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 .
Status of Claims
Claims 1,3-4,6-7,9-16 and 21-42 are pending.
Claims 28-42 are withdrawn from prosecution.
Claims 1,3-4,6-7,9-16 and 21-27 are rejected.
Response to Arguments
Applicant's arguments with respect to the rejection of claim 1 under 35 U.S.C. 103 in Applicant’s responses filed 08/04/2025 have been fully considered but they are not persuasive.
The rejection previously indicated in the rejection of now cancelled claim 2, that McGregor does not teach a sheath comprising a probe channel and an endoscope channel. Applicant’s remarks, see pages 8-10 echoes this stance.
However, in view of Applicant’s amendments, McGregor teaches the limitations of claim 1 (see the updated rejection below). That is, it appears that the instant application includes two separate channels, each of the two separate channels dedicated to the probe and the endoscope, respectively. This distinction, however, is not reflected in the claims and hence McGregor’s use of a single channel for both the endoscope and the fiber bundle meets the claimed limitation.
Hence, the claims stand rejected.
Withdrawn Objections
Pursuant of Applicant’s responses filed 08/04/2025, the objections made to claims 15 and 30 have been withdrawn.
Withdrawn Rejections
Pursuant of Applicant’s amendments filed 08/04/2025, the rejection of claims 6-7, 16, 27 under 35 U.S.C. 112(b) have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Lines 13 and 16 of claim 1 should be amended to recite --Raman spectral data--.
Line 15 of claim 1 should be amended to recite --wherein one or more applications--.
The last line of claim 1 should be amended to recite --Savitzky-Golay filter--.
Appropriate correction is required.
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.
Claims 1, 3-4, 6-7, 9, 16, 21-23 and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McGregor, et al., US 20210059513 A1.
Regarding claim 1, McGregor teaches a device (system 20 of fig. 1 and [0033]) comprising,
a probe (fiber bundle of [0043], arranged in a circle at a probe tip end 51 of distal end 40 according to [0049] of figs. 3A and 3B) wherein the probe comprises a laser fiber ([0033] discloses that the excitation fiber 24 is connected to receive light from light source 28, the light source configured to generate laser according to [0034]),
an endoscope, wherein the endoscope comprises a collection fiber ([0033] states that “Endoscope 22 comprises an excitation fiber 24 and one or more collection fibers 26”);
a sheath (guide sheath of [0038]), wherein the sheath comprises a probe channel ([0052] discloses that fiber bundle 50 is encased in the tubular sheath 54) and an endoscope channel ([0038] discloses that the endoscope is deployed through the guide sheath, meaning the bore of the guide sheath ([0017]) is for the endoscope), wherein the probe channel is configured to secure laser fiber channel ([0052] discloses that fiber bundle 50, which includes that is encased in the tubular sheath 54), wherein the endoscope channel is configured to secure the collection fiber ([0052] states that “Tubular sheath 54 may encase an outer layer 52 of fiber bundle 50 loosely enough to allow optical fibers 24 and/or 26 to slide longitudinally relative to one another as sheath 54 is flexed to follow curves”);
the laser fiber connected at its proximal end to a laser source for generating an excitation signal ([0033] states that “Excitation fiber 24 is connected to receive light from light source 28. Light from light source 28 is filtered by filter 30A and passes into endoscope 22. Light that emerges from the distal end 50 of endoscope 22 illuminates tissue T adjacent the end of endoscope 22 where some of the light undergoes Raman scattering”),
wherein an excitation signal filter is placed along a path of the excitation signal ([0033] states that “Light from light source 28 is filtered by filter 30A and passes into endoscope 22. Light that emerges from the distal end 50 of endoscope 22 illuminates tissue T adjacent the end of endoscope 22 where some of the light undergoes Raman scattering”);
the collection fiber connected at its proximal end to a spectrometer for receiving a collection signal generated by application of the excitation signal ([0033] further states that “Some of the Raman scattered light enters endoscope 22 and is carried to spectrograph 32 by way of filter 30B via collection fibers 26. Spectrograph 32 and detector 34 work together to produce a Raman spectrum of the light incident at spectrograph 32”), wherein the collection signal comprises raman spectral data ([0065] discloses “FIG. 4 is a flow chart depicting a method 100 for constructing a Raman endoscope for obtaining in vivo Raman spectra from the peripheral airways of the lungs”) , wherein a collection filter is placed along a path of the collection signal ([0033] further states that “Some of the Raman scattered light enters endoscope 22 and is carried to spectrograph 32 by way of filter 30B via collection fibers 26. Spectrograph 32 and detector 34 work together to produce a Raman spectrum of the light incident at spectrograph 32”);
