DETAILED ACTION
This office action is responsive to original claims filed on 11/26/2024. Presently, Claims 1 – 20 and 26 remain pending.
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 .
Claim Objections
Claims 1, 4, 6, 14, 16 and 18 are objected to because of the following informalities:
Claim 1, Line 4, “an nesting area” should be changed to “a nesting area”.
Claim 4, Line 2, “the group” should be changed to “a group”.
Claim 6, Line 1, “configured activate” should be changed to “configured to activate”.
Claim 8, Line 1, Claim 9, Line 1, Claim 10, Line 1, Claim 14, Line 2, and Claim 20, Line 1 recite “where”, which should be changed to “wherein”.
Claim 14, Line 1, “a repeat therapy” should be changed to “a repeated therapy”.
Claim 16, Line 2, “the group” should be changed to “a group”.
Claim 18, Line 1, “configured activate” should be changed to “configured to activate”.
Appropriate correction is required.
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of Claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 26 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
With regard to Claim 26, on Lines 7-9, “the marker is affixed to the exterior of the patient … to the internal organ from the exterior of the patient” impermissibly positively recite the human body.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-7, 9-11, 13-16, 18-19 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puleo et al (US 20210015454 A1; hereafter Puleo).
With regard to Claim 1, Puleo discloses a method of applying an energy to one or more target nerves within a patient (Puleo, Abstract; “… techniques for accurate positioning of an energy application device for neuromodulation treatment protocols. In one embodiment, a neuromodulation positioning patch is applied to a patient's skin.”), the method comprising:
providing an energy device having a marker (Puleo, Para 0004; “… neuromodulation energy application system is provided that includes a neuromodulation positioning patch.”), where the marker is detachable from the energy device and where the energy device comprises an nesting area (Puleo, Para 0052; “… the mating feature 54 … configured to couple to a complementary mating feature 90 formed in or disposed on a housing 91 of the energy application device 12.” Here the “complementary mating feature” is one nesting area of the energy device that permits coupling of the marker and the energy device.) permitting coupling of the marker and the energy device (Puleo, Para 0027; “The energy application device is coupled to a neuromodulation positioning patch 16 that is in position on a subject's skin and that holds or supports the energy application device 12 …”);
determining an area on an exterior surface of the patient that allows passage of energy from the energy device through the exterior surface to the one or more target nerves (Puleo, Para 0005; “… identifying or verifying a region of interest based on the acquired image data; determining a treatment position on the skin of the subject based on the region of interest; …”. Further in Para 0028; “… positioned via the neuromodulation positioning patch 16 on or above a subject's skin such that the energy pulses are delivered transdermally to a desired internal tissue (e., a peripheral tissue that includes one or more peripheral axon terminals).”);
affixing the marker on the area at the exterior surface (Puleo, Para 0057; “Upon identification, the neuromodulation positioning patch 16 may then be adhered into position.”);
coupling the energy device to the marker and to the patient such that the marker aligns the energy device towards the one or more target nerves (Puleo, Para 0027; “The energy application device is coupled to a neuromodulation positioning patch 16 that is in position on a subject's skin and that holds or supports the energy application device 12 at a treatment position during application of the neuromodulating energy.”);
applying energy from the energy device to the one or more target nerves through the exterior surface of the patient (Puleo, Para 0027; “The energy application device 12 is configured to receive energy pulses, e.g., via leads or wireless connection, that in use are directed to a region of interest 18 of an internal tissue or an organ of a subject … ”); and
detaching the energy device from the marker and the patient, where the marker remains affixed to the patient to permit subsequent attachment of the energy device to the marker and the patient (Puleo, Para 0049; “… in the uncoupled configuration, the neuromodulation positioning patch 16 is ready to receive either the ultrasound imaging probe 28 or an energy application device, depending on the next step in the treatment protocol.” Here the “uncoupled configuration” of the patch is when the energy device is removed and the patch remains affixed to patient.) and where the marker permits alignment of the energy device to the one or more target nerves (Puleo, Para 0025; “if a patient is prescribed a multi-dose treatment protocol that occurs over several days or weeks, the neuromodulation positioning patch may be applied to the patient at the beginning of the treatment protocol and may remain in place until the treatment protocol is complete to facilitate correct positioning of an energy application device.”).
With regard to Claim 2, Puleo discloses the method of claim 1, wherein determining the area on the exterior surface of the patient comprises noninvasive imaging (Puleo, Para 0041; “the ultrasound imaging probe 28 may be any suitable probe that is capable of acquiring image data of the internal tissue near and around the target tissue containing the region of interest 18.” Here “ultrasound imaging” is a type of noninvasive imaging.) of the patient to identify a target area containing the one or more target nerves (Puleo, Para 0040; “The operator acquires images until an image that includes the region of interest 18 is acquired. The position of the imaging probe 28 on the skin at the time of acquisition of images of the region of interest 18 may correspond to the treatment position 50.”).
