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 .
Information Disclosure Statement
The IDS's filed on 12/18/24, 03/12/25, 06/24/25, 10/02/25, 01/15/26, 04/03/26, and 06/08/26; except on the 12/18/24 IDS: foreign patent document citation number 191 on pg. 5 (EP 1499227B1) and NPL document citation number 577 on pg. 25 (Rothstein et al.), as the files are not in the file wrapper.
Claim Objections
Claims 33, 37, and 42 are objected to because of the following informalities:
in claim 33, line 2: “comprising” should be deleted;
in claim 37, line 7: “to the first” should be deleted; and
in claim 42, line 2: “comprising” should be deleted.
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 38-46 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.
Claim 38 recites “a first rigidizing device” in line 12, but it is not clear if this recitation is the same as, related to, or different from the recitation “a first rigidizing device” in line 2. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the first rigidizing device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are interpreted to be the same.
Claim 38 recites “a second rigidizing device” in line 12, but it is not clear if this recitation is the same as, related to, or different from the recitation “a second rigidizing device” in lines 2-3. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the second rigidizing device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are interpreted to be the same.
Claims 39-45 are rejected by virtue of their dependence from claim 38.
Claim 46 recites “a first rigidizing device” in line 12, but it is not clear if this recitation is the same as, related to, or different from the recitation “a first rigidizing device” in line 2. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the first rigidizing device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are interpreted to be the same.
Claim 46 recites “a second rigidizing device” in lines 12-13, but it is not clear if this recitation is the same as, related to, or different from the recitation “a second rigidizing device” in lines 2-3. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the second rigidizing device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are interpreted to be the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 37 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,539,624, hereinafter Tanner ‘624, in view of Rogers et al. (US Patent Application Publication 2017/0354318), hereinafter Rogers.
Regarding Claims 37 and 46, Tanner ‘624 claim 1 teaches a system/method (see claim 1) comprising:
a nested pair of rigidizing devices comprising a first rigidizing device and a second rigidizing device (see col. 36 ln. 7-9, the first and second rigidizing devices);
one or more processors (see col. 36 ln. 14-15, the controller which would necessarily include a processor); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (see col. 36 ln. 14-15, the controller which would necessarily include memory), the method comprising:
automatically performing a shape copying sequence (see col. 36 ln. 14-15), wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see col. 36 ln. 14-18, the alternate rigidizing of the first and second rigidizing devices),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see col. 36 ln. 14-18, the alternate translation of the shape copying sequence).
Tanner ‘624 claim 1 does not specifically teach receiving a copy command from a user input.
Rogers teaches an apparatus for performing surgical procedures including a flexible guide tube and a steering device (see abstract; Figs. 1A-1E, 4A-5K, and 9A-9F), in which a user, such as a surgeon, controls the instruments through control input devices 160 at a master console 150 and computer 151 (see ¶[0038]-[0039]; Fig. 1), such that the first rigidizing device is advanced only while the copy command is continuously received (¶[0047]-[0050] the control input devices 160 are motion sensitive handles that takes the input from the operator to generate control signals for the instruments). Here, as the input from the operator is used to generate the control signals, movement would indicate that corresponding and continuous input is received, such that advancing the first rigidizing device (or the second rigidizing device) occurs only while the copy command is continuously received. This is commensurate to the modality which is described in the specification of the present application via a button (see specification ¶[0140]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the operator control modality of Rogers with the rigidizing device of Tanner ‘624 claim 1 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) Tanner ‘624 claim 1 require a modality for the operation of the rigidizing devices and Rogers teaches one such modality; and/or (3) the motion sensitive handles of Rogers provide ease of movement in both position and orientation within the control space to generate the control signals (see Rogers ¶[0049]).
Claims 29-30, 32-36, 38-39, and 41-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 or 4 of Tanner ‘624, in view of Rogers.
