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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1, 4, 8, 10, 13, and 15 have been amended. Claims 6 and 9 have been cancelled. Claims 17-22 are newly added.
Claims 1-5, 7, 8, and 10-22 are currently pending.
Claim 22 is withdrawn due to constructively elected invention by original presentation.
Election/Restrictions
Newly submitted claim 22 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (i.e., claims 1-5, 7, 8, and 10-21) and Invention II (i.e., claim 22) are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed recite a materially different mode of operation. Claim 1 recites that the “position of the medical device relative to the anatomy is continuously maintained as the anatomy moves….” Claim 22, on the other hand, recites that the “position of the medical device is static and an action is performed on the anatomy so as to be timed with movement of the anatomy.” Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification (e.g., A61B 34/20 for Invention I and A61B 2017/00694 for Invention II);
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
In Figures 3B, 3C, 4B, and 4C the use of shading for the “probe 105” is not proper. See 37 C.F.R. 1.84(m). In each of these figures a portion of the probe 105 is “at least partially inserted into the brain.” ([0025] and [0026] of Applicant’s disclosure). The portion of the probe 105 inserted within the brain is submerged with the brain. This submerged portion should be distinguished with respect to the non-submerged portion (i.e., thinner lines and/or dashed lines).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 has a parallelism issue with respect to the steps performed by the system. The claim should read “…cause the system, to at least: obtain medical device data… obtain anatomy data… use the medical device data… cause the medical device….”
Claim 21 recites “…wherein a fixed position between a distal end of the medical device and the anatomy is maintained as the anatomy moves.” Claim 21 depends from claim 20, which already recites “a fixed position.” Accordingly, claim 21 should be amended to recite “the fixed position.”
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.
Claim 17 is 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 17 recites “a corresponding electrode circuit” then “the corresponding electrode circuit” and then “the electrical circuit.” It is not clear if “the electrical circuit” refers to “the electrode circuit” or a different circuit. It appears Applicant intended to recite “the electrode circuit.” (see, e.g., [0030]).
For purposes of a compact prosecution, Examiner is interpreting “the electrical circuit” as “the electrode circuit.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7, 8, and 10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite: using the data to synchronize a position of the medical device relative to the anatomy such that a position of the medical device relative to the anatomy is continuously maintained as the anatomy moves (claim 1).
Each of these claim limitations, as drafted and under its broadest reasonable interpretation, recites a mathematical concept (i.e., a mathematical relationship) because “using the data to synchronize a position of the medical device relative to the anatomy” is an example of “organizing information and manipulating information through mathematical correlations.” MPEP 2106.04(a)(2),I,A. For example, the data may include data from “optical light, lasers, or ultrasonic sensors” ([0028]), “physiological measurements” ([0029]), or “electrical measurements.” ([0030]). For each of these, the data requires further processing (e.g., determine how quickly light traveled to the surface and back or electrical measurements of the anatomy) in order to obtain useful information that may be used to “synchronize a position of the medical device relative to the anatomy.”
This judicial exception is not integrated into a practical application. Additional elements include “positioning a medical device relative to anatomy” and “obtaining data regarding a position of the anatomy” and “causing the medical device to interact with the anatomy.” These elements are recited at a high-level of generality. It is impossible to determine a practical application without knowing the particular medical device (e.g., microelectrode array, ultrasound probe, biopsy needle, etc.), the anatomy (e.g., brain, spine, lungs, etc.), or the data being used (e.g., range data determined by laser, electrical measurements that correlate to a position within the brain, or physiological measurements that indirectly affect the anatomy). Moreover, the claim limitation “causing the medical device to interact with the anatomy” is also recited at a high level of generality and does not indicate what the practical application might be.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As explained above, the steps are recited at a high-level of generality and lack any specificity that would amount to something significantly more. The “medical device,” “anatomy,” and “data” are not meaningful limitations that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself.
Dependent claims 2-5, 7, 8, and 10-22 do not add meaningful limitations, at least to the extent that the claims would amount to significantly more than the exception itself. For example, “moving the medical device in sync” (claims 2 and 11); “performing a function” (claims 3, 12, 18, and 19); “an electrical measurement of the anatomy” (claims 6 and 15); “a sensor coupled to optical light data, laser data, or ultrasonic data” (claims 7 and 16); “provides feedback” (claim 8), and “a distal end of the medical device [that] is moved in sync with the position of the anatomy” (claim 9) recite generic terms. Likewise, taking electrical measurements (claim 17) of anatomy is another high-level generality that does not transform the claims into patentable subject matter.