a processing system (analysis system 36 of [0033] and fig. 1) including at least on processor ([0097] discloses a processor and software module as components of the system), wherein one or applications are configured to run on the at least one processor and to receive and analyze the raman spectral data ([0033] further disclose that “Information characterizing the Raman spectrum is then passed to a spectrum analysis system 36. In some embodiments, spectrum analysis system 36 operates in real time or near real time.”),
the analyzing including autofluorescence removal by at least asymmetric truncated quadratic processing ([0073] states that “Further processing may also include autofluorescence removal. In an example embodiment, autofluorescence removal may be performed by using a fitted iterative sixth order polynomial procedure as described in J. Zhao, H. Lui, D. I. McLean and H. Zeng Automated autofluorescence background subtraction algorithm for biomedical Raman spectroscopy, Appl Spectrosc, 2007; 61: 1225-1232”) and noise removal with a Savitzky-Golay filter ([0073] states that “Real time spectra pre-processing may include the subtraction of the CCD dark count, followed by Raman shift and intensity calibration. Further processing may include a smoothing algorithm. In an example embodiment, a 13 point smoothing algorithm is used, as described in A. Savitzsky, M. J. Golay and M. J., Smoothing and differentiation of data by simplified least squares procedures, Analytical Chemistry (1964) 36: 1627-1639”).
Regarding claim 3, McGregor also teaches wherein the endoscope comprises a rigid endoscope or a flexible endoscope (paragraph 11 states that “Such endoscope is also flexible to navigate the twisty airways but maintain rigidity near a probe tip end to advance the endoscope forward towards the lesion of interest”).
Regarding claim 4, McGregor further teaches wherein the flexible endoscope comprises a fiberoptic endoscope (paragraph 16 states that “The endoscope includes at least one excitation optical fiber, a plurality of collection optical fibers and a sheath”).
Regarding claim 6, McGregor further teaches wherein the processing system includes a signal collection system, wherein the signal collection system comprises a spectrum collection range of 200 cm-1 to 4000 cm-1 (paragraph 35 states that “A prototype embodiment used a spectrometer that could be manually tuned to an approximately 2000 cm.sup.−1 wide spectral window anywhere within a Raman shift wavenumber range of 0 to 3400 cm.sup.−1. In some embodiments, the grating has a custom range of, for example, 1350 to 3050 cm.sup.−1”, the spectrometer being the signal collection system).
Regarding claim 7, McGregor further teaches wherein the laser source comprises a wavelength of 532 nm, 638 nm, 785 nm, or 1064 nm (paragraph 34 states “the laser generates light having a wavelength of 785 nm”).
Regarding claim 9, McGregor further teaches wherein the probe comprises a flexible, fiberoptic probe(paragraph 52 states that “Tubular sheath 54 may encase an outer layer 52 of fiber bundle 50 loosely enough to allow optical fibers 24 and/or 26 to slide longitudinally relative to one another as sheath 54 is flexed to follow curves”).
Regarding claim 16, McGregor further teaches wherein the probe comprises an outer diameter of up to 2.5 mm, a length of up to 2 m, or a combination thereof (paragraph 43 states that “The endoscope comprises a sheath having an outer diameter of less than 1.35 mm.”).
Regarding claim 21, McGregor further teaches wherein the endoscope comprises an arthroscope, a bronchoscope (paragraph 33), a colonoscope, a hysteroscope, a laparoscope, a laryngoscope, a mediastinoscope, sigmoidoscope, thoracoscope, ureteroscope, or an endoscope for use in operative endoscopy (paragraph 72).
Regarding claim 22, McGregor further teaches wherein the endoscopy comprises laryngoscopy (the use of the endoscopy sheath-probe device in a laryngoscopy is an intended use of the device, hence since McGregor teaches all the components of the device, McGregor teaches use of the device in a laryngoscopy. See MPEP 2114(II)).
Regarding claim 23, McGregor further teaches wherein the operative endoscopy comprises pancreatic laparoscopy (the use of the endoscopy sheath-probe device in a laryngoscopy is an intended use of the device, hence since McGregor teaches all the components of the device, McGregor teaches use of the device in a pancreatic laparoscopy. See MPEP 2114(II)).
