DETAILED ACTION
Claim Rejections - 35 USC § 112
1. 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.
2. Claims 4 and 5 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.
Regarding claims 4 and 5, the term “adaptable element” lacks proper antecedent basis in the claims. It appears the term should find support in “an adaptive element” in claim 1.
Claim Rejections - 35 USC § 102
3. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1, 2, 5-9, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0327973 (Pryor).
Regarding claim 1, Pryor teaches a reusable accessory (110, Fig. 3) for receiving a medication delivery device, comprising:
a housing (112, Fig. 3) configured to receive a medication delivery device (20);
an adaptive element (114, Fig. 4) coupled to the housing, the adaptive element
being configured to reversibly attach to the medication delivery device (see Fig. 5; paras. [0050]-[0061]); and
one or more attachment sensors (122, Fig.10, paras. [0054], ]0067], [0073], [0096-0097])
coupled to the housing, the one or more attachment sensors configured to detect the adaptive element reversibly attaching to the medication delivery device (see inductive sensor, para. [0008]).
Regarding claim 2, the one or more attachment sensors include an accelerometer configured to detect the one or more adaptive elements reversibly attaching to the medication delivery device (see para. [0097]).
Regarding claim 5, the adaptable element comprises an interchangeable collar reversibly coupled to the housing, wherein the interchangeable collar is configured to fit the medication delivery device (read as slider 118 in Fig. 7; paras [0053]-[0054]).
Regarding claim 6, further comprising: at least one user interface configured to communicate one or more notifications including an alert that the medication delivery device is not fully inserted into the reusable accessory, a time that the sensor last detected the adaptive element reversibly attaching to the medication delivery device, or whether there has been a missed dose (see cover 150 in Fig. 3 which includes apertures 152 to transmit light from LEDs 128 and 130; see para. [0052]).
Regarding claim 7, the reuseable accessory is a pen cap for an insulin pen that is the medication delivery device (see cap 110 in Fig. 3; see Abstract).
Regarding claims 8, an adaptive element is a clamping mechanism (180) configured to reversibly attach to the medication delivery device by clamping onto the medication delivery device received in the housing (see Figs. 11-14, para. [0058]).
Regarding claim 9, the clamping mechanism has a plurality of states, and the one or more attachment sensors are configured to detect a current state of the clamping mechanism from the plurality of states (explicitly stated in para. [0096]).
Regarding claim 15, the one or more attachment sensors configured to detect an improper removal of the medication delivery device caused by removal of medication delivery device while still being clamping onto by the clamping mechanism (explicitly stated in para. [0096]).
Regarding claim 16, Pryor teaches a method for detecting a medication delivery device in a reusable accessory, the reusable accessory comprising a housing configured to receive the medication delivery device, an adaptable element coupled to the housing, and one or more attachment sensors, the method comprising:
receiving, via the one or more attachment sensors, sensing data for receiving the medication delivery device in the housing of the reusable accessory (see para. [0096]);
determining, based on the received sensing data, whether the medication delivery device is reversibly attached, via the adaptable element, to the housing of the reusable accessory (see para. [0096]); and
presenting, via the at least one user interface, a status of the medication delivery device being reversibly attached to the reusable accessory via the adaptable element (see para. [0073]).
Regarding claim 17, the detecting of the medication delivery device being inserted into the housing comprises:
detecting, via a first proximity sensor of the one or more attachment sensors disposed adjacent to an open end of the housing, the medication delivery device entering a first position within the housing (see para. [0096]); and
changing at least one of the one or more attachment sensors from a standby mode to a high sensitivity mode upon the detecting of the medication delivery device entering the first position within the housing (see sensor activation in para. [0096]).
Regarding claim 18, further comprising:
the one or more attachment sensors include an accelerometer configured to detect for an acceleration corresponding to the reversibly attachment of the adaptable element to the medication delivery device (see para. [0097]).
