DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, as originally filed on July 2, 2023.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specifically, the patent documents and non-patent literature described in Paras 0001, 0006, 0007, 0125, 0126, 0204, 0213, and 0216 are not listed on an information disclosure statement for this application. Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “1706” has been used to designate “dose holding chamber” and “dose” (Para 0188). Appropriate correction is required.
Reference character “50” has been used to designate “pressurized propellant container” and “container” (Para 0145). Appropriate correction is required.
Reference character “70” has been used to designate “diffuser” and “capsule” (Para 0149). Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “1706” has been used to designate “dose holding chamber” and “dose” (Para 0188). Appropriate correction is required.
Reference character “50” has been used to designate “pressurized propellant container” and “container” (Para 0145). Appropriate correction is required.
Reference character “70” has been used to designate “diffuser” and “capsule” (Para 0149). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 3, 7, 8, and 10-12 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Papania et al. (2004/0134494).
As to Claim 1, Papania discloses a device (Figures 1, 3, and 7) for delivery of a compound (via 24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018) to a nasal cavity (via 54, best seen Figures 1, 3, and 7, “delivery of the nebulized agent from the nebulizer 32 to a patient can be through a nasal prong 54” Para 0081), the device (Figures 1, 3, and 7) comprising: an air compression chamber (via 92, best seen Figure 7, “An air supply 92 may include a direct, manually-operated, hand or foot pump 96, a direct, powered air source supplied by a portable compressor 98, a stationary compressor 100, or a rechargeable low-pressure air tank 102.” Para 0081); a manual pressure actuator (40, “pneumatic trigger and timer switch 40” Para 0070) that causes air to be released from the air compression chamber (via 92) upon actuation; a diffuser (144, “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.”, best seen Figure 5C) in communication with the air compression chamber (via 92, best seen Figure 5C); a drug chamber (24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018) in communication with the diffuser (144, via 38 - “The agent probe 28 can be connected to the ultrasonic nebulizer 36 via a section of flexible tubing 38 to carry a quantity of agent from vial 24 to nebulizer 36.” Para 0066), the drug chamber (24) configured to hold the compound (via 24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018); and a nozzle (54, best seen Figures 1, 3, and 7, “delivery of the nebulized agent from the nebulizer 32 to a patient can be through a nasal prong 54” Para 0081) in communication with the drug chamber (24), wherein air released from the air compression chamber (via 92) is configured to contact the diffuser (144) and propel the compound out of the nozzle (54) forming a plume.
Explicitly, Papania discloses “In operation, a user depresses a trigger and timer switch 40 connected to the ultrasonic nebulizer 36. In doing so, a signal is sent from the switch 40 to nebulizer drive electronics, or circuit, 42 connected to the ultrasonic nebulizer 36, wherein the signal can be processed. In turn, the nebulizer drive electronics 42 relays a signal to the ultrasonic nebulizer 36 to begin operation. The ultrasonic nebulizer 36 converts an agent drawn from vial 24 via the agent probe 28 into droplets of a very small size (preferably in a range of from 5 to 10 microns).” (Para 0066), whereby “Depression of the switch 40 opens the valve 44 which allows air stored within the air reservoir 46 to be released into the associated mixing chamber 48. The air that is expelled from the air reservoir 46 mixes with the nebulized agent in the mixing chamber 48, and opens the anti-backflow valve 50. The air and agent mixture then is free to flow past valve 50 and through a prong 54 into the naris of the patient.” (Para 0067).
In an alternative embodiment (best represented by Figure 2), the air compression chamber is on board the device as represented in Figure 2 by “air reservoir 46”. Regardless of which embodiment utilized the resultant effect is the same manual pressure actuator (40), diffuser (144), drug chamber (24), and nozzle (54). Hence, it would behoove Applicant to expressly recite the breadth and scope of the “air compression chamber” within the claim listing.
As to Claim 3, Papania discloses a trigger valve (44, “Depression of the switch 40 opens the valve 44 which allows air stored within the air reservoir 46 to be released into the associated mixing chamber 48. The air that is expelled from the air reservoir 46 mixes with the nebulized agent in the mixing chamber 48, and opens the anti-backflow valve 50. The air and agent mixture then is free to flow past valve 50 and through a prong 54 into the naris of the patient.” Para 0067) in communication with the air compression chamber (via 92, or alternatively 46) such that when the trigger valve (44) is rotated from an open state to a closed state, air in the air compression chamber (via 92, or alternatively 46) is blocked from contacting the diffuser (144) and propelling the compound (via 24) out of the nozzle (54). Explicitly, Papania discloses “The switch 40 then closes, preventing air from leaving the air reservoir 46.” (Para 0070).
As to Claim 7, Papania discloses the diffuser (144) is homogenously porous (best seen Figure 5C, via 146 - “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.” Para 0077 and “At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136.” Para 0078).
As to Claim 8, Papania discloses the compound is a drug (“vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018).
As to Claim 10, Papania discloses the diffuser (144) is porous (best seen Figure 5C, via 146 - “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.” Para 0077 and “At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136.” Para 0078) being a disk shaped member (“sleeve” Para 0077) including at least one conical shaped member (defined by the construction of 90, best seen Figure 5C) and having a distal aperture (via 138, “The pneumatic nebulizer 90 includes a housing 120 that can be connected to a compressed air supply (shown in FIGS. 3 and 7 as 92). The pneumatic nebulizer 90 can include an inlet orifice 122, an actuator, or accumulator, chamber 124, a valve plate 126, an orifice plate 106, an impact pin 128, a spring 132, a valve plate seating surface 134, a mixture chamber 136, a diaphragm 110, and an aerosol outlet 138.” Para 0076).
