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 .
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1-19 and Species C in the reply filed on October 2nd, 2025 is acknowledged. The traversal is on the ground(s) that the search and examination of all currently pending claims would not pose an undue burden on the Examiner. This is not found persuasive because as stated in the restriction requirement mailed May 2nd 2025, the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) since the method requires specific searching related to the specific type of sensors claimed.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/499,970, 62/499,952, 62/499,954, 62/499,971, 62/499,965, 62/493,002 and 16/071,311, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior filed provisional applications: 62/499,970, 62/499,952, 62/499,954, 62/499,971, 62/499,965, 62/493,002, fail to provide support for claims 1-19.
The prior filed parent application: 16/071,311 fails to provide support for claims 2-14 & 19.
While the prior provisional applications broadly depict a robot and corresponding navigation system that includes a sensor, there is not adequate support in the prior disclosures for the specifics with regards to the navigation and how it functions to control movement of the robotic arm. Accordingly, claims 1-19 are not entitled to the benefit of these prior provisional applications and will be awarded the priority date June 20, 2017. Additionally, none of the provisional applications nor the parent application provide support for a load sensor, a LiDAR sensor or the treatment parameters such that claims 2-14 & 19 are awarded the priority date of September 4th, 2021.
Claim Objections
Claims 1, 9, 11 & 18 objected to because of the following informalities:
Claim 1, line 8, “communications” should read --communication--,
Claim 9, line 2: “them” should read --the array of microneedles--,
Claim 9, line 3: “them” should read --the array of microneedles--,
Claim 11, line 5: “the first sensing” should read --the first sensing unit--,
Claim 18, line 3: “that treatment segments” should read --each treatment segment--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a first sensing unit and a second sensing unit” in claim 11.
In reference to the instant Application’s Specification, [0021] describes “In one embodiment, each of the first and second sensor units comprises a LiDAR sensor and at least one camera” such that the first and second sensing units are known electrical components.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-14, 16 & 18-19 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 2 recites the limitation “the end of the robotic arm” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-10 are also rejected by virtue of their dependency on claim 2.
Claim 3 recites the limitation “the forces” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the lengthwise axis” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “that vertical dimension” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-10 are also rejected by virtue of their dependency on claim 3.
Regarding claim 4, the claim recites “that acts” in line 2 and it is unclear if this is to be recited as an active method step as this is an apparatus claim, or as a functional limitation. For examination purposes, this limitation will be interpreted as “that is configured to act”.
Claim 4 recites the limitation “the electronic circuitry” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 4, the claim recites “a housing” in line 4 and it is unclear if this is the same housing or a different housing from the “housing” recited in line 3. For examination purposes, these are the same housing and the limitation will be interpreted as “the housing”.
Claims 5-10 are also rejected by virtue of their dependency on claim 4.
Regarding claim 7, the claim recites “each microneedle” in line 2 and it is unclear which microneedles these are referring to, the array of microneedles recited earlier in line 2 or a different set of microneedles. For examination purposes, these are the same microneedles and the limitation will be interpreted as “each microneedle of the array of microneedles”.
Regarding claim 7, the claim recites “selectively activatable” in line 2 and it is unclear if this is to be recited as an active method step as this is an apparatus claim, or as a functional limitation. For examination purposes, this limitation will be interpreted as “configured to be selectively activatable”.
Claim 7 recites the limitation “the skin” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 8-10 are also rejected by virtue of their dependency on claim 7.
Regarding claim 9, the claim recites “selectively extends … retracts” in lines 2-3 and it is unclear if this is to be recited as an active method step as this is an apparatus claim, or as a functional limitation. For examination purposes, this limitation will be interpreted as “configured to be selectively extended … retracted”.
Claim 10 is also rejected by virtue of its dependency on claim 9.
Regarding claim 10, the claim recites “each microneedles” in line 1 and it is unclear which microneedles these are referring to, the array of microneedles recited in claim 9, from which claim 10 depends, or a different set of microneedles. For examination purposes, these are the same microneedles and the limitation will be interpreted as “each microneedle of the array of microneedles”.
