DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed June 5, 2026.
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Response to Arguments
2. Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Fateh et al. (US PGPUB 2018/0353327 A1), previously utilized as a secondary reference in the most recent Office action, is being considered as a primary reference in the instant rejection 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.
3. Claim(s) 1-6, 9-11, 13-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fateh et al. (US PGPUB 2018/0353327 A1).
4. With regard to claims 1, 6, 10 and 15, Fateh discloses an adherence monitoring system (abstract; Figs. 1, 5, 6), comprising: a processor (processors, 502); and a sensor platform (universal modular attachment, 100, 500) configured to attach to a container (eye drop container, 104, 204, 304, via connector rings, 102, 202, 302; [0062]), wherein the sensor platform (100, 500) includes one or more sensors (motion sensor, 508; [0048-0049]; “an electromagnetic sensor, a positional sensor, a sound sensor (e.g., a microphone), a climate sensor (e.g., humidity sensor, temperature sensor, or smog sensor), pressure sensor, etc.”) configured to measure information relating to one or more instillation movements ([0052]; [0055]; [0060]; [0065]), wherein the information relating to one or more instillation movements includes a steadiness of the eye drop container during installation ([0022]; [0037]; [0052]; “the processor(s) 502 can parse motion data generated by the motion sensor 508 to detect when the eye drop container is being tilted or shaken. Such actions typically correspond to administrations of medication, and thus can be used to monitor adherence to a medication regimen”), biomechanical data relating to a posture, a limb position, and/or a dynamic movement of a user ([0019]; [0022-0023]; [0037]), a duration of an instillation pause ([0016]; [0025]; [0060]; [0066-0067]; [0069]), and a smoothness of a position trajectory of the eyedrop ([0019]; [0022]; [0038]; [0049]).
Fateh fails to explicitly disclose that the processor is configured to use the information relating to one or more instillation movements to determine instillation success, wherein instillation success includes an estimate of a likelihood of instillation success given the information relating to one or more instillation movements received from the sensor platform.
However, Fateh discloses that the processor (502) is configured to use the information relating to one or more instillation movements to determine adherence or non-adherence to a medication regimen ([0016-0017]; [0019]; [0023]; [0052]; Figs. 6, 7), and suggests the use of cameras/optical sensors to visually record activities during administration of medication ([0055]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have configured the processor disclosed by Fateh to explicitly use the information relating to one or more instillation movements to estimate and determine instillation success, since the components disclosed by Fateh are fully capable of providing such an estimate of instillation success through parsing of component data, as suggested by Fateh in paragraph [0025], [0052], [0061] and [0065], and one having ordinary skill in the art would recognize that such an estimate, through visually recorded administration of medication via cameras or optical sensors ([0055]), or other positional/force sensors ([0022]; [0037]), would serve as a useful tool in tracking adherence to the medication regimen, as suggested by Fateh in at least paragraph [0023].
5. With regard to claims 19 and 20, Fateh discloses a method of eye drop adherence monitoring (abstract; Figs. 1, 5, 6), comprising the steps of: obtaining information relating to one or more instillation movements from a sensor platform (100, 500) attached to an eye drop container (eye drop container, 104, 204, 304, via connector rings, 102, 202, 302; [0062]; [0052]; [0055]; [0060]; [0065]); wherein the information relating to one or more instillation movements includes a smoothness of a position trajectory of the container ([0019]; [0022]; [0038]; [0049]), biomechanical data relating to a posture, a limb position, and/or a dynamic movement of a user ([0019]; [0022-0023]; [0037]), a duration of an instillation pause ([0016]; [0025]; [0060]; [0066-0067]; [0069]), and a steadiness of the eye drop container (104, 204, 304) during installation ([0022]; [0037]; [0052]).
Fateh fails to explicitly disclose determining instillation success from the information relating to one or more instillation movements, wherein determining instillation success includes an estimate of a likelihood of instillation success given the smoothness of the position trajectory of the eye drop container.
However, Fateh discloses that the processor (502) is configured to use the information relating to one or more instillation movements to determine adherence or non-adherence to a medication regimen ([0016-0017]; [0019]; [0023]; [0052]; Figs. 6, 7), and suggests the use of cameras/optical sensors to visually record activities during administration of medication ([0055]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the determination step disclosed by Fateh to explicitly use the information relating to one or more instillation movements to estimate and determine instillation success, since the components disclosed by Fateh are fully capable of providing such an estimate of instillation success through parsing of component data, as suggested by Fateh in paragraph [0025], [0052], [0061] and [0065], and one having ordinary skill in the art would recognize that such an estimate, through visually recorded administration of medication via cameras or optical sensors ([0055]), or other positional/force sensors ([0022]; [0037]), would serve as a useful tool in tracking adherence to the medication regimen, as suggested by Fateh in at least paragraph [0023].
