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 .
Response to Amendment
This action is responsive to the amendment filed 09/15/2025. The previous claim, drawing and specification objections have been withdrawn in response to applicant’s amendments. A new 112 rejection is incorporated in response to applicant’s amendment. Claims 1-8 and 16-19 remain pending, withs claims 1-5 and 17 withdrawn in response to restriction.
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 6-8, 16 and 18-19 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 6 has been amended to recite “the opener is configured to be separated from the liquid storing member without using any tool other than the opener and the liquid storing member”. However, the specification fails to provide support for the use of no tools. Applicant asserts that this amendment is supported by figures 5-8 however, the figures and specification pg 4 ln 15-20 instead provide support for the inlet being used to retain the opener to allow for the opener and the liquid storing member to be moved relative to eachother. It is therefore seen that the inlet components acts as a tool for separating the liquid storing member and the opener. Therefore, an embodiment where no tools are used to separate the opener and the liquid storing member is not supported by the specification/drawing and the amendment is seen as pertaining to new matter.
Claims 7-8, 16 and 18-19 are rejected by dependency upon claim 6.
As applicant does not have support for the amendment regarding “without using any tool other than the opener and the liquid storing member” the claim is being interpreted as if the limitation was not present.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6-8 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 2019/0143053 A1) in view of Abrams (US 2011/0283996 A1).
Regarding claim 6, Chen discloses an atomization device (#10 fig 1, abstract), comprising: a disposable liquid supply module (#20 fig 1, par 0025 "The vial assembly 20 is removable and disposable") including: a liquid storing member (#100 fig 1-2) that stores a liquid therein (par 0021 "the vial 100 contains liquid medicament"); an opener (#110 fig 2, 5-7, par 0029) configured to form an opening on the liquid storing member (par 0029 discloses projection(s) 250 creating the opening in the puncturable seal of 100); and a container (#200 fig 2-4) having a buffering chamber (#232 fig 4-7), wherein two opposite sides of the buffering chamber of the container respectively have an inlet configured to allow an insertion of the liquid storing member (end of 200 at 262 see fig 4) and an outlet (end of 200 at 236 see fig 4); a carrier (#300 fig 1) detachably assembled to the disposable liquid supply module (par 0025 "The vial assembly 20 is removable" thus disclosing detachable); and the atomizing module (#236 fig 3, 4, 11, par 0027 "perforated membrane" and par 0036 driving element/piezo electric element of receptacle) cooresponding in position to the outlet and including a microporous film (#236 fig 3, 4, 11, par 0027 "perforated membrane." Par 0027 discloses using polyimide, polyethyelene, polypropylene, or polyether ether ketone as the material for the perforated membrane, which is the same material options disclosed in the applicant’s specification) that is fixed to the container that covers the outlet (#200 see fig 3-7) and a vibrator (par 0036 discloses a driving element/piezo electric element and substrate of receptacle/carrier 300. The driving element and substrate together form a “vibrator”) that is assembled to the carrier, wherein the microporous film detachably abuts against the vibrator (par 0036 " Consequently, a driving element of the receptacle 300 (not shown) is aligned and in contact with the perforated membrane"); wherein a volume of the buffering chamber is less than a volume of the liquid stored in the liquid storing member (see fig 5-7 showing the buffering chamber 232 smaller than the liquid stored in the liquid storing member); wherein the opener is configured to be separated from the liquid storing member by being inserted into the inlet and being moved relative to the liquid storing member so as to form the opening on the liquid storing member (par 0029 opener 110 moves relative to storing member 100, as the container/inlet pushes the opener into the storing member); wherein the disposable liquid supply module is configured to be pressed so that an external force is exerted onto the liquid storing member and an inner pressure of the liquid storing member is changed, such that a part of the liquid is driven to flow from the opening into the buffering chamber for an atomizing process of the atomizing module (see par 0034 and F2 of fig 6 disclosing the opener and the liquid storing member being pressed together to open the liquid storing member thus altering the internal pressure and allowing the liquid to flow through the opening into the buffering chamber).
Chen is silent to the container having a barrier arranged in the buffering chamber wherein the barrier is configured to divide the buffering chamber into a first chamber having the inlet and a second chamber having the outlet; and when the opener is separated from the liquid storing member and the opening of the liquid storing member is located in the first chamber by passing through the inlet, the opener is located in the first chamber and disposed on the barrier, and the liquid that flows from the opening toward the outlet is not in contact with the opener. Chen instead teaches the opener being disposed inside the liquid storing member.
