DETAILED ACTION
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 .
Response to Amendment
The amendment filed December 5, 2025 has been entered. Claims 1-17 and 20-21 remain pending in the application, and claims 18-19 were cancelled. Applicant’s amendments to the claims have overcome each and every claim objection, 112 rejection, and 103 rejection previously set forth in the Non- Final Office Action mailed June 17, 2025. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 103 Rejections below.
Claim Objections
Claims 8-9 are objected to because of the following informalities: “complimentary” should read “complementary”. Appropriate correction is required.
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.
Claims 1-4, 5-11, 13-16, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US20190200985A1; hereinafter known “Shelton”) in view of Kiani et al. (US20190374173A1; hereinafter known as “Kiani”).
Regarding claim 1, Shelton teaches an integrated physiological monitoring and tissue anchoring device (See Shelton abstract) having a distal portion and a proximal portion (See Shelton Figure 21 150200 is the shaft assembly which has a distal portion and a proximal portion), the device comprising: a clamp at the distal portion (See Shelton clamp 150300) comprising: at least one arm configured to grasp a side of tissue and having a top face and a bottom face (See Shelton Figure 21; [0318] “The end effector 150300 may include an anvil 150306 that is pivotally supported relative to the elongated channel 150302.”); an opposing substrate configured to engage an opposing side of the tissue and comprising a sensor mounted thereon that is configured to sense at least one physiological parameter from a gastrointestinal tract (See Shelton [0279] “The sensors 738 may be located on the staple cartridge 718 deck to determine tissue location using segmented electrodes. The torque sensors 744a-744e may be configured to sense force such as firing force, closure force, and/or articulation force, among others. Accordingly, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the staple cartridge 718 has tissue on it, and (4) the load and position on both articulation rods.”; Fig. 24 [0324] “The surgical staple cartridge 150304 can include a molded cartridge body 150194”); a cable connecting the handle to the clamp and having a frangible section at the distal portion at a location distal to the handle and proximal to the clamp such that the clamp is detachable from the cable at the frangible section (See Shelton Figure 21 clamp is detachable Figure 22; [0186] “The energy delivery implement is configured to deliver ultrasonic and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable extending initially through the shaft.”).
Shelton does not teach a controller operatively coupled to the sensor; and
a drug dispenser operably coupled to the controller, the controller programmed to actuate release of a medication from the drug dispenser into the patient in response to a determination that the at least one physiological parameter sensed by the sensor falls outside a threshold value or range for the at least one physiological parameter or in response to a determination that the at least one physiological parameter meets a pre-defined condition. However,
Kiani teaches a controller operatively coupled to the sensor ([0008] “A system to monitor for indications of opioid overdose and to deliver therapeutic drugs can comprise a sensor wearable by a user configured to obtain data indicative of at least one physiological parameter of the user; a signal processor configured to process the data to provide the at least one physiological parameter”; [0240] “The activation circuitry 1206”); and
a drug dispenser operably coupled to the controller, the controller programmed to actuate release of a medication from the drug dispenser into the patient in response to a determination that the at least one physiological parameter sensed by the sensor falls outside a threshold value or range for the at least one physiological parameter or in response to a determination that the at least one physiological parameter meets a pre-defined condition ([0007]; [0008] “a drug delivery apparatus wearable by the user and configured to deliver one or more doses of a therapeutic drug. The drug delivery apparatus can comprise a delivery device that includes a dose of a therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device to dispense the therapeutic drug from the reservoir through the drug delivery channel, and activation circuitry to activate the dispensing device.”; [0237] “The activation circuitry 1106 is configured receive an activation signal via the antenna 1114 and activate a delivery mechanism 1108 to dispense medication in the reservoir 1110 through the drug delivery channel 1112 through the skin, intramuscularly or intravenously”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Shelton to include a controller and drug dispenser. One would have been motivated to make this modification because setting a threshold can indicate respiratory distress to providing emergency treatment that can prevent irreparable harm from occurring, and a self-administering delivery device can administer medication without user action for opioid overdoes, as suggested by Kiani ([0007], [0199]).
Regarding claim 2, Shelton teaches the at least one arm is two arms separated by a space (See Shelton Figure 21-part 150200 has two arms 150306 and 150302).
Regarding claim 3, Shelton teaches the two arms form a substantially Y-shape (See Shelton Figure 21 part 150306 and 150302 form a y shape).
Regarding claim 4, Shelton teaches the distance between the two arms is greater than a width of the sensor (See Shelton Figure 21 part 150306 and 150302, the distance between is less than the tip width of sensor. See [0352] and 266471 Figure 31).
Regarding claim 5, Shelton teaches wherein each of the two arms (See Shelton Figure 21 part 150306 and 150302) comprises a prong at the distal end thereof configured to engage and grasp the side of the tissues (Shelton [0318] “an end effector 150300 comprising an elongated channel 150302 configured to operably support a surgical staple cartridge 150304 therein”; The staples are capable of engaging and grasping the tissue).
Regarding claim 6, Shelton teaches wherein the substrate (See Shelton Figure 21 adhesive mask could be created in bulk using screen printing technology on a polyester substrate also see [0358], the jaws 26001 and 26002 ) comprises a prong at a distal end thereof configured to engage and grasp the opposing side of the tissue (Shelton [0318] “an end effector 150300 comprising an elongated channel 150302 configured to operably support a surgical staple cartridge 150304 therein”; The staples are capable of engaging and grasping the tissue).
