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 of Applicant’s claim for priority under 35 U.S.C 119€ with reference to Applicant Number: 62/384,786 with a filing date of 9/8/2016.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 10 “por tis” should read – port is—
In lines 8-9, “a second air conduit in fluid communication with the second mouth “ should be deleted as it is a repeat limitation
In line 33 “of the breath analysis result” should read –on the breath analysis result--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, “the breath analysis device” in line 20 of the claim lacks antecedent basis.
Regarding claim 1, the limitation “receive in real time, via wireless communications from the personal portable device, a breath analysis result from a breath analysis test for the user performed with the personal portable device” is unclear since it sounds like the breath analysis device is part of the personal portable device but the claim also states the “wherein the mobile computing device is separate from the personal, portable device or the at least one breath analysis device” which indicates the personal, portable device and the breath analysis device are separate components of the system. The specification provides support for a separate device for atomization and for breath analysis. (Paragraph 4 of the published application, Paragraph 51 “ selection of one or more substances for vaporization may be made based on information obtained from other devices or systems, such as a breath analysis device”, paragraphs 81-83, describe the separate breath analysis device which are shown in Figs. 17-19)
For examination purposes, the examiner will assume that the breath analysis result is provided by the detection chamber (breath analysis device).
Claims 2-13 are rejected based on their reliance to claim 1.
Regarding claim 7, the limitation “the second mouth piece” lacks antecedent basis. The examiner assumes it should read –the second mouth port—
Regarding claim 8, the limitation “the second mouth piece” lacks antecedent basis. The examiner assumes it should read –the second mouth port—
Regarding claim 9, the limitation “the second mouth piece” lacks antecedent basis. The examiner assumes it should read –the second mouth port—
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 6-10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ljungberg (WO 2016/041576), hereinafter Ljungberg in view of Litherland et al (US 2002/0129812), further in view of Sakurada (2010/0089394), hereinafter Sakurada, and further in view of Brimer et al (US 2013/0317379), hereinafter Brimer.
Regarding claim 1, Shouldice teaches a system for managing inhalant devices (Fig. 2, paragraph 94, Fig. 3 ), comprising:
a personal, portable device (Fig. 2, paragraph 102, treatment device 242);
and
a mobile computer device (Fig. 2: 201, mobile computing device)with a microprocessor (Paragraph 48, program instructions encoded on a processor, paragraph 52) and wireless communications chip (paragraph 104, wireless communications between the computing device 201 and the treatment device 242), wherein the mobile computing device is separate from the personal, portable device or the at least one breath analysis device; (Fig. 2, paragraph 104, the devices are separate) further wherein the microprocessor is programmed to:
store data about an individual user, said data comprising identification data and health data (Paragraph 51, may interface with a medical information system storing medical records of the user, Paragraph 88, includes family history, height, weight);
receive in real time, via electronic communications from the personal portable device, use information about the individual user’s use of the substance contained in the inserted ampoule in conjunction with the personal nebulizer or vaporization device, wherein said use information includes duration of use and quantity of substance used (Paragraph 104, may count uses of the inhaler and communicate such data to a remote system, Paragraph 105, may track user compliance, user compliance would include duration of use and quantity used);
update the individual user’s health data with the user information and substance information (Paragraph 104, may count uses of the inhaler and communicate such data to a remote system, Paragraph 105, may track user compliance and may interact with device 201 to notify whether the medication was taken correctly);
receive in real time, via wireless communications from the personal portable device, a breath analysis result from a breath analysis test for the user performed with the personal portable device; (Paragraph 98, may measure air volume, paragraph 102, may communicate with devices such as a spirometer, paragraph 144, may use data available from a spirometer)
after receiving the breath analysis result, determine in real time, based at least in part of the breath analysis result, the type of substance and the dosing of said substance to be administered to said user through said personal device, (Paragraph 89, data from the treatment device may indicate the medication provided, Paragraph 102, the device 201 may adjust parameters, may change dosage, paragraph 102, the device may be adapted to communicate with a treatment device, paragraph 190, data monitored may include breath breathing conditions and patterns, seasonal factors, paragraph 191, a treatment dosage or a treatment device is determined based on the combination of data, Fig. 6) wherein the breath analysis result comprises one or more of breath airflow and pressure; (paragraph 88, breathing signals, such as rate, depth paragraph 98, measure forced expiratory volume, gas sensing), and
after determining the type and dosing, administer in real time said substance to the user through said personal device. (paragraph 204, the system determinations may feed in to dosage recommendations or recommended adjustments to a current dosage, a recommended treatment can be provided to the user by adjusting parameters of a device in communication with the system for administering or providing medication)
Shouldice does not teach the specifics of the personal, portable device.
