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 64-70 and new claims 89-100, in the reply filed on January 27, 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/21/2024, 12/20/2024, 8/18/2025, and 11/24/2025 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 64, 65, 67-70, 89, 91-96, 99, and 100 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Manogue (U.S. 2022/0212012, cited by Applicant). Regarding claim 64, Manogue discloses a method for increasing a ratio of procoagulant-to-anticoagulant activity at or near a site of bleeding in a subject (“VNS significantly shortens the reaction (r) time of blood to initiate clot formation. Moreover, VNS significantly increases thrombin generation at the injury site… VNS improves hemostasis by accelerating clot formation specifically at the site of tissue injury”, paragraph [0038], where the decreased time to clot formation and increased thrombin generation at the injury site is considered to satisfy the broadest reasonable interpretation for “increasing a ratio of procoagulant-to-anticoagulant activity at or near a site of bleeding”), the method comprising: for each respective electrode of at least one electrode, contacting skin of the subject with the respective electrode in a respective region of i) nerve structures of an auriculotemporal nerve (ATN) (“one or more electrodes configured to contact the patient's skin over the V1, V2 or V3 branch of the trigeminal nerve”, paragraph [0040]), ii) nerve structures connected to the ATN, iii) nerve structures of an auricular branch of a vagus nerve (ABVN), or iv) nerve structures connected to the ABVN (“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 applying, to each electrode of the at least one electrode, a respective stimulation pattern of at least one stimulation pattern within a frequency range from 5 to 150 Hertz (“stimulation of the vagus nerve may be applied, e.g., through the ear….This cycle may be repeated at a repetition rate of between about 0.1 Hz and 1000 Hz (e.g., 30 Hz)”, paragraph [0042]), wherein the respective stimulation pattern is configured to stimulate neural pathways leading to enervation of a spleen of the subject (“The vagus nerve is the main parasympathetic output of the autonomic nervous system, and interfaces with nearly every organ of the thorax and abdomen, including the heart, lungs, liver, and spleen.”, paragraph [0037]); wherein applying the at least one stimulation pattern over a period of time of at least one minute results in an increase in the ratio of procoagulant-to-anticoagulant activity at or near the site of bleeding in the subject (“stimulation of the vagus nerve may be applied, e.g., through the ear…a treatment duration of between 1 min and 40 min (e.g., 10 minutes, 20 minutes, or 30 minutes, etc.)”, paragraph [0042]).
Regarding claim 65, Manogue discloses that the site of bleeding is an injury site comprising at least one of a penetrating injury or a non-compressible injury (“The apparatuses and methods described herein may be suitable for therapeutically or prophylactically treating subjects suffering from or at risk from suffering from unwanted bleeding from any cause such as… injury…surgery. An unwanted bleeding treated using any of the apparatuses or methods described herein may include an internal hemorrhage or an external hemorrhage. An internal hemorrhage includes a hemorrhage in which blood is lost from the vascular system inside the body, such as into a body cavity or space. An external hemorrhage includes blood loss outside the body.”, paragraph [0056], where surgery is considered a penetrating injury and hemorrhage is considered a non-compressible injury as claimed).
Regarding claim 67, Manogue discloses that the at least one stimulation pattern is applied prior to and/or during a surgical procedure (“Controlling bleeding may include preventing and/or treating bleeding (e.g., surgical bleeding”, paragraph [0009]).
Regarding claim 68, it is respectfully submitted that the recitation “the at least one stimulation pattern is applied to reduce a likelihood of blood transfusion and/or to reduce a volume required for the blood transfusion” is directed to the intended use or intended result of the use of the method and does not patentably distinguish the method over that of the prior art.
Regarding claim 69, Manogue discloses that the at least one stimulation pattern is configured to create a transient increase in a coagulation potential of the subject (“VNS significantly increases thrombin generation at the injury site… VNS improves hemostasis by accelerating clot formation specifically at the site of tissue injury”, paragraph [0038]).
Regarding claim 70, Manogue discloses that the at least one stimulation pattern is configured to increase a rate of thrombin production at or near the site of bleeding (“VNS significantly increases thrombin generation at the injury site… VNS improves hemostasis by accelerating clot formation specifically at the site of tissue injury”, paragraph [0038]).
Regarding claim 89, Manogue discloses that applying the respective stimulation pattern comprises repeatedly i) applying over the period of time and ii) stopping the respective stimulation pattern for at least ten seconds (“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”, paragraph [0051]).
Regarding claim 91, Manogue discloses that the respective stimulation pattern comprises a variable frequency (“In some variations the frequency of stimulation is varying”, paragraph [0049]).
Regarding claim 92, Manogue discloses that the respective stimulation pattern comprises varying the variable frequency around a central frequency (“The frequency may be varied between 50 and 500 Hz”, paragraph [0049], where the central frequency would be considered 275 Hz).