With regard to Claim 3, Puleo discloses the method of claim 1, wherein the energy device comprises an ultrasound energy (Puleo, Para 0005; “… applying ultrasound energy from the ultrasound therapy probe through the treatment position to the region of interest treatment position”).
With regard to Claim 4, Puleo discloses the method of claim 1, wherein the marker comprises a sensor selected from the group consisting of a radio frequency identification (RFID) sensor and an electrical sensor (Puleo, Para 0038; “… the mating features (e.g., mating features 54, 56, 60, 62) … may also include one or more signal generators or indicators (e.g., RFID chip 57) …”. Here the disclosed mating feature 54 is a part of positioning patch 16 (i.e. the marker of the application)).
With regard to Claim 6, Puleo discloses the method of claim 1, wherein the energy device is configured activate only when the marker is coupled to the energy device (Puleo, Para 0060; “… control of the energy application device 12 may further use inputs from one or more mating features 92 to detect successful mating of the energy application device 12 and the neuromodulation positioning patch 16.” ; Page 11, Claim 12; “… the ultrasound therapy probe is configured to stop applying the neuromodulating energy when the coupling is not detected.”).
With regard to Claim 7, Puleo discloses the method of claim 1, wherein the one or more target nerves comprise a nerve selected from a group consisting of a superior ganglia of a vagus nerve, an inferior ganglia of the vagus nerve, a cervical vagus nerve, a thoracic vagus nerve, an abdominal vagus nerve, a celiac plexus nerve, a splenic nerve (Puleo, Para 0062; “the stored operating modes may include instructions for executing a set of modulation parameters associated with a particular treatment site, such as regions of interest in the liver, pancreas, gastrointestinal tract, spleen.” This disclosure explicitly indicates that the disclosed method is applicable to the spleen and other abdominal organs; these organs involve at least splenic nerve and abdominal vagus nerve.).
With regard to Claim 9, Puleo discloses the method of claim 1, where the energy device comprises one or more actuators to reposition the energy device in response to movement of the patient (Puleo, Para 0033; “… in addition to handheld configurations, the energy application device 12 may include steering mechanisms responsive to instructions from the controller 20. The steering mechanisms may orient or direct the energy application device 12 towards the region of interest 18, and the controller 20 may then focus the energy application onto the region of interest 18.”; further in Para 0040; “additional imaging data may be desired to verify the treatment position 50 and/or to acquire information for fine steering of the therapy probe.”).
With regard to Claim 10, Puleo discloses the method of claim 1, where applying energy from the energy device comprises applying a series of energy treatments to stimulate the one or more target nerves (Puleo, Para 0032; “the modulation parameters may include various stimulation time patterns, ranging from continuous to intermittent … The application frequency may be continuous or delivered at various time periods, for example, within a day or week.”) and varying a dosing parameter of one or more of the series of energy treatments to prevent nerve adaption of the one or more target nerves (Puleo, Para 0032; “The application of energy, in accordance with modulation parameters, such as the treatment duration, frequency, and amplitude, may be adjustably controlled to achieve a desired result.”).
With regard to Claim 11, Puleo discloses the method of claim 10, wherein varying the dosing parameter comprises altering a frequency of one or more of the series of energy treatments (Puleo, Para 0032; “The application of energy, in accordance with modulation parameters, such as the treatment duration, frequency, and amplitude, may be adjustably controlled to achieve a desired result.”).
With regard to Claim 13, Puleo discloses the method of claim 10, wherein varying the dosing parameter comprises altering frequency of one or more of the series of energy treatments (Puleo, Para 0032; “The application of energy, in accordance with modulation parameters, such as the treatment duration, frequency, and amplitude, may be adjustably controlled to achieve a desired result.”).
