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 .
This Office action is responsive to an amendment filed December 7, 2022. Claims 1-13 are pending. Claims 1-13 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 7, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 10 & 12 is/are objected to because of the following informalities:
In regards to claim 10, at line 5, the limitations “a spectrometer, which configured to perform a spectral analysis” should apparently read --a spectrometer, which is configured to perform a spectral analysis--.
In regards to claim 12, at lines 13-14, the limitations “for outputting the optical radiation therefrom to spectral analysis” should apparently read -- for outputting the optical radiation therefrom [[to]] for spectral analysis--; and, at lines 19-20, the limitations “the cavity locating at a distance from the access tip” should apparently read -- the cavity --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 & 13 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 1, at line 16, the claim ends with “and” and without a period (“.”) and therefore may be incomplete. It is unclear what else, if anything, is part of the claim; moreover, the limitation “there” renders the claim indefinite because one cannot ascertain what the pronoun is intended to represent.
In regards to claim 7, at line 2, the limitations “transmission fiber arrangement” renders the claim indefinite because, from the limitations “at least one or more transmission fiber arrangement” at line 4 of claim 1 from which the claim depends, it is unclear whether the claim requires one or more than transmission fiber arrangement.
In regards to claim 8, at lines 1-2, the limitations “transmission fiber arrangement” renders the claim indefinite because, from the limitations “at least one or more transmission fiber arrangement” at line 4 of claim 1 from which the claim depends, it is unclear whether the claim requires one or more than transmission fiber arrangement.
In regards to claim 13, at line 16, the limitations “there” renders the claim indefinite because one cannot ascertain what the pronoun is intended to represent.
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) 1-4, 7-8 & 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks et al. (US 2015/0182206) (“Hendriks” hereinafter) in view of Irisawa et al. (US 2018/0008243) (“Irisawa” hereinafter).
In regards to claim 1, Hendriks discloses a needle apparatus for taking a sample from inside of an object, the needle apparatus comprises
a stylet 10, which comprises a longitudinal hollow,
at least one transmission fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one transmission fiber arrangement 40 is located at an access tip of the stylet 10, the at least one transmission fiber arrangement 40 being configured to guide optical radiation from a second end of the at least one transmission fiber arrangement 40 to the first end of the at least one transmission fiber arrangement 40 and output the optical radiation therefrom,
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at least one reception fiber arrangement 40 in a longitudinal hollow such that a first end of the at least one reception fiber arrangement 40 is located at the access tip of the stylet 10, the at least one reception fiber arrangement 40 being configured to receive optical radiation from environment of the access tip of the stylet 10 and guide the optical radiation therefrom to a second end of the at least one reception fiber arrangement 40 and output the optical radiation from there (see at least fig. 4 and par 0030-0032).
Hendriks discloses the needle apparatus, as described above, that fails to explicitly teach a needle apparatus comprising at least one transmission fiber arrangement on a surface of a bottom of the longitudinal hollow and at least one reception fiber arrangement on the surface of the bottom of the longitudinal hollow.
However, Irisawa teaches that it is known to provide a needle apparatus comprising at least two fiber arrangement 16 on a surface (62a, 63a) of a
bottom of the longitudinal hollow (see at least figs. 3-11 and par 0012-0015, 0017-0018, 0061-0062, 0067-0069, 0073-0076, 0101 & 0107).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the medical apparatus of Hendriks wherein the at least one transmission fiber arrangement thereof is on a surface of a bottom of the longitudinal hollow as taught by Irisawa, and the at least one reception fiber arrangement thereof is on the surface of the bottom of the longitudinal hollow as taught by Irisawa since such a modification would amount to applying a known technique (i.e., as taught by Irisawa) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as fixing the first and second fiber arrangements to a bottom surface of the sample collection portion that a fixing member that covers the fiber arrangement (see at least par 0012-0015 & 0017-0018 of Irisawa) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Hendriks discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus wherein the hollow is filled with a filling material following an outer contour of the stylet, the filling with the filling material being matched with outer contour of the stylet, the filling material having a mechanical impedance different from a mechanical impedance of at least one of the following: the transmission fiber arrangement , the reception fiber arrangement and the stylet.