However, Litherland teaches a personal, portable device (Figs3-8, paragraph 23, a hand-held portable device) with an atomization chamber (Fig.8: 30), and an ampule holding chamber, (Fig. 3: adapter 26, paragraph 27) said ampoule holding chamber configured to hold a substance-containing ampoule (Paragraph 27, designed to hold ampoules 18 containing a liquid), and a first mouth port from which a user inhales a nebulized or vaporized substance (Fig. 3: 6), wherein the first mouth port is in fluid communication with a first air conduit (Fig. 2 in communication with interior of mouthpiece to nebulization chamber 30, Fig. 3, paragraph 29, capillary feed through ampoules to nebulizer and to mouthpiece) and the atomization chamber is separate from the ampoule (Figs. 3-8, the atomization chamber is separate from ampoule 18);
a plurality of ampoules (Fig. 8: multiple ampoules 18), each ampoule containing a substance comprising one or more therapeutic, homeopathic, or naturopathic formulations, remedies, or serums. (paragraph 4, contains drugs for treatment of ailments)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Shouldice so that the system includes an inhaler as taught by Litherland since Shouldice teaches using the device with an inhaler (Fig. 3, Fig. 6A) and the device of Litherland provides the ability to provide multiple drugs to the user as needed.
Litherland does not teach wherein each ampoule is coded with information about the contained substance.
However, Kotnik teaches an inhaler (Abstract, Fig. 1) which has ampules coded with information about the contained substance. (Paragraph 13, RFID 34 on container, paragraph 15)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the system of Shouldice to include ampules coded with information about the contained substance as taught by Kotnik in order to determine a desired amount of the liquid to atomize for the individual based on the identity of the individual and the type of liquid in the container. (paragraph 4)
Shouldice teaches using data from a spirometer or breath analyzer but does not teach the specifics of the breath analysis device.
Brimer teaches a spirometer (Abstract) having a detection chamber (Fig. 5: 104, a second mouth port (Fig. 5: 130), a second air conduit in fluid communication with the second mouth port into which a user exhales (Fig. 5: 138, paragraph 65, user exhales into the spirometer), a second air conduit in fluid communication with the second mouth port (this is a repeated limitation, air conduit 138 of Fig. 5), and one or more transducers or sensors disposed in or in proximity to the detection chamber (Paragraph 58, sensor 50, which is located in chamber 104 may be a pressure transducer), wherein the first mouth port is separate from the second mouth port and not in communication therewith(the first mouth port is part of the inhaler and so separate from the spirometer), and the first air conduit is separate from the separate air conduit and not in fluid communication therewith (the first mouth port is part of the inhaler and so separate from the spirometer)
It would have been obvious to a person of ordinary skill in the art to have included the spirometer as disclosed by Brimer since Shouldice teaches the use of the system with a spirometer and Brimer teaches a device that integrates with mobile devices to determine medication dosage and efficacy. (Fig. 26, Paragraph 99) The device of Brimer would provide the airflow measurements required to make dosage decisions in the system of Shouldice.
Regarding claim 2, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, and Kotnik further teaches wherein the one or more of said plurality of ampoules comprises a scannable code or RFID chip (Fig. 1: 34), and the personal device comprises a scanner or RFID reader. (Fig. 1: 38)
Regarding claim 6, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, and Litherland further teaches wherein said atomization chamber comprises one or more piezoelectric transducers or atomizers configured to vaporize or atomize the substance with sonic or ultrasonic energy. (paragraph 28)
Regarding claim 7, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, and Brimer further teaches wherein the second mouth piece is removably attached to the personal device. (Paragraph 7, a detachable mouthpiece, paragraph 52)
Regarding claim 8, Shouldice in view of Litherland, Kotnik and Brimer the system of claim 1, wherein the second mouth piece is slidingly attached to the personal device. (paragraph 52, Fig. 15, mouthpiece would slide on in a friction fit or snap fit engagement0
Regarding claim 9, Shouldice in view of Litherland, Kotnik and Brimer the system of claim 1, and Brimer further teaches wherein the second mouth piece is rotatably attached to the personal device. (paragraph 52, the mouthpiece may have a threaded engagement, mouthpiece may be engaged by aligning a projection, after insertion, the mouthpiece may be rotated to securely attach the mouthpiece)
Regarding claim10, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, and Shouldice further teaches the personal device further comprising a wireless communications chip. (Paragraph 102, the device communicates wirelessly with the treatment device, paragraph 132, the treatment device may have an electronic chip for communication)
Regarding claim 12, Shouldice in view of Litherland, Kotnik and Brimer the system of claim 1, further comprising a cable adapted to attach the personal device to the mobile computing device. (Paragraph 100, the device may be further adapted to communicate with external sensors via wired connections, paragraph 102, wired communication between the device and treatment device)
Regarding claim 13, Shouldice in view of Litherland, Kotnik and Brimer the system of claim 1, Shouldice in view of Litherland, Kotnik and Brimer wherein the mobile computing device and the personal device intercommunicate using short-range wireless communications. (Paragraph 132, RFID communication)
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of Litherland, Kotnik, Brimer, and further in view of Madjd et al (US 2015/0269348), hereinafter Madjd.
