DETAILED ACTION
This action is in response to amendments received on 4/19/2023. It is acknowledged that all of the originally filed claims 1-40 have been canceled and new claims 41-64 added. A complete action on the merits of claims 41-64 follows below.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 41-64 are objected to because of the following informalities: Claim set dated 4/19/2023 includes claim status indication (canceled) for what appears to be originally filed claims 1-40; however, two different sets of claims filed on 11/28/2022 exist in the application. The first set of claims are numbered 1-40 while the second set of claims filed on the same date include claims 1-36 as (canceled) and new claims 37-60 filed. Examiner has acted on the latest set of claims dated 4/19/2023 with claims 1-40 canceled and new claims 41-64 added; however, applicant needs to be persistent in numbering the claims to make it clear what claims are pending and which claims have been canceled.
(A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers.
Claims added by a preliminary amendment must have the status identifier (new) instead of (original), even when the preliminary amendment is present on the filing date of the application and such claim is treated as part of the original disclosure. If applicant files a subsequent amendment, applicant must use the status identifier (previously presented) if the claims are not being amended, or (currently amended) if the claims are being amended, in the subsequent amendment. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment.
The status identifier (not entered) is used for claims that were previously proposed in an amendment (e.g., after-final) that was denied entry. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 53-54 and 56-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hofmann (US Patent No. 5,439,440).
Regarding Claim 53, Hofmann teaches an apparatus for delivering a high voltage, sub-microsecond pulsed electric field (Col. 5, ll. 10-20 and Figs. 2-3), the apparatus comprising:
an elongate shaft 22; a distal end region comprising a first jaw (a first jaw comprising electrode 24 in Figs. 2-3) and a second jaw (a second jaw comprising electrode 26 in Figs. 2-3), the distal end region extending from a distal end of the elongate shaft (Col. 3, ll. 1-22);
a first side-facing electrode 24 on the first jaw (Figs. 2-3);
a second side-facing electrode 26 on the second jaw (Figs. 2-3), wherein the first side-facing electrode 24 and the second side-facing electrode 26 face a same direction so that they may be positioned against a same side of a target tissue (the position of the electrodes on the jaws are such that it allows the two electrodes to face the same direction by positioning the sides of the electrodes on the same surface tissue, see Figs. 2-3);
a proximal handle 28/30;
a control (movable handle 30) for opening and closing the first jaw and the second jaw (Col. 3, ll. 1-22); and
a spacing control configured to adjust an electrode spacing distance between the first side-facing electrode and the second side-facing electrode (in one interpretation “telescopic sleeve or sheath 42 covers the mechanism during insertion” Col. 3, ll. 20-22; thereby given the broadest reasonable interpretation, the sheath in the covered configuration controls squeezing the electrodes together providing a less spacing between them and in a retracted configuration allows the electrodes to move away from each other creating a more space between them. In a second interpretation handle 30 is used for both opening/closing the jaws as well as controlling a spacing between the electrodes as it opens and closes).
Regarding Claim 54, Hofmann teaches further comprising a sensor 38 configured to determine the electrode spacing distance between the first electrode and the second electrode (suitable sensing unit 38 senses the distance between the electrodes and generates a signal which is transmitted via conductor cable 40 to the pulse generator” Col. 3, ll. 17-20).
Regarding Claim 56, Hofmann teaches wherein the first side-facing electrode and the second side-facing electrode comprise needle electrodes, knife electrodes or other penetrating electrodes (given the broadest reasonable interpretation electrodes 24 and 26 are configured to penetrate in tissue with a force applied; moreover, Hofmann teaches a different embodiment using needle electrodes in Figs. 4-5).
Regarding Claim 57, Hofmann teaches wherein the first side-facing electrode 24 and the second side-facing electrode 26 comprise surface electrodes, plate electrodes or other non-penetrating electrodes (surface or plate electrodes as seen in Figs. 2-3).
Regarding Claim 58, Hofmann teaches further comprising a controller configured to receive the electrode spacing distance between the first side-facing electrode and the second side-facing electrode, and to adjust an applied pulsed electric field based, at least in part, on the electrode spacing distance between the first side-facing electrode and the second side-facing electrode (Col. 1, ll. 53-64 and Col. 3, ll. 23-55).
Claim Rejections - 35 USC § 102/103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 41-47, 49, 51-52 and 61-63 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hofmann (US Patent No. 5,439,440) or, in the alternative, under 35 U.S.C. 103 as obvious over Hofmann in view of Athos et al. (US Pub. No. 2018/0243558).
