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 .
Claim Objections
Claims 1, 3-4, and 8-10 are objected to because of the following informalities:
Claims 1 and 10 each omit “and” before the last items in their lists. Claim 1 at l. 2-3 and claim 10 at l. 3-4 should each recite “outer tube; and a bag having a sidewall”. Claim 10 at l. 12-13 should recite “the mouthpiece; and securing the inhalant”.
Claim 3 recites “wherein the in-use confirmation” which appears to be a typo of “wherein in the in-use configuration
Claim 4 recites “wherein the in-use configuration” which appears to be a typo of “wherein in the in-use configuration”.
Claim 8 recites “the inhalant agent” in the singular, but claim 7 previously introduced plural “inhalant agents”. The claims should be amended to consistently refer to either a singular agent or plural agents. The Examiner recommends amending claim 7 to recite “an inhalant agent[[s]]”.
Claim 9 recites “a metered amount of inhalant agents” which should refer back to “a metered amount of the inhalant agents” introduced in claim 7. The Examiner further recommends that if claim 7 is amended to recite a singular inhalant agent, claim 9 should be amended similarly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-10 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.
Claims 1 and 10 each recite “the continuous open end of the bag is semi-permanently affixed to the mouthpiece in an in-use configuration” (emphasis added). It is not clear what boundaries of claim scope are set forth by “semi-permanently” in this context, because the term “semi-permanently” suggests either partial permanence which is self-contradictory or situational permanence which lacks clear boundaries. The specification at [0007, 0024] merely repeats the language without further clarifying it. The claim language and the specification at [0024] and Fig. 3 suggest that the open end 1230 may be affixed to the mouthpiece 1100 and will remain fixed during use (i.e., while a user holds and inhales from the device 1000), but the attachment of the open end 1230 and mouthpiece 1100 may be physically reconfigured as desired, particularly between uses. For purposes of this office action, claims 1 and 10 are each interpreted as reciting “the continuous open end of the bag is removably
Claims 2-9 are rejected due to their dependency on claim 1.
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.
(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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Storz (US 2008/0029099 A1).
Regarding claim 1, Storz is directed to a valve balloon for inhalers and a valve mechanism therefor (Title, Abstract), which reads on an “inhalant containment device” as claimed:
The valve mechanism includes a valve housing 2 (“outer tube”) and a mouthpiece 5 (“inner tube”, forming the claimed “mouthpiece” together with the valve housing 2) ([0017, 0019], Figs. 4-5);
the valve mechanism includes the balloon 1 (“bag”) which has an open end to receive aerosol via a filling tube 4 ([0017], Fig. 1);
the mouthpiece 5 is fitted into the valve housing 2 ([0019], Figs. 4-5) which reads on “wherein the inner tube and outer tube are configured to concentrically align such that the inner tube is received within the outer tube” as claimed;
the mouthpiece 5 is removable from and insertable into the valve housing 2 and allows the valve to be opened ([0019, 0022], Figs. 1, 4-5), and the valve housing 2 is removably arranged in the balloon 1 [0020], which reads on “wherein the continuous open end of the bag is removably affixed to the mouthpiece in an in-use configuration such that the mouthpiece forms a channel to provide fluid communication between a distal end of the mouthpiece and the interior volume of the bag”.
PNG
media_image1.png
520
654
media_image1.png
Greyscale
Regarding claim 2, the mouthpiece 5 is removable from the valve housing 2 ([0019, 0022], Figs. 1, 4-5).
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.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Storz (US 2008/0029099 A1) in view of Arizer (Non-Patent Literature published Oct. 04, 2021 (date attained via Wayback Machine), available at https://www.swissvaporizer.ch/media/catalog/product/a/r/arizer-extreme-q-user-manual.pdf, copy attached herewith).
Storz is directed to a valve balloon for inhalers and a valve mechanism therefor (Title, Abstract). Storz discloses filling the valve balloon (Abstract), which reads on a “method of securing an inhalant within a bag, comprising: providing an inhalant containment device” as claimed:
The valve mechanism includes a valve housing 2 (“outer tube”) and a mouthpiece 5 (“inner tube”, forming the claimed “mouthpiece” together with the valve housing 2) ([0017, 0019], Figs. 4-5);
the valve mechanism includes the balloon 1 (“bag”) which has an open end to receive aerosol via a filling tube 4 ([0017], Fig. 1);
the mouthpiece 5 is fitted into the valve housing 2 ([0019], Figs. 4-5) which reads on “wherein the inner tube and outer tube are configured to concentrically align such that the inner tube is received within the outer tube” as claimed;
the mouthpiece 5 is removable from and insertable into the valve housing 2 and allows the valve to be opened ([0019, 0022], Figs. 1, 4-5), and the valve housing 2 is removably arranged in the balloon 1 [0020], which reads on “wherein the continuous open end of the bag is removably affixed to the mouthpiece in an in-use configuration such that the mouthpiece forms a channel to provide fluid communication between a distal end of the mouthpiece and the interior volume of the bag”;
However, Storz discloses filling the balloon 1 via a filling tube 4 and then subsequently installing the mouthpiece 5 to inhale ([0017, 0019], Figs. 1, 4-5), and thus Storz fails to explicitly disclose “filling the bag with the inhalant via the channel formed by the mouthpiece” (emphasis added);
Storz discloses a membrane 3 which automatically closes the valve ([0019], Fig. 5), which reads on “securing the inhalant within the bag by placing a cap over an opening of the mouthpiece”.
