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 Amendments filed 04/30/2026 have been entered.
Claims 1, 6, 7 and 12 have thereby been amended.
Claims 1, 3-7, 11, 12, 16 and 18 are being examined in this office action.
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.
Claim 7 is 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 7, according to the 04/30/2026 amendments, recites “a scannable identifier tag coupled with the drug product container, the fluid path, and the drug delivery device.” It is unclear if this language is used to claim a single identifier tag that is simultaneously coupled to each the drug product container, the fluid path, and the drug delivery device (for which it is unclear how a single tag would be capable of being coupled to all three distinct and separate structures, and for which support is lacking in the disclosure), or if the language is used to describe multiple of the same type of scannable identifier tags coupled to each of the three structures. Because the instant disclosure discloses separate tags coupled to each of the separate elements (see Fig. 11 and paras. [0057]-[0058] of the specification), for the purposes of examination, claim 7 is interpreted as claiming separate scannable identifier tags, each coupled to each of the drug product container, the fluid path, and the drug delivery device.
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.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen (US 20130317753) in view of Tsoukalis (US 20190001057), herein referred to as Tsoukalis’19, in further view of Lurvey (US 8679075) in further view of Palmroos (US 20090157432).
Regarding claim 1, Kamen discloses a drug delivery system for delivering a drug product (100), comprising: a drug product container containing a drug product (170); a fluid path adapted to receive the drug product from the drug product container (Fig. 1: bold line tubing connecting 170/148 to 7, and 7 to patient 2; page 20, para. [0361], sentence 2); and a drug delivery device positioned along and/or adjacent to the fluid path (7), the drug delivery device having: a housing (visualized in 830 in Fig. 8); a drive component at least partially supported by and/or surrounded by the housing (Fig. 152: motor 15204; page 23, para. [0384], sentence 5); and a controller (Fig. 1: 124A + 1) workingly coupled with the drive component for controlling the drug delivery device (page 23, para. [0384], sentence 5), wherein the controller is adapted to operate in a normal operation mode (page 2, para. [0032], sentence 3: standard/default operation according to provided patient-treatment parameters) and switch to a reserve mode when the drug product reaches or is estimated to reach a predetermined threshold (page 27, para. [0411], sentence 1), the controller further adapted to provide user notifications (page 27, para. [0411], last sentence) comprising at least one of haptic feedback, visual alerts, and audio feedback (page 27, para. [0411], last sentence; para. [0406], sentence 3, the monitoring client 11 being a smart-phone, laptop, tablet, etc., delivering visual/audio notifications) if a user does not change the drug product container (para. [0414], last sentence). However, although Kamen teaches escalating user notifications in response to detected errors (para. [0586], sentences 4-5), Kamen does not explicitly disclose escalating notifications, the fluid displacement assembly of the delivery device, or that the reduced flow rate is dispensed at a ramp-down rate. Kamen also fails to explicitly disclose the fluid displacement assembly surrounded by the housing.
Tsoukalis’19 teaches an analogous drug delivery system with a fluid displacement assembly at least partially supported by and/or surrounded by the housing (Fig. 4: curved portion of 14 surrounding label 23); the drive component adapted to drive the medicament through the fluid displacement assembly (Fig. 4: 23; page 5, para. [0049], sentence 4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery system of Kamen by incorporating the specific fluid displacement assembly surrounding the rotary peristaltic mechanism taught by Tsoukalis’19 in order to achieve a simple and cost-effective pumping mechanism in the drug delivery device.
Lurvey teaches an analogous drug delivery device, which provides a controller adapted to provide escalating user notifications wherein the escalating user notifications increase in frequency and/or intensity when any directed action by the user is not completed (col. 20, lines 37-40). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the escalating alarm system of the Kamen-Tsoukalis’19 device by incorporating the specific teaching of Lurvey that alarms will escalate for any action that is not completed or is ignored by the user, as such, escalating the intensity of the alarm for changing the drug product container as taught by Kamen, in order to ensure that the user is unable to ignore changing the drug product container.
