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
Drawings
The drawings are objected to because it is unclear what is meant to be illustrated in Figure 3. Even viewing Figure 3 in light of the specification, the figure fails to provide improved clarity of the inventive concept described in paragraph 26.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 5 of part (iii), it should state “gas to control bend and length of the cannula…”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jafari et al. (WO 2021/163615).
Regarding claim 1, Jafari discloses a microrobotic 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 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).
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 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 microrobotic 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 microrobotic 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).
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 2 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jafari in view of Xu et al. (WO 2022/170989).
Jafari is described above with respect to claims 1 and 6. 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, in various embodiments” (see page 7, lines 10-12), and that “The expansion is possible because of the hydraulic pressure against the microrobot's body, which comprises a multi-compartmented but continuous system made of soft material that expands and folds within itself. This enables navigation of the microrobotic tool in multiple directions as the functional compartments expand and fold with differential pressure” (see page 12, lines 21-25). While Jafari clearly teaches within these quotes that hydraulic control and hydraulic pressure is required, there is no explicit teaching of a fluidic pump that accomplishes the hydraulic features.
Regarding claims 7-9, 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). “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.
Specifically regarding claim 2, it is noted that Jafari fails to teach that the elongate device is connected to anything at its proximal end. The similar type of device disclosed by Xu is illustrated in Figure 7 as having 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. 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jafari alone.
While not explicitly stating that an instrument resides within the cannula of the micro robotic device, 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)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the stated advantage of “creating a supported safe access shaft for other instruments” means that other instrument(s) (i.e., surgical or diagnostic) would be positioned within the cannula shown in Figure 1C of Jafari.
Conclusion
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.
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/JAMES KISH/ Primary Examiner, Art Unit 3792