Regarding claim 11, the claim recites “first sensing unit and a second sensing unit” in lines 1-2 and it is unclear whether this is a sensor or a sensor in conjunction with hardware/software. Based on the 112(f) interpretation, above, and paragraph [0021] of the instant application’s Specification, this limitation will be interpreted as a LiDAR sensor and a camera, respectively.
Regarding claim 11, the claim recites “the treatment” in line 4 and it is unclear if this is referring to the treatment plan or the treatments recited in claim 1, from which claim 11 depends, or is a different treatment. For examination purposes, these are the same treatment plans and the limitation will be interpreted as “the treatment plan”.
Regarding claim 11, the claim recites “moves” in line 5 and it is unclear if this is to be recited as an active method step as this is an apparatus claim, or as a functional limitation. For examination purposes, this limitation will be interpreted as “is configured to move”.
Claims 12-13 are also rejected by virtue of their dependency on claim 11.
Claim 13 recites the limitation “the distance” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the nearest object” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the bed” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the left” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the operative portion” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the claim recites “each treatment” in line 2 and it is unclear which treatment this is referring to, the prescribed treatment recited earlier in line 2 or another treatment. For examination purposes, these are the same treatments and the limitation will be interpreted as “each prescribed treatment of the series of prescribed treatments”.
Claim 18 recites the limitation “the skin” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the claim recites “the treatment” in line 5 and it is unclear if this is referring to the treatment plan or the treatments recited in claim 1, from which claim 18 depends, or is a different treatment. For examination purposes, these are the same treatment plans and the limitation will be interpreted as “the treatments”.
Claim 19 is also rejected by virtue of its dependency on claim 18.
Claim 19 recites the limitation “the microneedle treatment tool” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation “the microneedles” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation “the RF energy” in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 & 15-18 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Hirvonen et al. (U.S. Pub. No. 20200046427, earliest effective filing date), herein referred to as “Hirvonen”.
Regarding claim 1, Hirvonen teaches a robotic system for treating a patient (Abstract: A system for automated laser-assisted dermatological treatment is provided; said system comprises a robot arm assembly), comprising:
a robotic arm (robot arm assembly) with an end effector (laser head 101) for treating the patient (Abstract: The system is configured to remove an undesirable dermatological condition from skin by directing laser energy to a pre-defined skin surface area intended for treatment), wherein the robotic arm is configured to be movable in a space surrounding the patient ([0062]: The robot arm assembly 120 is preferably configured to have at least six degrees of freedom, indicated on FIG. 2B by roman numerals I-VI), and the end effector is configured to be movable individually and co-movable with the robotic arm in said space ([0062]: The robot arm assembly 120 is preferably configured to have at least six degrees of freedom, indicated on FIG. 2B by roman numerals I-VI … The laser head 101 is further arranged to rotate about at least two orthogonal axes (herein V, VI) by means of the rotatable joint adapter 104);
a sensing device for acquiring data associating with coordinates and images of the end effector and the patient ([0072]: The laser head 101 further comprises an at least one image acquisition device and an at least one proximity sensor); and
a controller (controlling unit 110) in communications with the robotic arm and the sensing device ([0066]: The controlling unit 110 is configured to communicate with the robot arm 102 via a communication line 105a; and with the laser head 101—via a communication line 105b (FIG. 3)) for controlling movements of the robotic arm with the end effector and treatments of the patient with the end effector based on the acquired data and a treatment plan ([0065]: The controlling unit 110 is implemented to execute direct controls over the robot arm assembly 120 and therefore comprises at least mechanical (motion) controllers for the robot arm 102, laser function controllers for the laser head 101, and a controlling means for integrating and coordinating functions of the laser head 101 with that of the robot arm 102; [0076]: the treatment per se may be specified as a sequence of actions performed by the system 100 since a data on a skin surface area 501 intended for treatment and at least partly comprising an undesirable dermatological condition 410 has been input into the processing unit 111 or, in an absence of a distinct processing unit into the controlling unit 110 or a combination thereof).
