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
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: AU-2021902425 filed on 08/05/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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.
Claim 19 is 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 19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. The claim should properly depend on claim 13 rather than claim 1 because of the limitation “breaking the separable portion”. Examiner will interpret the claim as dependent upon claim 13 rather than claim 1.
Claim Objections
Claim 13 is objected to because of the following informalities: “wherein the plurality of adjacent panels are foldable relative to the central panel about the fold lines and can be secured to the central penal to define external walls of a housing in the formed device” should read ““wherein the plurality of adjacent panels are foldable relative to the central panel about the fold lines and can be secured to the central penal to define external walls of the housing in the formed device” (emphasis added). Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Powell (US 8413651).
1. Powell discloses a medication inhalation device (c. 2: 30 – 35, as best illustrated in Fig. 5) comprising a housing (10) that is movable between a collapsed state and an expanded state (see general teaching c. 8: 21 – 23), wherein when the housing is in the expanded state the housing defines a volume in which medication delivered from a medication delivery device can mix with air (see Fig. 4, general teaching c. 9: 35-39), and wherein when the housing is in the expanded state the housing comprises: external walls that define the volume (5, 6, 120 and 130, see general teaching c. 8: 18 - 26), a first end with an inlet opening adapted to receive a medication from a medication deliver device for delivering the medication to the volume (examiner considers bottom 5 as the first end, but additionally notes that end 120 may serve as the first end, see general teaching in c. 10: 16 – 20), and a second end (130) with an outlet opening adapted to communicate with a mouth of a user such that a mixture of air and medication can be inhaled from the volume by the user (examiner considers the outlet opening as extending from the base of mask 800 to the rim of mask 800, as illustrated in Fig. 5; see c. 8: 48 – 53, see further explanation below), the second end being convertible between a mouthpiece configuration and a mask configuration, wherein, in the mouthpiece configuration, the mouth of the user can be placed in relation to the outlet opening so that the mixture of air and medication can be inhaled (examiner considers the second end mask configuration 800 as fully capable of being converted to a mouthpiece configuration upon cutting/separating the mask 800 at its base where it attaches to end 130; the cut end would then be fully capable of use as a mouthpiece held to the lips; the spacer material is able to be cut, e.g. with scissors, per c. 3: 4 - 22), and wherein, in the mask configuration, the outlet opening envelops the mouth and a nose of the user such that the second end forms a sealing relationship with the face of the user so that the mixture of air and medication can be inhaled (see c. 8: 52 – 53; see also general teaching Fig. 14).
Without admitting otherwise, examiner notes that it would have been obvious to modify the second end 130 in Fig. 5 with a mouthpiece such as 40 in Fig. 2b so as to provide the second end being convertible between the mouthpiece configuration 40 and mask configuration 800, wherein, in the mouthpiece configuration, the mouth of the user can be placed in relation to the outlet opening so that the mixture of air and medication can be inhaled. In Fig. 2b, as well as Figs. 9 - 10, Powell discloses that the mouthpiece 40/400 may be covered by a foldable separable cover in order to switch between mask and mouthpiece configurations, see c. 8: 41 – 52, c. 10: 21 – 44. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the base of foldable mask 800 in Fig. 5 of Powell to separably cover a mouthpiece opening 40/400, as taught in Fig. 2b and Fig. 9 of Powell, for the benefit of having the multiple modes of operation in a single modal outlet. Upon performing the modification as outlined under the alternative interpretation, the second end is convertible between the mouthpiece configuration 40/400 and the mask configuration 800, wherein, in the mouthpiece configuration, the mouth of the user can be placed in relation to the outlet opening so that the mixture of air and medication can be inhaled.
3. Powell discloses the medication inhalation device of claim 1, wherein in the collapsed state the housing has a substantially flat configuration (see general teaching in c. 3: 22 – 33).
12. Powell discloses the medication inhalation device of claim 1, wherein the housing is tapered between the first end and the second end (see various tapering in Fig. 5 such as curved tapering between ends 120 and 130, as well as tapering of mask 800).
