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 preliminary amendment filed on February 27, 2023. As directed by the amendment: claims 32-52 have been cancelled. Thus, claims 1-31 are presently pending in this application.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 8-17, 23-25, and 28-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poutiatine et al. (WO 2007/081947 A2; hereinafter: “Poutiatine”).
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.).
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Figure A, Adapted from Figure 1B of Poutiatine.
Regarding Claim 2, Poutiatine discloses the drug delivery system wherein the destruction mechanism includes a chemical (¶¶ 0180-0182).
Regarding Claim 8, Poutiatine discloses the drug delivery system further comprising a body (38; Fig. 1D) with the drug holder disposed therein (¶ 0131); wherein the destruction mechanism is disposed in the body external to the drug holder (¶¶ 0180-0182).
Regarding Claim 9, Poutiatine discloses the drug delivery system wherein the destruction mechanism is attached to a package containing the drug holder therein (¶¶ 0180-0182).
Regarding Claim 10, Poutiatine discloses the drug delivery system further comprising an actuator (16; Fig. 1A) configured to be actuated by a user to cause the drug to be delivered out of the opening (¶¶ 0126, 0140).
Regarding Claim 11, 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 (¶¶ 0126, 0140, 0180-0182).
Regarding Claim 12, Poutiatine discloses the drug delivery system further comprising a processor (“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 (¶¶ 0098, 0102, 0106, 0126-0143, 0151, 0185-0186, 0264).
Regarding Claim 13, Poutiatine discloses the drug delivery system further comprising a body (18; Fig. 1A) with the drug holder disposed therein; wherein the processor is disposed in the body (Fig. 1D; ¶ 0131).
Regarding Claim 14, Poutiatine discloses the drug delivery system further comprising a communications interface (¶ 0150, 0151, 0158, 0179, 0180, 0231-0236) configured to electronically receive an instruction from an external device; wherein the external device includes the processor(¶ 0150, 0151, 0158, 0179, 0180, 0231-0236).
Regarding Claims 15 and 23, Poutiatine discloses the drug delivery system further comprising a location sensor configured to monitor geographic location (¶¶ 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 (¶¶ 0106, 0115, 0137, 0158).
Regarding Claims 16 and 24, Poutiatine discloses the drug delivery system further comprising a temperature sensor (¶¶ 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 (¶¶ 0097, 0098, 0106, 0109, 0122, 0123, 0158, 0230).
Regarding Claims 17 and 25, Poutiatine discloses the drug delivery system further comprising a humidity sensor configured to monitor humidity (¶¶ 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 (¶¶ 0098, 0106, 0109, 0115, 0122, 0123, 0145, 0158, 0242-0244).
Regarding Claims 20 and 28 , Poutiatine discloses the drug delivery system wherein the predetermined trigger event includes the processor identifying an unacceptable Drug Enforcement Administration (DEA) Registration Number (“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 , Poutiatine discloses the drug delivery system further comprising a tag storing data therein (“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 (¶¶ 0062, 0063, 0109-0113, 0126, 0127).
Regarding Claim 22 , 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 (¶¶ 0098, 0102, 0106, 0126-0143, 0151, 0185-0186, 0264).
Regarding Claim 30, Poutiatine discloses the drug delivery system herein the drug is one of ketamine, esketamine, naloxone, and sumatriptan (¶ 0139).
Regarding Claim 31, 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 (¶ 0139).
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) 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine in view of Lanzkowsky (U. S. Pub. No. 2018/0110939).
Regarding Claim 3, Poutiatine discloses the drug delivery system further comprising a barrier (“a valve or other controllable conduit”; ¶ 0181) configured to prevent the drug and the chemical from coming into contact with one another (¶¶ 0180-0182).
Poutiatine does not specifically disclose the drug delivery system wherein the activation of the destruction mechanism causes the barrier to break to allow the drug and the chemical to come into contact with one another.
Lanzkowsky teaches a drug delivery system comprising a destruction mechanism (402, 403; Fig. 4) configured to be activated and thereby destroy substantially all of a drug (401; Fig. 4) in a drug holder (302; Fig. 3-5); a barrier (402; Fig. 4) configured to prevent the drug and the chemical from coming into contact with one another (¶ 0098); wherein the activation of the destruction mechanism causes the barrier to break to allow the drug and the chemical to come into contact with one another (¶¶ 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 the drug delivery system of Poutiatine to include the activation of the destruction mechanism causes the barrier to break to allow the drug and the chemical to come into contact with one another as taught by Lanzkowsky for the purpose of resisting tampering and unauthorized usage of the drug (See Lanzkowsky: ¶ 0098).
Regarding Claim 7, Poutiatine discloses the drug delivery system, shown above.
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 the drug delivery system 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).
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Poutiatine in view of Adelaar et al. (U.S. Pat. No. 10,737,041; hereinafter: “Adelaar”).
Regarding Claim 4, Poutiatine discloses the drug delivery system of claim 2, shown above.
Poutiatine does not specifically disclose the drug delivery system wherein the chemical includes one of silica, bleach, charcoal, glycerol, sodium polyacrylate, activated carbon, zeolytes, and acid
Adelaar teaches a drug delivery system comprising a destruction mechanism having a chemical that includes activated carbon (Fig. 1, 5; col 4, ln 26-40; col 15, ln 11-37) for 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 drug delivery system of Poutiatine to include the chemical that includes activated carbon as taught by Adelaar for the purpose of rendering the drug inert (See Adelaar: col 15, ln 11-37).
Regarding Claim 5-6, Poutiatine discloses the drug delivery system of claim 1, shown above.
Poutiatine does not specifically disclose the drug delivery system wherein the destruction mechanism includes an absorbable material configured to absorb the drug therein and 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 drug delivery system of Poutiatine to include the destruction mechanism includes the absorbable material configured to absorb the drug therein and wherein the absorbable material includes sponge as taught by Adelaar for the purpose of rendering the drug inert (See Adelaar: col 15, ln 11-37).
Allowable Subject Matter
Claims 18-19 and 26-27 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 18 and similarly in dependent 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 claim 1 and similarly in dependent claim 27.
Conclusion
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785