Regarding claim 2, Hirvonen teaches wherein the end effector is supported on a load sensor on the end of the robotic arm so that the end effector is movable by the robotic arm to essentially any location in said space ([0072]: The laser head 101 further comprises an at least one image acquisition device and an at least one proximity sensor … The proximity sensor(s) may be any of the inductive, capacitive, photoelectric or ultrasonic sensors; [0073]: In one preferred embodiment the laser head 101 comprises three proximity sensors, preferably solid-state sensors, located at a certain distance from each other to form a triangle. A “three-point” measurement implemented via the aforesaid configuration ensures correct alignment of the laser head 101 with respect to a predetermined point at skin surface area intended for treatment and allows to overcome errors caused by skin irregularity and degree of curvature).
Regarding claim 15, Hirvonen teaches wherein the controller is in wired or wireless communications with the robotic arm and the sensing device ([0064]: The processing unit 111 may be further configured as a remote server workstation being in communication with the controlling unit 110 and/or the robot arm assembly 120 via wired and/or wireless connection; [0071]: The laser head 101 thus comprises a casing 301, having an aperture 302 for a lasing beam and a cable port 305 for receiving the communication line 105b, which connects the laser head 101 to the laser source (provided within the controlling unit 110, for example); see also Fig. 6).
Regarding claim 16, Hirvonen teaches wherein the controller is configured to receive the acquired data from the sensing device, process the received data to determine the coordinates of the robotic arm and the end effector, instruct the robotic arm to move so as to locate the operative portion of the end effector to a desired location relative to the patient and then the end effector to provide the treatment according to the treatment plan ([0080]: The robot arm assembly 120 is further configured, by means of the proximity sensors provided in the laser head 101, to estimate a starting position of the laser head 101 with regards to the skin surface area 501 based on the virtual model 502 and the grid 503; [0082]: After the laser head 101 has been aligned with respect to the aforesaid starting point within the skin portion 501a corresponding to the “first” virtual sub-area 504 (“S”), an image of said skin portion 501a is acquired by means of the image acquisition device; [0084]: Once reconstruction is complete the processing unit 111 is configured to issue a “START” command for initiating a series of actions performed by the robot arm assembly 120 and resulting in the removal of the dermatological condition 410 within the pre-defined skin surface area 501. In particular, the robot arm 102 is set to the starting position (“S”) and laser supply from the laser source to the laser head 101 is initiated; see also [0093]).
Regarding claim 17, Hirvonen teaches wherein the controller is a computer system, a control console, or a microcontroller unit (MCU) ([0064] The system 100 according to another preferred embodiment is illustrated by FIG. 3, said system 100 further comprising a processing unit 111 implemented as a computer workstation, such as a tablet computer, a portable computer, a mobile electronic device and the like).
Regarding claim 18, Hirvonen teaches wherein the treatment plan defines a series of prescribed treatments in which each treatment comprises treatment segments over the skin of the patient and treatment parameters for that treatment segments ([0009]: a processing unit configured to generate and store a virtual model of the pre-defined skin surface area intended for treatment, to identify a number of sub-areas within said model, wherein each sub-area corresponds to the individual skin portion within the boundaries of the pre-defined skin surface area intended for treatment; [0076]: a sequence of actions performed by the system 100 since a data on a skin surface area 501 intended for treatment and at least partly comprising an undesirable dermatological condition 410 has been input into the processing unit 111 or, in an absence of a distinct processing unit into the controlling unit 110 or a combination thereof, till the moment the robot arm assembly 120 has acquired a final position after having worked the entire area 501; see also [0093]).
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen as applied to claim 1 above, and further in view of Okazaki (U.S. Pub. No. 20110218676), herein referred to as “Okazaki”.
Regarding claim 3, Hirvonen fails to disclose wherein the load sensor is a three-axis load sensor for sensing the forces being applied to the end effector in three orthogonal axes, x, y and z, with the z-axis being the lengthwise axis of the end effector and the x- and y-axes being lateral dimensions perpendicular to that vertical dimension and each other.