As to Claim 11, Papania discloses the diffuser (144) is configured to act as a one-way check valve (via 126 - “The valve plate 126 is seated upon seating surface 134 above the actuator chamber 124. The impact pin 128 and spring 132 are operatively interposed between the valve plate 126 and the diaphragm 110. The orifice plate 106 is located above the diaphragm 110. The spring 132 is positioned around the impact pin 128 and between the diaphragm 110 and the valve plate 126 so that a force against the valve plate 126 can compress spring 132 and push the diaphragm 110 toward orifice plate 106. An agent can be introduced into chamber 112 between the diaphragm 110 and the orifice plate 106. The mixture chamber 136 is located above the orifice plate 106 and concentrically positioned around the plates 126, 106, pin 128, and spring 132 elements.” Para 0076; also see: “When the compressed air supply 92 supplies air through the inlet orifice 122 to the actuator chamber 124, the compressed air places pressure upon valve plate 126. As the air pressure builds against the valve plate 126, eventually the pressure overcomes the force of the spring 132. At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136. Movement of the impact pin 128 with valve plate 126 causes the diaphragm 110 to move in direct relation to the valve plate 126 and the impact pin 128.” Para 0078).
As to Claim 12, Papania discloses the diffuser (144) extends into the compound (via 24) in the drug chamber (24) through “The agent probe 28 can be connected to the ultrasonic nebulizer 36 via a section of flexible tubing 38 to carry a quantity of agent from vial 24 to nebulizer 36.” (Para 0066).
Claims 1, 2, 4, 7, 8, and 10-12 are rejected under pre-AIA 35 U.S.C. 102(a/e) as being anticipated by Tsutsui et al. (2011/0045088).
As to Claim 1, Tsutsui discloses a device (Figures 1-5) for delivery of a compound (M, “The powdered medicine reservoir comprises powdered therapeutic formulation (M).” Para 0034) to a nasal cavity (“A device is further comprised of a nozzle (6) which comprises a nozzle pipe (4) which is adapted to be inserted or partially inserted into the nasal cavity or a nostril of a subject.” Para 0034), the device (Figures 1-5) comprising: an air compression chamber (3, “FIG. 1 illustrates a single-use nasal spray applicator device. A device (1) is comprised of a deformable volume (2) and a flow inlet (3b) which comprises a manual air pump (3).” Para 0034); a manual pressure actuator (5, “A device (1) is further comprised of a valve assembly (5) which comprises a check valve (11) which comprises a flow outlet (3a), a valve disk (15), a spring (14), a flow passage (7), and a poppet (16) which further comprises a deflecting surface (17).” Para 0034) that causes air to be released (via pressure at 3a overcoming the spring 14, “FIG. 4a illustrates a first configuration, wherein a device is closed so that air cannot flow from the manual air pump (3), into a flow outlet (3a), and ultimately out of the nozzle hole (21a). In this embodiment, the closed configuration is provided by a spring (14) that is configured to keep a check valve (11) in a closed configuration and by a breakable cover (22) that is configured to block the flow of air out of the nozzle hole (21a). Thus, in the closed configuration, the nozzle (21) is a portion of the therapeutic reservoir (23). … In a second configuration, illustrated in FIG. 4b, a device is open so that air can flow through a device and ultimately out of the nozzle hole (21a). In this embodiment, the open configuration is provided by the removal of the breakable cover (22) and a flow of air from the manual pump (3) sufficient to open a check valve (11) and allow air to past a deflecting surface of a poppet (17) into a powdered therapeutic formulation reservoir (23) and ultimately out of the nozzle hole (21a). As is apparent from the description, the therapeutic reservoir (23) part of the airflow path from the deformable volume (2) (e.g., a manual pump) to the nozzle hole (21a) in the open configuration.” Para 0037) from the air compression chamber (3) upon actuation; a diffuser (13, “A poppet (16) is disposed within a flow passage (7) and a throat (12) which is in communication with a diffuser (13).” Para 0034) in communication with the air compression chamber (3); a drug chamber (23, “The nozzle (6) further comprises a flow restrictor (21), a breakable cover (22), and a powdered therapeutic reservoir (23). The powdered medicine reservoir comprises powdered therapeutic formulation (M).” Para 0034) in communication with the diffuser (13), the drug chamber (23) configured to hold the compound (M); and a nozzle (6, “A device is further comprised of a nozzle (6) which comprises a nozzle pipe (4) which is adapted to be inserted or partially inserted into the nasal cavity or a nostril of a subject. The nozzle (6) further comprises a flow restrictor (21), a breakable cover (22), and a powdered therapeutic reservoir (23). The powdered medicine reservoir comprises powdered therapeutic formulation (M).” Para 0034) in communication with the drug chamber (23), wherein air released from the air compression chamber (3) is configured to contact the diffuser (13), and propel the compound (M) out of the nozzle (6) forming a plume (M beyond 21a, as best seen Figure 4B; also see: “Plume geometry data provide information on the shape of the plume of TRG powder generated from a nozzle of an applicator described herein after pump actuation.” Para 0199 thru 0202).
As to Claim 2, Tsutsui discloses the manual pressure actuator (5) further comprises a lock pin (via the interaction of 11 and 14 to seal the closure of 3a, “FIG. 4a illustrates a first configuration, wherein a device is closed so that air cannot flow from the manual air pump (3), into a flow outlet (3a), and ultimately out of the nozzle hole (21a). In this embodiment, the closed configuration is provided by a spring (14) that is configured to keep a check valve (11) in a closed configuration and by a breakable cover (22) that is configured to block the flow of air out of the nozzle hole (21a). Thus, in the closed configuration, the nozzle (21) is a portion of the therapeutic reservoir (23). … In a second configuration, illustrated in FIG. 4b, a device is open so that air can flow through a device and ultimately out of the nozzle hole (21a). In this embodiment, the open configuration is provided by the removal of the breakable cover (22) and a flow of air from the manual pump (3) sufficient to open a check valve (11) and allow air to past a deflecting surface of a poppet (17) into a powdered therapeutic formulation reservoir (23) and ultimately out of the nozzle hole (21a). As is apparent from the description, the therapeutic reservoir (23) part of the airflow path from the deformable volume (2) (e.g., a manual pump) to the nozzle hole (21a) in the open configuration.” Para 0037), wherein the lock pin (via the interaction of 11 and 14 to seal the closure of 3a) is configured to maintain high pressure air in the air compression chamber (3).