Regarding claim 3, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, but does not teach wherein the microprocessor is further programmed to:
determine a health related recommendation for the individual user.
However, Madjd teaches a health management system (Abstract) which determines a health related recommendation for the individual user. (Paragraph 45, Paragraph 113, Figs. 4A-4C, recommends medications based on particular action zone the user is in, paragraph 48, zones may be based on expiratory flow readings)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Shouldice in view of Litherland, Kotnik and Brimer to include the health recommendation of a particular drug as taught by Madjd in order to provide the appropriate drug for the severity of the disease. (paragraph 45)
Regarding claim 4, Shouldice in view of Litherland, Kotnik, Brimer and Madjd teaches the system of claim 3, and Madjd further teaches wherein the health related recommendation comprises a recommendation for a substance or substances to be used in the personal device. (paragraph 45, the drug type to use)
Regarding claim 5, Shouldice in view of Litherland, Kotnik, Brimer and Madjd teaches the system of claim 4, and Madjd further teaches wherein the microprocessor is further programmed to:
display the health related recommendation for the individual user on the mobile communication device.(Paragraph 113, Figs. 4A-4C)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of Litherland, Kotnik, Brimer, and further in view of Bowen et al (US 2018/0043114), hereinafter Bowen.
Regarding claim 11, Shouldice in view of Litherland, Kotnik and Brimer teaches the system of claim 1, and Shouldice teaches a wired connection between the personal device and mobile computing device (paragraph 102) but does not explicitly state the personal device further comprising one or more communications ports.
However, Bowen teaches an electronic vaporizer (Abstract) which has one or more communication ports. (Paragraph 52, Fig. 1, USB connection)
It would have been obvious to a person of ordinary skill in the art to have provided the communication port as taught by Bowen in order to provide an optional wired charger and communication between the computer and the vaporizer controller)
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 -6 and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.11,419,818. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the instant claims are found in the patented claims.
Regarding claim 1, A system for managing inhalant devices, (Claim 1, a system for managing inhalant devices) comprising:
a personal, portable device with an atomization chamber and an ampoule holding chamber, said ampoule holding chamber configured to hold a substance-containing ampoule, and a first mouth port from which a user inhales a nebulized or vaporized substance, wherein the first mouth port is in fluid communication with a first air conduit and the atomization chamber is separate from the ampoule (Claim 1: a personal, portable nebulizer or vaporization device with an atomization chamber, an ampoule holding chamber configured to hold a substance-containing ampoule, and a first mouth port from which a user inhales a nebulized or vaporized substance, wherein the first mouth port is in fluid communication with a first air conduit and the atomization chamber is separate from the ampoule) ;
further comprising a detection chamber, a second mouth port, a second air conduit in fluid communication with the second mouth port into which a user exhales, a second air conduit in fluid communication with the second mouth port, and one or more transducers or sensors disposed in or in proximity to the detection chamber, wherein the first mouth port is separate from the second mouth port and not in fluid communication therewith, and the first air conduit is separate from the second air conduit and not in fluid communication therewith; (Claim 1, at least one breath analysis device with a detection chamber, a second mouth port into which a user exhales, a second air conduit in fluid communication with the second mouth port, and one or more transducers or sensors disposed in or in proximity to the detection chamber, wherein the first mouth port is separate from the second mouth port and not in fluid communication therewith, and the first air conduit is separate from the second air conduit and not in fluid communication therewith)
a plurality of ampoules, each ampoule containing a substance comprising one or more therapeutic, homeopathic, or naturopathic formulations, remedies, or serums, further wherein each ampoule is coded with information about the contained substance; (claim 1, a plurality of ampoules, each ampoule containing a substance comprising one or more therapeutic, homeopathic, or naturopathic formulations, remedies, or serums) and
a mobile computing device with a microprocessor and a wireless communications chip, (Claim 1, a mobile computing device with a microprocessor and a wireless communications chip )wherein the mobile computing device is separate from the personal, portable device or the at least one breath analysis device; (Claim 1, wherein the mobile computing device is separate from the personal, portable nebulizer or vaporizer or the at least one breath analysis device)