While dependent claims 4 and 5 recite more particular details (e.g., pulse state and cortical surface), these additional clarifications are not sufficient to ensure that the claim, as a whole, integrates the abstract idea into a practical application or amounts to significantly more than the judicial exception itself.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant states “[i]n rejecting the claims, the Examiner alleges the claims include limitations that constitute a mental process.” (page 7, Remarks). This is not correct. The Office Action found that the claim limitation recites a mathematical concept (i.e., a mathematical relationship) because “using the data to synchronize a position of the medical device relative to the anatomy” is an example of “organizing information and manipulating information through mathematical correlations.” MPEP 2106.04(a)(2),I,A.
Applicant alleges that the “the claims include additional elements that integrate the judicial exceptions into a practical application.” (page 7, Remarks). However, Applicant only provides this conclusory statement. Applicant does not refer to any additional elements or explain how these additional elements integrate the judicial exception into a practical application. As explained above, the additional elements are recited at a high level of generality and do not integrate the judicial exception into a practical application.
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 1-3, 5, 7, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) (previously cited in Office Action dated June 25, 2025).
GILGUNN discloses a method of synchronizing a medical device intervention. “[A]pparatus and method for surgeon-assisted rapid surgical implantation of devices into soft tissue.” (Abstract). GILGUNN’S apparatus includes a “processor 40” that “will analyze the body functions and movements to generate a dynamic system equation or equations to synchronize the actuation of the actuator 12 for placement of the device 14 into the tissue.” (emphasis added) (col. 13, lines 40-44).
GILGUNN discloses positioning a medical device relative to anatomy. See, e.g., Steps 13 and 14 at col. 11, lines 14-21. See also Step 31: “At this step, the actuator 12 is at the optimal implant location...” (emphasis added) (col. 13, lines 1-2).
GILGUNN discloses obtaining data regarding a position of the anatomy. “The laser ranging sub-system 30 references the surface of the tissue into which the device 14 is being implanted and monitors the fine motions of the tissue due to, for example, respiratory and pulsatile motions…This system works by reflecting laser beams off of the surface of the tissue, collecting the reflected light and determining variations in time taken for the light to travel from the source to the detector.” (emphasis added) (col. 12, lines 39-48). See also col. 13, lines 2-5: Before implantation “the tissue height has been referenced and the laser ranging sub-system 30 has a measure of the dynamic distance from the tissue surface 32 to the tip 26 of the device 14 to be implanted…,” (emphasis added).
GILGUNN discloses using the data to synchronize a position of the medical device relative to the anatomy. GILGUNN’S apparatus includes a “processor 40” that “will analyze the body functions and movements to generate a dynamic system equation or equations to synchronize the actuation of the actuator 12 for placement of the device 14 into the tissue.” (emphasis added) (col. 13, lines 40-44). See also claims 3 and 9 of GILGUNN.
GILGUNN teaches causing the medical device to interact with the anatomy. See Figure 8 of GILGUNN showing the devices 14 implanted into the brain surface.
With respect to the limitation such that a position of the medical device relative to the anatomy is continuously maintained as the anatomy moves, GILGUNN teaches that “[a]ccurate placement of the interface requires referencing of the tissue height, maintaining the relative height between the interface mounted on the insertion apparatus and the tissue as the tissue surface moves under pulsatile and respiratory motion….” (Column 6, lines 61-64). However, this statement is described in the background section of GILGUNN and it is not clear if GILGUNN sufficiently describes how to continuously maintain the position relative to the anatomy.
In the same field of endeavor, KANG teaches “[a] motion-compensating surgical tool system [that] includes a surgical tool…[and] an optical detection system… The optical detection system is configured to output a signal for the determination of a distance of the distal-most portion of the moveable component to a target during surgery.” (Abstract). KANG teaches that “[m]icrosurgery requires constant attention to and compensation for involuntary patient motion due to physiological processes such as breathing and cardiac pulsation….” ([0007]). One example of microsurgery is cerebral cortex neurosurgery. “The ‘tool-tissue’ relative motion is especially critical in the case of surface operations such as retina vitreous surgery and cerebral cortex neurosurgery where the fragile tissue's axial involuntary motion is a primary concern that requires high dexterity and constant attention from experienced surgeons.” ([0007]). KANG’s “tool is capable of tracking the tissue surface of a microsurgical target and of compensating the tool-tissue relative motion on a micrometer scale.” ([0042]). For example, “[t]he distance between the tool tip and the surgical target surface is determined from [a signal] by an automatic edge-searching algorithm. The target surface can be the surface of tissue, for example, or it could be within tissue. The micro linear motor is controlled by a computer according to feedback from the CP-OCT distance-sensor.” ([0022]).