With regard to Claim 14, Puleo discloses a method of performing a repeat therapy to treat one or more target nerves with energy (Puleo, Abstract; “… techniques for accurate positioning of an energy application device for neuromodulation treatment protocols.”) (Puleo, Para 0032; “… treatment duration with a specified stimulation pattern may last for one hour, repeated at, e.g., 72 hour intervals”), where a marker is affixed to a patient such that the marker is previously positioned on an exterior surface of the patient in alignment with the one or more target nerves within the patient (Puleo, Para 0025; “if a patient is prescribed a multi-dose treatment protocol that occurs over several days or weeks, the neuromodulation positioning patch may be applied to the patient at the beginning of the treatment protocol and may remain in place until the treatment protocol is complete to facilitate correct positioning of an energy application device.”), the method comprising:
coupling an energy device to the marker such that the marker aligns the energy device with the one or more target nerves (Puleo, Para 0027; “The energy application device is coupled to a neuromodulation positioning patch 16 that is in position on a subject's skin and that holds or supports the energy application device 12 at a treatment position during application of the neuromodulating energy.”);
applying energy from the energy device to the one or more target nerves through the exterior surface of the patient (Puleo, Para 0027; “The energy application device 12 is configured to receive energy pulses, e.g., via leads or wireless connection, that in use are directed to a region of interest 18 of an internal tissue or an organ of a subject … ”); and
detaching the energy device from the marker and the patient, where the marker remains affixed to the patient to permit subsequent attachment of the energy device to the marker and the patient (Puleo, Para 0049; “… in the uncoupled configuration, the neuromodulation positioning patch 16 is ready to receive either the ultrasound imaging probe 28 or an energy application device, depending on the next step in the treatment protocol.” Here the “uncoupled configuration” of the patch is when the energy device is removed and the patch remains affixed to patient.) and where the marker permits alignment of the energy device to the one or more target nerves (Puleo, Para 0025; “if a patient is prescribed a multi-dose treatment protocol that occurs over several days or weeks, the neuromodulation positioning patch may be applied to the patient at the beginning of the treatment protocol and may remain in place until the treatment protocol is complete to facilitate correct positioning of an energy application device.”).
With regard to Claim 15, Puleo discloses the method of claim 14, wherein the energy device comprises an ultrasound energy (Puleo, Para 0005; “… applying ultrasound energy from the ultrasound therapy probe through the treatment position to the region of interest treatment position”).
With regard to Claim 16, Puleo discloses the method of claim 14, wherein the marker comprises a sensor selected from the group consisting of a radio frequency identification (RFID) sensor and an electrical sensor (Puleo, Para 0038; “… the mating features (e.g., mating features 54, 56, 60, 62) … may also include one or more signal generators or indicators (e.g., RFID chip 57) …”. Here the disclosed mating feature 54 is a part of positioning patch 16 (i.e. the marker of the application)).
With regard to Claim 18, Puleo discloses the method of claim 14, wherein the energy device is configured activate only when the marker is coupled to the energy device (Puleo, Para 0060; “… control of the energy application device 12 may further use inputs from one or more mating features 92 to detect successful mating of the energy application device 12 and the neuromodulation positioning patch 16.” ; Page 11, Claim 12; “… the ultrasound therapy probe is configured to stop applying the neuromodulating energy when the coupling is not detected.”).
With regard to Claim 19, Puleo discloses the method of claim 14, wherein the one or more target nerves comprise a nerve selected from a group consisting of a superior ganglia of a vagus nerve, an inferior ganglia of the vagus nerve, a cervical vagus nerve, a thoracic vagus nerve, an abdominal vagus nerve, a celiac plexus nerve, and a splenic nerve (Puleo, Para 0062; “the stored operating modes may include instructions for executing a set of modulation parameters associated with a particular treatment site, such as regions of interest in the liver, pancreas, gastrointestinal tract, spleen.” This disclosure explicitly indicates that the disclosed method is applicable to the spleen and other abdominal organs; these organs involve at least splenic nerve and abdominal vagus nerve.).
With regard to Claim 26, Puleo discloses a system for providing a repeated therapy (Puleo, Para 0032; “… treatment duration with a specified stimulation pattern may last for one hour, repeated at, e.g., 72 hour intervals”) to an internal organ within a patient (Puleo, Para 0027; “the disclosed neuromodulation techniques may be used in conjunction with a neuromodulation system configured to be used to administer neuromodulating energy as part of a treatment protocol.”), the system comprising:
a marker configured to be affixed to an exterior of the patient (Puleo, Para 0057; “Upon identification, the neuromodulation positioning patch 16 may then be adhered into position.”); and
an energy device having an energy treatment portion (Puleo, Para 0027; “The depicted system includes a pulse generator 14 coupled to an energy application device 12 (e.g., an ultrasound therapy probe).”) and having a fastener configured to permit securing of the energy device to an exterior of the patient (Puleo, Para 0027; “… a neuromodulation positioning patch 16 that is in position on a subject's skin and that holds or supports the energy application device 12 at a treatment position …”), the energy device further including a mating surface to couple the marker and the energy device (Puleo, Para 0052; “… the mating feature 54 … configured to couple to a complementary mating feature 90 formed in or disposed on a housing 91 of the energy application device 12.” Here the “complementary mating feature” is one nesting area of the energy device that permits coupling of the marker and the energy device.), such that when the marker is affixed to the exterior of the patient the energy device can be coupled to the marker allowing for automatic alignment of the energy treatment portion to the internal organ from the exterior of the patient (Puleo, Para 0027; “The energy application device is coupled to a neuromodulation positioning patch 16 that is in position on a subject's skin and that holds or supports the energy application device 12 at a treatment position during application of the neuromodulating energy. The energy application device 12 is configured to receive energy pulses, e.g., via leads or wireless connection, that in use are directed to a region of interest 18 of an internal tissue or an organ of a subject.”).