further wherein the microprocessor is programmed to: store data about an individual user, said data comprising identification data and health data; (claim 1, wherein the microprocessor is programmed to: store data about an individual user, said data comprising identification data and health data)
receive in real time, via electronic communications from the personal portable device, use information about the individual user's use of the substance contained in the inserted ampoule in conjunction with the personal nebulizer or vaporization device, wherein said use information includes duration of use and quantity of substance used; (Claim 1, receive in real time, via wireless communications from the personal nebulizer or vaporization device, use information about the individual user's use of the substance contained in the inserted ampoule in conjunction with the personal nebulizer or vaporization device, wherein said use information includes duration of use and quantity of substance used)
update the individual user's health data with the use information and substance information; (Claim 1, update the individual user's health data with the use information and substance information)
receive in real time, via wireless communications from the personal portable device, a breath analysis result from a breath analysis test for the user performed with the personal portable device; (Claim 1, receive in real time, via wireless communications from the at least one breath analysis device, a breath analysis result from a breath analysis test for the user performed with the at least one breath analysis device)
after receiving the breath analysis result, determine in real time, based at least in part of the breath analysis result, the type of substance and the dosing of said substance to be administered to said user through said personal device, wherein the breath analysis result comprises one or more of breath airflow and pressure; (claim 1, after receiving the breath analysis result, determine in real time, based at least in part of the breath analysis result, the type of substance and the dosing of said substance to be administered to said user through said personal nebulizer or vaporization device wherein the breath analysis result comprises one or more of breath airflow and pressure)
after determining the type and dosing, administer in real time said substance to the user through said personal device. (Claim 1, administer in real time said substance to the user through said personal nebulizer or vaporization device.)
Regarding claim 2, the system of claim 1, wherein one or more of said plurality of ampoules comprises a scannable code or RFID chip, and the personal device comprises a scanner or RFID reader. (Claim 2, wherein one or more of said plurality of ampoules comprises an RFID chip, and the personal nebulizer or vaporization device comprises an RFID reader.)
Regarding claim 3, the system of claim 1, wherein the microprocessor is further programmed to: determine a health-related recommendation for the individual user. (Claim 4, determine a health-related recommendation to the user)
Regarding claim 4, the system of claim 3, wherein the health-related recommendation comprises a recommendation for a substance or substances to be used in the personal device. (Claim 5, the health-related recommendation comprises a recommendation for a substance or substances to be used in the personal nebulizer)
Regarding claim 5, the system of claim 4, wherein the microprocessor is further programmed to: display the health-related recommendation for the individual user on the mobile communication device. (Claim 6, display the health-related recommendation to the individual user on the mobile communication device)
Regarding claim 6, The system of claim 1, wherein said atomization chamber comprises one or more piezoelectric transducers or atomizers configured to vaporize or atomize the substance with sonic or ultrasonic energy. (Claim 7, the atomization chamber comprises one or more piezoelectric transducers or atomizers configured to vaporize or atomize the substance with sonic or ultrasonic energy)
Regarding claim 10, The system of claim 1, the personal device further comprising a wireless communications chip. (Claim 11, the personal nebulizer or vaporization device further comprising a wireless communications chip)
Regarding claim 11, The system of claim 1, the personal device further comprising one or more communications ports. (Claim 12, the personal nebulizer or vaporization device further comprising one or more communications ports)
Regarding claim 12, The system of claim 1, further comprising a cable adapted to attach the personal device to the mobile computing device. (claim 13, a cable adapted to attach the at least one breath analysis device to the mobile computing device)
Regarding claim 13, The system of claim 1, wherein the mobile computing device and the personal device intercommunicate using short-range wireless communications. (Claim 15, the mobile computing device, the personal nebulizer or vaporization device, and the at least one breath analysis device intercommunicate using short-range wireless communications. )
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785