DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed 12/29/2025 is acknowledged.
Claims 1, 3, 7-12 and 14-17 remain pending in the current application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 7-12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kittrell (US 5304173 A) in view of Svanberg (US 20080249517 A1).
Regarding claim 1, Kittrell teaches a system for diagnosis of a subject the system comprising a plurality of light emission and detection modules and a plurality of optical waveguides adapted to conduct light to or from a tissue site of the subject ((col. 1 lines 15-19) devices in which optical fibers are provided within a catheter and laser radiation is directed through the fibers for medical applications including diagnosis; (col. 1 lines 54-58) This fiber optic catheter contains a combination of: (1) a fiber optic viewing bundle; (2) a light source bundle for illuminating the region to be viewed; (3) a laser bundle for delivering laser light to the site for removal of tissue)
wherein each light emission and detection module of said plurality of light emission and detection modules is connected to a proximal end of exactly one optical waveguides of said plurality of optical waveguides ((col. 8 lines 36-45) The preferred embodiment of the fiber optic coupler 46, at the proximal end of the laser catheter 10, is a flat linear array of the optical fiber ends 40a-c' of optical fibers 20a'c'. In addition, optical fiber ends 40b" and 40c" depict optical fibers which do not appear in the sectional drawing FIG. 1 of the distal end of the laser catheter. The coupler 46 holds all nineteen optical fibers 40a-c" in a linear array. An additional optical fiber, shown as 20d in FIG. 19, may be incorporated if desired, with one end disposed in the proximal linear array and the other end connected to a laser power monitor)
wherein each of said light emission and detection modules comprises: at least one diagnostic light source for emission of diagnostic light within a wavelength range of infrared, visible or ultraviolet light ((col. 19 lines 26-28) Excitation light 95, FIG. 21, from a laser or conventional light source is sent into a selected optical fiber 20. The excitation light 95 should be of sufficiently low power so as not to injure the tissue; (col. 7 lines 63-64) Optical transparency may include ultraviolet, visible and infrared light, depending on the light and laser source used)
the diagnostic light source emitting at least one light beam ((col. 19 line 26) excitation light 95 from a laser or conventional light source)
at least one light detector, for detection of light ((col. 19 lines 42-53) FIG. 23 is a schematic of one type of spectral detector 65 which may be desirable to use with this system and which can detect many different wavelengths simultaneously. A diffraction grating 68 which disperses the return light from a target. The dispersed light is projected onto a multichannel detector 70 which has many detectors, each one of which corresponds to a single wavelength of light leaving the grating 68. In this manner the entire spectrum of the return light may be obtained in a very brief time because all wavelengths are collected simultaneously. A typical type of detector 70 is an array of photodiodes)
a focusing optical component ((col. 18 lines 62-63) The optical radiation from laser 92 is focused by lens 41 on mirror 98) and wherein each light emission and detection module is characterized by the optical waveguide connected to each light emission and detection module being configured so that at least one of the light beams from the at least one diagnostic light source is coupled into the proximal end of the connected optical waveguide by the at least one focusing optical component ((col. 19 lines 29-34) light passes through a beam splitter 52 or a mirror with a hole 50, FIG. 22. It is focused onto the input end 40 by a lens 41. The light exits the distal end of the optical fiber 20, passes through the optical shield 12, and impinges on the tissue 34 of FIG. 4)
and the diagnostic light transmitted back from the tissue being emitted from the proximal end of the connected optical waveguide having a higher numerical aperture (NA) than the focused beam coupled into the optical waveguide providing an emission at least partially in a different angular sector than an angular sector of the focused light beam, so that the diagnostic light scattered back from the tissue is detected by the at least one light detector ((col. 24 lines 31-49) The tissue scatters and absorbs the light, and in the latter case re-emits some fraction of this light, usually of a longer wavelength. This light re-enters the distal ends of the various optical fibers 20. The return light may come through the same or a different fiber and is then coupled out by the selector system 74 using, for example, a beam splitter. This light goes to either a monochromometer or a filter system 76 and then is detected by a photodiode, photomultiplier or other detector 64. A rapid scan control 90 moves the grating, or the prism, or whatever spectrum-selective element is used in monochromometer 76, so that it selects one wavelength after another, sequentially. In this way the entire spectral signal from the selected fiber(s) is converted into a time varying signal, which is coupled to computer 80 via the detector 78. Alternately, a multichannel analyzer 65 as shown in FIG. 23 may be used, collecting the entire spectrum simultaneously and coupling it to the computer 80).
