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 July 30, 2026. Claims 1, 4-6 & 8-16 are pending. New claims 15-16 have been added. Claims 1, 4-6 & 8-16 have been amended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6, 8-9 & 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2019/0254649) (“Walters” hereinafter) in view of Jaffe et al. (US 2002/0161281) (“Jaffe” hereinafter) further in view of Fleury et al. (US 2017/0245841) (“Fleury” hereinafter).
In regards to claim 1, Walters discloses a living tissue sampling method comprising:
inserting an endoscope inserted into a guide sheath (430, 720), into a body cavity of a subject (see at least figs. 4A & D, 5 & 7A-B and par 0063 & 0077);
receiving a three-dimensional image information of the body cavity generated by a device (such as CT) different from the endoscope (see at least par 0043, 0086 & 0103);
moving distal ends of the endoscope and the guide sheath (430, 720) close to a focused region (414, 714) of the body cavity (see at least par 0063 & 0077) based on the three-dimensional image (see at least par 0043, 0086 & 0103) and distal end position data of the endoscope (i.e., from position sensor system 220, see par 0048, 0063, 0074-0075, 0077 & 0087);
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then removing the endoscope from the guide sheath (430, 720) while maintaining a position of the guide sheath (430, 720) (see at least par 0063, 0069 & 0077);
then inserting a biopsy instrument 437 into the guide sheath (430, 720) to bring the biopsy instrument 437 close to the focused region (414, 714) (see at least figs. 4A & D, 5 & 7A-B and par 0063 & 0077); and
then sampling living tissue of the focused region (414, 714) by the biopsy instrument 437 (see at least figs. 4A & D, 5 & 7A-B and par 0063-0064, 0069, 0077 & 0099).
Walters discloses a living tissue sampling method, as described above, that fails to explicitly teach a method comprising moving distal ends of the endoscope and the guide sheath via one or more wires and maintaining a position of the guide sheath via the wires.
However, Jaffe teaches that it is known to provide a method comprising moving distal ends (22) of the endoscope 12 and the guide sheath 14 (see at least abstract, fig.
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1 and par 0028) via one or more wires (30A, 30B, 30C) (see at least figs. 2-3 and par 0041) and maintaining (e.g., by rigidizing) a position of the guide sheath 14 via the wires (30A, 30B, 30C) (see at least abstract).
Therefore, since Walters teaches that it is known to provide guide sheath (430, 720) that can be steered so as to orient distal end 435 toward lesion 414 (see at least par 0063), 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 Walters comprising moving distal ends of the endoscope and the guide sheath via one or more wires and maintaining a position of the guide sheath via the wires as taught by Jaffe since such a modification would amount to applying a known technique (i.e., as taught by Jaffe) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing an assembly, which is able to traverse tortuous body cavity paths without excessively contacting the walls of said tortuous body cavity paths (see at least par 0008 of Jaffe)--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).
Walters as modified by Jaffe discloses a living tissue sampling method, as described above, that fails to explicitly teach a method with the biopsy instrument comprising an image pickup appliance to bring the biopsy instrument close to the focused region based on images of the body cavity generated by the image pickup appliance.
However, Fleury teaches that it is known to provide a method with the biopsy instrument 120 comprising an image pickup appliance 110 to bring the biopsy
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instrument 120 close to the focused region based on images of the body cavity generated by the image pickup appliance 110 (see at least abstract, figs. 1-4 & 5A-B and par 0009-0011, 0019-0020 & 0022).
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 Walters as modified by Jaffe with the biopsy instrument comprising an image pickup appliance to bring the biopsy instrument close to the focused region based on images of the body cavity generated by the image pickup appliance as taught by Fleury since such a modification would amount to applying a known technique (i.e., as taught by Fleury) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as visualizing the site using an ultrasound signal generated by the ultrasound probe (see at least par 0010 of Fleury)--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, Walters discloses a biopsy support system comprising:
a guide sheath (430, 720) configured is to be inserted into a body cavity of a subject and manipulated to move and be held in a position via one more wires disposed within the guide sheath (see at least fig. 4A and par 0063);
an endoscope configured to be insertable into the guide sheath (430, 720), generate an endoscopic image of the body cavity and to output distal end position information of the endoscope (see at least par 0063);
a processor (i.e., of control system 112, see par 0036, 0041, 0049, 0085 & 0102) configured to:
determine distal end position data of the endoscope based on the distal end position information (i.e., from position sensor system 220, see par 0048, 0063, 0074-0075, 0077 & 0087);
receive a three-dimensional image generated by a device other than the endoscope (see at least par 0043, 0086 & 0103);
determine a distal end position of the endoscope based on the distal end position data (i.e., from position sensor system 220, see par 0048, 0063, 0074-0075, 0077 & 0087); and
generate a navigation image showing the distal end position of the endoscope on the three-dimensional image (see at least par 0043, 0086 & 0103); and
a biopsy instrument 437 configured to be insertable inside the guide sheath (430, 720), and sample living tissue of a focused region (414, 714) in the body cavity of the subject (see at least par 0063 & 0077).
