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 .
Status of Claims
This present office action is responsive to the Application filed on July 25, 2024. As directed, claims 1-8 are presently pending in this application.
Drawings
The drawings are objected to because of the following informalities:
Regarding figures 1-4, photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. See 37 CFR 1.84 (b)(1).
In Fig 1, the reference character, “114” deems to be directed to the bottom of the pipe tube point 116 instead of the structure of the “disbursement trigger” having an extending portion that can be pressed as described in ¶0046.
In Fig 1, the reference character, “104” (at least one valve) deems to be indicated above the fluid tank 112, the mask holder 106, and the master outer case 108 while claim 1 recites, “at least one valve air tightly positioned in the air container…at least one mask holder positioned above the top of the at least one valve…at least one mask outer case fixed on top of the at least one mask holder...the at least one fluid tank positioned on the top of the at least one mask holder” which renders the designation of 104 would be below reference characters, 106, 108, 112, and 110.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claims 1-8 are objected to because of the following informalities:
Claim 1 recites, “the at least one fluid tank” in ln 6 which Examiner suggest amending to read --at least one fluid tank-- as it has not been introduced.
Claims 2-4 are objected by virtue of dependency to claim 1.
Claim 5 recites, “Bernoulli’s Theory Enabler” in ln 4 which Examiner suggest amending to read --a Bernoulli’s Theory Enabler--
Claim 5 recites, “fluid form the” in ln 8 which Examiner suggest amending to read --fluid from the--
Claims 6-8 are objected by virtue of dependency to claim 5.
Appropriate correction is required.
Claim Interpretation
Claims 1 and 5 recite the terminology, “Bernoulli’s Theory Enabler” which is not a term of art and thus it is interpreted in light of Applicant’s specification to mean --a component that is positioned inside the fluid tank of the non-electric nebulizer system at the top region of the bottle or container for the delivery of the gas or air or mixture of gases-- as described in ¶0026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “at least one…” of each of said components in ln 2-13. Although the specification discloses that “the system [100] may comprise multiple such units and modules or the system may comprise any such numbers of said units and modules” in ¶0034, it does not demonstrate possession of the full genus encompassed by the claim, including configuration having differing numbers of the respective components and lacking the disclosed one-to-one structural relationships. For example, the claim permits a system having a plurality of containers while reciting only a single valve without specifying whether the valve is associated with each container or only one of the containers.
Thus, the examiner takes the position that the claim contains subject matter which was not reasonably described in the specification in such a way as to reasonably convey possession of the claimed invention.
Examiner suggest amending the claim to read --A non-electric nebulizer system comprises at least one unit comprising: a container, a valve…a mask holder…a mask outer case…a Bernoulli’s Theory Enabler…a fluid tank…a disbursement trigger…a pipe tube point…-- for clarity and consistency with ¶0034.
Claims 2-4 are rejected by virtue of dependency to claim 1.
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 1-8 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.
Claim 1 recites, “at least one…” of each of said components in ln 2-13 which renders claim indefinite. For example, the claim permits a system having a plurality of containers while reciting only a single valve without specifying whether the valve is associated with each container or only one of the containers or vice-versa where a plurality of valves may be introduced to a container while further comprising a mask holder or a plurality of mask holders to said valve or valves. It is not possible for one of ordinary skill to ascertain the metes and bounds of the claim and the skills artisan would not be apprised of the claim scope protected by the limitation, thus rendering the claim indefinite.
Claims 2-4 are rejected by virtue of dependency to claim 1.
Claim 5 recites, “at least one fluid tank…at least one mask outer case” in ln 3-4 which renders claim indefinite. Similarly, to claim 1, the claim permits a system having a plurality of fluid tanks while reciting only a single mask outer case or vice-versa without specifying whether the fluid tank is associated with each mask outer case or only one of the mask outer cases. It is not possible for one of ordinary skill to ascertain the metes and bounds of the claim and the skills artisan would not be apprised of the claim scope protected by the limitation, thus rendering the claim indefinite.
Claim 5 further recites, “activating the non-electric nebulizer by imitating movement of the fluid…using Bernoulli’s Theory Enabler” in ln 3-4 and “deactivating the non electric nebulizer by stopping the movement…based on the second input” in ln 8-9 render claim indefinite. It is unclear what mechanism/component is tied to the first input and the second input. Based on the specification, the “Bernoulli’s Theory Enabler” is activated upon the release of the high pressure of the gas or air (¶0041) which implies that the “Bernoulli’s Theory Enabler” is not tied to the initiating/stopping the movement of the flow. The “rotating” means or the “disbursement trigger” deems to be activating the described function (¶0046). The claim does not identify what structure or operation causes the fluid to move in response to the first input or stop the fluid in response to the second input. Thus, it is not possible for one of ordinary skill to ascertain the metes and bounds of the claim and rending the claim indefinite.