In the first example, KANG teaches that “[t]he surgical tool tip is pointed perpendicularly to a reflective target surface, which moves back and forth from the initial position. The tool tip senses the motion and adjusts to keep a constant distance D=1120 μm by moving together with the target surface.” ([0039]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to use data such that a position of the medical device relative to the anatomy is continuously maintained as the anatomy moves, as taught in KANG. GILGUNN already expresses a desire to maintain a relative height between the interface and the tissue. One of ordinary skill in the art would have been motivated to use a feedback system, as described in KANG, to keep a constant distance between tip and the target surface. There would have been a reasonable expectation of success as GILGUNN and KANG concern neurosurgery and use similar distance-measuring systems and medical tools.
With respect to claim 2, GILGUNN discloses synchronizing a position of the medical device relative to the anatomy comprises moving the medical device in sync with the position of the anatomy. GILGUNN discloses “positioning an end of the device in proximity of the soft tissue of the patient” (claim 3 of GILGUNN) and, while a distance between the surface and the actuator holding the device is known, “synchronizing motion of the actuator with the time-varying displacement of the surface of the soft tissue” (claim 9 of GILGUNN).
With respect to claim 3, GILGUNN discloses wherein synchronizing a position of the medical device relative to the anatomy comprises performing a function on the anatomy while the anatomy is in a specific state. With respect to the “function,” GILGUNN performs the same function as described in Applicant’s specification at [0024]. More specifically, GILGUNN inserts a device into the tissue. (see, e.g., “Step 35” at col. 13, lines 22-24). The “specific state” is determined through Steps 33A, 33B and 34A, 34B in which GILGUNN determines the force exerted by the tissue onto the device at contact, compares an actual distance travelled at contact to an expected value, and compares an actual force on the device to the expected force. (col. 13, lines 11-21). When this “specific state” of the tissue surface is known, the processor “adjusts the speed of the actuator 12 and the remaining distance it will travel to reach the implantation depth.” (col. 13, lines 22-24).
With respect to claim 5, GILGUNN discloses wherein the anatomy comprises a cortical surface. In describing accuracy of placing the device 14, GILGUNN discloses “a placement accuracy of <50 microns is necessary to ensure the correct cortical neuronal layer has been implanted.” (emphasis added). (col. 8, lines 48-50). See also Figures 7A and 7B.
With respect to claim 7, GILGUNN discloses obtaining data regarding a position of the anatomy comprises using a sensor coupled to optical light data, laser data, or ultrasonic data. Before implantation “the tissue height has been referenced and the laser ranging sub-system 30 has a measure of the dynamic distance from the tissue surface 32 to the tip 26 of the device 14 to be implanted.” (emphasis added) (col. 13, lines 2-5).
With respect to claims 20 and 21, GILGUNN does not explicitly teach that a fixed position is maintained between the medical device and the anatomy as the anatomy moves (claim 20) nor does GILGUNN explicitly teach wherein a fixed position between a distal end of the medical device and the anatomy is maintained as the anatomy moves. However, as discussed above, KANG teaches that “[t]he surgical tool tip is pointed perpendicularly to a reflective target surface, which moves back and forth from the initial position. The tool tip senses the motion and adjusts to keep a constant distance D=1120 μm by moving together with the target surface.” ([0039]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to use data such that a fixed position is maintained between the medical device and the anatomy as the anatomy moves, as taught in KANG. Likewise, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to use data such that a fixed position between a distal end of the medical device and the anatomy is maintained as the anatomy moves, as taught in KANG. GILGUNN already expresses a desire to maintain a relative height between the interface and the tissue. One of ordinary skill in the art would have been motivated to use a feedback system, as described in KANG, to keep a constant distance between tip and the target surface. There would have been a reasonable expectation of success as GILGUNN and KANG concern neurosurgery and use similar distance-measuring systems and medical tools.
Claims 4 and 18 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) as applied to claims 1 and 3 above, and further in view of U.S. Patent Appl. No. 2007/0156126 A1 (hereinafter “FLAHERTY”).
With respect to claim 4 (depending from claim 3), GILGUNN does not explicitly teach that the specific state comprises the anatomy being between pulses. As described above with respect to claim 3, GILGUNN performs a function on the anatomy when the anatomy is in a specific state. Notably, GILGUNN is concerned pulsatile and respiratory motion: “Accurate placement of the interface requires referencing of the tissue height, maintaining the relative height between the interface mounted on the insertion apparatus and the tissue as the tissue surface moves under pulsatile and respiratory motion, mapping and identifying the insertion location with an overlay of the interfaces and positioning the interface in space with respect to the tissue surface.” (emphasis added) (col. 5, lines 61-67: see also col. 13, lines 5-6: “…based on the motion of the tissue surface 32 due to pulsatile and respiratory motions.”)
