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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 March 2026 has been entered.
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 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky’106 (U.S. Publication Number 20180028106 – previously cited) in view of Rubin et. al.’756 (U.S. Publication Number 20180014756).
Regarding Claim 9, Leschinsky’106 discloses a method for treating pruritus utilizing, a motion sensing device associated with a subject (Paragraph [0051] - Motion detector 140 may be included in a set of sensors of the first watch 110), a method comprising:
receiving accelerometer data collected from the motion sensing device (Paragraph [0051] - Such motion detector may include one or multiple one-dimension, two-dimension, or three-dimension accelerometers, position sensors or gyroscopes),
detecting a hand movement utilizing the accelerometer data (Paragraph [0051] - detection of periodic limb movements of the subject for extracting signal features indicating persistent scratching of the subject's skin),
utilizing a computerized classification model to determine, based on the accelerometer data corresponding to the hand movement, that the hand movement indicates a scratch event (Paragraph [0034] - The microprocessor may in turn comprise any suitable programmable computing device or integrated circuit board capable of operating the sensors and other elements of the watch 110 in a manner described below. The first controller 120 may also include a computer memory element and control buttons suitable for operating the device 100 of the invention; Paragraphs [0055-0062]; Paragraph [0063] - each of the above measures may be assigned a certain weight so that the final score may be generated using individual importance of each of these measures; Figure 3), and
based on at least a first determination that the hand movement indicates the scratch event, initiating a treatment protocol for the subject to treat pruritus (Paragraph [0069] - Once the early allergy alert conditions are met and an alarm notification is sent, the first watch 110 may be further configured to assist in managing and mitigating the allergic reaction – which is causing pruritus - of a subject. The watch 110 may comprise a locator 160, which may be helpful in rapidly finding the subject by a caregiver; Paragraphs [0055-0062]).
Leschinsky’106 discloses a device comprising a three-dimensional accelerometer (Paragraph [0051] -Motion detector 140 may be included in a set of sensors of the first watch 110. Such motion detector may include one or multiple one-dimension, two-dimension, or three-dimension accelerometers) capable of capturing amplitude and frequency of motion across different planes pertaining to spatial orientation that fall in predetermined ranges (Paragraph [0059] - The amplitude of such periodic movements is in a range from about 0.5 inch to about 5 inch; Paragraph [0061] - The frequency of the periodic motions is about the same (within 20%) between successive series of periodic movement; Paragraph [0065] - 3-D accelerometers may be particularly useful in this case as they may allow to separate repeated motion of the watch 110 for different planes of spatial orientation). Leschinsky’106 fails to disclose a computerized model that calculates a vector magnitude of accelerometer data and a rolling coefficient of variation (CoV) based on the accelerometer data for the determination of hand movements.
Rubin et. al.’756 teaches calculating acceleration vector magnitudes and determining an average deviation from obtained signals – a rolling coefficient of variation (CoV) (Paragraph [0075] - At first (step 102), acceleration vector magnitude is calculated based on signals x.sub.i, y.sub.i, z.sub.i as: A.sub.i=√{square root over (x.sub.i.sup.2+y.sub.i.sup.2+z.sub.i.sup.2)}; Paragraph [0077] - To eliminate high-frequency hopping of computed values A.sub.i, the above sequence can be smoothed (step 103), for example, by method of exponential weighted moving average. Thereupon, a new array of values Ã.sub.i is formed, which is free of a high-frequency component. Various smoothing methods are known, which can be used depending on the frequency spectrum of signals x.sub.i, y.sub.i, z.sub.i generated by accelerometer 2; Paragraph [0080] - The values of acceleration vector magnitude Ã.sub.i are shown in FIG. 5 as a plot illustrating the changes of value Ã.sub.i in time; Paragraph [0115] - the dispersion, serving as a parameter for assessing the degree of deviation, is taken to be the average accelerometer signal deviation relative to the mean signal value). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Leschinsky’106 involving accelerometers to include calculating acceleration vector magnitudes from measured motion amplitudes in order to understand how acceleration of motion changes over time and comparing these vector magnitudes to average accelerometer signal deviation in order to smooth out motion-related data in order to identify motions that fall within predetermined ranges as seen in Rubin et. al.’756.
