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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-8, and 11-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Examiner does not believe there is support in the specification for the limitations “the illumination propagating from the light source to the luminescent mark without passing through the laser fiber along an illumination optical path disposed outside the laser fiber” and “the laser fiber being configured to direct the luminescent light proximally away from the endoscope body”. Examiner could not find anything in the disclosure that pointed to these limitations and does not believe that the disclosure of Figure 4 is enough to read on the limitations. Also, applicant has not provided the proper support for these limitations in the specification. Applicant is required to show support in the original disclosure for the new or amended claims (See, e.g., Hyatt v. Dudas, MPEP § 2163.04).
Regarding the first limitation “the illumination propagating from the light source to the luminescent mark without passing through the laser fiber along an illumination optical path disposed outside the laser fiber”, Figure 4 shows arrows coming from the target 435 that go towards the laser fiber 416, arrows “bouncing” within laser fiber 416, and arrows coming from luminescent mark 420 and going to laser fiber 416, target 435, and in another direction. However, figure 4 does not show any illumination propagating from the light source 414 and does not show the illumination propagating from the light source 414 to the luminescent mark 420 without passing through the laser fiber along an illumination optical path disposed outside the laser fiber. The claims require that there is light coming from light source 414 that goes directly to luminescent mark 420 without passing through laser fiber 416, however this is not described in the specification or shown in the figures.
Regarding the second limitation “the laser fiber being configured to direct the luminescent light proximally away from the endoscope body”, examiner does not find this language is supported with the broad recitation of “light from the luminescent mark can be captured from the laser fiber itself” (Para 30). What is recited in the specification is just that the laser fiber can also capture light from the luminescent mark, but there is nothing about the laser fiber directing the luminescent light proximally away from the endoscope body, or the sensor configured to receive this light from a proximal end of the laser fiber. The only disclosure of the laser fiber being connected to a feedback analyzer in the specification is in relation to Figure 3, which states “In some cases the feedback analyzer 330 can be coupled to the laser fiber 316, so as to receive indications of luminescence interacting with the laser fiber 316.” While Para 62 recites with respect to Figure 4 “The components of system 400 can be similar to, and connected in a similar fashion, to the corresponding components discuss with reference to FIGS. 1A-1B above, except where otherwise noted.”, Examiner is not sure if the disclosure with respect to Figure 3 can be combined to teach that the system of Figure 4 supports the laser fiber directing the luminescent light proximally away from the endoscope body, or the sensor configured to receive this light from a proximal end of the laser fiber. With respect to the disclosures of Figure 4, the only mention of luminescence being sent to spectrometer 425 and feedback analyzer 430 is luminescence captured from camera 412. (“The camera 412 can capture produced luminescence, which can be correlated to a temperature of the system 400 by used of the feedback analyzer 430 and spectrometer 425.”, (Para 64)).
Examiner suggests amending the claims to omit the language that is not supported by the specification or specifically point to the disclosure to show support. The limitations will not be rejected under art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 13, 15-16, and 24-25 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 8,201,997 Salour, hereinafter “Salour”.
Regarding claim 1, Salour discloses an endoscope (Col. 1, lines 50-51 and Col. 4, lines 24-27), comprising:
an endoscope body (Col. 1, lines 50-51 and Col. 4, lines 24-27), including a distal portion (Figure 3, element is the temperature sensing probe that would be located at the distal end of an endoscope) configured for at least partial insertion into a patient (Col. 4, lines 17-27);
a laser fiber extendable distally from the distal portion of the endoscope body (Figure 3, element 210; Col. 4, lines 17-27 this medical system can be in the form of an endoscope that is extended into the human body), the laser fiber being configured to at least one of optically sample or treat a target in an internal site of the patient (Figure 3, element 220 and 240 and Col. 3, lines 13-25; used for optical sampling, i.e. imaging);
a luminescent mark located on a distal end of the endoscope body (Figure 3, element 290), the luminescent mark having a luminescent characteristic correlative to temperature when the luminescent mark is illuminated (Col. 3, lines 26-27);
a light source (Figure 3, element 300) configured to illuminate the target and the luminescent mark with illumination (Col. 3, lines 26-37), the illumination propagating from the light source to the luminescent mark along an illumination optical path disposed outside the laser fiber (See Figure 3, the light transmitted from LED 300 travels along optical path 280 going into optical fiber 200 separate from laser fiber 210), the luminescent mark being configured to generate luminescent light in response to the illumination (Col. 3, lines 26-37), the laser fiber being configured to direct the luminescent light proximally away from the endoscope body (Figure 3, element 320; the light path from 290 is away from the endoscope end); and
a sensor located away from the endoscope body (Figure 3, element 330), the sensor being configured to receive the luminescent light from a proximal end of the laser fiber (Figure 3, element 330 receives light 320) and generate a luminescence response signal in response to the luminescent light (Col. 4, lines 6-10), the luminescence response signal providing an indication of a temperature of a target medium proximate the target in the internal site of the patient (Col. 4, lines 6-10, Col. 2, lines 60-65, and Col. 3, lines 26-37).