In the same field of endeavor, FLAHERTY teaches an insertion system for implanting devices within the brain. (see, e.g., [0003] and [0085]). FLAHERTY is particularly concerned about tissue movement prior to implantation. “For example, although a patient is typically placed under general anesthesia during an implantation procedure, certain parts of the body, such as, for example, the brain and various internal organs, may continue to move due to, for example, the patient's continued respiration and blood pressure (i.e., heart beat) functions. If the target tissue to which the sensor is to be implanted lies in one of those moving parts of the body, accurate positioning of the sensor or any other implant may be extremely difficult.” ([0004]).
FLAHERTY teaches an insertion system for implanting a sensor on a brain surface. “FIG. 1 shows an insertion system 100 used in, for example, inserting an implant 200 (e.g., two- or three-dimensional array of electrodes) into a patient's body, such as, for example, the brain (e.g., motor cortex of a human or animal brain).” ([0085]). FLAHERTY explicitly teaches observing the brain surface to insert the implant when the surface is stationary. “[T]he method may comprise detecting a characteristic of the target surface so as to determine a proper timing for insertion of the implant. According to another exemplary aspect, the proper timing may comprise a time period in which the target surface remains in a substantially stationary position.” ([0048]; see, e.g., [0128]-[0130] explaining system in greater detail).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to identify the timing and insert the electrode when the brain surface is substantially stationary (i.e., between pulses), as taught in FLAHERTY. One of ordinary skill in the art would have motivated to insert/implant the electrode between the pulses in order to be more accurate in positioning the electrode and to avoid trauma to the patient. (see, e.g., [0005] of FLAHERTY). There would have been a reasonable expectation of success as GILGUNN and FLAHERTY teach similar systems that both concern implanting sensors on the brain surface.
With respect to claim 18, GILGUNN does not explicitly teach wherein synchronizing a position of the medical device relative to the anatomy comprises performing a function on the anatomy during any pulse state of the anatomy.
As discussed above with respect to claim 4, FLAHERTY teaches identifying the timing of brain surface movement and inserting the electrode when the brain surface is substantially stationary (i.e., between pulses). ([0048]; see, e.g., [0128]-[0130] explaining system in greater detail). Between pulses is a “pulse state.”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to perform a function on the anatomy during any pulse state of the anatomy, as taught in FLAHERTY. One of ordinary skill in the art would have motivated to insert/implant the electrode between the pulses in order to be more accurate in positioning the electrode and to avoid trauma to the patient. (see, e.g., [0005] of FLAHERTY). There would have been a reasonable expectation of success as GILGUNN and FLAHERTY teach similar systems that both concern implanting sensors on the brain surface.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) as applied to claim 1 above, and further in view of Koirala, Nabin, et al. “Mapping of subthalamic nucleus using microelectrode recordings during deep brain stimulation.” Scientific Reports 10.1 (2020): 19241. (hereinafter referred to as “KOIRALA”).
With respect to claim 8, GILGUNN does not explicitly teach that the medical device includes at least one electrode that provides feedback on whether the medical device is in contact with the anatomy.
In the same field of endeavor, KOIRALA teaches that the success of deep brain stimulation (DBS) in the subthalamic nucleus (STN) depends upon correct placement of the electrodes. (page 1, paragraph beginning with “Deep brain stimulation…”). “To accomplish a high precision implantation in this region, preoperative MRI images-based navigation systems and intraoperative microelectrode recordings (MER) are widely used. The visualization technique for locating the STN by using preoperative MRI is prone to giving inaccurate results due to brain shift induced parenchymal alterations or cerebrospinal fluid loss. Hence, the intraoperative MER allows improving the target localization during stereotactic surgery by recording the electrical activity of the individual neurons from targeted structure.” (Id). Both “preoperative MRI images-based navigation systems and intraoperative microelectrode recordings (MER) are widely used.” (Id).
“During STN-DBS surgery, after the microelectrode passes in its trajectory through the dorsal region of the STN, it reaches a thin white matter layer before entering into the substantia nigra pars reticulata (SNr). This white matter layer is only a few hundred microns thick and usually cannot be identified before the electrode reaches the SNr.” (page 6, Discussion, second paragraph). “The analysis of specific electrophysiological parameters using spike and background activity characteristics from the MER recordings during STN-DBS allows a high accuracy for correct target detection in PD patients…We found that spiking rate was consistent for detecting the target depth and increased beta activity allowed identifying the STN borders and differentiate it from neighboring structures particularly the SNr.” (page 9, Conclusions).
Accordingly, KOIRALA teaches that the electrode provides feedback (i.e., MER) on whether the medical device is in contact with the anatomy (i.e., confirming contact with SNr).