However, Irisawa teaches that it is known to provide a needle apparatus wherein the hollow is filled with a filling material (65, 66, 70) following an outer contour of the stylet 60, the filling with the filling material (65, 66, 70) being matched with outer contour of the stylet 60, the filling material (65, 66, 70) having a mechanical impedance different from a mechanical impedance of the stylet 60 (see at least figs. 3-11 and par 0073-0076). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the medical apparatus of Hendriks wherein the hollow is filled with a filling material following an outer contour of the stylet, the filling with the filling material being matched with outer contour of the stylet, the filling material having a mechanical impedance different from a mechanical impedance of the stylet as taught by Irisawa since such a modification would amount to applying a known technique (i.e., as taught by Irisawa) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as fixing the first and second fiber arrangements to a bottom surface of the sample collection portion that a fixing member that covers the fiber arrangement (see at least par 0012-0015 & 0017-0018 of Irisawa) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Hendriks discloses the needle apparatus of claim 1, wherein the needle apparatus comprises a cavity 20, which is a cut-off in a perpendicular direction to a longitudinal axis of the stylet 10, at a distance from the access tip, the cavity 20 being configured to take a sample from the at least one organ (see at least figs. 4-6 and par 0031).
In regards to claim 4, Hendriks discloses the needle apparatus of claim 1, the at least one transmission fiber arrangement 40 comprises at least one optical fiber, and the at least one reception fiber arrangement 40 comprises at least one optical fiber, and the at least one transmission fiber arrangement 40 is capable of transmitting at least one of the following: ultraviolet light, visible light and infrared light (by virtue of being a optical fiber(s)) (see at least fig. 4 and par 0038 & 0053).
In regards to claim 7, Hendriks discloses the needle apparatus of claim 1, a curvature of a polished surface of the first end of the transmission fiber arrangement 40 and a shape of the access tip have a predetermined dependence for directing the optical radiation inside the object (see at least fig. 4).
In regards to claim 8, Hendriks discloses the needle apparatus of claim 1, the transmission fiber arrangement 40 is capable of outputting excitation light, and the reception fiber arrangement 40 is capable of receiving at least one of the following caused by the excitation light from the at least one organ in conjunction with a sampling: Raman-light and fluorescent light (by virtue of being optical fiber(s)) (see at least fig. 4 and par 0019 & 0038-0039).
In regards to claim 10, Hendriks discloses the needle apparatus of claim 1, the needle apparatus comprises an optical radiation source 64 (see at least par 0019, 0038 & 0042), which is configured to feed the optical radiation to the at least one transmission fiber arrangement 40 through the second end of the at least one transmission fiber arrangement 40, and the needle apparatus comprises a spectrometer , which configured to perform a spectral analysis of the optical radiation received from the second end of the at least one reception fiber 40 arrangement (see at least fig. 7 and par 0040-0041).
In regards to claim 11, Bowman discloses the needle apparatus of claim 10, wherein the spectrometer comprises one or more processors, and one or more memories including a computer program code; and the one or more memories and the computer program code being configured to, with the one or more processors, cause the spectrometer at least to perform the spectral analysis of the optical radiation received from the second end of the of the at least one reception fiber arrangement 40 (see at least fig. 7 and par 0040-0041).
In regards to claim 12, Hendriks discloses a method of performing sampling from an object with a needle apparatus,
guiding optical radiation from a second end of at least one transmission fiber arrangement 40 to a first end of the at least one transmission fiber arrangement 40 for outputting the optical radiation therefrom to the at least one organ, the at least one transmission fiber arrangement 40 extending in a longitudinal hollow such that the first end of the at least one transmission fiber arrangement 40 is located at an access tip of the stylet 10;
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receiving optical radiation from inside of the object with a first end of at least one reception fiber arrangement 40, the first end of the at least one reception fiber arrangement 40 locating at the access tip of the stylet 10;
guiding the optical radiation from the access tip to a second end of the at least one reception fiber arrangement 40 for outputting the optical radiation therefrom to spectral analysis (see at least fig. 7 and par 0040-0041), the at least one reception fiber arrangement 40 extending in a longitudinal hollow, and the at least one transmission fiber arrangement 40 and the at least one reception fiber arrangement 40 being located in a predetermined manner with respect to each other in the hollow; and
taking a sample from inside of the object with a cavity 20, which is a cut-off in a perpendicular direction to a longitudinal axis of the stylet 10, the cavity 20 locating at a distance from the access tip (see at least fig. 4 and par 0030-0032).