Abrams teaches a similar device involving a disposable liquid supply module including: a liquid storing member (#66 fig 6-10, #600 fig 26-28) that stores a liquid therein (par 0495 "liquid medication"); and an opener (#64 fig 6-8, 10, #600a fig 28) configured to form an opening on the liquid storing member (par 0495, see also liquid flowing out the opening in fig 7, 10 and 28), the opener is configured to be separated from the liquid storing member by being moved relative to the liquid storing member so as to form the opening on the liquid storing member (par 0499-0500, see also rotating arrow shown in fig 7, see fig 26-28, par 0519 discloses the opener 600a as being severed from the storing member 600 by blade 570 and then being moved relative to the container by paddle 572 to form the opening), and a container (#62 fig 6-7, 10, #511 fig 26-28) having a buffering chamber therein (see annotated fig 7 and 28 below) the container having a barrier (#62c fig 7, 10, #576 fig 26-28) arranged in the buffering chamber wherein the barrier is configured to divide the buffering chamber into a first chamber (see annotated fig 7 and 28 below) having the inlet and a second chamber (see annotated fig 7 and 28 below) having the outlet, and when the opener is separated from the liquid storing member and the opening of the liquid storing member is located in the first chamber by passing through the inlet, the opener is located in the first chamber and disposed on the barrier (see fig 7, 10 and 28), and the liquid that flows from the opening toward the outlet is not in contact with the opener (see fig 28).
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Abrams annotated fig 7
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Abrams annotated fig 28
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the puncturable seal opening of Chen with the break off tab opening mechanism of Abrams as doing so allows for the liquid storing member to be opened without the potential for the puncturable seal to obstruct the opening as Chen expresses can be an issue (see last few sentences of Chen par 0029) it would have been further obvious to utilize a follower paddle as disclosed in the embodiments of fig 26-28, or turn the device on its side to allow gravity to move the opener out of the fluid path as doing so insures that all liquid is able to drain out of the buffering chamber to be atomized (Abrams par 0519).
Regarding claim 7, modified Chen discloses the device of claim 6. Modified Chen further discloses the liquid storing member is inserted into the container (Chen: see fig 5-7 showing the top/opening of the liquid storing member being inserted in container 200, Abrams fig 7, 10 and 26-28), so that the opening is in spatial communication with the buffering chamber (Chen: see fig 5-7, Abrams: see fig 7, 10, 26-28).
Regarding claim 8, modified Chen discloses the device of claim 7. Abrams further discloses wherein the opener is configured to be separated from the liquid storing member by being retained in the inlet and being rotated relative to the liquid storing member (par 0499-0500, see also rotating arrow shown in fig 7).
Regarding claim 18, modified Chen discloses the device of claim 6. Abrams further discloses when the opener is separated from the liquid storing member and the opening of the liquid storing member is located in the first chamber, the opener is located at one lateral side of the opening, and the opening of the liquid storing member faces toward the barrier (see fig 28).
Regarding claim 19, modified Chen discloses the device of claim 6. Abrams further discloses when the opener is separated from the liquid storing member and the opening of the liquid storing member is located in the first chamber, the opener is located at one lateral side of the opening, and is not located between the opening and the barrier (see fig 28).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over modified Chen as applied to claim 6 above, and further in view of Byrnes (WO 2007/067855) and Lau (US 2001/0027301 A1).
Regarding claim 16, Chen discloses the device of claim 6. Chen does not expressly disclose a diameter of the opening is greater than 0 mm and is not greater than 8 mm, so that when no external force is exerted upon the liquid storing member, the liquid in the liquid storing member does not flow outside of the liquid storing member through the opening.
Byrnes teaches a similar aerosol generator (abstract) with a medicament storing member (#54 fig 12) having an opening formed thereon (#370 fig 13, par 0118 “outlet 370”) wherein the diameter of the opening is greater than 0 mm and is not greater than 8 mm (par 0118).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the opening of modified Chen be 0.5-2.5mm as taught by Byrnes as this range can accommodate various medicaments and their physical/chemical characteristics (Byrnes par 0118).
Lau teaches a liquid storing member (#20 fig 1, 3-4) storing a liquid therein (stored with #28 fig 1. 3-4, par 0019) with an opener (48 fig 1, 3) wherein the opening is sized such that when no external force is exerted upon the liquid storing member, the liquid in the liquid storing member does not flow outside of the liquid storing member through the opening (par 0030 discloses that dispensing of the liquid requires pressing the reservoir thus disclosing that the opening is sized to prevent liquid form being flowing out without an external force). Lau further discloses that the size of the opening can be adjusted dependent on the surface tension of the liquid and the desired droplet size (par 0033-0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date to adjust the size of the opening to allow for a specific droplet size to be produced when the liquid storing member is pressed as taught by Lau onto the device of modified Chen as doing so allows for a specific droplet size to be released into the buffer chamber when the storing member is pressed thus allowing a user to produce a single dose of medicament to be atomized at a time.
Response to Arguments
Applicant’s arguments with respect to claim 6 have been considered but are moot due to the 112(a) new matter rejection presented above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vogt CA 2745126 A1 discloses a vial breaker where the opener is disposed on a barrier
Loeffler US 2002/0134377 A1 discloses a liquid ampule with twist off tabs
Heyes US 7,029,465 B2 discloses a liquid ampule with a break off tab
Hetzer US 2009/0293868 A1 discloses a piercing opener
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.B.D./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785