Walters discloses a system, as described above, that fails to explicitly teach a system with the guide sheath configured to be manipulated to move and be held in a position via one or more wires disposed within the guide sheath.
However, Jaffe teaches that it is known to provide a system with the guide sheath 14 configured to be manipulated to move (see at least figs. 2-3 and par 0041)
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and be held in a position (e.g., by rigidizing) via one or more wires (30A, 30B, 30C) disposed within the guide sheath 14 (see at least abstract).
Therefore, since Walters teaches that it is known to provide guide sheath (430, 720) that can be steered so as to orient distal end 435 toward lesion 414 (see at least par 0063), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Walters with the guide sheath configured to be manipulated to move and be held in a position via one or more wires disposed within the guide sheath as taught by Jaffe since such a modification would amount to applying a known technique (i.e., as taught by Jaffe) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing an assembly, which is able to traverse tortuous body cavity paths without excessively contacting the walls of said tortuous body cavity paths (see at least par 0008 of Jaffe)--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).
Walters as modified by Jaffe discloses a system, as described above, that fails to explicitly teach a system with the biopsy instrument comprising an image pickup appliance configured to guide the biopsy instrument.
However, Fleury teaches that it is known to provide a system with the biopsy instrument 120 comprising an image pickup appliance 110 configured to guide the
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biopsy instrument 120 (see at least abstract, figs. 1-4 & 5A-B and par 0009-0011, 0019-0020 & 0022).
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 system of Walters as modified by Jaffe with the biopsy instrument comprising an image pickup appliance configured to guide the biopsy instrument as taught by Fleury since such a modification would amount to applying a known technique (i.e., as taught by Fleury) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as visualizing the site using an ultrasound signal generated by the ultrasound probe (see at least par 0010 of Fleury)--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 8, Walters as modified by Jaffe discloses the biopsy support system according to claim 6, that fails to explicitly teach a system wherein the biopsy instrument includes an insertion hole and the image pickup appliance is to be insertable inside the insertion hole. However, Fleury teaches that it is known to provide a system wherein the biopsy instrument 120 includes an insertion hole (e.g., lumen) and the image pickup appliance 110 is to be insertable inside the insertion hole (see at least abstract, figs. 1-4 & 5A-B and par 0009-0011, 0019-0020 & 0022). 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 Walters as modified by Jaffe wherein the biopsy instrument includes an insertion hole and the image pickup appliance is to be insertable inside the insertion hole as taught by Fleury since such a modification would amount to applying a known technique (i.e., as taught by Fleury) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as visualizing the site using an ultrasound signal generated by the ultrasound probe (see at least par 0010 of Fleury)--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 9, Walters as modified by Jaffe discloses the biopsy support system according to claim 8, that fails to explicitly teach a system wherein the image pickup appliance is an ultrasound probe. However, Fleury teaches that it is known to provide wherein the image pickup appliance 110 is an ultrasound probe (see at least abstract, figs. 1-4 & 5A-B and par 0009-0011, 0019-0020 & 0022). 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 Walters as modified by Jaffe wherein the image pickup appliance is an ultrasound probe as taught by Fleury since such a modification would amount to applying a known technique (i.e., as taught by Fleury) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as visualizing the site using an ultrasound signal generated by the ultrasound probe (see at least par 0010 of Fleury)--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, Walters discloses the biopsy support system according to claim 6, wherein the three-dimensional image information is acquired by an X-ray CT device (see at least par 0043 & 0086).
