DETAILED ACTION
This action is in response to the Applicant Remarks received on April 8, 2026. Claims 1-9, 11-14, 27-29, 33-34, and 66-67 are pending with claims 10, 15-26, 30-32, and 35-65 canceled and claims 1-2, 9, 13, 27, and 29 currently amended.
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 § 102
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.
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 27 and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bigfoot [US20190184092A1].
Regarding claim 27 (Currently Amended), the claim shares similar limitations to claims 1-2. For citations on rejection, see the citations of Bigfoot within the rejection of claims 1-2 below.
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 date 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 66 (New), the claim is rejected by virtue of its dependency on claim 27.
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, 28-30, 33-34, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Bigfoot [US20190184092A1] and Insulet [US20210038813A1].
Regarding claim 1 (Currently Amended), Bigfoot 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.”),
; and
a first light source that is activated based at least in part on a light 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.”)
Bigfoot does not explicitly disclose a motion sensor in the detail of the instant application.
Insulet, however, discloses:
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 motion 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 (Currently Amended), 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 light detection (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 (Currently Amended), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 1,
wherein the first light source illuminates text or a symbol (Bigfoot, Fig 1B illustrates the medication delivery cueing system with a reading of “23u”. and 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 10, the Applicant has elected to cancel the claim.
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 (Currently Amended), Bigfoot/Insulet discloses:
The light-based medication delivery cueing system of claim 12, further comprising:
An additional sensor,
wherein the second light source is activated based on performance of the first medication delivery instruction as detected by the additional sensor (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 29 (Currently Amended), the claim shares similar limitations to claims 1-2. For citations on rejection, see the rejection of claims 1-2 above.
Regarding claims 30-32, 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.
Regarding claim 67 (New), the claim is rejected by virtue of its dependency on claim 1.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bigfoot and Insulet as applied to claims 1-7, 9, 11-14, 27-29, 33-34, and 67 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.
Response to Arguments
Applicant’s arguments, see page 6 of 11 of the Remarks, filed April 8, 2026, with respect to the rejection of Claims 1-13 and 30 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections of claims 1-13 and 30 under 35 U.S.C 112(b) have been withdrawn.
Applicant's arguments filed April 8, 2026 have been fully considered but they are not persuasive.
Regarding claim 1, in the Remarks filed April 8, 2026 on page 7 of 11, para 4, the Applicant argues:
“The Office Action, citing paragraph 37 of Bigfoot, asserts that Bigfoot discloses a light source. However, paragraph 37 of Bigfoot actually discloses a "visual" notification – without describing any light source. Moreover, Bigfoot's visual notification is not necessarily provided by a light source, as such a visual notification could be provided by a mechanically movable component (e.g., one that has multiple colored surfaces that rotate, or has a portion that can protrude outward to visually notify the user). Thus, the Office Action has not identified disclosure of a light source in Bigfoot.”
The Examiner respectfully submits that Bigfoot does disclose a light source and a light that is detected to activate the light source. The instant application discloses a light, which is detected corresponding to a removal of a medication delivery device, and a light source, which is activated based at least in part on the light being detected.
Bigfoot discloses a light via the disclosure of using an optical sensor (as cited above) that detects when the cap is applied to and/or removed from the pen. As one of ordinary skill in the art would recognize, an optical sensor relies on observation of light.
Bigfoot discloses a light source that is activated based at least in part on the light being detected through the disclosure of the visual notifications mentioned in the Applicant’s argument above and the corresponding section above. The visual notification is provided when the user removes the pen cap from the injection pen within a threshold period of time “to indicate that the user may have recently used the pen to administer insulin” (Bigfoot, [0037]). Bigfoot illustrated this element in Figure 3 of the disclosure, which illustrates an illuminated display informing the user of the time of their last dose.
Regarding claim 1, in the Remarks filed April 8, 2026 on pages 7-8 of 11, paras 6 and 1, respectively, the Applicant argues:
“The Office Action fails to identify disclosure of Bigfoot's alleged light sensor detects a light corresponding to a removal of Bigfoot's alleged medication delivery device from a storage component. Rather, the Office Action identifies disclosure of light being detected from Bigfoot's pen cap being removed from Bigfoot's alleged medication delivery device (i.e., injection pen).”
The Examiner respectfully submits that the medication delivery device (i.e., injection pen) is stored within the pen cap, which Bigfoot discloses as a separate accessory from the medication delivery device (Bigfoot, [0031], “In some embodiments, systems, devices, and methods provided herein can automatically capture insulin delivery data, which may be captured using a connected and/or smart insulin injection pen or a connected and/or smart insulin pen accessory (e.g., a connected pen cap accessory).”); therefore, under broadest reasonable interpretation, the pen cap may be interpreted as a storage component.
Regarding claim 1, in the Remarks filed April 8, 2026 on page 8 of 11, para 2, the Applicant argues:
“As discussed above, the Office Action alleges that a person of ordinary skill in the art would modify Bigfoot’s device in view of Insulet to activate an alleged first light source based on a light detection and based on a motion detection. However, the Office Action does not identify actual disclosure of activating Bigfoot (or Insulet’s) alleged light source based on both light detection and motion detection. Rather, the Office Action alleges that activating a light source based on both light detection and motion detection is a combination of old elements.”
