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 without traverse of Group I, claims 1-14, in the reply filed on September 8, 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/20/2024, 3/18/2025, 06/03/2025, 10/28/2025, 11/24/2025, and 3/30/2026 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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.
(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 1-4 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manogue (U.S. 2020/0094055, cited by Applicant). Regarding claim 1, Manogue discloses a system, the system comprising :a wearable auricular neurostimulator (WANS) configured to wrap around an auricle of the subject (see Figures 3A-4), the WANS comprising at least one electrode 107/307/407/507, including i) one or more auriculotemporal nerve (ATN) electrodes configured to contact, when the WANS is worn by the subject, a respective region of skin of the subject for placing the at least one electrode in electrical communication with nerve structures of or leading to the auriculotemporal nerve (“the electrical vagus nerve stimulators may apply electrical stimulation from one or more electrodes on the surface of the patient's skin (e.g., the auricular region of the ear).”, paragraph [0040], where stimulation applied to the surface of the patient’s skin in the auricular region of the ear is considered to be placement “in electrical communication with nerve structures of or lead to the auriculotemporal nerve”), and/or ii) one or more auricular branch of the vagus nerve (ABVN) electrodes configured to contact, when the WANS is worn by the subject, a respective region of skin of the subject for placing the at least one electrode in electrical communication with nerve structures of or leading to the auricular branch of the vagus nerve (“the electrical vagus nerve stimulators may apply electrical stimulation from one or more electrodes on the surface of the patient's skin (e.g., the auricular region of the ear).”, paragraph [0040]); and pulse generating circuitry 101/302/402/506 configured to deliver electrical neurostimulation via the at least one electrode (“the controller 502 may be separate from or integrated with one or more drivers 510 and waveform generators 506 that may generate and provide power to the trigeminal stimulator (e.g., shown here as a trigeminal electrode 508) and vagus stimulator (shown as a vagus electrode 507)”, paragraph [0067]), wherein delivering the electrical neurostimulation comprises for each respective ATN electrode of the one or more ATN electrodes, causing the respective ATN electrode to output a first stimulation pattern within a first frequency range from 70 to 150 Hertz, and/or for each respective ABVN electrode of the one or more ABVN electrodes, causing the respective ABVN electrode to output a second stimulation pattern within a second frequency range from 5 to 30 Hertz (“Concurrently stimulation of the vagus nerve may be applied, e.g., through the ear. For example, stimulation of between about 0.1-10V, 0.1-10 mA, pulsed, e.g., rectangular pulses, for a burst duration that is continuous or repeating, with pulses having a duration of between 0.1 ms and 10 ms (e.g., 2 milliseconds). This cycle may be repeated at a repetition rate of between about 0.1 Hz and 1000 Hz (e.g., 30 Hz)”, paragraph [0042]). It is respectfully submitted that the recitation in the preamble of “for triggering a higher platelet activation rate into procoagulant types at an injury site in a subject” fails to further define the claimed invention over that of the prior art because it is directed to an intended use of the system rather than further defining a further structural aspect of the system. Furthermore, the recitation “wherein the electrical neurostimulation is configured to trigger the higher platelet activation rate into procoagulant types in the subject” fails to further define the claimed invention over that of the prior art because it is directed to the result of the electrical neurostimulation and as long as neurostimulation is provided that includes the claimed stimulation parameters, it is respectfully submitted that such stimulation would achieve the results as recited.
Regarding claim 2, it is respectfully submitted that the recitation “the electrical neurostimulation is delivered prior to donating platelets such that the donated platelets include a higher ratio of primed platelets” fails to further define the claimed system over that of the prior art because it is directed to a method by which the system is used (i.e. stimulation applied before donating platelets) rather than further defining the system itself.
Regarding claim 3, Manogue discloses that the first stimulation pattern comprises a frequency of 100 Hertz; and the second stimulation pattern comprises a frequency of 30 Hz (“Concurrently stimulation of the vagus nerve may be applied, e.g., through the ear. For example, stimulation of between about 0.1-10V, 0.1-10 mA, pulsed, e.g., rectangular pulses, for a burst duration that is continuous or repeating, with pulses having a duration of between 0.1 ms and 10 ms (e.g., 2 milliseconds). This cycle may be repeated at a repetition rate of between about 0.1 Hz and 1000 Hz (e.g., 30 Hz)”, paragraph [0042]).
Regarding claim 4, Manogue discloses that at least one of the one or more ABVN electrodes, when the WANS is worn by the subject, is in electrical communication with the Arnold's Nerve (“the electrical vagus nerve stimulators may apply electrical stimulation from one or more electrodes on the surface of the patient's skin (e.g., the auricular region of the ear).”, paragraph [0040], where the Arnold’s Nerve is known to be the auricular branch of the vagus nerve and, thus, an electrode placed in electrical communication with the auricular branch of the vagus nerve, like Manogue, is likewise placed in electrical communication with the Arnold’s Nerve).
Regarding claim 11, Manogue discloses that the pulse generating circuitry is configured to deliver the electrical neurostimulation repeatedly on a periodic basis (“Multiple stimulation periods may be separated by an “off period” extending for hours or even days, as mentioned above.”, paragraph [0049]).