It would have been obvious to one of ordinary skill in the art to use at least one electrode to provide feedback (e.g., MER) on whether the medical device is in contact with the anatomy. As taught in KOIRALA, the MER could be used to confirm whether the medical device is in contact with certain anatomy. One would have been motivated to acquire MER because, as taught in KOIRALA, the success of deep brain stimulation depends upon correct placement of the electrodes. (page 1, paragraph beginning with “Deep brain stimulation of the subthalamic…”). There would have been a reasonable expectation of success because MER is “widely used,” as taught by KOIRALA. (Id).
Claims 10-12, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) and U.S. Patent Appl. Publ. No. 2020/0281670 A1 to Moskowitz (hereinafter referred to as “MOSKOWITZ”).
With respect to claim 10, GILGUNN teaches a medical device positioning system configured to synchronize a relative position between a medical device and anatomy. “[A]pparatus and method for surgeon-assisted rapid surgical implantation of devices into soft tissue.” (Abstract). GILGUNN’S apparatus includes a “processor 40” that “will analyze the body functions and movements to generate a dynamic system equation or equations to synchronize the actuation of the actuator 12 for placement of the device 14 into the tissue.” (emphasis added) (col. 13, lines 40-44).
GILGUNN teaches a medical device including a probe. See Figure 8 in which the device 14 has two probes. GILGUNN also describes several prior art using probes having electrodes. “In the next few paragraphs, the challenge presented by the range of device types and materials will be established by reviewing the devices described in the literature.” (col. 3, lines 22-23). GILGUNN then describes probes and, more specifically, arrays and electrodes in the following paragraphs.
GILGUNN teaches at least one data processor (see, e.g., processor 40 at col. 7, line 67) and at least one memory (see, e.g., memory 42 at col. 8, line 1) including computer program code, the at least one memory and the computer program code (see, e.g., col. 6, lines 56-61) configured to, with the at least one data processor, cause the system, to at least (Id.) obtain medical device data regarding a position of medical device relative to anatomy. See, e.g., col. 11, lines 14-16: “Step 13: Determine the vertical distance and angular relationship between the actuator 12 and the surface 32 of the tissue in the implantation vicinity.”
GILGUNN teaches obtaining anatomy data regarding a position of the anatomy. “The laser ranging sub-system 30 references the surface of the tissue into which the device 14 is being implanted and monitors the fine motions of the tissue due to, for example, respiratory and pulsatile motions…This system works by reflecting laser beams off of the surface of the tissue, collecting the reflected light and determining variations in time taken for the light to travel from the source to the detector.” (emphasis added) (col. 12, lines 39-48). See also col. 13, lines 2-5: Before implantation “the tissue height has been referenced and the laser ranging sub-system 30 has a measure of the dynamic distance from the tissue surface 32 to the tip 26 of the device 14 to be implanted.” (emphasis added).
GILGUNN teaches causing the medical device to interact with the anatomy. See Figure 8 of GILGUNN showing the devices 14 implanted into the brain surface.
GILGUNN does explicitly teach all of using the medical device data and the anatomy data to continuously maintain a position of the medical device relative to the anatomy as the anatomy moves. Nevertheless, GILGUNN’S apparatus includes a “processor 40” that “will analyze the body functions and movements to generate a dynamic system equation or equations to synchronize the actuation of the actuator 12 for placement of the device 14 into the tissue.” (emphasis added) (col. 13, lines 40-44). GILGUNN also teaches that “[a]ccurate placement of the interface requires referencing of the tissue height, maintaining the relative height between the interface mounted on the insertion apparatus and the tissue as the tissue surface moves under pulsatile and respiratory motion….” (Column 6, lines 61-64). However, this statement is described in the background section of GILGUNN and it is not clear if GILGUNN sufficiently describes how to continuously maintain the position relative to the anatomy.
In the same field of endeavor, KANG teaches “[a] motion-compensating surgical tool system [that] includes a surgical tool…[and] an optical detection system… The optical detection system is configured to output a signal for the determination of a distance of the distal-most portion of the moveable component to a target during surgery.” (Abstract). KANG teaches that “[m]icrosurgery requires constant attention to and compensation for involuntary patient motion due to physiological processes such as breathing and cardiac pulsation….” ([0007]). One example of microsurgery is cerebral cortex neurosurgery. “The ‘tool-tissue’ relative motion is especially critical in the case of surface operations such as retina vitreous surgery and cerebral cortex neurosurgery where the fragile tissue's axial involuntary motion is a primary concern that requires high dexterity and constant attention from experienced surgeons.” ([0007]). KANG’s “tool is capable of tracking the tissue surface of a microsurgical target and of compensating the tool-tissue relative motion on a micrometer scale.” ([0042]). For example, “[t]he distance between the tool tip and the surgical target surface is determined from [a signal] by an automatic edge-searching algorithm. The target surface can be the surface of tissue, for example, or it could be within tissue. The micro linear motor is controlled by a computer according to feedback from the CP-OCT distance-sensor.” ([0022]).
