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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
All of claims 24-29 depend from apparatus claim 15. Each of these claims recite method steps (e.g., “controlling,” “activating,” and “applying”), rendering it unclear what, if any, limitations these claims place on the apparatus of claim 15. As all pending claims are apparatus claims, the examiner is considering the claims to require an apparatus capable of this use, but clarification is respectfully requested, including whether these claims do in fact impart a structural limitation on the apparatus.
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 15-30 and 33-36 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Tracey et al. (US 2018/0021217, hereinafter “Tracey I”).
In regards to claim 15, Tracey I discloses a system for controlling bleeding in a subject through neural stimulation, the system comprising:
1) at least one mechanical applicator (Fig. 25), each mechanical applicator of the at least one mechanical applicator being configured to apply non-invasive mechanical stimulation (par. 0081) to a respective region of one or more regions of a trigeminal nerve (par. 0083) of the subject via a respective skin surface of a face or an ear of the subject (par. 0018); and
2) a generator configured to deliver energy to each mechanical applicator of the at least one mechanical applicator for generating the non-invasive mechanical stimulation (par. 0081) at a predetermined (par. 0027) frequency for a predetermined period of time of at least one minute (pars. 0018-0019, 0124, 0130, 0160), thereby activating the trigeminal nerve to control bleeding (par. 0016).
In regards to claim 16, the at least one mechanical applicator comprises at least one ultrasound transducer (par. 0220).
In regards to claim 17, the non-invasive mechanical stimulation applied by each mechanical applicator of the at least one mechanical applicator applies acoustic energy to the respective region of the trigeminal nerve (par. 0103).
In regards to claim 18, the non-invasive mechanical stimulation delivers continuous mechanical pressure (par. 0099, “The force with which the mechanical stimulation is applied may also be constant”).
In regards to claim 19, the non-invasive mechanical stimulation delivers variable force (par. 0099, “The force with which the mechanical stimulation is applied may also be constant, or it may be variably”).
In regards to claim 20, the non-invasive mechanical stimulation is delivered at variable frequency (par. 0099, “Varying the force and/or frequency may be beneficial to ensure that the mechanical stimulation is effective”).
In regards to claim 21, the predetermined frequency is within a range spanning from 0.1 Hz to 500 Hz (par. 0109, “e.g., 50-500 Hz”).
In regards to claim 22, the predetermined period of time is at least 10 minutes (par. 0160, “ten minutes”).
In regards to claim 23, the one or more regions of the trigeminal nerve comprise at least one of a nucleus associated with the trigeminal nerve or a ganglion associated with the trigeminal nerve (par. 0083, “ganglions”).
In regards to claim 24 (as best understood), Tracey I’s system necessarily controls bleeding comprising improving hemostasis via accelerated clot formation as it applies stimulation at a frequency and duration disclosed by Applicant as providing this effect.
In regards to claim 25 (as best understood), Tracey I’s system is capable of activating the trigeminal nerve to control bleeding comprising activating the trigeminal nerve prior to bleeding for prophylactically treating the subject as it is a handheld or wearable system (par. 0081) that can be applied whenever the user desires.
In regards to claim 26 (as best understood), controlling bleeding comprises reducing a bleed time by greater than 20% (expressly disclosed at par. 0164, and necessarily providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 27 (as best understood), controlling bleeding comprises reducing a volume of blood loss by greater than 20% (Tracey I’s system necessarily provides this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 28 (as best understood), controlling bleeding comprises reducing at least one of a bleed time or a bleed volume in presence of an anticoagulant in the subject (Tracey I’s system is necessarily capable of providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 29 (as best understood), applying the non-invasive mechanical stimulation comprises continuously delivering the non-invasive mechanical stimulation until bleeding is controlled (Tracey I’s system is necessarily capable of providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect and can be used as long as the user desires).
In regards to claim 30, a wearable structure comprises the at least one mechanical applicator (pars. 0111-0112).
In regards to claim 33, the wearable structure is configured to be worn on a head of the subject (par. 0111, “ear”).
In regards to claim 34, the system further comprises at least one input control for activating, by the subject, the generator (par. 0027, “The input may be control input (e.g., from a physician or the patient) that modifies the treatment”).
In regards to claim 35, the system further comprises at least one sensor for detecting a condition of the subject (par. 0105, sensor for detecting force; par. 0111, sensor to detect successful delivery of stimulation; pars. 0117-0118, variety of sensors for feedback).
In regards to claim 36, the at least one sensor is in wired communication with a stimulator device comprising the generator and the at least one mechanical applicator (Figs. 31A-31B, par. 0118).
Claims 15, 17-30 and 33-36 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Tracey et al. (US 2008/0249439, hereinafter “Tracey II”).
In regards to claim 15, Tracey II discloses a system for controlling bleeding in a subject through neural stimulation (pars. 0013, 0068, 0151; Tracey II is capable of applying mechanical stimulation to the trigeminal nerve at a frequency and duration disclosed by Applicant as providing this effect), the system comprising:
1) at least one mechanical applicator (Fig. 25), each mechanical applicator of the at least one mechanical applicator being configured to apply non-invasive mechanical stimulation (par. 0013) to a respective region of one or more regions of a trigeminal nerve (par. 0068) of the subject via a respective skin surface of a face or an ear of the subject (par. 0013); and
2) a generator configured to deliver energy to each mechanical applicator of the at least one mechanical applicator for generating the non-invasive mechanical stimulation (par. 0068) at a predetermined (par. 0023) frequency for a predetermined period of time of at least one minute (pars. 0023-0024, 0151), thereby activating the trigeminal nerve to control bleeding (Tracey’s device is capable of this effect as it is capable of applying mechanical stimulation to the trigeminal nerve at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 17, the non-invasive mechanical stimulation applied by each mechanical applicator of the at least one mechanical applicator applies acoustic energy to the respective region of the trigeminal nerve (par. 0093).
