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 .
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on March 29, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
4. Claim(s) 1-2, 4-8, 10-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ajaelo (US PGPUB 2018/0193190 A1).
5. With regard to claims 1, 6, 10 and 15, 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 processor (108) is configured to use the information relating to one or more instillation movements to determine instillation success ([0108]; Fig. 6), 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]), and wherein the information relating to one or more instillation movements includes a smoothness of a position trajectory of the container (200; Figs. 2, 6, 7; [0081]; [0090]; [0099]; [0101]; [0103]).
6. With regard to claims 19-20, Ajaelo discloses a method of eye drop adherence monitoring (abstract; Figs. 1, 2, 6), comprising the steps of: obtaining information relating to one or more instillation movements from a sensor platform (126) attached to an eye drop container (200; [0081-0082]; [0084-0085]); and determining instillation success from the information relating to one or more instillation movements ([0108]; Fig. 6), 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]), and wherein the information relating to one or more instillation movements includes a smoothness of a position trajectory of the container (200; Figs. 2, 6, 7; [0081]; [0090]; [0099]; [0101]; [0103]).
7. With regard to claim 2, Ajaelo discloses that the processor (108) and the sensor platform (126) are integrated on a sleeve (“suitable for accommodating a drop container 200 partially or fully within the housing 126”; [0083]; [0086]; [0087]).
8. With regard to claims 4 and 5, Ajaelo discloses that the processor (108) is associated with a base station (“any network-enabled mobile device application or other data processing device capable of pairing via Blueooth®. The data may then be uploaded to a remote or cloud-based server through a network (e.g. a wide-area network, such as the Internet)”; [0112]); wherein the processor (108) is part of a microcontroller that facilitates wireless communication to the base station ([0025]; [0082]; [0087]; [0099]).
9. With regard to claims 7 and 16, Ajaelo discloses that biomechanical data relating to a posture includes a measurement of head tilt ([0085]; [0099]; [0101]; [0107]).
10. With regard to claims 8 and 17, Ajaelo discloses that biomechanical data relating to a limb position includes a measurement of an angle of elevation fora shoulder, and a measurement of a wrist height relative to the shoulder ([0091]; [0099]).
11. With regard to claim 11, Ajaelo discloses that the one or more sensors includes an inertial measurement unit (accelerometer, 114; [0085]; [0099]; [0101]; [0103]; [0107]).
12. With regard to claim 12, 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]).
13. With regard to claims 13 and 14, Ajaelo discloses a radio communication unit (wireless interface module, 116) integrated with the sensor platform (126; Figs. 2, 3; [0082]; [0085]); wherein the radio communication unit (116) is a backscatter radio communication unit ([0112]).
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.
14. Claim(s) 3, 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ajaelo in view of Fateh et al. (US PGPUB 2018/0353327 A1).
15. With regard to claim 3, while Ajaelo discloses that the processor (108) and sensor platform (126) may be structurally designed in a way suitable for accommodating the container (200) partially or fully within the sensor platform (126; [0086]), Ajaelo is silent in regard to the processor and the sensor platform being integrated on a sticker.
However, within the same field of endeavor, Fateh discloses universal modular attachments for eye drop containers (abstract; Figs. 2-6), comprising: a processor and a sensor platform (capacitive tactile pressure sensors or piezoelectric sensors) integrated onto a sticker (206; [0037-0038]; [0045]).
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 processor and sensor platform disclosed by Ajaelo to be incorporated on a sticker, similar to that disclosed by Fateh, in order to utilize an alternative, well-known, means of partially accommodating the container with an integrated sticker to detect when an individual grasps the eye drop container or deforms the container due to squeezing, as suggested by Fateh in paragraph [0037].
16. With regard to claims 9 and 18, Ajelo fails to explicitly disclose that the 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.
However, 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]).
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 information relating to one or more instillation movements disclosed by Ajaelo to include sensorimotor data relating to a proprioception quantification, a fine grasp force control, a tactile discrimination, and/or a hand function, similar to that disclosed by Fateh, in order to utilize motion, pressure and positional sensors data to detect when an individual grasps and squeezes the container to accurately track usage of the container in a convenient and inconspicuous manner, as suggested by Fateh in paragraphs [0022] and [0037].
Conclusion
17. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fateh (US PGPUB 2020/0113733) discloses a portable management and monitoring system for eye drop medication regiment.
Brue (US PGPUB 2015/0359667) discloses a system for eye medication compliance/tracking.
Eaton et al. (US PGPUB 2015/0289805) discloses performing and monitoring drug delivery.
18. 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..
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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