However, Okazaki discloses wherein the load sensor is a three-axis load sensor ([0114]: The force sensor 51 is a six-axis force sensor) for sensing the forces being applied to the end effector in three orthogonal axes, x, y and z, with the z-axis being the lengthwise axis of the end effector and the x- and y-axes being lateral dimensions perpendicular to that vertical dimension and each other ([0114]: the force sensor 51 is a general six-axis force sensor, and is designed to measure translation forces in three directions, xs, ys, and zs, applied between the supporting surface 302 and the measuring surface 301, and moments around the xs, ys, and zs axes, by using strain gauges 304 respectively attached onto three beams 303 disposed around the center axis with equal intervals. In the first embodiment, only the translation forces in the three directions, xs, ys, and zs, are used so that the force sensor 51 is utilized as a three-axis force sensor).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the load sensor of Hirvonen to be a three-axis load sensor, as taught by Okazaki, for the purpose of measuring a force F to be applied to the arm-end supporting member and measuring translation forces in three directions, xs, ys, and zs, applied between the supporting surface and the measuring surface (Okazaki: [0114]).
Regarding claim 4, Hirvonen discloses wherein the end effector comprises an operative portion that acts on the patient directly ([0071]: The laser head 101 thus comprises a casing 301, having an aperture 302 for a lasing beam), a tool control circuit for controlling actions of the end effector ([0066]: communication line 105b further comprises lasing beam delivery system, configured to deliver lasing beam from the power source (laser source), provided within the controlling unit 110 or separately therefrom, to the laser head 101 … the opposite end of the cable includes a beam collimator and isolator enclosed into the laser head 101), and a housing (housing 301) containing the electronic circuitry, wherein a proximal end of a housing is supported on the load sensor ([0072]: The laser head 101 further comprises an at least one image acquisition device and an at least one proximity sensor … The proximity sensor(s) may be any of the inductive, capacitive, photoelectric or ultrasonic sensors; wherein anything outside of the aperture 302 is seen as a proximal end), and a distal end of the housing supports the operative portion ([0071]: a casing 301, having an aperture 302 for a lasing beam).
Regarding claim 5, Hirvonen discloses wherein the end effector is a surgical instrument or a medical instrument (Abstract: The system is configured to remove an undesirable dermatological condition from skin by directing laser energy to a pre-defined skin surface area intended for treatment).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen in view of Okazaki as applied to claim 1 above, and further in view of Gildenberg (U.S. Pub. No. 20080247637), herein referred to as “Gildenberg”.
Regarding claim 6, Hirvonen in view of Okazaki fail to disclose wherein the end effector is a scalpel, scissors, an electrocauterizer, a gas plasma treatment tool, and/or a microneedle treatment tool.
However, Gildenberg discloses wherein the end effector is a scalpel, scissors, an electrocauterizer, a gas plasma treatment tool, and/or a microneedle treatment tool ([0047]: cannula 36 comprises the tissue piercing tip 37, for example, a needle).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the end effector of Hirvonen in view of Okazaki to be a microneedle treatment tool, as taught by Gildenberg, for the purpose of the procedure being faster and having more precise control over the location and depth of each injection (Gildenberg: [0027]).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen in view of Okazaki and Gildenberg as applied to claim 1 above, and further in view of Hirshberg (U.S. Pub. No. 20170095621), herein referred to as “Hirshberg”.
Regarding claim 7, Hirvonen in view of Okazaki and Gildenberg fail to disclose wherein the microneedle treatment tool comprises an array of microneedles configured such that each microneedle is selectively activatable to extend into or retract from the skin of the patient independently.
However, Hirshberg discloses wherein the microneedle treatment tool (needle system device 600) comprises an array of microneedles (array of needles 660) configured such that each microneedle is selectively activatable to extend into or retract from the skin of the patient independently ([0195]: With the aid of the ultrasound analysis the full 3D shape of the lesion is captured. Each needle 600 in the array, that has a portion of the lesion underneath it, is inserted to pass through the lesion and stop in benign tissue location deeper than the lesion; see Fig. 12). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the microneedle treatment tool of Hirvonen in view of Okazaki and Gildenberg to the microneedle tool of Hirshberg for the purpose of controlled and accurate slow to fast penetration, controlled and accurate slow to fast retraction and reducing the chance that unneeded benign tissues will be removed (Hirshberg: [0143], [0144], [0195]).