6. With regard to claim 2, Fateh discloses that the processor (502) and the sensor platform (100, 500 with connector rings, 102, 202, 302) are integrated on a sleeve ([0035]; [0039]; [0043]; [0062]).
7. With regard to claim 3, Fateh discloses a processor (502) and a sensor platform (capacitive tactile pressure sensors or piezoelectric sensors) integrated onto a sticker (206; [0037-0038]; [0045]).
8. With regard to claims 4 and 5, Fateh discloses that the processor (502, 602; Figs. 5, 6; network environment, 600) is associated with a base station (network-accessible server system, 606); wherein the processor (502, 602) is part of a microcontroller that facilitates wireless communication to the base station ([0063]; [0068]; [0080]).
9. With regard to claims 9 and 18, Fateh discloses that information relating to one or more instillation movements includes sensorimotor data relating to a proprioception quantification, a fine grasp force control, a tactile discrimination, and/or a hand function ([0019]; [0022]; [0037]; [0045]; [0052]).
10. With regard to claim 11, Fateh discloses that the one or more sensors includes a capacitive sensor ([0037]) and a magnetic switch ([0022]; [0049]).
11. With regard to claims 13 and 14, Fateh discloses a radio communication unit (communication module, 504 and one or more networks, 608a-c) integrated with the sensor platform (100, 500, 602; Figs. 5, 6, 7; [0050]; [0059]); wherein the radio communication unit is a backscatter radio communication unit ([0059]).
12. Claim(s) 7, 8, 12, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fateh, as applied to claims 1 and 15 above, and further in view of Ajaelo (US PGPUB 2018/0193190 A1).
13. With regard to claims 7, 8, 16 and 17, Fateh fails to explicitly disclose that the biomechanical data relating to a posture includes a measurement of thorax tilt, a measurement of head tilt, a measurement of a neck flexion-extension angle and/or a measurement of a neck lateral flexion angle; and that the biomechanical data relating to a limb position includes a measurement of an elbow flexion-extension angle, a measurement of an elbow supination-pronation angle, a measurement of an angle of elevation for a shoulder, a measurement of a plane of elevation of the shoulder, and a measurement of a wrist height relative to the shoulder.
However, within the same field of eye drop monitoring, Ajaelo discloses an adherence monitoring system (electronic eye drop and management system, 100; abstract; Figs. 1, 2, 6), comprising: a processor (electronic control unit, 108; [0073]; [0085]); and a sensor platform (housing, 126) configured to attach to a container (drop container, 200), wherein the sensor platform (126) includes one or more sensors (color sensors, 102, 104, 106; and accelerometer, 114) configured to measure information relating to one or more instillation movements ([0082]; [0084-0085]); wherein the information relating to one or more instillation movements includes biomechanical data relating to a posture, a limb position, and/or a dynamic movement of a user ([0085]; [0099]; [0101]; [0107]); wherein the biomechanical data relating to a posture includes a measurement of head tilt ([0085]; [0099]; [0101]; [0107]) and biomechanical data relating to a limb position includes a measurement of an angle of elevation for a shoulder, and a measurement of a wrist height relative to the shoulder ([0091]; [0099]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the biomechanical data disclosed by Fateh to include a measurement of head tilt, angle of elevation for a shoulder, and a measurement of a wrist height relative to the shoulder, similar to that disclosed by Ajaelo, in order to further track and provide precise administration of the medicament administration including the precise and accurate detection of when an eye is open and when the head is in a proper position, precise and accurate expulsion of any amount of drops as required, recording and monitoring all events during any administration of the drop, identification of the type of contents dispensed as well as tracking refills, as suggested by Ajaelo in paragraph [0081].
14. With regard to claim 12, Fateh fails to explicitly disclose that that the processor is configured to calculate a position trajectory for the eye drop container based on an orientation, a velocity, and a position of the eye drop container.
However, Ajaelo discloses that the processor (108) is configured to calculate a position trajectory for the eye drop container (200) based on an orientation, a velocity, and a position of the eye drop container ([0081]; [0085]; [0090]; [0099]; [0101]; [0103]; [0107]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have configured the processor disclosed by Fateh to calculate a position trajectory for the eye drop container based on an orientation, a velocity, and a position of the eye drop container, similar to that disclosed by Ajaelo, in order to detect and determine suitable/correct positioning of the eye drop container during use, as suggested by Ajaelo in paragraph [0099].
Conclusion
15. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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