Regarding claim 93, Manogue discloses that the at least one electrode comprises a plurality of electrodes, the method further comprising applying, to each electrode of a portion of the plurality of electrodes, a respective second stimulation pattern of the at least one stimulation pattern (“Stimulation may be performed using one or more patches configured to cover part of the body each containing one or more electrodes (an array of 2, 3, 4, 5, 10, or more electrodes)”, paragraph [0053], where the stimulation of the trigeminal nerve and vagus nerve of Manogue can each be considered the first or second stimulation pattern).
Regarding claim 94, Manogue discloses that to apply the respective second stimulation pattern comprises concurrently applying the respective second stimulation pattern with the respective stimulation pattern while avoiding simultaneous pulse triggering between the respective stimulation pattern and the respective second stimulation pattern (“ The pattern of concurrent stimulation for the vagus and the trigeminal may be arranged in a variety of different ways”, paragraph [0043]).
Regarding claim 95, Manogue discloses that a wearable auricular neurostimulator (WANS) comprises the at least one electrode; and contacting skin of the subject with the respective electrode comprises positioning the WANS around an auricle of the subject (see Figures 3A-4).
Regarding claim 96, Manogue discloses that applying the respective stimulation pattern comprises activating pulse generating circuitry 506 of a controller of the WANS (“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]).
Regarding claim 99, Manogue discloses that the site of bleeding is uterine bleeding (“The apparatuses and methods described herein may be suitable for therapeutically or prophylactically treating subjects suffering from or at risk from suffering from unwanted bleeding from any cause such as… childbirth”, paragraph [0056], where the unwanted bleeding during childbirth is described in paragraph [0006] as being uterine bleeding from postpartum hemorrhage).
Regarding claim 100, Manogue discloses that the at least one stimulation pattern is configured to treat abnormal uterine bleeding (AUB), heavy menstrual bleeding (HMB), and/or menorrhagia (“The apparatuses and methods described herein may be suitable for therapeutically or prophylactically treating subjects suffering from or at risk from suffering from unwanted bleeding from any cause such as… menstruation”, paragraph [0056]).
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 66 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Manogue (U.S. 2022/0212012, cited above). Regarding claim 66, Manogue discloses the invention substantially as claimed, including treating unwanted bleeding resulting from injury, surgery, internal hemorrhage, and external hemorrhage (see paragraph [0056]), but fails to disclose that the non-compressible injury is gastrointestinal bleeding. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the invention of Manogue to treat unwanted gastrointestinal bleeding, as it has been held that known work in one field of endeavor (the bleeding treatment of Manogue) may prompt variations of it for use in either the same field or a different one (treatment of gastrointestinal bleeding) based on design incentives or other market forces (the desire to treat a wider variety of bleeding disorders) if the variations are predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 90, Manogue discloses the invention substantially as claimed including that the respective stimulation pattern comprises repeatedly applying the respective stimulation pattern according to a duty cycle comprising an active period followed by an off period absent stimulation (“the trigeminal nerve stimulation has a duty cycle of >50%”, paragraph [0046]), but fails to disclose that the duty cycle is at least 90%. 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 such that the duty cycle is at least 90%, as it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05
Claims 97 and 98 are rejected under 35 U.S.C. 103 as being unpatentable over Manogue (U.S. 2022/0212012, cited above) in view of Tracey et al. (U.S. 2005/0282906). Manogue discloses the invention substantially as claimed, but fails to disclose receiving, by control circuitry from one or more sensors monitoring the subject, a plurality of sensor signals; analyzing, by the control circuitry, the plurality of sensor signals; and responsive to the analyzing, adjusting, by the control circuitry, at least one of an amplitude, a frequency, or a pulse width of the respective stimulation pattern, wherein 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 method of reducing bleed time in a subject that comprises applying electrical stimulation to a vagus nerve of a patient (“it has been shown by the inventor that electrical stimulation of the vagus nerve leads to decreased bleed time in laboratory mice”, paragraph [0009]). Additionally, Tracey teaches measuring the effect of the stimulation on prothrombin time, activated partial thromboplastin time, and activated clotting time (“Each specific test cuvette: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Activated clotting time (ACT) is a self-contained disposable test chamber preloaded with a dried preparation of chemical reagents, stabilizers and buffers.”, paragraph [0115] and Figures 5-7). It is well known in the area of electrical nerve stimulation to utilize feedback sensing whereby a plurality of sensor signals are received from the patient, analyzed, and then used to adjust the electrical nerve stimulation based on the received and analyzed sensor signals. As such, 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 receiving, by control circuitry from one or more sensors monitoring the subject, a plurality of sensor signals; analyzing, by the control circuitry, the plurality of sensor signals; and responsive to the analyzing, adjusting, by the control circuitry, at least one of an amplitude, a frequency, or a pulse width of the respective stimulation pattern, as it was known in the art that feedback in electrical nerve stimulation allows the stimulation to be fine-tuned to achieve optimal results. Furthermore, 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 measuring the effect of the stimulation on prothrombin time, activated partial thromboplastin time, and activated clotting time, in order to determine the success of the electrical nerve stimulation on the treatment of the bleeding disorder.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796