Regarding claim 12, Manogue discloses that delivering the electrical neurostimulation repeatedly on a periodic basis comprises delivering the electrical neurostimulation according to a duty cycle comprising an active period of at least 1 minute followed by ceasing delivery of the electrical neurostimulation for at least 10 seconds (“In performing any of the therapies described herein, the non-invasive stimulation may be scheduled or timed in a specific manner. For example, a period of stimulation (“on stimulation”) may be followed by a period during which stimulation is not applied (“off period”). The off period may be much longer than the on period. For example, the off period may be greater than an hour, greater than two hours, greater than four hours, greater than 8 hours, greater than 12 hours, greater than 24 hours, or greater than 2 days. The on period is the duration of a stimulation (which may include a frequency component), and may be less than 10 minutes, less than 5 minutes, less than 2 minutes, less than 1 minute, etc. The ratio of the on period and the off period may partially determine the duty cycle of stimulation.”, paragraph [0051]).
Regarding claim 13, Manogue discloses that delivering the electrical neurostimulation repeatedly on a periodic basis comprises delivering the electrical neurostimulation according to a duty cycle comprising at least a 90% active period followed by an off period absent stimulation (“Multiple stimulation periods may be separated by an “off period” extending for hours or even days, as mentioned above.”, paragraph [0049]).
Claims 1-5, 8, 10, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khodaparast et al. (U.S. 2020/0238085, cited by Applicant), herein Khodaparast. Regarding claim 1, Khodaparast discloses a system, the system comprising: a wearable auricular neurostimulator 200/280/300/340/350/400/500/600/800 (WANS) configured to wrap around an auricle of the subject (see Figures 2A-8A), the WANS comprising at least one electrode 220-228/282/503a-d, including i) one or more auriculotemporal nerve (ATN) electrodes configured to contact, when the WANS is worn by the subject, a respective region of skin of the subject for placing the at least one electrode in electrical communication with nerve structures of or leading to the auriculotemporal nerve (“an electrode 222 configured to be in proximity to a neural structure related to the auriculotemporal nerve”, paragraph [0080]), and/or ii) one or more auricular branch of the vagus nerve (ABVN) electrodes configured to contact, when the WANS is worn by the subject, a respective region of skin of the subject for placing the at least one electrode in electrical communication with nerve structures of or leading to the auricular branch of the vagus nerve (“an electrode configured to be in proximity to vagal related neural structures” and “an electrode configured to be in proximity to neural structures related to the great auricular nerve and/or its branches”, paragraph [0080]); and pulse generating circuitry 210 configured to deliver electrical neurostimulation via the at least one electrode (“the pulse generator 210 includes a battery, circuitry configured to produce therapy stimulation in communication with the electrodes of the auricular component 201”, paragraph [0091]), wherein delivering the electrical neurostimulation comprises for each respective ATN electrode of the one or more ATN electrodes, causing the respective ATN electrode to output a first stimulation pattern within a first frequency range from 70 to 150 Hertz (“a second of high frequency of between 70 and 150 Hz…is used at tissue surrounding the ear, such as the auriculotemporal electrode 222”, paragraph [0137]), and/or for each respective ABVN electrode of the one or more ABVN electrodes, causing the respective ABVN electrode to output a second stimulation pattern within a second frequency range from 5 to 30 Hertz (“a first or low frequency of between 1 to 30 Hz, or in particular one or more of…5 to 10 Hz, 10 to 15 Hz, 15 to 20 Hz, 20 to 25 Hz, 25 to 30 Hz may be used at an in-ear electrode such as the cymba electrode 204”, paragraph [0137]). It is respectfully submitted that the recitation in the preamble of “for triggering a higher platelet activation rate into procoagulant types at an injury site in a subject” fails to further define the claimed invention over that of the prior art because it is directed to an intended use of the system rather than further defining a further structural aspect of the system. Furthermore, the recitation “wherein the electrical neurostimulation is configured to trigger the higher platelet activation rate into procoagulant types in the subject” fails to further define the claimed invention over that of the prior art because it is directed to the result of the electrical neurostimulation and as long as neurostimulation is provided that includes the claimed stimulation parameters, it is respectfully submitted that such stimulation would achieve the results as recited.
Regarding claim 2, it is respectfully submitted that the recitation “the electrical neurostimulation is delivered prior to donating platelets such that the donated platelets include a higher ratio of primed platelets” fails to further define the claimed system over that of the prior art because it is directed to a method by which the system is used (i.e. stimulation applied before donating platelets) rather than further defining the system itself.
Regarding claim 3, Khodaparast discloses that the first stimulation pattern comprises a frequency of 100 Hertz (“Therapy included…High frequency (100 Hz) between the auriculotemporal electrode 222 and electrode 226.”, paragraph [0151]); and the second stimulation pattern comprises a frequency of 30 Hz.