Regarding claim 5, Salour discloses a signal analyzer (Figure 3, element 340; Col. 4, lines 6-10, Col. 2, lines 60-65) coupled to the sensor for analyzing the luminescence response signal and generating a resulting indication of the temperature at the target medium (Col. 4, lines 6-10, Col. 2, lines 60-65, and Col. 3, lines 26-37).
Regarding claim 13, Salour discloses the luminescent light comprises at least one of photoluminescence, candoluminescence, or thermoluminescence (Col. 3, lines 33-37; photoluminescence).
Regarding claim 15, Salour discloses a feedback analyzer coupled to the sensor (Figure 3, element 340) and including signal processing circuitry (Figure 3, element 340).
Regarding claim 16, Salour discloses a controller configured to interpret the luminescence response signal (Figure 3, element 340).
Regarding claim 24, Salour discloses the illumination optical path is disposed entirely outside the laser fiber (See Figure 3, the optical path 280 and 320 is disposed entirely outside the laser fiber 210).
Regarding claim 25, Salour discloses the luminescent mark is spaced apart from the laser fiber (Figure 3, mark 290 is spaced apart from laser fiber 210).
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.
Claim(s) 6-8, 11-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,201,997 Salour, hereinafter “Salour”, in view of US 2005/0203497 Speeg et al., hereinafter “Speeg” (cited previously).
Regarding claim 6, Salour discloses all the limitations of claim 1.
Salour does not disclose a laser system having a controller configured to control the laser fiber for treating the target at the internal site of the patient.
However, Speeg discloses a medical apparatus (Abstract) that uses luminescent marks to determine temperature (Para 37) and teaches a laser system (Figure 1, element 10 and Para 21) having a controller (Para 8 and Figure 2, element 25) configured to control the laser fiber for treating the target at the internal site of the patient (Figure 4, element 13 and Para 45).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included the controller and treatment as taught by Speeg, in the invention of Salour, in order to deliver energy treatment in a temperature controlled environment (Speeg; Para 8 and 45).
Regarding claim 7, Salour discloses an endoscope (Col. 1, lines 50-51 and Col. 4, lines 24-27), comprising:
an endoscope body (Col. 1, lines 50-51 and Col. 4, lines 24-27), including a distal portion (Figure 3, element is the temperature sensing probe that would be located at the distal end of an endoscope) configured for at least partial insertion into a patient (Col. 4, lines 17-27);
a laser fiber extendable distally from the distal portion of the endoscope body (Figure 3, element 210; Col. 4, lines 17-27 this medical system can be in the form of an endoscope that is extended into the human body), the laser fiber being configured to at least one of optically sample or treat a target in an internal site of the patient (Figure 3, element 220 and 240 and Col. 3, lines 13-25; used for optical sampling, i.e. imaging);
a luminescent mark located on a distal end of the endoscope body (Figure 3, element 290), the luminescent mark having a luminescent characteristic correlative to temperature when the luminescent mark is illuminated (Col. 3, lines 26-27);
a light source (Figure 3, element 300) configured to illuminate the target and the luminescent mark with illumination (Col. 3, lines 26-37), the luminescent mark being configured to generate luminescent light in response to the illumination (Col. 3, lines 26-37), the laser fiber being configured to direct the luminescent light proximally away from the endoscope body (Figure 3, element 320; the light path from 290 is away from the endoscope end); and
a sensor located away from the endoscope body (Figure 3, element 330), the sensor being configured to receive the luminescent light from a proximal end of the laser fiber (Figure 3, element 330 receives light 320) and generate a luminescence response signal in response to the luminescent light (Col. 4, lines 6-10), the luminescence response signal providing an indication of a temperature of a target medium proximate the target in the internal site of the patient (Col. 4, lines 6-10, Col. 2, lines 60-65, and Col. 3, lines 26-37).
Salour does not disclose an actuator configured to adjust a position of the laser fiber; and a controller configured to cause the actuator to automatically adjust the position of the laser fiber based on the temperature of the target medium.