Regarding claim 25, McGregor further teaches wherein the device is configured to permit collection of data in real time during an endoscopic procedure (paragraph 33 states that “spectrum analysis system 36 operates in real time or near real time”).
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.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over McGregor in view of Smith, et al., US 20150131091 A1.
Regarding claim 10, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the probe is configured to control an incidence laser angle.
However, Smith teaches a Raman spectrometer which includes, for example, a light source, a lens, a filter, an analyzer, and a detector that may be used to identify and/or quantify the substances (paragraph 10). Smith further indicates in paragraph 14 that “The beam manipulator may deflect the incident light for focus at a plurality of points on a sample. The beam manipulator may include one or more refracting optical components (e.g., polyhedron prisms) that may deflect the light”, and demonstrates how the incidence light is deflected in fig. 3.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor wherein the probe is configured to control an incidence laser angle, as taught by Smith, to control the fluence of the incidence light (paragraph 12) and hence provide a safe and efficient detection (paragraphs 11 and 13).
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Keeler, et al., US 20140194861 A1.
Regarding claim 11, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the probe comprises an offset distal tip, wherein the offset distal tip is configured to allow contact with a tissue site and control of an optimal incident laser distance.
However, Keeler teaches a catheter having an elongated housing with a channel disposed therein. A laser delivery member is movable and at least partially disposed within the channel. Paragraph 46 states that “the position of the laser delivery member 22 may optionally be varied by the user by moving the member 22 proximally or distally in order to adjust the angle of disposition of its distal end 24. Optionally, the offset of the central axis of the tip of the laser delivery member 22 from the central axis of the housing 12 may be varied by adjusting the distance that the delivery member 22 travels on the ramp 20 while keeping the central axis of the tip substantially parallel to the central axis of the housing 12…In addition, the catheter 10 containing the laser delivery member 22 may optionally be rotated along its central axis during the laser treatment and thereby apply laser energy to areas of the treatment site within the arc of the rotation”, hence teaching wherein the probe comprises an offset distal tip, wherein the offset distal tip is configured to allow contact with a tissue site and control of an optimal incident laser distance.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor, wherein the probe comprises an offset distal tip, wherein the offset distal tip is configured to allow contact with a tissue site and control of an optimal incident laser distance, as taught by Keeler, permitting ablation of an area larger than the area of the distal end of the catheter (abstract). That is, the offset allows control of the region to be illuminated by the laser source.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over McGregor in view of Yang, et al., US 20150216398 A1.
Regarding claim 12, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the probe is configured to control ambient lighting.
However, Yang teaches a multispectral scanning fiber endoscope (SFE) system was specifically designed and engineered for wide field, high-resolution and real-time fluorescence molecular imaging and guiding biopsy (paragraph 84), wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter (paragraph 101 states that “The target-to-background ratio was enhanced by over an order of magnitude when applying the real-time AF mitigation algorithm. By minimizing the background signal, multispectral fluorescence imaging can provide sufficient image contrast and quantitative target information for detecting small pre-cancerous lesions in vivo”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter, as taught by Yang, hence providing decreased effects of interfering background fluorescence, compensation for spectral cross-talk between fluorescent molecular labels, improved quantification of the fluorescence signal of interest, decreased quantitative errors associated with imaging distance and angle, improved co-registration of reflectance and fluorescence signals, or improved repeat measurements separated by sufficient time for tissue to change.
Regarding claim 13, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter.
However, Yang teaches multispectral scanning fiber endoscope (SFE) system was specifically designed and engineered for wide field, high-resolution and real-time fluorescence molecular imaging and guiding biopsy (paragraph 84), wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter (paragraph 94 states that “High optical density (OD) filters (Semrock, Inc, Rochester, N.Y.) were placed in front of the fluorescence detection PMTs to block light from the excitation laser sources”. The filters are high optical density band-pass filters according to paragraph 85”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter, as taught by Yang, hence providing decreased effects of interfering background fluorescence, compensation for spectral cross-talk between fluorescent molecular labels, improved quantification of the fluorescence signal of interest, decreased quantitative errors associated with imaging distance and angle, improved co-registration of reflectance and fluorescence signals, or improved repeat measurements separated by sufficient time for tissue to change.
Regarding claim 14, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the collection filter comprises a high-optical density long-pass filter.