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.
Claim(s) 4 – 8 and 10 – 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Sladek (US 20020129814).
4. Powell discloses the medication inhalation device of claim 1, but does not disclose wherein the housing comprises an internal wall which extends between the external walls to partition the volume into two chambers when in the expanded state, with the internal wall having an opening to allow fluid flow between the chambers. Sladek discloses the housing comprises an internal wall which extends between the external walls to partition the volume into two chambers when in the expanded state, with the internal wall having an opening to allow fluid flow between the chambers (see wall 56 with valve 12 defining volumes as illustrated in Fig. 3, [0057]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the spacer of Powell with the internal wall (and valve system) of Sladek for the benefit of reducing oropharyngeal deposition of the aerosol drug and by making synchronization of the MDI canister actuation with inhalation of the ejected medication less critical, see [0003].
5. Powell as modified by Sladek discloses the medication inhalation device of claim 4, wherein the housing has at least one one-way valve (see Sladek, [0052]).
6. Powell as modified by Sladek discloses the medication inhalation device of claim 4, wherein the housing has a one-way inhalation valve and a one-way exhalation valve (see Sladek, [0052]).
7. Powell as modified by Sladek discloses the medication inhalation device of claim 6, wherein the one-way inhalation valve is located on the internal wall and the one-way exhalation valve is located on an external wall (see 76 and 75 in Fig. 3 of Sladek).
8. Powell as modified by Sladek discloses the medication inhalation device of claim 6, wherein the one-way inhalation valve comprises a moveable flap (see [0074] in Sladek).
10. Powell discloses the medication inhalation device of claim 1, but does not disclose wherein the housing has a viewing window. Sladek discloses wherein the housing has a viewing window, see [0052], Fig. 1, window 8. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the housing of Powell with the viewing window of Sladek for the benefit of peering within and viewing the interior of the device, thus verifying proper function.
11. Powell discloses the medication inhalation device of claim 1, but does not explicitly disclose wherein the device is formed from a single unitary sheet of stock. Nonetheless, Sladek discloses wherein the device is formed from a single unitary sheet of stock, see [0052]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the housing of Powell according to the single sheet of Sladek for the benefit of reducing the number of parts, thus improving ease-of-assembly.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Sladek in view of Hyde (WO-2020198736).
9. Powell as modified discloses the medication inhalation device of claim 6, but does not disclose wherein the one-way inhalation valve is a flutter valve. Hyde discloses a similar spacer wherein the valves such as one-way inhalation valve includes a flutter valve (see p. 41: 18 – 27, the valve vibrates, and thus flutters). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the inhalation valve of Sladek according to the flutter valve of Hyde for the benefit of generating sound or tactile response verifying proper function of the device.
Allowable Subject Matter
Claims 13 and 15 – 19 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest all the features as claimed.
The following is an examiner’s statement of reasons for allowance:
Powell, the closest prior art of reference, fails to disclose a blank made from foldable board, wherein a separable portion can be separated from the formed device and increase a size of the second opening and form the mask configuration when the housing is in the expanded state of the formed device. Notably, while mask 800 may be separated from the spacer housing as described in the rejection above, separation from the expanded device decreases the size of the second opening.
Hyde and Sladek, referenced above, disclose a blank made from foldable board having a plurality of panels, wherein the expanded housing can deliver medication from a medication device to a second end, the second end having an opening forming a mouthpiece. See for example Figs. 7 and 12 of Sladek. While the second end mouthpiece is separable so as to increase the size of the second opening – for example, upon cutting the mouthpiece upstream of mouthpiece openings 72 – the separation would not cause a mask configuration able to envelope the mouth and nose of the user to form a sealing relationship with the user’s face so that medication can be inhaled from the volume. Notably, applicant’s housing is constructed with a tapered design allowing for increased volume at the separable portion so as to sufficiently envelope the nose and mouth upon separation, see Figs. 1 and 8.
As such, claims 13 and 15 – 19 patentably define over the closest prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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