However, Speeg teaches an actuator configured to adjust a position of the laser fiber (Para 42 and Figure 7); and
a controller (Para 8) configured to cause the actuator to automatically adjust the position of the laser fiber based on the temperature of the target medium (Para 8, “The main processor can automatically control the positioning of the light-emitting section within the treatment site… in response to the measured temperature”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included the actuator as taught by Speeg, in the invention of Salour, in order to deliver energy treatment in a temperature controlled environment (Speeg; Para 8 and 45).
Regarding claim 8, Salour discloses all the limitations of claim 6.
Salour does not disclose the controller is configured to adjust at least one setting of the laser system based at least in part on the indication of the temperature at the target medium.
However, Speeg teaches the controller is configured to adjust at least one setting of the laser system based at least in part on the indication of the temperature at the target medium (Para 8 and claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included the controller and treatment as taught by Speeg, in the invention of Salour, in order to deliver energy treatment in a temperature controlled environment (Speeg; Para 8 and 45).
Regarding claim 11, Salour discloses all the limitations of claim 6.
Salour does not disclose the luminescent mark comprises at least one of a piece of crystal, a crystalline material, a polycrystalline material, an organic component, or an arrangement of quantum dots.
However, Speeg teaches the luminescent mark comprises at least one of a piece of crystal, a crystalline material, a polycrystalline material, an organic component, or an arrangement of quantum dots (Para 47; the element 48 contains a known crystal alexandrite).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included a crystalline material as taught by Speeg, in the invention of Salour, in order to employ light scattering (Speeg; Para 37).
Regarding claim 12, Salour discloses all the limitations of claim 1.
Salour does not disclose the luminescent mark comprises at least one of crystalline phosphor ceramics, organic components, quantum dots, or nanostructures.
However, Speeg teaches the luminescent mark comprises at least one of crystalline phosphor ceramics, organic components, quantum dots, or nanostructures (Para 37; the alexandrite particles can be interpreted as nanostructures as that term is very broad).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included a nanostructures as taught by Speeg, in the invention of Salour, in order to employ light scattering (Speeg; Para 37).
Regarding claim 14, Salour discloses all the limitations of claim 1.
Salour does not disclose the luminescent mark has a diameter of about 100 nm or less.
However, Speeg teaches the luminescent mark has a diameter of about 100 nm or less (Para 37; alexandrite particles are nanostructures; they can be seen in Figure 6 to compare size with the optical fiber that is meant to be inserted into a human’s veins; it is inherent that the particles are 100 nm or less).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included a nanostructures as taught by Speeg, in the invention of Salour, in order to employ light scattering (Speeg; Para 37).
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0203497 Speeg et al., hereinafter “Speeg”, in view of US 8,201,997 Salour, hereinafter “Salour”.
Regarding claim 17, Speeg discloses a method of monitoring temperature near a target (Abstract) the method comprising:
providing a laser fiber (Figure 1, element 13 and Para 34) extendable distally from a distal portion of a medical probe (Figure 1, element 13 being distal from element 12), the laser fiber being configured to at least one of optically sample or treat the target (Figure 4, Figure 1, element 13 and Para 42; The therapeutic device is the optical fiber 13 that is being used to treat a patient in an internal site (see for example Para 44). The positioning device 70 uses rollers to roll, in and out, the optical fiber 13, i.e. the therapeutic device; optical fiber 13 treats a patient);
situating a luminescent mark on a distal end of the medical probe (Para 28 discuses that the optical fiber 13 is actuatable to extend distally past element 64, see Figure 4. The luminescent marks are on the distal end of the optical fiber 13 as shown in Figure 6, element 48);
illuminating the luminescent mark with illumination to induce luminescence (Para 37) of the luminescent mark (Figure 6, element 48 and Para 37), the luminescent mark having a luminescent characteristic correlative to temperature (Para 37 and 45); and
determining a temperature of the target based at least in part on the luminescence signal (Para 37).
Speeg does not disclose an endoscope body; the illumination propagating from a light source to the luminescent mark along an illumination optical path disposed outside the laser fiber; the luminescent mark generating luminescent light in response to the illumination, directing the luminescent light proximally away from the endoscope body along the laser fiber; receiving the luminescent light from a proximal end of the laser fiber with a sensor located away from the endoscope body; generating, with the sensor, a luminescence response signal in response to the luminescent light, the luminescence response signal providing an indication of a temperature of a target medium proximate the target; and determining a temperature of the target based at least in part on the luminescence response signal.