Regarding claim 7, Shelton teaches the at least one arm comprises a single arm (See Shelton Figure 21) having a prong at a distal end thereof (Shelton [0318] “an end effector 150300 comprising an elongated channel 150302 configured to operably support a surgical staple cartridge 150304 therein”; The staples are capable of engaging and grasping the tissue).
Regarding claim 8, Shelton teaches the distal end of the substrate defines an opening having a shape and size complimentary to the prong of the single arm (See Shelton Fig. 24 displays an opening/slot 150197 complementary to the staple cartridge [0325] “a slot 150193 defined in the cartridge body 150194 can be aligned with a longitudinal slot 150197 defined in the cartridge tray 150196”).
Regarding claim 9, Shelton teaches the prong of the single arm and the complimentary opening of the substrate are substantially V-shaped (See Shelton Figure 21 adhesive mask could be created in bulk using screen printing technology on a polyester substrate also see [0358], the jaws 26001 and 26002 form a v shape; [0318] the end effector and the channel with the staple cartridge 150305 form a v shape.).
Regarding claim 10, Shelton teaches the top surface of the substrate has a plurality comprises a plurality of ridges (See Shelton Figure 21 [0408], adhesive mask placed on staple cartridge, also see Figure 31 the staple cartridge forms ridges).
Regarding claim 11, Shelton teaches the bottom surface of the at least one arm comprises a plurality of ridges (See Shelton Figure 21 [0408], adhesive mask placed on staple cartridge, also see Figure 31 the staple cartridge forms ridges).
Regarding claim 13, Shelton teaches the sensor is mounted on a printed circuit board which, in turn, is mounted on the substrate (See Shelton Figure 21 the sensor is mounted on circuit board [0006] also see [0408], the sensors can be placed on substrate cartridge).
Regarding claim 14, Shelton teaches the top surface of the sensor is substantially flush with the top surface of the substrate (See Shelton the sensor is mounted on circuit board [0006] also see [0408], the sensors can be placed on substrate cartridge ).
Regarding claim 15, Shelton teaches the top surface of the sensor is proud of the top surface of the substrate (See Shelton Figure 21 the sensor is on top of the arm 150304).
Regarding claim 16, Shelton teaches wherein the at least one arm comprises a solid body with no window defined by the top face and the bottom face of the at least one arm (See Shelton Figure 24, which depicts the arm 150304 being a solid body not having a window).
Regarding claim 20, Shelton teaches a radio configured to communicate with an external device (See Shelton [0207], radio communication wireless); and a controller programmed to control the operation of the radio to send an alert to the external device in response to determining that the subject is experiencing a medical condition (See Shelton [0225][0264], microcontroller).
Regarding claim 21, Shelton teaches the device of claim 1.
Shelton does not teach wherein the medication of the drug dispenser comprises an opioid agonist.
However,
Kiani teaches wherein the medication of the drug dispenser comprises an opioid agonist ([0100] “The delivery device can automatically administers an opioid receptor antagonist in response to the indication of an opioid overdose event. The delivery device can comprise a patch that includes a reservoir with the medication, a needle, and a battery.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Shelton to include an opioid agonist. One would have been motivated to make this modification because it is critical to administer an opioid receptor agonist to victims of opioid overdoes as soon as possible and self-administering delivery devices can administer the medication without user action, as suggested by Kiani ([0199]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Kiani in view Burbank et al. (US20030120306A1; hereinafter known as “Burbank”).
Regarding claim 11, Shelton teaches the surface of the at least one arm comprises a plurality of ridges (See Shelton Figure 21 [0408], adhesive mask placed on staple cartridge, also see Figure 31 the staple cartridge forms ridges).
Shelton is does not explicitly teach the bottom surface having ridges.
However,
Burbank teaches the bottom surface having ridges (See Shelton Figure 3 ridge 22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Shelton with ridges on the bottom surface to maintain force and pressure when gripping the tissue (See Burbank [0024]).
Claim 12, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view Kiani in view of Hu et al. (US20140088387; hereinafter known “Hu”).
Regarding claim 12, Shelton teaches the sensor (See Shelton [0006]).
Shelton does not teach the reflective pulse oximeter.
However,
Hu teaches a pulse oximeter device and further teaches the reflective pulse oximeter (See Hu [0017]). It would be obvious to one ordinary skill in the art before the effective filing date of the present application to modify Shelton with a pulse oximeter sensor as taught by Hu to further diagnose users’ oxygen levels.
Regarding claim 17, Shelton teaches the top face and the bottom face (See Shelton Figure 21, the arms are extending from 150270).
Shelton does not teach one arm defines a window extending therethrough.
However,
Hu teaches the at least one arm defines a window extending therethrough (See Hu Figure 1 102 with window). It would be obvious to one ordinary skill in the art before the effective filing date of the present application to modify Shelton to include at least one arm defines a window extending therethrough as taught by Hu to grasp the tissue.
Response to Arguments
Applicant's arguments filed December 5, 2025 have been fully considered. With respect to the 103 Rejections in the Non-Final Office Action (See Pages 5-7 of Applicant’s Response), Applicant argues that Shelton does not teach a controller programmed to acuate release of a medication from a drug dispenser. Applicant also argues that Glen, Burbank, and Hu do not make up for this deficiency.
There are new grounds of claim rejections that were necessitated by the claim amendments.
The Kiani reference was not previously relied upon in the Non-Final Rejection. Kiani discloses the controller and drug dispenser described in claim 1, and it would be obvious to incorporate these elements into the device taught by Shelton as described in the 103 Rejection above.
Claims 2-17 and 20-21 are rejected because the rejection of claim 1 is proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 103 Rejections.
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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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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