Kittrell fails to teach distal end sections of the plurality of optical waveguides are configured to be individually interstitially positioned in use at different locations of the tissue in order to enable an effective diagnosis and/or treatment.
However, Svanberg teaches distal end sections of the plurality of optical waveguides are configured to be individually interstitially positioned in use at different locations of the tissue in order to enable an effective diagnosis and/or treatment ([0061] FIG. 1 is a schematic view of a device for interactive interstitial photodynamic light therapy (PDT) or photo-thermal therapy (PTT) and photodynamic diagnosis (PDD) of a site on and/or in a human being or an animal. A plurality of, or at least two, radiation conductors, such as light guides or optical fibres 6 are directly inserted in a tissue 8, which may be an organ, a tumour or any other tissue. The fibres 6 may be inserted with their distal ends, respectively, in the tissue 8 in a geometric pattern and interstitially. Thus fibres 6 are patient fibres. As shown in FIG. 1, the distal ends of the patient fibres 6 are arranged in a geometric pattern covering a certain area to be investigated and/or treated. The proximal ends of the patient fibres 6 arranged at a distance from the tissue are inserted and attached to a flat disc 3 of a switching means 1, as shown in FIG. 1. The flat disc 3 is arranged adjacent a second flat disc 4 and the flat discs are rotatable in relation to each other around a shaft 2)
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Kittrell and Svanberg are considered analogous because both disclose interstitial positioning of medical instruments for diagnosis. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to include optical fibers that poke out of the distal end of the device and analyze different points in the vasculature in order to provides a more advantageous way of accessing a tissue for interactive interstitial photodynamic or photothermal therapy and/or diagnosis of the tissue, and in particular allowing for increased flexibility, cost-effectiveness, or user friendliness (Svanberg [0019]).
Regarding claim 3, Kittrell teaches at least one diagnostic light source and at least one therapeutic light source coupled to each optical waveguide of the plurality of optical waveguides ((col. 1 lines 56-57) a light source bundle for illuminating the region to be viewed; a laser bundle for delivering laser light to the site for removal of tissue)
Regarding claim 7, Kittrell teaches configured for interactive photodynamic or photothermal therapy ((col. 19 line 22) therapies employing laser ablation)
and comprising at least one therapeutic light source for emission of therapeutic light within a wavelength range of infrared, visible or ultraviolet light, said therapeutic light source emitting at least one light beam which is coupled into the proximal end of the optical waveguide by means of the focusing optical component (((col. 19 lines 26-28) Excitation light 95, FIG. 21, from a laser or conventional light source is sent into a selected optical fiber 20. The excitation light 95 should be of sufficiently low power so as not to injure the tissue light passes through a beam splitter 52 or a mirror with a hole 50, FIG. 22. It is focused onto the input end 40 by a lens 41. The light exits the distal end of the optical fiber 20, passes through the optical shield 12, and impinges on the tissue 34 of FIG. 4; (col. 7 lines 63-64) Optical transparency may include ultraviolet, visible and infrared light, depending on the light and laser source used))
Regarding claim 8, Kittrell teaches wherein the diagnostic light source is the same as the therapeutic light source; or wherein the wavelength range of the diagnostic light source is the same as the wavelength range of the therapeutic light source ((col. 25 lines 3-11) In the preferred embodiment, the light source 98 is 476 nm radiation from an argon ion laser. The fluorescent light is monitored at peaks 550 and 600 nm, and valley 580 nm when the 600 nm peak is comparable to the 550 nm peak and the 600 nm peak to 580 nm valley ratio is much larger than one, this indicates healthy artery wall. When the 600 nm peak is much smaller than the 550 nm peak and the peak to valley ratio is near unity, this indicates the presence of plaque)