Regarding Claim 10, Leschinsky’106 in view of Rubin et. al.’756 discloses the method outlined in Claim 9 above. Additionally, Leschinsky’106 discloses initiating the treatment protocol is further based on a plurality of determinations that a plurality of hand movements each indicate a scratch event (Paragraph [0063] - A confidence score may be developed to assess the accuracy of itch detection based on how many of the preceding conditions are met—the more conditions that are met, the higher is the confidence score of detecting an onset of a new skin itch or rash; Paragraphs [0055-0062]), and
initiating the treatment protocol includes determining at least one of a therapeutic agent, a dosage, and a method of administration of the therapeutic agent (Paragraph [0073] - Assistance in rapidly locating a medication injector may prove very beneficial in such situations. The locator 160 may be further configured to communicate wirelessly with a beacon 108, which may in turn be affixed to a medication injector 109 containing epinephrine or another suitable injectable medication for treating allergy… provided to assure rapid access to all items needed for treating an allergy).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky’106 (U.S. Publication Number 20180028106 – previously cited) in view of Rubin et. al.’756 (U.S. Publication Number 20180014756) as applied to Claim 10 above, and further in view of Wei'335 (U.S. Publication Number 20190105335 - previously cited).
Regarding Claim 11, Leschinsky’106 in view of Rubin et. al.’756 discloses the method outlined in Claim 10 above. Additionally, Leschinsky’106 discloses therapeutic agents such as epinephrine (Paragraph [0073] - inject a medication such as epinephrine) and Benadryl (Paragraph [0075] - with a pill of a suitable antihistamine medication, such as Benadryl™), but fails to disclose a therapeutic agent from the group recited in Claim 11. Wei’335 teaches a therapeutic agent that can be used to treat areas of the skin that itch includes prednisone – which is one of the therapeutic agents listed in Claim 11 (Paragraph [0028] - The condition is treatable with oral antihistamines and in more severe cases with oral prednisone). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Leschinsky’106 in view of Rubin et. al.’756, more specifically the treatment protocols and the use of the locators in Leschinsky’106, to include the therapeutic agent prednisone in order to treat areas of the skin that itch due to allergies and other triggers as seen in Wei’335 (Paragraph [0028] - The triggers are usually allergy to a food item, such as seafood, but there are multiple triggers).
Regarding Claim 12, Leschinsky’106 in view of Rubin et. al.’756 discloses the method outlined in Claim 10 above. Additionally, Leschinsky’106 discloses therapeutic agents such as epinephrine (Paragraph [0073] - inject a medication such as epinephrine) and Benadryl (Paragraph [0075] - with a pill of a suitable antihistamine medication, such as Benadryl™), but fails to disclose a therapeutic agent consisting of crisaborole or abrocitinib. Wei’335 teaches a therapeutic agent that can be used to treat areas of the skin that itch – specifically atopic dermatitis - includes crisaborole (Paragraph [0027] - Recently, two new medications have been approved by the US FDA for atopic dermatitis: dupilumab (a monoclonal antibody) and crisaborole (an ointment)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Leschinsky’106 in view of Rubin et. al.’756, more specifically the treatment protocols and the use the of locators in Leschinsky’106, to include the therapeutic agent crisaborole in order to treat areas of the skin that itch since it has been approved by the US FDA to use on conditions with itchy skin as seen in Wei’335.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky’106 (U.S. Publication Number 20180028106 - previously cited) in view of Rubin et. al.’756 (U.S. Publication Number 20180014756) as applied to Claim 9 above, and further in view of Cronin et. al.'317 (WO Publication 2016142317 - previously cited).
Regarding Claim 13, Leschinsky’106 in view of Rubin et. al.’756 discloses the method outlined in Claim 9 above. Additionally, Leschinsky’106 discloses utilizing a user interface program with a display that allows user interaction to input data and information that would affect treatment protocol based on a first determination that a hand movement represents a scratch event (Paragraphs [0066-0067] and Paragraph [0098]). Leschinsky’106 fails to disclose the user interface as a graphical user interface. Cronin et. al.’317 teaches using a graphical user interface (GUI) (Paragraph [0065] - In this example, the wearable base GUI 248 includes an allergy selector 1500, which here shows that a user has selected "Peanuts"… The wearable base GUI 248 also includes a yes/no selector 1512 that allows the user to control whether or not the wearable device 204 auto-initiates allergy testing). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Leschinsky’106 in view of Rubin et. al.’756, more specifically the user interface of Leschinsky’106, to include a GUI in order to interact with the system’s displays visually as seen in Cronin et. al.’317. It is noted that Leschinsky’105 addresses the displays interacting with smartphones and tablets (Paragraph [0098]) which are known in the art to use GUI.