In the first example, KANG teaches that “[t]he surgical tool tip is pointed perpendicularly to a reflective target surface, which moves back and forth from the initial position. The tool tip senses the motion and adjusts to keep a constant distance D=1120 μm by moving together with the target surface.” ([0039]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to use data such that a position of the medical device relative to the anatomy is continuously maintained as the anatomy moves, as taught in KANG. GILGUNN already expresses a desire to maintain a relative height between the interface and the tissue. One of ordinary skill in the art would have been motivated to use a feedback system, as described in KANG, to keep a constant distance between tip and the target surface. There would have been a reasonable expectation of success as GILGUNN and KANG concern neurosurgery and use similar distance-measuring systems and medical tools.
While GILGUNN teaches the system having a processor and memory (see, e.g., col. 7, line 67 to col. 8, line 1), GILGUNN does not explicitly teach the memory includes computer program code, in which the at least one memory and the computer program code are configured to, with the at least one data processor, cause the system to perform the operations discussed above with respect to claim 1.
MOSKOWITZ teaches systems and methods for robotic surgery that can be integrated with real-time single modality and/or multi-modality fusion imaging/electrophysiological diagnostics. (Abstract). Computing device 5000 may be used to implement the system and it includes a processor that can process instructions for execution within the computing device, including instructions stored in the memory or on the storage device. (see, e.g., [0340]).
It would have been obvious to one skilled in the art to modify the memory of GILGUNN to include program code such that, with the at least one data processor, the system could perform the operations of GILGUNN. One would have been motivated to add the program code to the memory so that the system could be a standalone system that did not require an internet connection, which is susceptible to delays and outages, for receiving instructions. There would be a reasonable expectation of success because, as taught in MOSKOWITZ, a processor is capable of implementing a program code stored in memory to implement complex and carefully controlled tasks.
With respect to claim 11, GILGUNN teaches wherein the at least one memory and the computer program code are further configured to, with the at least one data processor, cause the system, to at least move the medical device in sync with the position of the anatomy. GILGUNN teaches “positioning an end of the device in proximity of the soft tissue of the patient” (claim 3 of GILGUNN) and, while a distance between the surface and the actuator holding the device is known, “synchronizing motion of the actuator with the time-varying displacement of the surface of the soft tissue” (claim 9 of GILGUNN).
With respect to claim 12, GILGUNN also teaches wherein the at least one memory and the computer program code are further configured to, with the at least one data processor, cause the system, to perform a function on the anatomy while the anatomy is in a specific state. With respect to the “function,” GILGUNN performs the same function as described in Applicant’s specification at [0024]. More specifically, GILGUNN inserts a device into the tissue. (see, e.g., “Step 35” at col. 13, lines 22-24). The “specific state” is determined through Steps 33A, 33B and 34A, 34B in which GILGUNN determines the force exerted by the tissue onto the device at contact, compares an actual distance travelled at contact to an expected value, and compares an actual force on the device to the expected force. (col. 13, lines 11-21). When this “specific state” of the tissue surface is known, the processor “adjusts the speed of the actuator 12 and the remaining distance it will travel to reach the implantation depth.” (col. 13, lines 22-24).
With respect to claim 14 (depending from claim 12), GILGUNN also teaches wherein the anatomy comprises a cortical surface. In describing accuracy of placing the device 14, GILGUNN teaches “a placement accuracy of <50 microns is necessary to ensure the correct cortical neuronal layer has been implanted.” (emphasis added) (col. 8, lines 48-50). See also Figures 7A and 7B.
With respect to claim 16, GILGUNN also teaches wherein the at least one memory and the computer program code are further configured to, with the at least one data processor, cause the system, to use a sensor coupled to optical light data, laser data, or ultrasonic data. Before implantation “the tissue height has been referenced and the laser ranging sub-system 30 has a measure of the dynamic distance from the tissue surface 32 to the tip 26 of the device 14 to be implanted.” (emphasis added) (col. 13, lines 2-5).
With respect to claim 19, GILGUNN does not explicitly teach wherein the at least one memory and the computer program code are further configured to, with the at least one data processor, cause the system, to perform a function on the anatomy during any pulse state of the anatomy.