As to Claim 4, Tsutsui discloses the manual pressure actuator (5) comprise a piston (via 16, “A device (1) is further comprised of a valve assembly (5) which comprises a check valve (11) which comprises a flow outlet (3a), a valve disk (15), a spring (14), a flow passage (7), and a poppet (16) which further comprises a deflecting surface (17).” Para 0034; also see: “This embodiment further provides a poppet (16) for inhibiting the downstream movement of a powdered therapeutic formulation (M) from a powdered therapeutic reservoir (23) into a valve assembly (5).” Para 0037).
As to Claim 7, Tsutsui discloses the diffuser (13) is homogenously porous.
As to Claim 8, Tsutsui discloses the compound (M) is a drug (“Formulations and methods of manufacture are provided for granisetron dry powder compositions suitable for intranasal administration.” Abstract; “Provided herein are unit dosages of a dry powder granisetron formulation suitable for intranasal administration, wherein when administered as a prophylaxis to cancer patients prior to administration of cancer chemotherapy, emesis is prevented in at least 80% of the patients.” Para 0017; also see: The extensive list of other chemotherapy drug compositions shown in Para 0017 “cisplatin, mechlorethamine, streptozcin, cyclophosphamide, carmustine, dacarbazine, hexamethylmelamine or procarbazine. In another embodiment, the emetogenic chemotherapy further comprises an additional cancer chemotherapy agent selected from carboplatin, cytarabine, doxorubicin, methotrexate, epirubicin, idarubicin, ifosfamide, or mitoxantrone” and “carmustine, cisplatin, cyclophosphamide, dacarbazine, mechlorethamine, streptozocin, carboplatin, cytarabine, doxorubicin, methotrexate, procarbazine, epirubicin, hexamethylmelamine, idarubicin, ifosfamide, irinotecan, mitoxantrone, capecitabine, docetaxel, etoposide, 5-fluorouracil, gemcitabine, mitomycin-C, paclitaxel, topotecan, bleomycin, busulfan, chlorambucil, cytarabine, 2-chlorodeoxyadenosine, fludarabine, hydroxyurea, dactnomycin, lomustine, 1-phenylalanine mustard, thioguanine, vinblastine, vincristine, vinorelbine” shown in Para 0135).
As to Claim 10, Tsutsui discloses the diffuser (13) is porous, the porous diffuser being a disk shaped member (as best seen Figure 4A and 4B) including at least one conical shaped member (defined by the slanted walls as best seen Figure 4A and 4B) having a distal aperture (defined by the seat upon which 13 and 17 are engaged as shown in Figure 4A).
As to Clam 11, Tsutsui discloses the diffuser (13) is configured to act as a one way check valve (via the interaction of 16 and 13, whereby as shown in Figure 4A the compound is prevented from entering the air compression chamber, and as shown in Figure 4B where by the compound is directed towards the nozzle (6).
As to Claim 12, Tsutsui discloses the diffuser (13) extends into the compound (M) in the drug chamber (25 via 23).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 3, 7-9, and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Winchell et al. (3,957,033).
As to Claim 1, Winchell discloses a device (Figure 2-5) for delivery of a compound (“radioisotope” via 23, “The capsule 23 shown in FIG. 6 is comprised of a shearable gas impermeable enclosure which contains a gaseous radioisotope useful for medical applications.” Column 5, Lines 40-50; also see: “A preferred radioisotope is a xenon-radioisotope including xenon-127, xenon-133, and xenon-129m. Other gaseous radioisotopes can be used including radon-222 and krypton-85.” Column 5, Lines 45-65 and “A disposable ventilation study system for dispensing a single-patient dosage of gaseous radioisotopes to patients for pulmonary function studies is disclosed. A gas impermeable capsule encloses the gaseous radioisotope and is stored within a radioactivity shielding body of valve means which shears the capsule to dispense the radioisotope to the patient. A breathing bag receives the patient's exhalation of the radioisotope and permits rebreathing of the radioisotope by the patient.” Abstract; “Radioactive isotopes of xenon and other radioisotopes are useful in the field of medicine and particularly in medical diagnosis. There is increasing use of xenon-133 in the medical field for studying blood flow in muscles, scanning the lungs for lung functional disorders (e.g., emphysema and emboli), scanning the brain and scanning for cardiac abnormalities. For scanning of the lungs, xenon-133 can be introduced into a human body by one of two processes.” Column 1, Lines 1-25; “The widest use of xenon-133 is in pulmonary function studies and this involves having the patient inhale a dose of gaseous xenon-133, and while the patient holds his breath a scintillation camera is used to take a picture of the patient' s lungs. This picture shows any portions of the patient's lungs not functioning or not properly functioning.” Column 1, Line 60 thru Column 2, Line 5) to the pulmonary system (“scanning the lungs for lung functional disorders”) of the patient, the device (Figures 2-5) comprising: an air compression chamber (24 of Figures 2 and 3 / 41 of Figures 4 and 5, wherein 24 – “Referring now to FIG. 2 there is shown a ventilation study system according to the teaching of this invention generally designated as 20 and generally comprised of patient breathing means 21, here in the form of a mouthpiece, a valve means 22 holding and capable of shearing the capsule 23 and a breathing bag 24. The ventilation study system 20 has an internal gas-retaining volume defined by the breathing bag 24 and the valve assembly 22 with the breathing means 21 representing an outlet to the volume.” Column 4, Lines 5-30, also see: “The cavity 34 of the breathing bag 24 forms a portion of the internal gas retaining volume of the ventilation system.” Column 4, Line 65 thru Column 5, Line 5; and wherein 41 – “ Insert 40 leading to cavity 25 of valve body 26 is connected to a rubber bulb expressor 41 for discharging the contents of the capsule 23 into the rest of the gas-retaining volume of the ventilation study system.” Column 5, Lines 20-35); a manual pressure actuator (26, “The breathing means 21 is connected to one end of the valve body 26 of valve means 22 in an air tight seal so that the breathing means is in communication with an internal cavity 25 of the valve means in which is positioned a shearable capsule 23 described more fully below in reference to FIG. 6.” Column 4, Lines 5-30; also see: “Valve body 26 has a bore 31 intersecting the cavity 25 at a position intermediate the ends of the cavity 25 and generally intermediate to the position of the capsule 23 with valve plug 30 being positioned within