Regarding Claims 29 and 38, Tanner ‘624 claims 3 or 4 teaches a method/system of controlling a nested pair of rigidizing devices (see claim 1), the method comprising:
a first rigidizing device (see col. 36 ln. 7) and a second rigidizing device (see col. 36 ln. 8-9);
one or more processors (see col. 36 ln. 14-15, the controller which would necessarily include a processor); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (see col. 36 ln. 14-15, the controller which would necessarily include memory), the method comprising:
automatically performing a shape copying sequence, wherein the shape copying sequence (see col. 36 ln. 14-15) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see col. 36 ln. 14-18, the alternate rigidizing of the first and second rigidizing devices),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see col. 36 ln. 14-18, the alternate translation of the shape copying sequence); and
preventing the first rigidizing device from advancing distal to the second rigidizing device (see col. 36 ln. 30-34 or ln. 35-39, the controller moving the first rigidizing device then terminating movement at a preset or sensor-determined position, which would prevent the first rigidizing device from advancing distal (i.e., in a distal direction, which falls under the BRI of the claim language) to the second rigidizing device).
Tanner ‘624 claims 3 or 4 does not specifically teach receiving a copy command from a user input.
Rogers teaches an apparatus for performing surgical procedures including a flexible guide tube and a steering device (see abstract; Figs. 1A-1E, 4A-5K, and 9A-9F), in which a user, such as a surgeon, controls the instruments through control input devices 160 at a master console 150 and computer 151 (see ¶[0038]-[0039]; Fig. 1), such that the first rigidizing device is advanced only while the copy command is continuously received (¶[0047]-[0050] the control input devices 160 are motion sensitive handles that takes the input from the operator to generate control signals for the instruments). Here, as the input from the operator is used to generate the control signals, movement would indicate that corresponding and continuous input is received, such that advancing the first rigidizing device (or the second rigidizing device) occurs only while the copy command is continuously received. This is commensurate to the modality which is described in the specification of the present application via a button (see specification ¶[0140]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the operator control modality of Rogers with the rigidizing device of Tanner ‘624 claims 3 or 4 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) Tanner ‘624 claims 3 or 4 require a modality for the operation of the rigidizing devices and Rogers teaches one such modality; and/or (3) the motion sensitive handles of Rogers provide ease of movement in both position and orientation within the control space to generate the control signals (see Rogers ¶[0049]).
Regarding Claims 30 and 39, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. The modified Tanner ‘624 claims 3 or 4 further teaches advancing the first rigidizing device comprises advancing the first rigidizing device only while the copy command is continuously received (see Rogers ).
Regarding Claims 32 and 41, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. Tanner ‘624 claims 3 or 4 further teaches the first rigidizing device is nested over the second rigidizing device (see col. 36 ln. 8-9, the second rigidizing device positioned radially within the first rigidizing device).
Regarding Claims 33 and 42, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. Tanner ‘624 claims 3 or 4 further teaches the shape copying sequence further comprises comprising rigidizing the second rigidizing device into the rigid state prior to advancing the first rigidizing device (see col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices).
Regarding Claims 34 and 43, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. Tanner ‘624 claims 3 or 4 further teaches the shape copying sequence further comprises de-rigidizing the first rigidizing device into the flexible state prior to advancing the first rigidizing device relative to the second rigidizing device (see col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices).
Regarding Claims 35 and 44, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. Tanner ‘624 claims 3 or 4 further teaches the shape copying sequence further comprises rigidizing the first rigidizing device into the rigid state after it has advanced relative to the second rigidizing device (see col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices).
Regarding Claims 36 and 45, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. Tanner ‘624 claims 3 or 4 further teaches prior to receiving the copy command, advancing the second rigidizing device in the flexible state while steering a distal end region of the second rigidizing device, wherein the first rigidizing device is in the rigid state (see col. 36 ln. 10-11, the steerable end, col. 36 ln. 14-18, the alternate translation and rigidizing of the first and second rigidizing devices).
Claims 31 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 or 4 of Tanner ‘624, in view of Rogers, and in view of Vargas et al. (US Patent Application Publication 2011/0282149 – cited by Applicant), hereinafter Vargas.
Regarding Claims 31 and 40, the modified Tanner ‘624 claims 3 or 4 teaches the method/system of claims 29 and 38 as stated above. The modified Tanner ‘624 claims 3 or 4 is silent regarding continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device.
Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mutually selected same lengths of Vargas with for the lengths in the modified Tanner ‘624 claims 3 or 4 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified Tanner ‘624 claims 3 or 4 require lengths for steering distal end and the alternating translation distance and Vargas teaches one such length relationship; and/or (3) this would allow the first rigidizing device (i.e., the sheath 2) can follow and track the steerable distal end (i.e., the steerable tip) (see Vargas ¶[0054] and Fig. 12G).
Claims 29, 31-38, and 40-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 19/344,491 (reference application) in view of Vargas. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claims 29 and 38, copending claim 2 teaches a method/system of controlling a nested pair of rigidizing devices (see claims 1-2), the method comprising:
a first rigidizing device (see claim 1, ln. 3-5, the second rigidizing device) and a second rigidizing device (see claim 1, ln. 3-5, the first rigidizing device);
the method comprising:
automatically performing a shape copying sequence (see claim 1, ln. 3-15, the alternate moving and rigidizing of the first and second rigidizing devices, see claim 2, ln. 1-2, the iterative repetition of the movement steps),
wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see claim 1, ln. 10-12, the movement of the second rigidizing device),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see claim 1, ln. 7-9, the second rigidizing device is more flexible than the first rigidizing device),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see claim 1, ln. 3-15, the alternate moving and rigidizing of the first and second rigidizing devices, see claim 2, ln. 1-2, the iterative repetition of the movement steps).
Copending claim 2 does not specifically teach a processor and memory, receiving a copy command from a user input, and preventing the first rigidizing device from advancing distal to the second rigidizing device.
Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the processor and memory of Vargas with copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the processor and memory are well known and understood in the art for controlling/facilitating movements of medical devices, including rigidizing device.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user input of Vargas with the modified copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the user providing input to control the rigidizing device provides a higher level of control and adaptability as compared to a complete autonomous system (i.e., no user input).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mutually selected same lengths of Vargas with for the lengths in the modified copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified copending claim 2 requires lengths for steering distal end and the alternating translation distance and Vargas teaches one such length relationship; and/or (3) this would allow the first rigidizing device (i.e., the sheath 2) can follow and track the steerable distal end (i.e., the steerable tip) (see Vargas ¶[0054] and Fig. 12G).
Regarding Claims 31 and 40, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. The modified copending claim 2 further teaches continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (see Vargas ¶[0054] the sequential advancement of the cannula structure 1d, includes the sheath 2 approximately flush with the steerable tip 3 of the core 1, as shown iteratively shown through Figs. 2A-2D).
Regarding Claims 32 and 41, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. Copending claim 2 further teaches the first rigidizing device is nested over the second rigidizing device (see claim 1, ln. 3-5, the second rigidizing device nested over the first rigidizing device).
Regarding Claims 33 and 42, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. Copending claim 2 further teaches the shape copying sequence further comprises comprising rigidizing the second rigidizing device into the rigid state prior to advancing the first rigidizing device (see claim 1, ln. 3-6).
Regarding Claims 34 and 43, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. Copending claim 2 further teaches the shape copying sequence further comprises de-rigidizing the first rigidizing device into the flexible state prior to advancing the first rigidizing device relative to the second rigidizing device (see claim 1, ln. 3-6).
Regarding Claims 35 and 44, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. Copending claim 2 further teaches the shape copying sequence further comprises rigidizing the first rigidizing device into the rigid state after it has advanced relative to the second rigidizing device (see claim 1, ln. 7-9).
Regarding Claims 36 and 45, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. Copending claim 2 further teaches prior to receiving the copy command, advancing the second rigidizing device in the flexible state (see claim 1, ln. 13-19)
while steering a distal end region of the second rigidizing device (see claim 2, ln. 1-2, the distal end is positioned (i.e., steered) through the body through the iteratively repeated movements),
wherein the first rigidizing device is in the rigid state (see claim 1, ln. 13-19).
Regarding Claims 37 and 46, copending claim 2 teaches a system/method (see claims 1-2) comprising:
a nested pair of rigidizing devices comprising a first rigidizing device and a second rigidizing device (see claim 1, ln. 3-5, the first rigidizing device nested within the second rigidizing device);
the method comprising:
automatically performing a shape copying sequence (see claim 1, ln. 3-15, the alternate moving and rigidizing of the first and second rigidizing devices, see claim 2, ln. 1-2, the iterative repetition of the movement steps),
wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see claim 1, ln. 10-12, the movement of the second rigidizing device),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see claim 1, ln. 7-9, the second rigidizing device is more flexible than the first rigidizing device),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see claim 1, ln. 3-15, the alternate moving and rigidizing of the first and second rigidizing devices, see claim 2, ln. 1-2, the iterative repetition of the movement steps).
Copending claim 2 does not specifically teach a processor and memory, and receiving a copy command from a user input.
Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the processor and memory of Vargas with copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the processor and memory are well known and understood in the art for controlling/facilitating movements of medical devices, including rigidizing device.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user input of Vargas with the modified copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the user providing input to control the rigidizing device provides a higher level of control and adaptability as compared to a complete autonomous system (i.e., no user input).
Claims 30 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 19/344,491 (reference application) in view of Vargas, and in view of Rogers.
Regarding Claims 30 and 39, the modified copending claim 2 teaches the method/system of claims 29 and 38 as stated above. The modified Copending claim 2 does not specifically teach that the first rigidizing device is advanced only while the copy command is continuously received.
Rogers teaches an apparatus for performing surgical procedures including a flexible guide tube and a steering device (see abstract; Figs. 1A-1E, 4A-5K, and 9A-9F), in which a user, such as a surgeon, controls the instruments through control input devices 160 at a master console 150 and computer 151 (see ¶[0038]-[0039]; Fig. 1), such that the first rigidizing device is advanced only while the copy command is continuously received (¶[0047]-[0050] the control input devices 160 are motion sensitive handles that takes the input from the operator to generate control signals for the instruments). Here, as the input from the operator is used to generate the control signals, movement would indicate that corresponding and continuous input is received, such that advancing the first rigidizing device (or the second rigidizing device) occurs only while the copy command is continuously received. This is commensurate to the modality which is described in the specification of the present application via a button (see specification ¶[0140]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the operator control modality of Rogers with the rigidizing device of the modified copending claim 2 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified copending claim 2 requires a modality for the operation of the rigidizing devices and Rogers teaches one such modality; and/or (3) the motion sensitive handles of Rogers provide ease of movement in both position and orientation within the control space to generate the control signals (see Rogers ¶[0049]).
Claims 29-35, 37-44, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 19/344,482 (reference application) in view of Vargas. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claims 29 and 38, copending claim 3 teaches a method/system of controlling a nested pair of rigidizing devices (see claims 1 and 3), the method comprising:
a first rigidizing device (see claim 1, ln. 2-3, the rigidizing overtube) and a second rigidizing device (see claim 1, ln. 2-3, the rigidizing endoscope);
the method comprising:
automatically performing a shape copying sequence (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized),
wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see claim 1, ln. 3-9, the movement of the overtube relative to the endoscope),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see claim 1, ln. 3-9, the alternate rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope).
Copending claim 3 does not specifically teach a processor and memory, receiving a copy command from a user input, and preventing the first rigidizing device from advancing distal to the second rigidizing device.
Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the processor and memory of Vargas with copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the processor and memory are well known and understood in the art for controlling/facilitating movements of medical devices, including rigidizing device.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user input of Vargas with the modified copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the user providing input to control the rigidizing device provides a higher level of control and adaptability as compared to a complete autonomous system (i.e., no user input).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mutually selected same lengths of Vargas with for the lengths in the modified copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified copending claim 3 requires lengths for steering distal end and the alternating translation distance and Vargas teaches one such length relationship; and/or (3) this would allow the first rigidizing device (i.e., the sheath 2) can follow and track the steerable distal end (i.e., the steerable tip) (see Vargas ¶[0054] and Fig. 12G).
Regarding Claims 31 and 40, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. The modified copending claim 3 further teaches continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (see Vargas ¶[0054] the sequential advancement of the cannula structure 1d, includes the sheath 2 approximately flush with the steerable tip 3 of the core 1, as shown iteratively shown through Figs. 2A-2D).
Regarding Claims 32 and 41, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. Copending claim 3 further teaches the first rigidizing device is nested over the second rigidizing device (see claim 1, ln. 2-3, the nested rigidizing overtube and endoscope).
Regarding Claims 33 and 42, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. Copending claim 3 further teaches the shape copying sequence further comprises comprising rigidizing the second rigidizing device into the rigid state prior to advancing the first rigidizing device (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized).
Regarding Claims 34 and 43, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. Copending claim 3 further teaches the shape copying sequence further comprises de-rigidizing the first rigidizing device into the flexible state prior to advancing the first rigidizing device relative to the second rigidizing device (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized).
Regarding Claims 35 and 44, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. Copending claim 3 further teaches the shape copying sequence further comprises rigidizing the first rigidizing device into the rigid state after it has advanced relative to the second rigidizing device (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized).
Regarding Claims 36 and 45, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. Copending claim 3 further teaches prior to receiving the copy command, advancing the second rigidizing device in the flexible state wherein the first rigidizing device is in the rigid state (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized).
The modified copending claim 3 does not specifically while the movement of the second rigidizing device, steering a distal end region of the second rigidizing device.
Vargas further teaches that movement of the second rigidizing device occurs while steering a distal end region of the second rigidizing device (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the steerable tip of Vargas with the rigidizing device of the modified copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified copending claims 3 requires a modality for steering the rigidizing devices and Vargas teaches one such modality; and/or (3) the steerable tip allows the working end of the cannula to be directed to a target site without substantially disturbing the length of the cannula behind it (see Vargas ¶[0046]).
Regarding Claims 37 and 46, copending claim 3 teaches a system/method (see claims 1 and 3) comprising:
a nested pair of rigidizing devices comprising a first rigidizing device and a second rigidizing device (see claim 1, ln. 2-3, the nested rigidizing overtube and rigidizing endoscope);
the method comprising:
automatically performing a shape copying sequence (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized),
wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (see claim 1, ln. 3-9, the movement of the overtube relative to the endoscope),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (see claim 1, ln. 3-9, the alternate rigidizing of the overtube and endoscope, see claim 3, ln. 1-5, the advancing tube is flexible while the other tube is rigidized),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see claim 1, ln. 3-9, the alternate moving and rigidizing of the overtube and endoscope).
Copending claim 3 does not specifically teach a processor and memory, and receiving a copy command from a user input.
Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the processor and memory of Vargas with copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the processor and memory are well known and understood in the art for controlling/facilitating movements of medical devices, including rigidizing device.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user input of Vargas with the modified copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results (2) the user providing input to control the rigidizing device provides a higher level of control and adaptability as compared to a complete autonomous system (i.e., no user input).
Claims 30 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 19/344,482 (reference application) in view of Vargas, and in view of Rogers.
Regarding Claims 30 and 39, the modified copending claim 3 teaches the method/system of claims 29 and 38 as stated above. The modified Copending claim 3 does not specifically teach that the first rigidizing device is advanced only while the copy command is continuously received.