Hendriks discloses a method of performing sampling from an object with a needle apparatus, as described above, that fails to explicitly teach a method wherein the at least one transmission fiber arrangement extends on a surface of a bottom of the longitudinal hollow and at least one reception fiber arrangement extends on the surface of the bottom of the longitudinal hollow.
However, Irisawa teaches that it is known to provide a method wherein at least two fiber arrangement 16 extends on a surface (62a, 63a) of a
bottom of the longitudinal hollow (see at least figs. 3-11 and par 0012-0015, 0017-0018, 0061-0062, 0067-0069, 0073-0076, 0101 & 0107).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Hendriks wherein the at least one transmission fiber arrangement thereof extends on a surface of a bottom of the longitudinal hollow as taught by Irisawa, and the at least one reception fiber arrangement thereof extends on the surface of the bottom of the longitudinal hollow as taught by Irisawa since such a modification would amount to applying a known technique (i.e., as taught by Irisawa) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as fixing the first and second fiber arrangements to a bottom surface of the sample collection portion that a fixing member that covers the fiber arrangement (see at least par 0012-0015 & 0017-0018 of Irisawa) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 13, Hendriks discloses a manufacturing method of a needle apparatus for taking a sample from an object, forming a longitudinal hollow in a stylet 10 of the needle apparatus
locating at least one transmission fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one transmission fiber arrangement 40 is located at the access tip of the stylet 10, the at least one transmission fiber arrangement 40 being configured to guide optical radiation from a second end of the at least one transmission fiber arrangement 40 to the first end of the at least one transmission fiber arrangement 40 and output the optical radiation therefrom;
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locating at least one reception fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one reception fiber arrangement 40 is located at the access tip of the stylet 10, the at least one reception fiber arrangement 40 being configured to receive optical radiation from environment of the access tip of the stylet 10 and guide the optical radiation therefrom to a second end of the at least one reception fiber arrangement 40 and output the optical radiation from there (see at least fig. 4 and par 0030-0032).
Hendriks discloses a manufacturing method, as described above, that fails to explicitly teach a manufacturing method comprising locating at least one transmission fiber arrangement on a surface of the longitudinal hollow; and locating at least one reception fiber arrangement on a surface of the longitudinal hollow.
However, Irisawa teaches that it is known to provide a manufacturing method comprising locating at least two fiber arrangements 16 on a surface (62a, 63a) of the longitudinal hollow (see at least figs. 3-11 and par 0012-0015, 0017-0018, 0061-0062, 0067-0069, 0073-0076, 0101 & 0107).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the manufacturing method of Hendriks comprising locating the at least one transmission fiber arrangement thereof on a surface of the longitudinal hollow as taught by Irisawa; and locating the at least one reception fiber arrangement thereof on a surface of the longitudinal hollow as taught by Irisawa since such a modification would amount to applying a known technique (i.e., as taught by Irisawa) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as fixing the first and second fiber arrangements to a bottom surface of the sample collection portion that a fixing member that covers the fiber arrangement (see at least par 0012-0015 & 0017-0018 of Irisawa) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (US 2015/0182206) in view of Irisawa (US 2018/0008243) further in view of Bierhoff et al. (US 2014/0236024) (“Bierhoff” hereinafter).