Regarding Claim 41, Hofmann teaches a system for delivering a sub-microsecond pulsed electric field (Col. 5, ll. 10-20 and Figs. 2-3), the system comprising:
an elongate applicator tool comprising: an elongate shaft 22;
a distal end region comprising a first jaw (a first jaw comprising electrode 24 in Figs. 2-3) and a second jaw (a second jaw comprising electrode 26 in Figs. 2-3), the distal end region extending from a distal end of the elongate shaft (Figs. 2-3 and Col. 3, ll. 1-22);
a first side-facing electrode 24 on the first jaw and a second side-facing electrode 26 on the second jaw, wherein the first side-facing electrode and the second side-facing electrode face a same direction (the position of the electrodes on the jaws are such that it allows the two electrodes to face the same direction by positioning the sides of the electrodes on the same surface tissue, see Figs. 2-3); a high voltage connector (Figs. 2-3); and
a pulse generator 36 configured to generate a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds, the pulse generator comprising a port configured to connect to the high voltage connector (Figs. 2-3), please note that Hofmann teaches “The waveforms of the electrical signal provided by the generator in the power pack 36 can be an exponentially decaying pulse, a square pulse, a unipolar oscillating pulse train or a bipolar oscillating pulse train. The electric field strength can be 0.2 kV cm to 20 kV/cm. The pulse length can be ten microseconds to one hundred milliseconds. There can be one to one hundred pulses per per second. Of course the waveform, electric field strength and pulse duration are dependent upon the type of cells and the type of macromolecules that are to enter the cells via electroporation” therefore, examiner takes the position that the generator is configured to generate a plurality of electric pulses having an amplitude of at least 0.1 kV; however, the duration stated seems to be greater than 1000 nanoseconds and not less than 1000 nanoseconds). Since Hofmann teaches “the waveform, electric field strength and pulse duration are dependent upon the type of cells and the type of macromolecules that are to enter the cells via electroporation” examiner takes the position that either the generator is configured to generate the plurality of electrical pulses having a duration of less than 1000 nanoseconds or in alternative, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the plurality of electrical pulses having a duration of less than 1000 nanoseconds in view of the teachings of Athos in order to generate more effective electric pulses (“Pulse lengths of between 10 and 900 nanoseconds for nsPEF have been particularly studied to be effective in stimulating an immune response. Pulse lengths of about 100 nanoseconds are of particular interest in that they are long enough to carry sufficient energy to be effective at low pulse numbers but short enough to be effective in the manner desired” [0065] of Athos).
Regarding Claim 42, Hofmann teaches further comprising a proximal handle (proximal section of the instrument configured to be held by a user including grip 28 and movable handle 30 in Figs. 2-3) including one or more controls (movable handle 30) configured to control opening and closing of the first jaw and the second jaw and/or articulation of the distal end region (Figs. 2-3 and Col. 3, ll. 1-22).
Regarding Claim 43, Hofmann teaches further comprising a spacing control configured to adjust a spacing between the first side-facing electrode 24 and the second side-facing electrode 26 (“movable handle 30 is pivotally mounted at an upper end to grip 28 and connects through a moveable or actuating link 32 to the electrode links controlling the spacing between them. They may be biased by spring means (not shown) acting between grip 28 and handle 30 to the open or outermost position. The electrodes are connected through conductors in a cable 34 to suitable power or pulse generator 36. A suitable sensing unit 38 senses the distance between the electrodes and generates a signal which is transmitted via conductor cable 40 to the pulse generator. A telescopic sleeve or sheath 42 covers the mechanism during insertion” Col. 3, ll. 10-22).
Regarding Claim 44, Hofmann teaches wherein the spacing control is configured to adjust the spacing between the first side-facing electrode 24 and the second side-facing electrode 26 from between about 0.5 mm to 1 mm or more (although the figures are not to scale, based on the size of the electrodes and the instrument used in the surgical procedure of Fig. 1, it is taken than the space between the electrodes is “more” than 0.5 mm to 1 mm in Fig. 3).
Regarding Claim 45, Hofmann teaches further comprising a jaw spacing control (movable handle 30) configured to set a jaw spacing distance between the first side-facing electrode 24 and the second side-facing electrode 26 in a closed configuration (by gripping tissue between the jaws, the movable handle 30 squeezes the jaws together creating or setting a jaw spacing distance between the first side-facing electrode 24 and the second side-facing electrode 26 in a closed configuration, see Col. 3, ll. 35-55).