However, Yang teaches multispectral scanning fiber endoscope (SFE) system was specifically designed and engineered for wide field, high-resolution and real-time fluorescence molecular imaging and guiding biopsy (paragraph 84), wherein the excitation signal filter comprises a high-optical density (OD) band-pass filter (paragraph 85 further states that “Fluorescence or diffuse reflected light is then collected by a concentric ring of high numerical aperture optical fibers which surround the single mode beam delivery fiber and lens assembly. The collected light is separated into four wavelength bands (Blue, Green, Red/NIR fluorescence and Red reflectance respectively) by three dichroic beam splitters. Each separate spectral band is then passed through a high optical density band-pass (>10 OD), or long-pass filter positioned in front of a high gain photomultiplier tube (PMT)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor wherein the collection filter comprises a high-optical density long-pass filter, as taught by Yang, hence providing decreased effects of interfering background fluorescence, compensation for spectral cross-talk between fluorescent molecular labels, improved quantification of the fluorescence signal of interest, decreased quantitative errors associated with imaging distance and angle, improved co-registration of reflectance and fluorescence signals, or improved repeat measurements separated by sufficient time for tissue to change.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McGregor in view of Yang, as applied to claim 14 above, and further in view of Smith, et al., US 20150131091 A1.
Regarding claim 15, McGregor in view of Yang teaches all the limitations of claim 14 above.
McGregor in view of Yang does not teach wherein the filter is configured to filter out elastic scattering.
However, Smith teaches a Raman spectrometer which includes, for example, a light source, a lens, a filter, an analyzer, and a detector that may be used to identify and/or quantify the substances (paragraph 10). Paragraph 10 further states “The light source may generate an incident light. The generated incident light may be in the form of a laser beam. The lens may collect scattered light from a spot illuminated by the incident light. The collected scattered light may include, for example, inelastic scattered light and elastic scattered light. The collected scattered light may be directed to the filter. The filter may filter out the elastic scattered laser light and pass the inelastic scattered light.”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor as modified by Yang, wherein the filter is configured to filter out elastic scattering, as taught by Smith, to provide a safe and efficient detection (paragraphs 10-13).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over McGregor in view of Pyro et al., US 20210275248 A1.
Regarding claim 24, McGregor teaches all the limitations of claim 1 above.
McGregor does not teach wherein the sheath is disposable.
However, Pyro teaches A multiple-modality ablation probe can include a tube configured to transmit mechanical modality energy from a first end to an obstruction in contact with a second end (abstract), wherein the sheath, that is the tube, is disposable (paragraph 29 states “Having the probe 604 capable of being easily (e.g., threadable, snap-fit, or the like) user-attachable and user-detachable from the handle 611 by the user can allow for the probe 604 to be disposable or one-time use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor, wherein the sheath is disposable, as taught by Pyro, Disposable or one-time use probes 604 can help reduce cross-patient contamination, lower costs associated with sterilization and tracking, and reduce the possibility of surgical site infection (paragraph 29).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over McGregor in view of Henry, et al., US 20120133932 A1.
Regarding claims 26-27, McGregor teaches all the limitations of claim 1.
McGregor does not teach wherein the device is configured to produce a maximum energy exposure of a target tissue, wherein the maximum energy exposure is sufficient to permit collection of Raman data without damaging the tissue; and wherein the maximum energy exposure is less than 5 joules/cm2.
However, Henry teaches a method and system for detecting target materials using a combination of stroboscopic signal amplification and Raman spectroscopy techniques (see abstract) wherein the device is configured to produce a maximum energy exposure of a target tissue, wherein the maximum energy exposure is sufficient to permit collection of Raman data without damaging the tissue; and wherein the maximum energy exposure is less than about 5 joules/cm2 (paragraph 106 states that “embodiments of the present invention may operate with a time to peak discharge as low as about 5 .mu.s, thereby yielding about 80 mJ/cm.sup.2/.mu.s (calculated as 0.4 J/cm.sup.2 divided by 5 .mu.s) for the energy per area per time to peak discharge.” In the instant case, an energy of 80mJ/cm2 satisfies the required maximum energy exposure of less than 5 J/cm2)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McGregor, wherein the device is configured to produce a maximum energy exposure of a target tissue, wherein the maximum energy exposure is sufficient to permit collection of Raman data without damaging the tissue; and wherein the maximum energy exposure is less than about 5 joules/cm2, as taught by Henry, provide improved signal enhancement, detect target substances in near-real-time, use relatively low levels of power for each measurement, and/or can withstand rough handling during normal operations (paragraph 10).
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 Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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/FAROUK A BRUCE/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797