In regards to claim 5, Hendriks discloses the needle apparatus of claim 4, that fails to explicitly teach a needle apparatus wherein the at least one transmission fiber arrangement comprises a plurality of optical fibers, and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light, at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light, and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light. However, Bierhoff teaches that it is known to provide to provide a needle apparatus wherein the at least one transmission fiber arrangement comprises a plurality of optical fibers (i.e., by virtue of being an optical fiber), and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light (i.e., by virtue of being an optical fiber), at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light (i.e., by virtue of being an optical fiber), and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light (i.e., by virtue of being an optical fiber) (see at least figs. 2-3 and par 0010, 0041 & 0060). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Irisawa the at least one transmission fiber arrangement comprises a plurality of optical fibers, and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light, at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light, and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light as taught by Bierhoff since such a modification would amount to applying a known technique (i.e., as taught by Bierhoff) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as adding an additional fiber that can be used for conveying light to or from the tip of the needle, thereby making the additional fiber available for improving the detection efficiency (see at least par 0010 & 0041 of Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 6, Hendriks as modified by Irisawa discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus, wherein the at least one transmission fiber arrangement and the at least one reception fiber arrangement, are side by side in a physical contact with each other at a bottom of the hollow. However, Bierhoff teaches that it is known to provide a needle apparatus, wherein the at least one transmission fiber arrangement 10 and the at least one reception fiber arrangement 10, are side by side in a physical contact with each other at a bottom of the hollow (see at least abstract, fig. 2 and par 0007-0009, 0039-0040 & 0042-0045). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Irisawa wherein at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light as taught by Bierhoff since such a modification would amount to applying a known technique (i.e., as taught by Bierhoff) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff) as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (US 2015/0182206) in view of Irisawa (US 2018/0008243) further in view of Hular et al. (US 2003/0045798) (“Hular” hereinafter).
Hendriks as modified by Irisawa discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus, wherein the needle apparatus comprises at least one electric wire on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet.
However, Hular teaches that it is known to provide a needle apparatus, wherein the needle apparatus comprises at least one electric wire 200 on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet 100 (see at least abstract, figs. 2A-B, 3-4 & 5A-H and par 0043-0044, 0047 & 0066-0067 & 0103).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Irisawa wherein the needle apparatus comprises at least one electric wire on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet as taught by Hular since such a modification would amount to applying a known technique (i.e., as taught by Hular) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as measuring various electrical properties including electrical impedance of the tissue near the probe tip such as the tissue type (see par 0066 & 0103 of Hular)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 1-4, 7-8 & 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks et al. (US 2015/0182206) (“Hendriks” hereinafter) in view of Bagwell et al. (US 2015/0208925) (“Bagwell” hereinafter).
In regards to claim 1, Hendriks discloses a needle apparatus for taking a sample from inside of an object, the needle apparatus comprises
a stylet 10, which comprises a longitudinal hollow,
at least one transmission fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one transmission fiber arrangement 40 is located at an access tip of the stylet 10, the at least one transmission fiber arrangement 40 being configured to guide optical radiation from a second end of the at least one transmission fiber arrangement 40 to the first end of the at least one transmission fiber arrangement 40 and output the optical radiation therefrom,
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at least one reception fiber arrangement 40 in a longitudinal hollow such that a first end of the at least one reception fiber arrangement 40 is located at the access tip of the stylet 10, the at least one reception fiber arrangement 40 being configured to receive optical radiation from environment of the access tip of the stylet 10 and guide the optical radiation therefrom to a second end of the at least one reception fiber arrangement 40 and output the optical radiation from there (see at least fig. 4 and par 0030-0032).
Hendriks discloses the needle apparatus, as described above, that fails to explicitly teach a needle apparatus comprising at least one transmission fiber arrangement on a surface of a bottom of the longitudinal hollow and at least one reception fiber arrangement on the surface of the bottom of the longitudinal hollow.