Regarding claim 9, Kittrell teaches wherein a reflector is used for coupling the light from the proximal end of the optical waveguides to the at least one detector ((col. 4 lines 64-69) Lenses or mirrors, and mechanical or optical aiming and focusing devices can be mounted inside of the shield. Light can be delivered to the tissue via one fiber, and the reflected light returned by means of the same or another "sensing" fiber for spectroscopic or other forms of analysis)
Regarding claim 10, Kittrell teaches the reflective member has at least one aperture for the diagnostic light to be transmitted through when travelling between the at least one diagnostic light source and the proximal end of the plurality of optical waveguides ((col. 21 lines 41-44) FIG. 27 depicts one prototype studied. In this prototype a single optical fiber 20 with a carefully cleaved or polished output tip 23 was rigidly centered inside a transparent optical shield 12. The fiber 20 had a 133 um core diameter and a numerical aperture of 0.21)
Regarding claim 11, Kittrell teaches the aperture is at least one hole or a slit (hole 51)
Regarding claim 12, Kittrell teaches one of the plurality of optical waveguides is a transmission waveguide used for transmitting the diagnostic light to the tissue site and at least two other optical waveguides of the plurality of optical waveguides are receiving waveguides for receiving backscattered light from the tissue site for detection ((col. 19 lines 29-42) light passes through a beam splitter 52 or a mirror with a hole 50, FIG. 22. It is focused onto the input end 40 by a lens 41. The light exits the distal end of the optical fiber 20, passes through the optical shield 12, and impinges on the tissue 34 of FIG. 4. The fluorescence and scattered light is returned via the same or a different optical fiber 20 to-the proximal end 40 of the optical fiber 20. This return light 54 is separated by the beam splitter 52, which may be of the polarizing type, or by the mirror 50 with hole 51 (FIG. 22). This return fluorescent or scattered light 54 enters a spectrum analyzer 60)
Regarding claim 14, Kittrell teaches the transmission waveguide is sequentially selected from among the plurality of optical waveguides by sequentially switching on and off the at least one diagnostic light source of the plurality of light emission and detection modules ((col. 18 lines 24-34) The shutter 44 is a mechanical shutter similar to that used on a camera, except that it is electrically driven and is activated by the computer. When a rapid sequence of exposures is desired, such as on a millisecond time scale, the computer 80 closes the shutter 44 and causes the motor 204 to move the translator 200 to a new position, bringing a new fiber into alignment. The shutter is then opened by the computer, allowing laser light to enter the selected fiber)
Regarding claim 15, Kittrell teaches an open beam path between the at least one light source and the proximal end of the plurality of optical waveguides, and between the proximal end of the plurality of optical waveguides and the at least one light detector ((col. 13 lines 10-15) Graded index optical fibers may also be used. The core 22 need not be solid; a fluid filled tube may also be considered an optical fiber 20. A gas or air filled hollow waveguide tube may also be used, and may be made of metal, glass or plastic, with an optional reflective coating inside)
Regarding claim 16, Kittrell teaches the plurality of optical waveguides configured to be arranged on the tissue site to perform spatially resolved measurements ((col. 5 lines 49-50) a means of delivering a precisely controllable dose of photons to remove a specified volume of tissue)
Regarding claim 17, Kittrell teaches at least one second focusing optical component is arranged in front of the at least one detector (multiple lenses 222).
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 12/29/2025, with respect to the rejection(s) of claim 1 under 35 US 102 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 the newly cited Svanberg reference.
Applicant argues persuasively that the primary Kittrell reference differs from the independent claim as amended due to the shield preventing the optical fibers from individually contacting portions of a patient’s anatomy. However, an updated search has uncovered the Svanberg reference where Figs. 1 and 2 clearly obviate this feature. As a result, the claims remain rejected under 35 USC 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797