Regarding Claim 14, Leschinsky’106 in view of Rubin et. al.’756, and further in view of Cronin et. al.’317 discloses the method outlined in Claim 13 above. Additionally, Leschinsky’106 discloses the user device is separate from the motion sensing device, and wherein the motion sensing device comprises a wearable device worn at an appendage of the individual (Paragraph [0008] - a novel watch-like devices and methods configured to be positioned on a subject's wrist and equipped with sensors to detect ambient conditions, physical activity and signs of allergic reaction; Paragraph [0067]; Paragraph [0071] - transmitted to a caregiver or a parent's smart phone wirelessly over the Internet; Paragraph [0077] - the design of the second watch 200 may be simplified as compared with the first watch 110…at least one of a second motion detector 240; Paragraph [0078]).
Regarding Claim 15, Leschinsky’106 in view of Rubin et. al.’756, and further in view of Cronin et. al.’317 discloses the method outlined in Claim 13 above. Additionally, Leschinsky’106 discloses applying the treatment protocol to the subject based on the recommendation (Paragraph [0069] - Once the early allergy alert conditions are met and an alarm notification is sent, the first watch 110 may be further configured to assist in managing and mitigating the allergic reaction of a subject… As time is of the essence, the use of a locator 160 may advantageously expedite finding the subject to start allergic treatment immediately).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky’106 (U.S. Publication Number 20180028106 - previously cited) in view of Rubin et. al.’756 (U.S. Publication Number 20180014756) as applied to Claim 9 above, and further in view of Sugaya’495 (WO Publication 2019130495 - previously cited) as evidenced by Wei'335 (U.S. Publication Number 20190105335 - previously cited).
Regarding Claim 16, Leschinsky’106 in view of Rubin et. al.’756 discloses the method outlined in Claim 9 above. Additionally, Leschinsky’106 discloses determining that a hand movement indicates a scratch event in order to provide treatment protocol (Paragraphs [0055-0062]; Paragraph [0069] - Once the early allergy alert conditions are met and an alarm notification is sent, the first watch 110 may be further configured to assist in managing and mitigating the allergic reaction of a subject… As time is of the essence, the use of a locator 160 may advantageously expedite finding the subject to start allergic treatment immediately), but fails to disclose the subject is diagnosed with atopic dermatitis and wherein the treatment protocol is to treat atopic dermatitis. Sugaya’495 teaches diagnosing eczema – a form of atopic dermatitis – and providing recommended treatment options (Page 6 Paragraph 3 - The storage module 160 stores a disease database acquired in advance from an external database, an external device or the like; Page 6 Paragraph 3 - the diagnosis module 173 is associated with the affected area and the symptom based on the response data of “back” as the affected area, “rash” as the symptom, and “strong” as the magnitude of the itching. Identify the disease by referring to the disease database. At this time, the diagnosis module 173 identifies the corresponding disease as "allergic eczema"; Page 7 Paragraph 3 - the diagnostic result notification module 174 proposes the user the medicine associated with the diagnosis). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Leschinsky’106 in view of Rubin et. al.’756, more specifically the user interface program of the system of Leschinsky’106, to include a disease database – as part of the medical information – in order to diagnose the scratch-related symptoms to more than one type of disease or illness as seen in Sugaya’495. It is noted that Leschinsky’106 used motion sensors that obtained different scratch-related characteristics such as spatial orientation for where a scratching episode was occurring (Paragraph [0059]) which could be used to different scratch-related episodes. Additionally, as evidenced by Wei'335, the location for which scratching occurs on the body is used to provide some insight into what type of illness or disease a person is experiencing (Paragraph [0066] - Dermatitis occurs frequently occur on the extremities (e.g. elbow and knee flexures in atopic dermatitis) and on the trunk and scalp for psoriasis. Hand eczema frequently occurs on the hand (contact dermatitis). Urticaria – common for allergies - can occur all over the body, the wheals appearing on the torso, neck and buttocks).
Response to Arguments
Applicant's arguments filed 30 March 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome prior rejections under 35 U.S.C. 103, but are still rejected under 35 U.S.C. 103 as necessitated by amendments and addressed in Paragraphs 4-7 above.
Conclusion
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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