In regards to claim 18, the non-invasive mechanical stimulation delivers continuous mechanical pressure (par. 0085, “The force with which the mechanical stimulation is applied may also be constant”).
In regards to claim 19, the non-invasive mechanical stimulation delivers variable force (par. 0085, “The force with which the mechanical stimulation is applied may also be constant, or it may be variably”).
In regards to claim 20, the non-invasive mechanical stimulation is delivered at variable frequency (par. 0085, “Varying the force and/or frequency may be beneficial to ensure that the mechanical stimulation is effective”).
In regards to claim 21, the predetermined frequency is within a range spanning from 0.1 Hz to 500 Hz (par. 0013, “e.g., 50-500 Hz”).
In regards to claim 22, the predetermined period of time is at least 10 minutes (par. 0151, “ten minutes”).
In regards to claim 23, the one or more regions of the trigeminal nerve comprise at least one of a nucleus associated with the trigeminal nerve or a ganglion associated with the trigeminal nerve (par. 0068, “ganglions”).
In regards to claim 24 (as best understood), Tracey II’s system necessarily controls bleeding comprising improving hemostasis via accelerated clot formation as it applies stimulation at a frequency and duration disclosed by Applicant as providing this effect.
In regards to claim 25 (as best understood), Tracey II’s system is capable of activating the trigeminal nerve to control bleeding comprising activating the trigeminal nerve prior to bleeding for prophylactically treating the subject as it is a handheld or wearable system (par. 0081) that can be applied whenever the user desires.
In regards to claim 26 (as best understood), controlling bleeding comprises reducing a bleed time by greater than 20% (necessarily providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 27 (as best understood), controlling bleeding comprises reducing a volume of blood loss by greater than 20% (Tracey II’s system necessarily provides this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 28 (as best understood), controlling bleeding comprises reducing at least one of a bleed time or a bleed volume in presence of an anticoagulant in the subject (Tracey II’s system is necessarily capable of providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect).
In regards to claim 29 (as best understood), applying the non-invasive mechanical stimulation comprises continuously delivering the non-invasive mechanical stimulation until bleeding is controlled (Tracey II’s system is necessarily capable of providing this effect as the system applies stimulation at a frequency and duration disclosed by Applicant as providing this effect and can be used as long as the user desires).
In regards to claim 30, a wearable structure comprises the at least one mechanical applicator (pars. 0011, 0031).
In regards to claim 33, the wearable structure is configured to be worn on a head of the subject (par. 0013, “ear”).
In regards to claim 34, the system further comprises at least one input control for activating, by the subject, the generator (par. 0023, “The input may be control input (e.g., from a physician or the patient) that modifies the treatment”).
In regards to claim 35, the system further comprises at least one sensor for detecting a condition of the subject (par. 0095, sensor for detecting force; par. 0101, sensor to detect successful delivery of stimulation; pars. 0107-0108, variety of sensors for feedback).
In regards to claim 36, the at least one sensor is in wired communication with a stimulator device comprising the generator and the at least one mechanical applicator (Figs. 31A-31B, par. 0108).
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.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tracey II in view of Sullivan et al. (US 2017/0165485, hereinafter “Sullivan”). Tracey II discloses the essential features of the claimed invention except for wherein the mechanical applicator comprises at least one ultrasound transducer. However, Sullivan in the same field of endeavor of neural stimulation teaches that it is known to stimulate the trigeminal nerve with an ultrasound transducer (par. 0071) to provide the predictable results of effectively stimulating a nerve through a target site on the scalp or skin (par. 0071). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tracey II by stimulate the trigeminal nerve with an ultrasound transducer to provide the predictable results of effectively stimulating a nerve through a target site on the scalp or skin with known means.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Tracey I in view of Harper et al. (US 2019/0151604, hereinafter “Harper”). Tracey I discloses the essential features of the claimed invention except the wearable structure is configured to be secured in place at least in part via a biocompatible adhesive; or wherein the wearable structure comprises an adhesive patch. However, Harper in the same field of endeavor of neural stimulation of structures including the trigeminal nerve (par. 0034) teaches providing a mechanical stimulator that structure is configured to be secured in place at least in part via a biocompatible adhesive; and wherein the wearable structure comprises an adhesive patch (pars. 0008, 0080, 0081) to provide the predictable results of better vibration transfer to the skin of the subject, and ultimately to the targeted nerve (par. 0080). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tracey I by providing a mechanical stimulator that structure is configured to be secured in place at least in part via a biocompatible adhesive; and wherein the wearable structure comprises an adhesive patch to provide the predictable results of better vibration transfer to the skin of the subject, and ultimately to the targeted nerve.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Tracey II in view of Harper. Tracey II discloses the essential features of the claimed invention except the wearable structure is configured to be secured in place at least in part via a biocompatible adhesive; or wherein the wearable structure comprises an adhesive patch. However, Harper in the same field of endeavor of neural stimulation of structures including the trigeminal nerve (par. 0034) teaches providing a mechanical stimulator that structure is configured to be secured in place at least in part via a biocompatible adhesive; and wherein the wearable structure comprises an adhesive patch (pars. 0008, 0080, 0081) to provide the predictable results of better vibration transfer to the skin of the subject, and ultimately to the targeted nerve (par. 0080). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tracey II by providing a mechanical stimulator that structure is configured to be secured in place at least in part via a biocompatible adhesive; and wherein the wearable structure comprises an adhesive patch to provide the predictable results of better vibration transfer to the skin of the subject, and ultimately to the targeted nerve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lamensdorf et al. (US 8,406,869) is another example of a trigeminal nerve stimulator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792
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