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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 10, 2025 has been entered.
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.
Claim(s) 1, 3, 5, 12, 14, 15, 19, 21, 23, 33, and 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2009/0028824 A1) in view of Flaherty et al. (US 2005/0203461 A1), Nielsen et al. (US 2006/0264835 A1), Hautaviita et al. (WO 2016/120207 A1) and Sluggett et al. (WO 2017/120639 A1)
With regard to claims 1, 3, 5, 12, 14, 15, 33, 35, and 37, Chiang et al. teach a tamper-resistant drug delivery device, comprising a removable cartridge (see components below which can be removed), a housing ([0044], [0045], represented by outline of 1600 in Fig. 16, exemplified in other embodiments showing the device structure), at least one processor (Fig. 16 controller 1672 would include a processor), and a user interface (Fig. 16 member 1678), the removable cartridge comprises a reservoir (Fig. 16 member 1604) containing a drug formulation suitable for subcutaneous, intradermal, or intramuscular administration and comprising an active pharmaceutical ingredient (ketamine (an NMDA receptor antagonist), [0108], [0109]); a cannula configured to deliver the drug formulation to the subject, the cannula in fluid communication with the reservoir (Fig. 16 fluid communicator 1606 which may be a needle or cannula [0030]); the housing comprises a pump mechanism configured for subcutaneously, intradermally, or intramuscularly administering the drug formulation from the reservoir to a subject (Fig. 16 member 1602, [0030]); upon coupling of the removable cartridge with the housing, the housing encloses the reservoir, the pump mechanism, and the cannula ([0044], [0045], represented by outline of 1600 in Fig. 16). Chiang et al. teach an inserter may be used (Figs. 6) but do not disclose a septum or automatic cannula system as recited. However, Flaherty et al. teach a medical delivery pump in which components may be separated into disposable and reusable components (exemplary Fig. 4D, [0132]) or in one piece (exemplary Fig. 2) which equivalently uses separate manual (exemplary Figs. 4) or integrated automatic cannula insertion systems which insert the cannula based on control signals (Figs. 9 spring 250, [0138], [0182]). The spring may be triggered to release by a solenoid which is electromagnetic in response to the control signal ([0138]). Further, Nielsen et al. teach using a septum over the opening through which a cannula is inserted to ensure sterility ([0092], Figs. 22, septum 331). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have disposable and reusable components separately housed in Chiang resulting in the removable cartridge and housing as Flaherty et al. teach having one piece or separate components which yield the same result and can provide the added benefit of reuse of some components. As combined the components are connected, the overall outer wall is taken to form the housing. The Examiner notes there is no overall structure to the removable cartridge claimed other than the components which comprise the cartridge. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an automatic cannula system triggered electromagnetically and a septum in Chiang et al. as Chiang et al. already teaches cannula insertion and the mechanism provided by Flaherty et al. provides equivalently for automatic insertion and yields the same predictable result. This would also be beneficial in preventing loss of a cannula insertion mechanism as it is incorporated into the pump. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a septum in Chiang et al. to enclose the cannula within the housing, thus sealing the cartridge and preventing the fill port from being exposed as Nielsen et al. teach this is beneficial to ensure sterility. Chiang et al. do not disclose an NFC tag to lock and unlock the system. However, Hautaviita et al. teach a drug delivery device which contains an NFC tag which when brought into communication with a reader (i.e. processor) allow the device to be unlocked and activated which enhances safety and prevents unintended use (Pg. 1 lines 14-25, Pg. 12 lines 15-31, Pg. 16 line 30-Pg. 17 line 2 and lines 19-27, Pg. 19 lines 8-26). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an NFC tag to communicate with a processor to unlock the device of Chiang et al. as in Hautaiita et al. as Hautaviita et al. teach this is beneficial to enhance safety and prevent unintended use. As combined the processor would be an additional processor separate from the one cited above and would be placed in the housing. As combined the NFC tag would work in conjunction with the cannula insertion mechanism to trigger release to prevent unintended use. Chiang et al. teach a selected release profile may be selected based on input at the interface which may include programmed release profiles ([0027], [0082], [0096]). Chiang et al. do not explicitly disclose the pre-programmed dose regimen which is selectable from a plurality of options in not configurable by the subject. However, Sluggett et al. teach an infusion pump which may have in interface with non-tamperable or non-editable infusions programs for selection be pre-programmed with a selection of regimens by a clinician which is beneficial to prevent tampering or error ([0014], [0073]-[0076], [0081]-[0083], [0099]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a non-tamperable interface providing a selection of infusion profiles in Chiang et al. as Sluggett et al. teach this is beneficial for safety and reduces error. As such the regimen is also locked as it cannot be changed.
With regard to claim 19, the pump may be used to deliver various drugs which may have various delivery requirements with regard to bolus delivery, continuous delivery, or flow rate ([0033], [0077], [0078], [0107], [0111], claim 46, claim 49).
With regard to claims 21 and 23, see Sluggett et al. see at least [0081].
With regard to claim 36, Flaherty et al. further teach the cannula can be retracted ([0182], retraction mechanism can be combined with any embodiments). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to retract the cannula in Chiang et al. as in Flaherty et al. as this would enhance safety by protecting the cannula after use and allow both insertion and retraction.