Regarding claims 19, Pryor teaches a reusable accessory adaption kit comprising:
a first reuseable accessory (110, Fig. 3) including a housing (112, Fig. 3) and one or more attachment sensors coupled to the housing (122, Fig.10, paras. [0054], ]0067], [0073], [0096-0097]);
a first adaptive element (114, Fig. 4) configured to reversibly attach to a first medication delivery device (20) while reversibly coupled to the housing of the reusable accessory (see paras. [0050]-[0061]; Fig. 5); and
a second adaptive element different from the first adaptive element (114; explicitly stated in para. [0056] as part of a kit comprising “several different” adapters), the second adaptive element configured to reversibly attach to a second medication delivery device while reversibly coupled to the housing of the reusable accessory (“with different dispensing devices” stated in para. [0056]), a geometry of the first medication delivery device different from a geometry of the second medication delivery device (see para. [0056] stating adapters of “various sizes and with various dispensing device coupling mechanisms to couple with different dispensing devices 20”), wherein the one or more attachment sensors are configured to detect:
the reversible attachment of the first adaptive element to the first medication delivery device, when the first medication delivery device is received in the housing of the reuseable accessory (see inductive sensor, para. [0008]), and
the reversible attachment of the second adaptive element to the second medication delivery device, when the second medication delivery device is received in the housing of the reuseable accessory (see inductive sensor, para. [0008]).
Regarding claim 20, the geometry of the second medication delivery device is incompatible with revisable attachment via the first adaptive element, and the geometry of the first medication delivery device is incompatible with the revisable attachment via the second adaptive element (see para. [0056] stating adapters of “various sizes and with various dispensing device coupling mechanisms to couple with different dispensing devices 20”).
5. Claims 1, 2, 5-7, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0401656 (Pryor).
Regarding claim 1, Pryor teaches a reusable accessory (110, Fig. 4) for receiving a medication delivery device, comprising:
a housing (112, Fig. 4) configured to receive a medication delivery device;
an adaptive element (114, Fig. 4) coupled to the housing, the adaptive element being configured to reversibly attach to the medication delivery device (see para. [0041]); and
one or more attachment sensors (722, Fig. 7, [0042]-[0048]) coupled to the housing, the one or more attachment sensors configured to detect the adaptive element reversibly attaching to the medication delivery device (722, explicitly stated in para. [0047]).
Regarding claim 2, the one or more attachment sensors include an accelerometer configured to detect the one or more adaptive elements reversibly attaching to the medication delivery device (see para. [0048]).
Regarding claim 5, the adaptable element comprises an interchangeable collar reversibly coupled to the housing, wherein the interchangeable collar is configured to fit the medication delivery device (read as slider 118 in Fig. 4; see paras. [0041]-[0044]).
Regarding claim 6, further comprising: at least one user interface configured to communicate one or more notifications including an alert that the medication delivery device is not fully inserted into the reusable accessory, a time that the sensor last detected the adaptive element reversibly attaching to the medication delivery device, or whether there has been a missed dose (interface 130 in Fig. 4; taught to communicate information to a user in para. [0043]).
Regarding claim 7, the reuseable accessory is a pen cap for an insulin pen that is the medication delivery device (see cap 110 in Fig. 4; pen 20 dispenses insulin as taught tin para. [0028], cap 130 is for the pen 20 as taught in para. [0030]).
Regarding claim 19, Pryor teaches a reusable accessory adaption kit comprising:
a first reuseable accessory (110, Fig. 4) including a housing (112, Fig. 4) and one or more attachment sensors (122, Fig. 6, [0042]-[0048]) coupled to the housing;
a first adaptive element (114, Fig. 4) configured to reversibly attach to a first medication delivery device while reversibly coupled to the housing of the reusable accessory (see para. [0041]); and
a second adaptive element different from the first adaptive element (114; see para. [0041]), the second adaptive element configured to reversibly attach to a second medication delivery device while reversibly coupled to the housing of the reusable accessory, a geometry of the first medication delivery device different from a geometry of the second medication delivery device (see teaching in para. [0041] of differing “various differently sized, shaped, and/or otherwise configured pens 20”), wherein the one or more attachment sensors are configured to detect:
the reversible attachment of the first adaptive element to the first medication delivery device, when the first medication delivery device is received in the housing of the reuseable accessory (722, explicitly stated in para. [0047]), and
the reversible attachment of the second adaptive element to the second medication delivery device, when the second medication delivery device is received in the housing of the reuseable accessory (722, explicitly stated in para. [0047]).
Regarding claim 20, the geometry of the second medication delivery device is incompatible with revisable attachment via the first adaptive element, and the geometry of the first medication delivery device is incompatible with the revisable attachment via the second adaptive element (see teaching in para. [0041] of differing “various differently sized, shaped, and/or otherwise configured pens 20”).