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 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Puleo in view of Sato et al (US 10413757 B2; hereafter Sato).
With regard to Claim 5, Puleo discloses all the limitations of Claim 1 as discussed above. Puleo does not clearly and explicitly disclose wherein the marker is configured to be magnetically coupled to the energy device.
Sato in the same field of endeavor discloses wherein the marker (couplant assembly) is configured to be magnetically coupled to the energy device (ultrasound transducers) (Sato, Column 14, Lines 14-25; “… a part of the couplant assembly is configured for attachment to an assembly that includes one or more ultrasound transducers … In general, any mechanism for attachment is suitable and may include sleeves, brackets, clips, tabs, magnetism, …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo, as suggested by Sato, in order to couple the marker and the energy device using magnetic means. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably coupling of the marker and the energy device and at the same time easy operation by users (Sato, Column 14, Lines 16-19; “In some embodiments, a component of the system holds the couplant or couplant assembly in contact with the transducer and is configured to be removed and replaced by the user.”).
With regard to Claim 17, Puleo discloses all the limitations of Claim 14 as discussed above. Puleo does not clearly and explicitly disclose wherein the marker is configured to be magnetically coupled to the energy device.
Sato in the same field of endeavor discloses wherein the marker (couplant assembly) is configured to be magnetically coupled to the energy device (ultrasound transducers) (Sato, Column 14, Lines 14-25; “… a part of the couplant assembly is configured for attachment to an assembly that includes one or more ultrasound transducers … In general, any mechanism for attachment is suitable and may include sleeves, brackets, clips, tabs, magnetism, …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo, as suggested by Sato, in order to couple the marker and the energy device using magnetic means. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably coupling of the marker and the energy device and at the same time easy operation by users (Sato, Column 14, Lines 16-19; “In some embodiments, a component of the system holds the couplant or couplant assembly in contact with the transducer and is configured to be removed and replaced by the user.”).
Claims 8, 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Puleo in view of Hamner et al (US 20210379374 A1; hereafter Hamner).
With regard to Claim 8, Puleo discloses all the limitations of Claim 1 as discussed above. Puleo does not clearly and explicitly disclose wherein the energy device is configured to monitor a respiration cycle of the patient.
Hamner in the same field of endeavor discloses wherein the energy device is configured to monitor a respiration cycle of the patient (Hamner, Para 0019; “… the respiration cycle by measurements from a sensor that detects events or phases of the respiratory cycle.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo, as suggested by Hamner, in order to monitor a respiration cycle of the patient. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved therapeutic benefit by applying neuromodulation at certain portion of respiration cycle (Hamner, Para 0056; “The stimulation can be advantageously correlated to the detected respiration phase, such as exhalation, providing potential synergistically increased effect of the stimulation and thus improved therapeutic benefit.”).
With regard to Claim 12, Puleo discloses all the limitations of Claim 11 as discussed above. Puleo does not clearly and explicitly disclose wherein altering the frequency comprises altering the frequency in a fixed step rate or a random step rate.
Hamner in the same field of endeavor discloses wherein altering the frequency comprises altering the frequency in a fixed step rate or a random step rate (Hamner, Para 0115; “Intraburst frequency can also be varied in a random or pseudorandom fashion during the burst to reduce habituation and/or increase comfort”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo, as suggested by Hamner, in order to alter the frequency in a fixed step or random step rate. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving treatment effect by preventing habituation of nerves to constant stimulations (Hamner, Para 0126; “Rhythmic or pseudorandom bursting patterns can prevent habituation of nerves, which occurs with constant stimulation.”).
With regard to Claim 20, Puleo discloses all the limitations of Claim 14 as discussed above. Puleo does not clearly and explicitly disclose wherein the energy device is configured to monitor a respiration cycle of the patient.
Hamner in the same field of endeavor discloses wherein the energy device is configured to monitor a respiration cycle of the patient (Hamner, Para 0019; “… the respiration cycle by measurements from a sensor that detects events or phases of the respiratory cycle.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo, as suggested by Hamner, in order to monitor a respiration cycle of the patient. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved therapeutic effect by applying neuromodulation at certain portion of respiration cycle (Hamner, Para 0056; “The stimulation can be advantageously correlated to the detected respiration phase, such as exhalation, providing potential synergistically increased effect of the stimulation and thus improved therapeutic benefit.”).
Conclusion
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798