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 .
This office action is in response to applicant’s communication of 2/27/2023. Currently claims 1-32 are pending and rejected below.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-8, 10, 12, 14, 16, 18, 20-22, 24-26 are is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by PALMER (WO 2020/069559 A1).
Palmer discloses a drug delivery system (100 and figures 1-3), comprising: a drug holder (124) configured to be coupled to a drug delivery device, the drug holder comprising a first cavity (106) configured to contain either a first drug or air therein, a second cavity (104) configured to contain either a second drug or air therein, and a seal member (122) located between the first and second cavities, configured to provide a fluid seal between the first and second cavities, and configured to be broken by a nasal drug delivery device to break the fluid seal (see page 5 lines 5-7 and 9-21).
Concerning claim 2 and the drug holder further comprises a head portion and a body portion that is distal to the head portion; the first and second cavities are each in the body portion; and the seal member is located in the body portion between the first and second cavities (see figures 1-3 and area body portion near 122).
Concerning claim 3 and the drug holder includes a vial (see 124 holder vial).
Concerning claim 4 and the first cavity contains the first drug, and the second cavity contains the second drug (see page 4 line 33 to page 5 line 19).
Concerning claim 6-7 and wherein the first drug and the second drug are the same or the first drug and the second drug are different (again see page 4 line 33 to page 5 line 19).
Concerning claim 8 and the nasal drug delivery device, wherein the seal member is configured to be broken by being pierced or punctured by at least one of a piston, a pin, and a needle of the nasal drug delivery device (see element 110).
Concerning claim 10 and actuating the drug delivery device of claim 4 to cause a plunger to push the first drug out of an opening formed in the drug delivery device; and after the first drug has been pushed out of the opening, actuating the drug delivery device again to cause the plunger to push the second drug out of the opening. (note disclosure of Palmer that states “…In another embodiment, the nozzle may be removable from a housing holding the first and second chambers, the first chamber being accessible after removal of the nozzle so that a cartridge or bladder holding the first substance may be inserted into the first chamber.
In another embodiment, the respiratory passage sprayer may include a level detector for measuring a level selected from the group consisting of: the first substance level in the first chamber, the second substance level in the second chamber, and a mixture of the first substance and the second substance in the second chamber following admixture of the first substance and the second substance in the second chamber. In another embodiment, the respiratory passage sprayer may include a channel configured to communicate between the second chamber and the nozzle to deliver a mixture of the first substance from the first chamber with the second substance from the second chamber…” (examiner is of the position that multiple dosings may be carried out with various levels of first and second substances).
Concerning claim 12 and the first cavity contains the first drug, the second cavity contains air, and the first cavity is distal to the second cavity (see figures 2-3 and state before second cavity is filled).
Concerning claim 14 and to cause a plunger to push both the first drug and the air out of an opening formed in the drug delivery device (this would be the case when only one substance is in the device).
Concerning claim 16 wherein the first cavity contains air, the second cavity contains the second drug, and the first cavity is distal to the second cavity (it is examiner’s position that this would occur if only the second substance was selected in the device).
Concerning claim 18 and to cause a plunger to push both the second drug and the air out of an opening formed in the drug delivery device. (again, it is examiner’s position that this would occur if only the second substance was selected in the device).
Concerning claim 20 and comprising a second seal member located proximal to the first and second cavities and configured to be broken by a drug delivery device to break a fluid seal provided by the second seal member.
Concerning claim 21 and comprising the nasal drug delivery device, wherein the drug delivery device comprises a tip configured to be positioned in a nose of a patient, the tip having an opening therein (see 102 nozzle).
Concerning claim 22 and the first cavity contains the first drug, and the second cavity contains the second drug; and the drug delivery device includes an actuator that is configured to be actuated in a first actuation to cause delivery of the first drug through the opening without causing delivery of the second drug through the opening, and that is configured to be actuated in a second actuation to cause delivery of the second drug through the opening (see actuator 108 and note it may only partially actuate to only move fluid from the upper chamber).
Concerning claim 24-25 and wherein the first drug and the second drug are the same or the first drug and the second drug are different (again see page 4 line 33 to page 5 line 19).
Concerning claim 26 and the first cavity contains the first drug, the second cavity contains air, and the drug delivery device is configured to simultaneously deliver the first drug and the air through the opening (it is examiners position that this would occur if only the first drug was included in this chamber).
Claim(s) 20, 28-30 are is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by SIPNOSE (WO 2015/025324 A1).
Concerning claim 20-28, Sipnose discloses a drug delivery system, comprising:a drug holder (100) comprising a first blister seal and a second blister seal (consecutive seals in figure 25e), the drug holder being configured to hold a drug between the first and second blister seals, and the first blister seal being distal to the second blister seal (see page 38 lines 20-22 in view of page 28 line 19 to page 34 line 28); and a nasal drug delivery device (figure 24) comprising a proximal tip (6) configured to be positioned in a nose of a patient, the tip having an opening therein, and an actuator (13) configured to be actuated to break the first blister seal and thereby create a force that causes the second blister seal to break and the drug to be delivered out of the opening (see figure 23e). Concerning claim 20 see figure 25e.
Concerning claim 29 the actuator includes a plunger configured to be actuated by moving proximally relative to the proximal tip (see figure 24 and 8)
Concerning claim 30 and the drug holder is located between the opening and the plunger (again (see figure 24 and 8).
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) 5, 9, 11, 13, 15, 17, 19, 23, 27, 31, 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over PALMER (WO 2020/069559 A1).
Palmer discloses the claimed invention except for explicitly stating that the specific drugs are wherein the first drug is one of ketamine, esketamine, naloxone, and sumatriptanl, and the second drug is one of ketamine, esketamine, naloxone, and sumatriptanl. It would have been obvious to one having ordinary skill in the art at the time the invention was made to wherein the first drug is one of ketamine, esketamine, naloxone, and sumatriptanl, and the second drug is one of ketamine, esketamine, naloxone, and sumatriptanl., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Further Palmer discloses that the drugs contemplated are “…Substances that may be administered using the respiratory sprayer disclosed herein include a carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an antioxidant, an enzyme activator, an enzyme inhibitor, an enzyme, an enzyme complex, and an organosulfur compound…”. It is examiner psotion that the drugs of ketamine, esketamine, naloxone, and sumatriptanl, fall under the classes of the drugs above as species of the genus’s disclosed above.
Further see CASPER et al. (US 5,823,183) which examiner is considering as relevant art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783