Regarding Claim 46, Hofmann teaches further comprising a sensor 38 configured to detect the jaw spacing distance between the first side-facing electrode and the second side-facing electrode (“suitable sensing unit 38 senses the distance between the electrodes and generates a signal which is transmitted via conductor cable 40 to the pulse generator” Col. 3, ll. 18-20).
Regarding Claim 47, Hofmann teaches wherein the one or more controls comprising a control configured to extend and retract the first and second side-facing electrodes from a housing 42 (Col. 3, ll. 1-22 especially “telescopic sleeve or sheath 42 covers the mechanism during insertion”).
Regarding Claim 49, Hofmann teaches wherein the first jaw and the second jaw are configured to open in parallel (Fig. 3).
Regarding Claim 51, Hofmann teaches further comprising a controller configured to adjust the plurality of electrical pulses from the pulse generator based, at least in part, on one of: a detected spacing between the first side-facing electrode and the second side-facing electrode (Col. 3, ll. 1-55); and a user provided spacing between the first side-facing electrode and the second side-facing electrode.
Regarding Claim 52, Hofmann teaches wherein the first and second side-facing electrodes are non-penetrating electrodes, penetrating electrodes, or a combination thereof (Figs. 2-3).
Regarding Claim 61, Hofmann teaches a method comprising:
detecting or setting a separation distance between a first side-facing electrode and a second side-facing electrode (a plurality of electrodes shown in Figs. 4-5) at a distal end region of an elongate applicator tool (Figs. 4-5 and Col. 3, ll. 56-Col. 4, ll. 4), the first side-facing electrode and the second side facing electrode contact a same side of a target tissue when the distal end region of the elongate applicator tool is placed against the target tissue (Col. 2, ll. 10-29, Col. 4, ll. 18-27, Figs. 4-5 and claim 12);
determining, based at least in part on the separation distance between the first and the second side-facing electrodes, an energy to be applied to the target tissue (Col. 3, ll. 23-55) in a plurality of electrical pulses having an amplitude of greater than 0.1 kV and a duration of less than 1000 nanoseconds, to treat the target tissue; and applying the energy to the first side-facing electrode and the second side-facing electrode (Figs. 4-5), please note that Hofmann teaches “The waveforms of the electrical signal provided by the generator in the power pack 36 can be an exponentially decaying pulse, a square pulse, a unipolar oscillating pulse train or a bipolar oscillating pulse train. The electric field strength can be 0.2 kV cm to 20 kV/cm. The pulse length can be ten microseconds to one hundred milliseconds. There can be one to one hundred pulses per second. Of course the waveform, electric field strength and pulse duration are dependent upon the type of cells and the type of macromolecules that are to enter the cells via electroporation” therefore, examiner takes the position that the generator is configured to generate a plurality of electric pulses having an amplitude of at least 0.1 kV; however, the duration stated seems to be greater than 1000 nanoseconds and not less than 1000 nanoseconds). Since Hofmann teaches “the waveform, electric field strength and pulse duration are dependent upon the type of cells and the type of macromolecules that are to enter the cells via electroporation” examiner takes the position that either the generator is configured to generate the plurality of electrical pulses having a duration of less than 1000 nanoseconds or in alternative, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the plurality of electrical pulses having a duration of less than 1000 nanoseconds in view of the teachings of Athos in order to generate more effective electric pulses (“Pulse lengths of between 10 and 900 nanoseconds for nsPEF have been particularly studied to be effective in stimulating an immune response. Pulse lengths of about 100 nanoseconds are of particular interest in that they are long enough to carry sufficient energy to be effective at low pulse numbers but short enough to be effective in the manner desired” [0065] of Athos).
Regarding Claim 62, Hofmann teaches further comprising adjusting or allowing to adjust the separation distance between the first side-facing electrode and the second side-facing electrode before or after detecting the separation distance between the first and second side-facing electrodes and/or transmitting the separation distance to a pulse generator (abstract and Col. 3, ll. 23-Col. 4, ll. 4).
Regarding Claim 63, Hofmann teaches wherein the first side-facing electrode is on a first jaw and a second side-facing electrode is on a second jaw, the method further comprising setting or allowing to set a closing distance between the first jaw and the second jaw (Figs. 2-3).
Claim Rejections - 35 USC § 103
Claims 48 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann in view of Athos.
Regarding Claim 48, Hofmann teaches the invention as applied above, but not wherein the elongate applicator tool is configured as a laparoscopic instrument, an endoscopic instrument, or a catheter, or for use through a channel of a laparoscope, an endoscope, or a catheter.