Kamen in view of Tsoukalis’19 teaches the drug delivery system wherein in the reserve mode, the controller causes the drug product to be dispensed at a reduced flow rate (Kamen: para. [0414]). However, Kamen in view of Tsoukalis’19 fails to explicitly teach that the reduced flow rate is dispensed at a ramp-down rate. Palmroos teaches an analogous drug delivery pumping system that teaches the changes in delivery rate as tapered on a gradient such that a reduction in the rate of drug delivery is delivered at a ramp-down rate wherein an infusion rate of the drive component progressively ramps down (page 5, para. [0052], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rate-reduction mode of the Kamen-Tsoukalis’19 system by incorporating the ramp-down “Taper” pump programming taught by Palmroos in order to avoid the associated safety risks of suddenly stopping or reducing the intravenous delivery of certain drugs.
Regarding claim 3, Kamen in view of Tsoukalis’19 in further view of Lurvey in further view of Palmroos teaches the drug delivery system of claim 1, as described above, wherein the controller is adapted to operate in the normal operation mode for a predetermined time (Kamen: page 19, para. [0357], sentence 1).
Regarding claim 4, Kamen in view of Tsoukalis’19 in further view of Lurvey in further view of Palmroos teaches the drug delivery system of claim 1, as described above, wherein the drug product container contains a reserve quantity of drug product to operation in the reserve mode (Kamen: predetermined amount of the residual volume; page 27, para. [0411], sentence 1).
Regarding claim 5, Kamen in view of Tsoukalis’19 in further view of Lurvey in further view of Palmroos teaches the drug delivery system of claim 1, as described above, wherein the controller further includes at least one of an alarm or a feedback mechanism to alert a user upon initiation of the reserve mode (Kamen: page 27, para. [0411], last sentence).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kamen (US 20130317753) in view of Tsoukalis (US 20190001057), herein referred to as Tsoukalis’19, in further view of Tsoukalis (EP 2708251), herein referred to as Tsoukalis’251.
Regarding claim 6, Kamen discloses a drug delivery system for delivering a drug product (100), comprising: a drug product container containing a drug product (170); a fluid path adapted to receive the drug product from the drug product container (Fig. 1: bold line tubing connecting 170/148 to 7, and 7 to patient 2; page 20, para. [0361], sentence 2); and a drug delivery device positioned along and/or adjacent to the fluid path (7), the drug delivery device having: a housing (visualized in 830 in Fig. 8); a drive component at least partially supported by and/or surrounded by the housing (Fig. 152: motor 15204; page 23, para. [0384], sentence 5); and a controller (Fig. 1: 124A + 1) workingly coupled with the drive component for controlling the drug delivery device (page 23, para. [0384], sentence 5), wherein the controller is adapted to send a user output when a low drug event has occurred (page 27, para. [0411], last sentence). However, Kamen does not explicitly disclose the fluid displacement assembly of the delivery device.
Tsoukalis’19 teaches an analogous drug delivery system with a fluid displacement assembly at least partially supported by and/or surrounded by the housing (Fig. 4: curved portion of 14 surrounding label 23); the drive component adapted to drive the medicament through the fluid displacement assembly (Fig. 4: 23; page 5, para. [0049], sentence 4), wherein the fluid displacement assembly comprises a rotary peristaltic pump (para. [0046], sentence 2) including a circular tubing loop positioned within a pump race to urge fluid through the fluid path (Fig. 4: peristaltic pump 23 with surrounding circular tubing loop 14). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery system of Kamen by incorporating the specific fluid displacement assembly surrounding the rotary peristaltic mechanism taught by Tsoukalis’19 in order to achieve a simple and cost-effective pumping mechanism in the drug delivery device. However, both Kamen and Thsoukalis’19 fail to disclose the detailed structures of the pump.