The Examiner respectfully submits that Bigfoot discloses activating the light source based on light detection (as discussed above) and motion detection (Bigfoot, [0092], emphasis-added, “A capping sensor for detecting possible capping events, uncapping events, and recapping events may be an analog or digital electronic sensor integrated with a pen cap, or, more generally, with an accessory, that responds to being attached or removed from an insulin pen. In one embodiment, it may incorporate a piezoelectric material that generates a small current when pressure (e.g., from being firmly affixed to an insulin pen) is exerted on it. In another embodiment, it may respond to relative motion between itself and a small magnetic element affixed to the medical delivery device.”).
Regarding claim 1, in the Remarks filed April 8, 2026 on page 9 of 11, para 2, the Applicant argues:
“Moreover, even if, a person of ordinary skill could possibly incorporate Insulet’s alleged light source activation into Bigfoot' s device, at best the result would be a visual alert – based on motion to alert the user of a confirmation request – different (and independent) from Bigfoot's alleged visual notification activation based on an alleged detection of light. Thus, such a modification of Bigfoot's device would not result in a light source that is activated based at least in part on light detection and motion detection in the manner recited in claim 1 as amended.”
The Examiner respectfully submits the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding claim 1, in the Remarks filed April 8, 2026 on page 8 of 11, para 3, the Applicant argues:
“Initially, the Office Action alleges that the first visual cue of claim 1 is not functionally related to the medical delivery device, despite corresponding to usage of the medication delivery device. Such a first visual cue is functional at least in a manner similar to that of "a claim to a color-coded indicia on a container in which the color indicates the expiration date of the container" which "may give rise to a functional relationship." MPEP 2111.05(II). Also, as recited in claim 1, activating of the first light source is the first visual cue and is based at least in part on a light detection and a motion detection – clearly functionally relating the first visual cue to the light detection and the motion detection. Thus, the first visual cue of claim 1 is functionally related to the light-based medication delivery cueing system.”
The Examiner respectfully submits that the MPEP section cited by the Applicant states (emphasis added), “may give rise to a functional relationship.” As defined by the Merriam-Website Dictionary, “may” is “used to indicate possibility or probability” – not certainty. The Examiner submits that the instant application more closely relates to being “directed to conveying a message or meaning to a human reader independent of the intended computer system, and/or the computer-readable medium merely serves as a support for information or data, no functional relationship exists” (MPEP 2111.05, III).
Regarding claim 1, in the Remarks filed April 8, 2026 on page 9 of 11, para 4, the Applicant argues:
“Also, the Office Action alleges, contrary to MPEP §2111.05(II) that a functional or structural relationship between printed matter and a physical substrate is alone insufficient to provide patentable weight over prior art. However, MPEP §2111.05(II) does not support such an assertion, but rather states that “[o]nce a functional relationship between the product and associated printed matter is found, the investigation shifts to the determination of whether the relationship is new and nonobvious.””
The Examiner respectfully submits that the Applicant is expressing the same sentiments in different terminology as the Examiner. In an effort to better explain the Examiner’s position, the Examiner submits that 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 because the relationship must be examined for being “new and nonobvious” before claim language can be determined to provide patentable weight over the prior art.
Regarding claim 27, in the Remarks filed April 8, 2026 on page 10 of 11, para 5, the Applicant argues:
“The Office Action does not identify disclosure of Bigfoot’s alleged light sensor being powered based on detection of an occurrence of a designated date by Bigfoot’s alleged timer in paragraph 104 of Bigfoot. Rather, paragraph 104 of Bigfoot explains that “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 before an updated recommendation may be made.” (Emphasis added.) Moreover, neither of paragraphs 37 and 45 of Bigfoot disclose Bigfoot’s alleged light sensor being powered on based on the timer in paragraph 104 of Bigfoot, but rather disclose providing visual notification to a user if a cap is removed before a date/within a threshold – as opposed to activating a light sensor upon detection of a date.”
The Examiner respectfully submits that the functionality of Bigfoot as cited in the arguments above in combination with the citations provided within claim 27. The timer of Bigfoot expires and results in a display being illuminated for the user to examine to instruct the user that a new blood glucose reading is needed.
Regarding claim 27, in the Remarks filed April 8, 2026 on page 11 of 11, para 1, the Applicant argues:
“While the Office Action alleges that independent claim 27 is obvious over Bigfoot in view of lnsulet, and refers generally to the rejection of independent claim 1, the Office Action does not particularly identify any features of claim 27 that are allegedly disclosed in Insulet. Accordingly, the rejection of claim 27 is unclear with respect to which disclosure of lnsulet allegedly corresponds to which features of claim 27, and the rejection fails to identify a credible rationale for modifying Bigfoot in a manner that would result in each feature of claim 27.”
The Examiner respectfully submits that in view of the amendments, claim 27 has been rejected under 35 U.S.C. 102(a)(1) as designated in the corresponding section above.
Conclusion
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.
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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