In the same field of invention, Athos teaches “For locations deeper within a subject, a retractable terminal can fit into a gastroscope, bronchoscope, colonoscope, or other endoscope or laparoscope. For example, a tumor in a patient's colon can be accessed and treated using a terminal within a colonoscope” [0078]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the surgical tool of Hofmann configured as a laparoscopic instrument, an endoscopic instrument, or a catheter, or for use through a channel of a laparoscope, an endoscope, or a catheter in view of the teachings of Athos in order to reach deeper locations within a subject for treatment.
Regarding Claim 64, Hofmann teaches the method as applied above, but is silent in teaching further comprising applying suction to seal the first and second side-facing electrodes to the target tissue while delivering the energy.
Athos teaches providing suction through vacuum holes 304 shown in Fig. 3 “to draw the entire tumor or a portion thereof into the chamber. The tumor is drawn so that one or more of the terminals 302 preferably penetrates the tumor” [0072]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a vacuum means to the embodiment of Figs. 4-5 of Hofmann in order to draw the tumor/target tissue closer to the needle electrodes for an easier penetration and treatment as Athos teaches.
Claims 50, 55-56 and 59-60 are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann alone or in alternative in view of Athos and further in view of Panescu et al. (US. Pub. No. 2014/0343416).
Regarding Claims 50 and 60, Hofmann teaches further comprising a proximal handle configured to be coupled to a robotic arm for computer controlled activation and/or positioning of the first and second side-facing electrodes (although Fig. 4 shows what appears to be a robotic arm, Hofmann does not specifically teach the proximal handle 28/30 in the embodiment of Figs. 2-3 is configured to be coupled to a robotic arm for computer controlled activation and/or positioning of the first and second side-facing electrodes.
In the same field of electroporation treatment Panescu teaches the use of a robotic arm 102 coupled to the treatment instrument near the operating table allowing the surgeon to view the surgical site and control the surgical instrument for easier and more precise control of the device including a control system with software programming instructions to implement some or all of the treatment methods, see Figs. 1A and 2A and [0019]-[0021], [0027]-[0028] and [0049]-[0050].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a robotic system as known in the art to carry the treatment by coupling the handle of Hofmann’s invention to a robotic arm for computer control of activation and/or positioning the instrument in the target area since it has been known to be beneficial to use these techniques to make it easier and more effective in view of the teachings of Panescu.
Regarding Claim 55, Hofmann teaches the invention as applied above, but does not teach wherein the distal end region is configured to be controllably bent to a bend angle relative to the elongate shaft and wherein the proximal handle comprises a control for selecting the bend angle.
Panescu teaches “In various other embodiments, flexible body can further house, or be integrated with cables, linkages, or other steering controls (not shown) that extend at least partially between the interface 122 and the tip 126 to controllably bend or turn the tip as shown for example by the dotted line versions of the bent tip 126, and in some embodiments control an optional end effector 132” [0032] and Fig. 1B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a flexible shaft combined with steerable mechanisms in the invention of Hofmann in order to allow easier navigation and positioning of the instrument in the target area as Panescu teaches.
Regarding Claim 56, Hofmann teaches the invention as applied above and although given the broadest reasonable interpretation one could push the electrodes 24/26 into tissue and penetrate tissue, Hofmann does not specifically teach wherein the first side-facing electrode and the second side-facing electrode comprise needle electrodes, knife electrodes or other penetrating electrodes.
Panescu teaches “some end effectors have a single working member such as a scalpel, a blade, needle, or an electrode. Other end effectors such as shown in the embodiment of FIG. 1B, have a pair or plurality of working members such as forceps, graspers, scissors, staplers, vessel sealers, biopsy tools, suturing tools, or clip appliers, for example. Examples of electrically activated or enabled end effectors include electrosurgical electrodes, ablation elements, transducers, sensors, cameras, probes, and the like” [0033].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the electrodes be penetrating electrodes for various different treatment procedures as it is known in the art in view of the teachings of Panescu.
Regarding Claim 59, Hofmann teaches the invention as applied above, but does not teach further comprising a suction inlet adjacent to the first and second side-facing electrodes. Panescu teaches “End effectors may also include conduits to convey fluids, gases or solids to perform, for example, suction, insufflation, irrigation, treatments requiring fluid delivery, accessory introduction, biopsy extraction and the like” in [0033]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a suction inlet adjacent to the first and second side-facing electrodes in order to allow suction in order to pull the target tissue closer and/or withdraw debris or biopsy tissue from the site as Panescu teaches.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794