Tsoukalis’251 teaches an analogous drug delivery pump configured to be compressed by a rotating eccentric hub (Fig. 2: eccentric hub 210/230) having a sleeve bearing positioned between the eccentric hub and the circular tubing loop to urge fluid through the fluid path (Figs. 2-3: sleeve bearing 2 between 210/230 and tubing loop 4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the peristaltic pump of the Kamen-Tsoukalis’19 delivery device by incorporating the eccentric hub and surrounding sleeve bearing taught by Tsoukalis’251, in order to efficiently and consistently squeeze the tubing to drive the fluid through it with improved accuracy (col. 11, para. [0040]).
Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsoukalis (US 20170290974), herein referred to as Tsoukalis’17 in view of Boyle (US 20170000946) in further view of Wehba (US 20070233520).
Regarding claim 7, Tsoukalis’17 discloses a drug delivery system for delivering a drug product (Fig. 7a), comprising: a drug product container containing a drug product (16b); a fluid path adapted to receive the drug product from the drug product container (tubing 26a + 54 + 56); a drug delivery device positioned along and/or adjacent to the fluid path (42); and a scannable identifier tag coupled with the drug product container (Fig. 3: 24; page, 6, para. [0107], sentence 1), the fluid path (Fig. 5: 24; page 6, para. [0110], sentences 3-4), the scannable identifier tag adapted to provide information regarding the drug product container (page 5, para. [0062]) selected from the following list: drug product date of manufacture, drug product expiration date, drug product volume (page 5, para. [0062]), drug product lot number, drug product model number, drug product region, and/or drug product temperature information when the scannable identifier tag is coupled with the drug product container. However, Tsoukalis’17 fails to disclose the information provided from the scannable identifier tag coupled with the fluid path or that the scannable identifier tag is coupled to the drug delivery device.
Boyle teaches an analogous drug delivery system wherein the scannable identifier tag coupled with the fluid path (Fig. 11: 180) is adapted to provide information selected from the following list: IV line date of manufacture, IV line expiration date, IV line lot number (page 8, para. [0074], end of column 1 and beginning of column 2), IV line model number, IV line region, IV line length and/or IV line time in use. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Tsoukalis’17 system by incorporating the scannable tag and verification of the IV lines taught by Boyle in order to further minimize the drug delivery error by further verifying the correct line pairing and preventing a future shortage of necessary line-types for future minimization the drug delivery error (page 8, para. [0074], end of column 1 and beginning of column 2). However, Tsoukalis’17 in view of Boyle fails to teach that the scannable identifier tag is coupled to and provides information regarding the drug delivery device.
Wehba teaches an analogous drug delivery system with scannable tags for verification, wherein the scannable identifier tag coupled with the drug delivery device (Figs. 1 and 5: 92 coupled to the infusion pump) is adapted to provide information (3131) selected from the following list: authenticating information, whether a cartridge is new, volume of drug product delivered, expiration information, desired priming volumes, desired flow rates (page 9, para. [0084], last sentence; order details: page 7, para. [0069], sentence 2), therapy log information, whether IV lines are new, and/or whether IV lines are compatible. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Tsoukalis’17-Boyle system by incorporating the scannable tag and verification of the drug delivery device taught by Wehba in order to further minimize the drug delivery error by further verifying the correct equipment and drug pairing and administration procedures for the patient (page 7, para. [0069], sentence 2).
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Laurence (US 20180353682) in view of Heikenfeld (US 20170095184) in further view of Schindhelm (US 20140364758).
Regarding claim 12, Laurence discloses a drug delivery system for delivering a medicament to a user, comprising: a drug product container containing a medicament (21); a fluid path adapted to at least selectively fluidly connected the drug product container and the user (300; page 11, para. [0147]); a sensor positioned adjacent and/or on the user (840, 11a, 11b; page 10, para. [0138]); and a drug delivery device positioned adjacent to and/or along the fluid path (10), the drug delivery device having: a housing (12) adapted to contact skin of the user (Fig. 1B: 810 as part of control system 800); a pump coupled with the housing (100); a drive component for driving the medicament through the pump (101); and a controller workingly coupled with the drive component (810) and the sensor, wherein the controller is adapted to adjust at least one parameter of the drive component (page 4, para. [0069]; page 17, para. [0201]). However, Laurence fails to explicitly disclose that the sensor can measure cytokine levels.
