a third wavelength, wherein the laser light of the third wavelength exits a laser source and the at least a portion of the third reflected laser light is reflected by a distal end of the optical fiber [Khatchaturov ¶¶0015, 0026, 0059, wherein reflection 91 is considered to read on an internal reflection].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khatchaturov in view of Balicki and Bukesov, as applied to claim 11 above, in further view of Koifman.
Regarding claim 12, Khatchaturov in view of Balicki and Bukesov teaches
The at least one non-transitory computer-readable medium of claim 11.
However, while Khatchaturov is considered to disclose measuring an internal reflection value [Khatchaturov ¶¶0026, 0059, Fig. 2, wherein reflection 91 is considered to define an internal reflection], Khatchaturov in view of Balicki and Bukesov fails to explicitly disclose wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to subtract a first internal reflection value from a first measured intensity value to determine the first intensity value and subtract a second internal reflection value from a second measured intensity value to determine the second intensity value.
Koifman discloses systems for estimating a distance between a distal end of an optical fiber and a target [In equation 1, F(t) is a time dependent function incorporating various geometrical and temporal variation of environment reflection, d(t) is a distance estimation between distal end 121 and a reflecting feature in environment 90, D is fiber core diameter, and NA(t) is the numerical aperture of light beam 150 (Koifman ¶0038)], wherein Koifman discloses subtracting a first internal reflection value from a first measured intensity value to determine the first intensity value [At block 404, a calibration beam is transmitted into the optical fiber. At block 406, the intensity of a reflection of the calibration beam is measured, such as with the sensor 110 described above… At block 414, the intensity of the reflection of the calibration beam is subtracted from the intensity of the reflection of the measurement beam. In this manner a reflection from the distal end of the fiber is separated from a reflection from the proximal end of the fiber. The reflection from the distal end of the fiber is related to the fiber integrity. Hence, the resultant intensity measurement after subtracting out the intensity of the calibration beam reflection is referred to herein as a calibrated intensity measurement. At block 416, the calibrated intensity measurement is analyzed to determine the integrity of the optical fiber. For example, the calibrated intensity measurement is compared to a threshold, in some embodiments (Koifman ¶0042)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Khatchaturov in view of Balicki and Bukesov to employ instructions to cause the processor circuit to subtract a first internal reflection value from a first measured intensity value to determine the first intensity value and subtract a second internal reflection value from a second measured intensity value to determine the second intensity value, in order to allow for calibration of subsequent measurements [Koifman ¶0042].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 7, filed 3 December 2025, with respect to the previously presented claim objections have been fully considered but they are not entirely persuasive. The Examiner notes that not each and every objection was addressed, see above for maintained objection(s).
Applicant’s arguments, see Applicant’s Remarks p. 7, with respect to the previously applied non-statutory double patenting provisional rejections have been fully considered and are persuasive. The rejections of claims 17-19 have been withdrawn in light of the Applicant’s amendments.
Applicant's arguments, see Applicant’s Remarks p. 7-8, with respect to the previously applied rejections under § 101 have been fully considered but they are not persuasive.
The Applicant asserts that amended claims 11 and 17 integrate the alleged judicial exceptions into a practical application of the system [the Examiner notes that claims 11 and 17 are respectively directed towards “at least one non-transitory computer-readable medium comprising a set of instructions” and “a method”] to estimate a distance between a target and a fiber tip during a urological procedure, wherein the Applicant directs attention to the limitations of “computing, during the surgical laser procedure, a ratio based on the first intensity value, the second intensity value, and the third intensity value” and “estimating, during the surgical laser procedure, a distance between a distal end of the optical fiber and the target based on the ratio” of claim 17 as providing an improvement to urological procedures as the distance between a target and the distal end of the fiber tip can be determined during the procedure. The Applicant further asserts that the claims integrate the alleged judicial exceptions into a practical application, as the claims include limitations that provide meaningful limits on the alleged judicial exceptions [Applicant refers to the claims being limited to urological procedures and determining distance between a fiber tip and a stone]. However, the Examiner disagrees with the Applicant’s arguments, as the Examiner notes that the alleged improvement “the distance between a target and the distal end of the fiber tip can be determined during the procedure” fails to reflect an improvement to the functioning of a computer or to another technology or technical field, as the alleged improvement is considered to be recited within limitations identified as being directed towards abstract ideas implemented on a generic computer, such that the alleged improvements are not considered to be directed towards the functioning of a computer or technology and are considered conclusory, as the Applicant fails to provide necessary details as to how the alleged improvement improves the functioning of a computer or technology [an improvement in the abstract idea itself… is not an improvement in technology (MPEP § 2106.05(a)); Specifically, the “improvements” analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity (MPEP § 2106.04(d)(1)]; and the additional elements fail to amount to more than a recitation of “apply it” (or equivalent) or mere instructions to implement the judicial exception on a computer merely as a tool to perform the limitations directed towards steps that may be performed in the mind or by hand with the assistance of pen and paper and using implicit mathematical formula(s) to derive a conclusion based on input of data. The Examiner further disagrees with the Applicant’s arguments, as the Examiner notes that merely limiting limitations of computing and estimating of claims 11 and 17 to be “during a urological surgical procedure” [claim 11, line 14] and “during the surgical laser procedure” [claim 17, lines 14 and 16] does not integrate the identified judicial exceptions into a practical application of the non-transitory computer-readable medium comprising a set of instructions or the method, and merely limit when the identified judicial exceptions may be performed. The mere recitation of the identified judicial exceptions occurring during a broadly recited urological surgical procedure/surgical laser procedure does not impart any of the particular methodology or equipment used in the recited procedures.