However, Salour teaches an endoscope body (Col. 1, lines 50-51 and Col. 4, lines 24-27);
the illumination propagating from a light source to the luminescent mark along an illumination optical path disposed outside the laser fiber (See Figure 3, the light transmitted from LED 300 travels along optical path 280 going into optical fiber 200 separate from laser fiber 210);
the luminescent mark generating luminescent light in response to the illumination (Col. 3, lines 26-37), directing the luminescent light proximally away from the endoscope body along the laser fiber (Figure 3, element 320; the light path from 290 is away from the endoscope end);
receiving the luminescent light from a proximal end of the laser fiber with a sensor (Figure 3, element 330) located away from the endoscope body (Figure 3, element 330 receives light 320);
generating, with the sensor, a luminescence response signal in response to the luminescent light (Col. 4, lines 6-10), the luminescence response signal providing an indication of a temperature of a target medium proximate the target; and
determining a temperature of the target based at least in part on the luminescence response signal (Col. 4, lines 6-10, Col. 2, lines 60-65, and Col. 3, lines 26-37).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included an endoscope and luminescence response as taught by Salour, in the invention of Speeg, in order to measure temperature when a user is undergoing an endoscopic examination (Salour; Col. 4, lines 17-27).
Regarding claim 18, Speeg discloses determining the temperature of the target comprises correlating the luminescent light to temperature based on a lookup table (Para 8 and 37).
Regarding claim 19, Speeg discloses the luminescent light comprises at least one of photoluminescence, candoluminescence, or thermoluminescence (Para 37 and 47; photoluminescence).
Regarding claim 20, Speeg discloses adjusting at least one setting associated with a treatment device based at least in part on the determined temperature (Para 8 and claim 8).
Claim(s) 21 rejected under 35 U.S.C. 103 as being unpatentable over US 8,201,997 Salour, hereinafter “Salour”, in view of US 5,419,312 Arenberg et al., hereinafter “Arenberg”.
Regarding claim 21, Salour discloses all the limitations of claim 1.
Salour does not disclose the sensor includes a spectrometer configured to generate the luminescence response signal in response to a spectrum of the luminescent light.
However, Arenberg discloses an endoscope device capable of diagnosis and treatment (Abstract) and teaches the sensor includes a spectrometer (Col. 20, lines 40-45) configured to generate the luminescence response signal in response to a spectrum of the luminescent light (Col. 21, lines 41-42, 47-51, Col. 22, lines 4-9 and 23-30).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a spectrometer as taught by Arenberg, in the invention of Salour, in order to allow the spectrometer to read the amount and spectrum of fluorescent light and to determine fluid pressure and temperature levels within the selected body cavity (Arenberg; Col. 22, lines 23-30).
Claim(s) 22 rejected under 35 U.S.C. 103 as being unpatentable over US 8,201,997 Salour, hereinafter “Salour”, in view of US 2005/0203497 Speeg et al., hereinafter “Speeg”, further in view of US 5,419,312 Arenberg et al., hereinafter “Arenberg”.
Regarding claim 22, Salour discloses all the limitations of claim 7.
Salour does not disclose the sensor includes a spectrometer configured to generate the luminescence response signal in response to a spectrum of the luminescent light.
However, Arenberg discloses an endoscope device capable of diagnosis and treatment (Abstract) and teaches the sensor includes a spectrometer (Col. 20, lines 40-45) configured to generate the luminescence response signal in response to a spectrum of the luminescent light (Col. 21, lines 41-42, 47-51, Col. 22, lines 4-9 and 23-30).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a spectrometer as taught by Arenberg, in the invention of Salour, in order to allow the spectrometer to read the amount and spectrum of fluorescent light and to determine fluid pressure and temperature levels within the selected body cavity (Arenberg; Col. 22, lines 23-30).
Claim(s) 23 rejected under 35 U.S.C. 103 as being unpatentable US 2005/0203497 Speeg et al., hereinafter “Speeg”, in view of US 8,201,997 Salour, hereinafter “Salour”, further in view of US 5,419,312 Arenberg et al., hereinafter “Arenberg”.
Regarding claim 23, Speeg discloses all the limitations of claim 17.
Speeg does not disclose the sensor includes a spectrometer configured to generate the luminescence response signal in response to a spectrum of the luminescent light.
However, Arenberg discloses an endoscope device capable of diagnosis and treatment (Abstract) and teaches the sensor includes a spectrometer (Col. 20, lines 40-45) configured to generate the luminescence response signal in response to a spectrum of the luminescent light (Col. 21, lines 41-42, 47-51, Col. 22, lines 4-9 and 23-30).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a spectrometer as taught by Arenberg, in the invention of Speeg, in order to allow the spectrometer to read the amount and spectrum of fluorescent light and to determine fluid pressure and temperature levels within the selected body cavity (Arenberg; Col. 22, lines 23-30).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because of the new ground of rejection.
Refer to the U.S.C. 112(a) written description rejection above for more details.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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