the bore 31.” Column 4, Lines 25-55) that causes air to be released (via flow of air through 31) from the air compression chamber (24/41) upon actuation (compression through squeezing); a diffuser (29 proximate 21, as shown best seen in Figure 7, “The expanded ends 27 have screens 29 which are gas-transmitting, particle-retaining screens provided to insure that any particulate material generated in the ventilation system 20, such as from shearing of capsule 23, is retained in the system 20.” Column 4, Lines 25-55) in communication (via the flow of air through 31) with the air compression chamber (24/41); a drug chamber (25 via 23, “The breathing means 21 is connected to one end of the valve body 26 of valve means 22 in an air tight seal so that the breathing means is in communication with an internal cavity 25 of the valve means in which is positioned a shearable capsule 23 described more fully below in reference to FIG. 6. The internal cavity 25 forms a portion of the internal gas and irradiation retaining volume of the ventilation study system 20.” Column 4, Lines 5-30; “The valve means 22 has a shielding valve body 26 of generally cylindrical cross section with expanded ends 27 and defining an interior cavity 25 for holding and generally enclosing capsule 23 in a manner shielding any radiation emitted from the capsule 23. … Valve body 26 has a bore 31 intersecting the cavity 25 at a position intermediate the ends of the cavity 25 and generally intermediate to the position of the capsule 23 with valve plug 30 being positioned within the bore 31. The valve plug 30 has an opening 28 concentric with the interior cavity 25 and the opening 28 is normally aligned with the internal cavity 25. The valve plug 30 has a stem 32 fitting a handle 33 for rotating the plug 30 to provide a shearing action at the intersection of the surfaces defining the interior cavity 25 and the opening 28 of the valve plug 30 to shear the capsule 23 into three pieces and release the radioisotope from the capsule 23.” Column 4, Line 25-55) in communication with the diffuser (29 proximate 21), the drug chamber (25 via 23) configured to hold the compound (“radioisotope” via 23); and a nozzle (21, “patient breathing means 21” Column 4, Lines 5-30) in communication with the drug chamber (25 via 23), wherein air released from the air compression chamber (24/41) is configured to contact the diffuser (29 proximate 21), and propel the compound (“radioisotope” via 23) out of the nozzle (21) forming a plume (“In an inhalation process, the patient breathes a gas containing xenon-133 and the xenon-133 is drawn directly into the patient's lungs.” Column 1, Lines 1-25; “a system providing a high concentration of radioisotope in one inhalation.” Column 6, Lines 1-20).
Yet, Winchell does not expressly disclose the application of the device (Figures 2-5) whereby the nozzle (21) delivers the compound (“radioisotope” via 23) to “a nasal cavity” as claimed in the preamble.
Although Winchell intends for the nozzle (21) to be in the form of a mouthpiece for the introduction of the compound (“radioisotope” via 23) into the pulmonary system of the patient, it should be noted the claimed “nasal cavity” is a known alternative anatomical entrance to the pulmonary system of the patient, whereby the resultant effect of the administration of the compound (“radioisotope” via 23) to the nose would also yield the administration of the compound (“radioisotope” via 23) to the lungs of the patient.
Consequently, should the mouth of the patient not be available for acceptance of the compound (“radioisotope” via 23) via the nozzle (21), the use of the nose of the patient would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to transport the compound from the ambient environment in the pulmonary system of the patient in order to perform the medical imaging procedure of ”scanning the lungs for lung functional disorders (e.g., emphysema and emboli), scanning the brain and scanning for cardiac abnormalities.” Column 1, Lines 1-25).
Applicant has not asserted the specific administration of the compound to the nasal cavity of the patient provides a particular advantage, solves a stated problem, or serves a particular purpose; thus, the use of the nasal cavity as the manner of introduction of the compound into the lungs of the patient lacks criticality in its design.
Hence, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Winchell, as the administration of the compound into the lungs of the patient would yield the predictable results of operating with inhalation by the patient to permit the compound to be introduced into the pulmonary system of the patient for scanning of the lung function of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the nozzle of Winchell to be utilized in the nasal cavity, a known result effective variable, in order to administer the compound into the pulmonary system of the patient for scanning of the lung function of the patient.
As to Claim 3, Winchell discloses a trigger valve (30, best seen Figure 7, “Valve body 26 has a bore 31 intersecting the cavity 25 at a position intermediate the ends of the cavity 25 and generally intermediate to the position of the capsule 23 with valve plug 30 being positioned within the bore 31. The valve plug 30 has an opening 28 concentric with the interior cavity 25 and the opening 28 is normally aligned with the internal cavity 25. The valve plug 30 has a stem 32 fitting a handle 33 for rotating the plug 30 to provide a shearing action at the intersection of the surfaces defining the interior cavity 25 and the opening 28 of the valve plug 30 to shear the capsule 23 into three pieces and release the radioisotope from the capsule 23.” Column 4, Lines 25-55) in communication with the air compression chamber (24/41) such that when the trigger valve (30) is rotated (via 33, “The valve plug 30 has a stem 32 fitting a handle 33 for rotating the plug 30 to provide a shearing action at the intersection of the surfaces defining the interior cavity 25 and the opening 28 of the valve plug 30 to shear the capsule 23 into three pieces and release the radioisotope from the capsule 23.” Column 4, Lines 25-55) from an open state (as shown in Figure 7, whereby 31 and 28 are aligned) to a closed state (whereby 31 and 28 are misaligned), air in the air compression chamber (24/41) is blocked from contacting the diffuser (29 proximate 21) and propelling the compound (“radioisotope” via 23) out of the nozzle (21).
As to Claim 7, Winchell discloses the diffuser (29 proximate 21) is homogenously porous.
As to Claim 8, Winchell discloses the compound (“radioisotope” via 23) is a diagnostic agent.