Claims 6-8 are rejected by virtue of dependency to claim 5.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steil (US Pat 3658059 A; cited in IDS filed 07/25/2024).
Regarding claim 1, Steil discloses, a non-electric nebulizer system (a device of Fig 1; claim 1) comprising:
- at least one container (a base 1, Fig 1);
- at least one valve air tightly positioned in the at least one container (Col 2, ln 1-9 implies a rubber button 10 on an actuating lever 11 acting as a valve to allow air supplied to the inhaler via a nozzle 4 when the lever is operated as shown in Fig 1);
- at least one mask holder (the intermediate part 2, Fig 1) positioned on the top of the at least one valve;
- at least one mask outer case (sleeve 17 which is rotated by a knurled ring 21, Fig 1) fixed on top of the at least one mask holder;
- at least one Bernoulli's Theory Enabler (the atomizing or suspending nozzle 4, Fig 1) positioned inside at least one fluid tank (a cavity of the 2, Fig 1 holding the medium 3 which is atomized by the nozzle);
- the at least one fluid tank (medium 3 is above a base of the intermediate part 2 as shown in Fig 1) positioned on the top of the at least one mask holder;
- at least one disbursement trigger (21 is arranged above the 2, Fig 1) fixed on top of the at least one mask outer case; and
- at least one pipe tube point (a tube 13 and a suspension outlet opening 14, Fig 1; Col 2, ln 10-18, “…opening adjoins a breathing mask”),
wherein the non-electric nebulizer system is activated based on movement of the at least one mask outer case in a clockwise direction for a predefined number of rotations (Col 2, ln 1-12, and 41-47 implies that the system is activated by turning the sleeve via the knurled ring for adjusting the rate of supply and to regulate the particle size, but allowing the suspension outlet to open and close while air is introduced by the lever 11; Examiner interprets the “activation” as to allowing the system to be used as intended including but not limited to unlocking, initiating a pressure/flow path, movement of the fluid, release of compressed gas, atomization, moving a valve or any other steps prior to or including the release of the liquid as broadest reasonable interpretation; Examiner notes that the “predefined number of rotation” can be a singular or any other number of rotation of the knurl ring which also rotates the baffle toward unblocking the outlet opening).
Regarding claim 2, Steil discloses the system of claim 1 as discussed above.
Steil further discloses, wherein the at least one pipe tube point enables the user to connect the non-electric nebulizer system with an external mask (a breathing mask 15, Fig 1; Col 2, ln 10-18, implies the pipe tube point enables the user to connect with an external mask indirectly via fluid communication) to use the non- electric nebulizer system in one or more favourable positions of the user (Examiner interprets the “one or more favourable positions” as to --any position or orientation relative to the user that permits or facilitates use of the device of Fig 1-- as broadest reasonable interpretation as the said position does not specifically require body posture, orientation, angle, or location of the external mask).
Regarding claim 3, Steil discloses the system of claim 1 as discussed above.
Steil further discloses, wherein the non-electric nebulizer system is deactivated based on movement of the mask outer case in an anti-clockwise direction for the predefined number of rotations (Col 2, ln 1-12, and 41-47, implies that the system can be deactivated by turning the sleeve via the knurl ring so that the baffle is rotated to block the outlet opening either an anti-clockwise direction or the clockwise direction as shown in Fig 1; Examiner notes that the “predefined number of rotation” can be a singular or any other number of rotation of the knurl ring which also rotates the baffle toward unblocking the outlet opening).