In regards to claim 14, Walters discloses the biopsy support system according to claim 6, wherein the body cavity of the subject is part of a respiratory system (e.g., lung or airways) (see at least par 0056, 0061 & 0088).
Claim(s) 4 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2019/0254649) (“Walters” hereinafter) in view of Jaffe et al. (US 2002/0161281) (“Jaffe” hereinafter), Fleury et al. (US 2017/0245841) (“Fleury” hereinafter) further in view of Prisco et al. (US 2010/0249507) (“Prisco” hereinafter).
In regards to claim 4, Walters as modified by Jaffe and Fleury discloses the method of claim 1, that fails to explicitly teach a method wherein the distal end position data is based on three-dimensional shape data determined from distal end position information received from the endoscope, and the living tissue sampling method further comprises showing a position of a distal end of the endoscope, derived from the distal end position data, on the three-dimensional image. However, Prisco teaches that it is known to provide a method wherein the distal end position data is based on three-dimensional shape data 710 determined from distal end position information received from the endoscope 110, and the method further comprises showing a position of a distal end of the endoscope 110, derived from the distal end position data, on the three-dimensional image (see at least figs. 4 & 7-9 and par 0028, 0030, 0042 & 0042 & 0044). 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 Walters as modified by Jaffe and Fleury wherein the distal end position data is based on three-dimensional shape data determined from distal end position information received from the endoscope, and the living tissue sampling method further comprises showing a position of a distal end of the endoscope, derived from the distal end position data, on the three-dimensional image as taught by Prisco since such a modification would amount to applying a known technique (i.e., as taught by Prisco) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing visual guidance to an operator for steering a tip of an endoscopic device towards one or more landmarks in a patient so as to make easier for the operator to keep track of the current direction of the endoscope tip (see at least par 0001 & 0007 of Prisco)--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 11, Walters as modified by Jaffe and Fleury discloses the biopsy support system according to claim 6, that fails to explicitly teach a system wherein the distal end position data is based on three-dimensional shape data determined from distal end position information received from the endoscope, and the processor is further configured to show a position of a distal end of the endoscope, derived from the distal end position data, on the three-dimensional image. However, Prisco discloses a system wherein the distal end position data is based on three-dimensional shape data 710 determined from distal end position information received from the endoscope 110, and the processor 140 is further configured to show a position of a distal end of the endoscope 110, derived from the distal end position data, on the three-dimensional image (see at least figs. 4 & 7-9 and par 0028, 0030, 0042 & 0042 & 0044). 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 Walters as modified by Jaffe as modified by Fleury wherein the endoscope acquires the distal end position information of the endoscope based on three-dimensional shape data, the processor determines the distal end position data of the endoscope from the distal end position information that is the three-dimensional shape data, and the processor checks the distal end position data of the endoscope that is obtained against the three-dimensional image information that is stored, and generates a navigation image showing a position, on the three-dimensional image, corresponding to the distal end position of the endoscope as taught by Prisco since such a modification would amount to applying a known technique (i.e., as taught by Prisco) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing visual guidance to an operator for steering a tip of an endoscopic device towards one or more landmarks in a patient so as to make easier for the operator to keep track of the current direction of the endoscope tip (see at least par 0001 & 0007 of Prisco)--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 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2019/0254649) (“Walters” hereinafter) in view of Jaffe et al. (US 2002/0161281) (“Jaffe” hereinafter), Fleury et al. (US 2017/0245841) (“Fleury” hereinafter), Prisco et al. (US 2010/0249507) (“Prisco” hereinafter) further in view of Komp et al. (US 2020/0195903) (“Komp” hereinafter).