Regarding claim 4, Khodaparast discloses that at least one of the one or more ABVN electrodes, when the WANS is worn by the subject, is in electrical communication with the Arnold's Nerve (“an electrode configured to be in proximity to vagal related neural structures” and “an electrode configured to be in proximity to neural structures related to the great auricular nerve and/or its branches”, paragraph [0080], where the Arnold’s Nerve is known to be the auricular branch of the vagus nerve and, thus, an electrode placed in electrical communication with the auricular branch of the vagus nerve, like Khodaparast, is likewise placed in electrical communication with the Arnold’s Nerve).
Regarding claim 5, Khodaparast discloses control circuitry configured to: receive, from one or more sensors monitoring the subject during the electrical neurostimulation, a plurality of sensor signals; analyze the plurality of sensor signals; and responsive to the analyzing, adjust at least one of a frequency and a pulse width of the first stimulation pattern and/or the second stimulation pattern (see paragraph [0145]).
Regarding claim 8, Khodaparast discloses that a diagnostic device comprises the one or more sensors; and receiving the plurality of sensor signals comprises receiving, from the diagnostic device, the plurality of sensor signals (see paragraph [0145]).
Regarding claim 10, Khodaparast discloses that the plurality of sensor signals comprises signals related to pupil measurements (“In other embodiments, imaging of pupillary changes (e.g., pupillary dilation) using, for example a common cellular phone and/or smart-glass glasses could be used to provide feedback to make therapy adjustments.”, paragraph [0145]).
Regarding claim 11, Khodaparast discloses that the pulse generating circuitry is configured to deliver the electrical neurostimulation repeatedly on a periodic basis (“ the therapy of the method 1401, including both the first stimulation 1402 and the second stimulation 1404 may be delivered for a first period of time, and the therapy of the method 1490 including both the first stimulation 1492 and the second stimulation 1494 may be delivered for a second period of time. The combined methods may be repeated for a number of cycles of the first period of time and the second period of time. ”, paragraph [0127]).
Regarding claim 14, Khodaparast discloses that the pulse generating circuitry is further configured to deliver the first stimulation pattern concurrently with the second stimulation pattern while avoiding simultaneous pulse triggering between the first stimulation pattern and the second stimulation pattern (see paragraph [0133]).
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.
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 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Manogue (U.S. 2020/0094055, cited above) in view of Tracey et al. (U.S. 2018/0021217). Manogue discloses the invention substantially as claimed, but fails to disclose control circuitry configured to: receive, from one or more sensors monitoring the subject during the electrical neurostimulation, a plurality of sensor signals; analyze the plurality of sensor signals; and responsive to the analyzing, adjust at least one of a frequency and a pulse width of the first stimulation pattern and/or the second stimulation pattern, wherein the one or more sensors comprises a thrombin concentration measurement sensor, a microfluidic chip comprises the one or more sensors, a diagnostic device comprises the one or more sensors; and receiving the plurality of sensor signals comprises receiving, from the diagnostic device, the plurality of sensor signals, or the one or more sensors are configured to measure prothrombin time, partial thromboplastin time, activated partial thromboplastin time, and/or activated clotting time. Tracey teaches a system for stimulating a subject’s inflammatory reflex to reduce bleed time (see Abstract) that includes an auricular stimulation device 2901 configured to wrap around an auricle of a subject (see Figure 29B) and including control circuitry configured to: receive, from one or more sensors monitoring the subject during the electrical neurostimulation, a plurality of sensor signals (“the stimulator receives feedback from one or more sensors. In particular, sensors for determining the level of one or more markers for inflammation may be useful to provide to help control or monitor stimulation”, paragraph [0117]); analyze the plurality of sensor signals; and responsive to the analyzing, adjust at least one of a frequency and a pulse width of the first stimulation pattern and/or the second stimulation pattern (“The systems and devices described herein may also include a controller that adjusts the treatment based upon user compliance and/or feedback.”, paragraph [0016], and “the stimulator receives feedback from one or more sensors. In particular, sensors for determining the level of one or more markers for inflammation may be useful to provide to help control or monitor stimulation”, paragraph [0117]), wherein the one or more sensors comprises a thrombin concentration measurement sensor (see paragraph [0248]), a microfluidic chip comprises the one or more sensors, a diagnostic device comprises the one or more sensors; and receiving the plurality of sensor signals comprises receiving, from the diagnostic device, the plurality of sensor signals, or the one or more sensors are configured to measure prothrombin time, partial thromboplastin time, activated partial thromboplastin time, and/or activated clotting time (see paragraph [0248]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Manogue to include control circuitry configured to: receive, from one or more sensors monitoring the subject during the electrical neurostimulation, a plurality of sensor signals; analyze the plurality of sensor signals; and responsive to the analyzing, adjust at least one of a frequency and a pulse width of the first stimulation pattern and/or the second stimulation pattern, wherein the one or more sensors comprises a thrombin concentration measurement sensor, a microfluidic chip comprises the one or more sensors, a diagnostic device comprises the one or more sensors; and receiving the plurality of sensor signals comprises receiving, from the diagnostic device, the plurality of sensor signals, or the one or more sensors are configured to measure prothrombin time, partial thromboplastin time, activated partial thromboplastin time, and/or activated clotting time, as taught by Tracey, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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