As to Claim 9, Winchell discloses the compound (“radioisotope” via 23) is a diagnostic agent for imaging (“scanning the lungs for lung functional disorders (e.g., emphysema and emboli), scanning the brain and scanning for cardiac abnormalities. For scanning of the lungs, xenon-133 can be introduced into a human body by one of two processes.” Column 1, Lines 1-25; “The widest use of xenon-133 is in pulmonary function studies and this involves having the patient inhale a dose of gaseous xenon-133, and while the patient holds his breath a scintillation camera is used to take a picture of the patient' s lungs. This picture shows any portions of the patient's lungs not functioning or not properly functioning.” Column 1, Line 60 thru Column 2, Line 5).
As to Claim 12, Winchell discloses the diffuser (29 proximate 21) extends into the compound (“radioisotope” via 23) in the drug chamber (25 via 23).
Claims 4 and 5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Freeman (2003/0021775).
As to Claims 4 and 5, Papania discloses the manual pressure actuator (40) for operating the air compression chamber (via 92, or alternatively 46), wherein the initial compression of the air achieved through “a direct, manually-operated, hand or foot pump 96, a direct, powered air source supplied by a portable compressor 98, a stationary compressor 100, or a rechargeable low-pressure air tank 102.” (Para 0081 related to 92) or alternatively through “the air reservoir 46 is recharged using an air reservoir charging pump 72 operatively connected to pump handle 18. The air reservoir charging pump 72 is located within the housing 10 and connected to the air reservoir 46. Specifically, the air reservoir 46 is recharged by manually and repeatedly applying pressure to a charging pump handle 18 connected to the housing 10 via a pin 74.” (Para 0071 related to 46). In each of these interactions, the depressing of the manual pressure actuator (40) results in a positive displacement of the air contained within the air compression chamber to be utilized in the dispensing of the compound. Yet, Papania does not expressly disclose the manual pressure actuator is a “piston” (Claim 4), or a “syringe” (Claim 5).
Freeman teaches a similar device to Papania for the dispensing of a compound under pressure (“first reservoir 10 is in fluid communication with a pump 18 which serves for streaming the protease solution from first reservoir 10 to an applicator 24 (which is described in greater detail hereinafter) under positive pressure.” Para 0073), wherein the construction of the manual pressure actuator may include various constructions of the positive displacement pump wherein the “Pump 18 may be an air pump, a piston-driven fluid pump, syringe pump or an impeller.” (Para 0073) in order to effectively provide the compound to treat the patient. In light of this construction, it is clear the manual pressure actuator of Freeman effectively provides a piston driven or syringe driven pressure to positively displace the compound to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manual pressure actuator of Papania to include the use of a piston or syringe as taught by Freeman to be known positive displacement devices suitable for imparting the delivery of a compound to a patient for treatment of the patient.
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Freeman (2003/0021775), as applied to Claim 5 and further in view of Lockhart (2,574,339).
As to Claim 6, the modified Papania, specifically Freeman teaches the use of syringes as a manual pressure actuator were known. Yet, the modified Papania does not expressly disclose the manual pressure actuator is a syrette.
Lockhart teaches equivalency between syringes and syrettes as known devices suitable for imparting a compound under positive pressure to be displaced from the device to the patient. In particular, Lockhart states “Syringes of this type known as syrettes are now commonly used by the military services. The principal object of the present invention is to make a syringe of this type which is cheaper in construction, more dependable in operation, and easier to use than devices of this kind heretofore available.” (Column 1, Lines 5-15). Thus, a syrette is a specific type of syringe (hypodermic), specifically adapted for single use. (Column 1, Lines 1-5).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the generic syringe of the modified Papania , as taught by Freeman, to be utilized with the specific hypodermic syringe (syrette) as taught by Lockhart to be a known device suitable for imparting compounds under pressure to be delivered to the patient for single use operations.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Makower et al. (2005/0240147).
As to Claim 9, Papania discloses the use of a compound, in the form of a drug (“vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018) via the nasal pathway to be administered to the patient (“The air and agent mixture then is free to flow past valve 50 and through a prong 54 into the naris of the patient.” Para 0067). Yet, Papania does not expressly disclose the compound could be an imaging agent for diagnostic treatment.
Makower teaches a similar device to Papania for the administration of compounds via the nasal passageway (“through a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. and positioned adjacent the area to which a diagnostic or therapeutic substance is to be injected.” Para 0167), wherein the compound encompasses various agents (“The term "diagnostic or therapeutic substance" as used herein is to be broadly construed to include any feasible drugs, prodrugs, proteins, gene therapy preparations, cells, diagnostic agents, contrast or imaging agents, biologicals, etc.” Para 0167).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the compound administered by Papania to include additional compounds suitable for administration through the nasal passageway including but not limited to “diagnostic agents, contrast or imaging agents” in order to diagnose conditions within the nasal pathway of the patient.
Claims 2, 13, 17, 18, 19, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Sappington (4,154,309).
As to Claim 2, Papania discloses the manual pressure actuator (40) for operating the air compression chamber (via 92, or alternatively 46), wherein the initial compression of the air achieved through “a direct, manually-operated, hand or foot pump 96, a direct, powered air source supplied by a portable compressor 98, a stationary compressor 100, or a rechargeable low-pressure air tank 102.” (Para 0081 related to 92) or alternatively through “the air reservoir 46 is recharged using an air reservoir charging pump 72 operatively connected to pump handle 18. The air reservoir charging pump 72 is located within the housing 10 and connected to the air reservoir 46. Specifically, the air reservoir 46 is recharged by manually and repeatedly applying pressure to a charging pump handle 18 connected to the housing 10 via a pin 74.” (Para 0071 related to 46). In each of these interactions, the depressing of the manual pressure actuator (40) results in a positive displacement of the air contained within the air compression chamber to be utilized in the dispensing of the compound. Yet, Papania does not expressly disclose the manual pressure actuator is a lock pin.
Sappington teaches a similar device to Papania for the dispensing of a compound under pressure wherein the pressurized fluid (via 7, “air line” Column 3, Lines 50-55) is delivered by a lock pin (29), which interacts with a valve (19) and a hand lever (8). Explicitly, Sappington teaches “a locking pin 29 may be inserted through the casing and overlap it and the valve means 19 so as to insure the keying of the valve means within the chamber 18 of the housing, and prevent its untimely removal particularly when air under high pressure is passing through the tool from the air line 7.” (Column 5, Lines 10-15). Thus, the resultant effect of the locking pin is the controlled operation and engagement of the compressed air though the device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the air compression chamber of Papania to include the use of a lock pin, as taught by Sappington to provide controlled operation and engagement of the compressed air though the device.