Regarding claim 8, Hirvonen in view of Okazaki, Gildenberg and Hirshberg disclose wherein the microneedle treatment tool is further configured to apply radio frequency (RF) waveforms, heat, light, and/or drug through the array of microneedles to the skin of the patient for therapy (Hirshberg: [0195]: (1) burning or killing the lesion by heat, vibration, electricity or chemicals; (2) injecting medication or chemicals to the lesion volume; (3) coloring the lesion).
Regarding claim 9, Hirvonen in view of Okazaki, Gildenberg and Hirshberg disclose wherein the array of microneedles (Hirshberg: array of needles 660) are supported on a structure in the end effector that selectively extends them out through a planar front face of the end effector and into the skin of the patient, or retracts them back behind the planar front face ([0195]: With the aid of the ultrasound analysis the full 3D shape of the lesion is captured. Each needle 600 in the array, that has a portion of the lesion underneath it, is inserted to pass through the lesion and stop in benign tissue location deeper than the lesion; see Fig. 12, structure not shown in the picture but a structure capable of performing the selective insertion/retraction is described in [0195]).
Regarding claim 10, Hirvonen in view of Okazaki, Gildenberg and Hirshberg disclose wherein a force applied to each microneedles to enter the skin of the patient is selected at varied levels ([0195]: With the aid of the ultrasound analysis the full 3D shape of the lesion is captured. Each needle 600 in the array, that has a portion of the lesion underneath it, is inserted to pass through the lesion and stop in benign tissue location deeper than the lesion; see Fig. 12, wherein depth is seen as being proportional to force such that the varied depths are seen as requiring different forces to achieve those depths).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen as applied to claim 1 above, and further in view of Gregerson et al. (U.S. Pub. No. 20200078097), herein referred to as “Gregerson”.
Regarding claim 11, Hirvonen fails to disclose wherein the sensing device comprises a first sensing unit and a second sensing unit, wherein the first sensing unit is disposed in said space at a stationary location vertically above the patient and directed at the patient, and the second sensing unit is attached on the end effector, such that during the treatment, the second sensing unit moves with the end effector, while the first sensing remains stationary on its support over the patient.
However, Gregerson discloses wherein the sensing device comprises a first sensing unit (motion tracking system 105) and a second sensing unit (a second optical sensing device 809), wherein the first sensing unit is disposed in said space at a stationary location vertically above the patient and directed at the patient ([0035]: The motion tracking system 105 in the embodiment of FIG. 1 includes a plurality of marker devices 119, 202 and 115 and a stereoscopic optical sensor device 111 that includes two or more cameras (e.g., IR cameras); see position of 111 in Fig. 1), and the second sensing unit (a second optical sensing device 809) is attached on the end effector ([0089]: the second optical sensing device 809 may be located on the robotic arm 101), such that during the treatment, the second sensing unit moves with the end effector ([0089]: may be configured to detect a distance of the robotic arm 101 from the patient 200), while the first sensing remains stationary on its support over the patient ([0035]: The motion tracking system 105 in the embodiment of FIG. 1 includes a plurality of marker devices 119, 202 and 115 and a stereoscopic optical sensor device 111 that includes two or more cameras (e.g., IR cameras); see stationary position of 111 in Fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sensing device of Hirvonen to the sensing device of Gregerson for the purpose of enabling the anatomical region of interest to be continually tracked, enabling the position of robotic arm and end effector to be tracked and detecting a distance of the robotic arm from the patient ([0035], [0089])
Regarding claim 12, Hirvonen in view of Gregerson disclose wherein each of the first and second sensor units comprises a LiDAR sensor (Gregerson: [0089]: In the embodiment of FIG. 8B, a second sensing device may include a second optical sensing device 809, such as a LIDAR device) and at least one camera ([0035]: The motion tracking system 105 in the embodiment of FIG. 1 includes a plurality of marker devices 119, 202 and 115 and a stereoscopic optical sensor device 111 that includes two or more cameras (e.g., IR cameras)), wherein the LiDAR sensor is configured to determine distances of the LiDAR sensor to surfaces of objects in its field of view ([0089]: a second optical sensing device 809, such as a LIDAR device or a similar non-contact optically-based system for detecting a distance to a target), and the at least one camera is configured to acquire stereoscopic images of the objects in its field of view ([0035]: The motion tracking system 105 in the embodiment of FIG. 1 includes a plurality of marker devices 119, 202 and 115 and a stereoscopic optical sensor device 111 that includes two or more cameras (e.g., IR cameras)).
