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 1-13 and 30 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.
Claim 1 recites the limitation “a first light source that is activated based at least in part on a first detection of the light and a second detection of the motion” in lines 5-6. The recitation creates ambiguity as it is unclear whether the terms “first” and “second” are referring to the term “detection” or the terms “light” and “motion”; thus, it is unclear whether the Applicant intends for the detection of the light is the first detection and the detection of the motion is the second detection or whether the Applicant intends for there to be a first detection of motion alongside the recited second detection of the motion.
For the purposes of examination, the Examiner assumes the Applicant intends for the enumeration to refer to the term “detection”; therefore, the Examiner assumes the “detection of the light” is the first detection and the “detection of the motion” is the second detection.
Similar ambiguity can be found in the recitation of “a third detection of the motion” in line 2 of claim 30 with no prior references to a first or second detection of the motion. For the purposes of examination, the Examiner follows the prior logic detailed above.
Claim 13 recites the limitation "the light-based medication cueing delivery system" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, the Examiner assumes the term is meant to match the term recited in line 1 of claim 13 and the surrounding claims by reciting, “the light-based medication delivery cueing system”.
Claims 2-12 are rejected by virtue of their dependency on claim 1.
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.
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.
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.
Claims 1-7, 9-14, 27-30, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bigfoot [US20190184092A1] and Insulet [US20210038813A1].
Regarding claim 1 (Original), Insulet discloses:
A light-based medication delivery cueing system comprising:
a light sensor and a motion sensor,
wherein the light sensor detects light corresponding to a removal of a medication delivery device from a storage component (Bigfoot, [0045], (emphasis added) “the cap may include a sensor (e.g., an optical sensor, a mechanical sensor, an electronic sensor, a magnetic sensor, etc.) that detects when the cap is applied to and/or removed from the pen.”),
wherein the motion sensor detects motion of the medication delivery device (Insulet, [0045], “The user-input device can be a button disposed on the device 102, an acceleration sensor for sensing motion of the medical device 102, or any other such input device.”); and
a first light source that is activated based at least in part on a first detection of the light (Bigfoot, [0037], “if the pen cap is removed from the injection pen within a threshold period of time (e.g., within 30 minutes or 1 hour) from a previous capping, the pen cap may provide a visual, audible, or vibrational notification to indicate that the user may have recently used the pen to administer insulin.”) and a second detection of the motion (Insulet, [0039], “The alert can be alarm provided visually, audibly, or by other means (e.g., such as vibrating).”),
wherein activating of the first light source is a first visual cue to perform a first medication delivery instruction (Insulet, [0039], “The wearable insulin pump 102 or the electronic device 106 can include an output device for alerting the user that user confirmation is requested.”).
It would have been obvious to one of ordinary still in the art before the effective filing date of the claimed invention to include in the medication delivery system of Bigfoot the ability to utilize motion sensors as taught by Insulet since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Furthermore, the written contents of a medication delivery device (e.g., adhesive labels, medical delivery instructions, or illuminating text/symbols) do not functionally or structurally relate to the physical substrate of the invention; therefore, any claim limitation directed towards the printed matter within the invention (as seen in claims 1, 3, 7, 9, 10, 14, 33, and 34) does not provide patentable weight over the prior art. As cited in the MPEP, "[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." Id. at 850, 117 USPQ2d at 1268 (See MPEP 2111.05 on Functional and Nonfunctional Descriptive Material.). Furthermore, a functional or structural relationship between the printed matter and the physical substrate of the invention alone is insufficient to provide patentable weight over a prior art. As cited in the MPEP, the relationship must be “new and nonobvious” (MPEP 2111.05, Section II).
Regarding claim 2 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein power is provided to the motion sensor based at least in part on the first detection of the light (Insulet, [0046], “In various embodiments, when a command is received at the medical device 102 from the electronic device 106, the electronic device 202, or from the local electronic device 116, an action associated with the command (e.g., delivery of a bolus) is not carried out until input is received from the user.”).
In other words, Insulet discloses a system to utilize sensors to prevent an action (e.g., with the motion sensor) from occurring until the user performs an action, and Bigfoot discloses a system that accepts cap interactions as user input, which, as cited in claim 1, utilizes a light sensor to detect light.
Regarding claim 3 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the light sensor, the motion sensor and the first light source are included in one or more adhesive labels that are attached to the medication delivery device (Bigfoot, [0035], “Systems, devices, and methods provided herein can include, use, or communicate with one or more accessories for a medication delivery device, such as an insulin pen (e.g., a pen cap for the insulin pen) that is (a) adapted to be secured to an injection pen and detect when the pen cap is secured to and/or released from the injection pen, (b) adapted to receive blood glucose data from a glucose sensor, and/or (c) adapted to provide therapy relevant information and/or recommendations to the user.”).