Arizer is a manual for the Extreme-Q Multi-purpose Hot Air Machine (Title). Arizer discloses a collection bag system wherein a user places a bag with a glass mouthpiece onto the machine, fills the bag, and then is able to inhale from the mouthpiece (p. 6 1st paragraph, see also image on p. 7 reproduced below). One of ordinary skill in the art would recognize that Storz’s valve balloon could be used similarly, that is, by filling Storz’s balloon 1 with the mouthpiece 5 installed instead of the filling tube 4 (which would read on the “filling” step as claimed), because Storz’s mouthpiece 5 is capable of opening the membrane 3 when pressed forward (Storz [0019], Fig. 4). This could advantageously simplify the filling and inhaling process by not requiring a user to switch out the filling tube 4 and mouthpiece 5.
PNG
media_image2.png
180
404
media_image2.png
Greyscale
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify Storz by filling the balloon 1 with the mouthpiece 5 installed (specifically, by filling with the mouthpiece 5 pushed forward to open the valve) rather than the filling tube 4, because both Storz and Arizer are directed to bags for storing inhalants, one of ordinary skill in the art would recognize that Storz’s balloon 1 could be filled similarly to Arizer’s which could advantageously simplify the filling, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Allowable Subject Matter
Claims 3-9 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.
Claims 3-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or suggest the limitations of dependent claim 3. Storz, Arizer, and Passarolla are the closest prior art of record. Storz is discussed above in the rejections of claims 1-2 and 10, Arizer is discussed in the rejection of claim 10, and Passarolla is discussed below in the citation of pertinent art.
Storz’s balloon 1 is not “folded over a distal end” of the valve housing 2 as recited in claim 3 (see Storz Fig. 4). Passarolla similarly fails to disclose its balloon being “folded over a distal end” of its balloon fixation ring and slipring (see 3rd-5th screenshots). Arizer discloses a bag folded over a first O-ring and positioned between the first O-ring and an inner glass tube (see p. 7, How to Assemble the Collection Bag), but such an O-ring does not read on an “outer tube” as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Passarolla (Non-Patent Literature published Jan. 15, 2022, available at https://www.youtube.com/watch?v=L1kUMNX7igM, description attached herewith) is a video and accompanying description directed to preparing vape balloons (Title). Passarolla discloses a balloon, an easy valve balloon adapter with mouthpiece, a balloon fixation ring, and a slipring (1st screenshot). In a first step, a tapered bottom of the balloon is inserted within the slipring and balloon fixation ring (2nd screenshot; p. 4 Step 1). Then, the valve balloon adapter is inserted within the tapered bottom of the balloon and adjusted as needed (3rd-5th screenshots; p. 4 Steps 2-4). Passarolla discloses that this allows a user to replace their vaporizer balloon (p. 4 first paragraph), which one of ordinary skill in the art would recognize is advantageous because such balloons may become dirty after repeated use.
Holyoake (US 2018/0085544 A1) is considered particularly relevant to claims 5-6. Holyoake is directed to a user interface and system for supplying gases to an airway. Gas is delivered to a patient from a transport gas supply via a secondary gas tube 280 ([1013], Fig. 67A). The secondary gas tube 280 is sealed by a one-sided valve or by a cap 288 [1014-1015]. The cap 288 is fitted onto the tube 280 to seal the end of the tube 280, and the cap 288 would be removed when the user wishes to connect it to the supply gas ([1015], Fig. 67F), the cap 288 being a hollow cylinder with a closed end as shown in Fig. 67F.
Storz II (US 6,513,524 B1) is considered particularly relevant to claim 8. Storz II is directed to an inhaler for production of aroma and/or vapors (Title). Storz II teaches tobacco as a suitable plant material to be vaporized and inhaled (Abstract). Using tobacco to produce aerosol is well-known.
Clements (US 2019/0125991 A1) is considered particularly relevant to claim 9. Clements is directed to a spacer device for an inhaler (Title). The device is for a metered-dose inhaler (Abstract), which is a well-known device for delivering a metered dose to a user [0002]. A full dose of an inhalant drug may be received within the bag and subsequently inhaled by a user [0059].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PATRICK MULLEN whose telephone number is (571)272-2373. The examiner can normally be reached M-F 10-7 ET.
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, Michael H. Wilson can be reached at (571) 270-3882. 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.
/MICHAEL PATRICK MULLEN/Examiner, Art Unit 1747
/ERIC YAARY/Examiner, Art Unit 1755