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 .
Response to Preliminary Amendment
This Office Action is responsive to the amendment filed on 22 Apr 2026. As directed by the amendment: claims 1 and 3 have been amended, claims 17 and 21-81 have been canceled, and no claims have been added. Thus, claims 1-16 and 18-20 are presently pending in this application.
Response to Arguments
I. Rejections Under 35 U.S.C. § 112
Applicant’s arguments, see Remarks, filed 22 Apr 2026, with respect to the rejection of claim 3 under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejection of claim 3 under 35 U.S.C. 112 has been withdrawn.
II. Rejections Under 35 U.S.C. § 102
Applicant’s arguments, see Remarks, filed 22 Apr 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schroeder et al (US 20190262212 A1, previously cited), hereinafter Schroeder, as explained in further detail below.
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US 20190262212 A1, previously cited), hereinafter Schroeder.
Regarding claim 1, Schroeder teaches a system for draining cerebrospinal fluid (CSF) though a subject's neck lymphatic system (a biofluid blood flow device for assisting in moving (draining) CSF fluid through a subject's neck lymphatic system [0038]-[0046]), the system comprising:
a signal generator (a device for generating external electrical stimulation, and thus will inherently comprise a signal generator [0038]-[0040], [0043]);
a plurality of electrodes operably connected to the signal generator ([0038],[0045],[0046] appropriate voltage/current for electrical stimulation of muscles can be applied with properly positioned electrodes); and
a controller operably connected to the signal generator ([0046] a programmable control unit connected to the signal generator), the controller comprising a processor and a memory, the memory having computer-executable instructions stored thereon that, when executed by the processor ([0052] the internal controls in the control unit include microcircuitry and memory as necessary for storing data and for programming the delivery schedule, stimulation sites, and the nature of the stimulation), cause the controller to:
deliver a neuromuscular electrical stimulation signal comprising at least one burst of pulses to at least one muscle in the subject's neck ([0014],[0038]-[0040],[0058] a neuromuscular electrical stimulation signal comprising a series of pulses is delivered to contract the muscles in the neck),
wherein the neuromuscular electrical stimulation signal is configured to induce a plurality of contractions of the at least one muscle ([0038]-[0040] the neuromuscular electrical stimulation induces a plurality of muscle contractions in the neck),
wherein the contractions of the at least one muscle are configured to squeeze at least one lymph node to create a pumping force ([0038]-[0040], [0058] the contractions of the muscle in the neck squeeze the muscles in the neck, thus creating a pumping force), and
wherein the pumping force is configured to direct CSF flow in a proximal direction ([0038]-[0040], [0058] by applying external electrical stimulation to a site on that muscle contracts that muscle and in doing so, asserts pressure on a targeted vein, lymph vessel, or CSF passageway; stimulate muscles in the neck to direct CSF movement from the brain and through the neck (in a proximal direction)).
Schroeder further discloses that the plurality of electrodes is configured to be placed at "any locations on the neck or limbs at which the introduction of stimulation could affect the flow of biofluid in any artery, vein, lymph vessel, or CSF/ISF passageway" (paragraph [0040]), including "between the anterior edge of the sternocleidomastoid muscle and the occipital triangle" (paragraph [0054]).
Schroeder does not explicitly disclose that the plurality of electrodes being configured for placement at origins and insertions of one or more musculus platysma, sternocleidomastoid, or trapezius in the subject's neck.
However, it is noted that there are no limitations in the system that structurally limit the plurality of electrodes to be placed at these particular locations. The location of placement of the plurality of electrodes is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 13, Schroeder teaches the system of claim 1, wherein the neuromuscular electrical stimulation signal comprises a plurality of bursts of pulses ([0014] the biofluid flow assist device is programmed to apply an appropriate series of pulses to a target for an appropriate duration).
Regarding claim 18, Schroeder teaches the system of claim 1, wherein the plurality of electrodes are surface electrodes (fig. 5 shows patch electrode).
Claims 2-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US 20190262212 A1, previously cited), hereinafter Schroeder, in view of Sachs et al (US 20200391021 A1, previously cited), hereinafter Sachs.
Regarding claim 2, Schroeder teaches the system of claim 1. Schroeder fails to teach a burst of pulses comprising rectangular pulses. Sachs teaches the at least one burst of pulses comprises rectangular pulses (figs. 17 and 18). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Sachs because there is some teaching, suggestion, or motivation to do so. Sachs teaches that stimulation pulses may have any morphology, however, ones with sine or rectangular shapes generally are preferred ([0095]). Therefore, rectangular pulses would be well known to a person having ordinary skill in the art.
Regarding claim 3, the combination of Schroeder and Sachs teaches the system of claim 2. Sachs further teaches the rectangular pulses are monophasic or biphasic pulses (figure 18 shows biphasic, figure 21b shows monophasic).
Regarding claim 4, the combination of Schroeder and Sachs teaches the system of claim 2. Sachs further teaches each of the rectangular pulses has a duration of about 0.5-1000 usec ([0096] most pulses used in LAMES systems commonly have duration of between 200 microseconds and 1 millisecond).
Regarding claim 5, Schroeder teaches the system of claim 1. Schroeder fails to teach that the burst of pulses comprises sinusoidal pulses. Sachs teaches the at least one burst of pulses comprises sinusoidal pulses ([0091] preferred pulse shape should be either sinusoidal or square wave shaped). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Sachs because there is some teaching, suggestion, or motivation to do so. Sachs teaches that the parameters of the pulses are “selected to achieve a desired pulse contraction goal without excessive fatigue or causing muscle damage” ([0091]).