As to Claim 13, Papania discloses a device (Figures 1, 3, and 7) for delivery of a compound (via 24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018) to a nasal cavity (via 54, best seen Figures 1, 3, and 7, “delivery of the nebulized agent from the nebulizer 32 to a patient can be through a nasal prong 54” Para 0081), the device (Figures 1, 3, and 7) comprising: an air compression chamber (via 92, best seen Figure 7, “An air supply 92 may include a direct, manually-operated, hand or foot pump 96, a direct, powered air source supplied by a portable compressor 98, a stationary compressor 100, or a rechargeable low-pressure air tank 102.” Para 0081); a manual pressure actuator (40, “pneumatic trigger and timer switch 40” Para 0070) that causes air to be released from the air compression chamber (via 92) upon actuation; a trigger valve (44, “Depression of the switch 40 opens the valve 44 which allows air stored within the air reservoir 46 to be released into the associated mixing chamber 48. The air that is expelled from the air reservoir 46 mixes with the nebulized agent in the mixing chamber 48, and opens the anti-backflow valve 50. The air and agent mixture then is free to flow past valve 50 and through a prong 54 into the naris of the patient.” Para 0067; also see: “The switch 40 then closes, preventing air from leaving the air reservoir 46.” Para 0070) configured to be in communication with the air compression chamber (via 92, or alternatively 46) such that when the trigger valve (44) is rotated from an open state to a closed state, air in the air compression chamber (via 92, or alternatively 46) is blocked from exiting the air compression chamber (via 92); a diffuser (144, “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.”, best seen Figure 5C) in communication with the trigger valve (44); a drug chamber (24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018) in communication with the diffuser (144, via 38 - “The agent probe 28 can be connected to the ultrasonic nebulizer 36 via a section of flexible tubing 38 to carry a quantity of agent from vial 24 to nebulizer 36.” Para 0066), the drug chamber (24) configured to hold the compound (via 24, best seen Figure 3, “vaccine or drug vial 24” Para 0062, “The vial is designed to contain a vaccine or drug composition.” Para 0018); and a nozzle (54, best seen Figures 1, 3, and 7, “delivery of the nebulized agent from the nebulizer 32 to a patient can be through a nasal prong 54” Para 0081) in communication with the drug chamber (24), wherein air released from the air compression chamber (via 92) is configured to contact the diffuser (144) and propel the compound out of the nozzle (54) forming a plume.
Explicitly, Papania discloses “In operation, a user depresses a trigger and timer switch 40 connected to the ultrasonic nebulizer 36. In doing so, a signal is sent from the switch 40 to nebulizer drive electronics, or circuit, 42 connected to the ultrasonic nebulizer 36, wherein the signal can be processed. In turn, the nebulizer drive electronics 42 relays a signal to the ultrasonic nebulizer 36 to begin operation. The ultrasonic nebulizer 36 converts an agent drawn from vial 24 via the agent probe 28 into droplets of a very small size (preferably in a range of from 5 to 10 microns).” (Para 0066), whereby “Depression of the switch 40 opens the valve 44 which allows air stored within the air reservoir 46 to be released into the associated mixing chamber 48. The air that is expelled from the air reservoir 46 mixes with the nebulized agent in the mixing chamber 48, and opens the anti-backflow valve 50. The air and agent mixture then is free to flow past valve 50 and through a prong 54 into the naris of the patient.” (Para 0067).
In an alternative embodiment (best represented by Figure 2), the air compression chamber is on board the device as represented in Figure 2 by “air reservoir 46”. Regardless of which embodiment utilized the resultant effect is the same manual pressure actuator (40), diffuser (144), drug chamber (24), and nozzle (54). Hence, it would behoove Applicant to expressly recite the breadth and scope of the “air compression chamber” within the claim listing.
Yet, Papania does not expressly disclose the manual pressure actuator is a lock pin.
Sappington teaches a similar device to Papania for the dispensing of a compound under pressure wherein the pressurized fluid (via 7, “air line” Column 3, Lines 50-55) is delivered by a lock pin (29), which interacts with a valve (19) and a hand lever (8). Explicitly, Sappington teaches “a locking pin 29 may be inserted through the casing and overlap it and the valve means 19 so as to insure the keying of the valve means within the chamber 18 of the housing, and prevent its untimely removal particularly when air under high pressure is passing through the tool from the air line 7.” (Column 5, Lines 10-15). Thus, the resultant effect of the locking pin is the controlled operation and engagement of the compressed air though the device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the air compression chamber of Papania to include the use of a lock pin, as taught by Sappington to provide controlled operation and engagement of the compressed air though the device.
As to Claim 17, the modified Papania, specifically Papania discloses the diffuser (144) is homogenously porous (best seen Figure 5C, via 146 - “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.” Para 0077 and “At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136.” Para 0078).
As to Claim 18, the modified Papania, specifically Papania discloses the diffuser (144) is configured to act as a one-way check valve (via 126 - “The valve plate 126 is seated upon seating surface 134 above the actuator chamber 124. The impact pin 128 and spring 132 are operatively interposed between the valve plate 126 and the diaphragm 110. The orifice plate 106 is located above the diaphragm 110. The spring 132 is positioned around the impact pin 128 and between the diaphragm 110 and the valve plate 126 so that a force against the valve plate 126 can compress spring 132 and push the diaphragm 110 toward orifice plate 106. An agent can be introduced into chamber 112 between the diaphragm 110 and the orifice plate 106. The mixture chamber 136 is located above the orifice plate 106 and concentrically positioned around the plates 126, 106, pin 128, and spring 132 elements.” Para 0076; also see: “When the compressed air supply 92 supplies air through the inlet orifice 122 to the actuator chamber 124, the compressed air places pressure upon valve plate 126. As the air pressure builds against the valve plate 126, eventually the pressure overcomes the force of the spring 132. At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136. Movement of the impact pin 128 with valve plate 126 causes the diaphragm 110 to move in direct relation to the valve plate 126 and the impact pin 128.” Para 0078).