In regards to claim 5, Walters as modified by Jaffe, Fleury and Prisco discloses the living tissue sampling method according to claim 4, that fails to explicitly teach a method wherein the endoscope includes, at the distal end, a pattern light projection device configured to project pattern light, and the three-dimensional shape data is based on an endoscopic image that is obtained by projection of the pattern light. However, Prisco teaches that it is known to provide a method wherein the endoscope 200 includes, at the distal end, a pattern light projection device 210 configured to project pattern light (see at least figs. 1-2, 3A & 5A-B and par 0040), and the three-dimensional shape data is based on an endoscopic image that is obtained by projection of the pattern light (see at least par 0040-0043, 0045 & 0047). 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 Walters as modified by Jaffe, Fleury and Prisco wherein the endoscope includes, at the distal end, a pattern light projection device configured to project pattern light, and the three-dimensional shape data is based on an endoscopic image that is obtained by projection of the pattern light as taught by Komp since such a modification would amount to applying a known technique (i.e., as taught by Komp) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as optionally or additionally determining the position of the endoscope based on a comparison of intra-operative and pre-operative 3D image data (see at least par 0074-0075 of Komp)--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 12, Walters as modified by Jaffe, Fleury and Prisco discloses the biopsy support system according to claim 11, that fails to explicitly teach a system wherein; the endoscope includes, at the distal end, a pattern light projection device configured to project pattern light, and the three- dimensional shape data is based on an endoscopic image that is obtained by projection of the pattern light. However, Komp discloses a system wherein; the endoscope 200 includes, at the distal end, a pattern light projection device 210 configured to project pattern light (see at least figs. 1-2, 3A & 5A-B and par 0040), and the three- dimensional shape data is based on an endoscopic image that is obtained by projection of the pattern light (see at least par 0040-0043, 0045 & 0047). 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 Walters as modified by Jaffe and Fleury wherein the endoscope includes, at a distal end portion, a pattern light projection device configured to project pattern light, and acquires the distal end position information of the endoscope based on the three-dimensional shape data by acquiring an endoscopic image that is obtained by projection of the pattern light, and the processor that is connected to the endoscope determines the distal end position data of the endoscope from the distal end position information by acquiring the endoscopic image that is obtained by projection of the pattern light and that is the distal end position information as taught by Komp since such a modification would amount to applying a known technique (i.e., as taught by Komp) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as optionally or additionally determining the position of the endoscope based on a comparison of intra-operative and pre-operative 3D image data (see at least par 0074 of Komp)--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) 10 & 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2019/0254649) (“Walters” hereinafter) in view of Jaffe et al. (US 2002/0161281) (“Jaffe” hereinafter), Fleury et al. (US 2017/0245841) (“Fleury” hereinafter) further in view of Sato (US 5,681,348).
In regards to claim 10, Walters as modified by Jaffe and Fleury discloses the biopsy support system according to claim 6, that fails to explicitly teach a system wherein the biopsy instrument is forceps. However, Sato teaches that it is known to provide a system wherein the biopsy instrument is forceps 1 (see at least figs. 3, 5, 7, 10, 13-14 and col. 4, lines 18-40). 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 system of Walters as modified by Jaffe and Fleury wherein the biopsy instrument is forceps as taught by Sato since such a modification would amount to applying a known technique (i.e., as taught by Sato) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing cups for collecting living tissues or for treating a lesion (see at least col. 4, lines 25-33 of Sato)--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 15, Walters as modified by Jaffe and Fleury discloses the biopsy support system according to claim 6, that fails to explicitly teach a system wherein the biopsy instrument comprises a biopsy cup. However, Sato teaches that it is known to provide a system wherein the biopsy instrument 1 comprises a biopsy cup (see at least figs. 3, 5, 7, 10, 13-14 and col. 4, lines 18-40). 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 system of Walters as modified by Jaffe and Fleury wherein the biopsy instrument comprises a biopsy cup as taught by Sato since such a modification would amount to applying a known technique (i.e., as taught by Sato) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing cups for collecting living tissues or for treating a lesion (see at least col. 4, lines 25-33 of Sato)--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 16, Walters as modified by Jaffe and Fleury discloses the biopsy support system according to claim 15, that fails to explicitly teach a system wherein a size of the biopsy instrument is the same as that of the endoscope. However, Sato teaches that it is known to provide a system wherein a size of the biopsy instrument 1 is the same (same outer diameter to the inner diameter of channel 51 of endoscope 50) as that of the endoscope 50 (see at least fig. 9 and col. 6, lines 61-67). 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 system of Walters as modified by Jaffe and Fleury wherein a size of the biopsy instrument is the same as that of the endoscope as taught by Sato since such a modification would amount to applying a known technique (i.e., as taught by Sato) to a known device (i.e., as taught by Walters) ready for improvement to achieve a predictable result such as providing a snug-fit between the forceps and the channel to keep a tight seal between the endoscope channel and the forceps--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).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-6 & 8-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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