As discussed above with respect to claim 4, FLAHERTY teaches identifying the timing of brain surface movement and inserting the electrode when the brain surface is substantially stationary (i.e., between pulses). ([0048]; see, e.g., [0128]-[0130] explaining system in greater detail). Between pulses is a “pulse state.”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to perform a function on the anatomy during any pulse state of the anatomy, as taught in FLAHERTY. One of ordinary skill in the art would have motivated to insert/implant the electrode between the pulses in order to be more accurate in positioning the electrode and to avoid trauma to the patient. (see, e.g., [0005] of FLAHERTY). There would have been a reasonable expectation of success as GILGUNN and FLAHERTY teach similar systems that both concern implanting sensors on the brain surface.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) and U.S. Patent Appl. Publ. No. 2020/0281670 A1 to Moskowitz (hereinafter referred to as “MOSKOWITZ”) as applied to claim 12 above, and further in view of U.S. Patent Appl. No. 2007/0156126 A1 (hereinafter “FLAHERTY”).
With respect to claim 13 (depending from claim 12), GILGUNN does not explicitly teach that the specific state comprises the anatomy being between pulses. As described above with respect to claim 3, GILGUNN performs a function on the anatomy when the anatomy is in a specific state. Notably, GILGUNN is concerned pulsatile and respiratory motion: “Accurate placement of the interface requires referencing of the tissue height, maintaining the relative height between the interface mounted on the insertion apparatus and the tissue as the tissue surface moves under pulsatile and respiratory motion, mapping and identifying the insertion location with an overlay of the interfaces and positioning the interface in space with respect to the tissue surface.” (emphasis added) (col. 5, lines 61-67: see also col. 13, lines 5-6: “…based on the motion of the tissue surface 32 due to pulsatile and respiratory motions.”)
In the same field of endeavor, FLAHERTY teaches an insertion system for implanting devices within the brain. (see, e.g., [0003] and [0085]). FLAHERTY is particularly concerned about tissue movement prior to implantation. “For example, although a patient is typically placed under general anesthesia during an implantation procedure, certain parts of the body, such as, for example, the brain and various internal organs, may continue to move due to, for example, the patient's continued respiration and blood pressure (i.e., heart beat) functions. If the target tissue to which the sensor is to be implanted lies in one of those moving parts of the body, accurate positioning of the sensor or any other implant may be extremely difficult.” ([0004]).
FLAHERTY teaches an insertion system for implanting a sensor on a brain surface. “FIG. 1 shows an insertion system 100 used in, for example, inserting an implant 200 (e.g., two- or three-dimensional array of electrodes) into a patient's body, such as, for example, the brain (e.g., motor cortex of a human or animal brain).” ([0085]). FLAHERTY explicitly teaches observing the brain surface to insert the implant when the surface is stationary. “[T]he method may comprise detecting a characteristic of the target surface so as to determine a proper timing for insertion of the implant. According to another exemplary aspect, the proper timing may comprise a time period in which the target surface remains in a substantially stationary position.” ([0048]; see, e.g., [0128]-[0130] explaining system in greater detail).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to identify the timing and insert the electrode when the brain surface is substantially stationary (i.e., between pulses), as taught in FLAHERTY. One of ordinary skill in the art would have motivated to insert/implant the electrode between the pulses in order to be more accurate in positioning the electrode and to avoid trauma to the patient. (see, e.g., [0005] of FLAHERTY). There would have been a reasonable expectation of success as GILGUNN and FLAHERTY teach similar systems that both concern implanting sensors on the brain surface.
Claim 15 is rejected under 35 U.S.C. 103 s being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) and U.S. Patent Appl. Publ. No. 2020/0281670 A1 to Moskowitz (hereinafter referred to as “MOSKOWITZ”) as applied to claim 10 above, and further in view of Koirala, Nabin, et al. “Mapping of subthalamic nucleus using microelectrode recordings during deep brain stimulation.” Scientific Reports 10.1 (2020): 19241. (hereinafter referred to as “KOIRALA”).
With respect to claim 15, GILGUNN and MOSKOWITZ do not explicitly teach that the at least one memory and the computer program code are further configured to, with the at least one data processor, cause the system, to take an electrical measurement of the anatomy [to] measure an anatomical position of the anatomy relative to the medical device.
In the same field of endeavor, KOIRALA teaches that the success of deep brain stimulation (DBS) in the subthalamic nucleus (STN) depends upon correct placement of the electrodes. (page 1, paragraph beginning with “Deep brain stimulation…”). “To accomplish a high precision implantation in this region, preoperative MRI images-based navigation systems and intraoperative microelectrode recordings (MER) are widely used. The visualization technique for locating the STN by using preoperative MRI is prone to giving inaccurate results due to brain shift induced parenchymal alterations or cerebrospinal fluid loss. Hence, the intraoperative MER allows improving the target localization during stereotactic surgery by recording the electrical activity of the individual neurons from targeted structure.” (Id). Both “preoperative MRI images-based navigation systems and intraoperative microelectrode recordings (MER) are widely used.” (Id).