However, Bagwell teaches that it is known to provide a needle apparatus comprising a transmission and/or reception fiber arrangement 39 on a surface of a
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bottom of the longitudinal hollow (see at least figs. 4 & 4A-C and par 0056).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the medical apparatus of Hendriks wherein the at least one transmission fiber arrangement thereof is on a surface of a bottom of the longitudinal hollow as taught by Bagwell, and the at least one reception fiber arrangement thereof is on the surface of the bottom of the longitudinal hollow as taught by Bagwell since such a modification would amount to applying a known technique (i.e., as taught by Bagwell) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the optical fiber(s) in a typical conventional core needle biopsy sample notch and maintaining the stylet optical fiber within an embedding matrix below the stylet sample notch (see at least par 0056 of Bagwell) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Hendriks discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus wherein the hollow is filled with a filling material following an outer contour of the stylet, the filling with the filling material being matched with outer contour of the stylet, the filling material having a mechanical impedance different from a mechanical impedance of at least one of the following: the transmission fiber arrangement , the reception fiber arrangement and the stylet. However, Bagwell teaches that it is known to provide a needle apparatus wherein the hollow is filled with a filling material 35 following an outer contour of the stylet 29, the filling with the filling material 35 being matched with outer contour of the stylet 29, the filling material 35 having a mechanical impedance different from a mechanical impedance of the stylet 29 (see at least figs. 4 & 4A-C and par 0056). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the medical apparatus of Hendriks wherein the hollow is filled with a filling material following an outer contour of the stylet, the filling with the filling material being matched with outer contour of the stylet, the filling material having a mechanical impedance different from a mechanical impedance of the stylet as taught by Bagwell since such a modification would amount to applying a known technique (i.e., as taught by Bagwell) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the optical fiber(s) in a typical conventional core needle biopsy sample notch and maintaining the stylet optical fiber within an embedding matrix below the stylet sample notch (see at least par 0056 of Bagwell) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Hendriks discloses the needle apparatus of claim 1, wherein the needle apparatus comprises a cavity 20, which is a cut-off in a perpendicular direction to a longitudinal axis of the stylet 10, at a distance from the access tip, the cavity 20 being configured to take a sample from the at least one organ (see at least figs. 4-6 and par 0031).
In regards to claim 4, Hendriks discloses the needle apparatus of claim 1, the at least one transmission fiber arrangement 40 comprises at least one optical fiber, and the at least one reception fiber arrangement 40 comprises at least one optical fiber, and the at least one transmission fiber arrangement 40 is capable of transmitting at least one of the following: ultraviolet light, visible light and infrared light (by virtue of being a optical fiber(s)) (see at least fig. 4 and par 0038 & 0053).
In regards to claim 7, Hendriks discloses the needle apparatus of claim 1, a curvature of a polished surface of the first end of the transmission fiber arrangement 40 and a shape of the access tip have a predetermined dependence for directing the optical radiation inside the object (see at least fig. 4).
In regards to claim 8, Hendriks discloses the needle apparatus of claim 1, the transmission fiber arrangement 40 is capable of outputting excitation light, and the reception fiber arrangement 40 is capable of receiving at least one of the following caused by the excitation light from the at least one organ in conjunction with a sampling: Raman-light and fluorescent light (by virtue of being optical fiber(s)) (see at least fig. 4 and par 0019 & 0038-0039).
In regards to claim 10, Hendriks discloses the needle apparatus of claim 1, the needle apparatus comprises an optical radiation source 64 (see at least par 0019, 0038 & 0042), which is configured to feed the optical radiation to the at least one transmission fiber arrangement 40 through the second end of the at least one transmission fiber arrangement 40, and the needle apparatus comprises a spectrometer , which configured to perform a spectral analysis of the optical radiation received from the second end of the at least one reception fiber 40 arrangement (see at least fig. 7 and par 0040-0041).
In regards to claim 11, Bowman discloses the needle apparatus of claim 10, wherein the spectrometer comprises one or more processors, and one or more memories including a computer program code; and the one or more memories and the computer program code being configured to, with the one or more processors, cause the spectrometer at least to perform the spectral analysis of the optical radiation received from the second end of the of the at least one reception fiber arrangement 40 (see at least fig. 7 and par 0040-0041).
In regards to claim 12, Hendriks discloses a method of performing sampling from an object with a needle apparatus,
guiding optical radiation from a second end of at least one transmission fiber arrangement 40 to a first end of the at least one transmission fiber arrangement 40 for outputting the optical radiation therefrom to the at least one organ, the at least one transmission fiber arrangement 40 extending in a longitudinal hollow such that the first end of the at least one transmission fiber arrangement 40 is located at an access tip of the stylet 10;
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receiving optical radiation from inside of the object with a first end of at least one reception fiber arrangement 40, the first end of the at least one reception fiber arrangement 40 locating at the access tip of the stylet 10;
guiding the optical radiation from the access tip to a second end of the at least one reception fiber arrangement 40 for outputting the optical radiation therefrom to spectral analysis (see at least fig. 7 and par 0040-0041), the at least one reception fiber arrangement 40 extending in a longitudinal hollow, and the at least one transmission fiber arrangement 40 and the at least one reception fiber arrangement 40 being located in a predetermined manner with respect to each other in the hollow; and
taking a sample from inside of the object with a cavity 20, which is a cut-off in a perpendicular direction to a longitudinal axis of the stylet 10, the cavity 20 locating at a distance from the access tip (see at least fig. 4 and par 0030-0032).