Heikenfeld teaches an analogous drug delivery device with an integrated sensor adapted to measure cytokine levels (324; page 4, para. [0040], last two sentences) in sweat from the user (page 5, para. [0043]), the sensor comprising a wearable sensor (Fig. 3, 324; Laurence: page 6, para. [0079], last sentence), that alter the delivery parameters of the drug and adjust at least one parameter of the drive component based on the cytokine level measured by the sensor, the controller further adapted to stop the drive component upon the cytokine level reaching a predetermined threshold (page 4, para. [0040], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Laurence drug delivery system by incorporating the sweat cytokine sensor and feedback taught by Heikenfeld in order to accurately and determine how much of the delivered drug has already been metabolized to accurately determine when the intended patient-specific delivery has been achieved (page 5, para. [0043]).
Schindhelm teaches an analogous drug delivery system having cytokine sensors (paras. [0155] and [0087]), the controller further adapted to alert emergency services upon the sensed level reaching the predetermined threshold (para. [0082], second half of the paragraph). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cytokine level sensing drug delivery device of Laurence-Heikenfeld by incorporating the feature of automatic emergency services contacting, as taught by Schindhelm, in order to get emergency care for the user if the critical cytokine levels reach a threshold, in order to treat potentially life-threatening allergic reactions.
Regarding claim 16, Laurence in view of Heikenfeld in further view of Schindhelm teaches the drug delivery system as in claim 12, as described above, wherein the sensor is wirelessly connected to the controller (Heikenfeld: page 3, para. [0030]; Laurence: page 9, para. [0121]).
Response to Arguments
Applicant's arguments filed 04/30/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Kamen’s escalating notifications are for error detection and are not tied to a specific user corrective action of changing the drug product container. However, this amended limitation now relies on the combination of Kamen in view of Lurvey. Kamen teaches that an alarm alerts the user to change the drug product container, and Lurvey teaches an escalating alarm system if a prompted action is not completed by the user. As such, it would have been obvious for a person of ordinary skill in the art to combine the teachings of Lurvey and Kamen such that the alarms escalate in response to the drug container not being changed after its initial alert. As the Kamen device already discloses an alert system for changing the drug container when it empties, it would be obvious and would not rely upon hindsight reasoning to incorporate Lurvey’s teaching of alarm escalation if the action is not completed.
Regarding claim 1, Applicant also argues that Palmroos does not teach using a taper/ramp-down rate as an autonomous reserve mode response. However, Palmroos is not relied upon to teach this limitation in full. Rather, Kamen is relied upon to teach that the flow rate of the drug is automatically reduced when the reserve mode is initiated. Palmroos is merely used to teach the incorporation of ramping/tapering down that flow rate to prevent a potential sudden drop in the flow rate.
Regarding claim 6, Applicant’s arguments regarding the amended limitation for the sleeve bearing are considered moot, as Tsoukalis’251 is now relied upon to teach the specific structures of the pump including the sleeve bearing around the eccentric hub.
Regarding claim 7, Applicant argues that the combined references fail to teach a single scannable tag coupled simultaneously to each of the drug product container, the fluid path, and the drug delivery device. However, Applicant’s disclosure fails to support this structural relationship, or how it would even be possible. The specification and drawings of the instant application both disclose separate scannable tags on each of the three elements, as are taught by the combination of references for the rejection of claim 7.
For these reasons, claims 1, 3-7, 11, 12, 16 and 18 stand rejected as recited above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kamen (US 20190167902) explicitly teaches that escalating alarms consist of alarms that increase in volume and/or intensity (para. [0079]).
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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