Accordingly, KOIRALA teaches acquiring intraoperative MER, which “allows improving the target localization…by recording the electrical activity of the individual neurons from targeted structure.” (i.e., taking an electrical measurement of the anatomy to measure or determine an anatomical position of the anatomy).
It would have been obvious to one of ordinary skill in the art to take an electrical measurement (e.g., MER) to measure or determine the anatomical position of the anatomy. The electrical measurements could be used in conjunction with MRI images to determine the anatomical position of the anatomy. One would have been motivated to acquire MER because, as taught in KOIRALA, the success of deep brain stimulation depends upon correct placement of the electrodes. (page 1, paragraph beginning with “Deep brain stimulation of the subthalamic…”). There would have been a reasonable expectation of success because MER is “widely used,” as taught by KOIRALA. (Id).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,408,571 B2 (hereinafter “GILGUNN”) and U.S. Patent Appl. No. 2013/0123759 A1 (hereinafter “KANG”) as applied to claim 1 above, and further in view of International Patent Publication No. WO 2023/245709 A1 (hereinafter “ZHENGTUO”).
GILGUNN does not explicitly teach that obtaining data regarding a position of the anatomy by taking an electrical measurement of the anatomy includes: using an electrode tip with a corresponding electrode circuit to obtain a first electrical measurement while the electrode circuit is electrically isolated in air; using the electrode tip with the corresponding electrode circuit to obtain a second electrical measurement while the electrode circuit is not electrically isolated in air; measuring a feedback based on the electrical circuit to determine if the medical device is in contact with the anatomy.
In the same field of endeavor, ZHENGTUO teaches systems for implanting electrode wires and bioelectrodes into a target, including the brain. (see, e.g., page 1, lines 13-14 and page 1, lines 19-25). ZHENGTUO suggests using robotic implantation systems. “Robots have the ability to complete work more accurately than humans and the ability to complete repetitive tasks more consistently.” (page 1, lines 42-43).
ZHENGTUO teaches that “[w]hen implanting, the implantation depth needs to be controlled. Two parameters related to the implantation depth are the initial implantation position (referring to the position along the z-axis of the implantation device 100) and the implantation stroke. The implantation stroke is achieved as described above by a defined stroke generated by the electromagnetic actuator or the pneumatic actuator itself. The initial implantation position may be represented by the distance between the tip of the needle portion 111 and the brain surface. To determine this distance, a system according to embodiments of the present disclosure may include a brain surface detection device capable of detecting that the conductive needle portion 111 contacts the brain surface. The brain surface detection device may include a detection circuit, the needle part 111 is connected to the detection circuit, and another part implanted in the living body is connected to the circuit, wherein a voltage measuring device is connected to the circuit, and the needle part 111 contacts the brain When the needle part 111 touches the surface of the brain, the circuit is turned on and the voltage measuring device measures the voltage, indicating that the needle part 111 is in contact with the surface of the brain.”
Accordingly, ZHENGTUO teaches determining the initial implantation position by detecting when the needle contacts the brain surface. When the needle is in contact with the brain surface, a voltage will be detected. When the needle is not in contact with the brain surface (i.e., electrically isolated in air), a voltage will not be detected. Measuring the voltage is a feedback that determines whether the needle is in contact with the brain surface.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GILGUNN system to include determining an initial implantation position by detecting a voltage when the needle contacts the brain surface, as described in ZHENGTUO. One of ordinary skill in the art would have been motivated to use ZHENGTUO’s method in order to determine the initial implantation position prior to implanting the electrode. There would have been a reasonable expectation of success as GILGUNN and ZHENGTUO describe similarly procedures for implanting electrodes.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection relies upon KANG for teaching using the data to synchronize a position of the medical device relative to the anatomy such that a position of the medical device relative to the anatomy is continuously maintained as the anatomy moves. Nonetheless, GILGUNN is relevant and teaches more than “actuation of the actuator…relative to the tissue movement,” as alleged by Applicant at page 8 of the Response. Specifically, GILGUNN teaches that “[a]ccurate placement of the interface requires referencing of the tissue height, maintaining the relative height between the interface mounted on the insertion apparatus and the tissue as the tissue surface moves under pulsatile and respiratory motion….” (Column 6, lines 61-64).
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2014/0336489 A1 describes an intracortical-detection device for implanting electrodes that provides compensation of pulsations of cerebral tissue. “According to this embodiment, the electrical read signal supplied by the voltage detector 60 is used for controlling in closed loop the second electric motor 10, so that the position of the detection device 41, and in particular the position of the first body 3 with respect to the second body 4, adapts dynamically as a function of the instantaneous pressure exerted by the cerebral tissue on the surface 30.” ([0057]).
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.
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/JASON P GROSS/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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