Applicant’s arguments, see Applicant’s Remarks p. 9, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The § 112(b) rejections of claims 1, 4, 6-7, 10, 11, 17, and those dependent therefrom have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-10, with respect to the rejection(s) of claim(s) 11 and 17 under § 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Khatchaturov (US-20130123769-A1, previously presented) in view of Balicki (US-10045882-B2, previously presented).
The Applicant asserts that the amended subject matter of claim 11 of “determine, via a first light detector, a first intensity values based on first reflected laser light corresponding to a laser source, wherein the first reflected laser light enters a proximal end of an optical fiber, exits a distal end of the optical fiber, reflects of a target, and enters the distal end of the optical fiber” and “determine, via a second and a third light detector, a second intensity value and a third intensity value respectively, based on second reflected laser light corresponding to the laser source, wherein the second reflected laser light is reflected off of the proximal end of the optical fiber” [emphasis added by Applicant] fails to be taught by previously presented Khatchaturov. The Applicant notes that claim 17 recites similar language to claim 11 and similarly fails to be taught by Khatchaturov. However, the Examiner disagrees with the Applicant’s argument with respect to the determination of a second intensity value and third intensity value, based on second reflected laser light corresponding to the laser source, wherein the second reflected laser light is reflected off of the proximal end of the optical fiber, as the Examiner notes that Khatchaturov does disclose measuring the intensity of the portion of the laser light reflected from the proximal end [Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026, Fig. 2); The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99. Moreover, by comparing successive reflections from target tissue 90 that result from light beams of varying numerical aperture, a crude assessment of distance 125 between target tissue 90 and distal fiber end 110 may be achieved (Khatchaturov ¶0059), wherein the Examiner notes that reflection 99 is light reflected from proximal end 130 of the optical fiber 100, and wherein any first measurement of light reflected from the proximal end may be the second intensity value and any additional measurement of light reflected from the proximal end may be the third intensity value]. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 11 and 17 with respect to “a second and a third light detector” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Khatchaturov is further modified by Balicki, as Balicki discloses subject matter regarding the use of a plurality of light detectors [Balicki Col 4:49-54].
Applicant's arguments, see Applicant’s Remarks p. 10-12, with respect to the previously applied rejections under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that the amended subject matter of claim 1 of “a mirror to direct, to the second light detector and the third light detector, the portion of the laser light reflected from the proximal end, the second light detector and the third light detector being configured to measure intensity of the portion of the laser light reflected from the proximal end” and “a processor and memory comprising instructions that when executed by the processor cause the processor to estimate a distance between the distal end of the optical fiber and the target based on the intensity of the reflected light measured by the first light detector and the intensity of the portion of the laser light reflected from the proximal end measured by the second light detector and the third light detector” [emphasis added by Applicant] fails to be taught by the previously cited references, as the Applicant notes that none of the cited references teach measuring intensity of reflections from both the target and the proximal end of the fiber as claimed, and then determining the distance between the target and the distal end of the fiber based on the measured intensities. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Khatchaturov does disclose measuring the intensity of the portion of the laser light reflected from the proximal end [Several difficulties impede such a straight forward measurement. (i) Separation of reflection 110 from reflections of light beam 150 from distal and proximal ends 120, 130 (respectively, reflections 91 and 99, FIG. 2) of optical fiber 100 is difficult, as the intensity of reflection 110 is much smaller than those of other reflections 91, 99 in fiber 100 (Khatchaturov ¶0026, Fig. 2); The proposed modulation of numerical aperture allows differentiating the weaker reflection 110 that arrives to sensor 320 from the more intense reflections 91 and 99 (Khatchaturov ¶0059), wherein the Examiner notes that reflection 99 is light reflected from proximal end 130 of the optical fiber 100], such that in light of the modification by Balicki, the intensity of the portion of the laser light reflected from the proximal end is measured by the second light detector and the third light detector [Balicki Col 4:49-54].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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, Charles Marmor II can be reached at (571) 272-4730. 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.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791