Regarding claim 6, the combination of Schroeder and Sachs teaches the system of claim 5. Sachs further teaches the sinusoidal pulses have a frequency of about 5-150 Hz ([0091] 2-10 Hz for non-tetanic pulse trains or 20-100 Hz for tetanic pulse trains, with amplitudes sufficient to induce muscle contractions and pulse durations of between 0.2 and 1 millisecond).
Regarding claim 8, Schroeder teaches the system of claim 1. Schroeder fails to teach detecting muscular contractions. Sachs teaches a sensor configured to detect muscular contractions,
wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to receive a feedback signal from the sensor, wherein the feedback signal comprises information related to a contraction state of the at least one muscle ([0023] Sensors may include muscle contraction sensors, muscle condition sensors, vital signs sensors, skin contact sensors, therapy end-point sensors, motion sensors and/or the like). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Sachs because there is some teaching, suggestion, or motivation to do so. Sachs teaches that “a plurality of sensors that provide feedback that assists in electrode selection, adjusting stimulation parameters and further may prevent the occurrence of undesirable conditions, such as temperature hotspots that may lead to burns of comatose or sedated patients” ([0010]).
Regarding claim 9, the combination of Schroeder and Sachs teaches the system of claim 8. Sachs further teaches the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to increase the magnitude of the neuromuscular stimulation signal until detecting the contraction of at least one muscle ([0102] Processor 13 receives signals from sensor 15 and patient interface unit 16, processes those signals, and provides signals to the stimulator 11 regarding when and how to stimulate nerve tissue to promote muscle contraction).
Regarding claim 10, the combination of Schroeder and Sachs teaches the system of claim 9. Sachs further teaches the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to further increase the magnitude of the neuromuscular electrical stimulation signal above a minimum current that induces the contraction of the at least one muscle ([0102] Processor 13 receives signals from sensor 15 and patient interface unit 16, processes those signals, and provides signals to the stimulator 11 regarding when and how to stimulate nerve tissue to promote muscle contraction).
Regarding claim 11, the combination of Schroeder and Sachs teaches the system of claim 10. The combination fails to teach that the electrical stimulation current is increased about 10-50% above the minimum current. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Schroeder and Sachs to specify the amount above the minimum current because it’s obvious to try (choosing from a finite number of identified, predictable solutions with a reasonable expectation of success). In order to cause a muscular contraction, the magnitude of the signal current has to be above the minimum current and the range provided of 10-50% has no specific benefit over any other range.
Regarding claim 12, the combination of Schroeder and Sachs teaches the system of claim 8. Sachs further teaches the sensor is a strain gauge ([0140] strain gauge pressure sensor).
Claims 7 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US 20190262212 A1, previously cited), hereinafter Schroeder, in view of Williams et al (US 20190201684 A1, previously cited), hereinafter Williams.
Regarding claim 7, Schroeder teaches the system of claim 1. Schroeder fails to teach the specific current delivered. Castel teaches the neuromuscular electrical stimulation signal is delivered with a current of about 10-100 mA ([0062] current amplitude that typically ranges between 25 milliamps and 140 milliamps). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Williams because it constitutes an overlapping range. According to MPEP 2144.05.I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”. Additionally, the base reference Schroeder states that appropriate voltage/current for electrical stimulation of muscles can be applied with properly positioned electrodes ([0046]). Therefore, the base reference has room for improvement and a motivation to select a customized current range.
Regarding claim 19, Schroeder teaches the system of claim 1. Schroeder fails to teach implantable electrodes. Williams teaches the plurality of electrodes are implantable electrodes ([0028] implanted intravenous electrode). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Williams because there is some teaching, suggestion, or motivation to do so. Williams teaches “the electrical stimulation is effective to attract proteins to the implanted electrode subjected to the electrical stimulation” ([0028]). While attracting proteins is not the aim of Schroeder, Williams does teach glymphatic drainage so implanting the electrodes is beneficial for the shared ultimate purpose of clearing waste product from the brain.
Regarding claim 20, the combination of Schroeder and Williams teaches the system of claim 19. Williams further teaches the signal generator is an implantable signal generator ([0110] implantable pulse generator).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US 20190262212 A1, previously cited), hereinafter Schroeder, in view of Castel et al (US 20070156182 A1, previously cited), hereinafter Castel.
Regarding claim 14, Schroeder teaches the system of claim 1. Schroeder fails to teach details of the bursts of pulses. Castel teaches the plurality of bursts of pulses is a series of about 5-50 bursts of pulses ([0079] burst frequency of approximately 0.1 Hz to 5 Hz for a duration of approximately 1 seconds to 120 seconds - multiplying frequency by duration gives the number of pulses ranging from 0.1 to 600). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Castel because it constitutes overlapping ranges and according to MPEP 2144.05.I, “a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness. In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003)”
Regarding claim 15, the combination of Schroeder and Castel teaches the system of claim 14. Castel further teaches the series is delivered at a frequency of about 0.02-1 Hz ([0079] burst frequency of approximately 0.1 Hz to 5 Hz).
Regarding claim 16, Schroeder teaches the system of claim 1. Schroeder fails to teach the time period that the electrical stimulation signal is delivered. Castel teaches the neuromuscular electrical stimulation signal is delivered for a period of about 5-60 minutes ([0079] Preferably, the frequency-sequenced pulse burst train pattern is applied to the patient for a total treatment time of approximately 1 minute to 60 minutes). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Schroeder with Castel because there is some teaching, suggestion, or motivation to do so. Castel teaches that “this therapy is also very comfortable and moderately aggressive” ([0079]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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