Regarding claim 5, Steil discloses, a method for inhaling fluid using a non-electric nebulizer (abstract; Col 1, ln 69- Col 2, ln 51, implies a method of using the inhaler of Fig 1), the method comprises:
- receiving a first input of a user for activation of the non-electric nebulizer (Col 2, ln 1-12; Examiner interprets the “first input” as any action/step of the user to use the device);
- activating the non-electric nebulizer by initiating movement of the fluid from at least one fluid tank (medium 3 is above a base of the intermediate part 2 as shown in Fig 1) to at least one mask outer case (sleeve 17 which is rotated by a knurled ring 21, Fig 1) using Bernoulli's Theory Enabler (the atomizing or suspending nozzle 4, Fig 1; Col 2, ln 1-12, and 41-47 implies that the system is activated by turning the sleeve via the knurled ring for adjusting the rate of supply and to regulate the particle size, but allowing the suspension outlet to open and close while air is introduced by the lever 11; Examiner interprets the “activation” as to allowing the system to be used as intended including but not limited to unlocking, initiating a pressure/flow path, movement of the fluid, release of compressed gas, atomization, moving a valve or any other steps prior to or including the release of the liquid as broadest reasonable interpretation; Examiner notes that the “predefined number of rotation” can be a singular or any number of rotation of the knurl ring which also rotates the baffle toward unblocking the outlet opening);
- inhaling the fluid by the user using the at least one mask outer case of the non-electric nebulizer (abstract; Col 2, ln 1-9, “…the inhaler only during actual breathing in”);
- receiving a second input of the user for deactivation of the non-electric nebulizer (Col 2, ln 1-12, and 41-47; Examiner interprets the “second input” as any action/step of the user to stop using the device); and
- deactivating the non-electric nebulizer by stopping the movement of the fluid from the at least one fluid tank based on the second input (Col 2, ln 1-12, and 41-47, implies that the system can be deactivated by turning the sleeve via the knurl ring so that the baffle is rotated to block the outlet opening either an anti-clockwise direction or the clockwise direction as shown in Fig 1 so that it is capable of preventing the fluid being delivered to the user).
Regarding claim 6, Steil discloses the method of claim 5 as discussed above.
Steil further discloses, wherein the first input of the user for the activation of the non-electric nebulizer is one of:- rotating the at least one mask outer case of the non-electric nebulizer in a clockwise direction for a predefined number of rotations (Col 2, ln 1-12, and 41-47; as discussed in claim 5 above).
Regarding claim 7, Steil discloses the method of claim 5 as discussed above.
Steil further discloses, wherein the second input of the user for the deactivation of the non-electric nebulizer is one of:- rotating the at least one mask outer case of the non-electric nebulizer in an anti- clockwise direction for a predefined number of rotations (Col 2, ln 1-12, and 41-47; as discussed in claim 5 above; Examiner notes that the “predefined number of rotation” can be a singular or any number of rotation of the knurl ring which also rotates the baffle toward unblocking the outlet opening).
Regarding claim 8, Steil discloses the method of claim 5 as discussed above.
Steil further discloses, connecting the non-electric nebulizer with an external mask (a breathing mask 15, Fig 1) using at least one tube point (a tube 13 and a suspension outlet opening 14, Fig 1; Col 2, ln 10-18, implies the pipe tube point enables the user to connect with an external mask indirectly via fluid communication) to use the non-electric nebulizer in one or more favorable positions of the user (Examiner interprets the “one or more favourable positions” as to --any position or orientation relative to the user that permits or facilitates use of the device of Fig 1-- as broadest reasonable interpretation as the said position does not specifically require body posture, orientation, angle, or location of the external mask).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the closest identified prior art of record is Steil (US Pat 3658059 A; cited in IDS filed 07/25/2024) and Greiner-Perth (US 20190247593 A1; cited in IDS filed 07/25/2024 as EP 3323455 A1).
Steil discloses the main components of claim 1 as discussed above, but the prior art does not specifically discloses the arrangement of the disbursement trigger which are activated by pressing and deactivated by releasing as the lever 11 of Fig 1 is arranged below the mask holder, the mask outer case, and the fluid tank.
Greiner-Perth discloses the non-electric nebulizer system (an inhalation device 10, Fig 1) comprising: - at least one container (a liquid reservoir 90, Figs 1-3); - at least one valve (an outlet switching valve 50, Figs 2-3) air tightly positioned in the at least one container; - at least one mask holder (a base component 60, Fig 3) positioned on the top of the at least one valve;
- at least one mask outer case (an inner housing 30, Fig 3) fixed on top of the at least one mask holder; - at least one Bernoulli's Theory Enabler (a nozzle arrangement 56 with a nozzle plate 57, Fig 2) positioned inside at least one fluid tank (a plurality of structural parts 54, 55 for conveying liquid as shown in Fig 2; ¶0055); - the at least one fluid tank (54, 55 which are inner components of 30 is arranged above the 60, Fig 3; ¶0055) positioned on the top of the at least one mask holder; - at least one disbursement trigger (an outer housing 40 arranged above the 30, Fig 3) fixed on top of the at least one mask outer case; and - at least one pipe tube point (a channel 43, Fig 1). While the deice of Fig 3 in view of Fig 2 may be capable of being press down by the rotational movement via a slotted guide having a shape of a helix, the prior art is silent on the system is activated by pressing the disbursement trigger and deactivated by releasing the disbursement trigger.
No other prior art is found which alternately would obviously satisfy the overall requirements of the instant claim. It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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, Kendra D 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.
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.
/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights