The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
The previous objections to the drawings and to claim 1 are overcome in view of the amendments to each.
On pages 5-6, the applicant argues that the previously cited Jafari reference “does not disclose the claimed steering channels positioned between the internal wall and the exterior wall of the continuous inverting-fold cannula, nor the specific mechanism by which selective extension of one or more steering channels cases distal eversion while the proximal deployed external wall remains anchored and stationary”. The examiner respectfully disagrees.
Jafari states that “expansion of the flexible body of the microrobot will be based on longitudinally-growing channels embedded coaxially and steering the device will be based on asymmetric expansion (only some channels selectively expanded)” (see page 9, lines 18-21, emphasis added). Additionally, in Figure 1B of Jafari, it explicitly shows the steering channels positioned between the internal wall and the exterior wall, for which the below reproduction of Figure 1B provides only the relevant aspect with the other portions removed:
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On page 6, the applicant argues that “Jafari does not teach or suggest the claimed ‘independently and reversibly filled with a fluid or gas to control bend and length of the cannula’ in combination with the anchored, stationary-wall everting structure recited in Claim 1.” The examiner respectfully disagrees.
Jafari teaches that “The steering system 104 may utilize electrical and/or mechanical controls, including hydraulic controls - differential pressure and/or expansion — to steer the direction of the propagation” (see page 7, lines 10-12). Merriam-Webster’s Online Dictionary defines “hydraulic” as one of the following (https://www.merriam-webster.com/dictionary/hydraulic):
operated, moved, or effected by means of water;
b: of or relating to water or other liquid in motion;
operated by the resistance offered or the pressure transmitted when a quantity of liquid (such as water or oil) is forced through a comparatively small orifice or through a tube.
As such, it is clear that the disclosure of Jafari teaches filling of the steering channels with a fluid. Additionally, Jafari teaches steering the device will be based on asymmetric expansion (only some channels selectively expanded)” (see page 9, lines 18-21, emphasis added). Therefore, Jafari teaches asymmetric filling of the steering tubes with fluid is used to control bend and length of the cannula.
For at least the reasons above, the applicant’s arguments are not persuasive and the following rejections apply.
Claim Rejections - 35 USC § 112
Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-12 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 1 is rejected because “the deployed external wall” in the fourth-to-last line lacks antecedent basis.
Claims 3-12 are rejected for containing the same issues as claim 1, based on dependency therefrom.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jafari et al. (WO 2021/163615) in view of Xu et al. (WO 2022/170989).
Regarding claim 1, Jafari discloses a micro-robotic device (see Title) comprising:
An elongated, flexible, steerable cannula (see page 3, lines 4-5) formed by an elongated tubular body (see left side of Figure 1B) having
A proximal end and a distal end (note that the top of the tubular body on the left side of Figure 1B represents a distal end, while the other side is a proximal end; Figure 1C also illustrates the tubular body with two ends where one end “B” is a distal end and the other is a proximal end “A”);
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An external wall forming an exterior surface and an internal wall forming an interior surface (see reproduction of Figure 1C of Jafari to the left), the external wall and internal wall being continuous and connected at a distal inverting fold forming an inverted external wall and an inverted internal wall, the cannula is tended by movement of the inverted external and internal wall through the inverted fold (“The microrobot utilizes a forward flexible motion based on expansion of cannulas and intussusception (folding back on itself). As such, it "lays and walks." The microrobot has a stationary portion and can expand by folding material. Therefore, the body lengthens as the material extends at the tip but the rest of the body does not move and thus there is no relative movement between the microrobot's body and the environmental surface” – page 12, lines 1-13); and
A tubular body (see body of device in reproduction of Figure 1C above) comprising a plurality of radially distributed steering channels positioned between the internal wall and the exterior wall (see labeled “Steering channels” in Figure 1C above), wherein (a) the steering channels are configured to be independently and reversibly filled with a fluid or gas to control bend and length of the cannula (Jafari states that “expansion of the flexible body of the microrobot will be based on longitudinally-growing channels embedded coaxially and steering the device will be based on asymmetric expansion (only some channels selectively expanded)” (see page 9, lines 18-21)), wherein the steering channels are circumferentially spaced around the long axis (see Figure 1B illustrating “radially adjustable channels) and selectively extended to cause asymmetric everting for bending (“steering the device will be based on asymmetric expansion (only some channels selectively expanded)” (see page 9, lines 18-21)), and (b) extension of one or more of the steering channels extends the tubular body distally by everting the inverted external and internal walls (“expansion of the flexible body of the microrobot will be based on longitudinally-growing channels embedded coaxially and steering the device will be based on asymmetric expansion (only some channels selectively expanded). By fine incremental control of channel growth, fine steering can be achieved without the use of wires” – page 9, line 18 through page 10, line 8).
While Figure 1A of Jafari illustrates a “micro-robotic platform” 102, there is no explicit description or clear illustration of the extendable robot being secured or fixed at its proximal end to such a platform, or teachings that the outer wall remains stationary by being secured to this platform.
Xu teaches a developable instrument and surgical robot system (see Title). “The developable tube further comprises a flippable region at the distal end, and the inner layer and the outer layer are connected to each other and can flip at the flippable region” (see Abstract). Figure 7 of Xu illustrates a proximal end connected to a platform support, which includes a fluid box 150 having a pressure sensor 160 and fluid control channel 152 contained therein, as well as a tube drive mechanism 120. Additionally, Xu teaches that “The inner layer 111 may be turned inside out at the expandable area 114 to form the outer layer 112, or the outer layer 112 may be turned inside out at the expandable area 114 to form the inner layer 111 … For example, the inner layer 111 is moved distally by a length L, the inner layer 111 of the length L is everted in the expandable region 114 to form the outer layer 112, and the fluid 140 fills the fluid cavity 113 grown by the eversion of the inner layer 111, Thereby the growable tube 110 can grow forward. The inner layer 111 is moved proximally by the length L', and the outer layer 112 of the length L' is inverted in the expandable region 114 to form the inner layer 111 so that the growable tube 110 can be retracted” (see page 4 of the Machine Translation, in the main paragraph beginning with “FIG. 1 shows…”). This example teaches an embodiment in which the outer layer will remain stationary while the inner layer grows/expands and everts to become additional outer layer at the distal end (i.e., at the expandable region 114 of Xu).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that such supporting structure would be found at the proximal end of the device disclosed by Jafari, since the hydraulic control of its device would require similar components to that of Xu. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that one of the inner or outer layer would have to be secured or affixed to such a support/platform at its proximal end so when the device is extended/retracted there will be predicted extension and retraction by the device re-folding inwardly or outwardly, as opposed to simply becoming flaccid.
Regarding claim 3, it can be seen in Figures 1B and 1C that the tubular body comprises radially distributed rigidity channels (“The aforementioned stiffening will not change microrobot morphology by embedding another set of longitudinal channels filled with a novel non-Newtonian fluid (NNF) inside the EFMR body… Increased viscosity of the fluid trapped inside each channel will lead to increased stiffness of the FMR body by increasing the pressure inside the NNF filled channels” – page 10, lines 2-8). See “Rigidity channels” labeled in the reproduction of Figure 1C above.
Regarding claim 4, it is noted that Figure 1B of Jafari illustrates that “Non-Newtonian fluid filled channels” (i.e., the rigidity channels) are located between the outer wall and the steering channels. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to switch the radial position of the steering and rigidity channels, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPC 70 (see MPEP 2144.04(VI)(C)). Additionally, it is noted that there is no criticality attributed to placement of the rigidity channels in relation to the steering channels, as the instant application explicitly states that “The radially distributed rigidity channels can be positioned between adjacent steering channels, circumscribing the steering channels, or circumscribed by the steering channels, or combinations thereof” (see paragraph 6 of PGPUB 2024/0307134, representative of the specification of the instant application). Finally, it is clear from Figure 1C of Jafari that the channels are all parallel to the long axis of the cannula.
