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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage App. PCT/EP2021/074091 filed September 1, 2021 and U.S. Provisional App. No. 63/073,016 filed September 1, 2020.
Status of Claims
This Office Action is responsive to the amendment filed on April 22, 2026. As directed by the amendment: claims 1, 4, 5 and 26-27 have been amended and claims 2 and 3 have been cancelled. Thus, claims 1 and 4-31 are presently pending in this application.
Claim(s) 1, 2, 8-17, 23-25, and 28-31 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poutiatine et al. (WO 2007/081947 A2). Claim(s) 3 and 7 were previously rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine et al. (WO 2007/081947 A2) in view of Lanzkowsky (U. S. Pub. No. 2018/0110939). Claim(s) 4-6 were previously rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine et al. (WO 2007/081947 A2) in view of Adelaar et al. (U.S. Pat. No. 10,737,041). Claims 18-19 and 26-27 were previously objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Claim Interpretation
The term “substantially” in the limitation “thereby destroy substantially all of the drug” in claim 1, 5, 26, and 27 are interpreted to not meaningfully alter the plain meaning of the “thereby destroy all of the drug” and allows for minor variance in manufacturing and minimal variations under conditions of use. See MPEP 2173.05 (b)
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.
Claim(s) 1, 4-5, 8-17, 20-25, and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine et al. (WO 2007/081947 A2; hereinafter: “Poutiatine”) in view of Minskoff (U.S. Pub. No. 2019/0314586).
Regarding Claim 1, Poutiatine discloses a drug delivery system, comprising: a tip (A, Fig. A annotated below) configured to be positioned in a nose of a patient (¶¶ 0098, 0102, 0106, 0264; Examiner notes: Poutiatine discloses the drug delivery system allows user to deliver the drug dosage form to the appropriate location including the nasal.), the tip having an opening (B, Fig. A annotated below) therein; a drug holder (40; Fig. 1A-1D) containing a drug (¶¶ 0126-0143) therein that is configured to exit through the opening (¶¶ 0126-0143); and a destruction mechanism (¶¶ 0122, 0139, 0181, 0182, 0234; Claims 33-35; Fig. 1D) configured to be activated and thereby destroy substantially all of the drug in the drug holder (¶¶ 0122, 0139, 0181, 0182, 0234; Claims 33-35; Examiner notes: Poutiatine discloses if the drug is a controlled substance such as an opioid, in case of malicious tampering, unauthorized opening, or disassembling the system is configured to cause dispensing of an opiate antagonist or a spoiling agent, thereby rendering the dosage forms unsuitable for use.); wherein the destruction mechanism includes a chemical (¶¶ 0180-0182).
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Figure A, Adapted from Figure 1B of Poutiatine.
Poutiatine does not specifically disclose the drug delivery system wherein the destruction mechanism including a barrier configured to prevent the drug and the chemical from coming into contact with one another; wherein activation of the destruction mechanism causes a piercing member to break the barrier to allow the drug and the chemical to come into contact with one another.
Minskoff teaches drug delivery system wherein a destruction mechanism (349; Fig. 3C, 3D) including a chemical (345; Fig. 3D); and a barrier (346; Fig. 3C, 3D) configured to prevent the drug and the chemical from coming into contact with one another (¶¶ 0186, 0187); wherein activation of the destruction mechanism causes a piercing member (392; Fig. 3D) to break the barrier to allow the drug and the chemical to come into contact with one another (¶ 0187; Fig. 3D) for the purpose of preventing intentional or unintentional access or contact with the medicament and rendering the medicament inaccessible or functionally neutralized (¶ 0187).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the destruction mechanism of Poutiatine to include the barrier configured to prevent the drug and the chemical from coming into contact with one another; wherein activation of the destruction mechanism causes the piercing member to break the barrier to allow the drug and the chemical to come into contact with one another as taught by Minskoff for the purpose of preventing intentional or unintentional access or contact with the medicament and rendering the medicament inaccessible or functionally neutralized (See Minskoff: ¶ 0187).
Regarding Claim 4, the modified device of Poutiatine discloses the drug delivery system wherein the chemical includes one of silica, bleach, charcoal, glycerol, sodium polyacrylate, activated carbon, zeolytes, and acid (See Minskoff: ¶ 0187).