6. Claims 1-10 and 13-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2024/145401 (Wakim).
Regarding claim 1, Wakim teaches a reusable accessory (2900, Fig. 29) for receiving a medication delivery device, comprising:
a housing (2902, Fig. 29) configured to receive a medication delivery device;
an adaptive element (2904, Fig. 29) coupled to the housing, the adaptive element being configured to reversibly attach to the medication delivery device (see para. [0209]); and
one or more attachment sensors (2908, Fig. 29; see para. [0210]) coupled to the housing, the one or more attachment sensors configured to detect the adaptive element reversibly attaching to the medication delivery device (see para. [0210]).
Regarding claim 2, the one or more attachment sensors include an accelerometer configured to detect the one or more adaptive elements reversibly attaching to the medication delivery device (see para. [0230]).
Regarding claim 3, the one or more attachment sensors include:
one or more proximity sensors coupled to the housing, the one or more proximity sensors being configured to detect the medication delivery device being inserted into the reusable accessory, and the accelerometer changes from a standby mode to a high sensitivity mode upon the detecting of the medication delivery device being inserted into the reusable accessory (all taught in para. [0230, noting the entering of the low or no power consumption mode after receiving no data from the accelerometer for a period of time).
Regarding claim 4, the adaptable element is an interchangeable snap ring reversibly coupled to a distal end of the housing of the reusable accessory device, wherein the interchangeable ring is configured to fit a geometry of a specific medication delivery device (1202; Fig. 12; see para. [0155]).
Regarding claim 5, the adaptable element comprises an interchangeable collar reversibly coupled to the housing, wherein the interchangeable collar is configured to fit the medication delivery device (1302; Fig. 130).
Regarding claim 6, further comprising: at least one user interface configured to communicate one or more notifications including an alert that the medication delivery device is not fully inserted into the reusable accessory, a time that the sensor last detected the adaptive element reversibly attaching to the medication delivery device, or whether there has been a missed dose (see para. [0221]).
Regarding claim 7, the reuseable accessory is a pen cap for an insulin pen that is the medication delivery device (102; see Fig. 1).
Regarding claims 8, an adaptive element is a clamping mechanism configured to reversibly attach to the medication delivery device by clamping onto the medication delivery device received in the housing (2904, Fig. 29; see para. [0209]).
Regarding claim 9, the clamping mechanism has a plurality of states, and the one or more attachment sensors are configured to detect a current state of the clamping mechanism from the plurality of states (release sensor [2908]; see para. [0209]).
Regarding claim 10, the clamping mechanism includes a clicking portion (see “clicker mechanism” in paras. [0192], [0257]) configured to rotate relative to the housing, and the one or more attachment sensors including a clicker sensor disposed adjacent to the clicking portion and to configured to detect when the clicking portion is in at least one rotational position.
Regarding claim 13, the one or more attachment sensors include a spring well sensor (3616, Fig. 36) configured to detect for a spring well of the clamping mechanism being in a specific position relative to the housing (see para. [0247]).
Regarding claim 14, a spring well includes a position indicator, and the spring well sensor detects spring well being in the specific position by detecting the position indicator moving into a position adjacent to the spring well sensor (see para. [0211]).
Regarding claim 15, the one or more attachment sensors configured to detect an improper removal of the medication delivery device caused by removal of medication delivery device while still being clamping onto by the clamping mechanism (see para. [0210]).
Regarding claim 16, Wakim teaches a method for detecting a medication delivery device in a reusable accessory, the reusable accessory comprising a housing configured to receive the medication delivery device, an adaptable element coupled to the housing, and one or more attachment sensors, the method comprising:
receiving, via the one or more attachment sensors, sensing data for receiving the medication delivery device in the housing of the reusable accessory (see para. [0222]);
determining, based on the received sensing data, whether the medication delivery device is reversibly attached, via the adaptable element, to the housing of the reusable accessory (see para. [0223]); and
presenting, via the at least one user interface, a status of the medication delivery device being reversibly attached to the reusable accessory via the adaptable element (see para. [0221]).
Regarding claim 17, the detecting of the medication delivery device being inserted into the housing comprises:
detecting, via a first proximity sensor of the one or more attachment sensors disposed adjacent to an open end of the housing, the medication delivery device entering a first position within the housing (see para. [0222]); and
changing at least one of the one or more attachment sensors from a standby mode to a high sensitivity mode upon the detecting of the medication delivery device entering the first position within the housing (see para. [0225]).