Regarding claim 5, Jafari teaches that “The aforementioned stiffening will not change microrobot morphology by embedding another set of longitudinal channels filled with a novel non-Newtonian fluid (NNF) inside the EFMR body… Increased viscosity of the fluid trapped inside each channel will lead to increased stiffness of the FMR body by increasing the pressure inside the NNF filled channels” (page 10, lines 2-8). Here, the stated “another set of longitudinal channels” refers to the rigidity channels.
Regarding claim 6, Jafari teaches that “The system further comprises a computing device that executes an artificial intelligence program configured to control the steering system” (see Abstract).
Regarding claims 7-9, Xu teaches “As shown in FIG. 7, in some embodiments, the growable device 100 (or 200) further includes a fluid controller 130. The fluid controller 130 is used to pressurize the fluid 140 to drive the fluid 140 to gradually fill the fluid cavity 113 between the outer layer 112 and the inner layer 111. In some embodiments, the fluid 140 may be a liquid fluid, such as physiological saline, or a gaseous fluid, such as air, carbon dioxide gas, or other inert gas. In some embodiments, the fluid controller 130 may include a gas pump or a liquid pump, or the like” (see 7th page of Machine Translation, paragraph beginning “FIG. 7 shows…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a fluid/gas pump and fluid/gas controller for an everting/folding robot, as taught by Xu, and to use such devices within the system of Jafari to accomplish the necessary hydraulic features required to pressurize the rigidity and steering channels. It is noted that Jafari teaches that “expansion of the flexible body of the microrobot will be based on longitudinally-growing channels embedded coaxially and steering the device will be based on asymmetric expansion (only some channels selectively expanded). By fine incremental control of channel growth, fine steering can be achieved without the use of wires” (page 9, line 18 through page 10, line 8). Therefore, it would have been obvious that each channel would need to be capable of being controlled hydraulically separately and independently from one another via such fluid pump(s) and fluid controller.
Regarding claim 10, it is noted that Xu teaches “In some embodiments, the fluid controller 130 may include a gas pump or a liquid pump, or the like” (see 7th page of Machine Translation, paragraph beginning “FIG. 7 shows…”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a plurality of gas or liquid pumps, or to utilize both for different channels (since Xu additionally states “or the like”), because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395). Additionally, there is no criticality stated within the instant application to utilizing a gas pump, a liquid pump, or for incorporating one or more of each into a single device, and it is known that pneumatic pressurization and hydraulic pressurization yield the same end result.
Regarding claim 11, it is noted that Figure 1A of Jafari illustrates a “steering system 104” and a “computer 106”. “[S]teering system 104 can provide commands or controls to the micro-robotic platform to guide operation of the robotic tool. Such commands can be based on inputs provided from sensing data from the one or more sensors of the micro-robotic platform. The steering system 104 may utilize electrical and/or mechanical controls, including hydraulic controls - differential pressure and/or expansion — to steer the direction of the propagation (see page 7, lines 7-19).
Regarding claim 12, Jafari teaches that “Once a target point has been reached, the “shaft-body” of the microrobot tool can be stiffened in order to provide a “safe” enlaced pathway or cavity that can be used to insert various other devices, such as, but not limited to, stents” (see page 9, line 25 through page 10, line 2). Additionally, Jafari teaches that “The above-described embodiments for the microrobotic system provide multiple advantages over existing technologies. Such microrobotic systems have a major advantage in accessing anatomical structures with complex morphology and anatomy, conforming to the pathway without injuring the tissues, and creating a supported safe access shaft for other instruments” (see page 23, lines 1-5).
Conclusion
THIS ACTION IS MADE FINAL. 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 JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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