Rogers teaches an apparatus for performing surgical procedures including a flexible guide tube and a steering device (see abstract; Figs. 1A-1E, 4A-5K, and 9A-9F), in which a user, such as a surgeon, controls the instruments through control input devices 160 at a master console 150 and computer 151 (see ¶[0038]-[0039]; Fig. 1), such that the first rigidizing device is advanced only while the copy command is continuously received (¶[0047]-[0050] the control input devices 160 are motion sensitive handles that takes the input from the operator to generate control signals for the instruments). Here, as the input from the operator is used to generate the control signals, movement would indicate that corresponding and continuous input is received, such that advancing the first rigidizing device (or the second rigidizing device) occurs only while the copy command is continuously received. This is commensurate to the modality which is described in the specification of the present application via a button (see specification ¶[0140]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the operator control modality of Rogers with the rigidizing device of the modified copending claim 3 because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) the modified copending claim 3 requires a modality for the operation of the rigidizing devices and Rogers teaches one such modality; and/or (3) the motion sensitive handles of Rogers provide ease of movement in both position and orientation within the control space to generate the control signals (see Rogers ¶[0049]).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 29, 31-38, and 40-46 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Vargas et al. (US Patent Application Publication 2011/0282149 – cited by Applicant), hereinafter Vargas.
Regarding Claims 29 and 38, Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a method/system of controlling a nested pair of rigidizing devices (see abstract; Figs. 1-2D and 14A-14C), the method comprising:
a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence, wherein the shape copying sequence (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D) comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process); and
preventing the first rigidizing device from advancing distal to the second rigidizing device (¶[0051] and ¶[0078] the length of the steerable tip 3 and the length L, are preferably mutually selected to be about the same length, so that the cannula (i.e., the sheath 2) can follow and track the steerable tip 3, ¶[0054] the distal end 1b of the sheath 2 is approximately flush with the steerable tip 3, such that, due to the same length, the sheath 2 would not be able to be advanced past the steerable tip 3; Fig. 12G).
Regarding Claims 31 and 40, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches continuing advancement of the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device (¶[0054] the sequential advancement of the cannula structure 1d, includes the sheath 2 approximately flush with the steerable tip 3 of the core 1, as shown iteratively shown through Figs. 2A-2D).
Regarding Claims 32 and 41, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches the first rigidizing device is nested over the second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D).
Regarding Claims 33 and 42, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches the shape copying sequence further comprises comprising rigidizing the second rigidizing device into the rigid state prior to advancing the first rigidizing device (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d).
Regarding Claims 34 and 43, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches the shape copying sequence further comprises de-rigidizing the first rigidizing device into the flexible state prior to advancing the first rigidizing device relative to the second rigidizing device (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d).
Regarding Claims 35 and 44, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches the shape copying sequence further comprises rigidizing the first rigidizing device into the rigid state after it has advanced relative to the second rigidizing device (¶[0054] the movement of the cannula structure 1d involves the core 1 and the sheath 2 alternating sequentially between rigid and flexible, so after the advance of the first rigidizing device (i.e., the sheath 2 as shown in Fig. 2D), the first rigidizing device would next be rigidized before movement of the second rigidizing device (i.e., the sheath 2 is rigid in Fig. 2A, before the movement of the core 1 in Fig. 2B)).
Regarding Claims 36 and 45, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas further teaches prior to receiving the copy command, advancing the second rigidizing device in the flexible state (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, the core 1 is in the flexible state, see Figs. 2A-2B)
while steering a distal end region of the second rigidizing device (¶[0054] the steerable tip 3; Figs. 2A-2D),
wherein the first rigidizing device is in the rigid state (¶[0054] during the movement of the core 1, the sheath 2 is in the rigid state, see Figs. 2A-2B).