Hendriks discloses a method of performing sampling from an object with a needle apparatus, as described above, that fails to explicitly teach a method wherein the at least one transmission fiber arrangement extends on a surface of a bottom of the longitudinal hollow and at least one reception fiber arrangement extends on the surface of the bottom of the longitudinal hollow.
However, Bagwell teaches that it is known to provide a method wherein the transmission and/or reception fiber arrangement 39 extends on a surface of a
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bottom of the longitudinal hollow (see at least figs. 4 & 4A-C and par 0056).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Hendriks wherein the at least one transmission fiber arrangement thereof extends on a surface of a bottom of the longitudinal hollow as taught by Bagwell, and the at least one reception fiber arrangement thereof extends on the surface of the bottom of the longitudinal hollow as taught by Bagwell since such a modification would amount to applying a known technique (i.e., as taught by Bagwell) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the optical fiber(s) in a typical conventional core needle biopsy sample notch and maintaining the stylet optical fiber within an embedding matrix below the stylet sample notch (see at least par 0056 of Bagwell) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 13, Hendriks discloses a manufacturing method of a needle apparatus for taking a sample from an object, forming a longitudinal hollow in a stylet 10 of the needle apparatus
locating at least one transmission fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one transmission fiber arrangement 40 is located at the access tip of the stylet 10, the at least one transmission fiber arrangement 40 being configured to guide optical radiation from a second end of the at least one transmission fiber arrangement 40 to the first end of the at least one transmission fiber arrangement 40 and output the optical radiation therefrom;
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locating at least one reception fiber arrangement 40 in the longitudinal hollow such that a first end of the at least one reception fiber arrangement 40 is located at the access tip of the stylet 10, the at least one reception fiber arrangement 40 being configured to receive optical radiation from environment of the access tip of the stylet 10 and guide the optical radiation therefrom to a second end of the at least one reception fiber arrangement 40 and output the optical radiation from there (see at least fig. 4 and par 0030-0032).
Hendriks discloses a manufacturing method, as described above, that fails to explicitly teach a manufacturing method comprising locating at least one transmission fiber arrangement on a surface of the longitudinal hollow; and locating at least one reception fiber arrangement on a surface of the longitudinal hollow.
However, Bagwell teaches that it is known to provide a manufacturing method comprising locating at least one transmission and/or reception fiber arrangement 39 on
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a surface of the longitudinal hollow (see at least figs. 4 & 4A-C and par 0056).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the manufacturing method of Hendriks comprising locating the at least one transmission fiber arrangement thereof on a surface of the longitudinal hollow as taught by Bagwell; and locating the at least one reception fiber arrangement thereof on a surface of the longitudinal hollow as taught by Bagwell since such a modification would amount to applying a known technique (i.e., as taught by Bagwell) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the optical fiber(s) in a typical conventional core needle biopsy sample notch and maintaining the stylet optical fiber within an embedding matrix below the stylet sample notch (see at least par 0056 of Bagwell) so as to provide the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (US 2015/0182206) in view of Bagwell (US 2015/0208925) further in view of Bierhoff et al. (US 2014/0236024) (“Bierhoff” hereinafter).