Regarding Claim 5, Poutiatine discloses a drug delivery system, comprising: a tip (A, Fig. A annotated below) configured to be positioned in a nose of a patient (¶¶ 0098, 0102, 0106, 0264; Examiner notes: Poutiatine discloses the drug delivery system allows user to deliver the drug dosage form to the appropriate location including the nasal.), the tip having an opening (B, Fig. A annotated below) therein; a drug holder (40; Fig. 1A-1D) containing a drug (¶¶ 0126-0143) therein that is configured to exit through the opening (¶¶ 0126-0143); and a destruction mechanism (¶¶ 0122, 0139, 0181, 0182, 0234; Claims 33-35; Fig. 1D) configured to be activated and thereby destroy substantially all of the drug in the drug holder (¶¶ 0122, 0139, 0181, 0182, 0234; Claims 33-35; Examiner notes: Poutiatine discloses if the drug is a controlled substance such as an opioid, in case of malicious tampering, unauthorized opening, or disassembling the system is configured to cause dispensing of an opiate antagonist or a spoiling agent, thereby rendering the dosage forms unsuitable for use.); wherein the destruction mechanism includes a chemical (¶¶ 0180-0182).
Poutiatine does not specifically disclose the drug delivery system wherein the destruction mechanism includes an absorbable material configured to absorb the drug therein.
Minskoff teaches drug delivery system wherein a destruction mechanism (349; Fig. 3C, 3D) including an absorbable material configured to absorb the drug therein (¶ 0187; Examiner notes: Minskoff discloses an absorbent, i.e. charcoal, and neutralizing agent to render the medicament inaccessible or functionally neutralized.) for the purpose of preventing intentional or unintentional access or contact with the medicament and rendering the medicament inaccessible or functionally neutralized (¶ 0187).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the destruction mechanism of Poutiatine to include the absorbable material configured to absorb the drug therein as taught by Minskoff for the purpose of preventing intentional or unintentional access or contact with the medicament and rendering the medicament inaccessible or functionally neutralized (See Minskoff: ¶ 0187).
Regarding Claim 8, the modified device of Poutiatine discloses the drug delivery system further comprising a body (See Poutiatine: 38; Fig. 1D) with the drug holder disposed therein (See Poutiatine: ¶ 0131); wherein the destruction mechanism is disposed in the body external to the drug holder (See Poutiatine: ¶¶ 0180-0182).
Regarding Claim 9, the modified device of Poutiatine discloses the drug delivery system wherein the destruction mechanism is attached to a package containing the drug holder therein (See Poutiatine: ¶¶ 0180-0182).
Regarding Claim 10, the modified device of Poutiatine discloses the drug delivery system further comprising an actuator (See Poutiatine: 16; Fig. 1A) configured to be actuated by a user to cause the drug to be delivered out of the opening (See Poutiatine: ¶¶ 0126, 0140).
Regarding Claim 11, the modified device of Poutiatine discloses the drug delivery system wherein after the activation of the destruction mechanism, the actuation of the actuator cannot cause the drug to be delivered out of the opening (See Poutiatine: ¶¶ 0126, 0140, 0180-0182).
Regarding Claim 12, the modified device of Poutiatine discloses the drug delivery system further comprising a processor (See Poutiatine: “processor within the device” 34; Fig. 1D; ¶¶ 0126, 0131) configured to cause the activation of the destruction mechanism in response to occurrence of a predetermined trigger event (See Poutiatine: ¶¶ 0098, 0102, 0106, 0126-0143, 0151, 0185-0186, 0264).
Regarding Claim 13, the modified device of Poutiatine discloses the drug delivery system further comprising a body (See Poutiatine: 18; Fig. 1A) with the drug holder disposed therein; wherein the processor is disposed in the body (See Poutiatine: Fig. 1D; ¶ 0131).
Regarding Claim 14, the modified device of Poutiatine discloses the drug delivery system further comprising a communications interface (See Poutiatine: ¶ 0150, 0151, 0158, 0179, 0180, 0231-0236) configured to electronically receive an instruction from an external device; wherein the external device includes the processor (See Poutiatine: ¶ 0150, 0151, 0158, 0179, 0180, 0231-0236).
Regarding Claims 15 and 23, the modified device of Poutiatine discloses the drug delivery system further comprising a location sensor configured to monitor geographic location (See Poutiatine: ¶¶ 0106, 0115, 0137, 0158); wherein the predetermined trigger event includes the geographic location sensed by the location sensor being an unacceptable geographic location as determined by the processor (See Poutiatine: ¶¶ 0106, 0115, 0137, 0158).
Regarding Claims 16 and 24, the modified device of Poutiatine discloses the drug delivery system further comprising a temperature sensor (See Poutiatine: ¶¶ 0097, 0098, 0106, 0123, 0158, 0230) configured to monitor temperature; wherein the predetermined trigger event includes the temperature sensed by the temperature sensor being an unacceptable temperature as determined by the processor (See Poutiatine: ¶¶ 0097, 0098, 0106, 0109, 0122, 0123, 0158, 0230).
Regarding Claims 17 and 25, the modified device of Poutiatine discloses the drug delivery system further comprising a humidity sensor configured to monitor humidity (See Poutiatine: ¶¶ 0098, 0106, 0109, 0115, 0122, 0123, 0145, 0158, 0242-0244); wherein the predetermined trigger event includes the humidity sensed by the humidity sensor being an unacceptable humidity as determined by the processor (See Poutiatine: ¶¶ 0098, 0106, 0109, 0115, 0122, 0123, 0145, 0158, 0242-0244).