Regarding claim 18, further comprising:
the one or more attachment sensors include an accelerometer configured to detect for an acceleration corresponding to the reversibly attachment of the adaptable element to the medication delivery device (see para. [0230]).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0327973 (Pryor) as applied above under 35 U.S.C. 102(a)(1).
Regarding claim 3, Pryor fails to explicitly teach that the one or more attachment sensors include:
one or more proximity sensors coupled to the housing, the one or more proximity sensors being configured to detect the medication delivery device being inserted into the reusable accessory, and the accelerometer changes from a standby mode to a high sensitivity mode upon the detecting of the medication delivery device being inserted into the reusable accessory.
However, the reference teaches powering the device upon use (e.g. para. [0115]), which indicates a higher sensitivity mode. Given the multiple sensors disclosed (e.g. para. [0096]), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the proximity sensors to detect the medication delivery device being inserted into the reusable accessory, and the accelerometer changes from a standby mode to a high sensitivity mode upon the detecting of the medication delivery device being inserted into the reusable accessory, having a predictable outcome absent a teaching of an unexpected result.
9. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0327973 (Pryor) as applied above under 35 U.S.C. 102(a)(1), in view of US 6,280,421 (Kirchhofer).
Regarding claim 4, Pryor as applied above fails to teach that the adaptable element is an interchangeable snap ring reversibly coupled to a distal end of the housing of the reusable accessory device, wherein the interchangeable ring is configured to fit a geometry of a specific medication delivery device.
Kirchhofer, analogous to injection devices with caps, teaches “snap rings” as well-known connection type among many other common forms of interconnection (col. 5, lines 1-9). Moreover, it is well known to vary components to match size.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptive element of Pryor, providing a snap ring as taught by Kirchhofer, motivated by the use of a suitable alternative connection means, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
10. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0401656 (Pryor) as applied above under 35 U.S.C. 102(a)(1), in view of US 6,280,421 (Kirchhofer).
Regarding claim 4, Pryor as applied above fails to teach that the adaptable element is an interchangeable snap ring reversibly coupled to a distal end of the housing of the reusable accessory device, wherein the interchangeable ring is configured to fit a geometry of a specific medication delivery device.
Kirchhofer, analogous to injection devices with caps, teaches “snap rings” as well-known connection type among many other common forms of interconnection (col. 5, lines 1-9). Moreover, it is well known to vary components to match size.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptive element of Pryor, providing a snap ring as taught by Kirchhofer, motivated by the use of a suitable alternative connection means, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
11. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2024/145401 (Wakim).
Regarding claim 11, Wakim as applied does not teach the clicking portion includes one or more rotational indicators, the rotation of the clicker portion causes the rotational indicator to recurringly rotate into a position adjacent to the clicking sensor in which the clicking sensor detects the rotational indicator.
However, Wakim discloses different rotational positions in the clicker (3606) found in Figure 36, noting the different rotational positions are those at the bottom of the V-shaped valleys in Figure 36C. Additionally, the reference teaches the use of sensors to detect “various pen cap events” (para. [0113]), including those between the cap and pen (para. [0210]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptive element of Wakim, providing the clicking portion includes one or more rotational indicators as taught by another embodiment of Wakim, and further configuring the sensors to detect these clicking positions, motivated by the use of a suitable clicking mechanism, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Regarding claim 12, Wakim as applied does not teach clicking portion includes one or more rotational indicators, and the one or more rotational indicators are rotated into a position adjacent to the clicking sensor when the clamping mechanism is in a clamped position configured to apply a clamping force to the medication delivery device.
However, Wakim discloses different rotational positions in the clicker (3606) proximate clampling links (3614a and b) found in Figure 36, noting the different rotational positions are those at the bottom of the V-shaped valleys in Figure 36C. Additionally, the reference teaches the use of sensors to detect “various pen cap events” (para. [0113]), including those between the cap and pen (para. [0210]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptive element of Wakim, providing the clicking portion includes one or more rotational indicators as taught by another embodiment of Wakim, and further configuring the sensors to detect these clicking positions, motivated by the use of a suitable clicking mechanism, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al., 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES N SMALLEY whose telephone number is (571)272-4547. The examiner can normally be reached M-F 9:00 am to 6:00 pm.
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, Nathan Jenness can be reached at (571) 270-5055. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES N SMALLEY/Examiner, Art Unit 3733
Prosecution Insights