In regards to claim 5, Hendriks discloses the needle apparatus of claim 4, that fails to explicitly teach a needle apparatus wherein the at least one transmission fiber arrangement comprises a plurality of optical fibers, and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light, at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light, and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light. However, Bierhoff teaches that it is known to provide to provide a needle apparatus wherein the at least one transmission fiber arrangement comprises a plurality of optical fibers (i.e., by virtue of being an optical fiber), and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light (i.e., by virtue of being an optical fiber), at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light (i.e., by virtue of being an optical fiber), and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light (i.e., by virtue of being an optical fiber) (see at least figs. 2-3 and par 0010, 0041 & 0060). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Bagwell the at least one transmission fiber arrangement comprises a plurality of optical fibers, and at least one first optical fiber of the at least one transmission fiber arrangement is configured to transmit the ultraviolet light, at least one second optical fiber of the at least one transmission fiber arrangement is configured to transmit the visible light, and at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light as taught by Bierhoff since such a modification would amount to applying a known technique (i.e., as taught by Bierhoff) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as adding an additional fiber that can be used for conveying light to or from the tip of the needle, thereby making the additional fiber available for improving the detection efficiency (see at least par 0010 & 0041 of Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 6, Hendriks as modified by Bagwell discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus, wherein the at least one transmission fiber arrangement and the at least one reception fiber arrangement, are side by side in a physical contact with each other at a bottom of the hollow. However, Bierhoff teaches that it is known to provide a needle apparatus, wherein the at least one transmission fiber arrangement 10 and the at least one reception fiber arrangement 10, are side by side in a physical contact with each other at a bottom of the hollow (see at least abstract, fig. 2 and par 0007-0009, 0039-0040 & 0042-0045). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Bagwell wherein at least one third optical fiber of the at least one transmission fiber arrangement is configured to transmit the infrared light as taught by Bierhoff since such a modification would amount to applying a known technique (i.e., as taught by Bierhoff) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as providing the transmission and reception fibers in the same lumen without sidewalls between the fibers, which helps prevent shadowing effects and improve fluorescence collection efficiency as is known in the art (see at least par 0007-0009 of US 2014/0236024 to Bierhoff)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (US 2015/0182206) in view of Bagwell (US 2015/0208925) further in view of Hular et al. (US 2003/0045798) (“Hular” hereinafter).
Hendriks as modified by Bagwell discloses the needle apparatus of claim 1, that fails to explicitly teach a needle apparatus, wherein the needle apparatus comprises at least one electric wire on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet.
However, Hular teaches that it is known to provide a needle apparatus, wherein the needle apparatus comprises at least one electric wire 200 on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet 100 (see at least abstract, figs. 2A-B, 3-4 & 5A-H and par 0043-0044, 0047 & 0066-0067 & 0103).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the needle apparatus of Hendriks as modified by Bagwell wherein the needle apparatus comprises at least one electric wire on the surface of the longitudinal hollow such that a first end of the at least one electric wire is located at an access tip of the stylet as taught by Hular since such a modification would amount to applying a known technique (i.e., as taught by Hular) to a known device (i.e., as taught by Hendriks) ready for improvement to achieve a predictable result such as measuring various electrical properties including electrical impedance of the tissue near the probe tip such as the tissue type (see par 0066 & 0103 of Hular)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 1-4, 7-8 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US 2002/0128570) (“Bowman” hereinafter) in view of Bagwell et al. (US 2015/0208925) (“Bagwell” hereinafter).
In regards to claim 1, Bowman discloses a needle apparatus 10 for taking a sample from inside of an object, the needle apparatus 10 comprises
a stylet 14, which comprises a longitudinal hollow,
at least one transmission fiber arrangement 73 in the longitudinal hollow such that a first end of the at least one transmission fiber arrangement 73 is located at an access tip of the stylet 14, the at least one transmission fiber arrangement 73 being configured to guide optical radiation from a second end of the at least one transmission fiber arrangement 73 to the first end of the at least one transmission fiber arrangement 73 and output the optical radiation therefrom,
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at least one reception fiber arrangement 75 in a longitudinal hollow such that a first end of the at least one reception fiber arrangement 75 is located at the access tip of the stylet 14, the at least one reception fiber arrangement 75 being configured to receive optical radiation from environment of the access tip of the stylet 14 and guide the optical radiation therefrom to a second end of the at least one reception fiber arrangement 75 and output the optical radiation from there (see at least fig. 5 and par 0033).
Bowman discloses the needle apparatus 10, as described above, that fails to explicitly t