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 .
Election/Restrictions
Applicant’s election without traverse of claims in the reply filed on 12/12/2025 is acknowledged.
Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claim Objections
Claims 2-5 are objected to because of the following informalities:
Claim 2-5, line 1, “A device according to claim 1” should be “The device according to claim 1”.
Appropriate correction is required.
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)(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.
(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) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeMore, JR. et al. (US 20200030139 A1), hereinafter DeMore.
Regarding claim 1, DeMore discloses a device for ameliorating symptoms associated with migraine comprising, in an integrated unit (see [0007] and figure 1):
an air delivery subassembly in a desktop unit (see figure 1, Coolstat Instrument. [0050] air flow is generated by fan/blower 101, and in which the air flow passes through or by air flow sensor 103, disposable/replaceable desiccant cartridge 105, heat sink 106, humidity, pressure and temperature sensor(s) 107, saline bag 500, peristaltic pump 159, manifold cartridge 137; figure 1-16b. [0051] FIG. 2 shows a representation of a portable device according to an embodiment of the invention. The device will be located next to the patient when in use and will either be mounted on an IV pole or placed on a horizontal surface. The device is comprised of multiple subassemblies which can be assembled largely independently. At the highest level, the device consists of top and bottom subassemblies 10, 30, respectively, which contain all other subassemblies) comprising:
an air inlet ([0052] air inlet 32 and inlet plenum 149; figure 9),
an air outlet ([0052] air outlet 135; figure 2, 4-5, and 12-14),
an air flow path connecting said air inlet and said air outlet (see arrow path figure 7 and 9),
a blower situated in said air flow path ([0053] centrifugal blower 101; figure 7) and configured to draw ambient air from said air inlet and force said ambient air through said air flow path and out said air outlet (see [0053] and figure 7),
a desiccant chamber situated in said air flow path ([0053] desiccant cartridge 105; figure 7) and configured to receive a removable and replaceable desiccant element ([0050] disposable/replaceable desiccant cartridge 105; figure 8; also see [0055]);
a heat sink situated in said air flow path ([0058] heat sink 106 and heat sink fan 127; figure 4-7) and configured to remove heat added to air in said air flow path during removal of moisture from said air by said desiccant element ([0058] The removal of moisture from the air by the desiccant cartridge 105 produces heat, with the air temperature at cartridge exit reaching temperatures in excess of 70° C. in some cases. To cool the air before it reaches the patient, a custom two-sided heatsink 106 is positioned downstream of the desiccant cartridge 105. The hot side 141 of the heatsink 106 is directly in the dry air stream. A fan 127 draws ambient air into the housing via second air inlet 132 and forces it across the other side 143 of the heatsink, cooling the dry air);
an air outlet sensor configured to measure air temperature, air flow rate, air pressure or a combination thereof ([0050] humidity, pressure and temperature sensor(s) 107; figure 1);
a handheld unit (see figure 1, Disposables and figure 17) comprising:
an air inlet port ([0073] a one-to-two connection element 225; figure 17) and tubing ([0073] air delivery tubes 223; figure 17);
a handheld unit outlet at the distal end of the tubing (nasal mask 113; figure 17);
an air path between said air inlet port of desktop unit and said handheld unit outlet (see figures 1, 7, 9, and 17 “air” arrows and air delivery tubes 221 and 223);
a water compartment ([0072] an independent water supply, e.g., a saline bag), including a closable access for the introduction of water ([0072] a water transfer port/opening 215; figure 16b);
a water path between said water compartment and said handheld unit outlet ([0072-0073] flexible transfer tube 117, water delivery tube 219, and water delivery tubes 227; figure 16b-17);
a nebulizer or ultrasonic transducer located and configured to convert water in said water path to water droplets just before the water enters the handheld unit outlet ([0048] misting nozzles located at the opening of the patient's nostrils. [0075] The ends of the distal water delivery tubes 227 are fitted with nozzle adaptors 237 which in turn are connected to nozzle components 239 each comprising a ring-shaped base 241 and a central nozzle 243 connected to the ring-shaped base 241 by a three or more upwardly extending spokes 245 that support and center the nozzle. Nozzle components 239 and nozzle adaptors 237 are preferably press fit together and the interface between them creates a swirl chamber geometry that generates spray; figure 20).
Regarding claim 2, DeMore discloses a device according to claim 1, further comprising a tube ([0072-0073] air delivery tube 221; figure 17) configured to attach at one end to said air outlet of said desktop unit (see [0072] and figure 17, attached to air outlet via manifold cartridge 137) and configured to attach at a second end to said air inlet port of said handheld unit (figure 17).
Regarding claim 3, DeMore discloses a device according to claim 1, further comprising a disposable nasal pillow configured to fit to a distal end of said handheld unit outlet (see [0014] and [0075], nasal pillows 247; figure 20).
Regarding claim 4, DeMore discloses a device according to claim 1, wherein said water path is configured to deliver water from said water compartment to said handheld unit outlet under the force of gravity (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Examiner notes: depending on the position of the water path in relation to the user, the water path may deliver the water under the force of gravity, i.e. if the independent water supply is hanging above a user while they are laying down during therapy delivery).
Regarding claim 5, DeMore discloses a device according to claim 1, further comprising a water pump configured and located to force water from said water compartment through said water path (see [0050], [0065], and [0072] fluid pump assembly 159/peristaltic pump 159; figure 1 and 12-14. [0072] When the manifold cartridge 137 is inserted into the complimentarily shaped interface 216 in the device housing, the rotary fluid pump engages the flexible transfer tube 177. When the fluid pump is activated, the rotating arm of the rotary fluid pump rotates, squeezing the flexible transfer tube 177 against a curved surface (the platen 179) of the fluid pump causing fluid in the fluid supply to be drawn into and forced through the transfer tube 177).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Todd (US 20130087144 A1) teaches a drug delivery system comprising a desktop unit and a handheld unit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785