Claim(s) 2, 8, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2009/0028824 A1), Flaherty et al. (US 2005/0203461 A1), Nielsen et al. (US 2006/0264835 A1), Hautaviita et al. (WO 2016/120207 A1), and Sluggett et al. (WO 2017/120639 A1) as applied to claim 1 above, and further in view of Charney et al. (US 2017/0181966 A1).
With regard to claims 2, 8, and 26, Chiang et al. teach a device substantially as claimed. Chiang et al. do not specifically disclose the dose provides an effective steady state drug plasma concentration for at least 8 hours and which reduces side effects. However, Charney et al. specifically discloses the dosages are titrated under the care of a physician to determine an amount that is effective to alleviate depression but does not cause dysphoria or psychosis and is dependent on various factors and once the dosage range is established can be provided on an as-needed, dose-to-effect basis ([0020], [0076], [0077], [0083]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention that the dosage provided by Chiang et al. provides an effective steady state drug plasma concentration for at least 8 hours which reduces side effects because Charney et al. teach dosage adjustment under the care of the physician to determine the effective dosage which varies based on various factors and would be effective without causing additional problems such as dysphoria or psychosis. As Charney et al. teach it is within the ordinary skill in the art to adjust the dose to find an effective amount for treatment one of ordinary skill would be able to provide a dose which yields an effective steady state drug plasma concentration.
With regard to claim 25, Chiang et al. teach a device substantially as claimed but does not recite the infusion rate as claimed. Charney et al. provides an exemplary rate in an intravenous example of 0.5 mg/kg over 40 minutes ([0048]). Charney et al. discloses the dosages are titrated under the care of a physician to determine an amount that is effective to alleviate depression but does not cause dysphoria or psychosis and is dependent on various factors and once the dosage range is established can be provided on an as-needed, dose-to-effect basis ([0020], [0076], [0077], [0083]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention that the dose may be delivered at a rate of 0.1 mg/hour in Chiang et al. as Charney et al. teach dosages are adjusted by the physician based on particular patient factors and the physician would be able to determine the rate as effective for treatment. The Examiner notes the rate is a functional recitation of the dose and a device would be capable of delivering at such a rate.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2009/0028824 A1), Flaherty et al. (US 2005/0203461 A1), Nielsen et al. (US 2006/0264835 A1), Hautaviita et al. (WO 2016/120207 A1), and Sluggett et al. (WO 2017/120639 A1) as applied to claim 1 above, and further in view of Kalyanpur et al. (US 2018/0060527 A1).
With regard to claim 22, Chiang et al. and Sluggett et al. teach communicating with a remote device but do not explicitly disclose monitoring remotely. However, Kalyanpur et al. teach a pump for delivering ketamine in the treatment of depression ([0004]) which uses wireless communication to program and monitor the delivery device to ensure proper usage (abstract, [0026], [0047], [0048], [0054]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate remote access, monitoring, or communications modules into the pump of Chaing et al. as combined with Sluggett et al. as Kalyanpur et al. teach it is effective to provide and ensure proper dosing.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2009/0028824 A1), Flaherty et al. (US 2005/0203461 A1), Nielsen et al. (US 2006/0264835 A1), Hautaviita et al. (WO 2016/120207 A1), and Sluggett et al. (WO 2017/120639 A1) as applied to claim 1 above, and further in view of Applicant Admitted Prior Art (AAPA).
With regard to claim 30, Chiang et al. teach a device substantially as claimed and that Ketamine can be delivered but does not specifically disclose a cyclodextrin excipient. However, AAPA discloses that cyclodextrin is known to assist in delivery and can dramatically influence solubility of the API in aqueous solutions, dissolution rates, can influence product stability, and pharmacokinetic properties of the pharmaceutical preparation ([204]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a cyclodextrin excipient along with the substance in Chiang et al. as AAPA discloses this is beneficial for influencing solubility, dissolution rate, product stability, and pharmacokinetic properties.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2009/0028824 A1), Flaherty et al. (US 2005/0203461 A1), Nielsen et al. (US 2006/0264835 A1), Hautaviita et al. (WO 2016/120207 A1), and Sluggett et al. (WO 2017/120639 A1) as applied to claim 1 above, and further in view of Seguin et al. (US 2016/0354558 A1).
With regard to claim 32, Chiang et al. discloses feedback maybe used ([0096]) but does not disclose the device is configured to limit the dose according to a set threshold. However, Sequin et al. teach a device for delivering ketamine ([0094]) and comparing measured values to stored threshold values to ensure dosing compliance and limit delivery if values are not within threshold limits ([0068], [0079]-[0082], [0088], claim 12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use threshold value comparisons to control dose delivery in Chiang et al. as Sequin teaches this is beneficial to ensure desired delivery as prescribed by the medical personnel.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant did not provide any detailed arguments beyond saying the references do not disclose the amended limitations, the limitation is found to be taught by Flaherty as rejected above. The objection to claim 1 is overcome by the amendments.
Conclusion
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783