As to Claim 19, the modified Papania, specifically Papania discloses the diffuser (144) is porous (best seen Figure 5C, via 146 - “A support sleeve 144 having holes 146 formed therein supports orifice plate 106 and diaphragm 110 at its upper end.” Para 0077 and “At this pressure, the compressed air moves the valve plate 126 away from valve plate seating surface 134 and air passes through holes 146 and enters the mixture chamber 136.” Para 0078) being a disk shaped member (“sleeve” Para 0077) including at least one conical shaped member (defined by the construction of 90, best seen Figure 5C) and having a distal aperture (via 138, “The pneumatic nebulizer 90 includes a housing 120 that can be connected to a compressed air supply (shown in FIGS. 3 and 7 as 92). The pneumatic nebulizer 90 can include an inlet orifice 122, an actuator, or accumulator, chamber 124, a valve plate 126, an orifice plate 106, an impact pin 128, a spring 132, a valve plate seating surface 134, a mixture chamber 136, a diaphragm 110, and an aerosol outlet 138.” Para 0076).
As to Claim 20, the modified Papania, specifically Papania discloses the diffuser (144) extends into the compound (via 24) in the drug chamber (24) through “The agent probe 28 can be connected to the ultrasonic nebulizer 36 via a section of flexible tubing 38 to carry a quantity of agent from vial 24 to nebulizer 36.” (Para 0066).
Claims 14 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Sappington (4,154,309), as applied to Claim 13, and further in view of Freeman (2003/0021775).
As to Claims 14 and 15, the modified Papania, specifically Papania discloses the manual pressure actuator (40) for operating the air compression chamber (via 92, or alternatively 46), wherein the initial compression of the air achieved through “a direct, manually-operated, hand or foot pump 96, a direct, powered air source supplied by a portable compressor 98, a stationary compressor 100, or a rechargeable low-pressure air tank 102.” (Para 0081 related to 92) or alternatively through “the air reservoir 46 is recharged using an air reservoir charging pump 72 operatively connected to pump handle 18. The air reservoir charging pump 72 is located within the housing 10 and connected to the air reservoir 46. Specifically, the air reservoir 46 is recharged by manually and repeatedly applying pressure to a charging pump handle 18 connected to the housing 10 via a pin 74.” (Para 0071 related to 46). In each of these interactions, the depressing of the manual pressure actuator (40) results in a positive displacement of the air contained within the air compression chamber to be utilized in the dispensing of the compound. Yet, the modified Papania does not expressly disclose the manual pressure actuator is a “piston” (Claim 4), or a “syringe” (Claim 5).
Freeman teaches a similar device to Papania for the dispensing of a compound under pressure (“first reservoir 10 is in fluid communication with a pump 18 which serves for streaming the protease solution from first reservoir 10 to an applicator 24 (which is described in greater detail hereinafter) under positive pressure.” Para 0073), wherein the construction of the manual pressure actuator may include various constructions of the positive displacement pump wherein the “Pump 18 may be an air pump, a piston-driven fluid pump, syringe pump or an impeller.” (Para 0073) in order to effectively provide the compound to treat the patient. In light of this construction, it is clear the manual pressure actuator of Freeman effectively provides a piston driven or syringe driven pressure to positively displace the compound to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manual pressure actuator of modified Papania to include the use of a piston or syringe as taught by Freeman to be known positive displacement devices suitable for imparting the delivery of a compound to a patient for treatment of the patient.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Papania et al. (2004/0134494) in view of Sappington (4,154,309) and Freeman (2003/0021775), as applied to Claim 15, and further in view of Lockhart (2,574,339)
As to Claim 16, the modified Papania, specifically Freeman teaches the use of syringes as a manual pressure actuator were known. Yet, the modified Papania does not expressly disclose the manual pressure actuator is a syrette.
Lockhart teaches equivalency between syringes and syrettes as known devices suitable for imparting a compound under positive pressure to be displaced from the device to the patient. In particular, Lockhart states “Syringes of this type known as syrettes are now commonly used by the military services. The principal object of the present invention is to make a syringe of this type which is cheaper in construction, more dependable in operation, and easier to use than devices of this kind heretofore available.” (Column 1, Lines 5-15). Thus, a syrette is a specific type of syringe (hypodermic), specifically adapted for single use. (Column 1, Lines 1-5).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the generic syringe of the modified Papania as taught by Freeman to be utilized with the specific hypodermic syringe (syrette) as taught by Lockhart to be a known device suitable for imparting compounds under pressure to be delivered to the patient for single use operations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,730,903.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claims, Claims 1 and 13, are merely broader than the patent claims, Claims 1 and 13. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, the instant claims are not patentably distinct from the patent claims.
Instant Claims
18/346,244
Patent Claims:
11,730,903
Difference is Underlined
1. A device for delivery of a compound to a nasal cavity, the device comprising: an air compression chamber; a manual pressure actuator that causes air to be released from the air compression chamber upon actuation; a diffuser in communication with the air compression chamber; a drug chamber in communication with the diffuser, the drug chamber configured to hold the compound; and a nozzle in communication with the drug chamber, wherein air released from the air compression chamber is configured to contact the diffuser, and propel the compound out of the nozzle forming a plume.
1. A device for delivery of a compound to a nasal cavity, the device comprising: an air compression chamber; a manual pressure actuator that causes air to be released from the air compression chamber upon actuation; a diffuser in communication with the air compression chamber; a drug chamber in communication with the diffuser and a diffusion tube, the drug chamber configured to hold the compound and the diffusion tube allowing for the released air to bypass the compound; and a nozzle in communication with the drug chamber, wherein air released from the air compression chamber is configured to flow through the diffuser to contact and propel the compound out of the nozzle forming a plume.
2. The device of claim 1, wherein the manual pressure actuator further comprises a lock pin, wherein the lock pin is configured to maintain high pressure air in the air compression chamber.
2. The device of claim 1, wherein the manual pressure actuator further comprises a lock pin, wherein the lock pin is configured to maintain high pressure air in the air compression chamber.
3. The device of claim 1, further comprising a trigger valve in communication with the air compression chamber such that when the trigger valve is rotated from an open state to a closed state, air in the air compression chamber is blocked from contacting the diffuser and propelling the compound out of the nozzle.
3. The device of claim 1, further comprising a trigger valve in communication with the air compression chamber such that when the trigger valve is rotated from an open state to a closed state, air in the air compression chamber is blocked from contacting the diffuser and propelling the compound out of the nozzle.
4. The device of claim 1, wherein the manual pressure actuator comprises a piston.
4. The device of claim 1, wherein the manual pressure actuator comprises a piston.
5. The device of claim 1, wherein the manual pressure actuator comprises a syringe.
5. The device of claim 1, wherein the manual pressure actuator comprises a syringe.
6. The device of claim 1, wherein the manual pressure actuator comprises a syrette.
6. The device of claim 1, wherein the manual pressure actuator comprises a syrette.
7. The device of claim 1, wherein the diffuser is heterogeneously porous or homogenously porous.
7. The device of claim 1, wherein the diffuser is heterogeneously porous or homogenously porous.
8. The device of claim 1, wherein the compound is a drug or diagnostic agent.
8. The device of claim 1, wherein the compound is a drug or diagnostic agent.
9. The device of claim 8, wherein the diagnostic agent is an imaging agent.
9. The device of claim 8, wherein the diagnostic agent is an imaging agent.
10. The device of claim 1, wherein the diffuser is porous, the porous diffuser being a disk-shaped member including at least one conical shaped member having a distal aperture.
10. The device of claim 1, wherein the diffuser is porous, the porous diffuser being a disk-shaped member including at least one conical shaped member having a distal aperture.
11. The device of claim 1, wherein the diffuser is configured to act as a one-way check valve.
11. The device of claim 1, wherein the diffuser is configured to act as a one-way check valve.
12. The device of claim 1, wherein the diffuser extends into the compound in the drug chamber.
12. The device of claim 1, wherein the diffuser extends into the compound in the drug chamber.
13. A device for delivering a compound to a nasal cavity, the device comprising: an air compression chamber; a manual pressure actuator comprising a lock pin, the manual pressure actuator configured to release air from the air compression chamber, the lock pin configured to maintain high pressure air in the air compression chamber; a trigger valve configured to be in communication with the air compression chamber such that when the trigger valve is rotated from an open state to a closed state, air in the air compression chamber is blocked from exiting the air compression chamber; a diffuser in communication with the trigger valve; a drug chamber in communication with the diffuser, the drug chamber configured to hold the compound; and a nozzle in communication with the drug chamber, wherein air released from the air compression chamber is configured to contact the diffuser, and propel the compound out of the nozzle forming a plume.
13. A device for delivering a compound to a nasal cavity, the device comprising: an air compression chamber; a manual pressure actuator comprising a lock pin, the manual pressure actuator configured to release air from the air compression chamber, the lock pin configured to maintain high pressure air in the air compression chamber; a trigger valve configured to be in communication with the air compression chamber such that when the trigger valve is rotated from an open state to a closed state, air in the air compression chamber is blocked from exiting the air compression chamber; a diffuser in communication with the trigger valve; a drug chamber in communication with the diffuser and a diffusion tube, the drug chamber configured to hold the compound and the diffusion tube allowing for the released air to bypass the compound; and a nozzle in communication with the drug chamber, wherein air released from the air compression chamber is configured to flow through the diffuser to contact and propel the compound out of the nozzle forming a plume.
14. The device of claim 13, wherein the manual pressure actuator further comprises a piston.
14. The device of claim 13, wherein the manual pressure actuator further comprises a piston.
15. The device of claim 13, wherein the manual pressure actuator further comprises a syringe.
15. The device of claim 13, wherein the manual pressure actuator further comprises a syringe.
16. The device of claim 13, wherein the manual pressure actuator further comprises a syrette.
16. The device of claim 13, wherein the manual pressure actuator further comprises a syrette.
17. The device of claim 13, wherein the diffuser is heterogeneously porous or homogenously porous.
17. The device of claim 13, wherein the diffuser is heterogeneously porous or homogenously porous.
18. The device of claim 13, wherein the diffuser is configured to act as a one-way check valve.
18. The device of claim 13, wherein the diffuser is configured to act as a one-way check valve.
19. The device of claim 13, wherein the diffuser is porous, the porous diffuser being a disk-shaped member including at least one conical shaped member having a distal aperture.
19. The device of claim 13, wherein the diffuser is porous, the porous diffuser being a disk-shaped member including at least one conical shaped member having a distal aperture.
20. The device of claim 13, wherein the diffuser extends into the compound in the drug chamber.
20. The device of claim 13, wherein the diffuser extends into the compound in the drug chamber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brugger (4,949,715) discloses an additional device for the delivery of a compound to the respiratory organs of a patient, having an air compression chamber (23), a manual pressure actuator (15), a diffuser (7), a drug chamber (8) and a nozzle (10). Although Brugger does not expressly disclose the use of nasal administration as claimed, the application of compounds with nasal and/or oral administration are well known.
Papania et al. (2009/0223513 and 2012/0118283) disclose additional delivery devices suitable for nasal delivery having the features of an air compression chamber, manual pressure actuator, diffuser, a drug chamber, and a nozzle. As Papania is similar to the instant rejection, it would behoove Applicant to further amend around each of the Papania references to address the limitations of the air compression chamber and the manual pressure actuator compared to the instantly disclosed invention.
Hoekman et al. (10,507,295) shares a common assignee with the instant application and discloses the features of a diffuser, a drug chamber, and a nozzle, wherein the delivery mechanism is a propellant and is absent to the express construction of an air compression chamber, and a manual pressure actuator. Although Hoekman is absent to the construction of the air compression chamber and the manual pressure actuator, various prior art references, especially Papania state the features of the air compression chamber and the manual pressure actuator were known. Thus, it would behoove Applicant to include additional features within the instant claim listing to further obviate the rejection of Papania and establish a chasm between the prior art made of record and the instantly claimed invention that is non-obvious and unable to be double patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785