Regarding Claims 37 and 46, Vargas teaches a shape-transferring cannula system that enables exploration of hollow body structures (see abstract; Figs. 1-2D and 14A-14C). Vargas teaches a system/method (see abstract; Figs. 1-2D and 14A-14C) comprising:
a nested pair of rigidizing devices comprising a first rigidizing device and a second rigidizing device (¶[0051] the core 1 and the sheath 2 rigidizing structures, the sheath 2 is the first rigidizing device nested over the core 1, which is the second rigidizing device; Figs. 1-2D);
one or more processors (¶[0093] the automatic controller 320, which would necessarily include at least one processor; Fig. 24); and
a memory coupled to the one or more processors, the memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer- implemented method for controlling the nested pair of rigidizing devices (¶[0093] the memory 322 with the logic for controlling the sequence of movements, so as to achieve a semi- or fully automated system; Fig. 24; see also generally ¶[0073]-[0079] the handles for advancing the core 1 and the sheath 2 through the body; Figs. 12A-12G), the method comprising:
receiving a copy command from a user input (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation through user command, such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D);
automatically performing a shape copying sequence while the copy command is received (¶[0054] the shape-transferring process starts with the core 1 and the steerable tip 3 advanced and steered through the body, then the sheath 2 is advanced over the core 1 and the shape is transferred, the operation is accomplished while the user command is received (the claim does not require continuous receiving of the command), such as via squeeze advancement mechanism (see generally ¶[0073]-[0079] and Figs. 12A-12G) or via the semi- or fully automated system (see generally ¶[0093] and Fig. 24); Figs. 1-2D), wherein the shape copying sequence comprises:
advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices (¶[0054] the shape-transferring process involves the sheath 2 advanced over the core 1 and the shape is transferred; Figs. 1-2D),
while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state (¶[0054] to advance the entire shape-transferring cannula structure 1d, the core 1 is made rigid, then the sheath 2 is relaxed, and then the sheath 2 is advanced over the core 1 and the steerable tip 3; Figs. 1-2d),
wherein the first rigidizing device is initially proximal to the second rigidizing device so that first rigidizing device copies the shape of the second rigidizing device (see Fig. 2B-2C, while in the middle of the cannula moving process, this would be considered the start of the shape copying/transferring process).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 30 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas as applied to claims 29 and 38 above, respectively, and in view of Rogers et al. (US Patent Application Publication 2017/0354318), hereinafter Rogers.
Regarding Claims 30 and 39, Vargas teaches the method/system of claims 29 and 38 as stated above. Vargas teaches different modalities for implementing the movement of the cannula structure 1d (see generally ¶[0073]-[0079] and Figs. 12A-12G, the handle modality, or see generally ¶[0093] and Fig. 24 for the semi- or fully automated system).
Vargas does not specifically teach that the first rigidizing device is advanced only while the copy command is continuously received.
Rogers teaches an apparatus for performing surgical procedures including a flexible guide tube and a steering device (see abstract; Figs. 1A-1E, 4A-5K, and 9A-9F), in which a user, such as a surgeon, controls the instruments through control input devices 160 at a master console 150 and computer 151 (see ¶[0038]-[0039]; Fig. 1), such that the first rigidizing device is advanced only while the copy command is continuously received (¶[0047]-[0050] the control input devices 160 are motion sensitive handles that takes the input from the operator to generate control signals for the instruments). Here, as the input from the operator is used to generate the control signals, movement would indicate that corresponding and continuous input is received, such that advancing the first rigidizing device (or the second rigidizing device) occurs only while the copy command is continuously received. This is commensurate to the modality which is described in the specification of the present application via a button (see specification ¶[0140]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the operator control modality of Rogers with the rigidizing device of Vargas because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; (2) Vargas requires a modality for the operation of the rigidizing devices and Rogers teaches one such modality; and/or (3) the motion sensitive handles of Rogers provide ease of movement in both position and orientation within the control space to generate the control signals (see Rogers ¶[0049]).
Conclusion
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/J.D.M./ Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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