Regarding claim 13, Hirvonen in view of Gregerson disclose wherein the acquired data by each sensing unit comprises an array of range data, and video data for a field of pixels, wherein the range data for each pixel is an optically derived LiDAR distance value of the distance from the LiDAR sensor to the nearest object met by a ray extending through that pixel from the LiDAR sensor ([0035]: The motion tracking system 105 in the embodiment of FIG. 1 includes a plurality of marker devices 119, 202 and 115 and a stereoscopic optical sensor device 111 that includes two or more cameras (e.g., IR cameras); [0051]: The motion tracking system 105 may repeatedly acquire new images from the optical sensing device 111; [0089]: a second optical sensing device 809, such as a LIDAR device; [0090]: In some embodiments, a processor (e.g., computer 113 in FIG. 1) may compare a distance between the robotic arm 101 and the patient 200 measured by the second sensing device 809 with the expected distance between the robotic arm 101 and the patient 200 according to the first sensing device (e.g., the motion tracking system 105); wherein taking multiple images is seen as video data and wherein it is known that if the sensor is a LIDAR sensor then the array of range data is an optically derived LiDAR distance value of the distance from the LiDAR sensor to the nearest object met by a ray extending through that pixel from the LiDAR sensor).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen as applied to claim 1 above, and further in view of Colmenares (U.S. Pub. No. 20210358139), herein referred to as “Colmenares”.
Regarding claim 14, Hirvonen fails to disclose wherein the sensing device comprises a LiDAR sensor located in a center of the bed above the patient; and a first stereoscopic camera and a second stereoscopic camera symmetrically located a distance to the left and right of the LiDAR sensor, respectively, wherein the LiDAR sensor and the first and second stereoscopic cameras are attached on a stationary support.
However, Colmenares discloses wherein the sensing device (camera array 110) comprises a LiDAR sensor ([0025]: the depth sensor 116 can include other types of dedicated depth detection hardware such as a LiDAR detector) located in a center of the bed above the patient (see Fig. 6); and a first stereoscopic camera and a second stereoscopic camera (a plurality of cameras 112; [0026]: cameras 112 to synthesize the output image as a 3D (or stereoscopic 2D) rendering of the scene 108)) symmetrically located a distance to the left and right of the LiDAR sensor (see Fig. 4a), respectively, wherein the LiDAR sensor and the first and second stereoscopic cameras are attached on a stationary support ([0022]: the camera array 110 includes a plurality of cameras 112 (identified individually as cameras 112a-112n); [0025]: the camera array 110 further includes a depth sensor 116; see Fig. 6).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sensing device of Hirvonen to be the sensing device of Colmenares for the purpose of estimating the surface geometry of the scene, synthesizing the output image as a rendering of the scene and the positioning to maximize the overlap of the fields of view (Colmenares: [0025], [0026], [0046]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hirvonen as applied to claim 1 above, and further in view of Hirshberg.
Regarding claim 19, Hirvonen fails to disclose wherein the treatment parameters for the microneedle treatment tool of the end effector comprise a heat or temperature setting, a choice of red or blue photodynamic therapy, a depth for the microneedles to be inserted, a duration of the treatment, a number of passes for a particular treatment segment, and/or a frequency of the RF energy to be applied.
However, Hirshberg discloses wherein the treatment parameters for the microneedle treatment tool of the end effector comprise a heat or temperature setting, a choice of red or blue photodynamic therapy, a depth for the microneedles to be inserted ([0195]: Each needle 600 in the array, that has a portion of the lesion underneath it, is inserted to pass through the lesion and stop in benign tissue location deeper than the lesion), a duration of the treatment, a number of passes for a particular treatment segment, and/or a frequency of the RF energy to be applied. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the end effector and treatment parameters of Hirvonen to the microneedle tool and treatment parameters of Hirshberg for the purpose of reducing the chance that unneeded benign tissues will be removed (Hirshberg: [0195]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794