Regarding Claims 20 and 28, the modified device of Poutiatine discloses the drug delivery system wherein the predetermined trigger event includes the processor identifying an unacceptable Drug Enforcement Administration (DEA) Registration Number [See Poutiatine: “RFID tag”; Fig. 22A, 22B; ¶¶ 0062, 0063, 0109-0113, 0126, 0127; Examiner notes: Poutiatine discloses reading the RFID tag as the predetermined trigger event, which would include unacceptable Drug Enforcement Administration (DEA) Registration Numbers].
Regarding Claims 21 and 29 , the modified device of Poutiatine discloses the drug delivery system further comprising a tag storing data therein (See Poutiatine: “RFID tag”; Fig. 22A, 22B; ¶¶ 0062, 0063, 0109-0113, 0126, 0127); wherein the predetermined trigger event includes the processor identifying unacceptable data received from the tag (See Poutiatine: ¶¶ 0062, 0063, 0109-0113, 0126, 0127).
Regarding Claim 22 , the modified device of Poutiatine discloses the drug delivery system wherein the destruction mechanism is configured to be automatically activated in response to occurrence of a predetermined trigger event (See Poutiatine: ¶¶ 0098, 0102, 0106, 0126-0143, 0151, 0185-0186, 0264).
Regarding Claim 30, the modified device of Poutiatine discloses the drug delivery system herein the drug is one of ketamine, esketamine, naloxone, and sumatriptan (See Poutiatine: ¶ 0139).
Regarding Claim 31, the modified device of Poutiatine discloses a drug product disposed in the system of claim 1 (shown above), wherein the drug product is one of ketamine, esketamine, naloxone, and sumatriptan (See Poutiatine: ¶ 0139).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine in view of Minskoff as applied to claim 5 above, and further in view of Adelaar et al. (U.S. Pat. No. 10,737,041; hereinafter: “Adelaar”).
Regarding Claim 6, the modified device of Poutiatine discloses the drug delivery system of claim 5, shown above.
The modified device of Poutiatine does not specifically disclose the drug delivery system wherein the destruction mechanism wherein the absorbable material includes silica or a sponge.
Adelaar teaches a drug delivery system comprising a destruction mechanism includes an absorbable material configured to absorb the drug therein (Fig. 1, 5; col 4, ln 26-40; col 15, ln 11-37) and wherein the absorbable material includes a sponge (col 4, ln 26-40; col 15, ln 11-37; Examiner notes: Adelaar discloses the absorbent material is activated carbon which acts as a sponge.) for the purpose of rendering the drug inert (col 15, ln 11-37for the purpose of rendering the drug inert (col 15, ln 11-37).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Poutiatine to include the absorbable material including sponge as taught by Adelaar for the purpose of rendering the drug inert (See Adelaar: col 15, ln 11-37).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine in view of Minskoff as applied to claim 1 above, and further in view of Lanzkowsky (U. S. Pub. No. 2018/0110939).
Regarding Claim 7, the modified device of Poutiatine discloses the drug delivery system of claim 1, shown above.
The modified device of Poutiatine does not specifically disclose the drug delivery system wherein the destruction mechanism is disposed in the drug holder.
Lanzkowsky teaches a drug delivery system comprising a destruction mechanism (402, 403; Fig. 4) disposed in in a drug holder (302; Fig. 3-5; ¶¶ 0096-0098) for the purpose of resisting tampering and unauthorized usage of the drug (¶ 0098).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify t the modified device of Poutiatine to include the destruction mechanism is disposed in the drug holder as taught by Lanzkowsky for the purpose of resisting tampering and unauthorized usage of the drug (See Lanzkowsky: ¶ 0098).
Allowable Subject Matter
Claims 26-27 are allowed.
Claims 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Prior art above fails to disclose or render obvious the drug delivery system further comprising a pH sensor configured to monitor pH; wherein the predetermined trigger event includes the pH sensed by the pH sensor being an unacceptable pH as determined by the processor, as recited in claim in dependent 18 and similarly in independent claim 26.
Prior art above fails to disclose or render obvious the drug delivery system further comprising an ultraviolet (UV) sensor configured to monitor UV exposure; wherein the predetermined trigger event includes the UV exposure sensed by the UV sensor being an unacceptable UV exposure as determined by the processor, as recited in dependent claim 19 and similarly in independent claim 27.
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “the destruction mechanism including a chemical; and a barrier configured to prevent the drug and the chemical from coming into contact with one another; wherein activation of the destruction mechanism causes a piercing member to break the barrier to allow the drug and the chemical to come into contact with one another” have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection over Poutiatine in view of Minskoff, shown 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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