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claim 4 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the light sensor, the motion sensor and the first light source are included within the medication delivery device (Bigfoot, [0054], “While aspects of the embodiments of the disclosure are described in terms of accessories and caps, one of ordinary skill in the art would understand that many of the features could be performed in an electronics package (i.e., a smart electronics) that is integratable with an insulin delivery device, attachable to an insulin delivery device, attachable to an insulin container, and more, all of which are specifically contemplated by the inventors of this disclosure.”).
Regarding claim 5 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the medication delivery device is a medication storage container (Bigfoot, [0054], “an insulin container”).
Regarding claim 6 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the medication delivery device is a medication injection device (Bigfoot, [0031], “smart insulin injection pen”).
Regarding claim 7 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the first medication delivery instruction is a cap removal instruction or a device shaking instruction (Bigfoot, [0104], “responsive to expiration of the timer, the display 124 on the pen cap 122 may instruct the user that a new blood glucose reading is needed”).
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claim 9 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the first light source illuminates text (Bigfoot, Fig 1B illustrates the medication delivery cueing system with a reading of “23u”).
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claim 10 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the first light source illuminates a symbol (Bigfoot, Fig 1B illustrates the medication delivery cueing system with a symbol of a syringe.).
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claim 11 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the first light source is activated by at least one of
causing the first light source to emit light (Bigfoot, [0051], “a user-selectable button or icon may be used to wake up a display on the smart pen”),
causing the first light source to flash, or
causing the first light source to change color.
Regarding claim 12 (Original), the claim shares similar limitations to claim 1. For citations on rejection, see the rejection of claim 1 above.
Although, claim 12 teaches a second light source, a second visual cue, and a second medication delivery instruction, whereas claim 1 discloses a first light source, a first visual cue, and a first medication delivery instruction.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that, given the technology as claimed for a first light source, a first visual cue, and a first medication delivery instruction were known in the field as evidenced by Bigfoot/Insulet, that the same technology could be used to perform a second iteration, (See MPEP 2144.04, VI, B as provided below for ease of reference).
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
Regarding claim 13 (Original), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 12,
wherein the second light source is activated based on performance of the first medication delivery instruction as detected by an additional sensor of the light-based medication cueing delivery system (Bigfoot, [0108], “In some embodiments, if there has been a recent dosage of insulin (e.g., within the last 1, 2, 3, or 4 hours) a warning screen might appear next to or over the recommendation to indicate that there has been a recent dose in order to prevent unintentional stacking of insulin.”).
Regarding claims 14 and 28 (Original), the claims share similar limitations to claim 1. For citations on rejection, see the rejection of claim 1 above.
Regarding claims 15-26, the claims were canceled by the Applicant prior to the First Action on the Merits of the Instant Application.
Regarding claim 27 (Original), the claim shares similar limitations to claims 1-2. For citations on rejection, see the rejection of claims 1-2 above.
Claim 27, however, introduces the following limitations distinct from claims 1-2:
A timer configured to detect an occurrence of a designated date, wherein the light sensor is powered based on a first detection of the occurrence of the designated date (Bigfoot, [0104], “responsive to expiration of the timer, the display 124 on the pen cap 122 may instruct the user that a new blood glucose reading is needed”).
Regarding claim 29 (Original), the claim shares similar limitations to claim 2. For citations on rejection, see the rejection of claim 2 above.
Although, claim 29 teaches a second detection of the light, whereas claim 2 teaches a first detection of the light.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an element could be powered based on a second detection of the light given the technology was available to power an element based on a first detection of the light (See MPEP 2144.04, VI, B as provided in claim 12 above).
Regarding claim 30 (Original), the obviousness rationale applied to claim 29 equally applies to claim 30. For citations on rejection, see the rejection of claim 29 above.
Regarding claims 31-32, the claims were canceled by the Applicant prior to the First Action on the Merits of the Instant Application.
Regarding claim 33 (Original), the claim shares similar limitations to claims 9-10. For citations on rejection, see the rejection of claims 9-10 above.
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claim 34 (Original), Bigfoot/Insulet discloses:
The system of claim 33,
wherein the medication delivery information relates to an expiration date of a medication (Bigfoot, [0104], “responsive to expiration of the timer, the display 124 on the pen cap 122 may instruct the user that a new blood glucose reading is needed”).
Regarding the patentable weight of written contents, please see claim 1 above.
Regarding claims 35-65, the claims were canceled by the Applicant prior to the First Action on the Merits of the Instant Application.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bigfoot and Insulet as applied to claims 1-7, 9-14, 27-30, and 33-34 above, and further in view of Novo [US20170232203A1].
Regarding claim 8 (Original), Bigfoot/Insulet discloses utilizing a light source via the light-based medication delivery cueing system of claim 1, but Bigfoot/Insulet does not explicitly disclose an organic light-emitting diode (OLED).
Novo, however, discloses:
The first light source is an organic light-emitting diode (OLED) (Novo, [0032], “The term display means covers any type of display capable of visually providing the specified functionality, e.g. a LCD or an OLED display.”).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of the OLED display utilized by Novo for the display of Bigfoot/Insulet.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious before the effective filing date of the claimed invention.
Conclusion
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/ Supervisory Patent Examiner, Art Unit 3715